Anterior Cervical Interbody Fusion Using a Polyetheretherketone (PEEK) Cage Device and Local Autograft Bone

Article Type
Changed
Display Headline
Anterior Cervical Interbody Fusion Using a Polyetheretherketone (PEEK) Cage Device and Local Autograft Bone
In a population of patients with high rates of tobacco use, diabetes mellitus, obesity, and other factors that negatively affect fusion rates, local autograft may be a good choice for efficacy and cost savings.

Anterior cervical discectomy and fusion (ACDF) has been performed with various techniques and devices for many years. Autologous iliac crest grafts were initially used for the Cloward1,2 and Robinson and Smith3 techniques, but because of iliac crest graft site complications (eg, pain, infection, fracture, dystrophic scarring4,5), the procedure was generally superseded by allograft implants. These implants were then supplemented with anterior locking plate devices. More recently, unitary devices combining a polyetheretherketone (PEEK) spacer with screw or blade fixation have been developed, such as the Zero P (Synthes, Inc.) and the ROI-C cervical cage (LDR). Bone graft is required to fill the cavity of these devices and to promote osseous union. Demineralized bone matrix,6 tricalcium phosphate,7,8 and bone morphogenetic protein (BMP) have been used for these purposes, but they add expense to the procedure and have been associated with several complications (eg, neck swelling, dysphagia associated with BMP).9

Although multiple studies have demonstrated effective fusion rates and good outcomes for both iliac crest autograft and grafting/spacer constructs, the debate over cost and “added value” remains unresolved. One institution, which has published articles reviewing the spine literature and its own data, concluded that iliac crest autograft was the most cost-effective and consistently successful ACDF procedure.5,10

The VA Portland Health Care System (VAPORHCS) has analyzed the use of local autograft sources at the surgical site to circumvent the need to make a second incision at the iliac crest and, theoretically, to decrease risks and expenses associated with iliac crest autograft, allograft bone, and artificial constructs. Given the paucity of data on this method, the case series presented here represents one of a few studies that analyze local autograft for promotion of arthrodesis in a PEEK spacer device.

This article will report on the prospectively collected results of consecutive cases performed by Dr. Ross using a ROI-C cervical cage for 1-level anterior cervical discectomy between August 2011 and November 2014. This study received institutional review board approval.

Methods

Neck disability index (NDI) forms were used to assess the impact of neck pain on patients’ ability to manage in everyday life. The NDI form was completed before surgery and 3 and 9 months after surgery.

Dr. Ross preferred to perform minimally invasive posterior cervical foraminotomy for unilateral radiculopathy. Therefore, all patients with radiculopathy had bilateral symptoms or a symptomatic midline disc protrusion not accessible from a posterior approach. Standard techniques were used to make a left-side approach to the anterior cervical spine except in cases in which a previous right-side approach could be reused. Under the microscope, the anterior longitudinal ligament and annulus were incised, and the anterior contents of the disc space were removed with curettes and pituitary rongeurs. Care was taken to remove all cartilage from beneath the anterior inferior lip of the rostral vertebral body and to remove a few millimeters of the anterior longitudinal ligament from the rostral vertebral body without use of monopolar cautery (Figure 1). A 2 mm Kerrison punch then was used to remove the anterior inferior lip of the rostral vertebral body, and this bone was saved for grafting. No bone wax was used within the disc space.

After all disc space cartilage was removed from the endplates, additional bone was obtained from the uncovertebral joints and posterior vertebral bodies as the decompression proceeded posteriorly. Occasionally, distraction posts were used if the disc space was too narrow for optimal visualization posteriorly. After decompression was achieved, a lordotic ROI-C cervical cage was packed in its lumen with the bone chips and impacted into the disc space under fluoroscopic guidance. The blades were impacted under fluoroscopic guidance as well. The wound was closed with absorbable suture.

Antibiotics were given for no more than 24 hours after surgery. Ketorolac was used for analgesia the night of the surgery, and patients were asked to not use nonsteroidal anti-inflammatory drugs for 3 months after surgery. Lateral radiographs were obtained 3 and 9 months after surgery and every 6 months thereafter until arthrodesis was detected.

Results

Seventy-seven consecutive patients underwent 1-level anterior cervical discectomy (Table 1). Twenty-four procedures were performed for radiculopathy, 52 for myelopathy, and 1 for central cord injury sustained in a fall by a patient with preexisting spinal stenosis. Surgery was performed at C3-C4 (25 cases), C4-C5 (11 cases), C5-C6 (15 cases), and C6-C7 (1 case) for patients with myelopathy. Surgery was performed at C3-C4 (2 cases), C4-C5 (3 cases), C5-C6 (9 cases), and C6-C7 (10 cases) for patients with radiculopathy.

 

 

Twenty-eight patients reported presurgery tobacco use. Although all tobacco-using patients agreed to cease use in the perioperative period, at least 9 admitted to resuming tobacco use immediately after surgery. Eighteen patients had diabetes mellitus. In 2 patients, a diagnosis of osteoporosis was made with dual-energy X-ray absorptiometry. One patient was a chronic user of steroids before and after surgery. Mean body mass index (BMI) was 30.6, and 13 patients were morbidly obese (BMI > 34).

In 2 cases, only a single blade was placed. The second blade could not be placed because of broken adjacent screws (1 case) or undetermined reason (1 case).

The mean time for follow-up was 17 months (range 3-34). Four patients were lost to follow-up: 3 after the 1-month postoperative visit and 1 with severe psychiatric problems after hospital discharge.

There were no new neurologic deficits, no wound infections, and no recurrent laryngeal nerve palsies in the 77 patients. Eight months after surgery, 1 patient with radiculopathy underwent foraminotomy at the index level for persisting foraminal stenosis. Two patients whose myelopathic symptoms persisted after surgery returned for minimally invasive posterior laminotomy to remove infolded ligamentum flavum. The presurgery and 3- and 9-month postsurgery NDI scores were available for 52 patients (Table 2). Before surgery the mean NDI score was 24 (range 8-40). Three months postsurgery the mean NDI score was 15 (range 2-27) for patients with myelopathy and 13 (range 2-28) for patients with radiculopathy. The patient with the highest NDI score (28) stated that though all his symptoms were relieved, he had gauged his responses to protect his disability claim. Nine months after surgery, the mean NDI scores were 9.5 (range 5-17) for patients with myelopathy and 6 (range 2-13) for patients with radiculopathy. No NDI score was higher postsurgery than presurgery.

Arthrodesis was defined as bony bridging between the adjacent vertebral bodies and the bone graft within the lumen of the device, anterior to the device, or posterior to the device. In Dr. Ross’ protocol, computed tomography (CT) scans or flexion-extension radiographs were obtained only if pseudarthrosis was suspected to avoid unnecessary radiation exposure. Sixty-six patients had at least the 3-month radiography follow-up available. All 52 patients with 9-month follow-up data achieved complete arthrodesis, as determined by plain film radiography. Bridging ossification was found anterior to the device in all but 9 patients. Trabeculated bone was growing through the lumen of the device in all cases (Figure 2). A broken blade without clinical correlation was noted on imaging for 1 patient.

The total cost of the ROI-C cervical cage (LDR) for VAPORHCS was $3,498, or $1,749 for the PEEK spacer plus $1,749 for 2 metal blades. In comparison, the total cost of a typical anterior locking plate would have been $6,700, or $3,200 for the plate plus $2,000 for 4 screws and $1,500 for an allograft fibular spacer. Demineralized bone matrix (1 mL) as used in cervical arthrodesis by other surgeons at VAPORHCS cost $279, or about $500 including shipping.

DISCUSSION

Anterior cervical discectomy with fusion is a very common and successful surgical procedure for cervical myelopathy, radiculopathy, and degenerative disease that has failed to be corrected with conservative therapy.10 Medicare data documented a 206% increase in 1-level fusion procedures for degenerative spine pathology performed between 1992 and 2005.11 When a procedure is performed so often, it is appropriate to review methods and analyze efficacy, cost, and cost-effectiveness.

According to a 2007 meta-analysis, the fusion rates of 1-level ACDF arthrodesis at 1-year follow-up are 97.1% in patients treated with anterior plates and 92.1% in patients treated with noninstrumented fusion.12 The rate disparity was larger for multiple-level fusion: 50% to 82.5% for instrumented cases12,13 vs 3% to 42% for noninstrumented cases.14-16 Given the higher fusion rates achieved with instrumentation, surgeons have favored its use in ACDF.

Computed Tomography Use

Computed tomography has long been considered the gold standard for assessing arthrodesis outcomes (eg, Siambanes and Mather).17 However, recent data on potential harm caused by CT-related ionizing radiation suggest a need for caution with routine CT use.18,19 For cervical spine CT, Schonfeld and colleagues found that the risk for excess thyroid cancers ranged from 1 to 33 cases per 10,000 CT scans.20 According to another report, “limiting neck CT scanning to a higher risk group would increase the gap between benefit and harm, whereas performing CT routinely on low-risk cases approaches a point where its harm equals or exceeds its benefit.”19 As some have questioned even routinepostoperative use of radiation in patients with unremarkable clinical courses—patients should be spared unnecessary exposure—CT scans or flexion-extensionradiographs were obtained at VAPORHCS only if clinical symptoms or radiographs were suggestive of pseudarthrosis.21 As none of the VAPORHCS patients had those symptoms, none underwent postoperative CT.

 

 

For anterior cervical arthrodesis, surgeon preference determines which of many different bone substrates can be used with instrumentation, which impacts the costs. Fusion substrates include structural autografts, structural allografts, morselized autografts, morselized allografts, demineralized allografts, porous ceramics and metals, and BMP. Given these many options, studies comparing the constructs are lacking, especially with regard to the cost of alternative fusion constructs that produce similar outcomes. The Centers for Disease Control and Prevention defines cost-benefit analysis as a “type of economic evaluation that measures both costs and benefits (ie, negative and positive consequences) associated with an intervention in dollar terms.”22 It has been reported that using iliac crest autografts with anterior plate instrumentation is the most cost-effective method, yet alternatives remain in use.5,10

For ACDF, iliac crest bone is an ideal and widely used construct substrate. Structural grafts harvested from the crest provide significant stability due to their bicortical or tricortical configuration with interposed osteoinductive and osteogenic cancellous bone. Few graft complications (eg, graft resorption) and no immunogenic or infectious complications have been reported for iliac crest bone. However, autologous iliac crest increases operative time, and donor-site morbidity has been reported.23,24 A retrospective questionnaire-based investigation by Silber and colleagues, who evaluated iliac crest bone graft site morbidity in 1-level ACDF, found that 26.1% of patients had pain at the iliac crest harvest site, and 15.7% had numbness.24 Other complications, which occurred at lower rates, were bruising, hematoma, pelvic fracture, and poor cosmesis.23,25 In addition, osteoporosis and comorbid conditions have made it a challenge to acquire iliac crest autograft, contributing to the popularity of alternative substrates.25

Allografts

An alternative to autografts, allografts have the advantages of reduced operative time and reduced donor-site morbidity.26 Major historical concerns with allografts have included risk for disease transmission, costs associated with sterilization and serologic screening of grafts, and lack of oversight, leading to human allografts being acquired from dubious sources and ending up in the operating room.27,28 Two major types of allografts are available: mineralized and demineralized.

Arthrodesis rates are inferior for mineralized (structural) allografts with instrumentation than for autografts with instrumentation.29 In addition, smoking and other comorbidities have influenced fusion rates more in allograft than autograft fusions.30-33 However, allografts are being widely used because they avoid the donor-site morbidity associated with autografts and because they are load bearing, can provide structural stability and an osteoconductive matrix, and can be used off the shelf without adding much time to surgery.

Demineralized matrix substrates are commercial osteoconductive and osteoinductive biomaterials approved for filling bone gaps and extending graft when combined with autograft.7,8 Despite their osteoinductive properties, these substrates have had a high degree of product inconsistency, in some cases leading to poor outcomes.34 The lack of randomized studies with these constructs has made the determination of clear indications a challenge.

The initial enthusiasm over use of BMP, another bone-graft substitute for cervical fusion, was curtailed by reports of adverse events (AEs). Effective in anterior lumbar spine fusions, BMP was adapted to off-label use in the cervical spine a few years ago.35 Initial studies by Baskin and colleagues and Bishop and colleagues showed its fusion rates superior to those of allograft.31,32 Both studies reported no significant AEs. However, studies by Dickerman and colleagues and Smucker and colleagues demonstrated increased soft-tissue swelling leading to dysphagia and prolonged hospitalization, which were attributed to higher dosage (no study has identified a precise dose for individual patients).36,37 In addition, the cost of BMP is higher than that of any other bone-graft option for ACDF.3 Osteolysis has also been reported with BMP use.38-40 Carragee and colleagues highlighted the potential carcinogenicity of BMP, but this finding was not corroborated by Lad and colleagues.41,42

Cost Considerations

In addition to surgical effectiveness, spine surgical device costs have come under increased scrutiny.43-45 In 2012, plates were reported to cost (without overhead or profit margin to hospitals) between $1,015 and $3,601, and allograft spacers were estimated to cost between $1,220 and $3,640, cage costs ranged from $1,942 to $4,347, and PEEK spacers cost from $4,930 to $5,246.5 Individual surgeon instrumentation costs varied 10-fold based on the fusion constructs used.5

In a cost-effectiveness review of anterior cervical techniques, cage alone was the least expensive technique, disc arthroplasty or cage/plate/bone substitute groups were the next most expensive, and autograft alone was the most expensive option due to hip graft site morbidity.43 In another study, operative time associated with harvesting an iliac crest graft was equivalent in cost to that of an interbody cage.44 Other studies have compared the costs of various anterior cervical fusion constructs.9,10,45,46 A limitation of these studies is that autologous bone often refers to iliac crest grafts rather than local autograft. Epstein reviewed data from these studies and concluded, “ACDF using dynamic plates and autografts are the most cost effective treatment for anterior cervical discectomy,” citing a cost of $1,015 for this construct.5 Although Epstein demonstrated the cost-effectiveness of autograft in an individual surgeon’s hands, the results also are significant in that the studies identified areas in which improvements can be made at other institutions. The ROI-C cervical cage and local autograft bone cost that the authors report is at the lower end of the range reported by Epstein.5

 

 

Device explant rates also can be a concern. Operative waste was well described in a retrospective analysis of 87 ACDF procedures.47 The study found that the cost of explanting devices implanted during the same intraoperative period was equivalent to 9.2% of the cost of permanently implanted constructs. Epstein addressed operative waste by using educational modules to evaluate spine surgeons’ decision making before and after education. After the intervention, the institution noted a marked decline in costs related to explanted devices—from 20% in 2010 (before education) to 5.8% of the total cost of implanted devices in 2010 (after education).5

In the present study, the authors demonstrated that use of local morselized autograft with a PEEK spacer for 1-level ACDF had excellent arthrodesis rates and minimal complications. Of the 52 patients with 9 month postoperative data, all achieved arthrodesis regardless of tobacco use. This method compares favorably with other fusion options in terms of radiographic arthrodesis rates. In addition, it avoids the donor-site morbidity associated with autografts from an iliac site but maintains the benefits of the osteogenic, osteoconductive, and osteoinductive properties of autograft bone. Use of local autograft avoids the costs associated with iliac crest autograft, including increased operating and anesthesia time, additional operating room supplies (drapes, sutures, etc) needed for operating at a second site, and prolonged hospital stay due to pain at the donor site. Use of local autograft also obviates complications at a second surgical site; purchase, storage, and sterilization of allograft; and the neck swelling, possible carcinogenicity, and cost of purchase of BMP. Other than the occasional reuse of distraction posts, this method involves no other expensive explant supplies.

Autografts have osteogenic, osteoconductive, and osteoinductive properties, and autograft fusion rates are generally superior to allograft fusion rates. Bone morphogenetic protein fusion rates may be comparable to autograft fusion rates.9,26,32 Shortcomings of iliac crest autografts include increased operative time, blood loss, and donor-site morbidity. Allografts are osteoconductive and osteoinductive, but their fusion rates are inferior to those of iliac crest autografts. Other shortcomings are infection transmission and immunogenicity risks, higher graft resorption and collapse rates, cost, and previous issues relating to provenance. Bone morphogenetic protein is the most osteoinductive material with fusion rates similar to those of autograft, but its use is associated with neck swelling, dysphagia, osteolysis, potential carcinogenicity, and high cost.9

 

Conclusion

Overall, use of local autograft with a PEEK spacer has all the advantages of iliac crest autograft along with the benefit of working within the same operative window as the ACDF, thus reducing the infection, bleeding, and pain risks that may be encountered with a second incision. This procedure is effective, inexpensive, and cost-effective compared with alternatives and may be preferable for 1-level ACDF. In a population of patients with high rates of tobacco use, diabetes mellitus, obesity, and other factors that negatively affect fusion rates, local autograft may be a good choice for efficacy and cost savings.

Acknowledgments
The authors thank Shirley McCartney, PhD, for editorial assistance and Andy Rekito, MS, for illustrative assistance.

References

1. Cloward RB. The anterior approach for removal of ruptured cervical disks. 1958. J Neurosurg Spine. 2007;6(5):496-511.

2. Cloward RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958;15(6):602-617.

3. Robinson RA, Smith GW. Anterolateral cervical disc removal and interbody fusion for cervical disc syndrome. SAS J. 2010;4(1):34-35.

4. Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011;42(suppl 2):S3-S15.

5. Epstein NE. Iliac crest autograft versus alternative constructs for anterior cervical spine surgery: pros, cons, and costs. Surg Neurol Int. 2012;3(suppl 3):S143-S156.

6. Gruskin E, Doll BA, Futrell FW, Schmitz JP, Hollinger JO. Demineralized bone matrix in bone repair: history and use. Adv Drug Deliv Rev. 2012;64(12):1063-1077.

7. Becker S, Maissen O, Ponomarev I, Stoll T, Rahn B, Wilke I. Osteopromotion by a beta-tricalcium phosphate/bone marrow hybrid implant for use in spine surgery. Spine (Phila Pa 1976). 2006;31(1):11-17.

8. Muschik M, Ludwig R, Halbhübner S, Bursche K, Stoll T. Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: preliminary results of a prospective clinical study. Eur Spine J. 2001;10(suppl 2):S178-S184.

9. Buttermann GR. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion. Spine J. 2008;8(3):426-435.

10. Epstein NE. Efficacy and outcomes of dynamic-plated single-level anterior diskectomy/fusion with additional analysis of comparative costs. Surg Neurol Int. 2011;2:9.

11. Wang MC, Kreuter W, Wolfla CE, Maiman DJ, Deyo RA. Trends and variations in cervical spine surgery in the United States: Medicare beneficiaries, 1992 to 2005. Spine (Phila Pa 1976). 2009;34(9):955-961.

12. Fraser JF, Härtl R. Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J Neurosurg Spine. 2007;6(4):298-303.

13. Nirala AP, Husain M, Vatsal DK. A retrospective study of multiple interbody grafting and long segment strut grafting following multilevel anterior cervical decompression. Br J Neurosurg. 2004;18(3):227-232.

14. Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993;75(9):1298-1307.

15. Cauthen JC, Kinard RE, Vogler JB, et al. Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients. Spine (Phila Pa 1976). 1998;23(2):188-192.

16. Emery SE, Fisher JR, Bohlman HH. Three-level anterior cervical discectomy and fusion: radiographic and clinical results. Spine (Phila Pa 1976). 1997;22(22):2622-2624.

17. Siambanes D, Mather S. Comparison of plain radiographs and CT scans in instrumented posterior lumbar interbody fusion. Orthopedics. 1998;21(2):165-167.

18. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

19. Hikino K, Yamamoto LG. The benefit of neck computed tomography compared with its harm (risk of cancer). J Trauma Acute Care Surg. 2015;78(1):126-131.

20. Schonfeld SJ, Lee C, Berrington de González A. Medical exposure to radiation and thyroid cancer. Clin Oncol (R Coll Radiol). 2011;23(4):244-250.

21. Bartels RH, Beems T, Schutte PJ, Verbeek AL. The rationale of postoperative radiographs after cervical anterior discectomy with stand-alone cage for radicular pain. J Neurosurg Spine. 2010;12(3):275-279.

22. Centers for Disease Control and Prevention. The different types of health assessments. Centers for Disease Control and Prevention website. http://www.cdc.gov/healthyplaces/types_health_assessments.htm. Updated July 25, 2012. Accessed April 8, 2016.

23. Schnee CL, Freese A, Weil RJ, Marcotte PJ. Analysis of harvest morbidity and radiographic outcome using autograft for anterior cervical fusion. Spine (Phila Pa 1976). 1997;22(19):2222-2227.

24. Silber JS, Anderson DG, Daffner SD, et al. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2003;28(2):134-139.

25. Seiler JG 3rd, Johnson J. Iliac crest autogenous bone grafting: donor site complications. J South Orthop Assoc. 2000;9(2):91-97.

26. Floyd T, Ohnmeiss D. A meta-analysis of autograft versus allograft in anterior cervical fusion. Eur Spine J. 2000;9(5):398-403.

27. Delloye C, Cornu O, Druez V, Barbier O. Bone allografts: what they can offer and what they cannot. J Bone Joint Surg Br. 2007;89(5):574-579.

28. Armour S. Illegal trade in bodies shakes loved ones. USA Today. http://usatoday30.usatoday.com/money/2006-04-26-body-parts-cover-usat_x.htm. Updated April 28, 2006. Accessed April 6, 2016.

29. Wigfield CC, Nelson RJ. Nonautologous interbody fusion materials in cervical spine surgery: how strong is the evidence to justify their use? Spine (Phila Pa 1976). 2001;26(6):687-694.

30. Bärlocher CB, Barth A, Krauss JK, Binggeli R, Seiler RW. Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients. Neurosurg Focus. 2002;12(1):E4.

31. Baskin DS, Ryan P, Sonntag V, Westmark R, Widmayer MA. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. Spine (Phila Pa 1976). 2003;28(12):1219-1224.

32. Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using autogeneic and allogeneic bone graft substrate: a prospective comparative analysis. J Neurosurg. 1996;85(2):206-210.

33. Martin GJ Jr, Haid RW Jr, MacMillan M, Rodts GE Jr, Berkman R. Anterior cervical discectomy with freeze-dried fibula allograft. Overview of 317 cases and literature review. Spine (Phila Pa 1976). 1999;24(9):852-858.

34. Bae HW, Zhao L, Kanim LE, Wong P, Delamarter RB, Dawson EG. Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products. Spine (Phila Pa 1976). 2006;31(12):1299-1306.

35. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech. 2002;15(5):337-349.

36. Dickerman RD, Reynolds AS, Morgan BC, Tompkins J, Cattorini J, Bennett M. rh-BMP-2 can be used safely in the cervical spine: dose and containment are the keys! Spine J. 2007;7(4):508-509.

37. Smucker JD, Rhee JM, Singh K, Yoon ST, Heller JG. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine (Phila Pa 1976). 2006;31(24):2813-2819.

38. Vaidya R, Carp J, Sethi A, Bartol S, Craig J, Les CM. Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2. Eur Spine J. 2007;16(8):1257-1265.

39. Vaidya R, Sethi A, Bartol S, Jacobson M, Coe C, Craig JG. Complications in the use of rhBMP-2 in PEEK cages for interbody spinal fusions. J Spinal Disord Tech. 2008;21(8):557-562.

40. Knox JB, Dai JM 3rd, Orchowski J. Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2. Spine (Phila Pa 1976). 2011;36(8):672-676.

41. Carragee EJ, Chu G, Rohatgi R, et al. Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis. J Bone Joint Surg Am. 2013;95(17):1537-1545.

42. Lad SP, Bagley JH, Karikari IO, et al. Cancer after spinal fusion: the role of bone morphogenetic protein. Neurosurgery. 2013;73(3):440-449.

43. Bhadra AK, Raman AS, Casey AT, Crawford RJ. Single-level cervical radiculopathy: clinical outcome and cost-effectiveness of four techniques of anterior cervical discectomy and fusion and disc arthroplasty. Eur Spine J. 2009;18(2):232-237.

44. Castro FP Jr, Holt RT, Majd M, Whitecloud TS 3rd. A cost analysis of two anterior cervical fusion procedures. J Spinal Disord. 2000;13(6):511-514.

45. Kandziora F, Pflugmacher R, Scholz M, et al. Treatment of traumatic cervical spine instability with interbody fusion cages: a prospective controlled study with a 2-year follow-up. Injury. 2005;36(suppl 2):B27-B35.

46. Vaidya R, Weir R, Sethi A, Meisterling S, Hakeos W, Wybo CD. Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence. J Bone Joint Surg Br. 2007;89(3):342-345.

47. Epstein NE, Schwall GS, Hood DC. The incidence and cost of devices explanted during single-level anterior diskectomy/fusions. Surg Neurol Int. 2011;2:23.

Article PDF
Author and Disclosure Information

Dr. Ozpinar and Dr. Mendez were medical students in the School of Medicine at the Oregon Health & Science University in Portland at the time this article was written. Dr. Ross is an associate professor in the Department of Neurological Surgery at the Oregon Health & Science University. Dr. Ross is also a neurosurgeon at the VA Portland Health Care System in Portland.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Issue
Federal Practitioner - 33(5)
Publications
Topics
Page Number
12-18
Legacy Keywords
Alp Ozpinar MD, Gustavo Mendez MD, Donald A. Ross MD, cervical interbody fusion, polyetheretherketone cage device, local autograft bone, PEEK,
Sections
Author and Disclosure Information

Dr. Ozpinar and Dr. Mendez were medical students in the School of Medicine at the Oregon Health & Science University in Portland at the time this article was written. Dr. Ross is an associate professor in the Department of Neurological Surgery at the Oregon Health & Science University. Dr. Ross is also a neurosurgeon at the VA Portland Health Care System in Portland.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Dr. Ozpinar and Dr. Mendez were medical students in the School of Medicine at the Oregon Health & Science University in Portland at the time this article was written. Dr. Ross is an associate professor in the Department of Neurological Surgery at the Oregon Health & Science University. Dr. Ross is also a neurosurgeon at the VA Portland Health Care System in Portland.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Article PDF
Article PDF
Related Articles
In a population of patients with high rates of tobacco use, diabetes mellitus, obesity, and other factors that negatively affect fusion rates, local autograft may be a good choice for efficacy and cost savings.
In a population of patients with high rates of tobacco use, diabetes mellitus, obesity, and other factors that negatively affect fusion rates, local autograft may be a good choice for efficacy and cost savings.

Anterior cervical discectomy and fusion (ACDF) has been performed with various techniques and devices for many years. Autologous iliac crest grafts were initially used for the Cloward1,2 and Robinson and Smith3 techniques, but because of iliac crest graft site complications (eg, pain, infection, fracture, dystrophic scarring4,5), the procedure was generally superseded by allograft implants. These implants were then supplemented with anterior locking plate devices. More recently, unitary devices combining a polyetheretherketone (PEEK) spacer with screw or blade fixation have been developed, such as the Zero P (Synthes, Inc.) and the ROI-C cervical cage (LDR). Bone graft is required to fill the cavity of these devices and to promote osseous union. Demineralized bone matrix,6 tricalcium phosphate,7,8 and bone morphogenetic protein (BMP) have been used for these purposes, but they add expense to the procedure and have been associated with several complications (eg, neck swelling, dysphagia associated with BMP).9

Although multiple studies have demonstrated effective fusion rates and good outcomes for both iliac crest autograft and grafting/spacer constructs, the debate over cost and “added value” remains unresolved. One institution, which has published articles reviewing the spine literature and its own data, concluded that iliac crest autograft was the most cost-effective and consistently successful ACDF procedure.5,10

The VA Portland Health Care System (VAPORHCS) has analyzed the use of local autograft sources at the surgical site to circumvent the need to make a second incision at the iliac crest and, theoretically, to decrease risks and expenses associated with iliac crest autograft, allograft bone, and artificial constructs. Given the paucity of data on this method, the case series presented here represents one of a few studies that analyze local autograft for promotion of arthrodesis in a PEEK spacer device.

This article will report on the prospectively collected results of consecutive cases performed by Dr. Ross using a ROI-C cervical cage for 1-level anterior cervical discectomy between August 2011 and November 2014. This study received institutional review board approval.

Methods

Neck disability index (NDI) forms were used to assess the impact of neck pain on patients’ ability to manage in everyday life. The NDI form was completed before surgery and 3 and 9 months after surgery.

Dr. Ross preferred to perform minimally invasive posterior cervical foraminotomy for unilateral radiculopathy. Therefore, all patients with radiculopathy had bilateral symptoms or a symptomatic midline disc protrusion not accessible from a posterior approach. Standard techniques were used to make a left-side approach to the anterior cervical spine except in cases in which a previous right-side approach could be reused. Under the microscope, the anterior longitudinal ligament and annulus were incised, and the anterior contents of the disc space were removed with curettes and pituitary rongeurs. Care was taken to remove all cartilage from beneath the anterior inferior lip of the rostral vertebral body and to remove a few millimeters of the anterior longitudinal ligament from the rostral vertebral body without use of monopolar cautery (Figure 1). A 2 mm Kerrison punch then was used to remove the anterior inferior lip of the rostral vertebral body, and this bone was saved for grafting. No bone wax was used within the disc space.

After all disc space cartilage was removed from the endplates, additional bone was obtained from the uncovertebral joints and posterior vertebral bodies as the decompression proceeded posteriorly. Occasionally, distraction posts were used if the disc space was too narrow for optimal visualization posteriorly. After decompression was achieved, a lordotic ROI-C cervical cage was packed in its lumen with the bone chips and impacted into the disc space under fluoroscopic guidance. The blades were impacted under fluoroscopic guidance as well. The wound was closed with absorbable suture.

Antibiotics were given for no more than 24 hours after surgery. Ketorolac was used for analgesia the night of the surgery, and patients were asked to not use nonsteroidal anti-inflammatory drugs for 3 months after surgery. Lateral radiographs were obtained 3 and 9 months after surgery and every 6 months thereafter until arthrodesis was detected.

Results

Seventy-seven consecutive patients underwent 1-level anterior cervical discectomy (Table 1). Twenty-four procedures were performed for radiculopathy, 52 for myelopathy, and 1 for central cord injury sustained in a fall by a patient with preexisting spinal stenosis. Surgery was performed at C3-C4 (25 cases), C4-C5 (11 cases), C5-C6 (15 cases), and C6-C7 (1 case) for patients with myelopathy. Surgery was performed at C3-C4 (2 cases), C4-C5 (3 cases), C5-C6 (9 cases), and C6-C7 (10 cases) for patients with radiculopathy.

 

 

Twenty-eight patients reported presurgery tobacco use. Although all tobacco-using patients agreed to cease use in the perioperative period, at least 9 admitted to resuming tobacco use immediately after surgery. Eighteen patients had diabetes mellitus. In 2 patients, a diagnosis of osteoporosis was made with dual-energy X-ray absorptiometry. One patient was a chronic user of steroids before and after surgery. Mean body mass index (BMI) was 30.6, and 13 patients were morbidly obese (BMI > 34).

In 2 cases, only a single blade was placed. The second blade could not be placed because of broken adjacent screws (1 case) or undetermined reason (1 case).

The mean time for follow-up was 17 months (range 3-34). Four patients were lost to follow-up: 3 after the 1-month postoperative visit and 1 with severe psychiatric problems after hospital discharge.

There were no new neurologic deficits, no wound infections, and no recurrent laryngeal nerve palsies in the 77 patients. Eight months after surgery, 1 patient with radiculopathy underwent foraminotomy at the index level for persisting foraminal stenosis. Two patients whose myelopathic symptoms persisted after surgery returned for minimally invasive posterior laminotomy to remove infolded ligamentum flavum. The presurgery and 3- and 9-month postsurgery NDI scores were available for 52 patients (Table 2). Before surgery the mean NDI score was 24 (range 8-40). Three months postsurgery the mean NDI score was 15 (range 2-27) for patients with myelopathy and 13 (range 2-28) for patients with radiculopathy. The patient with the highest NDI score (28) stated that though all his symptoms were relieved, he had gauged his responses to protect his disability claim. Nine months after surgery, the mean NDI scores were 9.5 (range 5-17) for patients with myelopathy and 6 (range 2-13) for patients with radiculopathy. No NDI score was higher postsurgery than presurgery.

Arthrodesis was defined as bony bridging between the adjacent vertebral bodies and the bone graft within the lumen of the device, anterior to the device, or posterior to the device. In Dr. Ross’ protocol, computed tomography (CT) scans or flexion-extension radiographs were obtained only if pseudarthrosis was suspected to avoid unnecessary radiation exposure. Sixty-six patients had at least the 3-month radiography follow-up available. All 52 patients with 9-month follow-up data achieved complete arthrodesis, as determined by plain film radiography. Bridging ossification was found anterior to the device in all but 9 patients. Trabeculated bone was growing through the lumen of the device in all cases (Figure 2). A broken blade without clinical correlation was noted on imaging for 1 patient.

The total cost of the ROI-C cervical cage (LDR) for VAPORHCS was $3,498, or $1,749 for the PEEK spacer plus $1,749 for 2 metal blades. In comparison, the total cost of a typical anterior locking plate would have been $6,700, or $3,200 for the plate plus $2,000 for 4 screws and $1,500 for an allograft fibular spacer. Demineralized bone matrix (1 mL) as used in cervical arthrodesis by other surgeons at VAPORHCS cost $279, or about $500 including shipping.

DISCUSSION

Anterior cervical discectomy with fusion is a very common and successful surgical procedure for cervical myelopathy, radiculopathy, and degenerative disease that has failed to be corrected with conservative therapy.10 Medicare data documented a 206% increase in 1-level fusion procedures for degenerative spine pathology performed between 1992 and 2005.11 When a procedure is performed so often, it is appropriate to review methods and analyze efficacy, cost, and cost-effectiveness.

According to a 2007 meta-analysis, the fusion rates of 1-level ACDF arthrodesis at 1-year follow-up are 97.1% in patients treated with anterior plates and 92.1% in patients treated with noninstrumented fusion.12 The rate disparity was larger for multiple-level fusion: 50% to 82.5% for instrumented cases12,13 vs 3% to 42% for noninstrumented cases.14-16 Given the higher fusion rates achieved with instrumentation, surgeons have favored its use in ACDF.

Computed Tomography Use

Computed tomography has long been considered the gold standard for assessing arthrodesis outcomes (eg, Siambanes and Mather).17 However, recent data on potential harm caused by CT-related ionizing radiation suggest a need for caution with routine CT use.18,19 For cervical spine CT, Schonfeld and colleagues found that the risk for excess thyroid cancers ranged from 1 to 33 cases per 10,000 CT scans.20 According to another report, “limiting neck CT scanning to a higher risk group would increase the gap between benefit and harm, whereas performing CT routinely on low-risk cases approaches a point where its harm equals or exceeds its benefit.”19 As some have questioned even routinepostoperative use of radiation in patients with unremarkable clinical courses—patients should be spared unnecessary exposure—CT scans or flexion-extensionradiographs were obtained at VAPORHCS only if clinical symptoms or radiographs were suggestive of pseudarthrosis.21 As none of the VAPORHCS patients had those symptoms, none underwent postoperative CT.

 

 

For anterior cervical arthrodesis, surgeon preference determines which of many different bone substrates can be used with instrumentation, which impacts the costs. Fusion substrates include structural autografts, structural allografts, morselized autografts, morselized allografts, demineralized allografts, porous ceramics and metals, and BMP. Given these many options, studies comparing the constructs are lacking, especially with regard to the cost of alternative fusion constructs that produce similar outcomes. The Centers for Disease Control and Prevention defines cost-benefit analysis as a “type of economic evaluation that measures both costs and benefits (ie, negative and positive consequences) associated with an intervention in dollar terms.”22 It has been reported that using iliac crest autografts with anterior plate instrumentation is the most cost-effective method, yet alternatives remain in use.5,10

For ACDF, iliac crest bone is an ideal and widely used construct substrate. Structural grafts harvested from the crest provide significant stability due to their bicortical or tricortical configuration with interposed osteoinductive and osteogenic cancellous bone. Few graft complications (eg, graft resorption) and no immunogenic or infectious complications have been reported for iliac crest bone. However, autologous iliac crest increases operative time, and donor-site morbidity has been reported.23,24 A retrospective questionnaire-based investigation by Silber and colleagues, who evaluated iliac crest bone graft site morbidity in 1-level ACDF, found that 26.1% of patients had pain at the iliac crest harvest site, and 15.7% had numbness.24 Other complications, which occurred at lower rates, were bruising, hematoma, pelvic fracture, and poor cosmesis.23,25 In addition, osteoporosis and comorbid conditions have made it a challenge to acquire iliac crest autograft, contributing to the popularity of alternative substrates.25

Allografts

An alternative to autografts, allografts have the advantages of reduced operative time and reduced donor-site morbidity.26 Major historical concerns with allografts have included risk for disease transmission, costs associated with sterilization and serologic screening of grafts, and lack of oversight, leading to human allografts being acquired from dubious sources and ending up in the operating room.27,28 Two major types of allografts are available: mineralized and demineralized.

Arthrodesis rates are inferior for mineralized (structural) allografts with instrumentation than for autografts with instrumentation.29 In addition, smoking and other comorbidities have influenced fusion rates more in allograft than autograft fusions.30-33 However, allografts are being widely used because they avoid the donor-site morbidity associated with autografts and because they are load bearing, can provide structural stability and an osteoconductive matrix, and can be used off the shelf without adding much time to surgery.

Demineralized matrix substrates are commercial osteoconductive and osteoinductive biomaterials approved for filling bone gaps and extending graft when combined with autograft.7,8 Despite their osteoinductive properties, these substrates have had a high degree of product inconsistency, in some cases leading to poor outcomes.34 The lack of randomized studies with these constructs has made the determination of clear indications a challenge.

The initial enthusiasm over use of BMP, another bone-graft substitute for cervical fusion, was curtailed by reports of adverse events (AEs). Effective in anterior lumbar spine fusions, BMP was adapted to off-label use in the cervical spine a few years ago.35 Initial studies by Baskin and colleagues and Bishop and colleagues showed its fusion rates superior to those of allograft.31,32 Both studies reported no significant AEs. However, studies by Dickerman and colleagues and Smucker and colleagues demonstrated increased soft-tissue swelling leading to dysphagia and prolonged hospitalization, which were attributed to higher dosage (no study has identified a precise dose for individual patients).36,37 In addition, the cost of BMP is higher than that of any other bone-graft option for ACDF.3 Osteolysis has also been reported with BMP use.38-40 Carragee and colleagues highlighted the potential carcinogenicity of BMP, but this finding was not corroborated by Lad and colleagues.41,42

Cost Considerations

In addition to surgical effectiveness, spine surgical device costs have come under increased scrutiny.43-45 In 2012, plates were reported to cost (without overhead or profit margin to hospitals) between $1,015 and $3,601, and allograft spacers were estimated to cost between $1,220 and $3,640, cage costs ranged from $1,942 to $4,347, and PEEK spacers cost from $4,930 to $5,246.5 Individual surgeon instrumentation costs varied 10-fold based on the fusion constructs used.5

In a cost-effectiveness review of anterior cervical techniques, cage alone was the least expensive technique, disc arthroplasty or cage/plate/bone substitute groups were the next most expensive, and autograft alone was the most expensive option due to hip graft site morbidity.43 In another study, operative time associated with harvesting an iliac crest graft was equivalent in cost to that of an interbody cage.44 Other studies have compared the costs of various anterior cervical fusion constructs.9,10,45,46 A limitation of these studies is that autologous bone often refers to iliac crest grafts rather than local autograft. Epstein reviewed data from these studies and concluded, “ACDF using dynamic plates and autografts are the most cost effective treatment for anterior cervical discectomy,” citing a cost of $1,015 for this construct.5 Although Epstein demonstrated the cost-effectiveness of autograft in an individual surgeon’s hands, the results also are significant in that the studies identified areas in which improvements can be made at other institutions. The ROI-C cervical cage and local autograft bone cost that the authors report is at the lower end of the range reported by Epstein.5

 

 

Device explant rates also can be a concern. Operative waste was well described in a retrospective analysis of 87 ACDF procedures.47 The study found that the cost of explanting devices implanted during the same intraoperative period was equivalent to 9.2% of the cost of permanently implanted constructs. Epstein addressed operative waste by using educational modules to evaluate spine surgeons’ decision making before and after education. After the intervention, the institution noted a marked decline in costs related to explanted devices—from 20% in 2010 (before education) to 5.8% of the total cost of implanted devices in 2010 (after education).5

In the present study, the authors demonstrated that use of local morselized autograft with a PEEK spacer for 1-level ACDF had excellent arthrodesis rates and minimal complications. Of the 52 patients with 9 month postoperative data, all achieved arthrodesis regardless of tobacco use. This method compares favorably with other fusion options in terms of radiographic arthrodesis rates. In addition, it avoids the donor-site morbidity associated with autografts from an iliac site but maintains the benefits of the osteogenic, osteoconductive, and osteoinductive properties of autograft bone. Use of local autograft avoids the costs associated with iliac crest autograft, including increased operating and anesthesia time, additional operating room supplies (drapes, sutures, etc) needed for operating at a second site, and prolonged hospital stay due to pain at the donor site. Use of local autograft also obviates complications at a second surgical site; purchase, storage, and sterilization of allograft; and the neck swelling, possible carcinogenicity, and cost of purchase of BMP. Other than the occasional reuse of distraction posts, this method involves no other expensive explant supplies.

Autografts have osteogenic, osteoconductive, and osteoinductive properties, and autograft fusion rates are generally superior to allograft fusion rates. Bone morphogenetic protein fusion rates may be comparable to autograft fusion rates.9,26,32 Shortcomings of iliac crest autografts include increased operative time, blood loss, and donor-site morbidity. Allografts are osteoconductive and osteoinductive, but their fusion rates are inferior to those of iliac crest autografts. Other shortcomings are infection transmission and immunogenicity risks, higher graft resorption and collapse rates, cost, and previous issues relating to provenance. Bone morphogenetic protein is the most osteoinductive material with fusion rates similar to those of autograft, but its use is associated with neck swelling, dysphagia, osteolysis, potential carcinogenicity, and high cost.9

 

Conclusion

Overall, use of local autograft with a PEEK spacer has all the advantages of iliac crest autograft along with the benefit of working within the same operative window as the ACDF, thus reducing the infection, bleeding, and pain risks that may be encountered with a second incision. This procedure is effective, inexpensive, and cost-effective compared with alternatives and may be preferable for 1-level ACDF. In a population of patients with high rates of tobacco use, diabetes mellitus, obesity, and other factors that negatively affect fusion rates, local autograft may be a good choice for efficacy and cost savings.

Acknowledgments
The authors thank Shirley McCartney, PhD, for editorial assistance and Andy Rekito, MS, for illustrative assistance.

Anterior cervical discectomy and fusion (ACDF) has been performed with various techniques and devices for many years. Autologous iliac crest grafts were initially used for the Cloward1,2 and Robinson and Smith3 techniques, but because of iliac crest graft site complications (eg, pain, infection, fracture, dystrophic scarring4,5), the procedure was generally superseded by allograft implants. These implants were then supplemented with anterior locking plate devices. More recently, unitary devices combining a polyetheretherketone (PEEK) spacer with screw or blade fixation have been developed, such as the Zero P (Synthes, Inc.) and the ROI-C cervical cage (LDR). Bone graft is required to fill the cavity of these devices and to promote osseous union. Demineralized bone matrix,6 tricalcium phosphate,7,8 and bone morphogenetic protein (BMP) have been used for these purposes, but they add expense to the procedure and have been associated with several complications (eg, neck swelling, dysphagia associated with BMP).9

Although multiple studies have demonstrated effective fusion rates and good outcomes for both iliac crest autograft and grafting/spacer constructs, the debate over cost and “added value” remains unresolved. One institution, which has published articles reviewing the spine literature and its own data, concluded that iliac crest autograft was the most cost-effective and consistently successful ACDF procedure.5,10

The VA Portland Health Care System (VAPORHCS) has analyzed the use of local autograft sources at the surgical site to circumvent the need to make a second incision at the iliac crest and, theoretically, to decrease risks and expenses associated with iliac crest autograft, allograft bone, and artificial constructs. Given the paucity of data on this method, the case series presented here represents one of a few studies that analyze local autograft for promotion of arthrodesis in a PEEK spacer device.

This article will report on the prospectively collected results of consecutive cases performed by Dr. Ross using a ROI-C cervical cage for 1-level anterior cervical discectomy between August 2011 and November 2014. This study received institutional review board approval.

Methods

Neck disability index (NDI) forms were used to assess the impact of neck pain on patients’ ability to manage in everyday life. The NDI form was completed before surgery and 3 and 9 months after surgery.

Dr. Ross preferred to perform minimally invasive posterior cervical foraminotomy for unilateral radiculopathy. Therefore, all patients with radiculopathy had bilateral symptoms or a symptomatic midline disc protrusion not accessible from a posterior approach. Standard techniques were used to make a left-side approach to the anterior cervical spine except in cases in which a previous right-side approach could be reused. Under the microscope, the anterior longitudinal ligament and annulus were incised, and the anterior contents of the disc space were removed with curettes and pituitary rongeurs. Care was taken to remove all cartilage from beneath the anterior inferior lip of the rostral vertebral body and to remove a few millimeters of the anterior longitudinal ligament from the rostral vertebral body without use of monopolar cautery (Figure 1). A 2 mm Kerrison punch then was used to remove the anterior inferior lip of the rostral vertebral body, and this bone was saved for grafting. No bone wax was used within the disc space.

After all disc space cartilage was removed from the endplates, additional bone was obtained from the uncovertebral joints and posterior vertebral bodies as the decompression proceeded posteriorly. Occasionally, distraction posts were used if the disc space was too narrow for optimal visualization posteriorly. After decompression was achieved, a lordotic ROI-C cervical cage was packed in its lumen with the bone chips and impacted into the disc space under fluoroscopic guidance. The blades were impacted under fluoroscopic guidance as well. The wound was closed with absorbable suture.

Antibiotics were given for no more than 24 hours after surgery. Ketorolac was used for analgesia the night of the surgery, and patients were asked to not use nonsteroidal anti-inflammatory drugs for 3 months after surgery. Lateral radiographs were obtained 3 and 9 months after surgery and every 6 months thereafter until arthrodesis was detected.

Results

Seventy-seven consecutive patients underwent 1-level anterior cervical discectomy (Table 1). Twenty-four procedures were performed for radiculopathy, 52 for myelopathy, and 1 for central cord injury sustained in a fall by a patient with preexisting spinal stenosis. Surgery was performed at C3-C4 (25 cases), C4-C5 (11 cases), C5-C6 (15 cases), and C6-C7 (1 case) for patients with myelopathy. Surgery was performed at C3-C4 (2 cases), C4-C5 (3 cases), C5-C6 (9 cases), and C6-C7 (10 cases) for patients with radiculopathy.

 

 

Twenty-eight patients reported presurgery tobacco use. Although all tobacco-using patients agreed to cease use in the perioperative period, at least 9 admitted to resuming tobacco use immediately after surgery. Eighteen patients had diabetes mellitus. In 2 patients, a diagnosis of osteoporosis was made with dual-energy X-ray absorptiometry. One patient was a chronic user of steroids before and after surgery. Mean body mass index (BMI) was 30.6, and 13 patients were morbidly obese (BMI > 34).

In 2 cases, only a single blade was placed. The second blade could not be placed because of broken adjacent screws (1 case) or undetermined reason (1 case).

The mean time for follow-up was 17 months (range 3-34). Four patients were lost to follow-up: 3 after the 1-month postoperative visit and 1 with severe psychiatric problems after hospital discharge.

There were no new neurologic deficits, no wound infections, and no recurrent laryngeal nerve palsies in the 77 patients. Eight months after surgery, 1 patient with radiculopathy underwent foraminotomy at the index level for persisting foraminal stenosis. Two patients whose myelopathic symptoms persisted after surgery returned for minimally invasive posterior laminotomy to remove infolded ligamentum flavum. The presurgery and 3- and 9-month postsurgery NDI scores were available for 52 patients (Table 2). Before surgery the mean NDI score was 24 (range 8-40). Three months postsurgery the mean NDI score was 15 (range 2-27) for patients with myelopathy and 13 (range 2-28) for patients with radiculopathy. The patient with the highest NDI score (28) stated that though all his symptoms were relieved, he had gauged his responses to protect his disability claim. Nine months after surgery, the mean NDI scores were 9.5 (range 5-17) for patients with myelopathy and 6 (range 2-13) for patients with radiculopathy. No NDI score was higher postsurgery than presurgery.

Arthrodesis was defined as bony bridging between the adjacent vertebral bodies and the bone graft within the lumen of the device, anterior to the device, or posterior to the device. In Dr. Ross’ protocol, computed tomography (CT) scans or flexion-extension radiographs were obtained only if pseudarthrosis was suspected to avoid unnecessary radiation exposure. Sixty-six patients had at least the 3-month radiography follow-up available. All 52 patients with 9-month follow-up data achieved complete arthrodesis, as determined by plain film radiography. Bridging ossification was found anterior to the device in all but 9 patients. Trabeculated bone was growing through the lumen of the device in all cases (Figure 2). A broken blade without clinical correlation was noted on imaging for 1 patient.

The total cost of the ROI-C cervical cage (LDR) for VAPORHCS was $3,498, or $1,749 for the PEEK spacer plus $1,749 for 2 metal blades. In comparison, the total cost of a typical anterior locking plate would have been $6,700, or $3,200 for the plate plus $2,000 for 4 screws and $1,500 for an allograft fibular spacer. Demineralized bone matrix (1 mL) as used in cervical arthrodesis by other surgeons at VAPORHCS cost $279, or about $500 including shipping.

DISCUSSION

Anterior cervical discectomy with fusion is a very common and successful surgical procedure for cervical myelopathy, radiculopathy, and degenerative disease that has failed to be corrected with conservative therapy.10 Medicare data documented a 206% increase in 1-level fusion procedures for degenerative spine pathology performed between 1992 and 2005.11 When a procedure is performed so often, it is appropriate to review methods and analyze efficacy, cost, and cost-effectiveness.

According to a 2007 meta-analysis, the fusion rates of 1-level ACDF arthrodesis at 1-year follow-up are 97.1% in patients treated with anterior plates and 92.1% in patients treated with noninstrumented fusion.12 The rate disparity was larger for multiple-level fusion: 50% to 82.5% for instrumented cases12,13 vs 3% to 42% for noninstrumented cases.14-16 Given the higher fusion rates achieved with instrumentation, surgeons have favored its use in ACDF.

Computed Tomography Use

Computed tomography has long been considered the gold standard for assessing arthrodesis outcomes (eg, Siambanes and Mather).17 However, recent data on potential harm caused by CT-related ionizing radiation suggest a need for caution with routine CT use.18,19 For cervical spine CT, Schonfeld and colleagues found that the risk for excess thyroid cancers ranged from 1 to 33 cases per 10,000 CT scans.20 According to another report, “limiting neck CT scanning to a higher risk group would increase the gap between benefit and harm, whereas performing CT routinely on low-risk cases approaches a point where its harm equals or exceeds its benefit.”19 As some have questioned even routinepostoperative use of radiation in patients with unremarkable clinical courses—patients should be spared unnecessary exposure—CT scans or flexion-extensionradiographs were obtained at VAPORHCS only if clinical symptoms or radiographs were suggestive of pseudarthrosis.21 As none of the VAPORHCS patients had those symptoms, none underwent postoperative CT.

 

 

For anterior cervical arthrodesis, surgeon preference determines which of many different bone substrates can be used with instrumentation, which impacts the costs. Fusion substrates include structural autografts, structural allografts, morselized autografts, morselized allografts, demineralized allografts, porous ceramics and metals, and BMP. Given these many options, studies comparing the constructs are lacking, especially with regard to the cost of alternative fusion constructs that produce similar outcomes. The Centers for Disease Control and Prevention defines cost-benefit analysis as a “type of economic evaluation that measures both costs and benefits (ie, negative and positive consequences) associated with an intervention in dollar terms.”22 It has been reported that using iliac crest autografts with anterior plate instrumentation is the most cost-effective method, yet alternatives remain in use.5,10

For ACDF, iliac crest bone is an ideal and widely used construct substrate. Structural grafts harvested from the crest provide significant stability due to their bicortical or tricortical configuration with interposed osteoinductive and osteogenic cancellous bone. Few graft complications (eg, graft resorption) and no immunogenic or infectious complications have been reported for iliac crest bone. However, autologous iliac crest increases operative time, and donor-site morbidity has been reported.23,24 A retrospective questionnaire-based investigation by Silber and colleagues, who evaluated iliac crest bone graft site morbidity in 1-level ACDF, found that 26.1% of patients had pain at the iliac crest harvest site, and 15.7% had numbness.24 Other complications, which occurred at lower rates, were bruising, hematoma, pelvic fracture, and poor cosmesis.23,25 In addition, osteoporosis and comorbid conditions have made it a challenge to acquire iliac crest autograft, contributing to the popularity of alternative substrates.25

Allografts

An alternative to autografts, allografts have the advantages of reduced operative time and reduced donor-site morbidity.26 Major historical concerns with allografts have included risk for disease transmission, costs associated with sterilization and serologic screening of grafts, and lack of oversight, leading to human allografts being acquired from dubious sources and ending up in the operating room.27,28 Two major types of allografts are available: mineralized and demineralized.

Arthrodesis rates are inferior for mineralized (structural) allografts with instrumentation than for autografts with instrumentation.29 In addition, smoking and other comorbidities have influenced fusion rates more in allograft than autograft fusions.30-33 However, allografts are being widely used because they avoid the donor-site morbidity associated with autografts and because they are load bearing, can provide structural stability and an osteoconductive matrix, and can be used off the shelf without adding much time to surgery.

Demineralized matrix substrates are commercial osteoconductive and osteoinductive biomaterials approved for filling bone gaps and extending graft when combined with autograft.7,8 Despite their osteoinductive properties, these substrates have had a high degree of product inconsistency, in some cases leading to poor outcomes.34 The lack of randomized studies with these constructs has made the determination of clear indications a challenge.

The initial enthusiasm over use of BMP, another bone-graft substitute for cervical fusion, was curtailed by reports of adverse events (AEs). Effective in anterior lumbar spine fusions, BMP was adapted to off-label use in the cervical spine a few years ago.35 Initial studies by Baskin and colleagues and Bishop and colleagues showed its fusion rates superior to those of allograft.31,32 Both studies reported no significant AEs. However, studies by Dickerman and colleagues and Smucker and colleagues demonstrated increased soft-tissue swelling leading to dysphagia and prolonged hospitalization, which were attributed to higher dosage (no study has identified a precise dose for individual patients).36,37 In addition, the cost of BMP is higher than that of any other bone-graft option for ACDF.3 Osteolysis has also been reported with BMP use.38-40 Carragee and colleagues highlighted the potential carcinogenicity of BMP, but this finding was not corroborated by Lad and colleagues.41,42

Cost Considerations

In addition to surgical effectiveness, spine surgical device costs have come under increased scrutiny.43-45 In 2012, plates were reported to cost (without overhead or profit margin to hospitals) between $1,015 and $3,601, and allograft spacers were estimated to cost between $1,220 and $3,640, cage costs ranged from $1,942 to $4,347, and PEEK spacers cost from $4,930 to $5,246.5 Individual surgeon instrumentation costs varied 10-fold based on the fusion constructs used.5

In a cost-effectiveness review of anterior cervical techniques, cage alone was the least expensive technique, disc arthroplasty or cage/plate/bone substitute groups were the next most expensive, and autograft alone was the most expensive option due to hip graft site morbidity.43 In another study, operative time associated with harvesting an iliac crest graft was equivalent in cost to that of an interbody cage.44 Other studies have compared the costs of various anterior cervical fusion constructs.9,10,45,46 A limitation of these studies is that autologous bone often refers to iliac crest grafts rather than local autograft. Epstein reviewed data from these studies and concluded, “ACDF using dynamic plates and autografts are the most cost effective treatment for anterior cervical discectomy,” citing a cost of $1,015 for this construct.5 Although Epstein demonstrated the cost-effectiveness of autograft in an individual surgeon’s hands, the results also are significant in that the studies identified areas in which improvements can be made at other institutions. The ROI-C cervical cage and local autograft bone cost that the authors report is at the lower end of the range reported by Epstein.5

 

 

Device explant rates also can be a concern. Operative waste was well described in a retrospective analysis of 87 ACDF procedures.47 The study found that the cost of explanting devices implanted during the same intraoperative period was equivalent to 9.2% of the cost of permanently implanted constructs. Epstein addressed operative waste by using educational modules to evaluate spine surgeons’ decision making before and after education. After the intervention, the institution noted a marked decline in costs related to explanted devices—from 20% in 2010 (before education) to 5.8% of the total cost of implanted devices in 2010 (after education).5

In the present study, the authors demonstrated that use of local morselized autograft with a PEEK spacer for 1-level ACDF had excellent arthrodesis rates and minimal complications. Of the 52 patients with 9 month postoperative data, all achieved arthrodesis regardless of tobacco use. This method compares favorably with other fusion options in terms of radiographic arthrodesis rates. In addition, it avoids the donor-site morbidity associated with autografts from an iliac site but maintains the benefits of the osteogenic, osteoconductive, and osteoinductive properties of autograft bone. Use of local autograft avoids the costs associated with iliac crest autograft, including increased operating and anesthesia time, additional operating room supplies (drapes, sutures, etc) needed for operating at a second site, and prolonged hospital stay due to pain at the donor site. Use of local autograft also obviates complications at a second surgical site; purchase, storage, and sterilization of allograft; and the neck swelling, possible carcinogenicity, and cost of purchase of BMP. Other than the occasional reuse of distraction posts, this method involves no other expensive explant supplies.

Autografts have osteogenic, osteoconductive, and osteoinductive properties, and autograft fusion rates are generally superior to allograft fusion rates. Bone morphogenetic protein fusion rates may be comparable to autograft fusion rates.9,26,32 Shortcomings of iliac crest autografts include increased operative time, blood loss, and donor-site morbidity. Allografts are osteoconductive and osteoinductive, but their fusion rates are inferior to those of iliac crest autografts. Other shortcomings are infection transmission and immunogenicity risks, higher graft resorption and collapse rates, cost, and previous issues relating to provenance. Bone morphogenetic protein is the most osteoinductive material with fusion rates similar to those of autograft, but its use is associated with neck swelling, dysphagia, osteolysis, potential carcinogenicity, and high cost.9

 

Conclusion

Overall, use of local autograft with a PEEK spacer has all the advantages of iliac crest autograft along with the benefit of working within the same operative window as the ACDF, thus reducing the infection, bleeding, and pain risks that may be encountered with a second incision. This procedure is effective, inexpensive, and cost-effective compared with alternatives and may be preferable for 1-level ACDF. In a population of patients with high rates of tobacco use, diabetes mellitus, obesity, and other factors that negatively affect fusion rates, local autograft may be a good choice for efficacy and cost savings.

Acknowledgments
The authors thank Shirley McCartney, PhD, for editorial assistance and Andy Rekito, MS, for illustrative assistance.

References

1. Cloward RB. The anterior approach for removal of ruptured cervical disks. 1958. J Neurosurg Spine. 2007;6(5):496-511.

2. Cloward RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958;15(6):602-617.

3. Robinson RA, Smith GW. Anterolateral cervical disc removal and interbody fusion for cervical disc syndrome. SAS J. 2010;4(1):34-35.

4. Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011;42(suppl 2):S3-S15.

5. Epstein NE. Iliac crest autograft versus alternative constructs for anterior cervical spine surgery: pros, cons, and costs. Surg Neurol Int. 2012;3(suppl 3):S143-S156.

6. Gruskin E, Doll BA, Futrell FW, Schmitz JP, Hollinger JO. Demineralized bone matrix in bone repair: history and use. Adv Drug Deliv Rev. 2012;64(12):1063-1077.

7. Becker S, Maissen O, Ponomarev I, Stoll T, Rahn B, Wilke I. Osteopromotion by a beta-tricalcium phosphate/bone marrow hybrid implant for use in spine surgery. Spine (Phila Pa 1976). 2006;31(1):11-17.

8. Muschik M, Ludwig R, Halbhübner S, Bursche K, Stoll T. Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: preliminary results of a prospective clinical study. Eur Spine J. 2001;10(suppl 2):S178-S184.

9. Buttermann GR. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion. Spine J. 2008;8(3):426-435.

10. Epstein NE. Efficacy and outcomes of dynamic-plated single-level anterior diskectomy/fusion with additional analysis of comparative costs. Surg Neurol Int. 2011;2:9.

11. Wang MC, Kreuter W, Wolfla CE, Maiman DJ, Deyo RA. Trends and variations in cervical spine surgery in the United States: Medicare beneficiaries, 1992 to 2005. Spine (Phila Pa 1976). 2009;34(9):955-961.

12. Fraser JF, Härtl R. Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J Neurosurg Spine. 2007;6(4):298-303.

13. Nirala AP, Husain M, Vatsal DK. A retrospective study of multiple interbody grafting and long segment strut grafting following multilevel anterior cervical decompression. Br J Neurosurg. 2004;18(3):227-232.

14. Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993;75(9):1298-1307.

15. Cauthen JC, Kinard RE, Vogler JB, et al. Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients. Spine (Phila Pa 1976). 1998;23(2):188-192.

16. Emery SE, Fisher JR, Bohlman HH. Three-level anterior cervical discectomy and fusion: radiographic and clinical results. Spine (Phila Pa 1976). 1997;22(22):2622-2624.

17. Siambanes D, Mather S. Comparison of plain radiographs and CT scans in instrumented posterior lumbar interbody fusion. Orthopedics. 1998;21(2):165-167.

18. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

19. Hikino K, Yamamoto LG. The benefit of neck computed tomography compared with its harm (risk of cancer). J Trauma Acute Care Surg. 2015;78(1):126-131.

20. Schonfeld SJ, Lee C, Berrington de González A. Medical exposure to radiation and thyroid cancer. Clin Oncol (R Coll Radiol). 2011;23(4):244-250.

21. Bartels RH, Beems T, Schutte PJ, Verbeek AL. The rationale of postoperative radiographs after cervical anterior discectomy with stand-alone cage for radicular pain. J Neurosurg Spine. 2010;12(3):275-279.

22. Centers for Disease Control and Prevention. The different types of health assessments. Centers for Disease Control and Prevention website. http://www.cdc.gov/healthyplaces/types_health_assessments.htm. Updated July 25, 2012. Accessed April 8, 2016.

23. Schnee CL, Freese A, Weil RJ, Marcotte PJ. Analysis of harvest morbidity and radiographic outcome using autograft for anterior cervical fusion. Spine (Phila Pa 1976). 1997;22(19):2222-2227.

24. Silber JS, Anderson DG, Daffner SD, et al. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2003;28(2):134-139.

25. Seiler JG 3rd, Johnson J. Iliac crest autogenous bone grafting: donor site complications. J South Orthop Assoc. 2000;9(2):91-97.

26. Floyd T, Ohnmeiss D. A meta-analysis of autograft versus allograft in anterior cervical fusion. Eur Spine J. 2000;9(5):398-403.

27. Delloye C, Cornu O, Druez V, Barbier O. Bone allografts: what they can offer and what they cannot. J Bone Joint Surg Br. 2007;89(5):574-579.

28. Armour S. Illegal trade in bodies shakes loved ones. USA Today. http://usatoday30.usatoday.com/money/2006-04-26-body-parts-cover-usat_x.htm. Updated April 28, 2006. Accessed April 6, 2016.

29. Wigfield CC, Nelson RJ. Nonautologous interbody fusion materials in cervical spine surgery: how strong is the evidence to justify their use? Spine (Phila Pa 1976). 2001;26(6):687-694.

30. Bärlocher CB, Barth A, Krauss JK, Binggeli R, Seiler RW. Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients. Neurosurg Focus. 2002;12(1):E4.

31. Baskin DS, Ryan P, Sonntag V, Westmark R, Widmayer MA. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. Spine (Phila Pa 1976). 2003;28(12):1219-1224.

32. Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using autogeneic and allogeneic bone graft substrate: a prospective comparative analysis. J Neurosurg. 1996;85(2):206-210.

33. Martin GJ Jr, Haid RW Jr, MacMillan M, Rodts GE Jr, Berkman R. Anterior cervical discectomy with freeze-dried fibula allograft. Overview of 317 cases and literature review. Spine (Phila Pa 1976). 1999;24(9):852-858.

34. Bae HW, Zhao L, Kanim LE, Wong P, Delamarter RB, Dawson EG. Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products. Spine (Phila Pa 1976). 2006;31(12):1299-1306.

35. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech. 2002;15(5):337-349.

36. Dickerman RD, Reynolds AS, Morgan BC, Tompkins J, Cattorini J, Bennett M. rh-BMP-2 can be used safely in the cervical spine: dose and containment are the keys! Spine J. 2007;7(4):508-509.

37. Smucker JD, Rhee JM, Singh K, Yoon ST, Heller JG. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine (Phila Pa 1976). 2006;31(24):2813-2819.

38. Vaidya R, Carp J, Sethi A, Bartol S, Craig J, Les CM. Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2. Eur Spine J. 2007;16(8):1257-1265.

39. Vaidya R, Sethi A, Bartol S, Jacobson M, Coe C, Craig JG. Complications in the use of rhBMP-2 in PEEK cages for interbody spinal fusions. J Spinal Disord Tech. 2008;21(8):557-562.

40. Knox JB, Dai JM 3rd, Orchowski J. Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2. Spine (Phila Pa 1976). 2011;36(8):672-676.

41. Carragee EJ, Chu G, Rohatgi R, et al. Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis. J Bone Joint Surg Am. 2013;95(17):1537-1545.

42. Lad SP, Bagley JH, Karikari IO, et al. Cancer after spinal fusion: the role of bone morphogenetic protein. Neurosurgery. 2013;73(3):440-449.

43. Bhadra AK, Raman AS, Casey AT, Crawford RJ. Single-level cervical radiculopathy: clinical outcome and cost-effectiveness of four techniques of anterior cervical discectomy and fusion and disc arthroplasty. Eur Spine J. 2009;18(2):232-237.

44. Castro FP Jr, Holt RT, Majd M, Whitecloud TS 3rd. A cost analysis of two anterior cervical fusion procedures. J Spinal Disord. 2000;13(6):511-514.

45. Kandziora F, Pflugmacher R, Scholz M, et al. Treatment of traumatic cervical spine instability with interbody fusion cages: a prospective controlled study with a 2-year follow-up. Injury. 2005;36(suppl 2):B27-B35.

46. Vaidya R, Weir R, Sethi A, Meisterling S, Hakeos W, Wybo CD. Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence. J Bone Joint Surg Br. 2007;89(3):342-345.

47. Epstein NE, Schwall GS, Hood DC. The incidence and cost of devices explanted during single-level anterior diskectomy/fusions. Surg Neurol Int. 2011;2:23.

References

1. Cloward RB. The anterior approach for removal of ruptured cervical disks. 1958. J Neurosurg Spine. 2007;6(5):496-511.

2. Cloward RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958;15(6):602-617.

3. Robinson RA, Smith GW. Anterolateral cervical disc removal and interbody fusion for cervical disc syndrome. SAS J. 2010;4(1):34-35.

4. Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011;42(suppl 2):S3-S15.

5. Epstein NE. Iliac crest autograft versus alternative constructs for anterior cervical spine surgery: pros, cons, and costs. Surg Neurol Int. 2012;3(suppl 3):S143-S156.

6. Gruskin E, Doll BA, Futrell FW, Schmitz JP, Hollinger JO. Demineralized bone matrix in bone repair: history and use. Adv Drug Deliv Rev. 2012;64(12):1063-1077.

7. Becker S, Maissen O, Ponomarev I, Stoll T, Rahn B, Wilke I. Osteopromotion by a beta-tricalcium phosphate/bone marrow hybrid implant for use in spine surgery. Spine (Phila Pa 1976). 2006;31(1):11-17.

8. Muschik M, Ludwig R, Halbhübner S, Bursche K, Stoll T. Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: preliminary results of a prospective clinical study. Eur Spine J. 2001;10(suppl 2):S178-S184.

9. Buttermann GR. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion. Spine J. 2008;8(3):426-435.

10. Epstein NE. Efficacy and outcomes of dynamic-plated single-level anterior diskectomy/fusion with additional analysis of comparative costs. Surg Neurol Int. 2011;2:9.

11. Wang MC, Kreuter W, Wolfla CE, Maiman DJ, Deyo RA. Trends and variations in cervical spine surgery in the United States: Medicare beneficiaries, 1992 to 2005. Spine (Phila Pa 1976). 2009;34(9):955-961.

12. Fraser JF, Härtl R. Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J Neurosurg Spine. 2007;6(4):298-303.

13. Nirala AP, Husain M, Vatsal DK. A retrospective study of multiple interbody grafting and long segment strut grafting following multilevel anterior cervical decompression. Br J Neurosurg. 2004;18(3):227-232.

14. Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993;75(9):1298-1307.

15. Cauthen JC, Kinard RE, Vogler JB, et al. Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients. Spine (Phila Pa 1976). 1998;23(2):188-192.

16. Emery SE, Fisher JR, Bohlman HH. Three-level anterior cervical discectomy and fusion: radiographic and clinical results. Spine (Phila Pa 1976). 1997;22(22):2622-2624.

17. Siambanes D, Mather S. Comparison of plain radiographs and CT scans in instrumented posterior lumbar interbody fusion. Orthopedics. 1998;21(2):165-167.

18. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

19. Hikino K, Yamamoto LG. The benefit of neck computed tomography compared with its harm (risk of cancer). J Trauma Acute Care Surg. 2015;78(1):126-131.

20. Schonfeld SJ, Lee C, Berrington de González A. Medical exposure to radiation and thyroid cancer. Clin Oncol (R Coll Radiol). 2011;23(4):244-250.

21. Bartels RH, Beems T, Schutte PJ, Verbeek AL. The rationale of postoperative radiographs after cervical anterior discectomy with stand-alone cage for radicular pain. J Neurosurg Spine. 2010;12(3):275-279.

22. Centers for Disease Control and Prevention. The different types of health assessments. Centers for Disease Control and Prevention website. http://www.cdc.gov/healthyplaces/types_health_assessments.htm. Updated July 25, 2012. Accessed April 8, 2016.

23. Schnee CL, Freese A, Weil RJ, Marcotte PJ. Analysis of harvest morbidity and radiographic outcome using autograft for anterior cervical fusion. Spine (Phila Pa 1976). 1997;22(19):2222-2227.

24. Silber JS, Anderson DG, Daffner SD, et al. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2003;28(2):134-139.

25. Seiler JG 3rd, Johnson J. Iliac crest autogenous bone grafting: donor site complications. J South Orthop Assoc. 2000;9(2):91-97.

26. Floyd T, Ohnmeiss D. A meta-analysis of autograft versus allograft in anterior cervical fusion. Eur Spine J. 2000;9(5):398-403.

27. Delloye C, Cornu O, Druez V, Barbier O. Bone allografts: what they can offer and what they cannot. J Bone Joint Surg Br. 2007;89(5):574-579.

28. Armour S. Illegal trade in bodies shakes loved ones. USA Today. http://usatoday30.usatoday.com/money/2006-04-26-body-parts-cover-usat_x.htm. Updated April 28, 2006. Accessed April 6, 2016.

29. Wigfield CC, Nelson RJ. Nonautologous interbody fusion materials in cervical spine surgery: how strong is the evidence to justify their use? Spine (Phila Pa 1976). 2001;26(6):687-694.

30. Bärlocher CB, Barth A, Krauss JK, Binggeli R, Seiler RW. Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients. Neurosurg Focus. 2002;12(1):E4.

31. Baskin DS, Ryan P, Sonntag V, Westmark R, Widmayer MA. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. Spine (Phila Pa 1976). 2003;28(12):1219-1224.

32. Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using autogeneic and allogeneic bone graft substrate: a prospective comparative analysis. J Neurosurg. 1996;85(2):206-210.

33. Martin GJ Jr, Haid RW Jr, MacMillan M, Rodts GE Jr, Berkman R. Anterior cervical discectomy with freeze-dried fibula allograft. Overview of 317 cases and literature review. Spine (Phila Pa 1976). 1999;24(9):852-858.

34. Bae HW, Zhao L, Kanim LE, Wong P, Delamarter RB, Dawson EG. Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products. Spine (Phila Pa 1976). 2006;31(12):1299-1306.

35. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech. 2002;15(5):337-349.

36. Dickerman RD, Reynolds AS, Morgan BC, Tompkins J, Cattorini J, Bennett M. rh-BMP-2 can be used safely in the cervical spine: dose and containment are the keys! Spine J. 2007;7(4):508-509.

37. Smucker JD, Rhee JM, Singh K, Yoon ST, Heller JG. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine (Phila Pa 1976). 2006;31(24):2813-2819.

38. Vaidya R, Carp J, Sethi A, Bartol S, Craig J, Les CM. Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2. Eur Spine J. 2007;16(8):1257-1265.

39. Vaidya R, Sethi A, Bartol S, Jacobson M, Coe C, Craig JG. Complications in the use of rhBMP-2 in PEEK cages for interbody spinal fusions. J Spinal Disord Tech. 2008;21(8):557-562.

40. Knox JB, Dai JM 3rd, Orchowski J. Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2. Spine (Phila Pa 1976). 2011;36(8):672-676.

41. Carragee EJ, Chu G, Rohatgi R, et al. Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis. J Bone Joint Surg Am. 2013;95(17):1537-1545.

42. Lad SP, Bagley JH, Karikari IO, et al. Cancer after spinal fusion: the role of bone morphogenetic protein. Neurosurgery. 2013;73(3):440-449.

43. Bhadra AK, Raman AS, Casey AT, Crawford RJ. Single-level cervical radiculopathy: clinical outcome and cost-effectiveness of four techniques of anterior cervical discectomy and fusion and disc arthroplasty. Eur Spine J. 2009;18(2):232-237.

44. Castro FP Jr, Holt RT, Majd M, Whitecloud TS 3rd. A cost analysis of two anterior cervical fusion procedures. J Spinal Disord. 2000;13(6):511-514.

45. Kandziora F, Pflugmacher R, Scholz M, et al. Treatment of traumatic cervical spine instability with interbody fusion cages: a prospective controlled study with a 2-year follow-up. Injury. 2005;36(suppl 2):B27-B35.

46. Vaidya R, Weir R, Sethi A, Meisterling S, Hakeos W, Wybo CD. Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence. J Bone Joint Surg Br. 2007;89(3):342-345.

47. Epstein NE, Schwall GS, Hood DC. The incidence and cost of devices explanted during single-level anterior diskectomy/fusions. Surg Neurol Int. 2011;2:23.

Issue
Federal Practitioner - 33(5)
Issue
Federal Practitioner - 33(5)
Page Number
12-18
Page Number
12-18
Publications
Publications
Topics
Article Type
Display Headline
Anterior Cervical Interbody Fusion Using a Polyetheretherketone (PEEK) Cage Device and Local Autograft Bone
Display Headline
Anterior Cervical Interbody Fusion Using a Polyetheretherketone (PEEK) Cage Device and Local Autograft Bone
Legacy Keywords
Alp Ozpinar MD, Gustavo Mendez MD, Donald A. Ross MD, cervical interbody fusion, polyetheretherketone cage device, local autograft bone, PEEK,
Legacy Keywords
Alp Ozpinar MD, Gustavo Mendez MD, Donald A. Ross MD, cervical interbody fusion, polyetheretherketone cage device, local autograft bone, PEEK,
Sections
Disallow All Ads
Alternative CME
Use ProPublica
Article PDF Media

Academic Reasonable Accommodations for Post-9/11 Veterans With Psychiatric Diagnoses, Part 2

Article Type
Changed
Display Headline
Academic Reasonable Accommodations for Post-9/11 Veterans With Psychiatric Diagnoses, Part 2
The health belief model guides health care providers in their conversations with post-9/11 veterans moving from the role of soldier to student.

Among the ever increasing number of post-9/11 veterans pursuing higher education are many who carry psychological injuries, which include depression, anxiety, and posttraumatic stress disorder (PTSD). The effects of these mental health issues can create acquired learning disabilities involving impairments in memory, attention, concentration, and abstract thinking.1-4 Such learning disabilities can prevent a soldier from successfully transitioning to student-veteran.

Academic reasonable accommodations for veterans with psychiatric diagnoses can strategically enhance student-veteran role integration. Similar to reasonable accommodations for physical diagnoses, academic accommodations for psychiatric conditions enhance qualifying student-veterans’ abilities to successfully pursue higher education by enabling them to compensate for deficits in memory, recall, concentration, and abstract thinking. Such assistance for veterans with disabilities has been advocated in order to promote academic progression and student empowerment.5,6 Although academic accommodations enable veterans to compensate for learning disabilities, such interventions are not routinely requested for a variety of reasons. There are several key factors influencing veterans’ decisions to request such accommodations.

To promote a healthy transition to the student-veteran role, health care providers (HCPs) should initiate conversations about potential acquired learning disabilities with post-9/11 veterans with psychiatric diagnoses who are or will become students. Unfortunately, the medical literature includes little information on this topic or on how to have these conversations. To date, there is no suggested theoretical framework for guiding such discussions.

As a foundation for such discussion, Part 1 of this article explained the implications of psychiatric diagnoses and other common factors that can significantly impede adult learning among post-9/11 veterans who are separated from service.7 Part 1 also addressed the fundamentals of academic reasonable accommodations, which are outlined in Table 1.

Through use of a theoretical model, part 2 of this study defines key factors influencing post-9/11 veterans’ decision to request academic reasonable accommodations for psychiatric diagnoses. It also provides practical advice for facilitating clinical conversations at each stage of the model to promote the acceptance of academic reasonable accommodations among eligible post-9/11 veterans.

Health Belief Model

The health belief model (HBM) can be adopted to understand the steps of veterans’ decision-making processes involving reasonable accommodations. The model outlines determinants of human behavior that influence the potential health care decision to deliberately mitigate harm from a perceived health threat.8,9 The 6 primary components are perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.8,9 The HBM previously has been applied to a diverse range of health behaviors involving prevention, medical regimen adherence, and utilization of health care services.10 Its application to learning impairment and academic reasonable accommodations is outlined in Table 2.

When the HBM framework is applied to academic accommodations, the perceived health threat is acquired learning disability. The desired health care decision is the act of requesting academic reasonable accommodations. The targeted population at risk is the post-9/11 veteran cohort with symptomatic psychiatric diagnoses who are enrolled in, or who are considering, postsecondary education.

The initial perceived susceptibility step determines the degree to which these veterans judge themselves as being at risk for learning impairment because of psychiatric diagnoses. During this step, it is imperative that HCPs educate veterans on how mental health conditions can alter adult learning styles. Clinicians should describe the negative effects of psychiatric symptoms on memory, concentration, focus, attention, and abstract thinking. Insight is developed in this step as veterans recognize that their academic endeavors potentially could be affected by underlying mental health symptoms.

Perceived Severity

Recognition of the perceived severity of impaired learning is the next step in HBM. Veterans will need to self-evaluate their actual or potential academic performance based on their current state of memory, concentration, focus, and attention. Although many veterans might determine that the impact is transient or minimal, a significant number of veterans will observe that their learning abilities are greatly affected. If veterans identify with loss of those skills since the onset of serious mental health issues, there should be further discussion regarding the existence of academic accommodations that address any learning impairment expected to last longer than 6 months.

As discussed in part 1, mental health diagnoses involving mood, though possessing individually distinct diagnostic criteria, create potentially similar global learning impairments in terms of decreased memory, poor concentration, and slowed executive functioning.1-4 Insight into the impact of any acquired learning disability from these mental health conditions and/or associated pharmacologic treatment can be encouraged if the clinician and client jointly review the client’s self-described premorbid learning style and compare it with the client’s current functioning in day-to-day activities requiring memory, concentration, and decision making. A clinician can use a gentle emphasis on the incongruities between premorbid learning ability and present-day impairments as a springboard for discussion about ways to compensate for learning impairments.

 

 

Additional insight can be elicited by providing practical examples of how other factors can accentuate the learning difficulties caused by serious or persistent psychiatric symptoms. By discussing these issues, clinicians can provide veterans with a more realistic understanding of potential obstacles in the postsecondary setting and the need for a strategic plan to address such challenges. For example, if a veteran takes prescription medications to manage underlying psychiatric conditions, a discussion regarding pertinent pharmacologic adverse effects (AEs) can highlight how academic performance might be affected. As outlined in part 1, fatigue, drowsiness, restlessness, mental grogginess, and insomnia are just a few medication AEs that may impair academic performance by negatively affecting memory, concentration, and executive functioning.

There are multiple circumstances that can increase the degree to which psychiatric symptoms impede recall, memory, insight, judgment, concentration, attention, organization, and abstract thinking. Impaired memory, poor concentration, irritability, and decreased attention can occur in the normal postmilitary transition period or as residual effects from mild-to-moderate traumatic brain injury. Multiple role responsibilities, such as being a spouse and parent, also can present significant mental distractions from academic endeavors. A physical impairment, such as tinnitus, hearing loss, or chronic pain, can impede classroom participation.

At this juncture, HCPs also should identify the academic consequences of impaired learning. Knowing these consequences will help veterans decide whether a course of action is needed to compensate for any learning disability that may be present. Inability to finish timed tests, difficulty taking notes, and inefficient studying are some of the more serious potential sequelae. Feared long-term consequences include a lack of progress through the required course load and, ultimately, failing courses.

A basic explanation of the potential financial effects of poor academic achievement provides another practical method for clinicians to outline negative consequences of an acquired learning disability. The student’s sole income for basic necessities is often the post-9/11 GI Bill, which pays for up to 36 months of education benefits and includes a living allowance and book stipend.

Unfortunately, given their financial dependence on the GI Bill, many veterans who withdraw from classes due to academic difficulties face economic uncertainty. If their withdrawal is not approved by the GI Bill program, these veterans must pay back all the money granted during the semester. Veterans who remain in school despite receiving failing marks cannot recover money spent on failed courses. This potentially results in veterans exceeding their entire GI Bill allotment before completing course requirements for their desired certificate or degree. Many veterans logically conclude that the potential financial devastation is a sufficiently severe consequence of impaired learning ability, and those who believe they have significantly impaired learning ability may become more motivated to reduce any risk of academic failure by pursuing academic accommodations.

In tandem with reviewing the potential severity of the problem, clinicians always should emphasize the availability of academic accommodations to circumvent the negative consequences of an acquired learning disability. Veterans who experience academic difficulties but are unaware of academic interventions may decide to forgo postsecondary education. By understanding basic details about accommodations, veterans can make the informed decision to pursue these interventions as part of a plan for academic success.

Perceived Benefits

Although identifying perceived susceptibility and perceived severity are necessary for veterans to consider academic reasonable accommodation use, eligible veterans still may not understand how these accommodations can apply to their situation. In the next step of HBM, veterans must view formal academic accommodations as a desirable solution to mitigate the effects of impaired learning ability. Veterans must appreciate the perceived benefits of such requests before they elect to pursue them.

At this point, HCPs should provide examples of academic accommodations to illustrate the simplicity and ease of such interventions. Tutoring, note-taking assistance, and providing additional time for testing are examples of a few types of accommodations featuring advantages that should be readily apparent to veterans returning to school. These measures not only lessen the likelihood of struggling academically, but also afford an opportunity to excel. By painting accommodations as a powerful method of self-advocacy, HCPs can inform veterans that accommodations enable a measure of control within the academic setting and assist with planning.

Perceived Barriers

Although identifying perceived benefits may be persuasive, discerning perceived barriers is an important HBM step that influences whether veterans will seek academic accommodations. Fortunately, many of the common barriers to accommodation requests are simply misconceptions that clinicians can address easily. For example, some veterans misconstrue reasonable accommodations as giving them an unfair advantage, which they find offensive to their personal integrity and pride. Clinicians should point out to these veterans that accommodations address deficits in learning abilities and merely level the academic playing field so the student-veteran is on par with those students without such impairments. The core work needed to pass the class remains unchanged by such accommodations.

 

 

Often a barrier is erected when veterans subscribe to the traditional military definition of disability, which is equated with having overwhelming physical injuries or paralyzing psychological states. These veterans are reluctant to request any formal accommodations, because they do not see themselves as having a disability under this restrictive definition. For these veterans, HCPs need to explain that the broad federal definition of disability does not imply veterans must be disabled in any other aspect of his or her life except for learning.

Some veterans do not want to draw attention to themselves either as a veteran or as a student with learning difficulties.11,12 Aware of civilian stereotyping of veterans, they prefer to remain anonymous. In this instance, clinicians should emphasize that psychiatric diagnoses are confidential and that only the reasonable accommodations are shared with the professor—not the underlying medical problem. The clinician also should emphasize that the accommodations are open to all eligible adult students, not just student-veterans. Therefore, use of such accommodations is not a disclosure of veteran status.

In conjunction with addressing client fears about stereotyping of both veterans and students with learning disabilities, HCPs should be mindful that mental health stigma is a significant barrier to seeking mental health services among military personnel, post-9/11 veterans, and college students.13,14 Therefore, clinicians should emphasize that academic accommodations for psychiatric diagnoses are not self-disclosing of psychiatric concerns and are usually the same accommodations used to address learning disabilities caused by other factors.

Veterans may believe that documentation obtained in support of reasonable accommodations is too intimidating or too personal to reveal. Not realizing that federal law prevents institutions from requesting in-depth documentation, veterans mistakenly believe that they must provide all medical documents in order to qualify for academic accommodations. To assuage these fears, clinicians should inform veterans that schools generally require only a documentation letter from a qualified provider and usually do not require other medical records.

To further alleviate veteran fears and promote a measure of client control, providers may find it beneficial to review the proposed medical documentation letter with the veteran and have the veteran approve the content. Figures 1 and 2 illustrate a basic medical documentation letter with optional institution-specific criteria. To ensure compliance with any applicable federal privacy regulations or local facility policy, clinicians should obtain an information release form from the veteran. The medical documentation letter can then be released to the veteran for hand delivery to the academic institution.

Veterans might be concerned about the potential lack of confidentiality regarding the diagnosis contributing to their learning disability. They also may worry that accommodations will prevent them from entering the field of their choice when they graduate, especially for law enforcement careers. These veterans can be reassured by informing them that use of academic accommodations is completely confidential during their school years and will not appear on their school graduation records. Recommending that veterans confirm the established confidentiality process with their schools may help allay fears about inadvertent release of private information by the institution.

Self-Efficacy and Cues to Action

Even after perceived benefits and barriers are identified, veterans still may not act unless they believe that they can intervene appropriately to address the problem. The HBM refers to this step as self-efficacy. Student-veterans must feel empowered to effectively make reasonable accommodation requests and negotiate any potential setbacks to the implementation of those accommodations. Health care providers should inform veterans about the availability of a disability resource center or other counseling service at each school that can help the student-veteran through the process of accommodation approval. Ideally, student-veterans also should receive guidance on how to approach professors regarding both the request for and the implementation of the approved reasonable accommodations.15 Counselors at the institution should offer this guidance and help veterans select the appropriate accommodations.

In the HBM, cues to action occur at every step. These cues consist of the influential factors promoting the desired behavior. Providing answers to common veteran questions about academic accommodations is one cue to action. Another is providing a written step-by-step guide explaining academic accommodations to veterans. (The author has created a veteran-centric guide to academic accommodations. The guide, which explains basic concepts and addresses common barriers to requesting such accommodations, is available upon request from [email protected]).

At all times, positive feedback from clinicians is important in motivating veterans to complete the entire process. Discussion may be stalled at any point if veterans overestimate current academic abilities or underestimate their level of impaired learning ability. Motivational interviewing techniques may help resolve this impasse. However, even if eligible veterans are not interested in pursuing academic accommodations, HCPs should leave the option open for consideration. Although interventions are most beneficial when instituted early in the student’s coursework, veterans can formally request academic accommodations at any stage of their academic career.

 

 

Conclusion

Formal academic accommodations are viable tools for cultivating academic success among student-veterans with significant psychiatric conditions. The adoption of such interventions requires understanding post-9/11 veterans’ motivation and concerns about formal academic accommodation requests. Application of the HBM can guide clinicians in their discussions with post-9/11 veterans. By understanding the veterans’ perspectives on the subject, HCPs can directly address the factors influencing the decision to seek academic accommodations.

Ensuring successful transition to the student-veteran role is of prime importance for veterans who bear emotional scars from military service. To this author’s knowledge, no structured educational programs currently exist that inform either post-9/11 veterans or their HCPs about pertinent aspects of academic accommodations for student-veterans with symptomatic psychiatric diagnoses that impede learning. Future endeavors need to include development of programs to inform veterans and providers about this important topic. Such programs should not only promote the dissemination of general information, but also explore specific ways to tailor accommodations to the cognitive needs of each veteran.

References

1. Burriss L, Ayers E, Ginsberg J, Powell DA. Learning and memory impairment in PTSD: relationship to depression. Depress Anxiety. 2008;25(2):149-157.

2. Sweeney JA, Kmiec JA, Kupfer DJ. Neuropsychologic impairments in bipolar and unipolar mood disorders on the CANTAB neurocognitive battery. Biol Psychiatry. 2000;48(7):674-684.

3. Chamberlain SR, Sahakian BJ. The neuropsychology of mood disorders. Curr Psychiatry Rep. 2006;8(6):458-463.

4. Jaeger J, Berns S, Uzelac S, Davis-Conway S. Neurocognitive deficits and disability in major depressive disorder. Psychiatry Res. 2006;145(1):39-48.

5. Branker C. Deserving design: the new generation of student veterans. J Postsecond Educ Disabil. 2009;22(1):59-66.

6. Burnett SE, Segoria J. Collaboration for military transition students from combat to college: it takes a community. J Postsecond Educ and Disabil. 2009;22(1):53-58.

7. Mitchell K. Understanding academic reasonable accommodations for post-9/11 veterans with psychiatric diagnoses—part 1, the foundation. Fed Pract. 2016;33(4):33-39.

8. Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the health belief model. Health Educ Q. 1988;15(2):175-183.

9. Glanz K, Rimer BK. Theory at a Glance: A Guide for Health Promotion Practice. 2nd ed. Bethesda, MD: U.S. Deptartment of Health and Human Services, National Institutes of Health, National Cancer Institute; 2005.

10. Janz NK, Becker MH. The health belief model: a decade later. Health Educ Q. 1984;11(1):1-47.

11. Salzer MS, Wick LC, Rogers JA. Familiarity with and use of accommodations and supports among postsecondary students with mental illnesses. Psychiatr Serv. 2008;59(4):370-375.

12. Shackelford AL. Documenting the needs of student veterans with disabilities: intersection roadblocks, solutions, and legal realities. J Postsecond Educ Disabil. 2009;22(1):36-42.

13. Eisenberg D, Downs MF, Golberstein E, Zivin K. Stigma and help seeking for mental health among college students. Med Care Res Rev. 2009;66(5):522-541.

14. Vogt D. Mental health related beliefs as a barrier to service use for military personnel and veterans: a review. Psychiatr Serv. 2011;62(2):135-142.

15. Palmer C, Roessler RT. Requesting classroom accommodations: self-advocacy and conflict resolution training for college students with disabilities. J Rehabil. 2000;66(3):38-43.

Article PDF
Author and Disclosure Information

Dr. Mitchell is a specialty medicine coordinator for VHA VISN 22 in Gilbert, Arizona, and the former medical director of the postdeployment clinic at the Phoenix VAMC in Arizona.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Issue
Federal Practitioner - 33(5)
Publications
Topics
Page Number
19-25
Legacy Keywords
Katherine Mitchell MD, post-9/11 veterans, posttraumatic stress disorder, mental health, academics
Sections
Author and Disclosure Information

Dr. Mitchell is a specialty medicine coordinator for VHA VISN 22 in Gilbert, Arizona, and the former medical director of the postdeployment clinic at the Phoenix VAMC in Arizona.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Dr. Mitchell is a specialty medicine coordinator for VHA VISN 22 in Gilbert, Arizona, and the former medical director of the postdeployment clinic at the Phoenix VAMC in Arizona.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Article PDF
Article PDF
Related Articles
The health belief model guides health care providers in their conversations with post-9/11 veterans moving from the role of soldier to student.
The health belief model guides health care providers in their conversations with post-9/11 veterans moving from the role of soldier to student.

Among the ever increasing number of post-9/11 veterans pursuing higher education are many who carry psychological injuries, which include depression, anxiety, and posttraumatic stress disorder (PTSD). The effects of these mental health issues can create acquired learning disabilities involving impairments in memory, attention, concentration, and abstract thinking.1-4 Such learning disabilities can prevent a soldier from successfully transitioning to student-veteran.

Academic reasonable accommodations for veterans with psychiatric diagnoses can strategically enhance student-veteran role integration. Similar to reasonable accommodations for physical diagnoses, academic accommodations for psychiatric conditions enhance qualifying student-veterans’ abilities to successfully pursue higher education by enabling them to compensate for deficits in memory, recall, concentration, and abstract thinking. Such assistance for veterans with disabilities has been advocated in order to promote academic progression and student empowerment.5,6 Although academic accommodations enable veterans to compensate for learning disabilities, such interventions are not routinely requested for a variety of reasons. There are several key factors influencing veterans’ decisions to request such accommodations.

To promote a healthy transition to the student-veteran role, health care providers (HCPs) should initiate conversations about potential acquired learning disabilities with post-9/11 veterans with psychiatric diagnoses who are or will become students. Unfortunately, the medical literature includes little information on this topic or on how to have these conversations. To date, there is no suggested theoretical framework for guiding such discussions.

As a foundation for such discussion, Part 1 of this article explained the implications of psychiatric diagnoses and other common factors that can significantly impede adult learning among post-9/11 veterans who are separated from service.7 Part 1 also addressed the fundamentals of academic reasonable accommodations, which are outlined in Table 1.

Through use of a theoretical model, part 2 of this study defines key factors influencing post-9/11 veterans’ decision to request academic reasonable accommodations for psychiatric diagnoses. It also provides practical advice for facilitating clinical conversations at each stage of the model to promote the acceptance of academic reasonable accommodations among eligible post-9/11 veterans.

Health Belief Model

The health belief model (HBM) can be adopted to understand the steps of veterans’ decision-making processes involving reasonable accommodations. The model outlines determinants of human behavior that influence the potential health care decision to deliberately mitigate harm from a perceived health threat.8,9 The 6 primary components are perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.8,9 The HBM previously has been applied to a diverse range of health behaviors involving prevention, medical regimen adherence, and utilization of health care services.10 Its application to learning impairment and academic reasonable accommodations is outlined in Table 2.

When the HBM framework is applied to academic accommodations, the perceived health threat is acquired learning disability. The desired health care decision is the act of requesting academic reasonable accommodations. The targeted population at risk is the post-9/11 veteran cohort with symptomatic psychiatric diagnoses who are enrolled in, or who are considering, postsecondary education.

The initial perceived susceptibility step determines the degree to which these veterans judge themselves as being at risk for learning impairment because of psychiatric diagnoses. During this step, it is imperative that HCPs educate veterans on how mental health conditions can alter adult learning styles. Clinicians should describe the negative effects of psychiatric symptoms on memory, concentration, focus, attention, and abstract thinking. Insight is developed in this step as veterans recognize that their academic endeavors potentially could be affected by underlying mental health symptoms.

Perceived Severity

Recognition of the perceived severity of impaired learning is the next step in HBM. Veterans will need to self-evaluate their actual or potential academic performance based on their current state of memory, concentration, focus, and attention. Although many veterans might determine that the impact is transient or minimal, a significant number of veterans will observe that their learning abilities are greatly affected. If veterans identify with loss of those skills since the onset of serious mental health issues, there should be further discussion regarding the existence of academic accommodations that address any learning impairment expected to last longer than 6 months.

As discussed in part 1, mental health diagnoses involving mood, though possessing individually distinct diagnostic criteria, create potentially similar global learning impairments in terms of decreased memory, poor concentration, and slowed executive functioning.1-4 Insight into the impact of any acquired learning disability from these mental health conditions and/or associated pharmacologic treatment can be encouraged if the clinician and client jointly review the client’s self-described premorbid learning style and compare it with the client’s current functioning in day-to-day activities requiring memory, concentration, and decision making. A clinician can use a gentle emphasis on the incongruities between premorbid learning ability and present-day impairments as a springboard for discussion about ways to compensate for learning impairments.

 

 

Additional insight can be elicited by providing practical examples of how other factors can accentuate the learning difficulties caused by serious or persistent psychiatric symptoms. By discussing these issues, clinicians can provide veterans with a more realistic understanding of potential obstacles in the postsecondary setting and the need for a strategic plan to address such challenges. For example, if a veteran takes prescription medications to manage underlying psychiatric conditions, a discussion regarding pertinent pharmacologic adverse effects (AEs) can highlight how academic performance might be affected. As outlined in part 1, fatigue, drowsiness, restlessness, mental grogginess, and insomnia are just a few medication AEs that may impair academic performance by negatively affecting memory, concentration, and executive functioning.

There are multiple circumstances that can increase the degree to which psychiatric symptoms impede recall, memory, insight, judgment, concentration, attention, organization, and abstract thinking. Impaired memory, poor concentration, irritability, and decreased attention can occur in the normal postmilitary transition period or as residual effects from mild-to-moderate traumatic brain injury. Multiple role responsibilities, such as being a spouse and parent, also can present significant mental distractions from academic endeavors. A physical impairment, such as tinnitus, hearing loss, or chronic pain, can impede classroom participation.

At this juncture, HCPs also should identify the academic consequences of impaired learning. Knowing these consequences will help veterans decide whether a course of action is needed to compensate for any learning disability that may be present. Inability to finish timed tests, difficulty taking notes, and inefficient studying are some of the more serious potential sequelae. Feared long-term consequences include a lack of progress through the required course load and, ultimately, failing courses.

A basic explanation of the potential financial effects of poor academic achievement provides another practical method for clinicians to outline negative consequences of an acquired learning disability. The student’s sole income for basic necessities is often the post-9/11 GI Bill, which pays for up to 36 months of education benefits and includes a living allowance and book stipend.

Unfortunately, given their financial dependence on the GI Bill, many veterans who withdraw from classes due to academic difficulties face economic uncertainty. If their withdrawal is not approved by the GI Bill program, these veterans must pay back all the money granted during the semester. Veterans who remain in school despite receiving failing marks cannot recover money spent on failed courses. This potentially results in veterans exceeding their entire GI Bill allotment before completing course requirements for their desired certificate or degree. Many veterans logically conclude that the potential financial devastation is a sufficiently severe consequence of impaired learning ability, and those who believe they have significantly impaired learning ability may become more motivated to reduce any risk of academic failure by pursuing academic accommodations.

In tandem with reviewing the potential severity of the problem, clinicians always should emphasize the availability of academic accommodations to circumvent the negative consequences of an acquired learning disability. Veterans who experience academic difficulties but are unaware of academic interventions may decide to forgo postsecondary education. By understanding basic details about accommodations, veterans can make the informed decision to pursue these interventions as part of a plan for academic success.

Perceived Benefits

Although identifying perceived susceptibility and perceived severity are necessary for veterans to consider academic reasonable accommodation use, eligible veterans still may not understand how these accommodations can apply to their situation. In the next step of HBM, veterans must view formal academic accommodations as a desirable solution to mitigate the effects of impaired learning ability. Veterans must appreciate the perceived benefits of such requests before they elect to pursue them.

At this point, HCPs should provide examples of academic accommodations to illustrate the simplicity and ease of such interventions. Tutoring, note-taking assistance, and providing additional time for testing are examples of a few types of accommodations featuring advantages that should be readily apparent to veterans returning to school. These measures not only lessen the likelihood of struggling academically, but also afford an opportunity to excel. By painting accommodations as a powerful method of self-advocacy, HCPs can inform veterans that accommodations enable a measure of control within the academic setting and assist with planning.

Perceived Barriers

Although identifying perceived benefits may be persuasive, discerning perceived barriers is an important HBM step that influences whether veterans will seek academic accommodations. Fortunately, many of the common barriers to accommodation requests are simply misconceptions that clinicians can address easily. For example, some veterans misconstrue reasonable accommodations as giving them an unfair advantage, which they find offensive to their personal integrity and pride. Clinicians should point out to these veterans that accommodations address deficits in learning abilities and merely level the academic playing field so the student-veteran is on par with those students without such impairments. The core work needed to pass the class remains unchanged by such accommodations.

 

 

Often a barrier is erected when veterans subscribe to the traditional military definition of disability, which is equated with having overwhelming physical injuries or paralyzing psychological states. These veterans are reluctant to request any formal accommodations, because they do not see themselves as having a disability under this restrictive definition. For these veterans, HCPs need to explain that the broad federal definition of disability does not imply veterans must be disabled in any other aspect of his or her life except for learning.

Some veterans do not want to draw attention to themselves either as a veteran or as a student with learning difficulties.11,12 Aware of civilian stereotyping of veterans, they prefer to remain anonymous. In this instance, clinicians should emphasize that psychiatric diagnoses are confidential and that only the reasonable accommodations are shared with the professor—not the underlying medical problem. The clinician also should emphasize that the accommodations are open to all eligible adult students, not just student-veterans. Therefore, use of such accommodations is not a disclosure of veteran status.

In conjunction with addressing client fears about stereotyping of both veterans and students with learning disabilities, HCPs should be mindful that mental health stigma is a significant barrier to seeking mental health services among military personnel, post-9/11 veterans, and college students.13,14 Therefore, clinicians should emphasize that academic accommodations for psychiatric diagnoses are not self-disclosing of psychiatric concerns and are usually the same accommodations used to address learning disabilities caused by other factors.

Veterans may believe that documentation obtained in support of reasonable accommodations is too intimidating or too personal to reveal. Not realizing that federal law prevents institutions from requesting in-depth documentation, veterans mistakenly believe that they must provide all medical documents in order to qualify for academic accommodations. To assuage these fears, clinicians should inform veterans that schools generally require only a documentation letter from a qualified provider and usually do not require other medical records.

To further alleviate veteran fears and promote a measure of client control, providers may find it beneficial to review the proposed medical documentation letter with the veteran and have the veteran approve the content. Figures 1 and 2 illustrate a basic medical documentation letter with optional institution-specific criteria. To ensure compliance with any applicable federal privacy regulations or local facility policy, clinicians should obtain an information release form from the veteran. The medical documentation letter can then be released to the veteran for hand delivery to the academic institution.

Veterans might be concerned about the potential lack of confidentiality regarding the diagnosis contributing to their learning disability. They also may worry that accommodations will prevent them from entering the field of their choice when they graduate, especially for law enforcement careers. These veterans can be reassured by informing them that use of academic accommodations is completely confidential during their school years and will not appear on their school graduation records. Recommending that veterans confirm the established confidentiality process with their schools may help allay fears about inadvertent release of private information by the institution.

Self-Efficacy and Cues to Action

Even after perceived benefits and barriers are identified, veterans still may not act unless they believe that they can intervene appropriately to address the problem. The HBM refers to this step as self-efficacy. Student-veterans must feel empowered to effectively make reasonable accommodation requests and negotiate any potential setbacks to the implementation of those accommodations. Health care providers should inform veterans about the availability of a disability resource center or other counseling service at each school that can help the student-veteran through the process of accommodation approval. Ideally, student-veterans also should receive guidance on how to approach professors regarding both the request for and the implementation of the approved reasonable accommodations.15 Counselors at the institution should offer this guidance and help veterans select the appropriate accommodations.

In the HBM, cues to action occur at every step. These cues consist of the influential factors promoting the desired behavior. Providing answers to common veteran questions about academic accommodations is one cue to action. Another is providing a written step-by-step guide explaining academic accommodations to veterans. (The author has created a veteran-centric guide to academic accommodations. The guide, which explains basic concepts and addresses common barriers to requesting such accommodations, is available upon request from [email protected]).

At all times, positive feedback from clinicians is important in motivating veterans to complete the entire process. Discussion may be stalled at any point if veterans overestimate current academic abilities or underestimate their level of impaired learning ability. Motivational interviewing techniques may help resolve this impasse. However, even if eligible veterans are not interested in pursuing academic accommodations, HCPs should leave the option open for consideration. Although interventions are most beneficial when instituted early in the student’s coursework, veterans can formally request academic accommodations at any stage of their academic career.

 

 

Conclusion

Formal academic accommodations are viable tools for cultivating academic success among student-veterans with significant psychiatric conditions. The adoption of such interventions requires understanding post-9/11 veterans’ motivation and concerns about formal academic accommodation requests. Application of the HBM can guide clinicians in their discussions with post-9/11 veterans. By understanding the veterans’ perspectives on the subject, HCPs can directly address the factors influencing the decision to seek academic accommodations.

Ensuring successful transition to the student-veteran role is of prime importance for veterans who bear emotional scars from military service. To this author’s knowledge, no structured educational programs currently exist that inform either post-9/11 veterans or their HCPs about pertinent aspects of academic accommodations for student-veterans with symptomatic psychiatric diagnoses that impede learning. Future endeavors need to include development of programs to inform veterans and providers about this important topic. Such programs should not only promote the dissemination of general information, but also explore specific ways to tailor accommodations to the cognitive needs of each veteran.

Among the ever increasing number of post-9/11 veterans pursuing higher education are many who carry psychological injuries, which include depression, anxiety, and posttraumatic stress disorder (PTSD). The effects of these mental health issues can create acquired learning disabilities involving impairments in memory, attention, concentration, and abstract thinking.1-4 Such learning disabilities can prevent a soldier from successfully transitioning to student-veteran.

Academic reasonable accommodations for veterans with psychiatric diagnoses can strategically enhance student-veteran role integration. Similar to reasonable accommodations for physical diagnoses, academic accommodations for psychiatric conditions enhance qualifying student-veterans’ abilities to successfully pursue higher education by enabling them to compensate for deficits in memory, recall, concentration, and abstract thinking. Such assistance for veterans with disabilities has been advocated in order to promote academic progression and student empowerment.5,6 Although academic accommodations enable veterans to compensate for learning disabilities, such interventions are not routinely requested for a variety of reasons. There are several key factors influencing veterans’ decisions to request such accommodations.

To promote a healthy transition to the student-veteran role, health care providers (HCPs) should initiate conversations about potential acquired learning disabilities with post-9/11 veterans with psychiatric diagnoses who are or will become students. Unfortunately, the medical literature includes little information on this topic or on how to have these conversations. To date, there is no suggested theoretical framework for guiding such discussions.

As a foundation for such discussion, Part 1 of this article explained the implications of psychiatric diagnoses and other common factors that can significantly impede adult learning among post-9/11 veterans who are separated from service.7 Part 1 also addressed the fundamentals of academic reasonable accommodations, which are outlined in Table 1.

Through use of a theoretical model, part 2 of this study defines key factors influencing post-9/11 veterans’ decision to request academic reasonable accommodations for psychiatric diagnoses. It also provides practical advice for facilitating clinical conversations at each stage of the model to promote the acceptance of academic reasonable accommodations among eligible post-9/11 veterans.

Health Belief Model

The health belief model (HBM) can be adopted to understand the steps of veterans’ decision-making processes involving reasonable accommodations. The model outlines determinants of human behavior that influence the potential health care decision to deliberately mitigate harm from a perceived health threat.8,9 The 6 primary components are perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.8,9 The HBM previously has been applied to a diverse range of health behaviors involving prevention, medical regimen adherence, and utilization of health care services.10 Its application to learning impairment and academic reasonable accommodations is outlined in Table 2.

When the HBM framework is applied to academic accommodations, the perceived health threat is acquired learning disability. The desired health care decision is the act of requesting academic reasonable accommodations. The targeted population at risk is the post-9/11 veteran cohort with symptomatic psychiatric diagnoses who are enrolled in, or who are considering, postsecondary education.

The initial perceived susceptibility step determines the degree to which these veterans judge themselves as being at risk for learning impairment because of psychiatric diagnoses. During this step, it is imperative that HCPs educate veterans on how mental health conditions can alter adult learning styles. Clinicians should describe the negative effects of psychiatric symptoms on memory, concentration, focus, attention, and abstract thinking. Insight is developed in this step as veterans recognize that their academic endeavors potentially could be affected by underlying mental health symptoms.

Perceived Severity

Recognition of the perceived severity of impaired learning is the next step in HBM. Veterans will need to self-evaluate their actual or potential academic performance based on their current state of memory, concentration, focus, and attention. Although many veterans might determine that the impact is transient or minimal, a significant number of veterans will observe that their learning abilities are greatly affected. If veterans identify with loss of those skills since the onset of serious mental health issues, there should be further discussion regarding the existence of academic accommodations that address any learning impairment expected to last longer than 6 months.

As discussed in part 1, mental health diagnoses involving mood, though possessing individually distinct diagnostic criteria, create potentially similar global learning impairments in terms of decreased memory, poor concentration, and slowed executive functioning.1-4 Insight into the impact of any acquired learning disability from these mental health conditions and/or associated pharmacologic treatment can be encouraged if the clinician and client jointly review the client’s self-described premorbid learning style and compare it with the client’s current functioning in day-to-day activities requiring memory, concentration, and decision making. A clinician can use a gentle emphasis on the incongruities between premorbid learning ability and present-day impairments as a springboard for discussion about ways to compensate for learning impairments.

 

 

Additional insight can be elicited by providing practical examples of how other factors can accentuate the learning difficulties caused by serious or persistent psychiatric symptoms. By discussing these issues, clinicians can provide veterans with a more realistic understanding of potential obstacles in the postsecondary setting and the need for a strategic plan to address such challenges. For example, if a veteran takes prescription medications to manage underlying psychiatric conditions, a discussion regarding pertinent pharmacologic adverse effects (AEs) can highlight how academic performance might be affected. As outlined in part 1, fatigue, drowsiness, restlessness, mental grogginess, and insomnia are just a few medication AEs that may impair academic performance by negatively affecting memory, concentration, and executive functioning.

There are multiple circumstances that can increase the degree to which psychiatric symptoms impede recall, memory, insight, judgment, concentration, attention, organization, and abstract thinking. Impaired memory, poor concentration, irritability, and decreased attention can occur in the normal postmilitary transition period or as residual effects from mild-to-moderate traumatic brain injury. Multiple role responsibilities, such as being a spouse and parent, also can present significant mental distractions from academic endeavors. A physical impairment, such as tinnitus, hearing loss, or chronic pain, can impede classroom participation.

At this juncture, HCPs also should identify the academic consequences of impaired learning. Knowing these consequences will help veterans decide whether a course of action is needed to compensate for any learning disability that may be present. Inability to finish timed tests, difficulty taking notes, and inefficient studying are some of the more serious potential sequelae. Feared long-term consequences include a lack of progress through the required course load and, ultimately, failing courses.

A basic explanation of the potential financial effects of poor academic achievement provides another practical method for clinicians to outline negative consequences of an acquired learning disability. The student’s sole income for basic necessities is often the post-9/11 GI Bill, which pays for up to 36 months of education benefits and includes a living allowance and book stipend.

Unfortunately, given their financial dependence on the GI Bill, many veterans who withdraw from classes due to academic difficulties face economic uncertainty. If their withdrawal is not approved by the GI Bill program, these veterans must pay back all the money granted during the semester. Veterans who remain in school despite receiving failing marks cannot recover money spent on failed courses. This potentially results in veterans exceeding their entire GI Bill allotment before completing course requirements for their desired certificate or degree. Many veterans logically conclude that the potential financial devastation is a sufficiently severe consequence of impaired learning ability, and those who believe they have significantly impaired learning ability may become more motivated to reduce any risk of academic failure by pursuing academic accommodations.

In tandem with reviewing the potential severity of the problem, clinicians always should emphasize the availability of academic accommodations to circumvent the negative consequences of an acquired learning disability. Veterans who experience academic difficulties but are unaware of academic interventions may decide to forgo postsecondary education. By understanding basic details about accommodations, veterans can make the informed decision to pursue these interventions as part of a plan for academic success.

Perceived Benefits

Although identifying perceived susceptibility and perceived severity are necessary for veterans to consider academic reasonable accommodation use, eligible veterans still may not understand how these accommodations can apply to their situation. In the next step of HBM, veterans must view formal academic accommodations as a desirable solution to mitigate the effects of impaired learning ability. Veterans must appreciate the perceived benefits of such requests before they elect to pursue them.

At this point, HCPs should provide examples of academic accommodations to illustrate the simplicity and ease of such interventions. Tutoring, note-taking assistance, and providing additional time for testing are examples of a few types of accommodations featuring advantages that should be readily apparent to veterans returning to school. These measures not only lessen the likelihood of struggling academically, but also afford an opportunity to excel. By painting accommodations as a powerful method of self-advocacy, HCPs can inform veterans that accommodations enable a measure of control within the academic setting and assist with planning.

Perceived Barriers

Although identifying perceived benefits may be persuasive, discerning perceived barriers is an important HBM step that influences whether veterans will seek academic accommodations. Fortunately, many of the common barriers to accommodation requests are simply misconceptions that clinicians can address easily. For example, some veterans misconstrue reasonable accommodations as giving them an unfair advantage, which they find offensive to their personal integrity and pride. Clinicians should point out to these veterans that accommodations address deficits in learning abilities and merely level the academic playing field so the student-veteran is on par with those students without such impairments. The core work needed to pass the class remains unchanged by such accommodations.

 

 

Often a barrier is erected when veterans subscribe to the traditional military definition of disability, which is equated with having overwhelming physical injuries or paralyzing psychological states. These veterans are reluctant to request any formal accommodations, because they do not see themselves as having a disability under this restrictive definition. For these veterans, HCPs need to explain that the broad federal definition of disability does not imply veterans must be disabled in any other aspect of his or her life except for learning.

Some veterans do not want to draw attention to themselves either as a veteran or as a student with learning difficulties.11,12 Aware of civilian stereotyping of veterans, they prefer to remain anonymous. In this instance, clinicians should emphasize that psychiatric diagnoses are confidential and that only the reasonable accommodations are shared with the professor—not the underlying medical problem. The clinician also should emphasize that the accommodations are open to all eligible adult students, not just student-veterans. Therefore, use of such accommodations is not a disclosure of veteran status.

In conjunction with addressing client fears about stereotyping of both veterans and students with learning disabilities, HCPs should be mindful that mental health stigma is a significant barrier to seeking mental health services among military personnel, post-9/11 veterans, and college students.13,14 Therefore, clinicians should emphasize that academic accommodations for psychiatric diagnoses are not self-disclosing of psychiatric concerns and are usually the same accommodations used to address learning disabilities caused by other factors.

Veterans may believe that documentation obtained in support of reasonable accommodations is too intimidating or too personal to reveal. Not realizing that federal law prevents institutions from requesting in-depth documentation, veterans mistakenly believe that they must provide all medical documents in order to qualify for academic accommodations. To assuage these fears, clinicians should inform veterans that schools generally require only a documentation letter from a qualified provider and usually do not require other medical records.

To further alleviate veteran fears and promote a measure of client control, providers may find it beneficial to review the proposed medical documentation letter with the veteran and have the veteran approve the content. Figures 1 and 2 illustrate a basic medical documentation letter with optional institution-specific criteria. To ensure compliance with any applicable federal privacy regulations or local facility policy, clinicians should obtain an information release form from the veteran. The medical documentation letter can then be released to the veteran for hand delivery to the academic institution.

Veterans might be concerned about the potential lack of confidentiality regarding the diagnosis contributing to their learning disability. They also may worry that accommodations will prevent them from entering the field of their choice when they graduate, especially for law enforcement careers. These veterans can be reassured by informing them that use of academic accommodations is completely confidential during their school years and will not appear on their school graduation records. Recommending that veterans confirm the established confidentiality process with their schools may help allay fears about inadvertent release of private information by the institution.

Self-Efficacy and Cues to Action

Even after perceived benefits and barriers are identified, veterans still may not act unless they believe that they can intervene appropriately to address the problem. The HBM refers to this step as self-efficacy. Student-veterans must feel empowered to effectively make reasonable accommodation requests and negotiate any potential setbacks to the implementation of those accommodations. Health care providers should inform veterans about the availability of a disability resource center or other counseling service at each school that can help the student-veteran through the process of accommodation approval. Ideally, student-veterans also should receive guidance on how to approach professors regarding both the request for and the implementation of the approved reasonable accommodations.15 Counselors at the institution should offer this guidance and help veterans select the appropriate accommodations.

In the HBM, cues to action occur at every step. These cues consist of the influential factors promoting the desired behavior. Providing answers to common veteran questions about academic accommodations is one cue to action. Another is providing a written step-by-step guide explaining academic accommodations to veterans. (The author has created a veteran-centric guide to academic accommodations. The guide, which explains basic concepts and addresses common barriers to requesting such accommodations, is available upon request from [email protected]).

At all times, positive feedback from clinicians is important in motivating veterans to complete the entire process. Discussion may be stalled at any point if veterans overestimate current academic abilities or underestimate their level of impaired learning ability. Motivational interviewing techniques may help resolve this impasse. However, even if eligible veterans are not interested in pursuing academic accommodations, HCPs should leave the option open for consideration. Although interventions are most beneficial when instituted early in the student’s coursework, veterans can formally request academic accommodations at any stage of their academic career.

 

 

Conclusion

Formal academic accommodations are viable tools for cultivating academic success among student-veterans with significant psychiatric conditions. The adoption of such interventions requires understanding post-9/11 veterans’ motivation and concerns about formal academic accommodation requests. Application of the HBM can guide clinicians in their discussions with post-9/11 veterans. By understanding the veterans’ perspectives on the subject, HCPs can directly address the factors influencing the decision to seek academic accommodations.

Ensuring successful transition to the student-veteran role is of prime importance for veterans who bear emotional scars from military service. To this author’s knowledge, no structured educational programs currently exist that inform either post-9/11 veterans or their HCPs about pertinent aspects of academic accommodations for student-veterans with symptomatic psychiatric diagnoses that impede learning. Future endeavors need to include development of programs to inform veterans and providers about this important topic. Such programs should not only promote the dissemination of general information, but also explore specific ways to tailor accommodations to the cognitive needs of each veteran.

References

1. Burriss L, Ayers E, Ginsberg J, Powell DA. Learning and memory impairment in PTSD: relationship to depression. Depress Anxiety. 2008;25(2):149-157.

2. Sweeney JA, Kmiec JA, Kupfer DJ. Neuropsychologic impairments in bipolar and unipolar mood disorders on the CANTAB neurocognitive battery. Biol Psychiatry. 2000;48(7):674-684.

3. Chamberlain SR, Sahakian BJ. The neuropsychology of mood disorders. Curr Psychiatry Rep. 2006;8(6):458-463.

4. Jaeger J, Berns S, Uzelac S, Davis-Conway S. Neurocognitive deficits and disability in major depressive disorder. Psychiatry Res. 2006;145(1):39-48.

5. Branker C. Deserving design: the new generation of student veterans. J Postsecond Educ Disabil. 2009;22(1):59-66.

6. Burnett SE, Segoria J. Collaboration for military transition students from combat to college: it takes a community. J Postsecond Educ and Disabil. 2009;22(1):53-58.

7. Mitchell K. Understanding academic reasonable accommodations for post-9/11 veterans with psychiatric diagnoses—part 1, the foundation. Fed Pract. 2016;33(4):33-39.

8. Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the health belief model. Health Educ Q. 1988;15(2):175-183.

9. Glanz K, Rimer BK. Theory at a Glance: A Guide for Health Promotion Practice. 2nd ed. Bethesda, MD: U.S. Deptartment of Health and Human Services, National Institutes of Health, National Cancer Institute; 2005.

10. Janz NK, Becker MH. The health belief model: a decade later. Health Educ Q. 1984;11(1):1-47.

11. Salzer MS, Wick LC, Rogers JA. Familiarity with and use of accommodations and supports among postsecondary students with mental illnesses. Psychiatr Serv. 2008;59(4):370-375.

12. Shackelford AL. Documenting the needs of student veterans with disabilities: intersection roadblocks, solutions, and legal realities. J Postsecond Educ Disabil. 2009;22(1):36-42.

13. Eisenberg D, Downs MF, Golberstein E, Zivin K. Stigma and help seeking for mental health among college students. Med Care Res Rev. 2009;66(5):522-541.

14. Vogt D. Mental health related beliefs as a barrier to service use for military personnel and veterans: a review. Psychiatr Serv. 2011;62(2):135-142.

15. Palmer C, Roessler RT. Requesting classroom accommodations: self-advocacy and conflict resolution training for college students with disabilities. J Rehabil. 2000;66(3):38-43.

References

1. Burriss L, Ayers E, Ginsberg J, Powell DA. Learning and memory impairment in PTSD: relationship to depression. Depress Anxiety. 2008;25(2):149-157.

2. Sweeney JA, Kmiec JA, Kupfer DJ. Neuropsychologic impairments in bipolar and unipolar mood disorders on the CANTAB neurocognitive battery. Biol Psychiatry. 2000;48(7):674-684.

3. Chamberlain SR, Sahakian BJ. The neuropsychology of mood disorders. Curr Psychiatry Rep. 2006;8(6):458-463.

4. Jaeger J, Berns S, Uzelac S, Davis-Conway S. Neurocognitive deficits and disability in major depressive disorder. Psychiatry Res. 2006;145(1):39-48.

5. Branker C. Deserving design: the new generation of student veterans. J Postsecond Educ Disabil. 2009;22(1):59-66.

6. Burnett SE, Segoria J. Collaboration for military transition students from combat to college: it takes a community. J Postsecond Educ and Disabil. 2009;22(1):53-58.

7. Mitchell K. Understanding academic reasonable accommodations for post-9/11 veterans with psychiatric diagnoses—part 1, the foundation. Fed Pract. 2016;33(4):33-39.

8. Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the health belief model. Health Educ Q. 1988;15(2):175-183.

9. Glanz K, Rimer BK. Theory at a Glance: A Guide for Health Promotion Practice. 2nd ed. Bethesda, MD: U.S. Deptartment of Health and Human Services, National Institutes of Health, National Cancer Institute; 2005.

10. Janz NK, Becker MH. The health belief model: a decade later. Health Educ Q. 1984;11(1):1-47.

11. Salzer MS, Wick LC, Rogers JA. Familiarity with and use of accommodations and supports among postsecondary students with mental illnesses. Psychiatr Serv. 2008;59(4):370-375.

12. Shackelford AL. Documenting the needs of student veterans with disabilities: intersection roadblocks, solutions, and legal realities. J Postsecond Educ Disabil. 2009;22(1):36-42.

13. Eisenberg D, Downs MF, Golberstein E, Zivin K. Stigma and help seeking for mental health among college students. Med Care Res Rev. 2009;66(5):522-541.

14. Vogt D. Mental health related beliefs as a barrier to service use for military personnel and veterans: a review. Psychiatr Serv. 2011;62(2):135-142.

15. Palmer C, Roessler RT. Requesting classroom accommodations: self-advocacy and conflict resolution training for college students with disabilities. J Rehabil. 2000;66(3):38-43.

Issue
Federal Practitioner - 33(5)
Issue
Federal Practitioner - 33(5)
Page Number
19-25
Page Number
19-25
Publications
Publications
Topics
Article Type
Display Headline
Academic Reasonable Accommodations for Post-9/11 Veterans With Psychiatric Diagnoses, Part 2
Display Headline
Academic Reasonable Accommodations for Post-9/11 Veterans With Psychiatric Diagnoses, Part 2
Legacy Keywords
Katherine Mitchell MD, post-9/11 veterans, posttraumatic stress disorder, mental health, academics
Legacy Keywords
Katherine Mitchell MD, post-9/11 veterans, posttraumatic stress disorder, mental health, academics
Sections
Disallow All Ads
Alternative CME
Article PDF Media

A Real Welcome Home: Permanent Housing for Homeless Veterans

Article Type
Changed
Display Headline
A Real Welcome Home: Permanent Housing for Homeless Veterans
Ending homelessness in Washington, DC, involves the collaboration of government and community partners who can identify and address risk factors for homelessness.

Mr. G is a 67-year-old veteran. During the Vietnam War, he had the “most dangerous job”: helicopter door gunner and mechanic. He served in multiple combat missions and was under constant threat of attack. On returning to the U.S., he experienced anger outbursts, nightmares, hypervigilance, and urges to engage in dangerous behavior, such as driving a motorcycle more than 100 mph. Then he began abusing alcohol and drugs. Mr. G’s behavior and substance abuse eventually led to strained family relationships, termination from a high-paying job, and homelessness.

In 2001, the Washington DC VAMC homeless and substance abuse staff provided outreach and services that helped him secure permanent subsidized housing, achieve and maintain sobriety, get treatment for posttraumatic stress disorder (PTSD), and get full-time employment. Mr. G has maintained permanent supported housing status for 9 years, regained a sense of purpose, remained drug- and alcohol-free since 2001, attended a Vietnam combat PTSD support group weekly, and been an exemplary employee for 8 years.

In 2009, on any given night in the U.S., more than 75,000 veterans were without a permanent home and living on the streets, as Mr. G had been.1 Nearly 150,000 other veterans were spending the night in an emergency shelter or transitional housing. In early 2010, the U.S. Interagency Council on Homelessness (USICH) developed a strategic plan to align federal resources toward 4 key objectives, which included preventing and ending homelessness among veterans. Since then, the most dramatic reductions in homelessness have occurred among veterans, with an overall 33% decline in chronic homelessness nationwide.

According to the U.S. Department of Housing and Urban Development (HUD), permanent housing is defined as community-based housing without a designated length of stay in which formerly homeless individuals live as independently as possible.2 Under permanent housing, a program participant must be the tenant on a lease for at least 1 year, and the lease is renewable and terminable only for cause. The federal definition of the chronically homeless is a person who is homeless and lives in a place not meant for human habitation, in a safe haven, or in an emergency shelter continuously for at least 1 year; or on at least 4 separate occasions within the past 3 years; and who can be diagnosed with ≥ 1 of the following conditions: substance use disorder, serious mental illness, developmental disability as defined in section 102 of the Developmental Disabilities Assistance Bill of Rights Act of 2000 (42 U.S.C. 15002), PTSD, cognitive impairments caused by brain injury, and chronic physical illness or disability.3

Ending homelessness makes sense from a variety of perspectives. From a moral perspective, no one should experience homelessness, but this is especially true for the men and women who have served in the U.S. military. From a health care and resources perspective, homelessness is associated with poorer medical outcomes; higher medical costs for emergency department visits and hospital admissions; longer stays (often for conditions that could be treated in ambulatory settings); and increased mortality.4-7 From a societal perspective, homelessness is associated with costs for shelters and other forms of temporary housing and with higher justice system costs stemming from police, court, and jail involvement.8 The higher justice system costs are in part attributable to significantly longer incarcerations for homeless persons than for demographically similar inmates who have been similarly charged but have housing.9 According to recent studies, significant cost reductions have been achieved by addressing homelessness and providing permanent housing, particularly for the chronically homeless with mental illness.10-14

This article describes the efforts that have been made, through collaborations and coalitions of government and community partners, to identify and address risk factors for homelessness in Washington, DC—and ultimately to end veteran homelessness in the nation’s capitol.

Historic Perspective on Veteran Homelessness

Although the problem was first described after the Revolutionary War and again after the Civil War, homelessness among U.S. veterans has only recently been academically studied. During the colonial period, men often were promised pensions or land grants in exchange for military service. Several states failed to deliver on these promises, throwing veterans into dire financial circumstances and leaving them homeless. By the end of the Civil War, the size of the veteran population (almost 2 million, counting only those who fought for the Union), combined with an unemployment rate of 40% and economic downturns, led to thousands of veterans becoming homeless.15,16

Homelessness among veterans continued after World War I. In 1932, more than 15,000 homeless and disabled “Bonus Army,” World War I veterans, marched on Washington to demand payment of the financial benefits promised for their military service.

 

 

Although World War II and Korean War veterans did not experience homelessness as previous veterans had, the problem resurfaced after Vietnam—the combat veterans of that war were overrepresented among the homeless.17,18 Those at highest risk ranged from age 35 to 44 years in the early years of the all-volunteer military. It has been suggested that their increased risk may reflect social selection—volunteers for military service came from poor economic backgrounds with fewer social supports.19 A more recent study found that 3.8% of more than 300,000 Iraq and Afghanistan veterans who were followed for 5 years after military discharge experienced a homeless episode.20 Female veterans similarly are overrepresented among the homeless.21 Female veterans represent only 1% of the overall female population, yet 3% to 4% are homeless.

Homelessness has always been a social problem, but only during the 1970s and 1980s did homelessness increase in importance—the number of visibly homeless people rose during that period—and investigators began to study and address the issue. Experts have described several factors that contributed to the increase in homelessness during that time.22,23 First, as part of the deinstitutionalization initiative, thousands of mentally ill persons were released from state mental hospitals without a plan in place for affordable or supervised housing. Second, single-room-occupancy dwellings in poor areas, where transient single men lived, were demolished, and affordable housing options decreased. Third, economic and social changes were factors, such as a decreased need for seasonal and unskilled labor; reduced likelihood that relatives will take in homeless family members; and decriminalized public intoxication, loitering, and vagrancy. Out of these conditions came an interest in studying the causes of and risk factors for veteran homelessness and in developing a multipronged approach to end veteran homelessness.

Demographics

Nationally, veterans account for 9% of the homeless population.24 Predominantly, they are single men living in urban areas—only about 9% are women—and 43% served during the Vietnam era.24 Among homeless veterans, minorities are overrepresented—45% are African American or Hispanic, as contrasted with 10% and 3%, respectively, of the general population. More than two-thirds served in the military for more than 3 years, and 76% have a history of mental illness or substance abuse. Compared with the general homeless population, homeless veterans are older, better educated, more likely to have been married, and more likely to have health insurance, primarily through the VA.24,25

The Washington, DC, metropolitan area encompasses the District of Columbia, northern Virginia, the tricounty area of southern Maryland, and Montgomery and Prince George’s counties in Maryland. Demographics for veterans in this area vary somewhat from national figures. According to the 2015 Point-in-Time survey of the homeless, veterans accounted for 5% of the homeless population (less than the national percentage). Most homeless veterans were single men (11.6% were women) and African American (65% of single adults, 85% of adults in families). Forty-five percent reported being employed and 40% had a substance use disorder or a serious mental illness. A large proportion also had at least 1 physical disability, such as hypertension, hepatitis, arthritis, diabetes mellitus, or heart disease.26

Risk Factors

Multiple studies and multivariate analyses have determined that veteran status is associated with an increased risk for homelessness for both male and female veterans.27 Female veterans were 3 times and male veterans 2 times more likely than nonveterans to become homeless, even when poverty, age, race, and geographic variation were controlled. A recent systematic review of U.S. veterans found that the strongest and most consistent risk factors for homelessness were substance use disorders and mental illness, particularly psychotic disorders. Posttraumatic stress disorder was not more significant than other mental conditions but it was a risk factor. Low income, unemployment, and poor money management were also factors.

Social risk factors include lack of support from family and friends. Military service with multiple deployments, transfers, and on-base housing may contribute to interruption of social support and lead to social isolation, thus increasing veterans’ risk for homelessness. Some studies have found that veterans are more likely to report physical injury or medical problems as contributing to homelessness and more likely to have 2 or more chronic medical conditions. Last, history of incarceration and adverse childhood experiences (eg, behavioral problems, family instability, foster care, childhood abuse) also have been found to be risk factors for homelessness among veterans and nonveterans alike.

Understanding these risk factors is an important step in addressing homelessness. Homelessness prevention efforts can screen for these risk factors and then intervene as quickly as possible. Access to mental health and substance abuse services, employment assistance, disability benefits and other income supports, and social services may prevent initial and subsequent episodes of homelessness. The VA, as the largest integrated health system in the U.S., is a critical safety net for low-income and disabled veterans with complex psychosocial needs. One study found access to VA service-connected pensions was protective against homelessness.28

 

 

Addressing Homelessness

There are 10 USICH-recommended strategies for ending veteran homelessness (Table 1). These strategies cannot be achieved by any single federal agency or exclusively by government agencies—they require multipronged approaches and private and public partnerships. In early 2011, the staff of the Washington DC VAMC homeless program identified a single point of contact who would regularly meet with each Continuum of Care local planning body and each Public Housing Authority (PHA). This contact could identify homeless veterans regardless of the agency from which they were requesting assistance. The contact also facilitated identification of specific bottleneck issues contributing to delays in housing veterans. One such issue was that veterans were filling out application forms by themselves, and in some cases, their information was incomplete, or supporting documents (eg, government-issued IDs) were missing. The VA team adjusted the procedures to better meet veterans’ needs. Now veterans identified as meeting requirements for housing assistance are enrolled in classes in which a caseworker reviews their completed applications to ensure they are complete and supporting documents included. If an ID is needed, the caseworker facilitates the process and then submits the veteran’s application to the local PHA for processing. The result has been no returned applications.

Another issue was that in some cases a veteran spoke with the PHA and indicated interest in an apartment and only later found out that the apartment failed inspection. There would then be back-and-forth communications between PHA and landlord to have repairs made so the unit could pass inspection, which often resulted in long delays. The solution was to have a stock of preinspected housing options. The Washington DC VAMC homeless program now has a housing specialist who identifies preinspected units and can expedite the lease to a veteran. In addition, the homeless program in partnership with the PHA now sets up regular meet-and-greet events for landlords and veterans so veterans can preview available rentals.

Housing-First Model

The homeless program readily adopted the housing-first model. This model focuses on helping individuals and families access housing as quickly as possible and remain permanently housed; this assistance is not time-limited but ongoing. After housing placement, the client can choose from an array of both time-limited and long-term services, which are individualized to promote housing stability and individual well-being. Most important, housing is not contingent on compliance with services. Instead, participants must comply with a standard lease agreement and are provided the services and support that can help them do so successfully. Services are determined by completing needs assessments. In addition, as a veteran is applying for housing, a caseworker actively uses motivational interviewing techniques to enhance the likelihood that the veteran will accept services.

 

Providing Core Service to Veterans

In 2012, the Washington DC VAMC opened the Community Resource and Referral Center (CRRC) as a one-stop shop for homeless and at-risk veterans in need of basic, core, wraparound services through the VA. Basic services include showers, laundry facilities, and a chapel. The CRRC has onsite psychiatric services that can engage veterans in mental health and substance abuse treatment. There is also an onsite primary care team who specialize in working with the homeless and can address any acute or chronic medical problems. For veterans who want to return to employment, there is an onsite Compensated Work Therapy program, which has uniquely partnered with the VAMC as well as community partners (eg, National Archives, Smithsonian Institution, Quantico National Cemetery, Arlington National Cemetery) to offer therapeutic job experiences that often lead to gainful full-time employment.

Veterans can use an onsite computer lab to complete resumes and apply for employment online, with the assistance of veteran peer specialists and vocational rehabilitation specialists. For veterans who are unable to work, the homeless program team assists with disability applications. Social Security, Veterans Benefits Administration representatives, and Legal Aid have office hours at the CRRC to provide one-stop shopping for veterans. Additional community partnerships have led to classes to help veterans manage income effectively, and veterans are assisted with completing tax returns.

Representatives from the Veterans Justice Outreach (VJO) and Health Care for Re-entry Veterans (HCRV) programs are also onsite. The VJO program provides outreach, assessment, and case management for justice-involved veterans to prevent unnecessary criminalization of mental illness and extended incarceration. A VJO program specialist works with courts, legal representatives, and jails and acts as a liaison to engage veterans in treatment and prevent incarcerations through jail diversion strategies. The HCRV program assists incarcerated veterans with reentry into the community through outreach and prerelease assessments, and referrals and links to medical, psychiatric, and social services, including employment services on release. This program also can provide short-term case management assistance on release.

 

 

In 2013, to further the implementation of the USICH strategies in the Washington, DC, metropolitan area, 12 local government and nonprofit agencies entered into the Veterans NOW coalition (Table 2). This collaboration enabled development of a coordinated effort to identify all area veterans experiencing homelessness, regardless of which agency the veterans contacted. Further, this team set up processes to assess veterans’ housing and service needs and to match each veteran to the most appropriate housing resource. There was consensus regarding use of the Service Prioritization Decision Assistance Tool (SPDAT) as the evidence-informed approach for prioritizing client needs and identifying areas in which support is most likely needed to prevent housing instability.29 More than 50 staff members at 20 different agencies in the District of Columbia have now been trained and are using this tool.

Outcomes

In 2010, the Point-in-Time count identified 718 homeless veterans in the Washington, DC, metropolitan area. By 2016, that number had dropped to 326 (55% reduction). During this same period, the number of veterans served by the Washington DC VAMC homeless program more than tripled, from 2,100 individuals in 2010 to nearly 6,400 in 2015. The coalition has housed or prevented homelessness for nearly 1,300 veterans during the past 2 years alone. Veterans were housed through multiple programs and efforts, including VA Supportive Housing (VASH), Supportive Services for Veteran Families, and Washington, DC Department of Human Services Permanent Supportive Housing. During the past year, > 60% of veterans were successfully placed in VASH housing within 90 days of application submission. Table 3 lists the national targets for assessing performance measurement and success. Not only were the various performance measure benchmarks exceeded, but more important, > 90% of veterans in VASH and Health Care for Homeless Veterans were able to keep their housing stabilized. Using SPDAT, the most chronically homeless and vulnerable were housed first, which accounts for the lower numbers of homeless Washington, DC, area veterans with substance abuse and mental health problems identified in the Point-in-Time survey.

Discussion

At the Washington DC VAMC, HCHV program staff members used evidence-based and evidence-informed tools, collaborated with community partners, and implemented recommended best practices to end veteran homelessness by 2015. Permanent supportive housing through VASH is crucial for helping veterans overcome their lack of income and in providing mechanisms for engaging in mental health and substance abuse services as well as primary care and therapeutic employment opportunities.

When former VA Secretary Eric K. Shinseki first announced the goal of ending veteran homelessness by 2015, many people questioned this goal’s attainability and feasibility. However, through the adoption of the strategies recommended by USICH, the establishment of government and community partnerships (including faith-based groups) and the implementation of programs addressing substance abuse issues, mental and physical health, income limitations, and employment, this goal now seems possible. Overall veteran homelessness decreased by 36% since 2010, and unsheltered homelessness decreased by nearly 50%.30 By the end of 2015, nearly 65,000 veterans are in permanent housing nationwide, and another 8,100 are in the process of obtaining permanent supportive housing. Also, 87% of unsheltered veterans were able to move to safe housing within 30 days of engagement. Last, Supportive Services for Veteran Families was able to assist more than 156,800 individuals (single veterans as well as their children and families).

Sustainability from a national perspective also depends on continued federal funding. Mr. G, described at the beginning of this article, served his country honorably but then experienced the factors that put him at risk for homelessness. Through a veteran-centric team approach, he was able to successfully address each of these factors. As there are another 500 homeless veterans in Washington, DC, much work still needs to be done. With important collaborations and partnerships now in place, the goal of ending veteran homelessness in the District of Columbia is within sight. When homelessness is a thing of the past, we will truly be able to Welcome Home each veteran.

References

1. U.S. Department of Housing and Urban Development, Office of Community Planning and Development; U.S. Department of Veterans Affairs, National Center on Homelessness Among Veterans Veteran Homelessness: A Supplemental Report to the 2009 Annual Homeless Assessment Report to Congress.https://www.hudexchange.info/resources/documents/2009AHARveterans Report.pdf. Accessed April 19, 2016.

2. HUD Exchange. Homeless emergency assistance and rapid transition to housing (HEARTH): defining “homeless” final rule. HUD Exchange website. https://www.hudexchange.info/resource/1928 /hearth-defining-homeless-final-rule. Published November 2011. Accessed April 5, 2016.

3. U.S. Department of Health and Human Services, Administration for Community Living (ACL), Administration on Intellectual and Developmental Disabilities. The Developmental Disabilities Assistance and Bill of Rights Act of 2000. http://www.acl.gov/Programs/AIDD/DDA_BOR _ACT_2000/docs/dd_act.pdf. Accessed April 5, 2016. 4. Hwang SW. Mortality among men using homeless shelters in Toronto, Ontario. JAMA. 2000;283(16):2152-2157.

5. O’Connell JJ. Premature Mortality in Homeless Populations: A Review of the Literature. Nashville, TN: National Health Care for the Homeless Council; 2005.

6. Salit SA, Kuhn EM, Hartz AJ, Vu JM, Mosso AL. Hopitalization costs associated with homelessness in New York City. N Engl J Med. 1998;338(24):1734-1740.

7. Kushel MB, Perry S, Bangsberg D, Clark R, Moss AR. Emergency department use among the homeless and marginally housed: results from a community-based study. Am J Public Health. 2002;92(5):778-784.

8. Larimer ME, Malone DK, Garner MD, et al. Healthcare and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems. JAMA. 2009;301(13):1349-1357.

9. McNeil DE, Binder RL, Robinson JC. Incarceration associated with homelessness, mental disorder, and co-occurring substance abuse. Psychiatr Serv. 2005;56(7):840-846.

10. Rosenheck R. Cost-effectiveness of services for mentally ill homeless people: the application of research to policy and practice. Am J Psychiatry. 2000;157(10):1563-1570.

11. Culhane DP, Metraux S, Hadley T. Public service reductions associated with placement of homeless people with severe mental illness in supportive housing. Housing Policy Debate. 2002;13(1):107-163.

12. Martinez TE, Burt MR. Impact of permanent supportive housing on the use of acute care health services by homeless adults. Psychiatr Serv. 2006;57(7):992-999.

13. Culhane DP, Parker WD, Poppe B, et al. Accountability, cost-effectiveness, and program performance: progress since 1998. In: Dennis D, Locke G, Khadduri J, eds. Toward Understanding Homelessness: The 2007 National Symposium on Homelessness Research. Washington, DC: Substance Abuse and Mental Health Services Administration, U.S. Dept of Health and Human Services; Office of Policy Development and Research, U.S. Dept of Housing and Urban Development; 2007.

14. Poulin SR, Maguire M, Metraux S, Culhane DP. Service use and costs for persons experiencing chronic homelessness in Philadelphia: a population-based study. Psychiatr Serv. 2010;61(11):1093-1098.

15. U.S. Department of Veterans Affairs. VA History in Brief. http://www.va.gov/opa/publications/archives /docs/history_in_brief.pdf. U.S. Department of Veteran Affairs website. Published December 27, 2013. Accessed April 19, 2016.

16. Kusmer KL. Down and Out, on the Road: The Homeless in American History. New York, NY: Oxford University Press; 2002.

17. Baumohl J, ed. Homelessness in America. Westport, CT: Oryx Press; 1996.

18. Fargo J, Metraux S, Byrne T, et al. Prevalence and risk of homelessness among U.S. veterans: a multisite investigation. http://www.va.gov/HOMELESS/docs/Center/Prevalence_Final.pdf. Published August 2011. Accessed April 19, 2016.

19. Tsai J, Mares AS, Rosenheck R, Gamache D. Do homeless veterans have the same needs and outcomes as non-veterans? Mil Med. 2012;177(1):27-31.

20. Metraux S, Clegg L, Daigh JD, Culhane DP, Kane V. Risk factors for becoming homeless among a cohort of veterans who served in the era of the Iraq and Afghanistan conflicts. Am J Public Health. 2013;103(suppl 2):S255-S261.

21. Perl L. Veterans and homelessness. Congressional research Service Report RL34024. https://www.fas .org/sgp/crs/misc/RL34024.pdf.Published November 6, 2015. Accessed April 7, 2016.

22. Rossi PH. Down and Out in America: The Origins of Homelessness. Chicago, IL: University of Chicago Press; 1989.

23. Burt M. Over the Edge: The Growth of Homelessness in the 1980s. New York, NY: Russell Sage Foundation; 1992.

24. National Coalition for the Homeless. Homeless Veterans [fact sheet]. http://www .nationalhomeless.org/factsheets/veterans.html. September 2009. Accessed April 19, 2016.

25. Tessler R, Rosenheck R, Gamache F. Comparison of homeless veterans with other homeless men in a large clinical outreach program. Psychiatr Q. 2002;73(2):109-119.

26. Chapman H. Homelessness in Metropolitan Washington: Results and Analysis From the 2015 Point-in-Time Count of Persons Experiencing Homelessness in the Metropolitan Washington Region. Metropolitan Washington Council of Governments website. https://www .mwcog.org/uploads/pub-documents/v15Wlk20150514094353.pdf. Published May 13, 2015. Accessed April 6, 2016.

27. Tsai J, Rosenheck R. Risk factors for homelessness among US veterans. Epidemiol Rev. 2015;37:177-195.

28. Edens EL, Kasprow W, Tsai J, Rosenheck R. Association of substance use and VA service-connected disability benefits with risk of homelessness among veterans. Am J Addict. 2011;20(5):412-419.

29. OrgCode Consulting. Service Prioritization Decision Assistance Tool (SPDAT). http://www.orgcode .com/product/spdat/. Accessed April 19, 2016.

30. Performance.gov. End veteran homelessness: progress update. Performance.gov website. https://www.performance.gov/content/end-veteran-homelessness#progressUpdate. Accessed April 6, 2016.

Article PDF
Author and Disclosure Information

Dr. Llorente is a geriatric psychiatrist and associate chief of staff for mental health, Mr. Morton is a social worker and coordinator of the Health Care for Homeless Veterans program, Ms. Boughton is a social worker and chief of social work services, and Dr. Crawford is a registered nurse and associate chief nurse for mental health, all at the Washington DC VAMC. Dr. Llorente is a professor of psychiatry at Georgetown University School of Medicine and Dr. Crawford is adjunct clinical professor of nursing at George Washington University, all in Washington, DC.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Issue
Federal Practitioner - 33(5)
Publications
Topics
Page Number
26-31
Legacy Keywords
homeless veterans, substance abuse, housing, Maria D. Llorente, Kevin Morton, Sevena Boughton, Patricia Crawford, U.S. Interagency Council on Homelessness
Sections
Author and Disclosure Information

Dr. Llorente is a geriatric psychiatrist and associate chief of staff for mental health, Mr. Morton is a social worker and coordinator of the Health Care for Homeless Veterans program, Ms. Boughton is a social worker and chief of social work services, and Dr. Crawford is a registered nurse and associate chief nurse for mental health, all at the Washington DC VAMC. Dr. Llorente is a professor of psychiatry at Georgetown University School of Medicine and Dr. Crawford is adjunct clinical professor of nursing at George Washington University, all in Washington, DC.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Dr. Llorente is a geriatric psychiatrist and associate chief of staff for mental health, Mr. Morton is a social worker and coordinator of the Health Care for Homeless Veterans program, Ms. Boughton is a social worker and chief of social work services, and Dr. Crawford is a registered nurse and associate chief nurse for mental health, all at the Washington DC VAMC. Dr. Llorente is a professor of psychiatry at Georgetown University School of Medicine and Dr. Crawford is adjunct clinical professor of nursing at George Washington University, all in Washington, DC.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Article PDF
Article PDF
Related Articles
Ending homelessness in Washington, DC, involves the collaboration of government and community partners who can identify and address risk factors for homelessness.
Ending homelessness in Washington, DC, involves the collaboration of government and community partners who can identify and address risk factors for homelessness.

Mr. G is a 67-year-old veteran. During the Vietnam War, he had the “most dangerous job”: helicopter door gunner and mechanic. He served in multiple combat missions and was under constant threat of attack. On returning to the U.S., he experienced anger outbursts, nightmares, hypervigilance, and urges to engage in dangerous behavior, such as driving a motorcycle more than 100 mph. Then he began abusing alcohol and drugs. Mr. G’s behavior and substance abuse eventually led to strained family relationships, termination from a high-paying job, and homelessness.

In 2001, the Washington DC VAMC homeless and substance abuse staff provided outreach and services that helped him secure permanent subsidized housing, achieve and maintain sobriety, get treatment for posttraumatic stress disorder (PTSD), and get full-time employment. Mr. G has maintained permanent supported housing status for 9 years, regained a sense of purpose, remained drug- and alcohol-free since 2001, attended a Vietnam combat PTSD support group weekly, and been an exemplary employee for 8 years.

In 2009, on any given night in the U.S., more than 75,000 veterans were without a permanent home and living on the streets, as Mr. G had been.1 Nearly 150,000 other veterans were spending the night in an emergency shelter or transitional housing. In early 2010, the U.S. Interagency Council on Homelessness (USICH) developed a strategic plan to align federal resources toward 4 key objectives, which included preventing and ending homelessness among veterans. Since then, the most dramatic reductions in homelessness have occurred among veterans, with an overall 33% decline in chronic homelessness nationwide.

According to the U.S. Department of Housing and Urban Development (HUD), permanent housing is defined as community-based housing without a designated length of stay in which formerly homeless individuals live as independently as possible.2 Under permanent housing, a program participant must be the tenant on a lease for at least 1 year, and the lease is renewable and terminable only for cause. The federal definition of the chronically homeless is a person who is homeless and lives in a place not meant for human habitation, in a safe haven, or in an emergency shelter continuously for at least 1 year; or on at least 4 separate occasions within the past 3 years; and who can be diagnosed with ≥ 1 of the following conditions: substance use disorder, serious mental illness, developmental disability as defined in section 102 of the Developmental Disabilities Assistance Bill of Rights Act of 2000 (42 U.S.C. 15002), PTSD, cognitive impairments caused by brain injury, and chronic physical illness or disability.3

Ending homelessness makes sense from a variety of perspectives. From a moral perspective, no one should experience homelessness, but this is especially true for the men and women who have served in the U.S. military. From a health care and resources perspective, homelessness is associated with poorer medical outcomes; higher medical costs for emergency department visits and hospital admissions; longer stays (often for conditions that could be treated in ambulatory settings); and increased mortality.4-7 From a societal perspective, homelessness is associated with costs for shelters and other forms of temporary housing and with higher justice system costs stemming from police, court, and jail involvement.8 The higher justice system costs are in part attributable to significantly longer incarcerations for homeless persons than for demographically similar inmates who have been similarly charged but have housing.9 According to recent studies, significant cost reductions have been achieved by addressing homelessness and providing permanent housing, particularly for the chronically homeless with mental illness.10-14

This article describes the efforts that have been made, through collaborations and coalitions of government and community partners, to identify and address risk factors for homelessness in Washington, DC—and ultimately to end veteran homelessness in the nation’s capitol.

Historic Perspective on Veteran Homelessness

Although the problem was first described after the Revolutionary War and again after the Civil War, homelessness among U.S. veterans has only recently been academically studied. During the colonial period, men often were promised pensions or land grants in exchange for military service. Several states failed to deliver on these promises, throwing veterans into dire financial circumstances and leaving them homeless. By the end of the Civil War, the size of the veteran population (almost 2 million, counting only those who fought for the Union), combined with an unemployment rate of 40% and economic downturns, led to thousands of veterans becoming homeless.15,16

Homelessness among veterans continued after World War I. In 1932, more than 15,000 homeless and disabled “Bonus Army,” World War I veterans, marched on Washington to demand payment of the financial benefits promised for their military service.

 

 

Although World War II and Korean War veterans did not experience homelessness as previous veterans had, the problem resurfaced after Vietnam—the combat veterans of that war were overrepresented among the homeless.17,18 Those at highest risk ranged from age 35 to 44 years in the early years of the all-volunteer military. It has been suggested that their increased risk may reflect social selection—volunteers for military service came from poor economic backgrounds with fewer social supports.19 A more recent study found that 3.8% of more than 300,000 Iraq and Afghanistan veterans who were followed for 5 years after military discharge experienced a homeless episode.20 Female veterans similarly are overrepresented among the homeless.21 Female veterans represent only 1% of the overall female population, yet 3% to 4% are homeless.

Homelessness has always been a social problem, but only during the 1970s and 1980s did homelessness increase in importance—the number of visibly homeless people rose during that period—and investigators began to study and address the issue. Experts have described several factors that contributed to the increase in homelessness during that time.22,23 First, as part of the deinstitutionalization initiative, thousands of mentally ill persons were released from state mental hospitals without a plan in place for affordable or supervised housing. Second, single-room-occupancy dwellings in poor areas, where transient single men lived, were demolished, and affordable housing options decreased. Third, economic and social changes were factors, such as a decreased need for seasonal and unskilled labor; reduced likelihood that relatives will take in homeless family members; and decriminalized public intoxication, loitering, and vagrancy. Out of these conditions came an interest in studying the causes of and risk factors for veteran homelessness and in developing a multipronged approach to end veteran homelessness.

Demographics

Nationally, veterans account for 9% of the homeless population.24 Predominantly, they are single men living in urban areas—only about 9% are women—and 43% served during the Vietnam era.24 Among homeless veterans, minorities are overrepresented—45% are African American or Hispanic, as contrasted with 10% and 3%, respectively, of the general population. More than two-thirds served in the military for more than 3 years, and 76% have a history of mental illness or substance abuse. Compared with the general homeless population, homeless veterans are older, better educated, more likely to have been married, and more likely to have health insurance, primarily through the VA.24,25

The Washington, DC, metropolitan area encompasses the District of Columbia, northern Virginia, the tricounty area of southern Maryland, and Montgomery and Prince George’s counties in Maryland. Demographics for veterans in this area vary somewhat from national figures. According to the 2015 Point-in-Time survey of the homeless, veterans accounted for 5% of the homeless population (less than the national percentage). Most homeless veterans were single men (11.6% were women) and African American (65% of single adults, 85% of adults in families). Forty-five percent reported being employed and 40% had a substance use disorder or a serious mental illness. A large proportion also had at least 1 physical disability, such as hypertension, hepatitis, arthritis, diabetes mellitus, or heart disease.26

Risk Factors

Multiple studies and multivariate analyses have determined that veteran status is associated with an increased risk for homelessness for both male and female veterans.27 Female veterans were 3 times and male veterans 2 times more likely than nonveterans to become homeless, even when poverty, age, race, and geographic variation were controlled. A recent systematic review of U.S. veterans found that the strongest and most consistent risk factors for homelessness were substance use disorders and mental illness, particularly psychotic disorders. Posttraumatic stress disorder was not more significant than other mental conditions but it was a risk factor. Low income, unemployment, and poor money management were also factors.

Social risk factors include lack of support from family and friends. Military service with multiple deployments, transfers, and on-base housing may contribute to interruption of social support and lead to social isolation, thus increasing veterans’ risk for homelessness. Some studies have found that veterans are more likely to report physical injury or medical problems as contributing to homelessness and more likely to have 2 or more chronic medical conditions. Last, history of incarceration and adverse childhood experiences (eg, behavioral problems, family instability, foster care, childhood abuse) also have been found to be risk factors for homelessness among veterans and nonveterans alike.

Understanding these risk factors is an important step in addressing homelessness. Homelessness prevention efforts can screen for these risk factors and then intervene as quickly as possible. Access to mental health and substance abuse services, employment assistance, disability benefits and other income supports, and social services may prevent initial and subsequent episodes of homelessness. The VA, as the largest integrated health system in the U.S., is a critical safety net for low-income and disabled veterans with complex psychosocial needs. One study found access to VA service-connected pensions was protective against homelessness.28

 

 

Addressing Homelessness

There are 10 USICH-recommended strategies for ending veteran homelessness (Table 1). These strategies cannot be achieved by any single federal agency or exclusively by government agencies—they require multipronged approaches and private and public partnerships. In early 2011, the staff of the Washington DC VAMC homeless program identified a single point of contact who would regularly meet with each Continuum of Care local planning body and each Public Housing Authority (PHA). This contact could identify homeless veterans regardless of the agency from which they were requesting assistance. The contact also facilitated identification of specific bottleneck issues contributing to delays in housing veterans. One such issue was that veterans were filling out application forms by themselves, and in some cases, their information was incomplete, or supporting documents (eg, government-issued IDs) were missing. The VA team adjusted the procedures to better meet veterans’ needs. Now veterans identified as meeting requirements for housing assistance are enrolled in classes in which a caseworker reviews their completed applications to ensure they are complete and supporting documents included. If an ID is needed, the caseworker facilitates the process and then submits the veteran’s application to the local PHA for processing. The result has been no returned applications.

Another issue was that in some cases a veteran spoke with the PHA and indicated interest in an apartment and only later found out that the apartment failed inspection. There would then be back-and-forth communications between PHA and landlord to have repairs made so the unit could pass inspection, which often resulted in long delays. The solution was to have a stock of preinspected housing options. The Washington DC VAMC homeless program now has a housing specialist who identifies preinspected units and can expedite the lease to a veteran. In addition, the homeless program in partnership with the PHA now sets up regular meet-and-greet events for landlords and veterans so veterans can preview available rentals.

Housing-First Model

The homeless program readily adopted the housing-first model. This model focuses on helping individuals and families access housing as quickly as possible and remain permanently housed; this assistance is not time-limited but ongoing. After housing placement, the client can choose from an array of both time-limited and long-term services, which are individualized to promote housing stability and individual well-being. Most important, housing is not contingent on compliance with services. Instead, participants must comply with a standard lease agreement and are provided the services and support that can help them do so successfully. Services are determined by completing needs assessments. In addition, as a veteran is applying for housing, a caseworker actively uses motivational interviewing techniques to enhance the likelihood that the veteran will accept services.

 

Providing Core Service to Veterans

In 2012, the Washington DC VAMC opened the Community Resource and Referral Center (CRRC) as a one-stop shop for homeless and at-risk veterans in need of basic, core, wraparound services through the VA. Basic services include showers, laundry facilities, and a chapel. The CRRC has onsite psychiatric services that can engage veterans in mental health and substance abuse treatment. There is also an onsite primary care team who specialize in working with the homeless and can address any acute or chronic medical problems. For veterans who want to return to employment, there is an onsite Compensated Work Therapy program, which has uniquely partnered with the VAMC as well as community partners (eg, National Archives, Smithsonian Institution, Quantico National Cemetery, Arlington National Cemetery) to offer therapeutic job experiences that often lead to gainful full-time employment.

Veterans can use an onsite computer lab to complete resumes and apply for employment online, with the assistance of veteran peer specialists and vocational rehabilitation specialists. For veterans who are unable to work, the homeless program team assists with disability applications. Social Security, Veterans Benefits Administration representatives, and Legal Aid have office hours at the CRRC to provide one-stop shopping for veterans. Additional community partnerships have led to classes to help veterans manage income effectively, and veterans are assisted with completing tax returns.

Representatives from the Veterans Justice Outreach (VJO) and Health Care for Re-entry Veterans (HCRV) programs are also onsite. The VJO program provides outreach, assessment, and case management for justice-involved veterans to prevent unnecessary criminalization of mental illness and extended incarceration. A VJO program specialist works with courts, legal representatives, and jails and acts as a liaison to engage veterans in treatment and prevent incarcerations through jail diversion strategies. The HCRV program assists incarcerated veterans with reentry into the community through outreach and prerelease assessments, and referrals and links to medical, psychiatric, and social services, including employment services on release. This program also can provide short-term case management assistance on release.

 

 

In 2013, to further the implementation of the USICH strategies in the Washington, DC, metropolitan area, 12 local government and nonprofit agencies entered into the Veterans NOW coalition (Table 2). This collaboration enabled development of a coordinated effort to identify all area veterans experiencing homelessness, regardless of which agency the veterans contacted. Further, this team set up processes to assess veterans’ housing and service needs and to match each veteran to the most appropriate housing resource. There was consensus regarding use of the Service Prioritization Decision Assistance Tool (SPDAT) as the evidence-informed approach for prioritizing client needs and identifying areas in which support is most likely needed to prevent housing instability.29 More than 50 staff members at 20 different agencies in the District of Columbia have now been trained and are using this tool.

Outcomes

In 2010, the Point-in-Time count identified 718 homeless veterans in the Washington, DC, metropolitan area. By 2016, that number had dropped to 326 (55% reduction). During this same period, the number of veterans served by the Washington DC VAMC homeless program more than tripled, from 2,100 individuals in 2010 to nearly 6,400 in 2015. The coalition has housed or prevented homelessness for nearly 1,300 veterans during the past 2 years alone. Veterans were housed through multiple programs and efforts, including VA Supportive Housing (VASH), Supportive Services for Veteran Families, and Washington, DC Department of Human Services Permanent Supportive Housing. During the past year, > 60% of veterans were successfully placed in VASH housing within 90 days of application submission. Table 3 lists the national targets for assessing performance measurement and success. Not only were the various performance measure benchmarks exceeded, but more important, > 90% of veterans in VASH and Health Care for Homeless Veterans were able to keep their housing stabilized. Using SPDAT, the most chronically homeless and vulnerable were housed first, which accounts for the lower numbers of homeless Washington, DC, area veterans with substance abuse and mental health problems identified in the Point-in-Time survey.

Discussion

At the Washington DC VAMC, HCHV program staff members used evidence-based and evidence-informed tools, collaborated with community partners, and implemented recommended best practices to end veteran homelessness by 2015. Permanent supportive housing through VASH is crucial for helping veterans overcome their lack of income and in providing mechanisms for engaging in mental health and substance abuse services as well as primary care and therapeutic employment opportunities.

When former VA Secretary Eric K. Shinseki first announced the goal of ending veteran homelessness by 2015, many people questioned this goal’s attainability and feasibility. However, through the adoption of the strategies recommended by USICH, the establishment of government and community partnerships (including faith-based groups) and the implementation of programs addressing substance abuse issues, mental and physical health, income limitations, and employment, this goal now seems possible. Overall veteran homelessness decreased by 36% since 2010, and unsheltered homelessness decreased by nearly 50%.30 By the end of 2015, nearly 65,000 veterans are in permanent housing nationwide, and another 8,100 are in the process of obtaining permanent supportive housing. Also, 87% of unsheltered veterans were able to move to safe housing within 30 days of engagement. Last, Supportive Services for Veteran Families was able to assist more than 156,800 individuals (single veterans as well as their children and families).

Sustainability from a national perspective also depends on continued federal funding. Mr. G, described at the beginning of this article, served his country honorably but then experienced the factors that put him at risk for homelessness. Through a veteran-centric team approach, he was able to successfully address each of these factors. As there are another 500 homeless veterans in Washington, DC, much work still needs to be done. With important collaborations and partnerships now in place, the goal of ending veteran homelessness in the District of Columbia is within sight. When homelessness is a thing of the past, we will truly be able to Welcome Home each veteran.

Mr. G is a 67-year-old veteran. During the Vietnam War, he had the “most dangerous job”: helicopter door gunner and mechanic. He served in multiple combat missions and was under constant threat of attack. On returning to the U.S., he experienced anger outbursts, nightmares, hypervigilance, and urges to engage in dangerous behavior, such as driving a motorcycle more than 100 mph. Then he began abusing alcohol and drugs. Mr. G’s behavior and substance abuse eventually led to strained family relationships, termination from a high-paying job, and homelessness.

In 2001, the Washington DC VAMC homeless and substance abuse staff provided outreach and services that helped him secure permanent subsidized housing, achieve and maintain sobriety, get treatment for posttraumatic stress disorder (PTSD), and get full-time employment. Mr. G has maintained permanent supported housing status for 9 years, regained a sense of purpose, remained drug- and alcohol-free since 2001, attended a Vietnam combat PTSD support group weekly, and been an exemplary employee for 8 years.

In 2009, on any given night in the U.S., more than 75,000 veterans were without a permanent home and living on the streets, as Mr. G had been.1 Nearly 150,000 other veterans were spending the night in an emergency shelter or transitional housing. In early 2010, the U.S. Interagency Council on Homelessness (USICH) developed a strategic plan to align federal resources toward 4 key objectives, which included preventing and ending homelessness among veterans. Since then, the most dramatic reductions in homelessness have occurred among veterans, with an overall 33% decline in chronic homelessness nationwide.

According to the U.S. Department of Housing and Urban Development (HUD), permanent housing is defined as community-based housing without a designated length of stay in which formerly homeless individuals live as independently as possible.2 Under permanent housing, a program participant must be the tenant on a lease for at least 1 year, and the lease is renewable and terminable only for cause. The federal definition of the chronically homeless is a person who is homeless and lives in a place not meant for human habitation, in a safe haven, or in an emergency shelter continuously for at least 1 year; or on at least 4 separate occasions within the past 3 years; and who can be diagnosed with ≥ 1 of the following conditions: substance use disorder, serious mental illness, developmental disability as defined in section 102 of the Developmental Disabilities Assistance Bill of Rights Act of 2000 (42 U.S.C. 15002), PTSD, cognitive impairments caused by brain injury, and chronic physical illness or disability.3

Ending homelessness makes sense from a variety of perspectives. From a moral perspective, no one should experience homelessness, but this is especially true for the men and women who have served in the U.S. military. From a health care and resources perspective, homelessness is associated with poorer medical outcomes; higher medical costs for emergency department visits and hospital admissions; longer stays (often for conditions that could be treated in ambulatory settings); and increased mortality.4-7 From a societal perspective, homelessness is associated with costs for shelters and other forms of temporary housing and with higher justice system costs stemming from police, court, and jail involvement.8 The higher justice system costs are in part attributable to significantly longer incarcerations for homeless persons than for demographically similar inmates who have been similarly charged but have housing.9 According to recent studies, significant cost reductions have been achieved by addressing homelessness and providing permanent housing, particularly for the chronically homeless with mental illness.10-14

This article describes the efforts that have been made, through collaborations and coalitions of government and community partners, to identify and address risk factors for homelessness in Washington, DC—and ultimately to end veteran homelessness in the nation’s capitol.

Historic Perspective on Veteran Homelessness

Although the problem was first described after the Revolutionary War and again after the Civil War, homelessness among U.S. veterans has only recently been academically studied. During the colonial period, men often were promised pensions or land grants in exchange for military service. Several states failed to deliver on these promises, throwing veterans into dire financial circumstances and leaving them homeless. By the end of the Civil War, the size of the veteran population (almost 2 million, counting only those who fought for the Union), combined with an unemployment rate of 40% and economic downturns, led to thousands of veterans becoming homeless.15,16

Homelessness among veterans continued after World War I. In 1932, more than 15,000 homeless and disabled “Bonus Army,” World War I veterans, marched on Washington to demand payment of the financial benefits promised for their military service.

 

 

Although World War II and Korean War veterans did not experience homelessness as previous veterans had, the problem resurfaced after Vietnam—the combat veterans of that war were overrepresented among the homeless.17,18 Those at highest risk ranged from age 35 to 44 years in the early years of the all-volunteer military. It has been suggested that their increased risk may reflect social selection—volunteers for military service came from poor economic backgrounds with fewer social supports.19 A more recent study found that 3.8% of more than 300,000 Iraq and Afghanistan veterans who were followed for 5 years after military discharge experienced a homeless episode.20 Female veterans similarly are overrepresented among the homeless.21 Female veterans represent only 1% of the overall female population, yet 3% to 4% are homeless.

Homelessness has always been a social problem, but only during the 1970s and 1980s did homelessness increase in importance—the number of visibly homeless people rose during that period—and investigators began to study and address the issue. Experts have described several factors that contributed to the increase in homelessness during that time.22,23 First, as part of the deinstitutionalization initiative, thousands of mentally ill persons were released from state mental hospitals without a plan in place for affordable or supervised housing. Second, single-room-occupancy dwellings in poor areas, where transient single men lived, were demolished, and affordable housing options decreased. Third, economic and social changes were factors, such as a decreased need for seasonal and unskilled labor; reduced likelihood that relatives will take in homeless family members; and decriminalized public intoxication, loitering, and vagrancy. Out of these conditions came an interest in studying the causes of and risk factors for veteran homelessness and in developing a multipronged approach to end veteran homelessness.

Demographics

Nationally, veterans account for 9% of the homeless population.24 Predominantly, they are single men living in urban areas—only about 9% are women—and 43% served during the Vietnam era.24 Among homeless veterans, minorities are overrepresented—45% are African American or Hispanic, as contrasted with 10% and 3%, respectively, of the general population. More than two-thirds served in the military for more than 3 years, and 76% have a history of mental illness or substance abuse. Compared with the general homeless population, homeless veterans are older, better educated, more likely to have been married, and more likely to have health insurance, primarily through the VA.24,25

The Washington, DC, metropolitan area encompasses the District of Columbia, northern Virginia, the tricounty area of southern Maryland, and Montgomery and Prince George’s counties in Maryland. Demographics for veterans in this area vary somewhat from national figures. According to the 2015 Point-in-Time survey of the homeless, veterans accounted for 5% of the homeless population (less than the national percentage). Most homeless veterans were single men (11.6% were women) and African American (65% of single adults, 85% of adults in families). Forty-five percent reported being employed and 40% had a substance use disorder or a serious mental illness. A large proportion also had at least 1 physical disability, such as hypertension, hepatitis, arthritis, diabetes mellitus, or heart disease.26

Risk Factors

Multiple studies and multivariate analyses have determined that veteran status is associated with an increased risk for homelessness for both male and female veterans.27 Female veterans were 3 times and male veterans 2 times more likely than nonveterans to become homeless, even when poverty, age, race, and geographic variation were controlled. A recent systematic review of U.S. veterans found that the strongest and most consistent risk factors for homelessness were substance use disorders and mental illness, particularly psychotic disorders. Posttraumatic stress disorder was not more significant than other mental conditions but it was a risk factor. Low income, unemployment, and poor money management were also factors.

Social risk factors include lack of support from family and friends. Military service with multiple deployments, transfers, and on-base housing may contribute to interruption of social support and lead to social isolation, thus increasing veterans’ risk for homelessness. Some studies have found that veterans are more likely to report physical injury or medical problems as contributing to homelessness and more likely to have 2 or more chronic medical conditions. Last, history of incarceration and adverse childhood experiences (eg, behavioral problems, family instability, foster care, childhood abuse) also have been found to be risk factors for homelessness among veterans and nonveterans alike.

Understanding these risk factors is an important step in addressing homelessness. Homelessness prevention efforts can screen for these risk factors and then intervene as quickly as possible. Access to mental health and substance abuse services, employment assistance, disability benefits and other income supports, and social services may prevent initial and subsequent episodes of homelessness. The VA, as the largest integrated health system in the U.S., is a critical safety net for low-income and disabled veterans with complex psychosocial needs. One study found access to VA service-connected pensions was protective against homelessness.28

 

 

Addressing Homelessness

There are 10 USICH-recommended strategies for ending veteran homelessness (Table 1). These strategies cannot be achieved by any single federal agency or exclusively by government agencies—they require multipronged approaches and private and public partnerships. In early 2011, the staff of the Washington DC VAMC homeless program identified a single point of contact who would regularly meet with each Continuum of Care local planning body and each Public Housing Authority (PHA). This contact could identify homeless veterans regardless of the agency from which they were requesting assistance. The contact also facilitated identification of specific bottleneck issues contributing to delays in housing veterans. One such issue was that veterans were filling out application forms by themselves, and in some cases, their information was incomplete, or supporting documents (eg, government-issued IDs) were missing. The VA team adjusted the procedures to better meet veterans’ needs. Now veterans identified as meeting requirements for housing assistance are enrolled in classes in which a caseworker reviews their completed applications to ensure they are complete and supporting documents included. If an ID is needed, the caseworker facilitates the process and then submits the veteran’s application to the local PHA for processing. The result has been no returned applications.

Another issue was that in some cases a veteran spoke with the PHA and indicated interest in an apartment and only later found out that the apartment failed inspection. There would then be back-and-forth communications between PHA and landlord to have repairs made so the unit could pass inspection, which often resulted in long delays. The solution was to have a stock of preinspected housing options. The Washington DC VAMC homeless program now has a housing specialist who identifies preinspected units and can expedite the lease to a veteran. In addition, the homeless program in partnership with the PHA now sets up regular meet-and-greet events for landlords and veterans so veterans can preview available rentals.

Housing-First Model

The homeless program readily adopted the housing-first model. This model focuses on helping individuals and families access housing as quickly as possible and remain permanently housed; this assistance is not time-limited but ongoing. After housing placement, the client can choose from an array of both time-limited and long-term services, which are individualized to promote housing stability and individual well-being. Most important, housing is not contingent on compliance with services. Instead, participants must comply with a standard lease agreement and are provided the services and support that can help them do so successfully. Services are determined by completing needs assessments. In addition, as a veteran is applying for housing, a caseworker actively uses motivational interviewing techniques to enhance the likelihood that the veteran will accept services.

 

Providing Core Service to Veterans

In 2012, the Washington DC VAMC opened the Community Resource and Referral Center (CRRC) as a one-stop shop for homeless and at-risk veterans in need of basic, core, wraparound services through the VA. Basic services include showers, laundry facilities, and a chapel. The CRRC has onsite psychiatric services that can engage veterans in mental health and substance abuse treatment. There is also an onsite primary care team who specialize in working with the homeless and can address any acute or chronic medical problems. For veterans who want to return to employment, there is an onsite Compensated Work Therapy program, which has uniquely partnered with the VAMC as well as community partners (eg, National Archives, Smithsonian Institution, Quantico National Cemetery, Arlington National Cemetery) to offer therapeutic job experiences that often lead to gainful full-time employment.

Veterans can use an onsite computer lab to complete resumes and apply for employment online, with the assistance of veteran peer specialists and vocational rehabilitation specialists. For veterans who are unable to work, the homeless program team assists with disability applications. Social Security, Veterans Benefits Administration representatives, and Legal Aid have office hours at the CRRC to provide one-stop shopping for veterans. Additional community partnerships have led to classes to help veterans manage income effectively, and veterans are assisted with completing tax returns.

Representatives from the Veterans Justice Outreach (VJO) and Health Care for Re-entry Veterans (HCRV) programs are also onsite. The VJO program provides outreach, assessment, and case management for justice-involved veterans to prevent unnecessary criminalization of mental illness and extended incarceration. A VJO program specialist works with courts, legal representatives, and jails and acts as a liaison to engage veterans in treatment and prevent incarcerations through jail diversion strategies. The HCRV program assists incarcerated veterans with reentry into the community through outreach and prerelease assessments, and referrals and links to medical, psychiatric, and social services, including employment services on release. This program also can provide short-term case management assistance on release.

 

 

In 2013, to further the implementation of the USICH strategies in the Washington, DC, metropolitan area, 12 local government and nonprofit agencies entered into the Veterans NOW coalition (Table 2). This collaboration enabled development of a coordinated effort to identify all area veterans experiencing homelessness, regardless of which agency the veterans contacted. Further, this team set up processes to assess veterans’ housing and service needs and to match each veteran to the most appropriate housing resource. There was consensus regarding use of the Service Prioritization Decision Assistance Tool (SPDAT) as the evidence-informed approach for prioritizing client needs and identifying areas in which support is most likely needed to prevent housing instability.29 More than 50 staff members at 20 different agencies in the District of Columbia have now been trained and are using this tool.

Outcomes

In 2010, the Point-in-Time count identified 718 homeless veterans in the Washington, DC, metropolitan area. By 2016, that number had dropped to 326 (55% reduction). During this same period, the number of veterans served by the Washington DC VAMC homeless program more than tripled, from 2,100 individuals in 2010 to nearly 6,400 in 2015. The coalition has housed or prevented homelessness for nearly 1,300 veterans during the past 2 years alone. Veterans were housed through multiple programs and efforts, including VA Supportive Housing (VASH), Supportive Services for Veteran Families, and Washington, DC Department of Human Services Permanent Supportive Housing. During the past year, > 60% of veterans were successfully placed in VASH housing within 90 days of application submission. Table 3 lists the national targets for assessing performance measurement and success. Not only were the various performance measure benchmarks exceeded, but more important, > 90% of veterans in VASH and Health Care for Homeless Veterans were able to keep their housing stabilized. Using SPDAT, the most chronically homeless and vulnerable were housed first, which accounts for the lower numbers of homeless Washington, DC, area veterans with substance abuse and mental health problems identified in the Point-in-Time survey.

Discussion

At the Washington DC VAMC, HCHV program staff members used evidence-based and evidence-informed tools, collaborated with community partners, and implemented recommended best practices to end veteran homelessness by 2015. Permanent supportive housing through VASH is crucial for helping veterans overcome their lack of income and in providing mechanisms for engaging in mental health and substance abuse services as well as primary care and therapeutic employment opportunities.

When former VA Secretary Eric K. Shinseki first announced the goal of ending veteran homelessness by 2015, many people questioned this goal’s attainability and feasibility. However, through the adoption of the strategies recommended by USICH, the establishment of government and community partnerships (including faith-based groups) and the implementation of programs addressing substance abuse issues, mental and physical health, income limitations, and employment, this goal now seems possible. Overall veteran homelessness decreased by 36% since 2010, and unsheltered homelessness decreased by nearly 50%.30 By the end of 2015, nearly 65,000 veterans are in permanent housing nationwide, and another 8,100 are in the process of obtaining permanent supportive housing. Also, 87% of unsheltered veterans were able to move to safe housing within 30 days of engagement. Last, Supportive Services for Veteran Families was able to assist more than 156,800 individuals (single veterans as well as their children and families).

Sustainability from a national perspective also depends on continued federal funding. Mr. G, described at the beginning of this article, served his country honorably but then experienced the factors that put him at risk for homelessness. Through a veteran-centric team approach, he was able to successfully address each of these factors. As there are another 500 homeless veterans in Washington, DC, much work still needs to be done. With important collaborations and partnerships now in place, the goal of ending veteran homelessness in the District of Columbia is within sight. When homelessness is a thing of the past, we will truly be able to Welcome Home each veteran.

References

1. U.S. Department of Housing and Urban Development, Office of Community Planning and Development; U.S. Department of Veterans Affairs, National Center on Homelessness Among Veterans Veteran Homelessness: A Supplemental Report to the 2009 Annual Homeless Assessment Report to Congress.https://www.hudexchange.info/resources/documents/2009AHARveterans Report.pdf. Accessed April 19, 2016.

2. HUD Exchange. Homeless emergency assistance and rapid transition to housing (HEARTH): defining “homeless” final rule. HUD Exchange website. https://www.hudexchange.info/resource/1928 /hearth-defining-homeless-final-rule. Published November 2011. Accessed April 5, 2016.

3. U.S. Department of Health and Human Services, Administration for Community Living (ACL), Administration on Intellectual and Developmental Disabilities. The Developmental Disabilities Assistance and Bill of Rights Act of 2000. http://www.acl.gov/Programs/AIDD/DDA_BOR _ACT_2000/docs/dd_act.pdf. Accessed April 5, 2016. 4. Hwang SW. Mortality among men using homeless shelters in Toronto, Ontario. JAMA. 2000;283(16):2152-2157.

5. O’Connell JJ. Premature Mortality in Homeless Populations: A Review of the Literature. Nashville, TN: National Health Care for the Homeless Council; 2005.

6. Salit SA, Kuhn EM, Hartz AJ, Vu JM, Mosso AL. Hopitalization costs associated with homelessness in New York City. N Engl J Med. 1998;338(24):1734-1740.

7. Kushel MB, Perry S, Bangsberg D, Clark R, Moss AR. Emergency department use among the homeless and marginally housed: results from a community-based study. Am J Public Health. 2002;92(5):778-784.

8. Larimer ME, Malone DK, Garner MD, et al. Healthcare and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems. JAMA. 2009;301(13):1349-1357.

9. McNeil DE, Binder RL, Robinson JC. Incarceration associated with homelessness, mental disorder, and co-occurring substance abuse. Psychiatr Serv. 2005;56(7):840-846.

10. Rosenheck R. Cost-effectiveness of services for mentally ill homeless people: the application of research to policy and practice. Am J Psychiatry. 2000;157(10):1563-1570.

11. Culhane DP, Metraux S, Hadley T. Public service reductions associated with placement of homeless people with severe mental illness in supportive housing. Housing Policy Debate. 2002;13(1):107-163.

12. Martinez TE, Burt MR. Impact of permanent supportive housing on the use of acute care health services by homeless adults. Psychiatr Serv. 2006;57(7):992-999.

13. Culhane DP, Parker WD, Poppe B, et al. Accountability, cost-effectiveness, and program performance: progress since 1998. In: Dennis D, Locke G, Khadduri J, eds. Toward Understanding Homelessness: The 2007 National Symposium on Homelessness Research. Washington, DC: Substance Abuse and Mental Health Services Administration, U.S. Dept of Health and Human Services; Office of Policy Development and Research, U.S. Dept of Housing and Urban Development; 2007.

14. Poulin SR, Maguire M, Metraux S, Culhane DP. Service use and costs for persons experiencing chronic homelessness in Philadelphia: a population-based study. Psychiatr Serv. 2010;61(11):1093-1098.

15. U.S. Department of Veterans Affairs. VA History in Brief. http://www.va.gov/opa/publications/archives /docs/history_in_brief.pdf. U.S. Department of Veteran Affairs website. Published December 27, 2013. Accessed April 19, 2016.

16. Kusmer KL. Down and Out, on the Road: The Homeless in American History. New York, NY: Oxford University Press; 2002.

17. Baumohl J, ed. Homelessness in America. Westport, CT: Oryx Press; 1996.

18. Fargo J, Metraux S, Byrne T, et al. Prevalence and risk of homelessness among U.S. veterans: a multisite investigation. http://www.va.gov/HOMELESS/docs/Center/Prevalence_Final.pdf. Published August 2011. Accessed April 19, 2016.

19. Tsai J, Mares AS, Rosenheck R, Gamache D. Do homeless veterans have the same needs and outcomes as non-veterans? Mil Med. 2012;177(1):27-31.

20. Metraux S, Clegg L, Daigh JD, Culhane DP, Kane V. Risk factors for becoming homeless among a cohort of veterans who served in the era of the Iraq and Afghanistan conflicts. Am J Public Health. 2013;103(suppl 2):S255-S261.

21. Perl L. Veterans and homelessness. Congressional research Service Report RL34024. https://www.fas .org/sgp/crs/misc/RL34024.pdf.Published November 6, 2015. Accessed April 7, 2016.

22. Rossi PH. Down and Out in America: The Origins of Homelessness. Chicago, IL: University of Chicago Press; 1989.

23. Burt M. Over the Edge: The Growth of Homelessness in the 1980s. New York, NY: Russell Sage Foundation; 1992.

24. National Coalition for the Homeless. Homeless Veterans [fact sheet]. http://www .nationalhomeless.org/factsheets/veterans.html. September 2009. Accessed April 19, 2016.

25. Tessler R, Rosenheck R, Gamache F. Comparison of homeless veterans with other homeless men in a large clinical outreach program. Psychiatr Q. 2002;73(2):109-119.

26. Chapman H. Homelessness in Metropolitan Washington: Results and Analysis From the 2015 Point-in-Time Count of Persons Experiencing Homelessness in the Metropolitan Washington Region. Metropolitan Washington Council of Governments website. https://www .mwcog.org/uploads/pub-documents/v15Wlk20150514094353.pdf. Published May 13, 2015. Accessed April 6, 2016.

27. Tsai J, Rosenheck R. Risk factors for homelessness among US veterans. Epidemiol Rev. 2015;37:177-195.

28. Edens EL, Kasprow W, Tsai J, Rosenheck R. Association of substance use and VA service-connected disability benefits with risk of homelessness among veterans. Am J Addict. 2011;20(5):412-419.

29. OrgCode Consulting. Service Prioritization Decision Assistance Tool (SPDAT). http://www.orgcode .com/product/spdat/. Accessed April 19, 2016.

30. Performance.gov. End veteran homelessness: progress update. Performance.gov website. https://www.performance.gov/content/end-veteran-homelessness#progressUpdate. Accessed April 6, 2016.

References

1. U.S. Department of Housing and Urban Development, Office of Community Planning and Development; U.S. Department of Veterans Affairs, National Center on Homelessness Among Veterans Veteran Homelessness: A Supplemental Report to the 2009 Annual Homeless Assessment Report to Congress.https://www.hudexchange.info/resources/documents/2009AHARveterans Report.pdf. Accessed April 19, 2016.

2. HUD Exchange. Homeless emergency assistance and rapid transition to housing (HEARTH): defining “homeless” final rule. HUD Exchange website. https://www.hudexchange.info/resource/1928 /hearth-defining-homeless-final-rule. Published November 2011. Accessed April 5, 2016.

3. U.S. Department of Health and Human Services, Administration for Community Living (ACL), Administration on Intellectual and Developmental Disabilities. The Developmental Disabilities Assistance and Bill of Rights Act of 2000. http://www.acl.gov/Programs/AIDD/DDA_BOR _ACT_2000/docs/dd_act.pdf. Accessed April 5, 2016. 4. Hwang SW. Mortality among men using homeless shelters in Toronto, Ontario. JAMA. 2000;283(16):2152-2157.

5. O’Connell JJ. Premature Mortality in Homeless Populations: A Review of the Literature. Nashville, TN: National Health Care for the Homeless Council; 2005.

6. Salit SA, Kuhn EM, Hartz AJ, Vu JM, Mosso AL. Hopitalization costs associated with homelessness in New York City. N Engl J Med. 1998;338(24):1734-1740.

7. Kushel MB, Perry S, Bangsberg D, Clark R, Moss AR. Emergency department use among the homeless and marginally housed: results from a community-based study. Am J Public Health. 2002;92(5):778-784.

8. Larimer ME, Malone DK, Garner MD, et al. Healthcare and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems. JAMA. 2009;301(13):1349-1357.

9. McNeil DE, Binder RL, Robinson JC. Incarceration associated with homelessness, mental disorder, and co-occurring substance abuse. Psychiatr Serv. 2005;56(7):840-846.

10. Rosenheck R. Cost-effectiveness of services for mentally ill homeless people: the application of research to policy and practice. Am J Psychiatry. 2000;157(10):1563-1570.

11. Culhane DP, Metraux S, Hadley T. Public service reductions associated with placement of homeless people with severe mental illness in supportive housing. Housing Policy Debate. 2002;13(1):107-163.

12. Martinez TE, Burt MR. Impact of permanent supportive housing on the use of acute care health services by homeless adults. Psychiatr Serv. 2006;57(7):992-999.

13. Culhane DP, Parker WD, Poppe B, et al. Accountability, cost-effectiveness, and program performance: progress since 1998. In: Dennis D, Locke G, Khadduri J, eds. Toward Understanding Homelessness: The 2007 National Symposium on Homelessness Research. Washington, DC: Substance Abuse and Mental Health Services Administration, U.S. Dept of Health and Human Services; Office of Policy Development and Research, U.S. Dept of Housing and Urban Development; 2007.

14. Poulin SR, Maguire M, Metraux S, Culhane DP. Service use and costs for persons experiencing chronic homelessness in Philadelphia: a population-based study. Psychiatr Serv. 2010;61(11):1093-1098.

15. U.S. Department of Veterans Affairs. VA History in Brief. http://www.va.gov/opa/publications/archives /docs/history_in_brief.pdf. U.S. Department of Veteran Affairs website. Published December 27, 2013. Accessed April 19, 2016.

16. Kusmer KL. Down and Out, on the Road: The Homeless in American History. New York, NY: Oxford University Press; 2002.

17. Baumohl J, ed. Homelessness in America. Westport, CT: Oryx Press; 1996.

18. Fargo J, Metraux S, Byrne T, et al. Prevalence and risk of homelessness among U.S. veterans: a multisite investigation. http://www.va.gov/HOMELESS/docs/Center/Prevalence_Final.pdf. Published August 2011. Accessed April 19, 2016.

19. Tsai J, Mares AS, Rosenheck R, Gamache D. Do homeless veterans have the same needs and outcomes as non-veterans? Mil Med. 2012;177(1):27-31.

20. Metraux S, Clegg L, Daigh JD, Culhane DP, Kane V. Risk factors for becoming homeless among a cohort of veterans who served in the era of the Iraq and Afghanistan conflicts. Am J Public Health. 2013;103(suppl 2):S255-S261.

21. Perl L. Veterans and homelessness. Congressional research Service Report RL34024. https://www.fas .org/sgp/crs/misc/RL34024.pdf.Published November 6, 2015. Accessed April 7, 2016.

22. Rossi PH. Down and Out in America: The Origins of Homelessness. Chicago, IL: University of Chicago Press; 1989.

23. Burt M. Over the Edge: The Growth of Homelessness in the 1980s. New York, NY: Russell Sage Foundation; 1992.

24. National Coalition for the Homeless. Homeless Veterans [fact sheet]. http://www .nationalhomeless.org/factsheets/veterans.html. September 2009. Accessed April 19, 2016.

25. Tessler R, Rosenheck R, Gamache F. Comparison of homeless veterans with other homeless men in a large clinical outreach program. Psychiatr Q. 2002;73(2):109-119.

26. Chapman H. Homelessness in Metropolitan Washington: Results and Analysis From the 2015 Point-in-Time Count of Persons Experiencing Homelessness in the Metropolitan Washington Region. Metropolitan Washington Council of Governments website. https://www .mwcog.org/uploads/pub-documents/v15Wlk20150514094353.pdf. Published May 13, 2015. Accessed April 6, 2016.

27. Tsai J, Rosenheck R. Risk factors for homelessness among US veterans. Epidemiol Rev. 2015;37:177-195.

28. Edens EL, Kasprow W, Tsai J, Rosenheck R. Association of substance use and VA service-connected disability benefits with risk of homelessness among veterans. Am J Addict. 2011;20(5):412-419.

29. OrgCode Consulting. Service Prioritization Decision Assistance Tool (SPDAT). http://www.orgcode .com/product/spdat/. Accessed April 19, 2016.

30. Performance.gov. End veteran homelessness: progress update. Performance.gov website. https://www.performance.gov/content/end-veteran-homelessness#progressUpdate. Accessed April 6, 2016.

Issue
Federal Practitioner - 33(5)
Issue
Federal Practitioner - 33(5)
Page Number
26-31
Page Number
26-31
Publications
Publications
Topics
Article Type
Display Headline
A Real Welcome Home: Permanent Housing for Homeless Veterans
Display Headline
A Real Welcome Home: Permanent Housing for Homeless Veterans
Legacy Keywords
homeless veterans, substance abuse, housing, Maria D. Llorente, Kevin Morton, Sevena Boughton, Patricia Crawford, U.S. Interagency Council on Homelessness
Legacy Keywords
homeless veterans, substance abuse, housing, Maria D. Llorente, Kevin Morton, Sevena Boughton, Patricia Crawford, U.S. Interagency Council on Homelessness
Sections
Disallow All Ads
Alternative CME
Use ProPublica
Article PDF Media

Veterans’ Satisfaction With Erectile Dysfunction Treatment

Article Type
Changed
Display Headline
Veterans’ Satisfaction With Erectile Dysfunction Treatment
Limited alternatives and lack of knowledge of behavioral methods shown to improve erectile functioning lead many veterans to continue erectile dysfunction treatment despite a lack of satisfaction.

A majority of men (70%) aged ≥ 70 years report erectile dysfunction (ED) in primary care settings.1 Further, the cost of ED medication is increasing: nationally, the VA spent $71.7 million on ED medications in 2013, triple the amount from 2006,2 despite a 2011 VA mandate limiting ED medication prescriptions to 4 doses per month per veteran.3 Unfortunately, although ED is common and costly, only about 12% of men in the community report being asked about their sexual health by their primary care provider (PCP) in the past 3 years.4 Further, little emphasis seems to be placed on preventive care. For example, men with ED in primary care clinics are unaware of ED risk factors such as hypertension, smoking, and obesity; indeed, only 17% of a large community sample could name 1 risk factor for ED.5 This is problematic because diet and exercise improve erectile functioning,yet men may not realize they can reduce ED through behavioral and lifestyle change.6

In addition, there is little research that investigates veterans’ satisfaction with ED treatment and its effectiveness. The taboo nature of talking about erections and sexual health may partially relate to the lack of research. When surveyed, PCPs noted that they do not talk about ED routinely with patients for reasons that include time constraints, lack of experience managing sexual problems, viewing ED medication as a lifestyle drug, perceiving ED as a nonserious concern, discomfort discussing the topic for both male and female PCPs, and viewing ED discussions as the responsibility of providers of the opposite gender.7-9

Given the dearth of ED research within the veteran population, the purpose of the current study was to (1) explore the level of treatment satisfaction of veterans prescribed an ED medication, phosphodiesterase type 5 inhibitor (PDE5); (2) assess patients’ perception of discussions with their PCPs about sexual health concerns; and (3) provide preliminary data on veterans’ knowledge of ED risk factors and identify possible areas for preventive education. This study was intended to highlight areas for further investigation to improve ED treatment satisfaction among veterans.

 

Methods

The authors conducted an anonymous survey with veterans who were prescribed an ED medication within the previous 12 months. In 2012, researchers obtained 8,000 names of veterans prescribed a PDE5 medication at the Clement J. Zablocki VA Medical Center (CJZVAMC) in Milwaukee, Wisconsin, and randomly selected 1,000 persons to mail a research survey to be returned anonymously. Three hundred ten surveys were returned, a 31% response rate, which was similar (32%) to a comparable large ED survey study, in which the participants were randomly selected to participate and also were not recruited by their PCP.10 Because 13 participants were excluded due to incomplete surveys or obtaining primary medical care services outside the VA, the current sample consisted of 297 participants. The CJZVAMC institutional review board approved the study in March 2013, and de-identified data were collected from March 2013 to March 2014.

The authors assessed demographics and treatment information, including whether veterans had talked with their PCP about sexual concerns.

Of the 297 participants, 55% were aged > 65 years. Racial/ethnic groups reflected the veteran population at CJZVAMC, with 78% identifying as European American, 17% as African American, 2% as Hispanic American, 2% as biracial, and 1% as Asian American or American Indian. Eighty-one percent were identified as Christian, and 10% reported no religious preference. Sixty-seven percent reported having a current sexual partner.

Measures

The International Index of Erectile Function (IIEF-5), an abridged version of a longer, 15-item instrument, was administered to assess participants’ erectile function.11,12 The IIEF-5 consists of 5 items that ask about participants’ erectile functioning over the past 6 months. Participants responded to items on a 1 to 5 scale ranging from “almost never/never” to “almost always/always”. Items were summed to create a total score that could range from 5 to 25. Total scores reflect erectile functioning and satisfaction, with low scores indicating greater dysfunction. This measure has shown high sensitivity (.98) and specificity (.88).11 Cut scores for the current study were consistent with the literature: mild ED = 17-21; mild-to-moderate ED = 12-16; moderate ED = 8-11; and severe ED = 5-7.13 Reliability in this sample was α = .93.

The authors were unable to find a validated measure assessing men’s knowledge of ED risk factors in the literature. Therefore, participants’ knowledge of ED risk factors was assessed using an online nonvalidated questionnaire entitled “Impotence [Erectile Dysfunction] Quiz: Test Your Medical IQ of ED” from www.emedicinehelp.com.13 Questions assess knowledge of specific risk factors (eg, age, obesity, depression, prostate cancer), symptoms, incidence rate, treatments, normal erectile functioning, and implications of ED. The questionnaire contains 16 items (3 true/false and 13 multiple choice items), and the total score corresponds to the percentage correct. According to the online version, the average score is 11 items correct (69%).13

 

 


A single item asked participants to identify behavioral changes they had tried to improve their erectile functioning. Options included taking medications at a different time, and/or decreasing tobacco, caffeine, or alcohol consumption. The Erectile Dysfunction Inventory of Treatment Satisfaction – Patient Version (EDITS) is an 11-item questionnaire administered to assess participants’ satisfaction with their medical treatment of ED.14 Items assess treatment satisfaction, ease of use, confidence in ability to perform, partner satisfaction, and naturalness of erections achieved during treatment. These items are rated on a scale ranging from 0 (dissatisfaction) to 4 (high satisfaction) and then summed, with total scores ranging from 0 (extremely dissatisfied) to 100 (extremely satisfied). The measure displayed high internal consistency (α = .90) and high test-retest reliability (r = .98).14 Several studies have used cutoff scores of 0 = very dissatisfied; 25 = dissatisfied; 50 = neither satisfied nor dissatisfied; 75 = satisfied; and 100 = very satisfied.15,16 These cut scores and classifiers were used in the current study; reliability was α = .92.

The authors further explored reasons for veteran dissatisfaction with ED treatment by asking participants to respond to a single item: “Why are you dissatisfied with your erectile dysfunction treatment?” They could indicate that they were satisfied or circle all options for dissatisfaction that applied (“I would like to receive more pills per month,” “The treatment does not work well,” or “I want more information about erectile dysfunction and treatment”), or write in a response. The authors inquired about the number of pills prescribed to ascertain whether dissatisfaction was due to VA-specific policies vs veterans’ understanding of ED and effectiveness of treatment, which providers have more ability to improve.

In addition to the quantitative data obtained from the completed surveys, unsolicited responses from participants to the principal investigator via phone calls, and letters regarding treatment satisfaction were gathered. The second author conducted a basic exploratory content analysis of these unsolicited responses to group them into themes related to this study, such as satisfaction or dissatisfaction with ED treatment.

 

Results

The authors first assessed levels of ED and satisfaction with treatment in the sample. On average, participants reported mild-to-moderate erectile dysfunction (M = 13.1; SD = 5.7), which is higher than that of the general population and consistent with samples of men referred for ED treatment.17,18 Satisfaction levels were slightly above neutral on the EDITS questionnaire (M = 58.3%; SD = 24.5). In response to a separate single-item question regarding reasons for dissatisfaction, only 6.4% of veterans reported being satisfied with their ED treatment.

According to respondents, the primary reasons for dissatisfaction were wanting more medication (46%), finding the treatment ineffective (26.7%), and desiring more information (24%). Further, ED severity was negatively correlated with satisfaction with ED treatment (r = .72, P < .01; note that higher scores correspond to less severe ED on this measure). However, despite moderate-to-low levels of satisfaction, 79.2% of patients planned to continue with their ED treatment (59.3% very likely and 19.9% moderately likely).

The authors also assessed participants’ communication with PCPs about their sexual functioning. Twenty-five percent reported not talking with their PCP about sexual concerns (despite all having been prescribed an ED medication in the past year). In this sample, talking with one’s PCP was not related to increased knowledge of ED risk factors (t [294] = .32, ns). Those who talked to their PCP tended to be less satisfied with treatment (M = 56.2; SD = 24.5) than those who did not talk to their PCP (M = 64.7; SD = 23.3; t (213) = -2.2; P = .03), likely because those who felt their treatment was working for them felt less need to talk to their provider. Indeed, those who talked to their PCP trended to have more severe levels of ED (M = 12.7; SD = 5.8) than those who did not (M = 14.2; SD = 5.3; t [285] = -1.91; P = .057; note that higher scores correspond to less severe ED on this measure). Finally, adults aged > 65 years were less likely to talk to their PCP than were younger adults (69% vs 81%); χ2 (1, N = 291) = 5.57; P = .018.

Generally, the level of knowledge of ED risk factors was lower than the average of respondents to the original online survey (62% vs 69%).13 Younger adults were slightly more knowledgeable (M = 64%; SD = 13) than were older adults (M = 60%; SD = 15), t (288.08) = 2.01; P = .046).

 

 

Finally, most veterans reported few attempted behavioral changes to address ED, such as taking medications at a different time or decreasing use of tobacco, caffeine, or alcohol (M = 1.3; SD = 1.1). Thirty percent had not tried any behavioral changes; 34.1% tried 1 change; and 35.9% had tried more than 1 behavioral change. In contrast, 89% of participants reported using a PDE5 medication. Eight-two percent of participants reported currently receiving ED treatment of some kind; within this group, 97.4% reported currently taking a PDE5 medication. Only 2.5% of veterans reported using other kinds of treatment, such as vacuum pump, suppository, over-the-counter medication, injections, and not using a PDE5 medication, whereas 6.7% were using other kinds of treatment as well as a PDE5 medication.

In addition to the quantitative responses, 48 participants wrote unsolicited comments about their experiences with ED treatment on their returned questionnaires. The principal investigator also received 9 telephone calls from intended study participants, who provided verbal feedback regarding their experience with ED treatment. Comments unrelated to the study were eliminated, and the remaining written and verbal responses were grouped into categories to identify themes. Mirroring the quantitative results, participants providing qualitative feedback were dissatisfied with their ED treatment. Specifically, 43% of the comments consisted of complaints regarding the ineffectiveness and/or undesirable adverse effects (AEs) of ED medications and other ED treatments, including physical AEs (eg, headaches), sentiments that treatment does not feel “natural,” and dissatisfaction with the quality and length of sexual encounters despite treatment. Yet 24% of the comments entailed requests for more and/or different ED medications. Less frequent, although significant, comments related to decreased sexual interest and performance because of other medical conditions, such as pain, prostate surgery, and hypertension (15%); desire for additional information about ED treatments from health care providers (9%); use of nonpharmacologic ED interventions (eg, vacuum pump, 7%); and concerns about their partners’ level of sexual dissatisfaction as a result of their ED (7%).

Discussion

The present study examined knowledge of ED risk factors and level of satisfaction with ED treatment in a veteran population. Pharmacologic interventions comprised the most prevalent form of ED treatment. Both quantitative and qualitative results indicated areas for improvement in veteran satisfaction with ED treatment. Overall, veterans reported being neither satisfied nor dissatisfied with their current ED treatment, although very few reported being satisfied in response to a single item. The discrepancy may be related to the negative wording of the latter question (“Why are you dissatisfied with your erectile dysfunction treatment?”), which potentially biased participants’ responses. Several veterans also provided many unsolicited comments regarding areas for improvement. Despite feeling neutral to dissatisfied with treatment, 80% planned to continue with treatment. Sources of dissatisfaction included restricted access to ED medication (eg, limiting pills to 4 per month), ineffectiveness of treatment (eg, poor quality of erection, lack of climax), physical AEs, a desire for more information about ED, and psychological and relational concerns (eg, partner sexual dissatisfaction). As one veteran in his 80s lamented in describing the apparent end to his sexual life despite current ED treatment, “Is that all there is? It is the end of the road.”

The authors identified several barriers to implementing potentially beneficial interventions other than ED medications. Specifically, despite receiving long-term treatment for ED, veteran participants showed average knowledge of information related to ED risk factors. Of concern, discussing sexual health concerns with a PCP was not associated with increased knowledge of ED risk factors. This may explain the finding that veterans plan to continue with medication treatment despite feeling only neutral to dissatisfied about their current ED treatment.

Veterans who talked to their PCP about ED were less satisfied with treatment than were those who did not talk to their PCP, likely because those who felt their treatment was working for them felt less need to talk to their provider. Indeed, those who talked to their PCP tended to have more severe ED than those who did not. It may be that veterans avoid discussing ED with their PCP until they reach advanced ED when it is too late for treatment to make a difference. The principal investigator’s receipt of unsolicited telephone calls from intended study participants desiring to discuss ED—something that has not occurred during the researchers’ involvement in dozens of prior health-related studies—illustrates the importance veterans place on sexual concerns and the need to encourage discussion about the topic in the context of health care appointments. Specifically, older adults would benefit from more conversations with PCPs as they reported less knowledge of ED risk factors and fewer conversations with PCPs about sexual concerns than did younger men.

 

 

Adverse Events

Given the AEs reported by veterans and the significant cost of ED medications within the VA system,2 increased use of alternative nonpharmacologic and preventive behavioral approaches would be clinically and economically beneficial. For example, in one study, men with ED who engaged in a lifestyle program that focused on weight loss, diet, and exercise were found more likely to experience improvements in erectile functioning compared with men who did not participate.6 Yet in the current study, 30% of participants had not attempted behavioral changes to address ED.

The VA’s Health Promotion and Disease Prevention (HPDP) Program focuses on preventive services and behavioral interventions to reduce health risks within primary care settings.19 This program may provide a framework for efforts to prevent and ameliorate ED. Specifically, coaching and education by HPDP experts could reduce PCPs’ discomfort with sexual health discussions and normalize the value of such conversations for both providers and patients. Existing HPDP behavioral interventions targeting areas such as weight loss and smoking cessation also could emphasize the potential secondary benefit of improved sexual functioning. To that end, preventive health campaigns could include sexual health and ED prevention as topics on patient education materials. Including sexual functioning on telephone or in-person prescreening questionnaires prior to routine appointments with PCPs also may facilitate destigmatization of sex as an important health topic.

Limitations

Limitations of the current study include its correlational design, which precludes conclusions regarding casual relationships among the variables in question. The authors cannot speculate about how well their sample represents the general veteran population given its low response rate (although comparable to a similar study).10 In addition, the lack of a validated measure of ED risk-factor knowledge meant reliance on an online questionnaire with unknown psychometric properties. To identify alternatives to pharmacologic treatment for ED, it would be beneficial for future research to examine the reasons for dissatisfaction among veterans, assessing satisfaction changes after implementation of behavioral and/or preventive interventions.

 

Conclusion

This study deepens the understanding of ED treatment efficacy among veterans in light of the paucity of available information. Overall, veterans are neutral to dissatisfied with their ED treatment, yet plan to continue it in the context of limited alternatives and possible lack of knowledge of behavioral methods shown to improve erectile functioning. Future studies that examine the reasons for continuing medication despite neutral satisfaction would help explore this finding. Based on these results, the authors recommend increased attention and discussion of sexual health during PCP visits and enhanced efforts toward using behavioral strategies to prevent and reduce ED. Encouragement from PCPs to address sexual health concerns earlier in a veteran’s treatment course—and in the context of behavioral and lifestyle change—may assist in preventing veterans’ sexual lives from prematurely reaching “the end of the road.”

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Clement J. Zablocki VA Medical Center in Milwaukee, Wisconsin.

References

1. Grover SA, Lowensteyn I, Kaouache M, et al. The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease. Arch Intern Med. 2006;166(2):213-219.

2. Miller K. In the war on impotence, the VA deploys Viagra and Cialis. Bloomberg Business Week. January 17, 2013. http://www.businessweek.com/articles/2013-01-17/in-the-war-on-impotence-the-va-deploys-viagra-and-cialis. Accessed April 7, 2016.

3. Phosphodiesterase Type 5 Inhibitors for the Treatment of BPH/LUTS and Penile Rehabilitation: Evidence Summary and Recommendations - December 2014. U.S. Department of Veterans Affairs website. http://www.pbm.va.gov/clinicalguidance/clinicalrecommendations/PDE5I_BPH_LUTS_Evidence_Summary_and_Recommendations.pdf. Accessed April 29, 2016.

4. Laumann EO, Glasser DB, Neves RC, Moreira ED Jr; GSSAB Investigators’ Group. A population-based survey of sexual activity, sexual problems and associated help-seeking behavior patterns in mature adults in the United States of America. Int J Impot Res. 2009;21(3):171-178.

5. Baumgartner MK, Hermanns T, Cohen A, et al. Patients’ knowledge about risk factors for erectile dysfunction is poor. J Sex Med. 2008;5(10):2399-2404.

6. Esposito K, Ciotola M, Giugliano F, et al. Effects of intensive lifestyle changes on erectile dysfunction in men. J Sex Med. 2009;6(1):243-250.

7. Macdowall W, Parker R, Nanchahal K, et al. ‘Talking of Sex’: developing and piloting a sexual health communication tool for use in primary care. Patient Educ Couns. 2010;81(3):332-337.

8. Ng CJ, Low WY, Tan NC, Choo WY. The role of general practitioners in the management of erectile dysfunction-a qualitative study. Int J Impot Res. 2004;16(1):60-63.

9. Tsimtsiou Z, Hatzimouratidis K, Nakopoulou E, Kyrana E, Salpigidis G, Hatzichristou D. Predictors of physicians’ involvement in addressing sexual health issues. J Sex Med. 2006;3(4):583-588.

10. Moreira ED Jr., Kim SC, Glasser D, Gingell C. Sexual activity, prevalence of sexual problems, and associated help-seeking patterns in men and women aged 40-80 years in Korea: data from the Global Study of Sexual Attitudes and Behaviors (GSSAB). J Sex Med. 2006;3(2):201-211.

11. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11(6):319-326.

12. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49(6):822-830.

13. Impotence [Erectile Dysfunction] Quiz: Test Your Medical IQ of ED. MedicineNet website. http://www.medicinenet.com/impotence_erectile_dysfunction_quiz/quiz.htm. Accessed April 20, 2016.

14. Ponholzer A, Temml C, Mock K, Marszalek M, Obermayr R, Madersbacher S. Prevalence and risk factors for erectile dysfunction in 2869 men using a validated questionnaire. Eur Urol. 2005;47(1):80-86.

15. Althof SE, Corty EW, Levine SB, et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology. 1999;53(4):793-799.

16. Lewis R, Bennett CJ, Borkon WD, et al. Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Urology. 2001;57(5):960-965.

17. Raina R, Lakin MM, Agarwal A, et al. Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up. Urology. 2003;62(1):110-115.

18. Safarinejad MR, Kolahi AA, Ghaedi G. Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. BJU Int. 2009; 104(3):376-383.

19. U.S. Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1120.02: Health promotion and disease prevention core program requirements. U.S. Department of Veterans Affairs website. http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2763. Published July 5, 2012. Accessed April 7, 2016.

Article PDF
Author and Disclosure Information

Dr. Sussman is a staff psychologist at Eastern Colorado VA Health Care System in Denver. Dr. Smith is the lead psychologist and Dr. Larsen is a staff psychologist at the Clement J. Zablocki VA Medical Center in Milwaukee, Wisconsin. Dr. Smith is an associate professor and Dr. Larsen is an assistant professor in the department of psychiatry and behavioral medicine at the Medical College of Wisconsin in Milwaukee. Ms. Reiter is a PhD graduate student at Marquette University in Milwaukee.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Issue
Federal Practitioner - 33(5)
Publications
Page Number
33-37
Sections
Author and Disclosure Information

Dr. Sussman is a staff psychologist at Eastern Colorado VA Health Care System in Denver. Dr. Smith is the lead psychologist and Dr. Larsen is a staff psychologist at the Clement J. Zablocki VA Medical Center in Milwaukee, Wisconsin. Dr. Smith is an associate professor and Dr. Larsen is an assistant professor in the department of psychiatry and behavioral medicine at the Medical College of Wisconsin in Milwaukee. Ms. Reiter is a PhD graduate student at Marquette University in Milwaukee.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Dr. Sussman is a staff psychologist at Eastern Colorado VA Health Care System in Denver. Dr. Smith is the lead psychologist and Dr. Larsen is a staff psychologist at the Clement J. Zablocki VA Medical Center in Milwaukee, Wisconsin. Dr. Smith is an associate professor and Dr. Larsen is an assistant professor in the department of psychiatry and behavioral medicine at the Medical College of Wisconsin in Milwaukee. Ms. Reiter is a PhD graduate student at Marquette University in Milwaukee.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Article PDF
Article PDF
Related Articles
Limited alternatives and lack of knowledge of behavioral methods shown to improve erectile functioning lead many veterans to continue erectile dysfunction treatment despite a lack of satisfaction.
Limited alternatives and lack of knowledge of behavioral methods shown to improve erectile functioning lead many veterans to continue erectile dysfunction treatment despite a lack of satisfaction.

A majority of men (70%) aged ≥ 70 years report erectile dysfunction (ED) in primary care settings.1 Further, the cost of ED medication is increasing: nationally, the VA spent $71.7 million on ED medications in 2013, triple the amount from 2006,2 despite a 2011 VA mandate limiting ED medication prescriptions to 4 doses per month per veteran.3 Unfortunately, although ED is common and costly, only about 12% of men in the community report being asked about their sexual health by their primary care provider (PCP) in the past 3 years.4 Further, little emphasis seems to be placed on preventive care. For example, men with ED in primary care clinics are unaware of ED risk factors such as hypertension, smoking, and obesity; indeed, only 17% of a large community sample could name 1 risk factor for ED.5 This is problematic because diet and exercise improve erectile functioning,yet men may not realize they can reduce ED through behavioral and lifestyle change.6

In addition, there is little research that investigates veterans’ satisfaction with ED treatment and its effectiveness. The taboo nature of talking about erections and sexual health may partially relate to the lack of research. When surveyed, PCPs noted that they do not talk about ED routinely with patients for reasons that include time constraints, lack of experience managing sexual problems, viewing ED medication as a lifestyle drug, perceiving ED as a nonserious concern, discomfort discussing the topic for both male and female PCPs, and viewing ED discussions as the responsibility of providers of the opposite gender.7-9

Given the dearth of ED research within the veteran population, the purpose of the current study was to (1) explore the level of treatment satisfaction of veterans prescribed an ED medication, phosphodiesterase type 5 inhibitor (PDE5); (2) assess patients’ perception of discussions with their PCPs about sexual health concerns; and (3) provide preliminary data on veterans’ knowledge of ED risk factors and identify possible areas for preventive education. This study was intended to highlight areas for further investigation to improve ED treatment satisfaction among veterans.

 

Methods

The authors conducted an anonymous survey with veterans who were prescribed an ED medication within the previous 12 months. In 2012, researchers obtained 8,000 names of veterans prescribed a PDE5 medication at the Clement J. Zablocki VA Medical Center (CJZVAMC) in Milwaukee, Wisconsin, and randomly selected 1,000 persons to mail a research survey to be returned anonymously. Three hundred ten surveys were returned, a 31% response rate, which was similar (32%) to a comparable large ED survey study, in which the participants were randomly selected to participate and also were not recruited by their PCP.10 Because 13 participants were excluded due to incomplete surveys or obtaining primary medical care services outside the VA, the current sample consisted of 297 participants. The CJZVAMC institutional review board approved the study in March 2013, and de-identified data were collected from March 2013 to March 2014.

The authors assessed demographics and treatment information, including whether veterans had talked with their PCP about sexual concerns.

Of the 297 participants, 55% were aged > 65 years. Racial/ethnic groups reflected the veteran population at CJZVAMC, with 78% identifying as European American, 17% as African American, 2% as Hispanic American, 2% as biracial, and 1% as Asian American or American Indian. Eighty-one percent were identified as Christian, and 10% reported no religious preference. Sixty-seven percent reported having a current sexual partner.

Measures

The International Index of Erectile Function (IIEF-5), an abridged version of a longer, 15-item instrument, was administered to assess participants’ erectile function.11,12 The IIEF-5 consists of 5 items that ask about participants’ erectile functioning over the past 6 months. Participants responded to items on a 1 to 5 scale ranging from “almost never/never” to “almost always/always”. Items were summed to create a total score that could range from 5 to 25. Total scores reflect erectile functioning and satisfaction, with low scores indicating greater dysfunction. This measure has shown high sensitivity (.98) and specificity (.88).11 Cut scores for the current study were consistent with the literature: mild ED = 17-21; mild-to-moderate ED = 12-16; moderate ED = 8-11; and severe ED = 5-7.13 Reliability in this sample was α = .93.

The authors were unable to find a validated measure assessing men’s knowledge of ED risk factors in the literature. Therefore, participants’ knowledge of ED risk factors was assessed using an online nonvalidated questionnaire entitled “Impotence [Erectile Dysfunction] Quiz: Test Your Medical IQ of ED” from www.emedicinehelp.com.13 Questions assess knowledge of specific risk factors (eg, age, obesity, depression, prostate cancer), symptoms, incidence rate, treatments, normal erectile functioning, and implications of ED. The questionnaire contains 16 items (3 true/false and 13 multiple choice items), and the total score corresponds to the percentage correct. According to the online version, the average score is 11 items correct (69%).13

 

 


A single item asked participants to identify behavioral changes they had tried to improve their erectile functioning. Options included taking medications at a different time, and/or decreasing tobacco, caffeine, or alcohol consumption. The Erectile Dysfunction Inventory of Treatment Satisfaction – Patient Version (EDITS) is an 11-item questionnaire administered to assess participants’ satisfaction with their medical treatment of ED.14 Items assess treatment satisfaction, ease of use, confidence in ability to perform, partner satisfaction, and naturalness of erections achieved during treatment. These items are rated on a scale ranging from 0 (dissatisfaction) to 4 (high satisfaction) and then summed, with total scores ranging from 0 (extremely dissatisfied) to 100 (extremely satisfied). The measure displayed high internal consistency (α = .90) and high test-retest reliability (r = .98).14 Several studies have used cutoff scores of 0 = very dissatisfied; 25 = dissatisfied; 50 = neither satisfied nor dissatisfied; 75 = satisfied; and 100 = very satisfied.15,16 These cut scores and classifiers were used in the current study; reliability was α = .92.

The authors further explored reasons for veteran dissatisfaction with ED treatment by asking participants to respond to a single item: “Why are you dissatisfied with your erectile dysfunction treatment?” They could indicate that they were satisfied or circle all options for dissatisfaction that applied (“I would like to receive more pills per month,” “The treatment does not work well,” or “I want more information about erectile dysfunction and treatment”), or write in a response. The authors inquired about the number of pills prescribed to ascertain whether dissatisfaction was due to VA-specific policies vs veterans’ understanding of ED and effectiveness of treatment, which providers have more ability to improve.

In addition to the quantitative data obtained from the completed surveys, unsolicited responses from participants to the principal investigator via phone calls, and letters regarding treatment satisfaction were gathered. The second author conducted a basic exploratory content analysis of these unsolicited responses to group them into themes related to this study, such as satisfaction or dissatisfaction with ED treatment.

 

Results

The authors first assessed levels of ED and satisfaction with treatment in the sample. On average, participants reported mild-to-moderate erectile dysfunction (M = 13.1; SD = 5.7), which is higher than that of the general population and consistent with samples of men referred for ED treatment.17,18 Satisfaction levels were slightly above neutral on the EDITS questionnaire (M = 58.3%; SD = 24.5). In response to a separate single-item question regarding reasons for dissatisfaction, only 6.4% of veterans reported being satisfied with their ED treatment.

According to respondents, the primary reasons for dissatisfaction were wanting more medication (46%), finding the treatment ineffective (26.7%), and desiring more information (24%). Further, ED severity was negatively correlated with satisfaction with ED treatment (r = .72, P < .01; note that higher scores correspond to less severe ED on this measure). However, despite moderate-to-low levels of satisfaction, 79.2% of patients planned to continue with their ED treatment (59.3% very likely and 19.9% moderately likely).

The authors also assessed participants’ communication with PCPs about their sexual functioning. Twenty-five percent reported not talking with their PCP about sexual concerns (despite all having been prescribed an ED medication in the past year). In this sample, talking with one’s PCP was not related to increased knowledge of ED risk factors (t [294] = .32, ns). Those who talked to their PCP tended to be less satisfied with treatment (M = 56.2; SD = 24.5) than those who did not talk to their PCP (M = 64.7; SD = 23.3; t (213) = -2.2; P = .03), likely because those who felt their treatment was working for them felt less need to talk to their provider. Indeed, those who talked to their PCP trended to have more severe levels of ED (M = 12.7; SD = 5.8) than those who did not (M = 14.2; SD = 5.3; t [285] = -1.91; P = .057; note that higher scores correspond to less severe ED on this measure). Finally, adults aged > 65 years were less likely to talk to their PCP than were younger adults (69% vs 81%); χ2 (1, N = 291) = 5.57; P = .018.

Generally, the level of knowledge of ED risk factors was lower than the average of respondents to the original online survey (62% vs 69%).13 Younger adults were slightly more knowledgeable (M = 64%; SD = 13) than were older adults (M = 60%; SD = 15), t (288.08) = 2.01; P = .046).

 

 

Finally, most veterans reported few attempted behavioral changes to address ED, such as taking medications at a different time or decreasing use of tobacco, caffeine, or alcohol (M = 1.3; SD = 1.1). Thirty percent had not tried any behavioral changes; 34.1% tried 1 change; and 35.9% had tried more than 1 behavioral change. In contrast, 89% of participants reported using a PDE5 medication. Eight-two percent of participants reported currently receiving ED treatment of some kind; within this group, 97.4% reported currently taking a PDE5 medication. Only 2.5% of veterans reported using other kinds of treatment, such as vacuum pump, suppository, over-the-counter medication, injections, and not using a PDE5 medication, whereas 6.7% were using other kinds of treatment as well as a PDE5 medication.

In addition to the quantitative responses, 48 participants wrote unsolicited comments about their experiences with ED treatment on their returned questionnaires. The principal investigator also received 9 telephone calls from intended study participants, who provided verbal feedback regarding their experience with ED treatment. Comments unrelated to the study were eliminated, and the remaining written and verbal responses were grouped into categories to identify themes. Mirroring the quantitative results, participants providing qualitative feedback were dissatisfied with their ED treatment. Specifically, 43% of the comments consisted of complaints regarding the ineffectiveness and/or undesirable adverse effects (AEs) of ED medications and other ED treatments, including physical AEs (eg, headaches), sentiments that treatment does not feel “natural,” and dissatisfaction with the quality and length of sexual encounters despite treatment. Yet 24% of the comments entailed requests for more and/or different ED medications. Less frequent, although significant, comments related to decreased sexual interest and performance because of other medical conditions, such as pain, prostate surgery, and hypertension (15%); desire for additional information about ED treatments from health care providers (9%); use of nonpharmacologic ED interventions (eg, vacuum pump, 7%); and concerns about their partners’ level of sexual dissatisfaction as a result of their ED (7%).

Discussion

The present study examined knowledge of ED risk factors and level of satisfaction with ED treatment in a veteran population. Pharmacologic interventions comprised the most prevalent form of ED treatment. Both quantitative and qualitative results indicated areas for improvement in veteran satisfaction with ED treatment. Overall, veterans reported being neither satisfied nor dissatisfied with their current ED treatment, although very few reported being satisfied in response to a single item. The discrepancy may be related to the negative wording of the latter question (“Why are you dissatisfied with your erectile dysfunction treatment?”), which potentially biased participants’ responses. Several veterans also provided many unsolicited comments regarding areas for improvement. Despite feeling neutral to dissatisfied with treatment, 80% planned to continue with treatment. Sources of dissatisfaction included restricted access to ED medication (eg, limiting pills to 4 per month), ineffectiveness of treatment (eg, poor quality of erection, lack of climax), physical AEs, a desire for more information about ED, and psychological and relational concerns (eg, partner sexual dissatisfaction). As one veteran in his 80s lamented in describing the apparent end to his sexual life despite current ED treatment, “Is that all there is? It is the end of the road.”

The authors identified several barriers to implementing potentially beneficial interventions other than ED medications. Specifically, despite receiving long-term treatment for ED, veteran participants showed average knowledge of information related to ED risk factors. Of concern, discussing sexual health concerns with a PCP was not associated with increased knowledge of ED risk factors. This may explain the finding that veterans plan to continue with medication treatment despite feeling only neutral to dissatisfied about their current ED treatment.

Veterans who talked to their PCP about ED were less satisfied with treatment than were those who did not talk to their PCP, likely because those who felt their treatment was working for them felt less need to talk to their provider. Indeed, those who talked to their PCP tended to have more severe ED than those who did not. It may be that veterans avoid discussing ED with their PCP until they reach advanced ED when it is too late for treatment to make a difference. The principal investigator’s receipt of unsolicited telephone calls from intended study participants desiring to discuss ED—something that has not occurred during the researchers’ involvement in dozens of prior health-related studies—illustrates the importance veterans place on sexual concerns and the need to encourage discussion about the topic in the context of health care appointments. Specifically, older adults would benefit from more conversations with PCPs as they reported less knowledge of ED risk factors and fewer conversations with PCPs about sexual concerns than did younger men.

 

 

Adverse Events

Given the AEs reported by veterans and the significant cost of ED medications within the VA system,2 increased use of alternative nonpharmacologic and preventive behavioral approaches would be clinically and economically beneficial. For example, in one study, men with ED who engaged in a lifestyle program that focused on weight loss, diet, and exercise were found more likely to experience improvements in erectile functioning compared with men who did not participate.6 Yet in the current study, 30% of participants had not attempted behavioral changes to address ED.

The VA’s Health Promotion and Disease Prevention (HPDP) Program focuses on preventive services and behavioral interventions to reduce health risks within primary care settings.19 This program may provide a framework for efforts to prevent and ameliorate ED. Specifically, coaching and education by HPDP experts could reduce PCPs’ discomfort with sexual health discussions and normalize the value of such conversations for both providers and patients. Existing HPDP behavioral interventions targeting areas such as weight loss and smoking cessation also could emphasize the potential secondary benefit of improved sexual functioning. To that end, preventive health campaigns could include sexual health and ED prevention as topics on patient education materials. Including sexual functioning on telephone or in-person prescreening questionnaires prior to routine appointments with PCPs also may facilitate destigmatization of sex as an important health topic.

Limitations

Limitations of the current study include its correlational design, which precludes conclusions regarding casual relationships among the variables in question. The authors cannot speculate about how well their sample represents the general veteran population given its low response rate (although comparable to a similar study).10 In addition, the lack of a validated measure of ED risk-factor knowledge meant reliance on an online questionnaire with unknown psychometric properties. To identify alternatives to pharmacologic treatment for ED, it would be beneficial for future research to examine the reasons for dissatisfaction among veterans, assessing satisfaction changes after implementation of behavioral and/or preventive interventions.

 

Conclusion

This study deepens the understanding of ED treatment efficacy among veterans in light of the paucity of available information. Overall, veterans are neutral to dissatisfied with their ED treatment, yet plan to continue it in the context of limited alternatives and possible lack of knowledge of behavioral methods shown to improve erectile functioning. Future studies that examine the reasons for continuing medication despite neutral satisfaction would help explore this finding. Based on these results, the authors recommend increased attention and discussion of sexual health during PCP visits and enhanced efforts toward using behavioral strategies to prevent and reduce ED. Encouragement from PCPs to address sexual health concerns earlier in a veteran’s treatment course—and in the context of behavioral and lifestyle change—may assist in preventing veterans’ sexual lives from prematurely reaching “the end of the road.”

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Clement J. Zablocki VA Medical Center in Milwaukee, Wisconsin.

A majority of men (70%) aged ≥ 70 years report erectile dysfunction (ED) in primary care settings.1 Further, the cost of ED medication is increasing: nationally, the VA spent $71.7 million on ED medications in 2013, triple the amount from 2006,2 despite a 2011 VA mandate limiting ED medication prescriptions to 4 doses per month per veteran.3 Unfortunately, although ED is common and costly, only about 12% of men in the community report being asked about their sexual health by their primary care provider (PCP) in the past 3 years.4 Further, little emphasis seems to be placed on preventive care. For example, men with ED in primary care clinics are unaware of ED risk factors such as hypertension, smoking, and obesity; indeed, only 17% of a large community sample could name 1 risk factor for ED.5 This is problematic because diet and exercise improve erectile functioning,yet men may not realize they can reduce ED through behavioral and lifestyle change.6

In addition, there is little research that investigates veterans’ satisfaction with ED treatment and its effectiveness. The taboo nature of talking about erections and sexual health may partially relate to the lack of research. When surveyed, PCPs noted that they do not talk about ED routinely with patients for reasons that include time constraints, lack of experience managing sexual problems, viewing ED medication as a lifestyle drug, perceiving ED as a nonserious concern, discomfort discussing the topic for both male and female PCPs, and viewing ED discussions as the responsibility of providers of the opposite gender.7-9

Given the dearth of ED research within the veteran population, the purpose of the current study was to (1) explore the level of treatment satisfaction of veterans prescribed an ED medication, phosphodiesterase type 5 inhibitor (PDE5); (2) assess patients’ perception of discussions with their PCPs about sexual health concerns; and (3) provide preliminary data on veterans’ knowledge of ED risk factors and identify possible areas for preventive education. This study was intended to highlight areas for further investigation to improve ED treatment satisfaction among veterans.

 

Methods

The authors conducted an anonymous survey with veterans who were prescribed an ED medication within the previous 12 months. In 2012, researchers obtained 8,000 names of veterans prescribed a PDE5 medication at the Clement J. Zablocki VA Medical Center (CJZVAMC) in Milwaukee, Wisconsin, and randomly selected 1,000 persons to mail a research survey to be returned anonymously. Three hundred ten surveys were returned, a 31% response rate, which was similar (32%) to a comparable large ED survey study, in which the participants were randomly selected to participate and also were not recruited by their PCP.10 Because 13 participants were excluded due to incomplete surveys or obtaining primary medical care services outside the VA, the current sample consisted of 297 participants. The CJZVAMC institutional review board approved the study in March 2013, and de-identified data were collected from March 2013 to March 2014.

The authors assessed demographics and treatment information, including whether veterans had talked with their PCP about sexual concerns.

Of the 297 participants, 55% were aged > 65 years. Racial/ethnic groups reflected the veteran population at CJZVAMC, with 78% identifying as European American, 17% as African American, 2% as Hispanic American, 2% as biracial, and 1% as Asian American or American Indian. Eighty-one percent were identified as Christian, and 10% reported no religious preference. Sixty-seven percent reported having a current sexual partner.

Measures

The International Index of Erectile Function (IIEF-5), an abridged version of a longer, 15-item instrument, was administered to assess participants’ erectile function.11,12 The IIEF-5 consists of 5 items that ask about participants’ erectile functioning over the past 6 months. Participants responded to items on a 1 to 5 scale ranging from “almost never/never” to “almost always/always”. Items were summed to create a total score that could range from 5 to 25. Total scores reflect erectile functioning and satisfaction, with low scores indicating greater dysfunction. This measure has shown high sensitivity (.98) and specificity (.88).11 Cut scores for the current study were consistent with the literature: mild ED = 17-21; mild-to-moderate ED = 12-16; moderate ED = 8-11; and severe ED = 5-7.13 Reliability in this sample was α = .93.

The authors were unable to find a validated measure assessing men’s knowledge of ED risk factors in the literature. Therefore, participants’ knowledge of ED risk factors was assessed using an online nonvalidated questionnaire entitled “Impotence [Erectile Dysfunction] Quiz: Test Your Medical IQ of ED” from www.emedicinehelp.com.13 Questions assess knowledge of specific risk factors (eg, age, obesity, depression, prostate cancer), symptoms, incidence rate, treatments, normal erectile functioning, and implications of ED. The questionnaire contains 16 items (3 true/false and 13 multiple choice items), and the total score corresponds to the percentage correct. According to the online version, the average score is 11 items correct (69%).13

 

 


A single item asked participants to identify behavioral changes they had tried to improve their erectile functioning. Options included taking medications at a different time, and/or decreasing tobacco, caffeine, or alcohol consumption. The Erectile Dysfunction Inventory of Treatment Satisfaction – Patient Version (EDITS) is an 11-item questionnaire administered to assess participants’ satisfaction with their medical treatment of ED.14 Items assess treatment satisfaction, ease of use, confidence in ability to perform, partner satisfaction, and naturalness of erections achieved during treatment. These items are rated on a scale ranging from 0 (dissatisfaction) to 4 (high satisfaction) and then summed, with total scores ranging from 0 (extremely dissatisfied) to 100 (extremely satisfied). The measure displayed high internal consistency (α = .90) and high test-retest reliability (r = .98).14 Several studies have used cutoff scores of 0 = very dissatisfied; 25 = dissatisfied; 50 = neither satisfied nor dissatisfied; 75 = satisfied; and 100 = very satisfied.15,16 These cut scores and classifiers were used in the current study; reliability was α = .92.

The authors further explored reasons for veteran dissatisfaction with ED treatment by asking participants to respond to a single item: “Why are you dissatisfied with your erectile dysfunction treatment?” They could indicate that they were satisfied or circle all options for dissatisfaction that applied (“I would like to receive more pills per month,” “The treatment does not work well,” or “I want more information about erectile dysfunction and treatment”), or write in a response. The authors inquired about the number of pills prescribed to ascertain whether dissatisfaction was due to VA-specific policies vs veterans’ understanding of ED and effectiveness of treatment, which providers have more ability to improve.

In addition to the quantitative data obtained from the completed surveys, unsolicited responses from participants to the principal investigator via phone calls, and letters regarding treatment satisfaction were gathered. The second author conducted a basic exploratory content analysis of these unsolicited responses to group them into themes related to this study, such as satisfaction or dissatisfaction with ED treatment.

 

Results

The authors first assessed levels of ED and satisfaction with treatment in the sample. On average, participants reported mild-to-moderate erectile dysfunction (M = 13.1; SD = 5.7), which is higher than that of the general population and consistent with samples of men referred for ED treatment.17,18 Satisfaction levels were slightly above neutral on the EDITS questionnaire (M = 58.3%; SD = 24.5). In response to a separate single-item question regarding reasons for dissatisfaction, only 6.4% of veterans reported being satisfied with their ED treatment.

According to respondents, the primary reasons for dissatisfaction were wanting more medication (46%), finding the treatment ineffective (26.7%), and desiring more information (24%). Further, ED severity was negatively correlated with satisfaction with ED treatment (r = .72, P < .01; note that higher scores correspond to less severe ED on this measure). However, despite moderate-to-low levels of satisfaction, 79.2% of patients planned to continue with their ED treatment (59.3% very likely and 19.9% moderately likely).

The authors also assessed participants’ communication with PCPs about their sexual functioning. Twenty-five percent reported not talking with their PCP about sexual concerns (despite all having been prescribed an ED medication in the past year). In this sample, talking with one’s PCP was not related to increased knowledge of ED risk factors (t [294] = .32, ns). Those who talked to their PCP tended to be less satisfied with treatment (M = 56.2; SD = 24.5) than those who did not talk to their PCP (M = 64.7; SD = 23.3; t (213) = -2.2; P = .03), likely because those who felt their treatment was working for them felt less need to talk to their provider. Indeed, those who talked to their PCP trended to have more severe levels of ED (M = 12.7; SD = 5.8) than those who did not (M = 14.2; SD = 5.3; t [285] = -1.91; P = .057; note that higher scores correspond to less severe ED on this measure). Finally, adults aged > 65 years were less likely to talk to their PCP than were younger adults (69% vs 81%); χ2 (1, N = 291) = 5.57; P = .018.

Generally, the level of knowledge of ED risk factors was lower than the average of respondents to the original online survey (62% vs 69%).13 Younger adults were slightly more knowledgeable (M = 64%; SD = 13) than were older adults (M = 60%; SD = 15), t (288.08) = 2.01; P = .046).

 

 

Finally, most veterans reported few attempted behavioral changes to address ED, such as taking medications at a different time or decreasing use of tobacco, caffeine, or alcohol (M = 1.3; SD = 1.1). Thirty percent had not tried any behavioral changes; 34.1% tried 1 change; and 35.9% had tried more than 1 behavioral change. In contrast, 89% of participants reported using a PDE5 medication. Eight-two percent of participants reported currently receiving ED treatment of some kind; within this group, 97.4% reported currently taking a PDE5 medication. Only 2.5% of veterans reported using other kinds of treatment, such as vacuum pump, suppository, over-the-counter medication, injections, and not using a PDE5 medication, whereas 6.7% were using other kinds of treatment as well as a PDE5 medication.

In addition to the quantitative responses, 48 participants wrote unsolicited comments about their experiences with ED treatment on their returned questionnaires. The principal investigator also received 9 telephone calls from intended study participants, who provided verbal feedback regarding their experience with ED treatment. Comments unrelated to the study were eliminated, and the remaining written and verbal responses were grouped into categories to identify themes. Mirroring the quantitative results, participants providing qualitative feedback were dissatisfied with their ED treatment. Specifically, 43% of the comments consisted of complaints regarding the ineffectiveness and/or undesirable adverse effects (AEs) of ED medications and other ED treatments, including physical AEs (eg, headaches), sentiments that treatment does not feel “natural,” and dissatisfaction with the quality and length of sexual encounters despite treatment. Yet 24% of the comments entailed requests for more and/or different ED medications. Less frequent, although significant, comments related to decreased sexual interest and performance because of other medical conditions, such as pain, prostate surgery, and hypertension (15%); desire for additional information about ED treatments from health care providers (9%); use of nonpharmacologic ED interventions (eg, vacuum pump, 7%); and concerns about their partners’ level of sexual dissatisfaction as a result of their ED (7%).

Discussion

The present study examined knowledge of ED risk factors and level of satisfaction with ED treatment in a veteran population. Pharmacologic interventions comprised the most prevalent form of ED treatment. Both quantitative and qualitative results indicated areas for improvement in veteran satisfaction with ED treatment. Overall, veterans reported being neither satisfied nor dissatisfied with their current ED treatment, although very few reported being satisfied in response to a single item. The discrepancy may be related to the negative wording of the latter question (“Why are you dissatisfied with your erectile dysfunction treatment?”), which potentially biased participants’ responses. Several veterans also provided many unsolicited comments regarding areas for improvement. Despite feeling neutral to dissatisfied with treatment, 80% planned to continue with treatment. Sources of dissatisfaction included restricted access to ED medication (eg, limiting pills to 4 per month), ineffectiveness of treatment (eg, poor quality of erection, lack of climax), physical AEs, a desire for more information about ED, and psychological and relational concerns (eg, partner sexual dissatisfaction). As one veteran in his 80s lamented in describing the apparent end to his sexual life despite current ED treatment, “Is that all there is? It is the end of the road.”

The authors identified several barriers to implementing potentially beneficial interventions other than ED medications. Specifically, despite receiving long-term treatment for ED, veteran participants showed average knowledge of information related to ED risk factors. Of concern, discussing sexual health concerns with a PCP was not associated with increased knowledge of ED risk factors. This may explain the finding that veterans plan to continue with medication treatment despite feeling only neutral to dissatisfied about their current ED treatment.

Veterans who talked to their PCP about ED were less satisfied with treatment than were those who did not talk to their PCP, likely because those who felt their treatment was working for them felt less need to talk to their provider. Indeed, those who talked to their PCP tended to have more severe ED than those who did not. It may be that veterans avoid discussing ED with their PCP until they reach advanced ED when it is too late for treatment to make a difference. The principal investigator’s receipt of unsolicited telephone calls from intended study participants desiring to discuss ED—something that has not occurred during the researchers’ involvement in dozens of prior health-related studies—illustrates the importance veterans place on sexual concerns and the need to encourage discussion about the topic in the context of health care appointments. Specifically, older adults would benefit from more conversations with PCPs as they reported less knowledge of ED risk factors and fewer conversations with PCPs about sexual concerns than did younger men.

 

 

Adverse Events

Given the AEs reported by veterans and the significant cost of ED medications within the VA system,2 increased use of alternative nonpharmacologic and preventive behavioral approaches would be clinically and economically beneficial. For example, in one study, men with ED who engaged in a lifestyle program that focused on weight loss, diet, and exercise were found more likely to experience improvements in erectile functioning compared with men who did not participate.6 Yet in the current study, 30% of participants had not attempted behavioral changes to address ED.

The VA’s Health Promotion and Disease Prevention (HPDP) Program focuses on preventive services and behavioral interventions to reduce health risks within primary care settings.19 This program may provide a framework for efforts to prevent and ameliorate ED. Specifically, coaching and education by HPDP experts could reduce PCPs’ discomfort with sexual health discussions and normalize the value of such conversations for both providers and patients. Existing HPDP behavioral interventions targeting areas such as weight loss and smoking cessation also could emphasize the potential secondary benefit of improved sexual functioning. To that end, preventive health campaigns could include sexual health and ED prevention as topics on patient education materials. Including sexual functioning on telephone or in-person prescreening questionnaires prior to routine appointments with PCPs also may facilitate destigmatization of sex as an important health topic.

Limitations

Limitations of the current study include its correlational design, which precludes conclusions regarding casual relationships among the variables in question. The authors cannot speculate about how well their sample represents the general veteran population given its low response rate (although comparable to a similar study).10 In addition, the lack of a validated measure of ED risk-factor knowledge meant reliance on an online questionnaire with unknown psychometric properties. To identify alternatives to pharmacologic treatment for ED, it would be beneficial for future research to examine the reasons for dissatisfaction among veterans, assessing satisfaction changes after implementation of behavioral and/or preventive interventions.

 

Conclusion

This study deepens the understanding of ED treatment efficacy among veterans in light of the paucity of available information. Overall, veterans are neutral to dissatisfied with their ED treatment, yet plan to continue it in the context of limited alternatives and possible lack of knowledge of behavioral methods shown to improve erectile functioning. Future studies that examine the reasons for continuing medication despite neutral satisfaction would help explore this finding. Based on these results, the authors recommend increased attention and discussion of sexual health during PCP visits and enhanced efforts toward using behavioral strategies to prevent and reduce ED. Encouragement from PCPs to address sexual health concerns earlier in a veteran’s treatment course—and in the context of behavioral and lifestyle change—may assist in preventing veterans’ sexual lives from prematurely reaching “the end of the road.”

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Clement J. Zablocki VA Medical Center in Milwaukee, Wisconsin.

References

1. Grover SA, Lowensteyn I, Kaouache M, et al. The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease. Arch Intern Med. 2006;166(2):213-219.

2. Miller K. In the war on impotence, the VA deploys Viagra and Cialis. Bloomberg Business Week. January 17, 2013. http://www.businessweek.com/articles/2013-01-17/in-the-war-on-impotence-the-va-deploys-viagra-and-cialis. Accessed April 7, 2016.

3. Phosphodiesterase Type 5 Inhibitors for the Treatment of BPH/LUTS and Penile Rehabilitation: Evidence Summary and Recommendations - December 2014. U.S. Department of Veterans Affairs website. http://www.pbm.va.gov/clinicalguidance/clinicalrecommendations/PDE5I_BPH_LUTS_Evidence_Summary_and_Recommendations.pdf. Accessed April 29, 2016.

4. Laumann EO, Glasser DB, Neves RC, Moreira ED Jr; GSSAB Investigators’ Group. A population-based survey of sexual activity, sexual problems and associated help-seeking behavior patterns in mature adults in the United States of America. Int J Impot Res. 2009;21(3):171-178.

5. Baumgartner MK, Hermanns T, Cohen A, et al. Patients’ knowledge about risk factors for erectile dysfunction is poor. J Sex Med. 2008;5(10):2399-2404.

6. Esposito K, Ciotola M, Giugliano F, et al. Effects of intensive lifestyle changes on erectile dysfunction in men. J Sex Med. 2009;6(1):243-250.

7. Macdowall W, Parker R, Nanchahal K, et al. ‘Talking of Sex’: developing and piloting a sexual health communication tool for use in primary care. Patient Educ Couns. 2010;81(3):332-337.

8. Ng CJ, Low WY, Tan NC, Choo WY. The role of general practitioners in the management of erectile dysfunction-a qualitative study. Int J Impot Res. 2004;16(1):60-63.

9. Tsimtsiou Z, Hatzimouratidis K, Nakopoulou E, Kyrana E, Salpigidis G, Hatzichristou D. Predictors of physicians’ involvement in addressing sexual health issues. J Sex Med. 2006;3(4):583-588.

10. Moreira ED Jr., Kim SC, Glasser D, Gingell C. Sexual activity, prevalence of sexual problems, and associated help-seeking patterns in men and women aged 40-80 years in Korea: data from the Global Study of Sexual Attitudes and Behaviors (GSSAB). J Sex Med. 2006;3(2):201-211.

11. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11(6):319-326.

12. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49(6):822-830.

13. Impotence [Erectile Dysfunction] Quiz: Test Your Medical IQ of ED. MedicineNet website. http://www.medicinenet.com/impotence_erectile_dysfunction_quiz/quiz.htm. Accessed April 20, 2016.

14. Ponholzer A, Temml C, Mock K, Marszalek M, Obermayr R, Madersbacher S. Prevalence and risk factors for erectile dysfunction in 2869 men using a validated questionnaire. Eur Urol. 2005;47(1):80-86.

15. Althof SE, Corty EW, Levine SB, et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology. 1999;53(4):793-799.

16. Lewis R, Bennett CJ, Borkon WD, et al. Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Urology. 2001;57(5):960-965.

17. Raina R, Lakin MM, Agarwal A, et al. Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up. Urology. 2003;62(1):110-115.

18. Safarinejad MR, Kolahi AA, Ghaedi G. Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. BJU Int. 2009; 104(3):376-383.

19. U.S. Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1120.02: Health promotion and disease prevention core program requirements. U.S. Department of Veterans Affairs website. http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2763. Published July 5, 2012. Accessed April 7, 2016.

References

1. Grover SA, Lowensteyn I, Kaouache M, et al. The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease. Arch Intern Med. 2006;166(2):213-219.

2. Miller K. In the war on impotence, the VA deploys Viagra and Cialis. Bloomberg Business Week. January 17, 2013. http://www.businessweek.com/articles/2013-01-17/in-the-war-on-impotence-the-va-deploys-viagra-and-cialis. Accessed April 7, 2016.

3. Phosphodiesterase Type 5 Inhibitors for the Treatment of BPH/LUTS and Penile Rehabilitation: Evidence Summary and Recommendations - December 2014. U.S. Department of Veterans Affairs website. http://www.pbm.va.gov/clinicalguidance/clinicalrecommendations/PDE5I_BPH_LUTS_Evidence_Summary_and_Recommendations.pdf. Accessed April 29, 2016.

4. Laumann EO, Glasser DB, Neves RC, Moreira ED Jr; GSSAB Investigators’ Group. A population-based survey of sexual activity, sexual problems and associated help-seeking behavior patterns in mature adults in the United States of America. Int J Impot Res. 2009;21(3):171-178.

5. Baumgartner MK, Hermanns T, Cohen A, et al. Patients’ knowledge about risk factors for erectile dysfunction is poor. J Sex Med. 2008;5(10):2399-2404.

6. Esposito K, Ciotola M, Giugliano F, et al. Effects of intensive lifestyle changes on erectile dysfunction in men. J Sex Med. 2009;6(1):243-250.

7. Macdowall W, Parker R, Nanchahal K, et al. ‘Talking of Sex’: developing and piloting a sexual health communication tool for use in primary care. Patient Educ Couns. 2010;81(3):332-337.

8. Ng CJ, Low WY, Tan NC, Choo WY. The role of general practitioners in the management of erectile dysfunction-a qualitative study. Int J Impot Res. 2004;16(1):60-63.

9. Tsimtsiou Z, Hatzimouratidis K, Nakopoulou E, Kyrana E, Salpigidis G, Hatzichristou D. Predictors of physicians’ involvement in addressing sexual health issues. J Sex Med. 2006;3(4):583-588.

10. Moreira ED Jr., Kim SC, Glasser D, Gingell C. Sexual activity, prevalence of sexual problems, and associated help-seeking patterns in men and women aged 40-80 years in Korea: data from the Global Study of Sexual Attitudes and Behaviors (GSSAB). J Sex Med. 2006;3(2):201-211.

11. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11(6):319-326.

12. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49(6):822-830.

13. Impotence [Erectile Dysfunction] Quiz: Test Your Medical IQ of ED. MedicineNet website. http://www.medicinenet.com/impotence_erectile_dysfunction_quiz/quiz.htm. Accessed April 20, 2016.

14. Ponholzer A, Temml C, Mock K, Marszalek M, Obermayr R, Madersbacher S. Prevalence and risk factors for erectile dysfunction in 2869 men using a validated questionnaire. Eur Urol. 2005;47(1):80-86.

15. Althof SE, Corty EW, Levine SB, et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology. 1999;53(4):793-799.

16. Lewis R, Bennett CJ, Borkon WD, et al. Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Urology. 2001;57(5):960-965.

17. Raina R, Lakin MM, Agarwal A, et al. Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up. Urology. 2003;62(1):110-115.

18. Safarinejad MR, Kolahi AA, Ghaedi G. Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. BJU Int. 2009; 104(3):376-383.

19. U.S. Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1120.02: Health promotion and disease prevention core program requirements. U.S. Department of Veterans Affairs website. http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2763. Published July 5, 2012. Accessed April 7, 2016.

Issue
Federal Practitioner - 33(5)
Issue
Federal Practitioner - 33(5)
Page Number
33-37
Page Number
33-37
Publications
Publications
Article Type
Display Headline
Veterans’ Satisfaction With Erectile Dysfunction Treatment
Display Headline
Veterans’ Satisfaction With Erectile Dysfunction Treatment
Sections
Disallow All Ads
Alternative CME
Use ProPublica
Article PDF Media

Adherence to Disease-Modifying Therapies in Patients With MS: A Retrospective Cohort Study

Article Type
Changed
Display Headline
Adherence to Disease-Modifying Therapies in Patients With MS: A Retrospective Cohort Study
A significant number of patients diagnosed with multiple sclerosis are not receiving promising new disease-modifying agents.

Multiple sclerosis (MS) is an autoimmune disorder in which the myelin of the brain and spinal cord is selectively targeted by immune-system cells. As a result, nerve transmission is disrupted, leading to a variety of unpredictable symptoms from weakness and a lack of balance to blindness and paralysis of the body. Clinically, MS can take 4 courses, including relapsing-remitting (RRMS), primary-progressive (PPMS), secondary-progressive, and progressive-relapsing.1 At onset, 85% of diagnosed patients have RRMS, and 10% to 15% have PPMS.2 If untreated, patients with RRMS become secondary-progressive, with progressive disability and indiscrete relapses.3 Hence, disease-modifying therapies are targeted toward decreasing the relapse rate as well as slowing the progression of the disease.4

Annually, about 16,000 veterans with MS receive health care services from the VHA.5 The C.W. Bill Young Bay Pines VA Healthcare System (BPVAHCS) is a level 1 facility that annually serves more than 105,000 veterans. The BPVAMC sees veterans with a wide variety of neurologic illnesses and has 5 full-time neurologists with subspecialty training. The BPVAHCS facility has outpatient clinics and a 200 inpatient bed facility. The Neurology Department sees 125 outpatients per week and consults on about 30 inpatients per week.

Methods

A retrospective review of BPVAHCS patients diagnosed with MS from January 2009 to July 2014 was performed with institutional review board approval. Patient data were collected from ICD-9-CM codes and kept confidential. A list of patients was collected from Neurology Clinic patient visits with “Multiple Sclerosis” on the problem list.

Patient medical records were reviewed to collect the following information: presence of rigorous diagnosis of MS, clinical course of MS in patient, presence or absence of disease-modifying therapy, and disease-modifying agents (DMAs) used.

Determining factors for DMA treatment included increasing tiredness, weakness, visual symptoms, and radiologic evidence (magnetic resonance imaging) of recurrent, active lesions. Each patient was examined on a case-by-case basis to assess whether or not the patient actually had MS and if so, whether they were being treated with DMAs. Only patients with RRMS were included. Patients were excluded from the study if they were deceased, not currently under BPVACHS care, or had symptoms of optic neuritis but were not fully indicative of MS. Patients with clinically isolated syndrome, probable diagnosis of MS, or PPMS also were excluded from the study.

Exclusion from this study was based on 2 additional premises. Patients were excluded if they discontinued an initial ABC (interferon beta-1a, interferon beta-1b, glatiramer acetate) due to DMA treatment relapse or adverse effects (AEs), such as injection site reactions, flulike symptoms, or depression. Additionally, patients who were not willing to take more DMA medications were excluded if they felt they were relatively stable (had infrequent relapses) and believed that additional medication was not worth the risk of potential AEs.

The study patients were seen and followed up by the neurologists. All the data for this study were based on interactions with the neurologists and not primary care providers (PCPs). Because MS treatment is complex, PCPs have little involvement in its management. The percentage of patients not on any DMAs was calculated from the list of BPVAHCS patients with RRMS.

The results were compared with a similar retrospective cohort study conducted using the Commercial Claims database and Medicare Supplemental and Coordination of Benefits database to identify individuals newly diagnosed with MS.6 This study was chosen because it was similar in methodology but investigated a comparable non-VA group. A 2-tailed difference between proportions test was then performed to determine whether the BPVAHCS patients with MS who were not treated with DMAs were significantly different from those from this non-VA population. Additionally, data from VA patients who were receiving DMAs were further examined and presented.

Results

At the BPVAHCS, 262 patients were diagnosed with MS and 43% were not treated with DMAs. Margolis and colleagues found that about 60% of its 11,061 newly diagnosed non-VA patients with MS remained untreated.6 Although the latter proportion is higher, a 2-tailed difference between proportions test indicates that the proportion of patients with MS being treated at the VA was significantly lower (P < .01).

Among the 148 patients who were diagnosed with MS and treated with DMA at BPVAHCS, 5 different DMAs were identified (Table). The most commonly prescribed regimen was glatiramer acetate, which was used by 56 of 148 patients (37.8%). Fifty-two patients (35.1%) used interferon beta-1a. Of the 2 interferon DMAs, beta-1a was twice as popular as beta-1b, which was prescribed to 22 (14.9%) of patients. Dimethyl fumarate (6.8%) and fingolimod (5.4%) were used sparingly, because they were new to the market (cost and availability also were factors). With time, increased efficacy and objective assessment of benefit in the reduction of the T2 lesion load may result in a greater use of these oral DMAs.7–9

 

 

Based on this evaluation, 43% of patients who were diagnosed with MS were untreated at BPVAHCS. Concern over treatment AEs, the inconvenience of injectable dosing, and patients who were not 100% service-connected and lost to follow-up because of the cost may have contributed to the poor rate of treatment.

Discussion

Injected-based DMAs, such as interferon beta-1a, interferon beta-1b, and glatiramer acetate, were first introduced in the 1990s, but these proved to be inconvenient and triggered AEs, including injection site reactions. Overall, their efficacy was about 30%, with interferon beta-1a showing a 27% reduction in relapses.10 In 2010, oral DMAs, such as fingolimod, were FDA approved. These oral DMAs were a significant improvement over injectable DMAs but still had AEs. Hence, their use was restricted to neurologists by the BPVAHCS, and rightfully so.

Still, newer and more effective oral DMAs are showing promise, such as dimethyl fumarate, teriflunomide, and alemtuzumab. These new DMAs have significantly impacted the treatment of MS as they are not only easier for patients to adhere to and for neurologists to prescribe, but most significantly, have had a 50% decrease in the rate of relapse.10 Yet, the newer oral DMAs were less commonly prescribed than the older treatments at BPVAHCS.

Since this study did not demonstrate increased use of oral DMAs at the BPVAHCS, more PCP and neurologist-focused educational programs on the use of DMAs may be beneficial. Educational programs should lead to a reevaluation of patients with MS to consider oral DMAs, which offer better efficacy and fewer AEs. The newer oral DMAs have shown a higher reduction of T2 lesions, and the significantly decreased incidence of relapses in many other medical facilities is quite promising for the BPVAHCS.7-9

The data collected at BPVAHCS were part of a quality improvement (QI) study that will be used by the Neurology Department to follow up on the patients with MS in order to implement DMA therapies. A questionnaire was developed for following up with BPVAHCS patients with MS. The primary purpose of the questionnaire is to help neurologists identify the reasons patients avoid DMA therapies and to reduce the number of BPVAHCS patients not on the most efficacious MS DMA treatment.

Conclusion

Multiple sclerosis is a disease without a cure. Current treatment strategies focus on modifying the course of the disease and managing its symptoms. However, even as promising new treatments emerge, the current literature suggests that a significant number of patients diagnosed with MS are not receiving DMAs and may not be receiving optimal treatment.11

Findings from this study indicate that although DMAs are optimal for patients with MS, they may not be prescribed as frequently at BPVAHCS as they are at a non-VA care facility. It is unclear whether this finding is explained by an educational gap, clinical differences between non-VA and VA patients, organizational factors, or a combination of these variables. Further study is warranted to examine the use of DMAs among veterans with MS and factors that facilitate or impede optimal practice. The BPVAHCS will use data from this retrospective cohort study in a QI initiative for patients with MS. Findings from the QI initiative will be reported using the Standards for Quality Improvement Reporting Excellence.12,13

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Bay Pines VA Healthcare System.

References

1. National Multiple Sclerosis Society. Types of MS. National Multiple Sclerosis Society website. http://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed April 7, 2016.

2. McKay KA, Kwan V, Duggan T, Tremlett H. Risk factors associated with the onset of relapsing-remitting and primary progressive multiple sclerosis: a systematic review. Biomed Res Int. 2015;2015:817238.

3. Gold R, Wolinsky JS, Amato MP, Comi G. Evolving expectations around early management of multiple sclerosis. Ther Adv Neurol Disord. 2010;3(6):351-367.

4. Ben-Zacharia A, Lublin FD. Talking About Initiating and Adhering to Treatment With Injectable Disease Modifying Agents. Washington, DC: National Multiple Sclerosis Society; 2009.

5. Cameron MH, Poel AJ, Haselkorn JK, Linke A, Bourdette D. Falls requiring medical attention among veterans with multiple sclerosis: a cohort study. J Rehabil Res Dev. 2011;48(1):13-20.

6. Margolis JM, Fowler R, Johnson BH, Kassed CA, Kahler K. Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study. BMC Neurol. 2011;11:122.

7. Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Scleroisis Study Group. Mult Scler. 2000;6(4):255-266.

8. Steinberg SC, Faris RJ, Chang CF, Chan A, Tankersley MA. Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin Drug Investig. 2010;30(2):89-100.

9. Agashivala N, Wu N, Abouzaid S, et al. Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study. BMC Neurol. 2013;13:138.

10. Williams UE, Oparah SK, Philip-Ephraim EE. Disease modifying therapy in multiple sclerosis. Int Sch Res Notices. 2014;2014:307064.

11. Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C. Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study. Eur J Neurol. 2016;23(3):489-493.

12. Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S; SQUIRE development group. Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project. Qual Saf Health Care. 2008;17(suppl 1):i3–i9.

13. Ogrinc G, Mooney SE, Estrada C, et al. The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration. Qual Saf Health Care. 2008;17(suppl 1):i13-i32.

Article PDF
Author and Disclosure Information

Mr. Huda is a research assistant and Dr. Frontera is chief of neurology, both at the C.W. Bill Young Bay Pines VA Healthcare System, in Florida.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Issue
Federal Practitioner - 33(5)
Publications
Topics
Page Number
43-45
Legacy Keywords
MS, neurology, disease-modifying therapies, multiple sclerosis, myelin, spinal cord, relapsing-remitting MS RRMS, primary-progressive MS, Hammad Huda, Alfred Frontera
Sections
Author and Disclosure Information

Mr. Huda is a research assistant and Dr. Frontera is chief of neurology, both at the C.W. Bill Young Bay Pines VA Healthcare System, in Florida.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Mr. Huda is a research assistant and Dr. Frontera is chief of neurology, both at the C.W. Bill Young Bay Pines VA Healthcare System, in Florida.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Article PDF
Article PDF
Related Articles
A significant number of patients diagnosed with multiple sclerosis are not receiving promising new disease-modifying agents.
A significant number of patients diagnosed with multiple sclerosis are not receiving promising new disease-modifying agents.

Multiple sclerosis (MS) is an autoimmune disorder in which the myelin of the brain and spinal cord is selectively targeted by immune-system cells. As a result, nerve transmission is disrupted, leading to a variety of unpredictable symptoms from weakness and a lack of balance to blindness and paralysis of the body. Clinically, MS can take 4 courses, including relapsing-remitting (RRMS), primary-progressive (PPMS), secondary-progressive, and progressive-relapsing.1 At onset, 85% of diagnosed patients have RRMS, and 10% to 15% have PPMS.2 If untreated, patients with RRMS become secondary-progressive, with progressive disability and indiscrete relapses.3 Hence, disease-modifying therapies are targeted toward decreasing the relapse rate as well as slowing the progression of the disease.4

Annually, about 16,000 veterans with MS receive health care services from the VHA.5 The C.W. Bill Young Bay Pines VA Healthcare System (BPVAHCS) is a level 1 facility that annually serves more than 105,000 veterans. The BPVAMC sees veterans with a wide variety of neurologic illnesses and has 5 full-time neurologists with subspecialty training. The BPVAHCS facility has outpatient clinics and a 200 inpatient bed facility. The Neurology Department sees 125 outpatients per week and consults on about 30 inpatients per week.

Methods

A retrospective review of BPVAHCS patients diagnosed with MS from January 2009 to July 2014 was performed with institutional review board approval. Patient data were collected from ICD-9-CM codes and kept confidential. A list of patients was collected from Neurology Clinic patient visits with “Multiple Sclerosis” on the problem list.

Patient medical records were reviewed to collect the following information: presence of rigorous diagnosis of MS, clinical course of MS in patient, presence or absence of disease-modifying therapy, and disease-modifying agents (DMAs) used.

Determining factors for DMA treatment included increasing tiredness, weakness, visual symptoms, and radiologic evidence (magnetic resonance imaging) of recurrent, active lesions. Each patient was examined on a case-by-case basis to assess whether or not the patient actually had MS and if so, whether they were being treated with DMAs. Only patients with RRMS were included. Patients were excluded from the study if they were deceased, not currently under BPVACHS care, or had symptoms of optic neuritis but were not fully indicative of MS. Patients with clinically isolated syndrome, probable diagnosis of MS, or PPMS also were excluded from the study.

Exclusion from this study was based on 2 additional premises. Patients were excluded if they discontinued an initial ABC (interferon beta-1a, interferon beta-1b, glatiramer acetate) due to DMA treatment relapse or adverse effects (AEs), such as injection site reactions, flulike symptoms, or depression. Additionally, patients who were not willing to take more DMA medications were excluded if they felt they were relatively stable (had infrequent relapses) and believed that additional medication was not worth the risk of potential AEs.

The study patients were seen and followed up by the neurologists. All the data for this study were based on interactions with the neurologists and not primary care providers (PCPs). Because MS treatment is complex, PCPs have little involvement in its management. The percentage of patients not on any DMAs was calculated from the list of BPVAHCS patients with RRMS.

The results were compared with a similar retrospective cohort study conducted using the Commercial Claims database and Medicare Supplemental and Coordination of Benefits database to identify individuals newly diagnosed with MS.6 This study was chosen because it was similar in methodology but investigated a comparable non-VA group. A 2-tailed difference between proportions test was then performed to determine whether the BPVAHCS patients with MS who were not treated with DMAs were significantly different from those from this non-VA population. Additionally, data from VA patients who were receiving DMAs were further examined and presented.

Results

At the BPVAHCS, 262 patients were diagnosed with MS and 43% were not treated with DMAs. Margolis and colleagues found that about 60% of its 11,061 newly diagnosed non-VA patients with MS remained untreated.6 Although the latter proportion is higher, a 2-tailed difference between proportions test indicates that the proportion of patients with MS being treated at the VA was significantly lower (P < .01).

Among the 148 patients who were diagnosed with MS and treated with DMA at BPVAHCS, 5 different DMAs were identified (Table). The most commonly prescribed regimen was glatiramer acetate, which was used by 56 of 148 patients (37.8%). Fifty-two patients (35.1%) used interferon beta-1a. Of the 2 interferon DMAs, beta-1a was twice as popular as beta-1b, which was prescribed to 22 (14.9%) of patients. Dimethyl fumarate (6.8%) and fingolimod (5.4%) were used sparingly, because they were new to the market (cost and availability also were factors). With time, increased efficacy and objective assessment of benefit in the reduction of the T2 lesion load may result in a greater use of these oral DMAs.7–9

 

 

Based on this evaluation, 43% of patients who were diagnosed with MS were untreated at BPVAHCS. Concern over treatment AEs, the inconvenience of injectable dosing, and patients who were not 100% service-connected and lost to follow-up because of the cost may have contributed to the poor rate of treatment.

Discussion

Injected-based DMAs, such as interferon beta-1a, interferon beta-1b, and glatiramer acetate, were first introduced in the 1990s, but these proved to be inconvenient and triggered AEs, including injection site reactions. Overall, their efficacy was about 30%, with interferon beta-1a showing a 27% reduction in relapses.10 In 2010, oral DMAs, such as fingolimod, were FDA approved. These oral DMAs were a significant improvement over injectable DMAs but still had AEs. Hence, their use was restricted to neurologists by the BPVAHCS, and rightfully so.

Still, newer and more effective oral DMAs are showing promise, such as dimethyl fumarate, teriflunomide, and alemtuzumab. These new DMAs have significantly impacted the treatment of MS as they are not only easier for patients to adhere to and for neurologists to prescribe, but most significantly, have had a 50% decrease in the rate of relapse.10 Yet, the newer oral DMAs were less commonly prescribed than the older treatments at BPVAHCS.

Since this study did not demonstrate increased use of oral DMAs at the BPVAHCS, more PCP and neurologist-focused educational programs on the use of DMAs may be beneficial. Educational programs should lead to a reevaluation of patients with MS to consider oral DMAs, which offer better efficacy and fewer AEs. The newer oral DMAs have shown a higher reduction of T2 lesions, and the significantly decreased incidence of relapses in many other medical facilities is quite promising for the BPVAHCS.7-9

The data collected at BPVAHCS were part of a quality improvement (QI) study that will be used by the Neurology Department to follow up on the patients with MS in order to implement DMA therapies. A questionnaire was developed for following up with BPVAHCS patients with MS. The primary purpose of the questionnaire is to help neurologists identify the reasons patients avoid DMA therapies and to reduce the number of BPVAHCS patients not on the most efficacious MS DMA treatment.

Conclusion

Multiple sclerosis is a disease without a cure. Current treatment strategies focus on modifying the course of the disease and managing its symptoms. However, even as promising new treatments emerge, the current literature suggests that a significant number of patients diagnosed with MS are not receiving DMAs and may not be receiving optimal treatment.11

Findings from this study indicate that although DMAs are optimal for patients with MS, they may not be prescribed as frequently at BPVAHCS as they are at a non-VA care facility. It is unclear whether this finding is explained by an educational gap, clinical differences between non-VA and VA patients, organizational factors, or a combination of these variables. Further study is warranted to examine the use of DMAs among veterans with MS and factors that facilitate or impede optimal practice. The BPVAHCS will use data from this retrospective cohort study in a QI initiative for patients with MS. Findings from the QI initiative will be reported using the Standards for Quality Improvement Reporting Excellence.12,13

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Bay Pines VA Healthcare System.

Multiple sclerosis (MS) is an autoimmune disorder in which the myelin of the brain and spinal cord is selectively targeted by immune-system cells. As a result, nerve transmission is disrupted, leading to a variety of unpredictable symptoms from weakness and a lack of balance to blindness and paralysis of the body. Clinically, MS can take 4 courses, including relapsing-remitting (RRMS), primary-progressive (PPMS), secondary-progressive, and progressive-relapsing.1 At onset, 85% of diagnosed patients have RRMS, and 10% to 15% have PPMS.2 If untreated, patients with RRMS become secondary-progressive, with progressive disability and indiscrete relapses.3 Hence, disease-modifying therapies are targeted toward decreasing the relapse rate as well as slowing the progression of the disease.4

Annually, about 16,000 veterans with MS receive health care services from the VHA.5 The C.W. Bill Young Bay Pines VA Healthcare System (BPVAHCS) is a level 1 facility that annually serves more than 105,000 veterans. The BPVAMC sees veterans with a wide variety of neurologic illnesses and has 5 full-time neurologists with subspecialty training. The BPVAHCS facility has outpatient clinics and a 200 inpatient bed facility. The Neurology Department sees 125 outpatients per week and consults on about 30 inpatients per week.

Methods

A retrospective review of BPVAHCS patients diagnosed with MS from January 2009 to July 2014 was performed with institutional review board approval. Patient data were collected from ICD-9-CM codes and kept confidential. A list of patients was collected from Neurology Clinic patient visits with “Multiple Sclerosis” on the problem list.

Patient medical records were reviewed to collect the following information: presence of rigorous diagnosis of MS, clinical course of MS in patient, presence or absence of disease-modifying therapy, and disease-modifying agents (DMAs) used.

Determining factors for DMA treatment included increasing tiredness, weakness, visual symptoms, and radiologic evidence (magnetic resonance imaging) of recurrent, active lesions. Each patient was examined on a case-by-case basis to assess whether or not the patient actually had MS and if so, whether they were being treated with DMAs. Only patients with RRMS were included. Patients were excluded from the study if they were deceased, not currently under BPVACHS care, or had symptoms of optic neuritis but were not fully indicative of MS. Patients with clinically isolated syndrome, probable diagnosis of MS, or PPMS also were excluded from the study.

Exclusion from this study was based on 2 additional premises. Patients were excluded if they discontinued an initial ABC (interferon beta-1a, interferon beta-1b, glatiramer acetate) due to DMA treatment relapse or adverse effects (AEs), such as injection site reactions, flulike symptoms, or depression. Additionally, patients who were not willing to take more DMA medications were excluded if they felt they were relatively stable (had infrequent relapses) and believed that additional medication was not worth the risk of potential AEs.

The study patients were seen and followed up by the neurologists. All the data for this study were based on interactions with the neurologists and not primary care providers (PCPs). Because MS treatment is complex, PCPs have little involvement in its management. The percentage of patients not on any DMAs was calculated from the list of BPVAHCS patients with RRMS.

The results were compared with a similar retrospective cohort study conducted using the Commercial Claims database and Medicare Supplemental and Coordination of Benefits database to identify individuals newly diagnosed with MS.6 This study was chosen because it was similar in methodology but investigated a comparable non-VA group. A 2-tailed difference between proportions test was then performed to determine whether the BPVAHCS patients with MS who were not treated with DMAs were significantly different from those from this non-VA population. Additionally, data from VA patients who were receiving DMAs were further examined and presented.

Results

At the BPVAHCS, 262 patients were diagnosed with MS and 43% were not treated with DMAs. Margolis and colleagues found that about 60% of its 11,061 newly diagnosed non-VA patients with MS remained untreated.6 Although the latter proportion is higher, a 2-tailed difference between proportions test indicates that the proportion of patients with MS being treated at the VA was significantly lower (P < .01).

Among the 148 patients who were diagnosed with MS and treated with DMA at BPVAHCS, 5 different DMAs were identified (Table). The most commonly prescribed regimen was glatiramer acetate, which was used by 56 of 148 patients (37.8%). Fifty-two patients (35.1%) used interferon beta-1a. Of the 2 interferon DMAs, beta-1a was twice as popular as beta-1b, which was prescribed to 22 (14.9%) of patients. Dimethyl fumarate (6.8%) and fingolimod (5.4%) were used sparingly, because they were new to the market (cost and availability also were factors). With time, increased efficacy and objective assessment of benefit in the reduction of the T2 lesion load may result in a greater use of these oral DMAs.7–9

 

 

Based on this evaluation, 43% of patients who were diagnosed with MS were untreated at BPVAHCS. Concern over treatment AEs, the inconvenience of injectable dosing, and patients who were not 100% service-connected and lost to follow-up because of the cost may have contributed to the poor rate of treatment.

Discussion

Injected-based DMAs, such as interferon beta-1a, interferon beta-1b, and glatiramer acetate, were first introduced in the 1990s, but these proved to be inconvenient and triggered AEs, including injection site reactions. Overall, their efficacy was about 30%, with interferon beta-1a showing a 27% reduction in relapses.10 In 2010, oral DMAs, such as fingolimod, were FDA approved. These oral DMAs were a significant improvement over injectable DMAs but still had AEs. Hence, their use was restricted to neurologists by the BPVAHCS, and rightfully so.

Still, newer and more effective oral DMAs are showing promise, such as dimethyl fumarate, teriflunomide, and alemtuzumab. These new DMAs have significantly impacted the treatment of MS as they are not only easier for patients to adhere to and for neurologists to prescribe, but most significantly, have had a 50% decrease in the rate of relapse.10 Yet, the newer oral DMAs were less commonly prescribed than the older treatments at BPVAHCS.

Since this study did not demonstrate increased use of oral DMAs at the BPVAHCS, more PCP and neurologist-focused educational programs on the use of DMAs may be beneficial. Educational programs should lead to a reevaluation of patients with MS to consider oral DMAs, which offer better efficacy and fewer AEs. The newer oral DMAs have shown a higher reduction of T2 lesions, and the significantly decreased incidence of relapses in many other medical facilities is quite promising for the BPVAHCS.7-9

The data collected at BPVAHCS were part of a quality improvement (QI) study that will be used by the Neurology Department to follow up on the patients with MS in order to implement DMA therapies. A questionnaire was developed for following up with BPVAHCS patients with MS. The primary purpose of the questionnaire is to help neurologists identify the reasons patients avoid DMA therapies and to reduce the number of BPVAHCS patients not on the most efficacious MS DMA treatment.

Conclusion

Multiple sclerosis is a disease without a cure. Current treatment strategies focus on modifying the course of the disease and managing its symptoms. However, even as promising new treatments emerge, the current literature suggests that a significant number of patients diagnosed with MS are not receiving DMAs and may not be receiving optimal treatment.11

Findings from this study indicate that although DMAs are optimal for patients with MS, they may not be prescribed as frequently at BPVAHCS as they are at a non-VA care facility. It is unclear whether this finding is explained by an educational gap, clinical differences between non-VA and VA patients, organizational factors, or a combination of these variables. Further study is warranted to examine the use of DMAs among veterans with MS and factors that facilitate or impede optimal practice. The BPVAHCS will use data from this retrospective cohort study in a QI initiative for patients with MS. Findings from the QI initiative will be reported using the Standards for Quality Improvement Reporting Excellence.12,13

Acknowledgments
This material is the result of work supported with resources and the use of facilities at the Bay Pines VA Healthcare System.

References

1. National Multiple Sclerosis Society. Types of MS. National Multiple Sclerosis Society website. http://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed April 7, 2016.

2. McKay KA, Kwan V, Duggan T, Tremlett H. Risk factors associated with the onset of relapsing-remitting and primary progressive multiple sclerosis: a systematic review. Biomed Res Int. 2015;2015:817238.

3. Gold R, Wolinsky JS, Amato MP, Comi G. Evolving expectations around early management of multiple sclerosis. Ther Adv Neurol Disord. 2010;3(6):351-367.

4. Ben-Zacharia A, Lublin FD. Talking About Initiating and Adhering to Treatment With Injectable Disease Modifying Agents. Washington, DC: National Multiple Sclerosis Society; 2009.

5. Cameron MH, Poel AJ, Haselkorn JK, Linke A, Bourdette D. Falls requiring medical attention among veterans with multiple sclerosis: a cohort study. J Rehabil Res Dev. 2011;48(1):13-20.

6. Margolis JM, Fowler R, Johnson BH, Kassed CA, Kahler K. Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study. BMC Neurol. 2011;11:122.

7. Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Scleroisis Study Group. Mult Scler. 2000;6(4):255-266.

8. Steinberg SC, Faris RJ, Chang CF, Chan A, Tankersley MA. Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin Drug Investig. 2010;30(2):89-100.

9. Agashivala N, Wu N, Abouzaid S, et al. Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study. BMC Neurol. 2013;13:138.

10. Williams UE, Oparah SK, Philip-Ephraim EE. Disease modifying therapy in multiple sclerosis. Int Sch Res Notices. 2014;2014:307064.

11. Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C. Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study. Eur J Neurol. 2016;23(3):489-493.

12. Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S; SQUIRE development group. Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project. Qual Saf Health Care. 2008;17(suppl 1):i3–i9.

13. Ogrinc G, Mooney SE, Estrada C, et al. The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration. Qual Saf Health Care. 2008;17(suppl 1):i13-i32.

References

1. National Multiple Sclerosis Society. Types of MS. National Multiple Sclerosis Society website. http://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed April 7, 2016.

2. McKay KA, Kwan V, Duggan T, Tremlett H. Risk factors associated with the onset of relapsing-remitting and primary progressive multiple sclerosis: a systematic review. Biomed Res Int. 2015;2015:817238.

3. Gold R, Wolinsky JS, Amato MP, Comi G. Evolving expectations around early management of multiple sclerosis. Ther Adv Neurol Disord. 2010;3(6):351-367.

4. Ben-Zacharia A, Lublin FD. Talking About Initiating and Adhering to Treatment With Injectable Disease Modifying Agents. Washington, DC: National Multiple Sclerosis Society; 2009.

5. Cameron MH, Poel AJ, Haselkorn JK, Linke A, Bourdette D. Falls requiring medical attention among veterans with multiple sclerosis: a cohort study. J Rehabil Res Dev. 2011;48(1):13-20.

6. Margolis JM, Fowler R, Johnson BH, Kassed CA, Kahler K. Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study. BMC Neurol. 2011;11:122.

7. Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Scleroisis Study Group. Mult Scler. 2000;6(4):255-266.

8. Steinberg SC, Faris RJ, Chang CF, Chan A, Tankersley MA. Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin Drug Investig. 2010;30(2):89-100.

9. Agashivala N, Wu N, Abouzaid S, et al. Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study. BMC Neurol. 2013;13:138.

10. Williams UE, Oparah SK, Philip-Ephraim EE. Disease modifying therapy in multiple sclerosis. Int Sch Res Notices. 2014;2014:307064.

11. Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C. Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study. Eur J Neurol. 2016;23(3):489-493.

12. Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S; SQUIRE development group. Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project. Qual Saf Health Care. 2008;17(suppl 1):i3–i9.

13. Ogrinc G, Mooney SE, Estrada C, et al. The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration. Qual Saf Health Care. 2008;17(suppl 1):i13-i32.

Issue
Federal Practitioner - 33(5)
Issue
Federal Practitioner - 33(5)
Page Number
43-45
Page Number
43-45
Publications
Publications
Topics
Article Type
Display Headline
Adherence to Disease-Modifying Therapies in Patients With MS: A Retrospective Cohort Study
Display Headline
Adherence to Disease-Modifying Therapies in Patients With MS: A Retrospective Cohort Study
Legacy Keywords
MS, neurology, disease-modifying therapies, multiple sclerosis, myelin, spinal cord, relapsing-remitting MS RRMS, primary-progressive MS, Hammad Huda, Alfred Frontera
Legacy Keywords
MS, neurology, disease-modifying therapies, multiple sclerosis, myelin, spinal cord, relapsing-remitting MS RRMS, primary-progressive MS, Hammad Huda, Alfred Frontera
Sections
Disallow All Ads
Alternative CME
Article PDF Media

Analysis of Hospitalist Discontinuity

Article Type
Changed
Display Headline
A qualitative analysis of patients' experience with hospitalist service handovers

Studies examining the importance of continuity of care have shown that patients who maintain a continuous relationship with a single physician have improved outcomes.[1, 2] However, most of these studies were performed in the outpatient, rather than the inpatient setting. With over 35 million patients admitted to hospitals in 2013, along with the significant increase in hospital discontinuity over recent years, the impact of inpatient continuity of care on quality outcomes and patient satisfaction is becoming increasingly relevant.[3, 4]

Service handoffs, when a physician hands over treatment responsibility for a panel of patients and is not expected to return, are a type of handoff that contributes to inpatient discontinuity. In particular, service handoffs between hospitalists are an especially common and inherently risky type of transition, as there is a severing of an established relationship during a patient's hospitalization. Unfortunately, due to the lack of evidence on the effects of service handoffs, current guidelines are limited in their recommendations.[5] Whereas several recent studies have begun to explore the effects of these handoffs, no prior study has examined this issue from a patient's perspective.[6, 7, 8]

Patients are uniquely positioned to inform us about their experiences in care transitions. Furthermore, with patient satisfaction now affecting Medicare reimbursement rates, patient experiences while in the hospital are becoming even more significant.[9] Despite this emphasis toward more patient‐centered care, no study has explored the hospitalized patient's experience with hospitalist service handoffs. Our goal was to qualitatively assess the hospitalized patients' experiences with transitions between hospitalists to develop a conceptual model to inform future work on improving inpatient transitions of care.

METHODS

Sampling and Recruitment

We conducted bedside interviews of hospitalized patients at an urban academic medical center from October 2014 through December 2014. The hospitalist service consists of a physician and an advanced nurse practitioner (ANP) who divide a panel of patients that consist of general medicine and subspecialty patients who are often comanaged with hepatology, oncology, and nephrology subspecialists. We performed a purposive selection of patients who could potentially comment on their experience with a hospitalist service transition using the following method: 48 hours after a service handoff (ie, an outgoing physician completing 1 week on service, then transfers the care of the patient to a new oncoming hospitalist), oncoming hospitalists were approached and asked if any patient on their service had experienced a service handoff and still remained in the hospital. A 48‐hour time period was chosen to give the patients time to familiarize themselves with their new hospitalist, allowing them to properly comment on the handoff. Patients who were managed by the ANP, who were non‐English speaking, or who were deemed to have an altered mental status based on clinical suspicion by the interviewing physician (C.M.W.) were excluded from participation. Following each weekly service transition, a list of patients who met the above criteria was collected from 4 nonteaching hospitalist services, and were approached by the primary investigator (C.M.W.) and asked if they would be willing to participate. All patients were general medicine patients and no exclusions were made based on physical location within the hospital. Those who agreed provided signed written consent prior to participation to allow access to the electronic health records (EHRs) by study personnel.

Data Collection

Patients were administered a 9‐question, semistructured interview that was informed by expert opinion and existing literature, which was developed to elicit their perspective regarding their transition between hospitalists.[10, 11] No formal changes were made to the interview guide during the study period, and all patients were asked the same questions. Outcomes from interim analysis guided further questioning in subsequent interviews so as to increase the depth of patient responses (ie, Can you explain your response in greater depth?). Prior to the interview, patients were read a description of a hospitalist, and were reminded which hospitalists had cared for them during their stay (see Supporting Information, Appendix 1, in the online version of this article). If family members or a caregiver were present at the time of interview, they were asked not to comment. No repeat interviews were carried out.

All interviews were performed privately in single‐occupancy rooms, digitally recorded using an iPad (Apple, Cupertino, CA) and professionally transcribed verbatim (Rev, San Francisco, CA). All analysis was performed using MAXQDA Software (VERBI Software GmbH, Berlin, Germany). We obtained demographic information about each patient through chart review

Data Analysis

Grounded theory was utilized, with an inductive approach with no a priori hypothesis.[12] The constant comparative method was used to generate emerging and reoccurring themes.[13] Units of analysis were sentences and phrases. Our research team consisted of 4 academic hospitalists, 2 with backgrounds in clinical medicine, medical education, and qualitative analysis (J.M.F., V.M.A.), 1 as a clinician (C.M.W.), and 1 in health economics (D.O.M.). Interim analysis was performed on a weekly basis (C.M.W.), during which time a coding template was created and refined through an iterative process (C.M.W., J.M.F.). All disagreements in coded themes were resolved through group discussion until full consensus was reached. Each week, responses were assessed for thematic saturation.[14] Interviews were continued if new themes arose during this analysis. Data collection was ended once we ceased to extract new topics from participants. A summary of all themes was then presented to a group of 10 patients who met the same inclusion criteria for respondent validation and member checking. All reporting was performed within the Standards for Reporting Qualitative Research, with additional guidance derived from the Consolidated Criteria for Reporting Qualitative Research.[15, 16] The University of Chicago Institutional Review Board approved this protocol.

RESULTS

In total, 43 eligible patients were recruited, and 40 (93%) agreed to participate. Interviewed patients were between 51 and 65 (39%) years old, had a mean age of 54.5 (15) years, were predominantly female (65%), African American (58%), had a median length of stay at the time of interview of 6.5 days (interquartile range [IQR]: 48), and had an average of 2.0 (IQR: 13) hospitalists oversee their care at the time of interview (Table 1). Interview times ranged from 10:25 to 25:48 minutes, with an average of 15:32 minutes.

Respondent Characteristics
Value
  • NOTE: Abbreviations: IQR, interquartile range; LOS, length of stay; SD, standard deviation.

Response rate, n (%) 40/43 (93)
Age, mean SD 54.5 15
Sex, n (%)
Female 26 (65)
Male 14 (35)
Race, n (%)
African American 23 (58)
White 16 (40)
Hispanic 1 (2)
Median LOS at time of interview, d (IQR) 6.5 (48)
Median no. of hospitalists at time of interview, n (IQR) 2.0 (13)

We identified 6 major themes on patient perceptions of hospitalist service handoffs including (1) physician‐patient communication, (2) transparency in the hospitalist transition process, (3) indifference toward the hospitalist transition, (4) hospitalist‐subspecialist communication, (5) recognition of new opportunities due to a transition, and (6) hospitalists' bedside manner (Table 2).

Key Themes and Subthemes on Hospitalist Service Changeovers
Themes Subthemes Representative Quotes
Physician‐patient communication Patients dislike redundant communication with oncoming hospitalist. I mean it's just you always have to explain your situation over and over and over again. (patient 14)
When I said it once already, then you're repeating it to another doctor. I feel as if that hospitalist didn't talk to the other hospitalist. (patient 7)
Poor communication can negatively affect the doctor‐patient relationship. They don't really want to explain things. They don't think I'll understand. I think & yeah, I'm okay. You don't even have to put it in layman's terms. I know medical. I'm in nursing school. I have a year left. But even if you didn't know that, I would still hope you would try to tell me what was going on instead of just doing it in your head, and treating it. (patient 2)
I mean it's just you always have to explain your situation over and over and over again. After a while you just stop trusting them. (patient 20)
Good communication can positively affect the doctor‐patient relationship. Just continue with the communication, the open communication, and always stress to me that I have a voice and just going out of their way to do whatever they can to help me through whatever I'm going through. (patient 1)
Transparency in transition Patients want to be informed prior to a service changeover. I think they should be told immediately, even maybe given prior notice, like this may happen, just so you're not surprised when it happens. (patient 15)
When the doctor approached me, he let me know that he wasn't going to be here the next day and there was going to be another doctor coming in. That made me feel comfortable. (patient 9)
Patients desire a more formalized process in the service changeover. People want things to be consistent. People don't like change. They like routine. So, if he's leaving, you're coming on, I'd like for him to bring you in, introduce you to me, and for you just assure me that I'll take care of you. (patient 4)
Just like when you get a new medication, you're given all this information on it. So when you get a new hospitalist, shouldn't I get all the information on them? Like where they went to school, what they look like. (patient 23)
Patients want clearer definition of the roles the physicians will play in their care. The first time I was hospitalized for the first time I had all these different doctors coming in, and I had the residency, and the specialists, and the department, and I don't know who's who. What I asked them to do is when they come in the room, which they did, but introduce it a little more for me. Write it down like these are the special team and these are the doctors because even though they come in and give me their name, I have no idea what they're doing. (patient 5)
Someone should explain the setup and who people are. Someone would say, Okay when you're in a hospital this is your [doctor's] role. Like they should have booklets and everything. (patient 19)
Indifference toward transition Many patients have trust in service changeovers. [S]o as long as everybody's on board and communicates well and efficiently, I don't have a problem with it. (patient 6)
To me, it really wasn't no preference, as long as I was getting the care that I needed. (patient 21)
It's not a concern as long as they're on the same page. (patient 17)
Hospitalist‐specialist communication Patients are concerned about communication between their hospitalist and their subspecialists. The more cooks you get in the kitchen, the more things get to get lost, so I'm always concerned that they're not sharing the same information, especially when you're getting asked the same questions that you might have just answered the last hour ago. (patient 9)
I don't know if the hospitalist are talking to them [subspecialist]. They haven't got time. (patient 35)
Patients place trust in the communication between hospitalist and subspecialist. I think among the teams themselveswhich is my pain doctor, Dr. K's group, the oncology group itself, they switch off and trade with each other and they all speak the same language so that works out good. (patient 3)
Lack of interprofessional communication can lead to patient concern. I was afraid that one was going to drop the ball on something and not pass something on, or you know. (patient 11)
I had numerous doctors who all seemed to not communicate with each other at all or did so by email or whatever. They didn't just sit down together and say we feel this way and we feel that way. I didn't like that at all. (patient 10)
New opportunities due to transition Patients see new doctor as opportunity for medical reevaluation. I see it as two heads are better than one, three heads are better than one, four heads are better than one. When people put their heads together to work towards a common goal, especially when they're, you know, people working their craft, it can't be bad. (patient 9)
I finally got my ears looked atbecause I've asked to have my ears looked at since Mondayand the new doc is trying to make an effort to look at them. (patient 39)
Patients see service changeover as an opportunity to form a better personal relationship. Having a new hospitalist it gives you opportunity for a new beginning. (patient 11)
Bedside manner Good bedside manner can assist in a service changeover. Some of them are all business‐like but some of them are, Well how do you feel today? Hi, how are you? So this made a little difference. You feel more comfortable. You're going to be more comfortable with them. Their bedside manner helps. (patient 16)
It's just like when a doctor sits down and talks to you, they just seem more relaxed and more .... I know they're very busy and they have lots of things to do and other patients to see, but while they're in there with you, you know, you don't get too much time with them. So bedside manner is just so important. (patient 24)
Poor bedside manner can be detrimental in transition. [B]ecause they be so busy they claim they don't have time just to sit and talk to a patient, and make sure they all right. (patient 17)

Physician‐Patient Communication

Communication between the physician and the patient was an important element in patients' assessment of their experience. Patient's tended to divide physician‐patient communication into 2 categories: good communication, which consisted of open communication (patient 1) and patient engagement, and bad communication, which was described as physicians not sharing information or taking the time to explain the course of care in words that I'll understand (patient 2). Patients also described dissatisfaction with redundant communication between multiple hospitalists and the frustration of often having to describe their clinical course to multiple providers.

Transparency in Communication

The desire to have greater transparency in the handoff process was another common theme. This was likely due to the fact that 34/40 (85%) of surveyed patients were unaware that a service changeover had ever taken place. This lack of transparency was viewed to have further downstream consequences as patients stated that there should be a level of transparency, and when it's not, then there is always trust issues (patient 1). Upon further questioning as to how to make the process more transparent, many patients recommended a formalized, face‐to‐face introduction involving the patient and both hospitalists, in which the outgoing hospitalist would, bring you [oncoming hospitalist] in, and introduce you to me (patient 4).

Patients often stated that given the large spectrum of physicians they might encounter during their stay (ie, medical student, resident, hospitalist attending, subspecialty fellow, subspecialist attending), clearer definitions of physicians' roles are needed.

Hospitalist‐Specialist Communication

Concern about the communication between their hospitalist and subspecialist was another predominant theme. Conflicting and unclear directions from multiple services were especially frustrating, as a patient stated, One guy took me off this pill, the other guy wants me on that pill, I'm like okay, I can't do both (patient 8). Furthermore, a subset of patients referenced their subspecialist as their primary care provider and preferred their subspecialist for guidance in their hospital course, rather than their hospitalist. This often appeared in cases where the patient had an established relationship with the subspecialist prior to their hospitalization.

New Opportunities Due to Transition

Patients expressed positive feelings toward service handoffs by viewing the transition as an opportunity for medical reevaluation by a new physician. Patients told of instances in which a specific complaint was not being addressed by the first physician, but would be addressed by the second (oncoming) physician. A commonly expressed idea was that the oncoming physician might know something that he [Dr. B] didn't know, and since Dr. B was only here for a week, why not give him [oncoming hospitalist] a chance (patient 10). Patients would also describe the transition as an opportunity to form, and possibly improve, therapeutic alliances with a new hospitalist.

Bedside Manner

Bedside manner was another commonly mentioned thematic element. Patients were often quick to forget prior problems or issues that they may have suffered because of the transition if the oncoming physician was perceived to have a good bedside manner, often described as someone who formally introduced themselves, was considered relaxed, and would take the time to sit and talk with the patient. As a patient put it, [S]he sat down and got to know meand asked me what I wanted to do (patient 12). Conversely, patients described instances in which a perceived bad bedside manner led to a poor relationship between the physician and the patient, in which trust and comfort (patient 11) were sacrificed.

Indifference Toward Transition

In contrast to some of the previous findings, which called for improved interactions between physicians and patients, we also discovered a theme of indifference toward the transition. Several patients stated feelings of trust with the medical system, and were content with the service changeover as long as they felt that their medical needs were being met. Patients also tended to express a level of acceptance with the transition, and tended to believe that this was the price we pay for being here [in the hospital] (patient 7).

Conceptual Model

Following the collection and analysis of all patient responses, all themes were utilized to construct the ideal patient‐centered service handoff. The ideal transition describes open lines of communication between all involved parties, is facilitated by multiple modalities, such as the EHRs and nursing staff, and recognizes the patient as the primary stakeholder (Figure 1).

Figure 1
Conceptual model of the ideal patient experience with a service handoff. Abbreviations: EHR, electronic health record.

DISCUSSION

To our knowledge, this is the first qualitative investigation of the hospitalized patient's experience with service handoffs between hospitalists. The patient perspective adds a personal and first‐hand description of how fragmented care may impact the hospitalized patient experience.

Of the 6 themes, communication was found to be the most pertinent to our respondents. Because much of patient care is an inherently communicative activity, it is not surprising that patients, as well as patient safety experts, have focused on communication as an area in need of improvement in transition processes.[17, 18] Moreover, multiple medical societies have directly called for improvements within this area, and have specifically recommended clear and direct communication of treatment plans between the patient and physician, timely exchange of information, and knowledge of who is primarily in charge of the patients care.[11] Not surprisingly, each of these recommendations appears to be echoed by our participants. This theme is especially important given that good physician‐patient communication has been noted to be a major goal in achieving patient‐centered care, and has been positively correlated to medication adherence, patient satisfaction, and physical health outcomes.[19, 20, 21, 22, 23]

Although not a substitute for face‐to‐face interactions, other communication interventions between physicians and patients should be considered. For example, get to know me posters placed in patient rooms have been shown to encourage communication between patients and physicians.[24] Additionally, physician face cards have been used to improve patients' abilities to identify and clarify physicians' roles in patient care.[25] As a patient put it, If they got a new one [hospitalist], just as if I got a new medicationprint out information on themlike where they went to med school, and stuff(patient 13). These modalities may represent highly implementable, cost‐effective adjuncts to current handoff methods that may improve lines of communication between physicians and patients.

In addition to the importance placed on physician‐patient communication, interprofessional communication between hospitalists and subspecialists was also highly regarded. Studies have shown that practice‐based interprofessional communication, such as daily interdisciplinary rounds and the use of external facilitators, can improve healthcare processes and outcomes.[26] However, these interventions must be weighed with the many conflicting factors that both hospitalists and subspecialists face on daily basis, including high patient volumes, time limitations, patient availability, and scheduling conflicts.[27] None the less, the strong emphasis patients placed on this line of communication highlights this domain as an area in which hospitalist and subspecialist can work together for systematic improvement.

Patients also recognized the complexity of the transfer process between hospitalists and called for improved transparency. For example, patients repeatedly requested to be informed prior to any changes in their hospitalists, a request that remains consistent with current guidelines.[11] There also existed a strong desire for a more formalized process of transitioning between hospitalists, which often described a handoff procedure that would occur at the patient's bedside. This desire seems to be mirrored in the data that show that patients prefer to interact with their care team at the bedside and report higher satisfaction when they are involved with their care.[28, 29] Unfortunately, this desire for more direct interaction with physicians runs counter to the current paradigm of patient care, where most activities on rounds do not take place at the bedside.[30]

In contrast to patient's calls for improved transparency, an equally large portion of patients expressed relative indifference to the transition. Whereas on the surface this may seem salutary, some studies suggest that a lack of patient activation and engagement may have adverse effects toward patients' overall care.[31] Furthermore, others have shown evidence of better healthcare experiences, improved health outcomes, and lower costs in patients who are more active in their care.[30, 31] Altogether, this suggests that despite some patients' indifference, physicians should continue to engage patients in their hospital care.[32]

Although prevailing sentiments among patient safety advocates are that patient handoffs are inherently dangerous and place patients at increased risk of adverse events, patients did not always share this concern. A frequently occurring theme was that the transition is an opportunity for medical reevaluation or the establishment of a new, possibly improved therapeutic alliance. Recognizing this viewpoint offers oncoming hospitalists the opportunity to focus on issues that the patient may have felt were not being properly addressed with their prior physician.

Finally, although our conceptual model is not a strict guideline, we believe that any future studies should consider this framework when constructing interventions to improve service‐level handoffs. Several interventions already exist. For instance, educational interventions, such as patient‐centered interviewing, have been shown to improve patient satisfaction, compliance with medications, lead to fewer lawsuits, and improve health outcomes.[33, 34, 35] Additional methods of keeping the patient more informed include physician face sheets and performance of the handoff at the patient's bedside. Although well known in nursing literature, the idea of physicians performing handoffs at the patient's bedside is a particularly patient‐centric process.[36] This type of intervention may have the ability to transform the handoff from the current state of a 2‐way street, in which information is passed between 2 hospitalists, to a 3‐way stop, in which both hospitalists and the patient are able to communicate at this critical junction of care.

Although our study does offer new insight into the effects of discontinuous care, its exploratory nature does have limitations. First, being performed at a single academic center limits our ability to generalize our findings. Second, perspectives of those who did not wish to participate, patients' family members or caregivers, and those who were not queried, could highly differ from those we interviewed. Additionally, we did not collect data on patients' diagnoses or reason for admission, thus limiting our ability to assess if certain diagnosis or subpopulations predispose patients to experiencing a service handoff. Third, although our study was restricted to English‐speaking patients only, we must consider that non‐English speakers would likely suffer from even greater communication barriers than those who took part in our study. Finally, our interviews and data analysis were conducted by hospitalists, which could have subconsciously influenced the interview process, and the interpretation of patient responses. However, we tried to mitigate these issues by having the same individual interview all participants, by using an interview guide to ensure cross‐cohort consistency, by using open‐ended questions, and by attempting to give patients every opportunity to express themselves.

CONCLUSIONS

From a patients' perspective, inpatient service handoffs are often opaque experiences that are highlighted by poor communication between physicians and patients. Although deficits in communication and transparency acted as barriers to a patient‐centered handoff, physicians should recognize that service handoffs may also represent opportunities for improvement, and should focus on these domains when they start on a new service.

Disclosures

All funding for this project was provided by the Section of Hospital Medicine at The University of Chicago Medical Center. The data from this article were presented at the Society of Hospital Medicine Annual Conference, National Harbor, March 31, 2015, and at the Society of General Internal Medicine National Meeting in Toronto, Canada, April 23, 2015. The authors report that no conflicts of interest, financial or otherwise, exist.

Files
References
  1. Sharma G, Fletcher KE, Zhang D, Kuo Y‐F, Freeman JL, Goodwin JS. Continuity of outpatient and inpatient care by primary care physicians for hospitalized older adults. JAMA. 2009;301(16):16711680.
  2. Nyweide DJ, Anthony DL, Bynum JPW, et al. Continuity of care and the risk of preventable hospitalization in older adults. JAMA Intern Med. 2013;173(20):18791885.
  3. Agency for Healthcare Research and Quality. HCUPnet: a tool for identifying, tracking, and analyzing national hospital statistics. Available at: http://hcupnet.ahrq.gov/HCUPnet.jsp?Id=82B37DA366A36BAD6(8):438444.
  4. Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433440.
  5. Epstein K, Juarez E, Epstein A, Loya K, Singer A. The impact of fragmentation of hospitalist care on length of stay. J Hosp Med. 2010;5(6):335338.
  6. Turner J, Hansen L, Hinami K, et al. The impact of hospitalist discontinuity on hospital cost, readmissions, and patient satisfaction. J Gen Intern Med. 2014;29(7):10041008.
  7. O'Leary KJ, Turner J, Christensen N, et al. The effect of hospitalist discontinuity on adverse events. J Hosp Med. 2015;10(3):147151.
  8. Agency for Healthcare Research and Quality. HCAHPS Fact Sheet. CAHPS Hospital Survey August 2013. Available at: http://www.hcahpsonline.org/files/August_2013_HCAHPS_Fact_Sheet3.pdf. Accessed February 2, 2015.
  9. Behara R, Wears RL, Perry SJ, et al. A conceptual framework for studying the safety of transitions in emergency care. In: Henriksen K, Battles JB, Marks ES, eds. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005:309321. Concepts and Methodology; vol 2. Available at: http://www.ncbi.nlm.nih.gov/books/NBK20522. Accessed January 15, 2015.
  10. Snow V, Beck D, Budnitz T, et al. Transitions of care consensus policy statement American College of Physicians‐Society of General Internal Medicine‐Society of Hospital Medicine‐American Geriatrics Society‐American College of Emergency Physicians‐Society of Academic Emergency Medicine. J Gen Intern Med. 2009;24(8):971976.
  11. Watling CJ, Lingard L. Grounded theory in medical education research: AMEE guide no. 70. Med Teach. 2012;34(10):850861.
  12. Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36(4):391409.
  13. Morse JM. The significance of saturation. Qual Health Res. 1995;5(2):147149.
  14. O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):12451251.
  15. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32‐item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349357.
  16. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314323.
  17. The Joint Commission. Hot Topics in Healthcare, Issue 2. Transitions of care: the need for collaboration across entire care continuum. Available at: http://www.jointcommission.org/assets/1/6/TOC_Hot_Topics.pdf. Accessed April 9, 2015.
  18. Zolnierek KBH, Dimatteo MR. Physician communication and patient adherence to treatment: a meta‐analysis. Med Care. 2009;47(8):826834.
  19. Desai NR, Choudhry NK. Impediments to adherence to post myocardial infarction medications. Curr Cardiol Rep. 2013;15(1):322.
  20. Zandbelt LC, Smets EMA, Oort FJ, Godfried MH, Haes HCJM. Medical specialists' patient‐centered communication and patient‐reported outcomes. Med Care. 2007;45(4):330339.
  21. Clever SL, Jin L, Levinson W, Meltzer DO. Does doctor‐patient communication affect patient satisfaction with hospital care? Results of an analysis with a novel instrumental variable. Health Serv Res. 2008;43(5 pt 1):15051519.
  22. Michie S, Miles J, Weinman J. Patient‐centredness in chronic illness: what is it and does it matter? Patient Educ Couns. 2003;51(3):197206.
  23. Billings JA, Keeley A, Bauman J, et al. Merging cultures: palliative care specialists in the medical intensive care unit. Crit Care Med. 2006;34(11 suppl):S388S393.
  24. Arora VM, Schaninger C, D'Arcy M, et al. Improving inpatients' identification of their doctors: use of FACE cards. Jt Comm J Qual Patient Saf. 2009;35(12):613619.
  25. Zwarenstein M, Goldman J, Reeves S. Interprofessional collaboration: effects of practice‐based interventions on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2009;(3):CD000072.
  26. Gonzalo JD, Heist BS, Duffy BL, et al. Identifying and overcoming the barriers to bedside rounds: a multicenter qualitative study. Acad Med. 2014;89(2):326334.
  27. Lehmann LS, Brancati FL, Chen MC, Roter D, Dobs AS. The effect of bedside case presentations on patients' perceptions of their medical care. N Engl J Med. 1997;336(16):11501155.
  28. Gonzalo JD, Wolpaw DR, Lehman E, Chuang CH. Patient‐centered interprofessional collaborative care: factors associated with bedside interprofessional rounds. J Gen Intern Med. 2014;29(7):10401047.
  29. Stickrath C, Noble M, Prochazka A, et al. Attending rounds in the current era: what is and is not happening. JAMA Intern Med. 2013;173(12):10841089.
  30. Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013;32(2):207214.
  31. Greene J, Hibbard JH, Sacks R, Overton V, Parrotta CD. When patient activation levels change, health outcomes and costs change, too. Health Aff Proj Hope. 2015;34(3):431437.
  32. Smith RC, Marshall‐Dorsey AA, Osborn GG, et al. Evidence‐based guidelines for teaching patient‐centered interviewing. Patient Educ Couns. 2000;39(1):2736.
  33. Hall JA, Roter DL, Katz NR. Meta‐analysis of correlates of provider behavior in medical encounters. Med Care. 1988;26(7):657675.
  34. Huycke LI, Huycke MM. Characteristics of potential plaintiffs in malpractice litigation. Ann Intern Med. 1994;120(9):792798.
  35. Gregory S, Tan D, Tilrico M, Edwardson N, Gamm L. Bedside shift reports: what does the evidence say? J Nurs Adm. 2014;44(10):541545.
Article PDF
Issue
Journal of Hospital Medicine - 11(10)
Page Number
675-681
Sections
Files
Files
Article PDF
Article PDF

Studies examining the importance of continuity of care have shown that patients who maintain a continuous relationship with a single physician have improved outcomes.[1, 2] However, most of these studies were performed in the outpatient, rather than the inpatient setting. With over 35 million patients admitted to hospitals in 2013, along with the significant increase in hospital discontinuity over recent years, the impact of inpatient continuity of care on quality outcomes and patient satisfaction is becoming increasingly relevant.[3, 4]

Service handoffs, when a physician hands over treatment responsibility for a panel of patients and is not expected to return, are a type of handoff that contributes to inpatient discontinuity. In particular, service handoffs between hospitalists are an especially common and inherently risky type of transition, as there is a severing of an established relationship during a patient's hospitalization. Unfortunately, due to the lack of evidence on the effects of service handoffs, current guidelines are limited in their recommendations.[5] Whereas several recent studies have begun to explore the effects of these handoffs, no prior study has examined this issue from a patient's perspective.[6, 7, 8]

Patients are uniquely positioned to inform us about their experiences in care transitions. Furthermore, with patient satisfaction now affecting Medicare reimbursement rates, patient experiences while in the hospital are becoming even more significant.[9] Despite this emphasis toward more patient‐centered care, no study has explored the hospitalized patient's experience with hospitalist service handoffs. Our goal was to qualitatively assess the hospitalized patients' experiences with transitions between hospitalists to develop a conceptual model to inform future work on improving inpatient transitions of care.

METHODS

Sampling and Recruitment

We conducted bedside interviews of hospitalized patients at an urban academic medical center from October 2014 through December 2014. The hospitalist service consists of a physician and an advanced nurse practitioner (ANP) who divide a panel of patients that consist of general medicine and subspecialty patients who are often comanaged with hepatology, oncology, and nephrology subspecialists. We performed a purposive selection of patients who could potentially comment on their experience with a hospitalist service transition using the following method: 48 hours after a service handoff (ie, an outgoing physician completing 1 week on service, then transfers the care of the patient to a new oncoming hospitalist), oncoming hospitalists were approached and asked if any patient on their service had experienced a service handoff and still remained in the hospital. A 48‐hour time period was chosen to give the patients time to familiarize themselves with their new hospitalist, allowing them to properly comment on the handoff. Patients who were managed by the ANP, who were non‐English speaking, or who were deemed to have an altered mental status based on clinical suspicion by the interviewing physician (C.M.W.) were excluded from participation. Following each weekly service transition, a list of patients who met the above criteria was collected from 4 nonteaching hospitalist services, and were approached by the primary investigator (C.M.W.) and asked if they would be willing to participate. All patients were general medicine patients and no exclusions were made based on physical location within the hospital. Those who agreed provided signed written consent prior to participation to allow access to the electronic health records (EHRs) by study personnel.

Data Collection

Patients were administered a 9‐question, semistructured interview that was informed by expert opinion and existing literature, which was developed to elicit their perspective regarding their transition between hospitalists.[10, 11] No formal changes were made to the interview guide during the study period, and all patients were asked the same questions. Outcomes from interim analysis guided further questioning in subsequent interviews so as to increase the depth of patient responses (ie, Can you explain your response in greater depth?). Prior to the interview, patients were read a description of a hospitalist, and were reminded which hospitalists had cared for them during their stay (see Supporting Information, Appendix 1, in the online version of this article). If family members or a caregiver were present at the time of interview, they were asked not to comment. No repeat interviews were carried out.

All interviews were performed privately in single‐occupancy rooms, digitally recorded using an iPad (Apple, Cupertino, CA) and professionally transcribed verbatim (Rev, San Francisco, CA). All analysis was performed using MAXQDA Software (VERBI Software GmbH, Berlin, Germany). We obtained demographic information about each patient through chart review

Data Analysis

Grounded theory was utilized, with an inductive approach with no a priori hypothesis.[12] The constant comparative method was used to generate emerging and reoccurring themes.[13] Units of analysis were sentences and phrases. Our research team consisted of 4 academic hospitalists, 2 with backgrounds in clinical medicine, medical education, and qualitative analysis (J.M.F., V.M.A.), 1 as a clinician (C.M.W.), and 1 in health economics (D.O.M.). Interim analysis was performed on a weekly basis (C.M.W.), during which time a coding template was created and refined through an iterative process (C.M.W., J.M.F.). All disagreements in coded themes were resolved through group discussion until full consensus was reached. Each week, responses were assessed for thematic saturation.[14] Interviews were continued if new themes arose during this analysis. Data collection was ended once we ceased to extract new topics from participants. A summary of all themes was then presented to a group of 10 patients who met the same inclusion criteria for respondent validation and member checking. All reporting was performed within the Standards for Reporting Qualitative Research, with additional guidance derived from the Consolidated Criteria for Reporting Qualitative Research.[15, 16] The University of Chicago Institutional Review Board approved this protocol.

RESULTS

In total, 43 eligible patients were recruited, and 40 (93%) agreed to participate. Interviewed patients were between 51 and 65 (39%) years old, had a mean age of 54.5 (15) years, were predominantly female (65%), African American (58%), had a median length of stay at the time of interview of 6.5 days (interquartile range [IQR]: 48), and had an average of 2.0 (IQR: 13) hospitalists oversee their care at the time of interview (Table 1). Interview times ranged from 10:25 to 25:48 minutes, with an average of 15:32 minutes.

Respondent Characteristics
Value
  • NOTE: Abbreviations: IQR, interquartile range; LOS, length of stay; SD, standard deviation.

Response rate, n (%) 40/43 (93)
Age, mean SD 54.5 15
Sex, n (%)
Female 26 (65)
Male 14 (35)
Race, n (%)
African American 23 (58)
White 16 (40)
Hispanic 1 (2)
Median LOS at time of interview, d (IQR) 6.5 (48)
Median no. of hospitalists at time of interview, n (IQR) 2.0 (13)

We identified 6 major themes on patient perceptions of hospitalist service handoffs including (1) physician‐patient communication, (2) transparency in the hospitalist transition process, (3) indifference toward the hospitalist transition, (4) hospitalist‐subspecialist communication, (5) recognition of new opportunities due to a transition, and (6) hospitalists' bedside manner (Table 2).

Key Themes and Subthemes on Hospitalist Service Changeovers
Themes Subthemes Representative Quotes
Physician‐patient communication Patients dislike redundant communication with oncoming hospitalist. I mean it's just you always have to explain your situation over and over and over again. (patient 14)
When I said it once already, then you're repeating it to another doctor. I feel as if that hospitalist didn't talk to the other hospitalist. (patient 7)
Poor communication can negatively affect the doctor‐patient relationship. They don't really want to explain things. They don't think I'll understand. I think & yeah, I'm okay. You don't even have to put it in layman's terms. I know medical. I'm in nursing school. I have a year left. But even if you didn't know that, I would still hope you would try to tell me what was going on instead of just doing it in your head, and treating it. (patient 2)
I mean it's just you always have to explain your situation over and over and over again. After a while you just stop trusting them. (patient 20)
Good communication can positively affect the doctor‐patient relationship. Just continue with the communication, the open communication, and always stress to me that I have a voice and just going out of their way to do whatever they can to help me through whatever I'm going through. (patient 1)
Transparency in transition Patients want to be informed prior to a service changeover. I think they should be told immediately, even maybe given prior notice, like this may happen, just so you're not surprised when it happens. (patient 15)
When the doctor approached me, he let me know that he wasn't going to be here the next day and there was going to be another doctor coming in. That made me feel comfortable. (patient 9)
Patients desire a more formalized process in the service changeover. People want things to be consistent. People don't like change. They like routine. So, if he's leaving, you're coming on, I'd like for him to bring you in, introduce you to me, and for you just assure me that I'll take care of you. (patient 4)
Just like when you get a new medication, you're given all this information on it. So when you get a new hospitalist, shouldn't I get all the information on them? Like where they went to school, what they look like. (patient 23)
Patients want clearer definition of the roles the physicians will play in their care. The first time I was hospitalized for the first time I had all these different doctors coming in, and I had the residency, and the specialists, and the department, and I don't know who's who. What I asked them to do is when they come in the room, which they did, but introduce it a little more for me. Write it down like these are the special team and these are the doctors because even though they come in and give me their name, I have no idea what they're doing. (patient 5)
Someone should explain the setup and who people are. Someone would say, Okay when you're in a hospital this is your [doctor's] role. Like they should have booklets and everything. (patient 19)
Indifference toward transition Many patients have trust in service changeovers. [S]o as long as everybody's on board and communicates well and efficiently, I don't have a problem with it. (patient 6)
To me, it really wasn't no preference, as long as I was getting the care that I needed. (patient 21)
It's not a concern as long as they're on the same page. (patient 17)
Hospitalist‐specialist communication Patients are concerned about communication between their hospitalist and their subspecialists. The more cooks you get in the kitchen, the more things get to get lost, so I'm always concerned that they're not sharing the same information, especially when you're getting asked the same questions that you might have just answered the last hour ago. (patient 9)
I don't know if the hospitalist are talking to them [subspecialist]. They haven't got time. (patient 35)
Patients place trust in the communication between hospitalist and subspecialist. I think among the teams themselveswhich is my pain doctor, Dr. K's group, the oncology group itself, they switch off and trade with each other and they all speak the same language so that works out good. (patient 3)
Lack of interprofessional communication can lead to patient concern. I was afraid that one was going to drop the ball on something and not pass something on, or you know. (patient 11)
I had numerous doctors who all seemed to not communicate with each other at all or did so by email or whatever. They didn't just sit down together and say we feel this way and we feel that way. I didn't like that at all. (patient 10)
New opportunities due to transition Patients see new doctor as opportunity for medical reevaluation. I see it as two heads are better than one, three heads are better than one, four heads are better than one. When people put their heads together to work towards a common goal, especially when they're, you know, people working their craft, it can't be bad. (patient 9)
I finally got my ears looked atbecause I've asked to have my ears looked at since Mondayand the new doc is trying to make an effort to look at them. (patient 39)
Patients see service changeover as an opportunity to form a better personal relationship. Having a new hospitalist it gives you opportunity for a new beginning. (patient 11)
Bedside manner Good bedside manner can assist in a service changeover. Some of them are all business‐like but some of them are, Well how do you feel today? Hi, how are you? So this made a little difference. You feel more comfortable. You're going to be more comfortable with them. Their bedside manner helps. (patient 16)
It's just like when a doctor sits down and talks to you, they just seem more relaxed and more .... I know they're very busy and they have lots of things to do and other patients to see, but while they're in there with you, you know, you don't get too much time with them. So bedside manner is just so important. (patient 24)
Poor bedside manner can be detrimental in transition. [B]ecause they be so busy they claim they don't have time just to sit and talk to a patient, and make sure they all right. (patient 17)

Physician‐Patient Communication

Communication between the physician and the patient was an important element in patients' assessment of their experience. Patient's tended to divide physician‐patient communication into 2 categories: good communication, which consisted of open communication (patient 1) and patient engagement, and bad communication, which was described as physicians not sharing information or taking the time to explain the course of care in words that I'll understand (patient 2). Patients also described dissatisfaction with redundant communication between multiple hospitalists and the frustration of often having to describe their clinical course to multiple providers.

Transparency in Communication

The desire to have greater transparency in the handoff process was another common theme. This was likely due to the fact that 34/40 (85%) of surveyed patients were unaware that a service changeover had ever taken place. This lack of transparency was viewed to have further downstream consequences as patients stated that there should be a level of transparency, and when it's not, then there is always trust issues (patient 1). Upon further questioning as to how to make the process more transparent, many patients recommended a formalized, face‐to‐face introduction involving the patient and both hospitalists, in which the outgoing hospitalist would, bring you [oncoming hospitalist] in, and introduce you to me (patient 4).

Patients often stated that given the large spectrum of physicians they might encounter during their stay (ie, medical student, resident, hospitalist attending, subspecialty fellow, subspecialist attending), clearer definitions of physicians' roles are needed.

Hospitalist‐Specialist Communication

Concern about the communication between their hospitalist and subspecialist was another predominant theme. Conflicting and unclear directions from multiple services were especially frustrating, as a patient stated, One guy took me off this pill, the other guy wants me on that pill, I'm like okay, I can't do both (patient 8). Furthermore, a subset of patients referenced their subspecialist as their primary care provider and preferred their subspecialist for guidance in their hospital course, rather than their hospitalist. This often appeared in cases where the patient had an established relationship with the subspecialist prior to their hospitalization.

New Opportunities Due to Transition

Patients expressed positive feelings toward service handoffs by viewing the transition as an opportunity for medical reevaluation by a new physician. Patients told of instances in which a specific complaint was not being addressed by the first physician, but would be addressed by the second (oncoming) physician. A commonly expressed idea was that the oncoming physician might know something that he [Dr. B] didn't know, and since Dr. B was only here for a week, why not give him [oncoming hospitalist] a chance (patient 10). Patients would also describe the transition as an opportunity to form, and possibly improve, therapeutic alliances with a new hospitalist.

Bedside Manner

Bedside manner was another commonly mentioned thematic element. Patients were often quick to forget prior problems or issues that they may have suffered because of the transition if the oncoming physician was perceived to have a good bedside manner, often described as someone who formally introduced themselves, was considered relaxed, and would take the time to sit and talk with the patient. As a patient put it, [S]he sat down and got to know meand asked me what I wanted to do (patient 12). Conversely, patients described instances in which a perceived bad bedside manner led to a poor relationship between the physician and the patient, in which trust and comfort (patient 11) were sacrificed.

Indifference Toward Transition

In contrast to some of the previous findings, which called for improved interactions between physicians and patients, we also discovered a theme of indifference toward the transition. Several patients stated feelings of trust with the medical system, and were content with the service changeover as long as they felt that their medical needs were being met. Patients also tended to express a level of acceptance with the transition, and tended to believe that this was the price we pay for being here [in the hospital] (patient 7).

Conceptual Model

Following the collection and analysis of all patient responses, all themes were utilized to construct the ideal patient‐centered service handoff. The ideal transition describes open lines of communication between all involved parties, is facilitated by multiple modalities, such as the EHRs and nursing staff, and recognizes the patient as the primary stakeholder (Figure 1).

Figure 1
Conceptual model of the ideal patient experience with a service handoff. Abbreviations: EHR, electronic health record.

DISCUSSION

To our knowledge, this is the first qualitative investigation of the hospitalized patient's experience with service handoffs between hospitalists. The patient perspective adds a personal and first‐hand description of how fragmented care may impact the hospitalized patient experience.

Of the 6 themes, communication was found to be the most pertinent to our respondents. Because much of patient care is an inherently communicative activity, it is not surprising that patients, as well as patient safety experts, have focused on communication as an area in need of improvement in transition processes.[17, 18] Moreover, multiple medical societies have directly called for improvements within this area, and have specifically recommended clear and direct communication of treatment plans between the patient and physician, timely exchange of information, and knowledge of who is primarily in charge of the patients care.[11] Not surprisingly, each of these recommendations appears to be echoed by our participants. This theme is especially important given that good physician‐patient communication has been noted to be a major goal in achieving patient‐centered care, and has been positively correlated to medication adherence, patient satisfaction, and physical health outcomes.[19, 20, 21, 22, 23]

Although not a substitute for face‐to‐face interactions, other communication interventions between physicians and patients should be considered. For example, get to know me posters placed in patient rooms have been shown to encourage communication between patients and physicians.[24] Additionally, physician face cards have been used to improve patients' abilities to identify and clarify physicians' roles in patient care.[25] As a patient put it, If they got a new one [hospitalist], just as if I got a new medicationprint out information on themlike where they went to med school, and stuff(patient 13). These modalities may represent highly implementable, cost‐effective adjuncts to current handoff methods that may improve lines of communication between physicians and patients.

In addition to the importance placed on physician‐patient communication, interprofessional communication between hospitalists and subspecialists was also highly regarded. Studies have shown that practice‐based interprofessional communication, such as daily interdisciplinary rounds and the use of external facilitators, can improve healthcare processes and outcomes.[26] However, these interventions must be weighed with the many conflicting factors that both hospitalists and subspecialists face on daily basis, including high patient volumes, time limitations, patient availability, and scheduling conflicts.[27] None the less, the strong emphasis patients placed on this line of communication highlights this domain as an area in which hospitalist and subspecialist can work together for systematic improvement.

Patients also recognized the complexity of the transfer process between hospitalists and called for improved transparency. For example, patients repeatedly requested to be informed prior to any changes in their hospitalists, a request that remains consistent with current guidelines.[11] There also existed a strong desire for a more formalized process of transitioning between hospitalists, which often described a handoff procedure that would occur at the patient's bedside. This desire seems to be mirrored in the data that show that patients prefer to interact with their care team at the bedside and report higher satisfaction when they are involved with their care.[28, 29] Unfortunately, this desire for more direct interaction with physicians runs counter to the current paradigm of patient care, where most activities on rounds do not take place at the bedside.[30]

In contrast to patient's calls for improved transparency, an equally large portion of patients expressed relative indifference to the transition. Whereas on the surface this may seem salutary, some studies suggest that a lack of patient activation and engagement may have adverse effects toward patients' overall care.[31] Furthermore, others have shown evidence of better healthcare experiences, improved health outcomes, and lower costs in patients who are more active in their care.[30, 31] Altogether, this suggests that despite some patients' indifference, physicians should continue to engage patients in their hospital care.[32]

Although prevailing sentiments among patient safety advocates are that patient handoffs are inherently dangerous and place patients at increased risk of adverse events, patients did not always share this concern. A frequently occurring theme was that the transition is an opportunity for medical reevaluation or the establishment of a new, possibly improved therapeutic alliance. Recognizing this viewpoint offers oncoming hospitalists the opportunity to focus on issues that the patient may have felt were not being properly addressed with their prior physician.

Finally, although our conceptual model is not a strict guideline, we believe that any future studies should consider this framework when constructing interventions to improve service‐level handoffs. Several interventions already exist. For instance, educational interventions, such as patient‐centered interviewing, have been shown to improve patient satisfaction, compliance with medications, lead to fewer lawsuits, and improve health outcomes.[33, 34, 35] Additional methods of keeping the patient more informed include physician face sheets and performance of the handoff at the patient's bedside. Although well known in nursing literature, the idea of physicians performing handoffs at the patient's bedside is a particularly patient‐centric process.[36] This type of intervention may have the ability to transform the handoff from the current state of a 2‐way street, in which information is passed between 2 hospitalists, to a 3‐way stop, in which both hospitalists and the patient are able to communicate at this critical junction of care.

Although our study does offer new insight into the effects of discontinuous care, its exploratory nature does have limitations. First, being performed at a single academic center limits our ability to generalize our findings. Second, perspectives of those who did not wish to participate, patients' family members or caregivers, and those who were not queried, could highly differ from those we interviewed. Additionally, we did not collect data on patients' diagnoses or reason for admission, thus limiting our ability to assess if certain diagnosis or subpopulations predispose patients to experiencing a service handoff. Third, although our study was restricted to English‐speaking patients only, we must consider that non‐English speakers would likely suffer from even greater communication barriers than those who took part in our study. Finally, our interviews and data analysis were conducted by hospitalists, which could have subconsciously influenced the interview process, and the interpretation of patient responses. However, we tried to mitigate these issues by having the same individual interview all participants, by using an interview guide to ensure cross‐cohort consistency, by using open‐ended questions, and by attempting to give patients every opportunity to express themselves.

CONCLUSIONS

From a patients' perspective, inpatient service handoffs are often opaque experiences that are highlighted by poor communication between physicians and patients. Although deficits in communication and transparency acted as barriers to a patient‐centered handoff, physicians should recognize that service handoffs may also represent opportunities for improvement, and should focus on these domains when they start on a new service.

Disclosures

All funding for this project was provided by the Section of Hospital Medicine at The University of Chicago Medical Center. The data from this article were presented at the Society of Hospital Medicine Annual Conference, National Harbor, March 31, 2015, and at the Society of General Internal Medicine National Meeting in Toronto, Canada, April 23, 2015. The authors report that no conflicts of interest, financial or otherwise, exist.

Studies examining the importance of continuity of care have shown that patients who maintain a continuous relationship with a single physician have improved outcomes.[1, 2] However, most of these studies were performed in the outpatient, rather than the inpatient setting. With over 35 million patients admitted to hospitals in 2013, along with the significant increase in hospital discontinuity over recent years, the impact of inpatient continuity of care on quality outcomes and patient satisfaction is becoming increasingly relevant.[3, 4]

Service handoffs, when a physician hands over treatment responsibility for a panel of patients and is not expected to return, are a type of handoff that contributes to inpatient discontinuity. In particular, service handoffs between hospitalists are an especially common and inherently risky type of transition, as there is a severing of an established relationship during a patient's hospitalization. Unfortunately, due to the lack of evidence on the effects of service handoffs, current guidelines are limited in their recommendations.[5] Whereas several recent studies have begun to explore the effects of these handoffs, no prior study has examined this issue from a patient's perspective.[6, 7, 8]

Patients are uniquely positioned to inform us about their experiences in care transitions. Furthermore, with patient satisfaction now affecting Medicare reimbursement rates, patient experiences while in the hospital are becoming even more significant.[9] Despite this emphasis toward more patient‐centered care, no study has explored the hospitalized patient's experience with hospitalist service handoffs. Our goal was to qualitatively assess the hospitalized patients' experiences with transitions between hospitalists to develop a conceptual model to inform future work on improving inpatient transitions of care.

METHODS

Sampling and Recruitment

We conducted bedside interviews of hospitalized patients at an urban academic medical center from October 2014 through December 2014. The hospitalist service consists of a physician and an advanced nurse practitioner (ANP) who divide a panel of patients that consist of general medicine and subspecialty patients who are often comanaged with hepatology, oncology, and nephrology subspecialists. We performed a purposive selection of patients who could potentially comment on their experience with a hospitalist service transition using the following method: 48 hours after a service handoff (ie, an outgoing physician completing 1 week on service, then transfers the care of the patient to a new oncoming hospitalist), oncoming hospitalists were approached and asked if any patient on their service had experienced a service handoff and still remained in the hospital. A 48‐hour time period was chosen to give the patients time to familiarize themselves with their new hospitalist, allowing them to properly comment on the handoff. Patients who were managed by the ANP, who were non‐English speaking, or who were deemed to have an altered mental status based on clinical suspicion by the interviewing physician (C.M.W.) were excluded from participation. Following each weekly service transition, a list of patients who met the above criteria was collected from 4 nonteaching hospitalist services, and were approached by the primary investigator (C.M.W.) and asked if they would be willing to participate. All patients were general medicine patients and no exclusions were made based on physical location within the hospital. Those who agreed provided signed written consent prior to participation to allow access to the electronic health records (EHRs) by study personnel.

Data Collection

Patients were administered a 9‐question, semistructured interview that was informed by expert opinion and existing literature, which was developed to elicit their perspective regarding their transition between hospitalists.[10, 11] No formal changes were made to the interview guide during the study period, and all patients were asked the same questions. Outcomes from interim analysis guided further questioning in subsequent interviews so as to increase the depth of patient responses (ie, Can you explain your response in greater depth?). Prior to the interview, patients were read a description of a hospitalist, and were reminded which hospitalists had cared for them during their stay (see Supporting Information, Appendix 1, in the online version of this article). If family members or a caregiver were present at the time of interview, they were asked not to comment. No repeat interviews were carried out.

All interviews were performed privately in single‐occupancy rooms, digitally recorded using an iPad (Apple, Cupertino, CA) and professionally transcribed verbatim (Rev, San Francisco, CA). All analysis was performed using MAXQDA Software (VERBI Software GmbH, Berlin, Germany). We obtained demographic information about each patient through chart review

Data Analysis

Grounded theory was utilized, with an inductive approach with no a priori hypothesis.[12] The constant comparative method was used to generate emerging and reoccurring themes.[13] Units of analysis were sentences and phrases. Our research team consisted of 4 academic hospitalists, 2 with backgrounds in clinical medicine, medical education, and qualitative analysis (J.M.F., V.M.A.), 1 as a clinician (C.M.W.), and 1 in health economics (D.O.M.). Interim analysis was performed on a weekly basis (C.M.W.), during which time a coding template was created and refined through an iterative process (C.M.W., J.M.F.). All disagreements in coded themes were resolved through group discussion until full consensus was reached. Each week, responses were assessed for thematic saturation.[14] Interviews were continued if new themes arose during this analysis. Data collection was ended once we ceased to extract new topics from participants. A summary of all themes was then presented to a group of 10 patients who met the same inclusion criteria for respondent validation and member checking. All reporting was performed within the Standards for Reporting Qualitative Research, with additional guidance derived from the Consolidated Criteria for Reporting Qualitative Research.[15, 16] The University of Chicago Institutional Review Board approved this protocol.

RESULTS

In total, 43 eligible patients were recruited, and 40 (93%) agreed to participate. Interviewed patients were between 51 and 65 (39%) years old, had a mean age of 54.5 (15) years, were predominantly female (65%), African American (58%), had a median length of stay at the time of interview of 6.5 days (interquartile range [IQR]: 48), and had an average of 2.0 (IQR: 13) hospitalists oversee their care at the time of interview (Table 1). Interview times ranged from 10:25 to 25:48 minutes, with an average of 15:32 minutes.

Respondent Characteristics
Value
  • NOTE: Abbreviations: IQR, interquartile range; LOS, length of stay; SD, standard deviation.

Response rate, n (%) 40/43 (93)
Age, mean SD 54.5 15
Sex, n (%)
Female 26 (65)
Male 14 (35)
Race, n (%)
African American 23 (58)
White 16 (40)
Hispanic 1 (2)
Median LOS at time of interview, d (IQR) 6.5 (48)
Median no. of hospitalists at time of interview, n (IQR) 2.0 (13)

We identified 6 major themes on patient perceptions of hospitalist service handoffs including (1) physician‐patient communication, (2) transparency in the hospitalist transition process, (3) indifference toward the hospitalist transition, (4) hospitalist‐subspecialist communication, (5) recognition of new opportunities due to a transition, and (6) hospitalists' bedside manner (Table 2).

Key Themes and Subthemes on Hospitalist Service Changeovers
Themes Subthemes Representative Quotes
Physician‐patient communication Patients dislike redundant communication with oncoming hospitalist. I mean it's just you always have to explain your situation over and over and over again. (patient 14)
When I said it once already, then you're repeating it to another doctor. I feel as if that hospitalist didn't talk to the other hospitalist. (patient 7)
Poor communication can negatively affect the doctor‐patient relationship. They don't really want to explain things. They don't think I'll understand. I think & yeah, I'm okay. You don't even have to put it in layman's terms. I know medical. I'm in nursing school. I have a year left. But even if you didn't know that, I would still hope you would try to tell me what was going on instead of just doing it in your head, and treating it. (patient 2)
I mean it's just you always have to explain your situation over and over and over again. After a while you just stop trusting them. (patient 20)
Good communication can positively affect the doctor‐patient relationship. Just continue with the communication, the open communication, and always stress to me that I have a voice and just going out of their way to do whatever they can to help me through whatever I'm going through. (patient 1)
Transparency in transition Patients want to be informed prior to a service changeover. I think they should be told immediately, even maybe given prior notice, like this may happen, just so you're not surprised when it happens. (patient 15)
When the doctor approached me, he let me know that he wasn't going to be here the next day and there was going to be another doctor coming in. That made me feel comfortable. (patient 9)
Patients desire a more formalized process in the service changeover. People want things to be consistent. People don't like change. They like routine. So, if he's leaving, you're coming on, I'd like for him to bring you in, introduce you to me, and for you just assure me that I'll take care of you. (patient 4)
Just like when you get a new medication, you're given all this information on it. So when you get a new hospitalist, shouldn't I get all the information on them? Like where they went to school, what they look like. (patient 23)
Patients want clearer definition of the roles the physicians will play in their care. The first time I was hospitalized for the first time I had all these different doctors coming in, and I had the residency, and the specialists, and the department, and I don't know who's who. What I asked them to do is when they come in the room, which they did, but introduce it a little more for me. Write it down like these are the special team and these are the doctors because even though they come in and give me their name, I have no idea what they're doing. (patient 5)
Someone should explain the setup and who people are. Someone would say, Okay when you're in a hospital this is your [doctor's] role. Like they should have booklets and everything. (patient 19)
Indifference toward transition Many patients have trust in service changeovers. [S]o as long as everybody's on board and communicates well and efficiently, I don't have a problem with it. (patient 6)
To me, it really wasn't no preference, as long as I was getting the care that I needed. (patient 21)
It's not a concern as long as they're on the same page. (patient 17)
Hospitalist‐specialist communication Patients are concerned about communication between their hospitalist and their subspecialists. The more cooks you get in the kitchen, the more things get to get lost, so I'm always concerned that they're not sharing the same information, especially when you're getting asked the same questions that you might have just answered the last hour ago. (patient 9)
I don't know if the hospitalist are talking to them [subspecialist]. They haven't got time. (patient 35)
Patients place trust in the communication between hospitalist and subspecialist. I think among the teams themselveswhich is my pain doctor, Dr. K's group, the oncology group itself, they switch off and trade with each other and they all speak the same language so that works out good. (patient 3)
Lack of interprofessional communication can lead to patient concern. I was afraid that one was going to drop the ball on something and not pass something on, or you know. (patient 11)
I had numerous doctors who all seemed to not communicate with each other at all or did so by email or whatever. They didn't just sit down together and say we feel this way and we feel that way. I didn't like that at all. (patient 10)
New opportunities due to transition Patients see new doctor as opportunity for medical reevaluation. I see it as two heads are better than one, three heads are better than one, four heads are better than one. When people put their heads together to work towards a common goal, especially when they're, you know, people working their craft, it can't be bad. (patient 9)
I finally got my ears looked atbecause I've asked to have my ears looked at since Mondayand the new doc is trying to make an effort to look at them. (patient 39)
Patients see service changeover as an opportunity to form a better personal relationship. Having a new hospitalist it gives you opportunity for a new beginning. (patient 11)
Bedside manner Good bedside manner can assist in a service changeover. Some of them are all business‐like but some of them are, Well how do you feel today? Hi, how are you? So this made a little difference. You feel more comfortable. You're going to be more comfortable with them. Their bedside manner helps. (patient 16)
It's just like when a doctor sits down and talks to you, they just seem more relaxed and more .... I know they're very busy and they have lots of things to do and other patients to see, but while they're in there with you, you know, you don't get too much time with them. So bedside manner is just so important. (patient 24)
Poor bedside manner can be detrimental in transition. [B]ecause they be so busy they claim they don't have time just to sit and talk to a patient, and make sure they all right. (patient 17)

Physician‐Patient Communication

Communication between the physician and the patient was an important element in patients' assessment of their experience. Patient's tended to divide physician‐patient communication into 2 categories: good communication, which consisted of open communication (patient 1) and patient engagement, and bad communication, which was described as physicians not sharing information or taking the time to explain the course of care in words that I'll understand (patient 2). Patients also described dissatisfaction with redundant communication between multiple hospitalists and the frustration of often having to describe their clinical course to multiple providers.

Transparency in Communication

The desire to have greater transparency in the handoff process was another common theme. This was likely due to the fact that 34/40 (85%) of surveyed patients were unaware that a service changeover had ever taken place. This lack of transparency was viewed to have further downstream consequences as patients stated that there should be a level of transparency, and when it's not, then there is always trust issues (patient 1). Upon further questioning as to how to make the process more transparent, many patients recommended a formalized, face‐to‐face introduction involving the patient and both hospitalists, in which the outgoing hospitalist would, bring you [oncoming hospitalist] in, and introduce you to me (patient 4).

Patients often stated that given the large spectrum of physicians they might encounter during their stay (ie, medical student, resident, hospitalist attending, subspecialty fellow, subspecialist attending), clearer definitions of physicians' roles are needed.

Hospitalist‐Specialist Communication

Concern about the communication between their hospitalist and subspecialist was another predominant theme. Conflicting and unclear directions from multiple services were especially frustrating, as a patient stated, One guy took me off this pill, the other guy wants me on that pill, I'm like okay, I can't do both (patient 8). Furthermore, a subset of patients referenced their subspecialist as their primary care provider and preferred their subspecialist for guidance in their hospital course, rather than their hospitalist. This often appeared in cases where the patient had an established relationship with the subspecialist prior to their hospitalization.

New Opportunities Due to Transition

Patients expressed positive feelings toward service handoffs by viewing the transition as an opportunity for medical reevaluation by a new physician. Patients told of instances in which a specific complaint was not being addressed by the first physician, but would be addressed by the second (oncoming) physician. A commonly expressed idea was that the oncoming physician might know something that he [Dr. B] didn't know, and since Dr. B was only here for a week, why not give him [oncoming hospitalist] a chance (patient 10). Patients would also describe the transition as an opportunity to form, and possibly improve, therapeutic alliances with a new hospitalist.

Bedside Manner

Bedside manner was another commonly mentioned thematic element. Patients were often quick to forget prior problems or issues that they may have suffered because of the transition if the oncoming physician was perceived to have a good bedside manner, often described as someone who formally introduced themselves, was considered relaxed, and would take the time to sit and talk with the patient. As a patient put it, [S]he sat down and got to know meand asked me what I wanted to do (patient 12). Conversely, patients described instances in which a perceived bad bedside manner led to a poor relationship between the physician and the patient, in which trust and comfort (patient 11) were sacrificed.

Indifference Toward Transition

In contrast to some of the previous findings, which called for improved interactions between physicians and patients, we also discovered a theme of indifference toward the transition. Several patients stated feelings of trust with the medical system, and were content with the service changeover as long as they felt that their medical needs were being met. Patients also tended to express a level of acceptance with the transition, and tended to believe that this was the price we pay for being here [in the hospital] (patient 7).

Conceptual Model

Following the collection and analysis of all patient responses, all themes were utilized to construct the ideal patient‐centered service handoff. The ideal transition describes open lines of communication between all involved parties, is facilitated by multiple modalities, such as the EHRs and nursing staff, and recognizes the patient as the primary stakeholder (Figure 1).

Figure 1
Conceptual model of the ideal patient experience with a service handoff. Abbreviations: EHR, electronic health record.

DISCUSSION

To our knowledge, this is the first qualitative investigation of the hospitalized patient's experience with service handoffs between hospitalists. The patient perspective adds a personal and first‐hand description of how fragmented care may impact the hospitalized patient experience.

Of the 6 themes, communication was found to be the most pertinent to our respondents. Because much of patient care is an inherently communicative activity, it is not surprising that patients, as well as patient safety experts, have focused on communication as an area in need of improvement in transition processes.[17, 18] Moreover, multiple medical societies have directly called for improvements within this area, and have specifically recommended clear and direct communication of treatment plans between the patient and physician, timely exchange of information, and knowledge of who is primarily in charge of the patients care.[11] Not surprisingly, each of these recommendations appears to be echoed by our participants. This theme is especially important given that good physician‐patient communication has been noted to be a major goal in achieving patient‐centered care, and has been positively correlated to medication adherence, patient satisfaction, and physical health outcomes.[19, 20, 21, 22, 23]

Although not a substitute for face‐to‐face interactions, other communication interventions between physicians and patients should be considered. For example, get to know me posters placed in patient rooms have been shown to encourage communication between patients and physicians.[24] Additionally, physician face cards have been used to improve patients' abilities to identify and clarify physicians' roles in patient care.[25] As a patient put it, If they got a new one [hospitalist], just as if I got a new medicationprint out information on themlike where they went to med school, and stuff(patient 13). These modalities may represent highly implementable, cost‐effective adjuncts to current handoff methods that may improve lines of communication between physicians and patients.

In addition to the importance placed on physician‐patient communication, interprofessional communication between hospitalists and subspecialists was also highly regarded. Studies have shown that practice‐based interprofessional communication, such as daily interdisciplinary rounds and the use of external facilitators, can improve healthcare processes and outcomes.[26] However, these interventions must be weighed with the many conflicting factors that both hospitalists and subspecialists face on daily basis, including high patient volumes, time limitations, patient availability, and scheduling conflicts.[27] None the less, the strong emphasis patients placed on this line of communication highlights this domain as an area in which hospitalist and subspecialist can work together for systematic improvement.

Patients also recognized the complexity of the transfer process between hospitalists and called for improved transparency. For example, patients repeatedly requested to be informed prior to any changes in their hospitalists, a request that remains consistent with current guidelines.[11] There also existed a strong desire for a more formalized process of transitioning between hospitalists, which often described a handoff procedure that would occur at the patient's bedside. This desire seems to be mirrored in the data that show that patients prefer to interact with their care team at the bedside and report higher satisfaction when they are involved with their care.[28, 29] Unfortunately, this desire for more direct interaction with physicians runs counter to the current paradigm of patient care, where most activities on rounds do not take place at the bedside.[30]

In contrast to patient's calls for improved transparency, an equally large portion of patients expressed relative indifference to the transition. Whereas on the surface this may seem salutary, some studies suggest that a lack of patient activation and engagement may have adverse effects toward patients' overall care.[31] Furthermore, others have shown evidence of better healthcare experiences, improved health outcomes, and lower costs in patients who are more active in their care.[30, 31] Altogether, this suggests that despite some patients' indifference, physicians should continue to engage patients in their hospital care.[32]

Although prevailing sentiments among patient safety advocates are that patient handoffs are inherently dangerous and place patients at increased risk of adverse events, patients did not always share this concern. A frequently occurring theme was that the transition is an opportunity for medical reevaluation or the establishment of a new, possibly improved therapeutic alliance. Recognizing this viewpoint offers oncoming hospitalists the opportunity to focus on issues that the patient may have felt were not being properly addressed with their prior physician.

Finally, although our conceptual model is not a strict guideline, we believe that any future studies should consider this framework when constructing interventions to improve service‐level handoffs. Several interventions already exist. For instance, educational interventions, such as patient‐centered interviewing, have been shown to improve patient satisfaction, compliance with medications, lead to fewer lawsuits, and improve health outcomes.[33, 34, 35] Additional methods of keeping the patient more informed include physician face sheets and performance of the handoff at the patient's bedside. Although well known in nursing literature, the idea of physicians performing handoffs at the patient's bedside is a particularly patient‐centric process.[36] This type of intervention may have the ability to transform the handoff from the current state of a 2‐way street, in which information is passed between 2 hospitalists, to a 3‐way stop, in which both hospitalists and the patient are able to communicate at this critical junction of care.

Although our study does offer new insight into the effects of discontinuous care, its exploratory nature does have limitations. First, being performed at a single academic center limits our ability to generalize our findings. Second, perspectives of those who did not wish to participate, patients' family members or caregivers, and those who were not queried, could highly differ from those we interviewed. Additionally, we did not collect data on patients' diagnoses or reason for admission, thus limiting our ability to assess if certain diagnosis or subpopulations predispose patients to experiencing a service handoff. Third, although our study was restricted to English‐speaking patients only, we must consider that non‐English speakers would likely suffer from even greater communication barriers than those who took part in our study. Finally, our interviews and data analysis were conducted by hospitalists, which could have subconsciously influenced the interview process, and the interpretation of patient responses. However, we tried to mitigate these issues by having the same individual interview all participants, by using an interview guide to ensure cross‐cohort consistency, by using open‐ended questions, and by attempting to give patients every opportunity to express themselves.

CONCLUSIONS

From a patients' perspective, inpatient service handoffs are often opaque experiences that are highlighted by poor communication between physicians and patients. Although deficits in communication and transparency acted as barriers to a patient‐centered handoff, physicians should recognize that service handoffs may also represent opportunities for improvement, and should focus on these domains when they start on a new service.

Disclosures

All funding for this project was provided by the Section of Hospital Medicine at The University of Chicago Medical Center. The data from this article were presented at the Society of Hospital Medicine Annual Conference, National Harbor, March 31, 2015, and at the Society of General Internal Medicine National Meeting in Toronto, Canada, April 23, 2015. The authors report that no conflicts of interest, financial or otherwise, exist.

References
  1. Sharma G, Fletcher KE, Zhang D, Kuo Y‐F, Freeman JL, Goodwin JS. Continuity of outpatient and inpatient care by primary care physicians for hospitalized older adults. JAMA. 2009;301(16):16711680.
  2. Nyweide DJ, Anthony DL, Bynum JPW, et al. Continuity of care and the risk of preventable hospitalization in older adults. JAMA Intern Med. 2013;173(20):18791885.
  3. Agency for Healthcare Research and Quality. HCUPnet: a tool for identifying, tracking, and analyzing national hospital statistics. Available at: http://hcupnet.ahrq.gov/HCUPnet.jsp?Id=82B37DA366A36BAD6(8):438444.
  4. Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433440.
  5. Epstein K, Juarez E, Epstein A, Loya K, Singer A. The impact of fragmentation of hospitalist care on length of stay. J Hosp Med. 2010;5(6):335338.
  6. Turner J, Hansen L, Hinami K, et al. The impact of hospitalist discontinuity on hospital cost, readmissions, and patient satisfaction. J Gen Intern Med. 2014;29(7):10041008.
  7. O'Leary KJ, Turner J, Christensen N, et al. The effect of hospitalist discontinuity on adverse events. J Hosp Med. 2015;10(3):147151.
  8. Agency for Healthcare Research and Quality. HCAHPS Fact Sheet. CAHPS Hospital Survey August 2013. Available at: http://www.hcahpsonline.org/files/August_2013_HCAHPS_Fact_Sheet3.pdf. Accessed February 2, 2015.
  9. Behara R, Wears RL, Perry SJ, et al. A conceptual framework for studying the safety of transitions in emergency care. In: Henriksen K, Battles JB, Marks ES, eds. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005:309321. Concepts and Methodology; vol 2. Available at: http://www.ncbi.nlm.nih.gov/books/NBK20522. Accessed January 15, 2015.
  10. Snow V, Beck D, Budnitz T, et al. Transitions of care consensus policy statement American College of Physicians‐Society of General Internal Medicine‐Society of Hospital Medicine‐American Geriatrics Society‐American College of Emergency Physicians‐Society of Academic Emergency Medicine. J Gen Intern Med. 2009;24(8):971976.
  11. Watling CJ, Lingard L. Grounded theory in medical education research: AMEE guide no. 70. Med Teach. 2012;34(10):850861.
  12. Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36(4):391409.
  13. Morse JM. The significance of saturation. Qual Health Res. 1995;5(2):147149.
  14. O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):12451251.
  15. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32‐item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349357.
  16. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314323.
  17. The Joint Commission. Hot Topics in Healthcare, Issue 2. Transitions of care: the need for collaboration across entire care continuum. Available at: http://www.jointcommission.org/assets/1/6/TOC_Hot_Topics.pdf. Accessed April 9, 2015.
  18. Zolnierek KBH, Dimatteo MR. Physician communication and patient adherence to treatment: a meta‐analysis. Med Care. 2009;47(8):826834.
  19. Desai NR, Choudhry NK. Impediments to adherence to post myocardial infarction medications. Curr Cardiol Rep. 2013;15(1):322.
  20. Zandbelt LC, Smets EMA, Oort FJ, Godfried MH, Haes HCJM. Medical specialists' patient‐centered communication and patient‐reported outcomes. Med Care. 2007;45(4):330339.
  21. Clever SL, Jin L, Levinson W, Meltzer DO. Does doctor‐patient communication affect patient satisfaction with hospital care? Results of an analysis with a novel instrumental variable. Health Serv Res. 2008;43(5 pt 1):15051519.
  22. Michie S, Miles J, Weinman J. Patient‐centredness in chronic illness: what is it and does it matter? Patient Educ Couns. 2003;51(3):197206.
  23. Billings JA, Keeley A, Bauman J, et al. Merging cultures: palliative care specialists in the medical intensive care unit. Crit Care Med. 2006;34(11 suppl):S388S393.
  24. Arora VM, Schaninger C, D'Arcy M, et al. Improving inpatients' identification of their doctors: use of FACE cards. Jt Comm J Qual Patient Saf. 2009;35(12):613619.
  25. Zwarenstein M, Goldman J, Reeves S. Interprofessional collaboration: effects of practice‐based interventions on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2009;(3):CD000072.
  26. Gonzalo JD, Heist BS, Duffy BL, et al. Identifying and overcoming the barriers to bedside rounds: a multicenter qualitative study. Acad Med. 2014;89(2):326334.
  27. Lehmann LS, Brancati FL, Chen MC, Roter D, Dobs AS. The effect of bedside case presentations on patients' perceptions of their medical care. N Engl J Med. 1997;336(16):11501155.
  28. Gonzalo JD, Wolpaw DR, Lehman E, Chuang CH. Patient‐centered interprofessional collaborative care: factors associated with bedside interprofessional rounds. J Gen Intern Med. 2014;29(7):10401047.
  29. Stickrath C, Noble M, Prochazka A, et al. Attending rounds in the current era: what is and is not happening. JAMA Intern Med. 2013;173(12):10841089.
  30. Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013;32(2):207214.
  31. Greene J, Hibbard JH, Sacks R, Overton V, Parrotta CD. When patient activation levels change, health outcomes and costs change, too. Health Aff Proj Hope. 2015;34(3):431437.
  32. Smith RC, Marshall‐Dorsey AA, Osborn GG, et al. Evidence‐based guidelines for teaching patient‐centered interviewing. Patient Educ Couns. 2000;39(1):2736.
  33. Hall JA, Roter DL, Katz NR. Meta‐analysis of correlates of provider behavior in medical encounters. Med Care. 1988;26(7):657675.
  34. Huycke LI, Huycke MM. Characteristics of potential plaintiffs in malpractice litigation. Ann Intern Med. 1994;120(9):792798.
  35. Gregory S, Tan D, Tilrico M, Edwardson N, Gamm L. Bedside shift reports: what does the evidence say? J Nurs Adm. 2014;44(10):541545.
References
  1. Sharma G, Fletcher KE, Zhang D, Kuo Y‐F, Freeman JL, Goodwin JS. Continuity of outpatient and inpatient care by primary care physicians for hospitalized older adults. JAMA. 2009;301(16):16711680.
  2. Nyweide DJ, Anthony DL, Bynum JPW, et al. Continuity of care and the risk of preventable hospitalization in older adults. JAMA Intern Med. 2013;173(20):18791885.
  3. Agency for Healthcare Research and Quality. HCUPnet: a tool for identifying, tracking, and analyzing national hospital statistics. Available at: http://hcupnet.ahrq.gov/HCUPnet.jsp?Id=82B37DA366A36BAD6(8):438444.
  4. Arora VM, Manjarrez E, Dressler DD, Basaviah P, Halasyamani L, Kripalani S. Hospitalist handoffs: a systematic review and task force recommendations. J Hosp Med. 2009;4(7):433440.
  5. Epstein K, Juarez E, Epstein A, Loya K, Singer A. The impact of fragmentation of hospitalist care on length of stay. J Hosp Med. 2010;5(6):335338.
  6. Turner J, Hansen L, Hinami K, et al. The impact of hospitalist discontinuity on hospital cost, readmissions, and patient satisfaction. J Gen Intern Med. 2014;29(7):10041008.
  7. O'Leary KJ, Turner J, Christensen N, et al. The effect of hospitalist discontinuity on adverse events. J Hosp Med. 2015;10(3):147151.
  8. Agency for Healthcare Research and Quality. HCAHPS Fact Sheet. CAHPS Hospital Survey August 2013. Available at: http://www.hcahpsonline.org/files/August_2013_HCAHPS_Fact_Sheet3.pdf. Accessed February 2, 2015.
  9. Behara R, Wears RL, Perry SJ, et al. A conceptual framework for studying the safety of transitions in emergency care. In: Henriksen K, Battles JB, Marks ES, eds. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005:309321. Concepts and Methodology; vol 2. Available at: http://www.ncbi.nlm.nih.gov/books/NBK20522. Accessed January 15, 2015.
  10. Snow V, Beck D, Budnitz T, et al. Transitions of care consensus policy statement American College of Physicians‐Society of General Internal Medicine‐Society of Hospital Medicine‐American Geriatrics Society‐American College of Emergency Physicians‐Society of Academic Emergency Medicine. J Gen Intern Med. 2009;24(8):971976.
  11. Watling CJ, Lingard L. Grounded theory in medical education research: AMEE guide no. 70. Med Teach. 2012;34(10):850861.
  12. Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36(4):391409.
  13. Morse JM. The significance of saturation. Qual Health Res. 1995;5(2):147149.
  14. O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):12451251.
  15. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32‐item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349357.
  16. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314323.
  17. The Joint Commission. Hot Topics in Healthcare, Issue 2. Transitions of care: the need for collaboration across entire care continuum. Available at: http://www.jointcommission.org/assets/1/6/TOC_Hot_Topics.pdf. Accessed April 9, 2015.
  18. Zolnierek KBH, Dimatteo MR. Physician communication and patient adherence to treatment: a meta‐analysis. Med Care. 2009;47(8):826834.
  19. Desai NR, Choudhry NK. Impediments to adherence to post myocardial infarction medications. Curr Cardiol Rep. 2013;15(1):322.
  20. Zandbelt LC, Smets EMA, Oort FJ, Godfried MH, Haes HCJM. Medical specialists' patient‐centered communication and patient‐reported outcomes. Med Care. 2007;45(4):330339.
  21. Clever SL, Jin L, Levinson W, Meltzer DO. Does doctor‐patient communication affect patient satisfaction with hospital care? Results of an analysis with a novel instrumental variable. Health Serv Res. 2008;43(5 pt 1):15051519.
  22. Michie S, Miles J, Weinman J. Patient‐centredness in chronic illness: what is it and does it matter? Patient Educ Couns. 2003;51(3):197206.
  23. Billings JA, Keeley A, Bauman J, et al. Merging cultures: palliative care specialists in the medical intensive care unit. Crit Care Med. 2006;34(11 suppl):S388S393.
  24. Arora VM, Schaninger C, D'Arcy M, et al. Improving inpatients' identification of their doctors: use of FACE cards. Jt Comm J Qual Patient Saf. 2009;35(12):613619.
  25. Zwarenstein M, Goldman J, Reeves S. Interprofessional collaboration: effects of practice‐based interventions on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2009;(3):CD000072.
  26. Gonzalo JD, Heist BS, Duffy BL, et al. Identifying and overcoming the barriers to bedside rounds: a multicenter qualitative study. Acad Med. 2014;89(2):326334.
  27. Lehmann LS, Brancati FL, Chen MC, Roter D, Dobs AS. The effect of bedside case presentations on patients' perceptions of their medical care. N Engl J Med. 1997;336(16):11501155.
  28. Gonzalo JD, Wolpaw DR, Lehman E, Chuang CH. Patient‐centered interprofessional collaborative care: factors associated with bedside interprofessional rounds. J Gen Intern Med. 2014;29(7):10401047.
  29. Stickrath C, Noble M, Prochazka A, et al. Attending rounds in the current era: what is and is not happening. JAMA Intern Med. 2013;173(12):10841089.
  30. Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013;32(2):207214.
  31. Greene J, Hibbard JH, Sacks R, Overton V, Parrotta CD. When patient activation levels change, health outcomes and costs change, too. Health Aff Proj Hope. 2015;34(3):431437.
  32. Smith RC, Marshall‐Dorsey AA, Osborn GG, et al. Evidence‐based guidelines for teaching patient‐centered interviewing. Patient Educ Couns. 2000;39(1):2736.
  33. Hall JA, Roter DL, Katz NR. Meta‐analysis of correlates of provider behavior in medical encounters. Med Care. 1988;26(7):657675.
  34. Huycke LI, Huycke MM. Characteristics of potential plaintiffs in malpractice litigation. Ann Intern Med. 1994;120(9):792798.
  35. Gregory S, Tan D, Tilrico M, Edwardson N, Gamm L. Bedside shift reports: what does the evidence say? J Nurs Adm. 2014;44(10):541545.
Issue
Journal of Hospital Medicine - 11(10)
Issue
Journal of Hospital Medicine - 11(10)
Page Number
675-681
Page Number
675-681
Article Type
Display Headline
A qualitative analysis of patients' experience with hospitalist service handovers
Display Headline
A qualitative analysis of patients' experience with hospitalist service handovers
Sections
Article Source
© 2016 Society of Hospital Medicine
Disallow All Ads
Correspondence Location
Address for correspondence and reprint requests: Charlie M. Wray, DO, Hospitalist Research Scholar–Clinical Associate, Section of Hospital Medicine, University of Chicago Medical Center, 5841 S. Maryland Avenue, MC 5000, Chicago, IL 60637; Telephone: 415‐595‐9662; E‐mail: [email protected]
Content Gating
Gated (full article locked unless allowed per User)
Gating Strategy
First Peek Free
Article PDF Media
Media Files

A Retrospective Analysis of Hemostatic Techniques in Primary Total Knee Arthroplasty: Traditional Electrocautery, Bipolar Sealer, and Argon Beam Coagulation

Article Type
Changed
Display Headline
A Retrospective Analysis of Hemostatic Techniques in Primary Total Knee Arthroplasty: Traditional Electrocautery, Bipolar Sealer, and Argon Beam Coagulation

Total knee arthroplasty (TKA) is a reliable and successful treatment for end-stage degenerative joint disease of the knee. Given the reproducibility of its generally excellent outcomes, TKA is increasingly being performed.1 However, the potential complications of this procedure can be devastating.2-4 The arthroplasty literature has shed light on the detrimental effects of postoperative blood loss and anemia.5,6 In addition, the increase in transfusion burden among patients is not without risk.7 Given these concerns, surgeons have been tasked with determining the ideal methods for minimizing blood transfusions and postoperative hematomas and anemia. Several strategies have been described.8-11 Hemostasis can be achieved with use of intravenous medications, intra-articular agents, or electrocautery devices. Electrocautery technologies include traditional electrocautery (TE), saline-coupled bipolar sealer (BS), and argon beam coagulation (ABC). There is controversy as to whether outcomes are better with one hemostasis method over another and whether these methods are worth the additional cost.

In traditional (Bovie) electrocautery, a unipolar device delivers an electrical current to tissues through a pencil-like instrument. Intraoperative tissue temperatures can exceed 400°C.12 In BS, radiofrequency energy is delivered through a saline medium, which increases the contact area, acts as an electrode, and maintains a cooler environment during electrocautery. Proposed advantages are reduced tissue destruction and absence of smoke.12 There is evidence both for10,12-16 and against17-20 use of BS in total joint arthroplasty. ABC, a novel hemostasis method, has been studied in the context of orthopedics21,22 but not TKA specifically. ABC establishes a monopolar electric circuit between a handheld device and the target tissues by channeling electrons through ionized argon gas. Hemostasis is achieved through thermal coagulation. Tissue penetration can be adjusted by changing power, probe-to-target distance, and duration of use.23 We conducted a study to assess the efficacy of all 3 electrocautery methods during TKA. We hypothesized the 3 methods would be clinically equivalent with respect to estimated blood loss (EBL), 48-hour wound drainage, operative time, and change from preoperative hemoglobin (Hb) level.

Methods

We conducted a retrospective cohort study of consecutive primary TKAs performed by Dr. Levine between October 2010 and November 2011. Patients were identified by querying an internal database. Exclusion criteria were prior ipsilateral open knee procedure, prior fracture, nonuse of our standard hemostatic protocol, and either tourniquet time under 40 minutes or intraoperative documentation of tourniquet failure. As only 9 patients were initially identified for the TE cohort, the same database was used to add 32 patients treated between April 2009 and October 2009 (before our institution began using BS and ABC).

Clinical charts were reviewed, and baseline demographics (age, body mass index [BMI], preoperative Hb level) were abstracted, as were outcome metrics (EBL, 48-hour wound drainage, operative time, postoperative transfusions, adverse events (AEs) before discharge, and change in Hb level from before surgery to after surgery, in recovery room and on discharge). Statistical analyses were performed with JMP Version 10.0.0 (SAS Institute). Given the hypothesis that the 3 hemostasis methods would be clinically equivalent, 2 one-sided tests (TOSTs) of equivalence were performed with an α of 0.05. With TOST, the traditional null and alternative hypotheses are reversed; thus, P < .05 identifies statistical equivalence. The advantage of this study design is that equivalence can be identified, whereas traditional study designs can identify only a lack of statistical difference.24 We used our consensus opinions to set clinical insignificance thresholds for EBL (150 mL), wound drainage (150 mL), decrease from postoperative Hb level (1 g/dL), and operative time (10 minutes). Patients who received a blood transfusion were subsequently excluded from analysis in order to avoid skewing Hb-level depreciation calculations. Analysis of variance (ANOVA) and χ2 tests were used to compare preoperative variables, transfusion requirements, hospital length of stay, and AE rates by hemostasis type.

Cautery Technique

In all cases, TE was used for surgical dissection, which followed a standard midvastus approach. Then, for meniscal excision, the capsule and meniscal attachment sites were treated with TE, BS, or ABC. During cement hardening, an available supplemental cautery option was used to achieve hemostasis of the suprapatellar fat pad and visible meniscal attachment sites. All other aspects of the procedure and the postoperative protocols—including the anticoagulation and rapid rehabilitation (early ambulation and therapy) protocols—were similar for all patients. The standard anticoagulation protocol was to use low-molecular-weight heparin, unless contraindicated. Tranexamic acid was not used at our institution during the study period.

Results

For the study period, 280 cases (41 TE, 203 BS, 36 ABC) met the inclusion criteria. Of the 280 TKAs, 261 (93.21%) were performed for degenerative arthritis. There was no statistically significant difference among cohorts in indication (χ2 = 1.841, P = .398) or sex (χ2 = 1.176, P= .555).

 

 

Table 1 lists the cohorts’ baseline demographics (mean age, BMI, preoperative Hb level) and comparative ANOVA results. TOSTs of equivalence were performed to compare operative time, EBL, 48-hour wound drainage, and postoperative Hb-level depreciation among hemostasis types. Changes in Hb level were calculated for the immediate postoperative period and time of discharge (Table 2). ANOVA of hospital length of stay demonstrated no significant difference in means among groups (P = .09).

The cohorts were compared with respect to use of postoperative transfusions and incidence of postoperative AEs (Table 3). The TE cohort did not have any AEs. Of the 203 BS patients, 14 (7%) had 1 or more AEs, which included acute kidney injury (3 cases), electrolyte disturbance (3), urinary tract infection (2), oxygen desaturation (2), altered mental status (1), pneumonia (1), arrhythmia (1), congestive heart failure exacerbation (1), dehiscence (1), pulmonary embolism (2), and hypotension (1). Of the 36 ABC patients, 1 (3%) had arrhythmia, pneumonia, sepsis, and altered mental status.

Discussion

With the population aging, the demand for TKA is greater than ever.1 As surgical volume increases, the ability to minimize the rates of intraoperative bleeding, postoperative anemia, and transfusion is becoming increasingly important to patients and the healthcare system. There is no consensus as to which cautery method is ideal. Other investigators have identified differences in clinical outcomes between cautery systems, but reported results are largely conflicting.10,12-20 In addition, no one has studied the utility of ABC in TKA. In the present retrospective cohort analysis, we hypothesized that TE, BS, and ABC would be clinically equivalent in primary TKA with respect to EBL, 48-hour wound drainage, operative time, and change from preoperative Hb level.

The data on hemostatic technology in primary TKA are inconclusive. In an age- and sex-matched study comparing TE and BS in primary TKA, BS used with shed blood autotransfusion reduced homologous blood transfusions by a factor of 5.16 In addition, BS patients lost significantly less total visible blood (intraoperative EBL, postoperative drain output), and their magnitude of postoperative Hb-level depreciations at time of discharge was significantly lower. In a multicenter, prospective randomized trial comparing TE with BS, adjusted blood loss and need for autologous blood transfusions were lower in BS patients,10 though there was no significant difference in Knee Society Scale scores between the 2 treatment arms. However, analysis was potentially biased in that multiple authors had financial ties to Salient Surgical Technologies, the manufacturer of the BS device used in the study. Other prospective randomized trials of patients who had primary TKA with either TE or BS did not find any significant difference in postoperative Hb level, postoperative drainage, or transfusion requirements.19 ABC has been studied in the context of orthopedics but not joint arthroplasty specifically. This technology was anecdotally identified as a means of attaining hemostasis in foot and ankle surgery after failure of TE and other conventional means.22 ABC has also been identified as a successful adjuvant to curettage in the treatment of aneurysmal bone cysts.21 However, ABC has not been compared with TE or BS in the orthopedic literature.

In the present study, analysis of preoperative variables revealed a statistically but not clinically significant difference in BMI among cohorts. Mean (SD) BMI was 35.6 (6.5) for TE patients, 35.8 (9.7) for BS patients, and 40.9 (11.3) for ABC patients. (Previously, BMI did not correlate with intraoperative blood loss in TKA.25) Analysis also revealed a statistically significant but clinically insignificant and inconsequential difference in Hb level among cohorts. Mean (SD) preoperative Hb level was 13.5 (1.6) g/dL for TE patients, 12.8 (1.4) g/dL for BS patients, and 13.0 (1.6) g/dL for ABC patients. As decreases from preoperative baseline Hb levels were the intended focus of analysis—not absolute Hb levels—this finding does not refute postoperative analyses.

Our results suggest that, though TE may have relatively longer operative times in primary TKA, it is clinically equivalent to BS and ABC with respect to EBL and postoperative change in Hb levels. In addition, postoperative drainage was lower in TE than in BS and ABC, which were equivalent. No significant differences were found among hemostasis types with respect to postoperative transfusion requirements.

The prevalence distribution of predischarge AEs trended toward significance (χ2 = 5.957, P = .051), despite not meeting the predetermined α level. Rates of predischarge AEs were 0% (0/41) for TE patients, 7% (14/203) for BS patients, and 3% (1/36) for ABC patients. AEs included acute kidney injuries, electrolyte disturbances, urinary tract infections, oxygen desaturation, altered mental status, sepsis/infections, arrhythmias, congestive heart failure exacerbation, dehiscence, pulmonary embolism, and hypotension. Clearly, many of these AEs are not attributable to the hemostasis system used.

 

 

Limitations of this study include its retrospective design, documentation inadequate to account for drainage amount reinfused, and limited data on which clinical insignificance thresholds were based. In addition, reliance on historical data may have introduced bias into the analysis. The historical data used to increase the size of the TE cohort may reflect a period of relative inexperience and may have contributed to the longer operative times relative to those of the ABC cohort (Dr. Levine used ABC later in his career).

Traditional electrocautery remains a viable option in primary TKA. With its low cost and hemostasis equivalent to that of BS and ABC, TE deserves consideration equal to that given to these more modern hemostasis technologies. Cost per case is about $10 for TE versus $500 for BS and $110 for ABC.17 Soaring healthcare expenditures may warrant returning to TE or combining cautery techniques and other agents in primary TKA in order to reduce the number of transfusions and associated surgical costs.

References

1.    Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012;308(12):1227-1236.

2.    Leijtens B, Kremers van de Hei K, Jansen J, Koëter S. High complication rate after total knee and hip replacement due to perioperative bridging of anticoagulant therapy based on the 2012 ACCP guideline. Arch Orthop Trauma Surg. 2014;134(9):1335-1341.

3.    Park CH, Lee SH, Kang DG, Cho KY, Lee SH, Kim KI. Compartment syndrome following total knee arthroplasty: clinical results of late fasciotomy. Knee Surg Relat Res. 2014;26(3):177-181.

4.    Pedersen AB, Mehnert F, Sorensen HT, Emmeluth C, Overgaard S, Johnsen SP. The risk of venous thromboembolism, myocardial infarction, stroke, major bleeding and death in patients undergoing total hip and knee replacement: a 15-year retrospective cohort study of routine clinical practice. Bone Joint J. 2014;96-B(4):479-485.

5.    Carson JL, Poses RM, Spence RK, Bonavita G. Severity of anaemia and operative mortality and morbidity. Lancet. 1988;1(8588):727-729.

6.    Carson JL, Duff A, Poses RM, et al. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996;348(9034):1055-1060.

7.    Dodd RY. Current risk for transfusion transmitted infections. Curr Opin Hematol. 2007;14(6):671-676.

8.    Kang DG, Khurana S, Baek JH, Park YS, Lee SH, Kim KI. Efficacy and safety using autotransfusion system with postoperative shed blood following total knee arthroplasty in haemophilia. Haemophilia. 2014;20(1):129-132.

9.    Aguilera X, Martinez-Zapata MJ, Bosch A, et al. Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial. J Bone Joint Surg Am. 2013;95(22):2001-2007.

10.  Marulanda GA, Krebs VE, Bierbaum BE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop. 2009;38(12):E179-E183.

11.  Katkhouda N, Friedlander M, Darehzereshki A, et al. Argon beam coagulation versus fibrin sealant for hemostasis following liver resection: a randomized study in a porcine model. Hepatogastroenterology. 2013;60(125):1110-1116.

12.  Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008;5(2):125-131.

13.  Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010;20:352-356.

14.   Clement RC, Kamath AF, Derman PB, Garino JP, Lee GC. Bipolar sealing in revision total hip arthroplasty for infection: efficacy and cost analysis. J Arthroplasty. 2012;27(7):1376-1381.

15.  Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007;22(4 suppl 1):82-85.

16.  Pfeiffer M, Bräutigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005;3:Doc10.

17.  Morris MJ, Barrett M, Lombardi AV Jr, Tucker TL, Berend KR. Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty. J Arthroplasty. 2013;28(9):1614-1617.

18.  Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011;93(6):513-518.

19.  Plymale MF, Capogna BM, Lovy AJ, Adler ML, Hirsh DM, Kim SJ. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective randomized trial. J Arthroplasty. 2012;27(6):1133-1137.e1.

20.   Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system—an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010;25(7):1072-1077.

21.  Cummings JE, Smith RA, Heck RK Jr. Argon beam coagulation as adjuvant treatment after curettage of aneurysmal bone cysts: a preliminary study. Clin Orthop Relat Res. 2010;468(1):231-237.

22.  Adams ML, Steinberg JS. Argon beam coagulation in foot and ankle surgery. J Foot Ankle Surg. 2011;50(6):780-782.

23.  Neumayer L, Vargo D. Principles of preoperative and operative surgery. In: Townsend CM Jr, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery. 19th ed. Philadelphia, PA: Elsevier Saunders; 2012:211-239.

24.  Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011;26(2):192-196.

25.  Hrnack SA, Skeen N, Xu T, Rosenstein AD. Correlation of body mass index and blood loss during total knee and total hip arthroplasty. Am J Orthop. 2012;41(10):467-471.

Article PDF
Author and Disclosure Information

Brett D. Rosenthal, MD, Bryan D. Haughom, MD, and Brett R. Levine, MD, MS

Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Issue
The American Journal of Orthopedics - 45(4)
Publications
Topics
Page Number
E187-E191
Legacy Keywords
total knee arthroplasty, TKA, arthroplasty, knee, bipolar, coagulation, hemostatic, techniques, study, rosenthal, haughom, levine
Sections
Author and Disclosure Information

Brett D. Rosenthal, MD, Bryan D. Haughom, MD, and Brett R. Levine, MD, MS

Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Author and Disclosure Information

Brett D. Rosenthal, MD, Bryan D. Haughom, MD, and Brett R. Levine, MD, MS

Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Article PDF
Article PDF

Total knee arthroplasty (TKA) is a reliable and successful treatment for end-stage degenerative joint disease of the knee. Given the reproducibility of its generally excellent outcomes, TKA is increasingly being performed.1 However, the potential complications of this procedure can be devastating.2-4 The arthroplasty literature has shed light on the detrimental effects of postoperative blood loss and anemia.5,6 In addition, the increase in transfusion burden among patients is not without risk.7 Given these concerns, surgeons have been tasked with determining the ideal methods for minimizing blood transfusions and postoperative hematomas and anemia. Several strategies have been described.8-11 Hemostasis can be achieved with use of intravenous medications, intra-articular agents, or electrocautery devices. Electrocautery technologies include traditional electrocautery (TE), saline-coupled bipolar sealer (BS), and argon beam coagulation (ABC). There is controversy as to whether outcomes are better with one hemostasis method over another and whether these methods are worth the additional cost.

In traditional (Bovie) electrocautery, a unipolar device delivers an electrical current to tissues through a pencil-like instrument. Intraoperative tissue temperatures can exceed 400°C.12 In BS, radiofrequency energy is delivered through a saline medium, which increases the contact area, acts as an electrode, and maintains a cooler environment during electrocautery. Proposed advantages are reduced tissue destruction and absence of smoke.12 There is evidence both for10,12-16 and against17-20 use of BS in total joint arthroplasty. ABC, a novel hemostasis method, has been studied in the context of orthopedics21,22 but not TKA specifically. ABC establishes a monopolar electric circuit between a handheld device and the target tissues by channeling electrons through ionized argon gas. Hemostasis is achieved through thermal coagulation. Tissue penetration can be adjusted by changing power, probe-to-target distance, and duration of use.23 We conducted a study to assess the efficacy of all 3 electrocautery methods during TKA. We hypothesized the 3 methods would be clinically equivalent with respect to estimated blood loss (EBL), 48-hour wound drainage, operative time, and change from preoperative hemoglobin (Hb) level.

Methods

We conducted a retrospective cohort study of consecutive primary TKAs performed by Dr. Levine between October 2010 and November 2011. Patients were identified by querying an internal database. Exclusion criteria were prior ipsilateral open knee procedure, prior fracture, nonuse of our standard hemostatic protocol, and either tourniquet time under 40 minutes or intraoperative documentation of tourniquet failure. As only 9 patients were initially identified for the TE cohort, the same database was used to add 32 patients treated between April 2009 and October 2009 (before our institution began using BS and ABC).

Clinical charts were reviewed, and baseline demographics (age, body mass index [BMI], preoperative Hb level) were abstracted, as were outcome metrics (EBL, 48-hour wound drainage, operative time, postoperative transfusions, adverse events (AEs) before discharge, and change in Hb level from before surgery to after surgery, in recovery room and on discharge). Statistical analyses were performed with JMP Version 10.0.0 (SAS Institute). Given the hypothesis that the 3 hemostasis methods would be clinically equivalent, 2 one-sided tests (TOSTs) of equivalence were performed with an α of 0.05. With TOST, the traditional null and alternative hypotheses are reversed; thus, P < .05 identifies statistical equivalence. The advantage of this study design is that equivalence can be identified, whereas traditional study designs can identify only a lack of statistical difference.24 We used our consensus opinions to set clinical insignificance thresholds for EBL (150 mL), wound drainage (150 mL), decrease from postoperative Hb level (1 g/dL), and operative time (10 minutes). Patients who received a blood transfusion were subsequently excluded from analysis in order to avoid skewing Hb-level depreciation calculations. Analysis of variance (ANOVA) and χ2 tests were used to compare preoperative variables, transfusion requirements, hospital length of stay, and AE rates by hemostasis type.

Cautery Technique

In all cases, TE was used for surgical dissection, which followed a standard midvastus approach. Then, for meniscal excision, the capsule and meniscal attachment sites were treated with TE, BS, or ABC. During cement hardening, an available supplemental cautery option was used to achieve hemostasis of the suprapatellar fat pad and visible meniscal attachment sites. All other aspects of the procedure and the postoperative protocols—including the anticoagulation and rapid rehabilitation (early ambulation and therapy) protocols—were similar for all patients. The standard anticoagulation protocol was to use low-molecular-weight heparin, unless contraindicated. Tranexamic acid was not used at our institution during the study period.

Results

For the study period, 280 cases (41 TE, 203 BS, 36 ABC) met the inclusion criteria. Of the 280 TKAs, 261 (93.21%) were performed for degenerative arthritis. There was no statistically significant difference among cohorts in indication (χ2 = 1.841, P = .398) or sex (χ2 = 1.176, P= .555).

 

 

Table 1 lists the cohorts’ baseline demographics (mean age, BMI, preoperative Hb level) and comparative ANOVA results. TOSTs of equivalence were performed to compare operative time, EBL, 48-hour wound drainage, and postoperative Hb-level depreciation among hemostasis types. Changes in Hb level were calculated for the immediate postoperative period and time of discharge (Table 2). ANOVA of hospital length of stay demonstrated no significant difference in means among groups (P = .09).

The cohorts were compared with respect to use of postoperative transfusions and incidence of postoperative AEs (Table 3). The TE cohort did not have any AEs. Of the 203 BS patients, 14 (7%) had 1 or more AEs, which included acute kidney injury (3 cases), electrolyte disturbance (3), urinary tract infection (2), oxygen desaturation (2), altered mental status (1), pneumonia (1), arrhythmia (1), congestive heart failure exacerbation (1), dehiscence (1), pulmonary embolism (2), and hypotension (1). Of the 36 ABC patients, 1 (3%) had arrhythmia, pneumonia, sepsis, and altered mental status.

Discussion

With the population aging, the demand for TKA is greater than ever.1 As surgical volume increases, the ability to minimize the rates of intraoperative bleeding, postoperative anemia, and transfusion is becoming increasingly important to patients and the healthcare system. There is no consensus as to which cautery method is ideal. Other investigators have identified differences in clinical outcomes between cautery systems, but reported results are largely conflicting.10,12-20 In addition, no one has studied the utility of ABC in TKA. In the present retrospective cohort analysis, we hypothesized that TE, BS, and ABC would be clinically equivalent in primary TKA with respect to EBL, 48-hour wound drainage, operative time, and change from preoperative Hb level.

The data on hemostatic technology in primary TKA are inconclusive. In an age- and sex-matched study comparing TE and BS in primary TKA, BS used with shed blood autotransfusion reduced homologous blood transfusions by a factor of 5.16 In addition, BS patients lost significantly less total visible blood (intraoperative EBL, postoperative drain output), and their magnitude of postoperative Hb-level depreciations at time of discharge was significantly lower. In a multicenter, prospective randomized trial comparing TE with BS, adjusted blood loss and need for autologous blood transfusions were lower in BS patients,10 though there was no significant difference in Knee Society Scale scores between the 2 treatment arms. However, analysis was potentially biased in that multiple authors had financial ties to Salient Surgical Technologies, the manufacturer of the BS device used in the study. Other prospective randomized trials of patients who had primary TKA with either TE or BS did not find any significant difference in postoperative Hb level, postoperative drainage, or transfusion requirements.19 ABC has been studied in the context of orthopedics but not joint arthroplasty specifically. This technology was anecdotally identified as a means of attaining hemostasis in foot and ankle surgery after failure of TE and other conventional means.22 ABC has also been identified as a successful adjuvant to curettage in the treatment of aneurysmal bone cysts.21 However, ABC has not been compared with TE or BS in the orthopedic literature.

In the present study, analysis of preoperative variables revealed a statistically but not clinically significant difference in BMI among cohorts. Mean (SD) BMI was 35.6 (6.5) for TE patients, 35.8 (9.7) for BS patients, and 40.9 (11.3) for ABC patients. (Previously, BMI did not correlate with intraoperative blood loss in TKA.25) Analysis also revealed a statistically significant but clinically insignificant and inconsequential difference in Hb level among cohorts. Mean (SD) preoperative Hb level was 13.5 (1.6) g/dL for TE patients, 12.8 (1.4) g/dL for BS patients, and 13.0 (1.6) g/dL for ABC patients. As decreases from preoperative baseline Hb levels were the intended focus of analysis—not absolute Hb levels—this finding does not refute postoperative analyses.

Our results suggest that, though TE may have relatively longer operative times in primary TKA, it is clinically equivalent to BS and ABC with respect to EBL and postoperative change in Hb levels. In addition, postoperative drainage was lower in TE than in BS and ABC, which were equivalent. No significant differences were found among hemostasis types with respect to postoperative transfusion requirements.

The prevalence distribution of predischarge AEs trended toward significance (χ2 = 5.957, P = .051), despite not meeting the predetermined α level. Rates of predischarge AEs were 0% (0/41) for TE patients, 7% (14/203) for BS patients, and 3% (1/36) for ABC patients. AEs included acute kidney injuries, electrolyte disturbances, urinary tract infections, oxygen desaturation, altered mental status, sepsis/infections, arrhythmias, congestive heart failure exacerbation, dehiscence, pulmonary embolism, and hypotension. Clearly, many of these AEs are not attributable to the hemostasis system used.

 

 

Limitations of this study include its retrospective design, documentation inadequate to account for drainage amount reinfused, and limited data on which clinical insignificance thresholds were based. In addition, reliance on historical data may have introduced bias into the analysis. The historical data used to increase the size of the TE cohort may reflect a period of relative inexperience and may have contributed to the longer operative times relative to those of the ABC cohort (Dr. Levine used ABC later in his career).

Traditional electrocautery remains a viable option in primary TKA. With its low cost and hemostasis equivalent to that of BS and ABC, TE deserves consideration equal to that given to these more modern hemostasis technologies. Cost per case is about $10 for TE versus $500 for BS and $110 for ABC.17 Soaring healthcare expenditures may warrant returning to TE or combining cautery techniques and other agents in primary TKA in order to reduce the number of transfusions and associated surgical costs.

Total knee arthroplasty (TKA) is a reliable and successful treatment for end-stage degenerative joint disease of the knee. Given the reproducibility of its generally excellent outcomes, TKA is increasingly being performed.1 However, the potential complications of this procedure can be devastating.2-4 The arthroplasty literature has shed light on the detrimental effects of postoperative blood loss and anemia.5,6 In addition, the increase in transfusion burden among patients is not without risk.7 Given these concerns, surgeons have been tasked with determining the ideal methods for minimizing blood transfusions and postoperative hematomas and anemia. Several strategies have been described.8-11 Hemostasis can be achieved with use of intravenous medications, intra-articular agents, or electrocautery devices. Electrocautery technologies include traditional electrocautery (TE), saline-coupled bipolar sealer (BS), and argon beam coagulation (ABC). There is controversy as to whether outcomes are better with one hemostasis method over another and whether these methods are worth the additional cost.

In traditional (Bovie) electrocautery, a unipolar device delivers an electrical current to tissues through a pencil-like instrument. Intraoperative tissue temperatures can exceed 400°C.12 In BS, radiofrequency energy is delivered through a saline medium, which increases the contact area, acts as an electrode, and maintains a cooler environment during electrocautery. Proposed advantages are reduced tissue destruction and absence of smoke.12 There is evidence both for10,12-16 and against17-20 use of BS in total joint arthroplasty. ABC, a novel hemostasis method, has been studied in the context of orthopedics21,22 but not TKA specifically. ABC establishes a monopolar electric circuit between a handheld device and the target tissues by channeling electrons through ionized argon gas. Hemostasis is achieved through thermal coagulation. Tissue penetration can be adjusted by changing power, probe-to-target distance, and duration of use.23 We conducted a study to assess the efficacy of all 3 electrocautery methods during TKA. We hypothesized the 3 methods would be clinically equivalent with respect to estimated blood loss (EBL), 48-hour wound drainage, operative time, and change from preoperative hemoglobin (Hb) level.

Methods

We conducted a retrospective cohort study of consecutive primary TKAs performed by Dr. Levine between October 2010 and November 2011. Patients were identified by querying an internal database. Exclusion criteria were prior ipsilateral open knee procedure, prior fracture, nonuse of our standard hemostatic protocol, and either tourniquet time under 40 minutes or intraoperative documentation of tourniquet failure. As only 9 patients were initially identified for the TE cohort, the same database was used to add 32 patients treated between April 2009 and October 2009 (before our institution began using BS and ABC).

Clinical charts were reviewed, and baseline demographics (age, body mass index [BMI], preoperative Hb level) were abstracted, as were outcome metrics (EBL, 48-hour wound drainage, operative time, postoperative transfusions, adverse events (AEs) before discharge, and change in Hb level from before surgery to after surgery, in recovery room and on discharge). Statistical analyses were performed with JMP Version 10.0.0 (SAS Institute). Given the hypothesis that the 3 hemostasis methods would be clinically equivalent, 2 one-sided tests (TOSTs) of equivalence were performed with an α of 0.05. With TOST, the traditional null and alternative hypotheses are reversed; thus, P < .05 identifies statistical equivalence. The advantage of this study design is that equivalence can be identified, whereas traditional study designs can identify only a lack of statistical difference.24 We used our consensus opinions to set clinical insignificance thresholds for EBL (150 mL), wound drainage (150 mL), decrease from postoperative Hb level (1 g/dL), and operative time (10 minutes). Patients who received a blood transfusion were subsequently excluded from analysis in order to avoid skewing Hb-level depreciation calculations. Analysis of variance (ANOVA) and χ2 tests were used to compare preoperative variables, transfusion requirements, hospital length of stay, and AE rates by hemostasis type.

Cautery Technique

In all cases, TE was used for surgical dissection, which followed a standard midvastus approach. Then, for meniscal excision, the capsule and meniscal attachment sites were treated with TE, BS, or ABC. During cement hardening, an available supplemental cautery option was used to achieve hemostasis of the suprapatellar fat pad and visible meniscal attachment sites. All other aspects of the procedure and the postoperative protocols—including the anticoagulation and rapid rehabilitation (early ambulation and therapy) protocols—were similar for all patients. The standard anticoagulation protocol was to use low-molecular-weight heparin, unless contraindicated. Tranexamic acid was not used at our institution during the study period.

Results

For the study period, 280 cases (41 TE, 203 BS, 36 ABC) met the inclusion criteria. Of the 280 TKAs, 261 (93.21%) were performed for degenerative arthritis. There was no statistically significant difference among cohorts in indication (χ2 = 1.841, P = .398) or sex (χ2 = 1.176, P= .555).

 

 

Table 1 lists the cohorts’ baseline demographics (mean age, BMI, preoperative Hb level) and comparative ANOVA results. TOSTs of equivalence were performed to compare operative time, EBL, 48-hour wound drainage, and postoperative Hb-level depreciation among hemostasis types. Changes in Hb level were calculated for the immediate postoperative period and time of discharge (Table 2). ANOVA of hospital length of stay demonstrated no significant difference in means among groups (P = .09).

The cohorts were compared with respect to use of postoperative transfusions and incidence of postoperative AEs (Table 3). The TE cohort did not have any AEs. Of the 203 BS patients, 14 (7%) had 1 or more AEs, which included acute kidney injury (3 cases), electrolyte disturbance (3), urinary tract infection (2), oxygen desaturation (2), altered mental status (1), pneumonia (1), arrhythmia (1), congestive heart failure exacerbation (1), dehiscence (1), pulmonary embolism (2), and hypotension (1). Of the 36 ABC patients, 1 (3%) had arrhythmia, pneumonia, sepsis, and altered mental status.

Discussion

With the population aging, the demand for TKA is greater than ever.1 As surgical volume increases, the ability to minimize the rates of intraoperative bleeding, postoperative anemia, and transfusion is becoming increasingly important to patients and the healthcare system. There is no consensus as to which cautery method is ideal. Other investigators have identified differences in clinical outcomes between cautery systems, but reported results are largely conflicting.10,12-20 In addition, no one has studied the utility of ABC in TKA. In the present retrospective cohort analysis, we hypothesized that TE, BS, and ABC would be clinically equivalent in primary TKA with respect to EBL, 48-hour wound drainage, operative time, and change from preoperative Hb level.

The data on hemostatic technology in primary TKA are inconclusive. In an age- and sex-matched study comparing TE and BS in primary TKA, BS used with shed blood autotransfusion reduced homologous blood transfusions by a factor of 5.16 In addition, BS patients lost significantly less total visible blood (intraoperative EBL, postoperative drain output), and their magnitude of postoperative Hb-level depreciations at time of discharge was significantly lower. In a multicenter, prospective randomized trial comparing TE with BS, adjusted blood loss and need for autologous blood transfusions were lower in BS patients,10 though there was no significant difference in Knee Society Scale scores between the 2 treatment arms. However, analysis was potentially biased in that multiple authors had financial ties to Salient Surgical Technologies, the manufacturer of the BS device used in the study. Other prospective randomized trials of patients who had primary TKA with either TE or BS did not find any significant difference in postoperative Hb level, postoperative drainage, or transfusion requirements.19 ABC has been studied in the context of orthopedics but not joint arthroplasty specifically. This technology was anecdotally identified as a means of attaining hemostasis in foot and ankle surgery after failure of TE and other conventional means.22 ABC has also been identified as a successful adjuvant to curettage in the treatment of aneurysmal bone cysts.21 However, ABC has not been compared with TE or BS in the orthopedic literature.

In the present study, analysis of preoperative variables revealed a statistically but not clinically significant difference in BMI among cohorts. Mean (SD) BMI was 35.6 (6.5) for TE patients, 35.8 (9.7) for BS patients, and 40.9 (11.3) for ABC patients. (Previously, BMI did not correlate with intraoperative blood loss in TKA.25) Analysis also revealed a statistically significant but clinically insignificant and inconsequential difference in Hb level among cohorts. Mean (SD) preoperative Hb level was 13.5 (1.6) g/dL for TE patients, 12.8 (1.4) g/dL for BS patients, and 13.0 (1.6) g/dL for ABC patients. As decreases from preoperative baseline Hb levels were the intended focus of analysis—not absolute Hb levels—this finding does not refute postoperative analyses.

Our results suggest that, though TE may have relatively longer operative times in primary TKA, it is clinically equivalent to BS and ABC with respect to EBL and postoperative change in Hb levels. In addition, postoperative drainage was lower in TE than in BS and ABC, which were equivalent. No significant differences were found among hemostasis types with respect to postoperative transfusion requirements.

The prevalence distribution of predischarge AEs trended toward significance (χ2 = 5.957, P = .051), despite not meeting the predetermined α level. Rates of predischarge AEs were 0% (0/41) for TE patients, 7% (14/203) for BS patients, and 3% (1/36) for ABC patients. AEs included acute kidney injuries, electrolyte disturbances, urinary tract infections, oxygen desaturation, altered mental status, sepsis/infections, arrhythmias, congestive heart failure exacerbation, dehiscence, pulmonary embolism, and hypotension. Clearly, many of these AEs are not attributable to the hemostasis system used.

 

 

Limitations of this study include its retrospective design, documentation inadequate to account for drainage amount reinfused, and limited data on which clinical insignificance thresholds were based. In addition, reliance on historical data may have introduced bias into the analysis. The historical data used to increase the size of the TE cohort may reflect a period of relative inexperience and may have contributed to the longer operative times relative to those of the ABC cohort (Dr. Levine used ABC later in his career).

Traditional electrocautery remains a viable option in primary TKA. With its low cost and hemostasis equivalent to that of BS and ABC, TE deserves consideration equal to that given to these more modern hemostasis technologies. Cost per case is about $10 for TE versus $500 for BS and $110 for ABC.17 Soaring healthcare expenditures may warrant returning to TE or combining cautery techniques and other agents in primary TKA in order to reduce the number of transfusions and associated surgical costs.

References

1.    Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012;308(12):1227-1236.

2.    Leijtens B, Kremers van de Hei K, Jansen J, Koëter S. High complication rate after total knee and hip replacement due to perioperative bridging of anticoagulant therapy based on the 2012 ACCP guideline. Arch Orthop Trauma Surg. 2014;134(9):1335-1341.

3.    Park CH, Lee SH, Kang DG, Cho KY, Lee SH, Kim KI. Compartment syndrome following total knee arthroplasty: clinical results of late fasciotomy. Knee Surg Relat Res. 2014;26(3):177-181.

4.    Pedersen AB, Mehnert F, Sorensen HT, Emmeluth C, Overgaard S, Johnsen SP. The risk of venous thromboembolism, myocardial infarction, stroke, major bleeding and death in patients undergoing total hip and knee replacement: a 15-year retrospective cohort study of routine clinical practice. Bone Joint J. 2014;96-B(4):479-485.

5.    Carson JL, Poses RM, Spence RK, Bonavita G. Severity of anaemia and operative mortality and morbidity. Lancet. 1988;1(8588):727-729.

6.    Carson JL, Duff A, Poses RM, et al. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996;348(9034):1055-1060.

7.    Dodd RY. Current risk for transfusion transmitted infections. Curr Opin Hematol. 2007;14(6):671-676.

8.    Kang DG, Khurana S, Baek JH, Park YS, Lee SH, Kim KI. Efficacy and safety using autotransfusion system with postoperative shed blood following total knee arthroplasty in haemophilia. Haemophilia. 2014;20(1):129-132.

9.    Aguilera X, Martinez-Zapata MJ, Bosch A, et al. Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial. J Bone Joint Surg Am. 2013;95(22):2001-2007.

10.  Marulanda GA, Krebs VE, Bierbaum BE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop. 2009;38(12):E179-E183.

11.  Katkhouda N, Friedlander M, Darehzereshki A, et al. Argon beam coagulation versus fibrin sealant for hemostasis following liver resection: a randomized study in a porcine model. Hepatogastroenterology. 2013;60(125):1110-1116.

12.  Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008;5(2):125-131.

13.  Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010;20:352-356.

14.   Clement RC, Kamath AF, Derman PB, Garino JP, Lee GC. Bipolar sealing in revision total hip arthroplasty for infection: efficacy and cost analysis. J Arthroplasty. 2012;27(7):1376-1381.

15.  Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007;22(4 suppl 1):82-85.

16.  Pfeiffer M, Bräutigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005;3:Doc10.

17.  Morris MJ, Barrett M, Lombardi AV Jr, Tucker TL, Berend KR. Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty. J Arthroplasty. 2013;28(9):1614-1617.

18.  Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011;93(6):513-518.

19.  Plymale MF, Capogna BM, Lovy AJ, Adler ML, Hirsh DM, Kim SJ. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective randomized trial. J Arthroplasty. 2012;27(6):1133-1137.e1.

20.   Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system—an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010;25(7):1072-1077.

21.  Cummings JE, Smith RA, Heck RK Jr. Argon beam coagulation as adjuvant treatment after curettage of aneurysmal bone cysts: a preliminary study. Clin Orthop Relat Res. 2010;468(1):231-237.

22.  Adams ML, Steinberg JS. Argon beam coagulation in foot and ankle surgery. J Foot Ankle Surg. 2011;50(6):780-782.

23.  Neumayer L, Vargo D. Principles of preoperative and operative surgery. In: Townsend CM Jr, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery. 19th ed. Philadelphia, PA: Elsevier Saunders; 2012:211-239.

24.  Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011;26(2):192-196.

25.  Hrnack SA, Skeen N, Xu T, Rosenstein AD. Correlation of body mass index and blood loss during total knee and total hip arthroplasty. Am J Orthop. 2012;41(10):467-471.

References

1.    Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012;308(12):1227-1236.

2.    Leijtens B, Kremers van de Hei K, Jansen J, Koëter S. High complication rate after total knee and hip replacement due to perioperative bridging of anticoagulant therapy based on the 2012 ACCP guideline. Arch Orthop Trauma Surg. 2014;134(9):1335-1341.

3.    Park CH, Lee SH, Kang DG, Cho KY, Lee SH, Kim KI. Compartment syndrome following total knee arthroplasty: clinical results of late fasciotomy. Knee Surg Relat Res. 2014;26(3):177-181.

4.    Pedersen AB, Mehnert F, Sorensen HT, Emmeluth C, Overgaard S, Johnsen SP. The risk of venous thromboembolism, myocardial infarction, stroke, major bleeding and death in patients undergoing total hip and knee replacement: a 15-year retrospective cohort study of routine clinical practice. Bone Joint J. 2014;96-B(4):479-485.

5.    Carson JL, Poses RM, Spence RK, Bonavita G. Severity of anaemia and operative mortality and morbidity. Lancet. 1988;1(8588):727-729.

6.    Carson JL, Duff A, Poses RM, et al. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996;348(9034):1055-1060.

7.    Dodd RY. Current risk for transfusion transmitted infections. Curr Opin Hematol. 2007;14(6):671-676.

8.    Kang DG, Khurana S, Baek JH, Park YS, Lee SH, Kim KI. Efficacy and safety using autotransfusion system with postoperative shed blood following total knee arthroplasty in haemophilia. Haemophilia. 2014;20(1):129-132.

9.    Aguilera X, Martinez-Zapata MJ, Bosch A, et al. Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial. J Bone Joint Surg Am. 2013;95(22):2001-2007.

10.  Marulanda GA, Krebs VE, Bierbaum BE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop. 2009;38(12):E179-E183.

11.  Katkhouda N, Friedlander M, Darehzereshki A, et al. Argon beam coagulation versus fibrin sealant for hemostasis following liver resection: a randomized study in a porcine model. Hepatogastroenterology. 2013;60(125):1110-1116.

12.  Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008;5(2):125-131.

13.  Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010;20:352-356.

14.   Clement RC, Kamath AF, Derman PB, Garino JP, Lee GC. Bipolar sealing in revision total hip arthroplasty for infection: efficacy and cost analysis. J Arthroplasty. 2012;27(7):1376-1381.

15.  Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007;22(4 suppl 1):82-85.

16.  Pfeiffer M, Bräutigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005;3:Doc10.

17.  Morris MJ, Barrett M, Lombardi AV Jr, Tucker TL, Berend KR. Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty. J Arthroplasty. 2013;28(9):1614-1617.

18.  Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011;93(6):513-518.

19.  Plymale MF, Capogna BM, Lovy AJ, Adler ML, Hirsh DM, Kim SJ. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective randomized trial. J Arthroplasty. 2012;27(6):1133-1137.e1.

20.   Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system—an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010;25(7):1072-1077.

21.  Cummings JE, Smith RA, Heck RK Jr. Argon beam coagulation as adjuvant treatment after curettage of aneurysmal bone cysts: a preliminary study. Clin Orthop Relat Res. 2010;468(1):231-237.

22.  Adams ML, Steinberg JS. Argon beam coagulation in foot and ankle surgery. J Foot Ankle Surg. 2011;50(6):780-782.

23.  Neumayer L, Vargo D. Principles of preoperative and operative surgery. In: Townsend CM Jr, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery. 19th ed. Philadelphia, PA: Elsevier Saunders; 2012:211-239.

24.  Walker E, Nowacki AS. Understanding equivalence and noninferiority testing. J Gen Intern Med. 2011;26(2):192-196.

25.  Hrnack SA, Skeen N, Xu T, Rosenstein AD. Correlation of body mass index and blood loss during total knee and total hip arthroplasty. Am J Orthop. 2012;41(10):467-471.

Issue
The American Journal of Orthopedics - 45(4)
Issue
The American Journal of Orthopedics - 45(4)
Page Number
E187-E191
Page Number
E187-E191
Publications
Publications
Topics
Article Type
Display Headline
A Retrospective Analysis of Hemostatic Techniques in Primary Total Knee Arthroplasty: Traditional Electrocautery, Bipolar Sealer, and Argon Beam Coagulation
Display Headline
A Retrospective Analysis of Hemostatic Techniques in Primary Total Knee Arthroplasty: Traditional Electrocautery, Bipolar Sealer, and Argon Beam Coagulation
Legacy Keywords
total knee arthroplasty, TKA, arthroplasty, knee, bipolar, coagulation, hemostatic, techniques, study, rosenthal, haughom, levine
Legacy Keywords
total knee arthroplasty, TKA, arthroplasty, knee, bipolar, coagulation, hemostatic, techniques, study, rosenthal, haughom, levine
Sections
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Obesity Has Minimal Impact on Short-Term Functional Scores After Reverse Shoulder Arthroplasty for Rotator Cuff Tear Arthropathy

Article Type
Changed
Display Headline
Obesity Has Minimal Impact on Short-Term Functional Scores After Reverse Shoulder Arthroplasty for Rotator Cuff Tear Arthropathy

Body mass index (BMI) is thought to be a predictor of body composition, with higher values indicating more adipose tissue. BMI is a measure of mass with respect to height. The World Health Organization1 has established health categories based on BMI measurements. Values from 18.5 to 24.9 kg/m2 are deemed to represent normal weight; those from 25 to 30 kg/m2, overweight; and those higher than 30 kg/m2, obesity. BMI is not a perfect tool, but it is the most widely used tool in clinical and research practice because of its relative reliability and ease of use.2 Being overweight or obese (according to BMI) is increasingly common among adults worldwide, and particularly in the United States. An estimated 39% of adults worldwide are overweight, and 13% are obese.1 An estimated 69% of US adults are overweight, including 35.1% who are obese.2

Various pathologies have been treated with reverse shoulder arthroplasty (RSA), and results have been promising,3-9 but little is known about patient demographic and clinical factors that may adversely affect outcomes. Recent work suggests younger age7 and failed prior arthroplasty may adversely affect RSA outcomes.10 Higher BMI has also been implicated as a cause of increased perioperative and immediate postoperative complications of RSA with minimum 90-day follow-up, but no one has examined shoulder function scores at minimum 2-year follow-up.11,12

We conducted a study to examine shoulder function scores, mobility, patient satisfaction, and complications at minimum 2-year follow-up in normal-weight, overweight, and obese patients who underwent RSA. We hypothesized that, compared with normal-weight patients, obese patients would have worse shoulder function scores, worse mobility, and more complications.

Materials and Methods

Inclusion Criteria and Demographics

After obtaining Institutional Review Board approval for this study, we used a prospective shoulder arthroplasty registry to identify patients (N = 77) who had rotator cuff tear arthropathy (RCTA) treated with primary RSA and then had minimum 2-year follow-up. The study period was 2004-2011. All patients had RCTA diagnosed with physical examination findings and anteroposterior, scapular Y, and axillary radiographs. RCTA was graded 1 to 5 using the classification system of Hamada and colleagues.13 Rotator cuff status was determined with preoperative computed tomography arthrogram (CTA) or magnetic resonance imaging (MRI) and confirmed at time of surgery. BMI calculations were based on height and weight measured at initial office visit. Thirty-four patients had normal weight (BMI <25 kg/m2), 21 were overweight (BMI 25-30 kg/m2), and 22 were obese (BMI >30 kg/m2). Patient demographic and clinical characteristics reviewed also included age, sex, follow-up duration, arm dominance, complications, prevalence of depression, and prevalence of diabetes. All RSAs were performed by the same surgeon (Dr. Edwards) at a single high-volume shoulder arthroplasty center.

Shoulder function scores evaluated before surgery and at final follow-up included Constant score,14 American Shoulder and Elbow Surgeons (ASES) score,15 Western Ontario Osteoarthritis Shoulder (WOOS) index,16 Single Assessment Numeric Evaluation (SANE),17 and mobility. Satisfaction was assessed by having patients describe themselves as very dissatisfied, dissatisfied, satisfied, or very satisfied. All intraoperative and postoperative complications were recorded.

Surgical Technique and Postoperative Rehabilitation

The Aequalis RSA system (Tornier) was used for all patients during the study period. The RSA technique used has been well described.18,19 A standard postoperative rehabilitation protocol was followed.19,20

Clinical and Radiographic Assessment

Patients were prospectively enrolled in a shoulder arthroplasty outcomes registry and followed clinically. Mean follow-up was 3.16 years (range, 2-8 years). Before surgery, patients were examined by the surgeon. Examinations were repeated 1 week, 6 weeks, 3 months, 6 months, and 12 months after surgery and annually thereafter. Mobility (active range of motion) was determined with a handheld goniometer. Strength of abduction was measured with a handheld digital dynamometer (Chatillon digital force gauge, 200 lbf; Ametek). Anteroposterior in plane of scapula, scapular Y, and axillary radiographs were obtained at each clinic appointment.

Before surgery, the surgeon reviewed all radiographs. Each RCTA was given a Hamada grade (1-5).13 Glenoid erosion in the coronal plane was classified (E0, E1, E2, E3) according to Sirveaux and colleagues.21 Hamada grades and glenoid erosion types are listed in Table 1. The overall trend in classification by BMI group was statistically significant for Hamada grade (P = .004) but not glenoid erosion type (P = .153).

Before surgery, the surgeon also evaluated rotator cuff status using CTA or MRI. All patients had full-thickness tears of the supraspinatus and infraspinatus. The subscapularis was variably present, and subscapularis repair was performed when the subscapularis was intact. Rotator cuff status is listed in Table 2. There were no significant differences in the distribution of intact subscapularis (P = .402) or teres minor (P = .188) among the normal-weight, overweight, and obese groups. No patient had a latissimus dorsi transfer at time of RSA.

 

 

Statistical Analysis

Independent-samples t tests assuming unequal variances were used to compare the 3 BMI groups on age, follow-up duration, preoperative shoulder function scores, and mobility. Chi-square tests were used to identify any significant group differences in comorbidities (eg, complications, arm dominance, prevalence of depression, prevalence of diabetes) and patient satisfaction. Repeated-measures analysis of variance was used to evaluate main effects, changes from before surgery to final follow-up, and BMI group differences, as well as differences in changes from before surgery to final follow-up among the 3 BMI groups.

Results

Among BMI groups (<25 kg/m2, 25-30 kg/m2, >30 kg/m2), there were no statistically significant preoperative differences in age, sex, follow-up duration, complications, arm dominance, prevalence of depression, or prevalence of diabetes (P >. 05) (Table 3). Table 4 lists the groups’ preoperative and final follow-up data (Constant score, ASES score, WOOS index, SANE, mobility). There were no statistically significant preoperative group differences in Constant score, ASES score, WOOS index, SANE, mobility, or patient satisfaction (P > .05) (Tables 5, 6).

All groups’ shoulder function scores and mobility improved significantly from before surgery to final follow-up (P < .001) (Table 5). The groups’ magnitudes of change (improvement) from before surgery to final follow-up were almost identical, with no significant differences in shoulder function scores or mobility (Table 5). The only significant difference was in Constant–Strength, which was higher in the obese group (P = .017) (Table 5). Patient satisfaction ratings improved after surgery, with 79% of the normal-weight group reporting being satisfied or very satisfied with their shoulders (Table 6). The overweight and obese groups gave similar satisfied (81%) and very satisfied (82%) ratings. The small differences between group satisfaction scores were nonsignificant (P = .967).

Complications

The normal-weight group had 4 complications: periprosthetic infection (2 cases), intraoperative humeral fracture (1), and scapular spine stress fracture (1). The overweight group had 1 complication, an acromial stress fracture that was successfully treated with conservative measures. The obese group had 1 patient with 2 postoperative dislocations. The first dislocation was treated with closed reduction and bracing, and the second required revision surgery. There was no statistical difference in complications among the groups (P = .680).

Discussion

To our knowledge, this is the first study of the effects of varying BMI on functional outcomes of RSA with minimum 2-year follow-up. There appears to be minimal impact on shoulder function scores, complications, and patient satisfaction among normal-weight, overweight, and obese patients with RCTA treated by the same surgeon using similar techniques.

The relationship between obesity and increased perioperative risks or poorer surgical outcomes has been well established in orthopedic surgery. In a systematic review, Falagas and Kompoti22 found increased risk for perioperative and nosocomial infections in obese patients. Schoenfeld and colleagues23 and Jiang and colleagues24 reported increased risk for complications in spinal surgery. The total joint arthroplasty literature is rife with evidence suggesting higher BMI leads to increased risk for complications, including infection and deep venous thrombosis, as well as decreased functional outcome scores.25-29 Recent studies on shoulder surgery have shown worse outcomes in rotator cuff repair30 and a higher revision rate in hemiarthroplasy.31

Other RSA studies have examined short-term complications or perioperative risk factors associated with BMI. In a study using slightly different BMI groupings, Gupta and colleagues12 reported significantly higher complication rates for RSA patients with BMI higher than 35 kg/m2 compared to patients with BMI of 25 to 35 kg/m2 and compared to patients with BMI lower than 25 kg/m2. Their study highlighted medical and surgical complications and used a short follow-up period (minimum, 90 days). It did not assess shoulder function scores, and included multiple indications for RSA (eg, RCTA, proximal humerus fracture, inflammatory arthropathy). In another study, higher BMI was reported as a risk factor for early dislocation after RSA, but only 11 patients with a history of dislocation were assessed, and minimum follow-up was 6 months.32 We know of only one study that addressed RSA outcomes in obese patients and used minimum 2-year follow-up, but its primary endpoint was rate of complications, and it did not report shoulder function scores.11 Li and colleagues33 conducted a study similar to ours, but with primary total shoulder arthroplasty (TSA) patients, and reported similar results. Relative to normal BMI, higher BMI did not have a detrimental effect on short-term improvement in shoulder function after TSA.

Given the US obesity epidemic, our study results are encouraging. Depending on many factors, obesity remains a risk factor for poor outcomes in patients who undergo orthopedic surgery. As our results show, however, patients with higher BMI can obtain functional outcomes similar to those experienced by patients with normal-weight BMI after RSA for RCTA.

 

 

The primary limitation of this study was its retrospective design. Strengths of the study included its having a single surgeon and a single diagnosis: RCTA. In addition, each group was robust in size, a standard operative/postoperative protocol was used, and clinical results were measured with multiple validated shoulder function scores.

Conclusion

Improved shoulder function scores, mobility, and patient satisfaction can be expected after RSA for RCTA in patients with BMI higher than 30 kg/m2. These patients did not exhibit an increase in complications at short-term follow-up.

References

1.    World Health Organization. Obesity and overweight [factsheet 311]. Updated January 2015. http://www.who.int/mediacentre/factsheets/fs311/en/. Accessed March 27, 2016.

2.    National Center for Health Statistics, Centers for Disease Control and Prevention. Obesity and overweight. Updated February 25, 2016. http://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Accessed March 27, 2016.

3.    Boileau P, Gonzalez JF, Chuinard C, Bicknell R, Walch G. Reverse total shoulder arthroplasty after failed rotator cuff surgery. J Shoulder Elbow Surg. 2009;18(4):600-606.

4.    Drake GN, O’Connor DP, Edwards TB. Indications for reverse total shoulder arthroplasty in rotator cuff disease. Clin Orthop Relat Res. 2010;468(6):1526-1533.

5.    Gerber C, Pennington SD, Nyffeler RW. Reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2009;17(5):284-289.

6.    Lenarz C, Shishani Y, McCrum C, Nowinski RJ, Edwards TB, Gobezie R. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient? Early observations. Clin Orthop Relat Res. 2011;469(12):3324-3331.

7.    Muh SJ, Streit JJ, Wanner JP, et al. Early follow-up of reverse total shoulder arthroplasty in patients sixty years of age or younger. J Bone Joint Surg Am. 2013;95(20):1877-1883.

8.    Wall B, Nové-Josserand L, O’Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007;89(7):1476-1485.

9.    Young AA, Smith MM, Bacle G, Moraga C, Walch G. Early results of reverse shoulder arthroplasty in patients with rheumatoid arthritis. J Bone Joint Surg Am. 2011;93(20):1915-1923.

10.  Boileau P, Melis B, Duperron D, Moineau G, Rumian AP, Han Y. Revision surgery of reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(10):1359-1370.

11.  Beck JD, Irgit KS, Andreychik CM, Maloney PJ, Tang X, Harter GD. Reverse total shoulder arthroplasty in obese patients. J Hand Surg Am. 2013;38(5):965-970.

12.  Gupta AK, Chalmers PN, Rahman Z, et al. Reverse total shoulder arthroplasty in patients of varying body mass index. J Shoulder Elbow Surg. 2014;23(1):35-42.

13.  Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;(254):92-96.

14.  Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;(214):160-164.

15.  Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons standardized shoulder assessment form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

16.  Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: the Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001;9(8):771-778.

17.  Williams GN, Gangel TJ, Arciero RA, Uhorchak JM, Taylor DC. Comparison of the Single Assessment Numeric Evaluation method and two shoulder rating scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221.

18.  Gartsman GM, Edwards TB. Shoulder Arthroplasty. Philadelpia, PA: Saunders Elsevier; 2008.

19.  Liotard JP, Edwards TB, Padey A, Walch G, Boulahia A. Hydrotherapy rehabilitation after shoulder surgery. Tech Shoulder Elbow Surg. 2003;4:44-49.

20.  Trappey GJ 4th, O’Connor DP, Edwards TB. What are the instability and infection rates after reverse shoulder arthroplasty? Clin Orthop Relat Res. 2011;469(9):2505-2511.

21.  Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004;86(3):388-395.

22.  Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006;6(7):438-446.

23.  Schoenfeld AJ, Carey PA, Cleveland AW 3rd, Bader JO, Bono CM. Patient factors, comorbidities, and surgical characteristics that increase mortality and complication risk after spinal arthrodesis: a prognostic study based on 5,887 patients. Spine J. 2013;13(10):1171-1179.

24.  Jiang J, Teng Y, Fan Z, Khan S, Xia Y. Does obesity affect the surgical outcome and complication rates of spinal surgery? A meta-analysis. Clin Orthop Relat Res. 2014;472(3):968-975.

25.  Bozic KJ, Lau E, Kurtz S, et al. Patient-related risk factors for periprosthetic joint infection and postoperative mortality following total hip arthroplasty in Medicare patients. J Bone Joint Surg Am. 2012;94(9):794-800.

26.  Franklin PD, Li W, Ayers DC. The Chitranjan Ranawat Award: functional outcome after total knee replacement varies with patient attributes. Clin Orthop Relat Res. 2008;466(11):2597-2604.

27.  Huddleston JI, Wang Y, Uquillas C, Herndon JH, Maloney WJ. Age and obesity are risk factors for adverse events after total hip arthroplasty. Clin Orthop Relat Res. 2012;470(2):490-496.

28.  Jämsen E, Nevalainen P, Eskelinen A, Huotari K, Kalliovalkama J, Moilanen T. Obesity, diabetes, and preoperative hyperglycemia as predictors of periprosthetic joint infection: a single-center analysis of 7181 primary hip and knee replacements for osteoarthritis. J Bone Joint Surg Am. 2012;94(14):e101.

29.   Naziri Q, Issa K, Malkani AL, Bonutti PM, Harwin SF, Mont MA. Bariatric orthopaedics: total knee arthroplasty in super-obese patients (BMI > 50 kg/m2). Survivorship and complications. Clin Orthop Relat Res. 2013;471(11):3523-3530.

30.  Warrender WJ, Brown OL, Abboud JA. Outcomes of arthroscopic rotator cuff repairs in obese patients. J Shoulder Elbow Surg. 2011;20(6):961-967.

31.   Singh JA, Sperling JW, Cofield RH. Risk factors for revision surgery after humeral head replacement: 1,431 shoulders over 3 decades. J Shoulder Elbow Surg. 2012;21(8):1039-1044.

32.  Chalmers PN, Rahman Z, Romeo AA, Nicholson GP. Early dislocation after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(5):737-744.

33.  Li X, Williams PN, Nguyen JT, Craig EV, Warren RF, Gulotta LV. Functional outcomes after total shoulder arthroplasty in obese patients. J Bone Joint Surg Am. 2013;95(21):e160.

Article PDF
Author and Disclosure Information

Brent J. Morris, MD, Richard E. Haigler, MD, John M. Cochran, BS, Mitzi S. Laughlin, PhD, Hussein A. Elkousy, MD, Gary M. Gartsman, MD, and T. Bradley Edwards, MD

Authors’ Disclosure Statement: Dr. Morris reports that he is a paid consultant to Tornier, Inc. (now Wright Medical Group, Inc.). Dr. Edwards reports that he received financial support from Tornier, Inc. for the database used to collect data for this study and that he receives royalties from and is a consultant to Tornier, Inc. (now Wright Medical Group, Inc.). The other authors report no actual or potential conflict of interest in relation to this article.

Issue
The American Journal of Orthopedics - 45(4)
Publications
Topics
Page Number
E180-E186
Legacy Keywords
obesity, obese, weight, shoulder arthroplasty, shoulder, arthroplasty, rotator cuff tear, rotator cuff, arthropathy, body mass index, BMI, RSA, RCTA, morris, haigler, cochran, laughlin, elkousy, gartsman, edwards
Sections
Author and Disclosure Information

Brent J. Morris, MD, Richard E. Haigler, MD, John M. Cochran, BS, Mitzi S. Laughlin, PhD, Hussein A. Elkousy, MD, Gary M. Gartsman, MD, and T. Bradley Edwards, MD

Authors’ Disclosure Statement: Dr. Morris reports that he is a paid consultant to Tornier, Inc. (now Wright Medical Group, Inc.). Dr. Edwards reports that he received financial support from Tornier, Inc. for the database used to collect data for this study and that he receives royalties from and is a consultant to Tornier, Inc. (now Wright Medical Group, Inc.). The other authors report no actual or potential conflict of interest in relation to this article.

Author and Disclosure Information

Brent J. Morris, MD, Richard E. Haigler, MD, John M. Cochran, BS, Mitzi S. Laughlin, PhD, Hussein A. Elkousy, MD, Gary M. Gartsman, MD, and T. Bradley Edwards, MD

Authors’ Disclosure Statement: Dr. Morris reports that he is a paid consultant to Tornier, Inc. (now Wright Medical Group, Inc.). Dr. Edwards reports that he received financial support from Tornier, Inc. for the database used to collect data for this study and that he receives royalties from and is a consultant to Tornier, Inc. (now Wright Medical Group, Inc.). The other authors report no actual or potential conflict of interest in relation to this article.

Article PDF
Article PDF

Body mass index (BMI) is thought to be a predictor of body composition, with higher values indicating more adipose tissue. BMI is a measure of mass with respect to height. The World Health Organization1 has established health categories based on BMI measurements. Values from 18.5 to 24.9 kg/m2 are deemed to represent normal weight; those from 25 to 30 kg/m2, overweight; and those higher than 30 kg/m2, obesity. BMI is not a perfect tool, but it is the most widely used tool in clinical and research practice because of its relative reliability and ease of use.2 Being overweight or obese (according to BMI) is increasingly common among adults worldwide, and particularly in the United States. An estimated 39% of adults worldwide are overweight, and 13% are obese.1 An estimated 69% of US adults are overweight, including 35.1% who are obese.2

Various pathologies have been treated with reverse shoulder arthroplasty (RSA), and results have been promising,3-9 but little is known about patient demographic and clinical factors that may adversely affect outcomes. Recent work suggests younger age7 and failed prior arthroplasty may adversely affect RSA outcomes.10 Higher BMI has also been implicated as a cause of increased perioperative and immediate postoperative complications of RSA with minimum 90-day follow-up, but no one has examined shoulder function scores at minimum 2-year follow-up.11,12

We conducted a study to examine shoulder function scores, mobility, patient satisfaction, and complications at minimum 2-year follow-up in normal-weight, overweight, and obese patients who underwent RSA. We hypothesized that, compared with normal-weight patients, obese patients would have worse shoulder function scores, worse mobility, and more complications.

Materials and Methods

Inclusion Criteria and Demographics

After obtaining Institutional Review Board approval for this study, we used a prospective shoulder arthroplasty registry to identify patients (N = 77) who had rotator cuff tear arthropathy (RCTA) treated with primary RSA and then had minimum 2-year follow-up. The study period was 2004-2011. All patients had RCTA diagnosed with physical examination findings and anteroposterior, scapular Y, and axillary radiographs. RCTA was graded 1 to 5 using the classification system of Hamada and colleagues.13 Rotator cuff status was determined with preoperative computed tomography arthrogram (CTA) or magnetic resonance imaging (MRI) and confirmed at time of surgery. BMI calculations were based on height and weight measured at initial office visit. Thirty-four patients had normal weight (BMI <25 kg/m2), 21 were overweight (BMI 25-30 kg/m2), and 22 were obese (BMI >30 kg/m2). Patient demographic and clinical characteristics reviewed also included age, sex, follow-up duration, arm dominance, complications, prevalence of depression, and prevalence of diabetes. All RSAs were performed by the same surgeon (Dr. Edwards) at a single high-volume shoulder arthroplasty center.

Shoulder function scores evaluated before surgery and at final follow-up included Constant score,14 American Shoulder and Elbow Surgeons (ASES) score,15 Western Ontario Osteoarthritis Shoulder (WOOS) index,16 Single Assessment Numeric Evaluation (SANE),17 and mobility. Satisfaction was assessed by having patients describe themselves as very dissatisfied, dissatisfied, satisfied, or very satisfied. All intraoperative and postoperative complications were recorded.

Surgical Technique and Postoperative Rehabilitation

The Aequalis RSA system (Tornier) was used for all patients during the study period. The RSA technique used has been well described.18,19 A standard postoperative rehabilitation protocol was followed.19,20

Clinical and Radiographic Assessment

Patients were prospectively enrolled in a shoulder arthroplasty outcomes registry and followed clinically. Mean follow-up was 3.16 years (range, 2-8 years). Before surgery, patients were examined by the surgeon. Examinations were repeated 1 week, 6 weeks, 3 months, 6 months, and 12 months after surgery and annually thereafter. Mobility (active range of motion) was determined with a handheld goniometer. Strength of abduction was measured with a handheld digital dynamometer (Chatillon digital force gauge, 200 lbf; Ametek). Anteroposterior in plane of scapula, scapular Y, and axillary radiographs were obtained at each clinic appointment.

Before surgery, the surgeon reviewed all radiographs. Each RCTA was given a Hamada grade (1-5).13 Glenoid erosion in the coronal plane was classified (E0, E1, E2, E3) according to Sirveaux and colleagues.21 Hamada grades and glenoid erosion types are listed in Table 1. The overall trend in classification by BMI group was statistically significant for Hamada grade (P = .004) but not glenoid erosion type (P = .153).

Before surgery, the surgeon also evaluated rotator cuff status using CTA or MRI. All patients had full-thickness tears of the supraspinatus and infraspinatus. The subscapularis was variably present, and subscapularis repair was performed when the subscapularis was intact. Rotator cuff status is listed in Table 2. There were no significant differences in the distribution of intact subscapularis (P = .402) or teres minor (P = .188) among the normal-weight, overweight, and obese groups. No patient had a latissimus dorsi transfer at time of RSA.

 

 

Statistical Analysis

Independent-samples t tests assuming unequal variances were used to compare the 3 BMI groups on age, follow-up duration, preoperative shoulder function scores, and mobility. Chi-square tests were used to identify any significant group differences in comorbidities (eg, complications, arm dominance, prevalence of depression, prevalence of diabetes) and patient satisfaction. Repeated-measures analysis of variance was used to evaluate main effects, changes from before surgery to final follow-up, and BMI group differences, as well as differences in changes from before surgery to final follow-up among the 3 BMI groups.

Results

Among BMI groups (<25 kg/m2, 25-30 kg/m2, >30 kg/m2), there were no statistically significant preoperative differences in age, sex, follow-up duration, complications, arm dominance, prevalence of depression, or prevalence of diabetes (P >. 05) (Table 3). Table 4 lists the groups’ preoperative and final follow-up data (Constant score, ASES score, WOOS index, SANE, mobility). There were no statistically significant preoperative group differences in Constant score, ASES score, WOOS index, SANE, mobility, or patient satisfaction (P > .05) (Tables 5, 6).

All groups’ shoulder function scores and mobility improved significantly from before surgery to final follow-up (P < .001) (Table 5). The groups’ magnitudes of change (improvement) from before surgery to final follow-up were almost identical, with no significant differences in shoulder function scores or mobility (Table 5). The only significant difference was in Constant–Strength, which was higher in the obese group (P = .017) (Table 5). Patient satisfaction ratings improved after surgery, with 79% of the normal-weight group reporting being satisfied or very satisfied with their shoulders (Table 6). The overweight and obese groups gave similar satisfied (81%) and very satisfied (82%) ratings. The small differences between group satisfaction scores were nonsignificant (P = .967).

Complications

The normal-weight group had 4 complications: periprosthetic infection (2 cases), intraoperative humeral fracture (1), and scapular spine stress fracture (1). The overweight group had 1 complication, an acromial stress fracture that was successfully treated with conservative measures. The obese group had 1 patient with 2 postoperative dislocations. The first dislocation was treated with closed reduction and bracing, and the second required revision surgery. There was no statistical difference in complications among the groups (P = .680).

Discussion

To our knowledge, this is the first study of the effects of varying BMI on functional outcomes of RSA with minimum 2-year follow-up. There appears to be minimal impact on shoulder function scores, complications, and patient satisfaction among normal-weight, overweight, and obese patients with RCTA treated by the same surgeon using similar techniques.

The relationship between obesity and increased perioperative risks or poorer surgical outcomes has been well established in orthopedic surgery. In a systematic review, Falagas and Kompoti22 found increased risk for perioperative and nosocomial infections in obese patients. Schoenfeld and colleagues23 and Jiang and colleagues24 reported increased risk for complications in spinal surgery. The total joint arthroplasty literature is rife with evidence suggesting higher BMI leads to increased risk for complications, including infection and deep venous thrombosis, as well as decreased functional outcome scores.25-29 Recent studies on shoulder surgery have shown worse outcomes in rotator cuff repair30 and a higher revision rate in hemiarthroplasy.31

Other RSA studies have examined short-term complications or perioperative risk factors associated with BMI. In a study using slightly different BMI groupings, Gupta and colleagues12 reported significantly higher complication rates for RSA patients with BMI higher than 35 kg/m2 compared to patients with BMI of 25 to 35 kg/m2 and compared to patients with BMI lower than 25 kg/m2. Their study highlighted medical and surgical complications and used a short follow-up period (minimum, 90 days). It did not assess shoulder function scores, and included multiple indications for RSA (eg, RCTA, proximal humerus fracture, inflammatory arthropathy). In another study, higher BMI was reported as a risk factor for early dislocation after RSA, but only 11 patients with a history of dislocation were assessed, and minimum follow-up was 6 months.32 We know of only one study that addressed RSA outcomes in obese patients and used minimum 2-year follow-up, but its primary endpoint was rate of complications, and it did not report shoulder function scores.11 Li and colleagues33 conducted a study similar to ours, but with primary total shoulder arthroplasty (TSA) patients, and reported similar results. Relative to normal BMI, higher BMI did not have a detrimental effect on short-term improvement in shoulder function after TSA.

Given the US obesity epidemic, our study results are encouraging. Depending on many factors, obesity remains a risk factor for poor outcomes in patients who undergo orthopedic surgery. As our results show, however, patients with higher BMI can obtain functional outcomes similar to those experienced by patients with normal-weight BMI after RSA for RCTA.

 

 

The primary limitation of this study was its retrospective design. Strengths of the study included its having a single surgeon and a single diagnosis: RCTA. In addition, each group was robust in size, a standard operative/postoperative protocol was used, and clinical results were measured with multiple validated shoulder function scores.

Conclusion

Improved shoulder function scores, mobility, and patient satisfaction can be expected after RSA for RCTA in patients with BMI higher than 30 kg/m2. These patients did not exhibit an increase in complications at short-term follow-up.

Body mass index (BMI) is thought to be a predictor of body composition, with higher values indicating more adipose tissue. BMI is a measure of mass with respect to height. The World Health Organization1 has established health categories based on BMI measurements. Values from 18.5 to 24.9 kg/m2 are deemed to represent normal weight; those from 25 to 30 kg/m2, overweight; and those higher than 30 kg/m2, obesity. BMI is not a perfect tool, but it is the most widely used tool in clinical and research practice because of its relative reliability and ease of use.2 Being overweight or obese (according to BMI) is increasingly common among adults worldwide, and particularly in the United States. An estimated 39% of adults worldwide are overweight, and 13% are obese.1 An estimated 69% of US adults are overweight, including 35.1% who are obese.2

Various pathologies have been treated with reverse shoulder arthroplasty (RSA), and results have been promising,3-9 but little is known about patient demographic and clinical factors that may adversely affect outcomes. Recent work suggests younger age7 and failed prior arthroplasty may adversely affect RSA outcomes.10 Higher BMI has also been implicated as a cause of increased perioperative and immediate postoperative complications of RSA with minimum 90-day follow-up, but no one has examined shoulder function scores at minimum 2-year follow-up.11,12

We conducted a study to examine shoulder function scores, mobility, patient satisfaction, and complications at minimum 2-year follow-up in normal-weight, overweight, and obese patients who underwent RSA. We hypothesized that, compared with normal-weight patients, obese patients would have worse shoulder function scores, worse mobility, and more complications.

Materials and Methods

Inclusion Criteria and Demographics

After obtaining Institutional Review Board approval for this study, we used a prospective shoulder arthroplasty registry to identify patients (N = 77) who had rotator cuff tear arthropathy (RCTA) treated with primary RSA and then had minimum 2-year follow-up. The study period was 2004-2011. All patients had RCTA diagnosed with physical examination findings and anteroposterior, scapular Y, and axillary radiographs. RCTA was graded 1 to 5 using the classification system of Hamada and colleagues.13 Rotator cuff status was determined with preoperative computed tomography arthrogram (CTA) or magnetic resonance imaging (MRI) and confirmed at time of surgery. BMI calculations were based on height and weight measured at initial office visit. Thirty-four patients had normal weight (BMI <25 kg/m2), 21 were overweight (BMI 25-30 kg/m2), and 22 were obese (BMI >30 kg/m2). Patient demographic and clinical characteristics reviewed also included age, sex, follow-up duration, arm dominance, complications, prevalence of depression, and prevalence of diabetes. All RSAs were performed by the same surgeon (Dr. Edwards) at a single high-volume shoulder arthroplasty center.

Shoulder function scores evaluated before surgery and at final follow-up included Constant score,14 American Shoulder and Elbow Surgeons (ASES) score,15 Western Ontario Osteoarthritis Shoulder (WOOS) index,16 Single Assessment Numeric Evaluation (SANE),17 and mobility. Satisfaction was assessed by having patients describe themselves as very dissatisfied, dissatisfied, satisfied, or very satisfied. All intraoperative and postoperative complications were recorded.

Surgical Technique and Postoperative Rehabilitation

The Aequalis RSA system (Tornier) was used for all patients during the study period. The RSA technique used has been well described.18,19 A standard postoperative rehabilitation protocol was followed.19,20

Clinical and Radiographic Assessment

Patients were prospectively enrolled in a shoulder arthroplasty outcomes registry and followed clinically. Mean follow-up was 3.16 years (range, 2-8 years). Before surgery, patients were examined by the surgeon. Examinations were repeated 1 week, 6 weeks, 3 months, 6 months, and 12 months after surgery and annually thereafter. Mobility (active range of motion) was determined with a handheld goniometer. Strength of abduction was measured with a handheld digital dynamometer (Chatillon digital force gauge, 200 lbf; Ametek). Anteroposterior in plane of scapula, scapular Y, and axillary radiographs were obtained at each clinic appointment.

Before surgery, the surgeon reviewed all radiographs. Each RCTA was given a Hamada grade (1-5).13 Glenoid erosion in the coronal plane was classified (E0, E1, E2, E3) according to Sirveaux and colleagues.21 Hamada grades and glenoid erosion types are listed in Table 1. The overall trend in classification by BMI group was statistically significant for Hamada grade (P = .004) but not glenoid erosion type (P = .153).

Before surgery, the surgeon also evaluated rotator cuff status using CTA or MRI. All patients had full-thickness tears of the supraspinatus and infraspinatus. The subscapularis was variably present, and subscapularis repair was performed when the subscapularis was intact. Rotator cuff status is listed in Table 2. There were no significant differences in the distribution of intact subscapularis (P = .402) or teres minor (P = .188) among the normal-weight, overweight, and obese groups. No patient had a latissimus dorsi transfer at time of RSA.

 

 

Statistical Analysis

Independent-samples t tests assuming unequal variances were used to compare the 3 BMI groups on age, follow-up duration, preoperative shoulder function scores, and mobility. Chi-square tests were used to identify any significant group differences in comorbidities (eg, complications, arm dominance, prevalence of depression, prevalence of diabetes) and patient satisfaction. Repeated-measures analysis of variance was used to evaluate main effects, changes from before surgery to final follow-up, and BMI group differences, as well as differences in changes from before surgery to final follow-up among the 3 BMI groups.

Results

Among BMI groups (<25 kg/m2, 25-30 kg/m2, >30 kg/m2), there were no statistically significant preoperative differences in age, sex, follow-up duration, complications, arm dominance, prevalence of depression, or prevalence of diabetes (P >. 05) (Table 3). Table 4 lists the groups’ preoperative and final follow-up data (Constant score, ASES score, WOOS index, SANE, mobility). There were no statistically significant preoperative group differences in Constant score, ASES score, WOOS index, SANE, mobility, or patient satisfaction (P > .05) (Tables 5, 6).

All groups’ shoulder function scores and mobility improved significantly from before surgery to final follow-up (P < .001) (Table 5). The groups’ magnitudes of change (improvement) from before surgery to final follow-up were almost identical, with no significant differences in shoulder function scores or mobility (Table 5). The only significant difference was in Constant–Strength, which was higher in the obese group (P = .017) (Table 5). Patient satisfaction ratings improved after surgery, with 79% of the normal-weight group reporting being satisfied or very satisfied with their shoulders (Table 6). The overweight and obese groups gave similar satisfied (81%) and very satisfied (82%) ratings. The small differences between group satisfaction scores were nonsignificant (P = .967).

Complications

The normal-weight group had 4 complications: periprosthetic infection (2 cases), intraoperative humeral fracture (1), and scapular spine stress fracture (1). The overweight group had 1 complication, an acromial stress fracture that was successfully treated with conservative measures. The obese group had 1 patient with 2 postoperative dislocations. The first dislocation was treated with closed reduction and bracing, and the second required revision surgery. There was no statistical difference in complications among the groups (P = .680).

Discussion

To our knowledge, this is the first study of the effects of varying BMI on functional outcomes of RSA with minimum 2-year follow-up. There appears to be minimal impact on shoulder function scores, complications, and patient satisfaction among normal-weight, overweight, and obese patients with RCTA treated by the same surgeon using similar techniques.

The relationship between obesity and increased perioperative risks or poorer surgical outcomes has been well established in orthopedic surgery. In a systematic review, Falagas and Kompoti22 found increased risk for perioperative and nosocomial infections in obese patients. Schoenfeld and colleagues23 and Jiang and colleagues24 reported increased risk for complications in spinal surgery. The total joint arthroplasty literature is rife with evidence suggesting higher BMI leads to increased risk for complications, including infection and deep venous thrombosis, as well as decreased functional outcome scores.25-29 Recent studies on shoulder surgery have shown worse outcomes in rotator cuff repair30 and a higher revision rate in hemiarthroplasy.31

Other RSA studies have examined short-term complications or perioperative risk factors associated with BMI. In a study using slightly different BMI groupings, Gupta and colleagues12 reported significantly higher complication rates for RSA patients with BMI higher than 35 kg/m2 compared to patients with BMI of 25 to 35 kg/m2 and compared to patients with BMI lower than 25 kg/m2. Their study highlighted medical and surgical complications and used a short follow-up period (minimum, 90 days). It did not assess shoulder function scores, and included multiple indications for RSA (eg, RCTA, proximal humerus fracture, inflammatory arthropathy). In another study, higher BMI was reported as a risk factor for early dislocation after RSA, but only 11 patients with a history of dislocation were assessed, and minimum follow-up was 6 months.32 We know of only one study that addressed RSA outcomes in obese patients and used minimum 2-year follow-up, but its primary endpoint was rate of complications, and it did not report shoulder function scores.11 Li and colleagues33 conducted a study similar to ours, but with primary total shoulder arthroplasty (TSA) patients, and reported similar results. Relative to normal BMI, higher BMI did not have a detrimental effect on short-term improvement in shoulder function after TSA.

Given the US obesity epidemic, our study results are encouraging. Depending on many factors, obesity remains a risk factor for poor outcomes in patients who undergo orthopedic surgery. As our results show, however, patients with higher BMI can obtain functional outcomes similar to those experienced by patients with normal-weight BMI after RSA for RCTA.

 

 

The primary limitation of this study was its retrospective design. Strengths of the study included its having a single surgeon and a single diagnosis: RCTA. In addition, each group was robust in size, a standard operative/postoperative protocol was used, and clinical results were measured with multiple validated shoulder function scores.

Conclusion

Improved shoulder function scores, mobility, and patient satisfaction can be expected after RSA for RCTA in patients with BMI higher than 30 kg/m2. These patients did not exhibit an increase in complications at short-term follow-up.

References

1.    World Health Organization. Obesity and overweight [factsheet 311]. Updated January 2015. http://www.who.int/mediacentre/factsheets/fs311/en/. Accessed March 27, 2016.

2.    National Center for Health Statistics, Centers for Disease Control and Prevention. Obesity and overweight. Updated February 25, 2016. http://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Accessed March 27, 2016.

3.    Boileau P, Gonzalez JF, Chuinard C, Bicknell R, Walch G. Reverse total shoulder arthroplasty after failed rotator cuff surgery. J Shoulder Elbow Surg. 2009;18(4):600-606.

4.    Drake GN, O’Connor DP, Edwards TB. Indications for reverse total shoulder arthroplasty in rotator cuff disease. Clin Orthop Relat Res. 2010;468(6):1526-1533.

5.    Gerber C, Pennington SD, Nyffeler RW. Reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2009;17(5):284-289.

6.    Lenarz C, Shishani Y, McCrum C, Nowinski RJ, Edwards TB, Gobezie R. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient? Early observations. Clin Orthop Relat Res. 2011;469(12):3324-3331.

7.    Muh SJ, Streit JJ, Wanner JP, et al. Early follow-up of reverse total shoulder arthroplasty in patients sixty years of age or younger. J Bone Joint Surg Am. 2013;95(20):1877-1883.

8.    Wall B, Nové-Josserand L, O’Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007;89(7):1476-1485.

9.    Young AA, Smith MM, Bacle G, Moraga C, Walch G. Early results of reverse shoulder arthroplasty in patients with rheumatoid arthritis. J Bone Joint Surg Am. 2011;93(20):1915-1923.

10.  Boileau P, Melis B, Duperron D, Moineau G, Rumian AP, Han Y. Revision surgery of reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(10):1359-1370.

11.  Beck JD, Irgit KS, Andreychik CM, Maloney PJ, Tang X, Harter GD. Reverse total shoulder arthroplasty in obese patients. J Hand Surg Am. 2013;38(5):965-970.

12.  Gupta AK, Chalmers PN, Rahman Z, et al. Reverse total shoulder arthroplasty in patients of varying body mass index. J Shoulder Elbow Surg. 2014;23(1):35-42.

13.  Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;(254):92-96.

14.  Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;(214):160-164.

15.  Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons standardized shoulder assessment form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

16.  Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: the Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001;9(8):771-778.

17.  Williams GN, Gangel TJ, Arciero RA, Uhorchak JM, Taylor DC. Comparison of the Single Assessment Numeric Evaluation method and two shoulder rating scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221.

18.  Gartsman GM, Edwards TB. Shoulder Arthroplasty. Philadelpia, PA: Saunders Elsevier; 2008.

19.  Liotard JP, Edwards TB, Padey A, Walch G, Boulahia A. Hydrotherapy rehabilitation after shoulder surgery. Tech Shoulder Elbow Surg. 2003;4:44-49.

20.  Trappey GJ 4th, O’Connor DP, Edwards TB. What are the instability and infection rates after reverse shoulder arthroplasty? Clin Orthop Relat Res. 2011;469(9):2505-2511.

21.  Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004;86(3):388-395.

22.  Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006;6(7):438-446.

23.  Schoenfeld AJ, Carey PA, Cleveland AW 3rd, Bader JO, Bono CM. Patient factors, comorbidities, and surgical characteristics that increase mortality and complication risk after spinal arthrodesis: a prognostic study based on 5,887 patients. Spine J. 2013;13(10):1171-1179.

24.  Jiang J, Teng Y, Fan Z, Khan S, Xia Y. Does obesity affect the surgical outcome and complication rates of spinal surgery? A meta-analysis. Clin Orthop Relat Res. 2014;472(3):968-975.

25.  Bozic KJ, Lau E, Kurtz S, et al. Patient-related risk factors for periprosthetic joint infection and postoperative mortality following total hip arthroplasty in Medicare patients. J Bone Joint Surg Am. 2012;94(9):794-800.

26.  Franklin PD, Li W, Ayers DC. The Chitranjan Ranawat Award: functional outcome after total knee replacement varies with patient attributes. Clin Orthop Relat Res. 2008;466(11):2597-2604.

27.  Huddleston JI, Wang Y, Uquillas C, Herndon JH, Maloney WJ. Age and obesity are risk factors for adverse events after total hip arthroplasty. Clin Orthop Relat Res. 2012;470(2):490-496.

28.  Jämsen E, Nevalainen P, Eskelinen A, Huotari K, Kalliovalkama J, Moilanen T. Obesity, diabetes, and preoperative hyperglycemia as predictors of periprosthetic joint infection: a single-center analysis of 7181 primary hip and knee replacements for osteoarthritis. J Bone Joint Surg Am. 2012;94(14):e101.

29.   Naziri Q, Issa K, Malkani AL, Bonutti PM, Harwin SF, Mont MA. Bariatric orthopaedics: total knee arthroplasty in super-obese patients (BMI > 50 kg/m2). Survivorship and complications. Clin Orthop Relat Res. 2013;471(11):3523-3530.

30.  Warrender WJ, Brown OL, Abboud JA. Outcomes of arthroscopic rotator cuff repairs in obese patients. J Shoulder Elbow Surg. 2011;20(6):961-967.

31.   Singh JA, Sperling JW, Cofield RH. Risk factors for revision surgery after humeral head replacement: 1,431 shoulders over 3 decades. J Shoulder Elbow Surg. 2012;21(8):1039-1044.

32.  Chalmers PN, Rahman Z, Romeo AA, Nicholson GP. Early dislocation after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(5):737-744.

33.  Li X, Williams PN, Nguyen JT, Craig EV, Warren RF, Gulotta LV. Functional outcomes after total shoulder arthroplasty in obese patients. J Bone Joint Surg Am. 2013;95(21):e160.

References

1.    World Health Organization. Obesity and overweight [factsheet 311]. Updated January 2015. http://www.who.int/mediacentre/factsheets/fs311/en/. Accessed March 27, 2016.

2.    National Center for Health Statistics, Centers for Disease Control and Prevention. Obesity and overweight. Updated February 25, 2016. http://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Accessed March 27, 2016.

3.    Boileau P, Gonzalez JF, Chuinard C, Bicknell R, Walch G. Reverse total shoulder arthroplasty after failed rotator cuff surgery. J Shoulder Elbow Surg. 2009;18(4):600-606.

4.    Drake GN, O’Connor DP, Edwards TB. Indications for reverse total shoulder arthroplasty in rotator cuff disease. Clin Orthop Relat Res. 2010;468(6):1526-1533.

5.    Gerber C, Pennington SD, Nyffeler RW. Reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2009;17(5):284-289.

6.    Lenarz C, Shishani Y, McCrum C, Nowinski RJ, Edwards TB, Gobezie R. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient? Early observations. Clin Orthop Relat Res. 2011;469(12):3324-3331.

7.    Muh SJ, Streit JJ, Wanner JP, et al. Early follow-up of reverse total shoulder arthroplasty in patients sixty years of age or younger. J Bone Joint Surg Am. 2013;95(20):1877-1883.

8.    Wall B, Nové-Josserand L, O’Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007;89(7):1476-1485.

9.    Young AA, Smith MM, Bacle G, Moraga C, Walch G. Early results of reverse shoulder arthroplasty in patients with rheumatoid arthritis. J Bone Joint Surg Am. 2011;93(20):1915-1923.

10.  Boileau P, Melis B, Duperron D, Moineau G, Rumian AP, Han Y. Revision surgery of reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(10):1359-1370.

11.  Beck JD, Irgit KS, Andreychik CM, Maloney PJ, Tang X, Harter GD. Reverse total shoulder arthroplasty in obese patients. J Hand Surg Am. 2013;38(5):965-970.

12.  Gupta AK, Chalmers PN, Rahman Z, et al. Reverse total shoulder arthroplasty in patients of varying body mass index. J Shoulder Elbow Surg. 2014;23(1):35-42.

13.  Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;(254):92-96.

14.  Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;(214):160-164.

15.  Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons standardized shoulder assessment form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

16.  Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: the Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001;9(8):771-778.

17.  Williams GN, Gangel TJ, Arciero RA, Uhorchak JM, Taylor DC. Comparison of the Single Assessment Numeric Evaluation method and two shoulder rating scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221.

18.  Gartsman GM, Edwards TB. Shoulder Arthroplasty. Philadelpia, PA: Saunders Elsevier; 2008.

19.  Liotard JP, Edwards TB, Padey A, Walch G, Boulahia A. Hydrotherapy rehabilitation after shoulder surgery. Tech Shoulder Elbow Surg. 2003;4:44-49.

20.  Trappey GJ 4th, O’Connor DP, Edwards TB. What are the instability and infection rates after reverse shoulder arthroplasty? Clin Orthop Relat Res. 2011;469(9):2505-2511.

21.  Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004;86(3):388-395.

22.  Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006;6(7):438-446.

23.  Schoenfeld AJ, Carey PA, Cleveland AW 3rd, Bader JO, Bono CM. Patient factors, comorbidities, and surgical characteristics that increase mortality and complication risk after spinal arthrodesis: a prognostic study based on 5,887 patients. Spine J. 2013;13(10):1171-1179.

24.  Jiang J, Teng Y, Fan Z, Khan S, Xia Y. Does obesity affect the surgical outcome and complication rates of spinal surgery? A meta-analysis. Clin Orthop Relat Res. 2014;472(3):968-975.

25.  Bozic KJ, Lau E, Kurtz S, et al. Patient-related risk factors for periprosthetic joint infection and postoperative mortality following total hip arthroplasty in Medicare patients. J Bone Joint Surg Am. 2012;94(9):794-800.

26.  Franklin PD, Li W, Ayers DC. The Chitranjan Ranawat Award: functional outcome after total knee replacement varies with patient attributes. Clin Orthop Relat Res. 2008;466(11):2597-2604.

27.  Huddleston JI, Wang Y, Uquillas C, Herndon JH, Maloney WJ. Age and obesity are risk factors for adverse events after total hip arthroplasty. Clin Orthop Relat Res. 2012;470(2):490-496.

28.  Jämsen E, Nevalainen P, Eskelinen A, Huotari K, Kalliovalkama J, Moilanen T. Obesity, diabetes, and preoperative hyperglycemia as predictors of periprosthetic joint infection: a single-center analysis of 7181 primary hip and knee replacements for osteoarthritis. J Bone Joint Surg Am. 2012;94(14):e101.

29.   Naziri Q, Issa K, Malkani AL, Bonutti PM, Harwin SF, Mont MA. Bariatric orthopaedics: total knee arthroplasty in super-obese patients (BMI > 50 kg/m2). Survivorship and complications. Clin Orthop Relat Res. 2013;471(11):3523-3530.

30.  Warrender WJ, Brown OL, Abboud JA. Outcomes of arthroscopic rotator cuff repairs in obese patients. J Shoulder Elbow Surg. 2011;20(6):961-967.

31.   Singh JA, Sperling JW, Cofield RH. Risk factors for revision surgery after humeral head replacement: 1,431 shoulders over 3 decades. J Shoulder Elbow Surg. 2012;21(8):1039-1044.

32.  Chalmers PN, Rahman Z, Romeo AA, Nicholson GP. Early dislocation after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(5):737-744.

33.  Li X, Williams PN, Nguyen JT, Craig EV, Warren RF, Gulotta LV. Functional outcomes after total shoulder arthroplasty in obese patients. J Bone Joint Surg Am. 2013;95(21):e160.

Issue
The American Journal of Orthopedics - 45(4)
Issue
The American Journal of Orthopedics - 45(4)
Page Number
E180-E186
Page Number
E180-E186
Publications
Publications
Topics
Article Type
Display Headline
Obesity Has Minimal Impact on Short-Term Functional Scores After Reverse Shoulder Arthroplasty for Rotator Cuff Tear Arthropathy
Display Headline
Obesity Has Minimal Impact on Short-Term Functional Scores After Reverse Shoulder Arthroplasty for Rotator Cuff Tear Arthropathy
Legacy Keywords
obesity, obese, weight, shoulder arthroplasty, shoulder, arthroplasty, rotator cuff tear, rotator cuff, arthropathy, body mass index, BMI, RSA, RCTA, morris, haigler, cochran, laughlin, elkousy, gartsman, edwards
Legacy Keywords
obesity, obese, weight, shoulder arthroplasty, shoulder, arthroplasty, rotator cuff tear, rotator cuff, arthropathy, body mass index, BMI, RSA, RCTA, morris, haigler, cochran, laughlin, elkousy, gartsman, edwards
Sections
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility

Article Type
Changed
Display Headline
Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility

Patients undergoing total knee arthroplasty (TKA) may benefit from focused postoperative rehabilitation. Although there is limited research comparing different rehabilitation protocols after TKA,1 any type of rehabilitation often helps to optimize range of motion (ROM), strength, balance, and ambulation.2 Early mobilization and rehabilitation after TKA reduces pain, fear, anxiety, and risk of postoperative venous thromboembolic disease.3 Earlier discharge to home or community settings deceases time for inpatient rehabilitation, patient and family education, and gait training, which places a greater emphasis on outpatient rehabilitation.4

Although rapid rehabilitation protocols have gained wide acceptance, concern remains that a higher intensity intervention initiated immediately after hospital discharge could lead to an increased incidence of pain and swelling, and to poorer ROM and functional outcomes.5 Progressive weight-bearing activities, such as walking, are routinely recommended during rehabilitation to facilitate return to normal function. Not all patients are capable of full weight-bearing activity in the early postoperative period and assistive devices (ADs), such as walkers, crutches, and canes, are routinely employed. An opportunity to enhance early TKA rehabilitation exists with devices that allow functional gait training while modifying weight-bearing forces across the joint. Assistive devices, hydrotherapy (walking in water),6,7 and lower body positive-pressure chambers8 can reduce the forces at the knee during weight-bearing exercise.

Lower body positive-pressure devices have been extensively studied in physiological response of healthy humans;9-12 in disease states such as cerebral palsy13 and obesity;14 and in other postoperative orthopedic conditions, such as anterior cruciate ligament reconstruction, meniscectomy,8 microfracture,15 TKA,16 and Achilles tendon repair.17 These studies demonstrate that a lower body positive-pressure treadmill is associated with minimal cardiovascular effect while producing a significant decrease in ground reaction forces without altering gait kinematics.

We postulated that an anti-gravity treadmill may be safe and effective for gait training during rehabilitation following TKA. The primary objective was to determine the safety and feasibility of using the AlterG® Anti-Gravity Treadmill® device for postoperative gait training during rehabilitation following TKA. The secondary objective was to determine the effects of gait training (land-based vs anti-gravity) during postoperative rehabilitation on subjective patient outcomes assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), mobility assessed by the Timed Up and Go test (TUG), and pain assessed by a Numerical Rating Scale (NRS) to conduct a power analysis to determine sample sizes for efficacy studies based on these preliminary findings.

MethodsParticipants/Patient Enrollment and Study Overview

After signing an Institutional Review Board-approved consent, 30 patients were enrolled, and TKA surgeries were performed by 1 of 5 surgeons at 1 hospital. To be enrolled in the study, subjects must have (1) had a unilateral primary TKA, (2) been discharged from the hospital to home (not to a skilled nursing facility), (3) had only 3 to 4 home physical therapy (PT) sessions, (4) agreed to further outpatient PT at a single site, and (5) agreed to complete patient questionnaires. Exclusion criteria included (1) inability to meet inclusion criteria, (2) gross musculoskeletal deformity, (3) uncontrolled chronic or systemic disease, and (4) inability to follow instructions because of mental impairment, substance abuse, or addiction. Home PT was conducted for 3 to 4 sessions after surgery, and outpatient PT was continued at the study site per protocol for 4 weeks; subjects were asked to return for follow-up 3 months postoperatively. Patients were randomized on the first day of their outpatient PT to either a land-based (control) or an anti-gravity-based group using the AlterG Anti-Gravity Treadmill (AlterG group) gait training during outpatient PT sessions. Patients attended outpatient PT 2 days per week for 4 weeks for a total of 8 sessions. Therapy sessions lasted 45 to 60 minutes and included manual therapy, gait training, and therapeutic exercises/activities. The KOOS18,19 and TUG20 scores were evaluated at baseline (ie, first therapy session), end of physical therapy (EOPT) (ie, at final therapy session), and end of study (EOS) (ie, 3 months postoperatively). The NRS for pain was evaluated at baseline and at EOPT. Physical therapists were questioned for satisfaction with the anti-gravity rehabilitation protocol at EOPT.

Physical Therapy Protocols

All patients were treated consistently by 1 of 5 physical therapists at 1 outpatient setting; physical therapists averaged 11 years of experience in treating orthopedic conditions. Care was delivered in accordance with professional standards and the therapist’s assessment of medical necessity. Considerations included, but were not limited to, overall general health, any medical comorbidity, support system, and an ongoing assessment of ROM, strength, pain, and functional status. Each PT session started with a 5- to 10-minute warm-up on a standard cycle ergometer and was followed by manual therapy, gait training (land-based vs anti-gravity), therapeutic exercises/activities, and treatment modalities.

 

 

The time spent, activities selected, and modalities or physical agents chosen during the PT session were based on the patient’s needs and progress toward his/her functional goals. Manual therapy techniques consisted of soft-tissue mobilization, passive ROM, joint mobilization, passive stretching, scar mobilization, manual resistive exercises, and proprioceptive neuromuscular facilitation techniques. Therapeutic exercises/activities consisted of lower extremity resistance exercises (weight bearing and non-weight bearing), ROM exercises, stretching, balance, stair training, agility, activities of daily life (ADL) training, and a comprehensive home exercise program. Modalities or physical agents used during this study included moist hot packs, cold packs, ultrasound, electrical stimulation, and Kinesio Tape. Physical agents were incorporated into the individual’s plan of care based on medical necessity when deemed appropriate by the treating therapist. The exercise prescription was based on an individual’s status and tolerance and the number of sets and repetitions were based on fatigue.

Gait Training

The patients were randomized (1:1) to either land-based or anti-gravity gait training. For the control group, land-based gait training was performed with or without an appropriate AD and appropriate assistance, tactile cueing, and verbal cueing from a physical therapist. Duration (minutes) and gait-training progression were dependent on the participant’s functional goals, pain level (assessed throughout treatment), and level of fatigue. For the AlterG group, gait training was performed in the AlterG Anti-Gravity Treadmill, M320 (Alter-G; Figure 1). On day 1, the AlterG pressure chamber was set to allow only 50% of the patient’s body weight to be transmitted to the treadmill floor, and speed was controlled by the patient according to his/her comfort level. The percentage of body weight was adjusted to allow for a safe and normalized gait pattern with a pain level no greater than 5 (0 to 10 scale) throughout the PT session. A report card was recorded at each PT session, including body-weight setting (%), speed (miles per hour), incline (%), and duration (minutes) (Figure 2). For subsequent visits, the body-weight setting was started from the end point of the previous session.

 

Data Collection and Analysis

SPSS version 12.0 (SPSS Inc.) was used for all analyses, and an alpha level of .05 determined statistical significance when comparing group differences. The safety and feasibility of the anti-gravity (AlterG) vs land-based (control) gait training was assessed by the presence (or absence) of adverse events (AEs) and complications, and the date the patient discontinued use of his/her AD. A chi-square test was used to assess differences between control and AlterG groups regarding patient discontinuance of an AD. Additionally, for patients randomized to AlterG, a report card summarized means and frequencies for body weight, speed, incline, and duration. At EOPT, the frequency of therapists who were satisfied with the AlterG Anti-Gravity Treadmill as part of the rehabilitation protocol was reported. The preliminary effects of gait training (land-based vs anti-gravity) during postoperative rehabilitation on functional outcomes (subjective patient outcomes assessed by KOOS, mobility assessed by the TUG test, and pain assessed by a NRS) were evaluated by independent sample t tests. Paired sample t tests were used to compare each of the functional outcomes at EOPT or EOS to the baseline value.

Results

Of the 30 patients enrolled, 29 (96.7%; 29/30) patients completed the study; 1 patient, who could not complete all PT sessions because of medical and transportation issues, was excluded. The remaining 29 patients comprised the study population (control = 15; AlterG = 14). All patients were compliant with PT protocols.

Patient demographics were similar between the control and AlterG groups (Table 1). The control group comprised 9 women (60%; 9/15) and 6 men (40%; 6/15), age 69.9 ± 7.8 years and a body mass index of 28.8 ± 4.2. Similarly, the AlterG group comprised 7 women (50%; 7/14) and 7 men (50%; 7/14), age 66.5 ± 7.8 years and a body mass index of 28.4 ± 5.2.

At the baseline PT visit, patients in the control and AlterG groups had similar KOOS, TUG, and NRS scores. At baseline, mean KOOS for symptoms, pain, sports/recreation, ADL, and quality of life were 52.7, 52.9, 22.7, 64, and 31.8, respectively, although 50% of patients did not complete the sports/recreation subset of the KOOS. In addition, the mean time to complete the TUG test was 14.5 seconds, which was within the normal limits for disabled patients. This was slightly longer than normal mobility (TUG <10 seconds),20 but patients had relatively low levels of pain (mean NRS = 2.5, on a scale of 0-11).

All patients completed the PT protocols without indication of injury or AEs related to their operative knee. Three patients (10.3%; 3/29) experienced a deep venous thromboembolism (DVT), 2 in the control group (13.3%; 2/15), and 1 in the AlterG group (7.1%; 1/14). Venous thromboembolism protocol of enoxaparin 30 mg twice daily while in the hospital and enoxaparin 40 mg once daily for 10 days after discharge was followed for all patients.

 

 

Overall, more than half of patients (55.2%; 16/29) discontinued their AD during the 4-week PT period, with the remaining discontinuing prior to EOPT (24.1%; 7/29) or after EOPT (20.7%; 6/29). No statistically significant differences were found between the control and AlterG groups regarding discontinuance of AD.

Among those randomized to the AlterG group, all patients performed within the protocol established for the device for body-weight setting, treadmill speed, and duration of walking. The average body-weight treadmill setting increased by ~30% over the treatment period, from 55% at baseline to 84% at EOPT. The average speed increased by ~70%, from 1.6 mph at baseline to 2.7 mph at EOPT. The mean duration of AlterG use increased by ~75%, from 7.2 minutes at baseline to 12.7 minutes at EOPT. All physical therapists (100%) reported satisfaction with the AlterG for use in early postoperative rehabilitation and reported that patients’ treatment progressed positively.

While functional outcomes (KOOS, TUG, or NRS) did not vary with the type of gait training (P > .2 for land-based vs anti-gravity), functional outcomes improved over time (all P < .01 from baseline to EOPT and all P < .01 from baseline to EOS).

The KOOS scores improved from baseline to EOPT and from baseline to EOS (ie, 3-month follow-up visit) for both treatment groups (Figure 3). More patients completed the sports/recreation portion of the KOOS scores at EOPT and EOS compared to baseline. Forty-three percent and 25% of patients did not complete KOOS sports/recreation questions at EOPT and EOS, respectively, compared to 50% at baseline. This suggests that patients were improving to a level where sports/recreation scores were more applicable than directly after TKA surgery. The TUG scores had the greatest improvement from baseline to EOPT, with a decrease in time of 5 seconds and 7 seconds for the control and AlterG groups, respectively, and slight improvement from EOPT to EOS, with a decrease in time of 1 second and 2 seconds for the control and AlterG groups, respectively (Table 2). By the EOS, the values for the TUG tests for both treatment groups were within normal (<10 seconds) range.20 The NRS scores improved from baseline to EOPT with a score of 1 ± 1 in both control and AlterG groups.

 

Using these preliminary efficacy results, a post-hoc power analysis (α = .05 and 1β = 80%) was performed with the ADL domain of KOOS as the primary endpoint. Based on a standard deviation of 20 points and an effect size of 5 points, the sample size was estimated to be N = 250 per treatment group.

Discussion

We conducted a pilot study to assess, primarily, the feasibility and safety, and, secondarily, the efficacy, of a lower body positive-pressure treadmill for rehabilitation of patients after TKA. This small study showed that use of the AlterG Anti-Gravity Treadmill was not only safe and feasible during postoperative TKA rehabilitation, but also was well tolerated by patients and was rated highly satisfactory by physical therapists. Patients who used AlterG during gait training improved functionally (in terms of KOOS, TUG, and NRS) after 8 treatment sessions compared to baseline. However, there were no statistical differences between groups (control vs AlterG). Thus, these results suggest that an anti-gravity device for gait training may be a useful adjunct for postoperative TKA rehabilitation, but further studies are needed to determine the efficacy of anti-gravity compared to traditional land-based gait training.

The study of rehabilitation protocols during postoperative PT involved consideration of a number of issues. First, differences in functional outcomes compared to traditional rehabilitation could not be detected in this study because of the small number of patients, but the patients treated with anti-gravity gait training showed improvement in functional outcomes over time and did not report any added complications. Given that the primary outcome of this study was safety and feasibility, these added efficacy results are supplemental and useful in helping to plan studies. Second, the functional outcomes used to measure the efficacy of the anti-gravity treadmill may not be sensitive enough to detect differences between rehabilitation protocols. Use of a treadmill to measure speed improvement, endurance, and tolerance in both groups could be valuable in future studies. More studies may need to refine characteristics that are important to postoperative rehabilitation success, and quantitative and subjective measures that must be defined.

The results reported here using an anti-gravity treadmill for postoperative TKA rehabilitation support the safety and feasibility that has been reported in other orthopedic rehabilitation settings. Anti-gravity treadmills, which have been used to study patients after meniscectomy or anterior cruciate ligament reconstruction8 and Achilles repair,17 have demonstrated predictable decreases in ground reaction forces with increasing positive-pressure unweighting, reductions in pain with ambulation, and allowance of earlier institution of walking and jogging during rehabilitation.17

 

 

Patient safety is an important attribute for any postoperative rehabilitation protocol, especially in an elderly population undergoing major surgery. One of our important goals was to assess the safety of AlterG. We noted no AEs attributable to the device, which was supported by work indicating no adverse impact on systemic cardiovascular parameters in a similar lower body positive-pressure environment.9 Although 3 patients (10%) developed symptomatic DVT, there were no differences between the groups in the incidence of DVT. Use of an anti-gravity treadmill has also been examined for cardiovascular responses in TKA patients. In a study of 24 adults with TKA, researchers found that anti-gravity support allowed TKA patients to walk at faster speeds and tolerate greater inclines with lower heart rate, blood pressure, and oxygen consumption.21 With respect to efficacy of the rehabilitation intervention, we demonstrated significant improvements in all functional outcomes in both groups but no differences between the study groups. We concluded that AlterG was at least as effective as standard therapy in this small cohort. TKA is a very successful procedure, and the improvement in pain and function after surgery is fairly dramatic in most patients, regardless of specific rehabilitation protocols. Therefore, the substantial improvement in clinical outcomes may overshadow any enhanced benefits of the anti-gravity treadmill. Further investigations into the efficacy of AlterG are needed in a larger cohort to determine if this type of treatment is more beneficial than traditional land-based gait training.

Standard scoring systems such as KOOS, TUG, and NRS may not be sensitive enough to detect differences between treatment groups with small sample sizes. Given the results of the post hoc power analysis, a large number of patients (N = 250/group) would be necessary to detect any potential difference in clinical outcomes between the 2 groups. Larger studies are required to answer relevant questions, and additional outcome measures may be needed to detect differences between treatment groups. Relevant questions include whether earlier institution of the anti-gravity device during the immediate TKA postoperative period would be beneficial compared to standard postoperative PT, and whether PT enhanced with the anti-gravity device has incremental benefit in functional outcomes and in time to reach those goals. Finally, given the present attention to healthcare expenses, a cost-benefit analysis of anti-gravity device treatment vs traditional PT would be useful. Once the patient has become familiar with the function of an anti-gravity treadmill, gait therapy could proceed without the direct intervention of the therapist, potentially improving efficient delivery of rehabilitation services.

Studying the effect of different postoperative rehabilitation protocols after orthopedic surgeries can be challenging. In a large (N > 350) randomized controlled trial to study the effect of ergometer cycling after hip and knee replacement, patients who used the cycle ergometer had a higher Western Ontario and McMaster Universities Arthritis Index and greater satisfaction than those who did not after hip arthroplasty, but not after TKA.22 Improvements in muscular coordination and proprioception with the cycle ergometer may have been offset by increases in edema, joint effusion, and pain from the loading of the joint and the relatively fast rate of cycling compared to passive motion or ambulation. While many therapists and surgeons advocate cycling for rehabilitation after knee surgery, the need remains for a better definition of an optimal TKA rehabilitation program. A study of 82 patients comparing early progressive strength training to no early strength training showed no difference in the 6-minute walk test at 8 weeks.23 A systematic review of progressive resistance training (PRT) found that although postoperative PRT is safe and feasible, the methodological quality of existing studies is too low to allow conclusions regarding its efficacy.24 Gait training in an environment where weight-bearing loads can be closely controlled, monitored, and individualized may be an ideal methodology to enhance rehabilitation and return to function for knee replacement surgery.

This current study showed that the use of AlterG as an adjunct for postoperative rehabilitation is safe, accepted by patients and therapists, and leads to clinical functional outcomes that are at least as good as traditional postoperative TKA rehabilitation. We conclude that AlterG demonstrates utility and a potential for innovation in TKA rehabilitation.

References

1.    NIH Consensus Statement on total knee arthroplasty. NIH Consensus State Sci Statements. 2003;20(1):1-34.

2.    Jones CA, Voaklander DC, Suarez-Almazor ME. Determinants of function after total knee arthroplasty. Phys Ther. 2003;83(8):696-706.

3.    Pearse EO, Caldwell BF, Lockwood RJ, Hollard J. Early mobilisation after conventional knee replacement may reduce the risk of post-operative venous thromboembolism. J Bone Joint Surg Br. 2007;89(3):316-322.

4.    Westby MD, Kennedy D, Jones D, Jones A, Doyle-Waters MM, Backman C. Post-acute physiotherapy for primary total knee arthroplasty. Cochrane Database Syst Rev. 2008. doi.10.1002/14651858.CD007099

5.    Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011;41(12):932-941.

6.    Ivanenko YP, Grasso R, Macellari V, Lacquaniti F. Control of foot trajectory in human locomotion: role of ground contact forces in simulated reduced gravity. J Neurophysiol. 2002;87(6):3070-3089.

7.    Pöyhönen T, Keskinen KL, Kyröläinen H, Hautala A, Savolainen J, Mälkiä E. Neuromuscular function during therapeutic knee exercise under water and on dry land. Arch Phys Med Rehabil. 2001;82(10):1446-1452.

8.    Eastlack RK, Hargens AR, Groppo ER, Steinbach GC, White KK, Pedowitz RA. Lower body positive-pressure exercise after knee surgery. Clin Orthop Rel Res. 2005;431:213-219.

9.    Cutuk A, Groppo ER, Quigley EJ, White KW, Pedowitz RA, Hargens AR. Ambulation in simulated fractional gravity using lower body positive pressure: cardiovascular safety and gait analyses. J Appl Physiol. 2006;101(3):771-777.

10.   Gojanovic B, Cutti P, Shultz R, Matheson GO. Maximal physiological parameters during partial body-weight support treadmill testing. Med Sci Sports Exerc. 2012;44(10):1935-1941.

11.  Figueroa MA, Manning J, Escamilla P. Physiological responses to the AlterG Anti-Gravity Treadmill. Int J Applied Sci Tech. 2011;1:92-97.

12.  Hoffman MD, Donaghe HE. Physiological responses to body weight-supported treadmill exercise in healthy adults. Arch Phys Med Rehabil. 2011;92(6):960-966.

13.  Kurz MJ, Corr B, Stuberg W, Volkman KG, Smith N. Evaluation of lower body positive pressure supported treadmill training for children with cerebral palsy. Pediatr Phys Ther. 2011;23(3):232-239.

14.  Christian M. Managing knee osteoarthritis: the effects of anti-gravity treadmill exercise on joint pain and physical function. Available at: http://mspace.lib.umanitoba.ca/handle/1993/8580. Accessed March 31, 2016.

15.  Wilk KE, Macrina LC, Reinhold MM. Rehabilitation following microfracture of the knee. Cartilage. 2010;1(2):96-107.

16.  Patil SS, Branovacki G, Martin MR, Pulido PA, Levy YD, Colwell CW Jr. 14-year median follow-up using the press-fit condylar sigma design for total knee arthroplasty. J Arthroplasty. 2013;28(8):1286-1290.

17.  Saxena A, Granot A. Use of an anti-gravity treadmill in the rehabilitation of the operated achilles tendon: a pilot study. J Foot Ankle Surg. 2011;50(5):558-561.

18.   Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version. Scand J Med Sci Sports. 1998;8(6):439-448.

19.  Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17.

20.  Timed Up and Go (TUG). Available at: http://www.rheumatology.org/I-Am-A/Rheumatologist/Research/Clinician-Researchers/Timed-Up-Go-TUG Accessed: March 15, 2016.

21.  Webber SC, Horvey KJ, Yurach Pikaluk MT, Butcher SJ. Cardiovascular responses in older adults with total knee arthroplasty at rest and with exercise on a positive pressure treadmill. Eur J Appl Physiol. 2014;114(3):653-662.

22.  Liebs TR, Herzberg W, Ruther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip and knee replacement surgery: a randomized control trial. J Bone Joint Surg Am. 2010;92(4):814-822.

23.  Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res. 2014;66(12):1856-1866.

24.  Skoffer B, Dalgas U, Mechlenburg I. Progressive resistance training before and after total hip and knee arthroplasty: a systematic review. Clin Rehabil. 2015;29(1):14-29.

Article PDF
Author and Disclosure Information

William D. Bugbee, MD, Pamela A. Pulido, BSN, Timothy Goldberg, PT, COMT, and Darryl D. D’Lima, MD, PhD

Authors’ Disclosure Statement: The authors received research funding from AlterG in support of this project.

Issue
The American Journal of Orthopedics - 45(4)
Publications
Topics
Page Number
E167-E173
Legacy Keywords
anti-gravity, gravity, knee, knee replacement, replacement, rehabilitation, treadmill, total knee arthroplasty, TKA, physical therapy, study, bugbee, pulido, goldberg, d'lima
Sections
Author and Disclosure Information

William D. Bugbee, MD, Pamela A. Pulido, BSN, Timothy Goldberg, PT, COMT, and Darryl D. D’Lima, MD, PhD

Authors’ Disclosure Statement: The authors received research funding from AlterG in support of this project.

Author and Disclosure Information

William D. Bugbee, MD, Pamela A. Pulido, BSN, Timothy Goldberg, PT, COMT, and Darryl D. D’Lima, MD, PhD

Authors’ Disclosure Statement: The authors received research funding from AlterG in support of this project.

Article PDF
Article PDF

Patients undergoing total knee arthroplasty (TKA) may benefit from focused postoperative rehabilitation. Although there is limited research comparing different rehabilitation protocols after TKA,1 any type of rehabilitation often helps to optimize range of motion (ROM), strength, balance, and ambulation.2 Early mobilization and rehabilitation after TKA reduces pain, fear, anxiety, and risk of postoperative venous thromboembolic disease.3 Earlier discharge to home or community settings deceases time for inpatient rehabilitation, patient and family education, and gait training, which places a greater emphasis on outpatient rehabilitation.4

Although rapid rehabilitation protocols have gained wide acceptance, concern remains that a higher intensity intervention initiated immediately after hospital discharge could lead to an increased incidence of pain and swelling, and to poorer ROM and functional outcomes.5 Progressive weight-bearing activities, such as walking, are routinely recommended during rehabilitation to facilitate return to normal function. Not all patients are capable of full weight-bearing activity in the early postoperative period and assistive devices (ADs), such as walkers, crutches, and canes, are routinely employed. An opportunity to enhance early TKA rehabilitation exists with devices that allow functional gait training while modifying weight-bearing forces across the joint. Assistive devices, hydrotherapy (walking in water),6,7 and lower body positive-pressure chambers8 can reduce the forces at the knee during weight-bearing exercise.

Lower body positive-pressure devices have been extensively studied in physiological response of healthy humans;9-12 in disease states such as cerebral palsy13 and obesity;14 and in other postoperative orthopedic conditions, such as anterior cruciate ligament reconstruction, meniscectomy,8 microfracture,15 TKA,16 and Achilles tendon repair.17 These studies demonstrate that a lower body positive-pressure treadmill is associated with minimal cardiovascular effect while producing a significant decrease in ground reaction forces without altering gait kinematics.

We postulated that an anti-gravity treadmill may be safe and effective for gait training during rehabilitation following TKA. The primary objective was to determine the safety and feasibility of using the AlterG® Anti-Gravity Treadmill® device for postoperative gait training during rehabilitation following TKA. The secondary objective was to determine the effects of gait training (land-based vs anti-gravity) during postoperative rehabilitation on subjective patient outcomes assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), mobility assessed by the Timed Up and Go test (TUG), and pain assessed by a Numerical Rating Scale (NRS) to conduct a power analysis to determine sample sizes for efficacy studies based on these preliminary findings.

MethodsParticipants/Patient Enrollment and Study Overview

After signing an Institutional Review Board-approved consent, 30 patients were enrolled, and TKA surgeries were performed by 1 of 5 surgeons at 1 hospital. To be enrolled in the study, subjects must have (1) had a unilateral primary TKA, (2) been discharged from the hospital to home (not to a skilled nursing facility), (3) had only 3 to 4 home physical therapy (PT) sessions, (4) agreed to further outpatient PT at a single site, and (5) agreed to complete patient questionnaires. Exclusion criteria included (1) inability to meet inclusion criteria, (2) gross musculoskeletal deformity, (3) uncontrolled chronic or systemic disease, and (4) inability to follow instructions because of mental impairment, substance abuse, or addiction. Home PT was conducted for 3 to 4 sessions after surgery, and outpatient PT was continued at the study site per protocol for 4 weeks; subjects were asked to return for follow-up 3 months postoperatively. Patients were randomized on the first day of their outpatient PT to either a land-based (control) or an anti-gravity-based group using the AlterG Anti-Gravity Treadmill (AlterG group) gait training during outpatient PT sessions. Patients attended outpatient PT 2 days per week for 4 weeks for a total of 8 sessions. Therapy sessions lasted 45 to 60 minutes and included manual therapy, gait training, and therapeutic exercises/activities. The KOOS18,19 and TUG20 scores were evaluated at baseline (ie, first therapy session), end of physical therapy (EOPT) (ie, at final therapy session), and end of study (EOS) (ie, 3 months postoperatively). The NRS for pain was evaluated at baseline and at EOPT. Physical therapists were questioned for satisfaction with the anti-gravity rehabilitation protocol at EOPT.

Physical Therapy Protocols

All patients were treated consistently by 1 of 5 physical therapists at 1 outpatient setting; physical therapists averaged 11 years of experience in treating orthopedic conditions. Care was delivered in accordance with professional standards and the therapist’s assessment of medical necessity. Considerations included, but were not limited to, overall general health, any medical comorbidity, support system, and an ongoing assessment of ROM, strength, pain, and functional status. Each PT session started with a 5- to 10-minute warm-up on a standard cycle ergometer and was followed by manual therapy, gait training (land-based vs anti-gravity), therapeutic exercises/activities, and treatment modalities.

 

 

The time spent, activities selected, and modalities or physical agents chosen during the PT session were based on the patient’s needs and progress toward his/her functional goals. Manual therapy techniques consisted of soft-tissue mobilization, passive ROM, joint mobilization, passive stretching, scar mobilization, manual resistive exercises, and proprioceptive neuromuscular facilitation techniques. Therapeutic exercises/activities consisted of lower extremity resistance exercises (weight bearing and non-weight bearing), ROM exercises, stretching, balance, stair training, agility, activities of daily life (ADL) training, and a comprehensive home exercise program. Modalities or physical agents used during this study included moist hot packs, cold packs, ultrasound, electrical stimulation, and Kinesio Tape. Physical agents were incorporated into the individual’s plan of care based on medical necessity when deemed appropriate by the treating therapist. The exercise prescription was based on an individual’s status and tolerance and the number of sets and repetitions were based on fatigue.

Gait Training

The patients were randomized (1:1) to either land-based or anti-gravity gait training. For the control group, land-based gait training was performed with or without an appropriate AD and appropriate assistance, tactile cueing, and verbal cueing from a physical therapist. Duration (minutes) and gait-training progression were dependent on the participant’s functional goals, pain level (assessed throughout treatment), and level of fatigue. For the AlterG group, gait training was performed in the AlterG Anti-Gravity Treadmill, M320 (Alter-G; Figure 1). On day 1, the AlterG pressure chamber was set to allow only 50% of the patient’s body weight to be transmitted to the treadmill floor, and speed was controlled by the patient according to his/her comfort level. The percentage of body weight was adjusted to allow for a safe and normalized gait pattern with a pain level no greater than 5 (0 to 10 scale) throughout the PT session. A report card was recorded at each PT session, including body-weight setting (%), speed (miles per hour), incline (%), and duration (minutes) (Figure 2). For subsequent visits, the body-weight setting was started from the end point of the previous session.

 

Data Collection and Analysis

SPSS version 12.0 (SPSS Inc.) was used for all analyses, and an alpha level of .05 determined statistical significance when comparing group differences. The safety and feasibility of the anti-gravity (AlterG) vs land-based (control) gait training was assessed by the presence (or absence) of adverse events (AEs) and complications, and the date the patient discontinued use of his/her AD. A chi-square test was used to assess differences between control and AlterG groups regarding patient discontinuance of an AD. Additionally, for patients randomized to AlterG, a report card summarized means and frequencies for body weight, speed, incline, and duration. At EOPT, the frequency of therapists who were satisfied with the AlterG Anti-Gravity Treadmill as part of the rehabilitation protocol was reported. The preliminary effects of gait training (land-based vs anti-gravity) during postoperative rehabilitation on functional outcomes (subjective patient outcomes assessed by KOOS, mobility assessed by the TUG test, and pain assessed by a NRS) were evaluated by independent sample t tests. Paired sample t tests were used to compare each of the functional outcomes at EOPT or EOS to the baseline value.

Results

Of the 30 patients enrolled, 29 (96.7%; 29/30) patients completed the study; 1 patient, who could not complete all PT sessions because of medical and transportation issues, was excluded. The remaining 29 patients comprised the study population (control = 15; AlterG = 14). All patients were compliant with PT protocols.

Patient demographics were similar between the control and AlterG groups (Table 1). The control group comprised 9 women (60%; 9/15) and 6 men (40%; 6/15), age 69.9 ± 7.8 years and a body mass index of 28.8 ± 4.2. Similarly, the AlterG group comprised 7 women (50%; 7/14) and 7 men (50%; 7/14), age 66.5 ± 7.8 years and a body mass index of 28.4 ± 5.2.

At the baseline PT visit, patients in the control and AlterG groups had similar KOOS, TUG, and NRS scores. At baseline, mean KOOS for symptoms, pain, sports/recreation, ADL, and quality of life were 52.7, 52.9, 22.7, 64, and 31.8, respectively, although 50% of patients did not complete the sports/recreation subset of the KOOS. In addition, the mean time to complete the TUG test was 14.5 seconds, which was within the normal limits for disabled patients. This was slightly longer than normal mobility (TUG <10 seconds),20 but patients had relatively low levels of pain (mean NRS = 2.5, on a scale of 0-11).

All patients completed the PT protocols without indication of injury or AEs related to their operative knee. Three patients (10.3%; 3/29) experienced a deep venous thromboembolism (DVT), 2 in the control group (13.3%; 2/15), and 1 in the AlterG group (7.1%; 1/14). Venous thromboembolism protocol of enoxaparin 30 mg twice daily while in the hospital and enoxaparin 40 mg once daily for 10 days after discharge was followed for all patients.

 

 

Overall, more than half of patients (55.2%; 16/29) discontinued their AD during the 4-week PT period, with the remaining discontinuing prior to EOPT (24.1%; 7/29) or after EOPT (20.7%; 6/29). No statistically significant differences were found between the control and AlterG groups regarding discontinuance of AD.

Among those randomized to the AlterG group, all patients performed within the protocol established for the device for body-weight setting, treadmill speed, and duration of walking. The average body-weight treadmill setting increased by ~30% over the treatment period, from 55% at baseline to 84% at EOPT. The average speed increased by ~70%, from 1.6 mph at baseline to 2.7 mph at EOPT. The mean duration of AlterG use increased by ~75%, from 7.2 minutes at baseline to 12.7 minutes at EOPT. All physical therapists (100%) reported satisfaction with the AlterG for use in early postoperative rehabilitation and reported that patients’ treatment progressed positively.

While functional outcomes (KOOS, TUG, or NRS) did not vary with the type of gait training (P > .2 for land-based vs anti-gravity), functional outcomes improved over time (all P < .01 from baseline to EOPT and all P < .01 from baseline to EOS).

The KOOS scores improved from baseline to EOPT and from baseline to EOS (ie, 3-month follow-up visit) for both treatment groups (Figure 3). More patients completed the sports/recreation portion of the KOOS scores at EOPT and EOS compared to baseline. Forty-three percent and 25% of patients did not complete KOOS sports/recreation questions at EOPT and EOS, respectively, compared to 50% at baseline. This suggests that patients were improving to a level where sports/recreation scores were more applicable than directly after TKA surgery. The TUG scores had the greatest improvement from baseline to EOPT, with a decrease in time of 5 seconds and 7 seconds for the control and AlterG groups, respectively, and slight improvement from EOPT to EOS, with a decrease in time of 1 second and 2 seconds for the control and AlterG groups, respectively (Table 2). By the EOS, the values for the TUG tests for both treatment groups were within normal (<10 seconds) range.20 The NRS scores improved from baseline to EOPT with a score of 1 ± 1 in both control and AlterG groups.

 

Using these preliminary efficacy results, a post-hoc power analysis (α = .05 and 1β = 80%) was performed with the ADL domain of KOOS as the primary endpoint. Based on a standard deviation of 20 points and an effect size of 5 points, the sample size was estimated to be N = 250 per treatment group.

Discussion

We conducted a pilot study to assess, primarily, the feasibility and safety, and, secondarily, the efficacy, of a lower body positive-pressure treadmill for rehabilitation of patients after TKA. This small study showed that use of the AlterG Anti-Gravity Treadmill was not only safe and feasible during postoperative TKA rehabilitation, but also was well tolerated by patients and was rated highly satisfactory by physical therapists. Patients who used AlterG during gait training improved functionally (in terms of KOOS, TUG, and NRS) after 8 treatment sessions compared to baseline. However, there were no statistical differences between groups (control vs AlterG). Thus, these results suggest that an anti-gravity device for gait training may be a useful adjunct for postoperative TKA rehabilitation, but further studies are needed to determine the efficacy of anti-gravity compared to traditional land-based gait training.

The study of rehabilitation protocols during postoperative PT involved consideration of a number of issues. First, differences in functional outcomes compared to traditional rehabilitation could not be detected in this study because of the small number of patients, but the patients treated with anti-gravity gait training showed improvement in functional outcomes over time and did not report any added complications. Given that the primary outcome of this study was safety and feasibility, these added efficacy results are supplemental and useful in helping to plan studies. Second, the functional outcomes used to measure the efficacy of the anti-gravity treadmill may not be sensitive enough to detect differences between rehabilitation protocols. Use of a treadmill to measure speed improvement, endurance, and tolerance in both groups could be valuable in future studies. More studies may need to refine characteristics that are important to postoperative rehabilitation success, and quantitative and subjective measures that must be defined.

The results reported here using an anti-gravity treadmill for postoperative TKA rehabilitation support the safety and feasibility that has been reported in other orthopedic rehabilitation settings. Anti-gravity treadmills, which have been used to study patients after meniscectomy or anterior cruciate ligament reconstruction8 and Achilles repair,17 have demonstrated predictable decreases in ground reaction forces with increasing positive-pressure unweighting, reductions in pain with ambulation, and allowance of earlier institution of walking and jogging during rehabilitation.17

 

 

Patient safety is an important attribute for any postoperative rehabilitation protocol, especially in an elderly population undergoing major surgery. One of our important goals was to assess the safety of AlterG. We noted no AEs attributable to the device, which was supported by work indicating no adverse impact on systemic cardiovascular parameters in a similar lower body positive-pressure environment.9 Although 3 patients (10%) developed symptomatic DVT, there were no differences between the groups in the incidence of DVT. Use of an anti-gravity treadmill has also been examined for cardiovascular responses in TKA patients. In a study of 24 adults with TKA, researchers found that anti-gravity support allowed TKA patients to walk at faster speeds and tolerate greater inclines with lower heart rate, blood pressure, and oxygen consumption.21 With respect to efficacy of the rehabilitation intervention, we demonstrated significant improvements in all functional outcomes in both groups but no differences between the study groups. We concluded that AlterG was at least as effective as standard therapy in this small cohort. TKA is a very successful procedure, and the improvement in pain and function after surgery is fairly dramatic in most patients, regardless of specific rehabilitation protocols. Therefore, the substantial improvement in clinical outcomes may overshadow any enhanced benefits of the anti-gravity treadmill. Further investigations into the efficacy of AlterG are needed in a larger cohort to determine if this type of treatment is more beneficial than traditional land-based gait training.

Standard scoring systems such as KOOS, TUG, and NRS may not be sensitive enough to detect differences between treatment groups with small sample sizes. Given the results of the post hoc power analysis, a large number of patients (N = 250/group) would be necessary to detect any potential difference in clinical outcomes between the 2 groups. Larger studies are required to answer relevant questions, and additional outcome measures may be needed to detect differences between treatment groups. Relevant questions include whether earlier institution of the anti-gravity device during the immediate TKA postoperative period would be beneficial compared to standard postoperative PT, and whether PT enhanced with the anti-gravity device has incremental benefit in functional outcomes and in time to reach those goals. Finally, given the present attention to healthcare expenses, a cost-benefit analysis of anti-gravity device treatment vs traditional PT would be useful. Once the patient has become familiar with the function of an anti-gravity treadmill, gait therapy could proceed without the direct intervention of the therapist, potentially improving efficient delivery of rehabilitation services.

Studying the effect of different postoperative rehabilitation protocols after orthopedic surgeries can be challenging. In a large (N > 350) randomized controlled trial to study the effect of ergometer cycling after hip and knee replacement, patients who used the cycle ergometer had a higher Western Ontario and McMaster Universities Arthritis Index and greater satisfaction than those who did not after hip arthroplasty, but not after TKA.22 Improvements in muscular coordination and proprioception with the cycle ergometer may have been offset by increases in edema, joint effusion, and pain from the loading of the joint and the relatively fast rate of cycling compared to passive motion or ambulation. While many therapists and surgeons advocate cycling for rehabilitation after knee surgery, the need remains for a better definition of an optimal TKA rehabilitation program. A study of 82 patients comparing early progressive strength training to no early strength training showed no difference in the 6-minute walk test at 8 weeks.23 A systematic review of progressive resistance training (PRT) found that although postoperative PRT is safe and feasible, the methodological quality of existing studies is too low to allow conclusions regarding its efficacy.24 Gait training in an environment where weight-bearing loads can be closely controlled, monitored, and individualized may be an ideal methodology to enhance rehabilitation and return to function for knee replacement surgery.

This current study showed that the use of AlterG as an adjunct for postoperative rehabilitation is safe, accepted by patients and therapists, and leads to clinical functional outcomes that are at least as good as traditional postoperative TKA rehabilitation. We conclude that AlterG demonstrates utility and a potential for innovation in TKA rehabilitation.

Patients undergoing total knee arthroplasty (TKA) may benefit from focused postoperative rehabilitation. Although there is limited research comparing different rehabilitation protocols after TKA,1 any type of rehabilitation often helps to optimize range of motion (ROM), strength, balance, and ambulation.2 Early mobilization and rehabilitation after TKA reduces pain, fear, anxiety, and risk of postoperative venous thromboembolic disease.3 Earlier discharge to home or community settings deceases time for inpatient rehabilitation, patient and family education, and gait training, which places a greater emphasis on outpatient rehabilitation.4

Although rapid rehabilitation protocols have gained wide acceptance, concern remains that a higher intensity intervention initiated immediately after hospital discharge could lead to an increased incidence of pain and swelling, and to poorer ROM and functional outcomes.5 Progressive weight-bearing activities, such as walking, are routinely recommended during rehabilitation to facilitate return to normal function. Not all patients are capable of full weight-bearing activity in the early postoperative period and assistive devices (ADs), such as walkers, crutches, and canes, are routinely employed. An opportunity to enhance early TKA rehabilitation exists with devices that allow functional gait training while modifying weight-bearing forces across the joint. Assistive devices, hydrotherapy (walking in water),6,7 and lower body positive-pressure chambers8 can reduce the forces at the knee during weight-bearing exercise.

Lower body positive-pressure devices have been extensively studied in physiological response of healthy humans;9-12 in disease states such as cerebral palsy13 and obesity;14 and in other postoperative orthopedic conditions, such as anterior cruciate ligament reconstruction, meniscectomy,8 microfracture,15 TKA,16 and Achilles tendon repair.17 These studies demonstrate that a lower body positive-pressure treadmill is associated with minimal cardiovascular effect while producing a significant decrease in ground reaction forces without altering gait kinematics.

We postulated that an anti-gravity treadmill may be safe and effective for gait training during rehabilitation following TKA. The primary objective was to determine the safety and feasibility of using the AlterG® Anti-Gravity Treadmill® device for postoperative gait training during rehabilitation following TKA. The secondary objective was to determine the effects of gait training (land-based vs anti-gravity) during postoperative rehabilitation on subjective patient outcomes assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), mobility assessed by the Timed Up and Go test (TUG), and pain assessed by a Numerical Rating Scale (NRS) to conduct a power analysis to determine sample sizes for efficacy studies based on these preliminary findings.

MethodsParticipants/Patient Enrollment and Study Overview

After signing an Institutional Review Board-approved consent, 30 patients were enrolled, and TKA surgeries were performed by 1 of 5 surgeons at 1 hospital. To be enrolled in the study, subjects must have (1) had a unilateral primary TKA, (2) been discharged from the hospital to home (not to a skilled nursing facility), (3) had only 3 to 4 home physical therapy (PT) sessions, (4) agreed to further outpatient PT at a single site, and (5) agreed to complete patient questionnaires. Exclusion criteria included (1) inability to meet inclusion criteria, (2) gross musculoskeletal deformity, (3) uncontrolled chronic or systemic disease, and (4) inability to follow instructions because of mental impairment, substance abuse, or addiction. Home PT was conducted for 3 to 4 sessions after surgery, and outpatient PT was continued at the study site per protocol for 4 weeks; subjects were asked to return for follow-up 3 months postoperatively. Patients were randomized on the first day of their outpatient PT to either a land-based (control) or an anti-gravity-based group using the AlterG Anti-Gravity Treadmill (AlterG group) gait training during outpatient PT sessions. Patients attended outpatient PT 2 days per week for 4 weeks for a total of 8 sessions. Therapy sessions lasted 45 to 60 minutes and included manual therapy, gait training, and therapeutic exercises/activities. The KOOS18,19 and TUG20 scores were evaluated at baseline (ie, first therapy session), end of physical therapy (EOPT) (ie, at final therapy session), and end of study (EOS) (ie, 3 months postoperatively). The NRS for pain was evaluated at baseline and at EOPT. Physical therapists were questioned for satisfaction with the anti-gravity rehabilitation protocol at EOPT.

Physical Therapy Protocols

All patients were treated consistently by 1 of 5 physical therapists at 1 outpatient setting; physical therapists averaged 11 years of experience in treating orthopedic conditions. Care was delivered in accordance with professional standards and the therapist’s assessment of medical necessity. Considerations included, but were not limited to, overall general health, any medical comorbidity, support system, and an ongoing assessment of ROM, strength, pain, and functional status. Each PT session started with a 5- to 10-minute warm-up on a standard cycle ergometer and was followed by manual therapy, gait training (land-based vs anti-gravity), therapeutic exercises/activities, and treatment modalities.

 

 

The time spent, activities selected, and modalities or physical agents chosen during the PT session were based on the patient’s needs and progress toward his/her functional goals. Manual therapy techniques consisted of soft-tissue mobilization, passive ROM, joint mobilization, passive stretching, scar mobilization, manual resistive exercises, and proprioceptive neuromuscular facilitation techniques. Therapeutic exercises/activities consisted of lower extremity resistance exercises (weight bearing and non-weight bearing), ROM exercises, stretching, balance, stair training, agility, activities of daily life (ADL) training, and a comprehensive home exercise program. Modalities or physical agents used during this study included moist hot packs, cold packs, ultrasound, electrical stimulation, and Kinesio Tape. Physical agents were incorporated into the individual’s plan of care based on medical necessity when deemed appropriate by the treating therapist. The exercise prescription was based on an individual’s status and tolerance and the number of sets and repetitions were based on fatigue.

Gait Training

The patients were randomized (1:1) to either land-based or anti-gravity gait training. For the control group, land-based gait training was performed with or without an appropriate AD and appropriate assistance, tactile cueing, and verbal cueing from a physical therapist. Duration (minutes) and gait-training progression were dependent on the participant’s functional goals, pain level (assessed throughout treatment), and level of fatigue. For the AlterG group, gait training was performed in the AlterG Anti-Gravity Treadmill, M320 (Alter-G; Figure 1). On day 1, the AlterG pressure chamber was set to allow only 50% of the patient’s body weight to be transmitted to the treadmill floor, and speed was controlled by the patient according to his/her comfort level. The percentage of body weight was adjusted to allow for a safe and normalized gait pattern with a pain level no greater than 5 (0 to 10 scale) throughout the PT session. A report card was recorded at each PT session, including body-weight setting (%), speed (miles per hour), incline (%), and duration (minutes) (Figure 2). For subsequent visits, the body-weight setting was started from the end point of the previous session.

 

Data Collection and Analysis

SPSS version 12.0 (SPSS Inc.) was used for all analyses, and an alpha level of .05 determined statistical significance when comparing group differences. The safety and feasibility of the anti-gravity (AlterG) vs land-based (control) gait training was assessed by the presence (or absence) of adverse events (AEs) and complications, and the date the patient discontinued use of his/her AD. A chi-square test was used to assess differences between control and AlterG groups regarding patient discontinuance of an AD. Additionally, for patients randomized to AlterG, a report card summarized means and frequencies for body weight, speed, incline, and duration. At EOPT, the frequency of therapists who were satisfied with the AlterG Anti-Gravity Treadmill as part of the rehabilitation protocol was reported. The preliminary effects of gait training (land-based vs anti-gravity) during postoperative rehabilitation on functional outcomes (subjective patient outcomes assessed by KOOS, mobility assessed by the TUG test, and pain assessed by a NRS) were evaluated by independent sample t tests. Paired sample t tests were used to compare each of the functional outcomes at EOPT or EOS to the baseline value.

Results

Of the 30 patients enrolled, 29 (96.7%; 29/30) patients completed the study; 1 patient, who could not complete all PT sessions because of medical and transportation issues, was excluded. The remaining 29 patients comprised the study population (control = 15; AlterG = 14). All patients were compliant with PT protocols.

Patient demographics were similar between the control and AlterG groups (Table 1). The control group comprised 9 women (60%; 9/15) and 6 men (40%; 6/15), age 69.9 ± 7.8 years and a body mass index of 28.8 ± 4.2. Similarly, the AlterG group comprised 7 women (50%; 7/14) and 7 men (50%; 7/14), age 66.5 ± 7.8 years and a body mass index of 28.4 ± 5.2.

At the baseline PT visit, patients in the control and AlterG groups had similar KOOS, TUG, and NRS scores. At baseline, mean KOOS for symptoms, pain, sports/recreation, ADL, and quality of life were 52.7, 52.9, 22.7, 64, and 31.8, respectively, although 50% of patients did not complete the sports/recreation subset of the KOOS. In addition, the mean time to complete the TUG test was 14.5 seconds, which was within the normal limits for disabled patients. This was slightly longer than normal mobility (TUG <10 seconds),20 but patients had relatively low levels of pain (mean NRS = 2.5, on a scale of 0-11).

All patients completed the PT protocols without indication of injury or AEs related to their operative knee. Three patients (10.3%; 3/29) experienced a deep venous thromboembolism (DVT), 2 in the control group (13.3%; 2/15), and 1 in the AlterG group (7.1%; 1/14). Venous thromboembolism protocol of enoxaparin 30 mg twice daily while in the hospital and enoxaparin 40 mg once daily for 10 days after discharge was followed for all patients.

 

 

Overall, more than half of patients (55.2%; 16/29) discontinued their AD during the 4-week PT period, with the remaining discontinuing prior to EOPT (24.1%; 7/29) or after EOPT (20.7%; 6/29). No statistically significant differences were found between the control and AlterG groups regarding discontinuance of AD.

Among those randomized to the AlterG group, all patients performed within the protocol established for the device for body-weight setting, treadmill speed, and duration of walking. The average body-weight treadmill setting increased by ~30% over the treatment period, from 55% at baseline to 84% at EOPT. The average speed increased by ~70%, from 1.6 mph at baseline to 2.7 mph at EOPT. The mean duration of AlterG use increased by ~75%, from 7.2 minutes at baseline to 12.7 minutes at EOPT. All physical therapists (100%) reported satisfaction with the AlterG for use in early postoperative rehabilitation and reported that patients’ treatment progressed positively.

While functional outcomes (KOOS, TUG, or NRS) did not vary with the type of gait training (P > .2 for land-based vs anti-gravity), functional outcomes improved over time (all P < .01 from baseline to EOPT and all P < .01 from baseline to EOS).

The KOOS scores improved from baseline to EOPT and from baseline to EOS (ie, 3-month follow-up visit) for both treatment groups (Figure 3). More patients completed the sports/recreation portion of the KOOS scores at EOPT and EOS compared to baseline. Forty-three percent and 25% of patients did not complete KOOS sports/recreation questions at EOPT and EOS, respectively, compared to 50% at baseline. This suggests that patients were improving to a level where sports/recreation scores were more applicable than directly after TKA surgery. The TUG scores had the greatest improvement from baseline to EOPT, with a decrease in time of 5 seconds and 7 seconds for the control and AlterG groups, respectively, and slight improvement from EOPT to EOS, with a decrease in time of 1 second and 2 seconds for the control and AlterG groups, respectively (Table 2). By the EOS, the values for the TUG tests for both treatment groups were within normal (<10 seconds) range.20 The NRS scores improved from baseline to EOPT with a score of 1 ± 1 in both control and AlterG groups.

 

Using these preliminary efficacy results, a post-hoc power analysis (α = .05 and 1β = 80%) was performed with the ADL domain of KOOS as the primary endpoint. Based on a standard deviation of 20 points and an effect size of 5 points, the sample size was estimated to be N = 250 per treatment group.

Discussion

We conducted a pilot study to assess, primarily, the feasibility and safety, and, secondarily, the efficacy, of a lower body positive-pressure treadmill for rehabilitation of patients after TKA. This small study showed that use of the AlterG Anti-Gravity Treadmill was not only safe and feasible during postoperative TKA rehabilitation, but also was well tolerated by patients and was rated highly satisfactory by physical therapists. Patients who used AlterG during gait training improved functionally (in terms of KOOS, TUG, and NRS) after 8 treatment sessions compared to baseline. However, there were no statistical differences between groups (control vs AlterG). Thus, these results suggest that an anti-gravity device for gait training may be a useful adjunct for postoperative TKA rehabilitation, but further studies are needed to determine the efficacy of anti-gravity compared to traditional land-based gait training.

The study of rehabilitation protocols during postoperative PT involved consideration of a number of issues. First, differences in functional outcomes compared to traditional rehabilitation could not be detected in this study because of the small number of patients, but the patients treated with anti-gravity gait training showed improvement in functional outcomes over time and did not report any added complications. Given that the primary outcome of this study was safety and feasibility, these added efficacy results are supplemental and useful in helping to plan studies. Second, the functional outcomes used to measure the efficacy of the anti-gravity treadmill may not be sensitive enough to detect differences between rehabilitation protocols. Use of a treadmill to measure speed improvement, endurance, and tolerance in both groups could be valuable in future studies. More studies may need to refine characteristics that are important to postoperative rehabilitation success, and quantitative and subjective measures that must be defined.

The results reported here using an anti-gravity treadmill for postoperative TKA rehabilitation support the safety and feasibility that has been reported in other orthopedic rehabilitation settings. Anti-gravity treadmills, which have been used to study patients after meniscectomy or anterior cruciate ligament reconstruction8 and Achilles repair,17 have demonstrated predictable decreases in ground reaction forces with increasing positive-pressure unweighting, reductions in pain with ambulation, and allowance of earlier institution of walking and jogging during rehabilitation.17

 

 

Patient safety is an important attribute for any postoperative rehabilitation protocol, especially in an elderly population undergoing major surgery. One of our important goals was to assess the safety of AlterG. We noted no AEs attributable to the device, which was supported by work indicating no adverse impact on systemic cardiovascular parameters in a similar lower body positive-pressure environment.9 Although 3 patients (10%) developed symptomatic DVT, there were no differences between the groups in the incidence of DVT. Use of an anti-gravity treadmill has also been examined for cardiovascular responses in TKA patients. In a study of 24 adults with TKA, researchers found that anti-gravity support allowed TKA patients to walk at faster speeds and tolerate greater inclines with lower heart rate, blood pressure, and oxygen consumption.21 With respect to efficacy of the rehabilitation intervention, we demonstrated significant improvements in all functional outcomes in both groups but no differences between the study groups. We concluded that AlterG was at least as effective as standard therapy in this small cohort. TKA is a very successful procedure, and the improvement in pain and function after surgery is fairly dramatic in most patients, regardless of specific rehabilitation protocols. Therefore, the substantial improvement in clinical outcomes may overshadow any enhanced benefits of the anti-gravity treadmill. Further investigations into the efficacy of AlterG are needed in a larger cohort to determine if this type of treatment is more beneficial than traditional land-based gait training.

Standard scoring systems such as KOOS, TUG, and NRS may not be sensitive enough to detect differences between treatment groups with small sample sizes. Given the results of the post hoc power analysis, a large number of patients (N = 250/group) would be necessary to detect any potential difference in clinical outcomes between the 2 groups. Larger studies are required to answer relevant questions, and additional outcome measures may be needed to detect differences between treatment groups. Relevant questions include whether earlier institution of the anti-gravity device during the immediate TKA postoperative period would be beneficial compared to standard postoperative PT, and whether PT enhanced with the anti-gravity device has incremental benefit in functional outcomes and in time to reach those goals. Finally, given the present attention to healthcare expenses, a cost-benefit analysis of anti-gravity device treatment vs traditional PT would be useful. Once the patient has become familiar with the function of an anti-gravity treadmill, gait therapy could proceed without the direct intervention of the therapist, potentially improving efficient delivery of rehabilitation services.

Studying the effect of different postoperative rehabilitation protocols after orthopedic surgeries can be challenging. In a large (N > 350) randomized controlled trial to study the effect of ergometer cycling after hip and knee replacement, patients who used the cycle ergometer had a higher Western Ontario and McMaster Universities Arthritis Index and greater satisfaction than those who did not after hip arthroplasty, but not after TKA.22 Improvements in muscular coordination and proprioception with the cycle ergometer may have been offset by increases in edema, joint effusion, and pain from the loading of the joint and the relatively fast rate of cycling compared to passive motion or ambulation. While many therapists and surgeons advocate cycling for rehabilitation after knee surgery, the need remains for a better definition of an optimal TKA rehabilitation program. A study of 82 patients comparing early progressive strength training to no early strength training showed no difference in the 6-minute walk test at 8 weeks.23 A systematic review of progressive resistance training (PRT) found that although postoperative PRT is safe and feasible, the methodological quality of existing studies is too low to allow conclusions regarding its efficacy.24 Gait training in an environment where weight-bearing loads can be closely controlled, monitored, and individualized may be an ideal methodology to enhance rehabilitation and return to function for knee replacement surgery.

This current study showed that the use of AlterG as an adjunct for postoperative rehabilitation is safe, accepted by patients and therapists, and leads to clinical functional outcomes that are at least as good as traditional postoperative TKA rehabilitation. We conclude that AlterG demonstrates utility and a potential for innovation in TKA rehabilitation.

References

1.    NIH Consensus Statement on total knee arthroplasty. NIH Consensus State Sci Statements. 2003;20(1):1-34.

2.    Jones CA, Voaklander DC, Suarez-Almazor ME. Determinants of function after total knee arthroplasty. Phys Ther. 2003;83(8):696-706.

3.    Pearse EO, Caldwell BF, Lockwood RJ, Hollard J. Early mobilisation after conventional knee replacement may reduce the risk of post-operative venous thromboembolism. J Bone Joint Surg Br. 2007;89(3):316-322.

4.    Westby MD, Kennedy D, Jones D, Jones A, Doyle-Waters MM, Backman C. Post-acute physiotherapy for primary total knee arthroplasty. Cochrane Database Syst Rev. 2008. doi.10.1002/14651858.CD007099

5.    Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011;41(12):932-941.

6.    Ivanenko YP, Grasso R, Macellari V, Lacquaniti F. Control of foot trajectory in human locomotion: role of ground contact forces in simulated reduced gravity. J Neurophysiol. 2002;87(6):3070-3089.

7.    Pöyhönen T, Keskinen KL, Kyröläinen H, Hautala A, Savolainen J, Mälkiä E. Neuromuscular function during therapeutic knee exercise under water and on dry land. Arch Phys Med Rehabil. 2001;82(10):1446-1452.

8.    Eastlack RK, Hargens AR, Groppo ER, Steinbach GC, White KK, Pedowitz RA. Lower body positive-pressure exercise after knee surgery. Clin Orthop Rel Res. 2005;431:213-219.

9.    Cutuk A, Groppo ER, Quigley EJ, White KW, Pedowitz RA, Hargens AR. Ambulation in simulated fractional gravity using lower body positive pressure: cardiovascular safety and gait analyses. J Appl Physiol. 2006;101(3):771-777.

10.   Gojanovic B, Cutti P, Shultz R, Matheson GO. Maximal physiological parameters during partial body-weight support treadmill testing. Med Sci Sports Exerc. 2012;44(10):1935-1941.

11.  Figueroa MA, Manning J, Escamilla P. Physiological responses to the AlterG Anti-Gravity Treadmill. Int J Applied Sci Tech. 2011;1:92-97.

12.  Hoffman MD, Donaghe HE. Physiological responses to body weight-supported treadmill exercise in healthy adults. Arch Phys Med Rehabil. 2011;92(6):960-966.

13.  Kurz MJ, Corr B, Stuberg W, Volkman KG, Smith N. Evaluation of lower body positive pressure supported treadmill training for children with cerebral palsy. Pediatr Phys Ther. 2011;23(3):232-239.

14.  Christian M. Managing knee osteoarthritis: the effects of anti-gravity treadmill exercise on joint pain and physical function. Available at: http://mspace.lib.umanitoba.ca/handle/1993/8580. Accessed March 31, 2016.

15.  Wilk KE, Macrina LC, Reinhold MM. Rehabilitation following microfracture of the knee. Cartilage. 2010;1(2):96-107.

16.  Patil SS, Branovacki G, Martin MR, Pulido PA, Levy YD, Colwell CW Jr. 14-year median follow-up using the press-fit condylar sigma design for total knee arthroplasty. J Arthroplasty. 2013;28(8):1286-1290.

17.  Saxena A, Granot A. Use of an anti-gravity treadmill in the rehabilitation of the operated achilles tendon: a pilot study. J Foot Ankle Surg. 2011;50(5):558-561.

18.   Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version. Scand J Med Sci Sports. 1998;8(6):439-448.

19.  Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17.

20.  Timed Up and Go (TUG). Available at: http://www.rheumatology.org/I-Am-A/Rheumatologist/Research/Clinician-Researchers/Timed-Up-Go-TUG Accessed: March 15, 2016.

21.  Webber SC, Horvey KJ, Yurach Pikaluk MT, Butcher SJ. Cardiovascular responses in older adults with total knee arthroplasty at rest and with exercise on a positive pressure treadmill. Eur J Appl Physiol. 2014;114(3):653-662.

22.  Liebs TR, Herzberg W, Ruther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip and knee replacement surgery: a randomized control trial. J Bone Joint Surg Am. 2010;92(4):814-822.

23.  Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res. 2014;66(12):1856-1866.

24.  Skoffer B, Dalgas U, Mechlenburg I. Progressive resistance training before and after total hip and knee arthroplasty: a systematic review. Clin Rehabil. 2015;29(1):14-29.

References

1.    NIH Consensus Statement on total knee arthroplasty. NIH Consensus State Sci Statements. 2003;20(1):1-34.

2.    Jones CA, Voaklander DC, Suarez-Almazor ME. Determinants of function after total knee arthroplasty. Phys Ther. 2003;83(8):696-706.

3.    Pearse EO, Caldwell BF, Lockwood RJ, Hollard J. Early mobilisation after conventional knee replacement may reduce the risk of post-operative venous thromboembolism. J Bone Joint Surg Br. 2007;89(3):316-322.

4.    Westby MD, Kennedy D, Jones D, Jones A, Doyle-Waters MM, Backman C. Post-acute physiotherapy for primary total knee arthroplasty. Cochrane Database Syst Rev. 2008. doi.10.1002/14651858.CD007099

5.    Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011;41(12):932-941.

6.    Ivanenko YP, Grasso R, Macellari V, Lacquaniti F. Control of foot trajectory in human locomotion: role of ground contact forces in simulated reduced gravity. J Neurophysiol. 2002;87(6):3070-3089.

7.    Pöyhönen T, Keskinen KL, Kyröläinen H, Hautala A, Savolainen J, Mälkiä E. Neuromuscular function during therapeutic knee exercise under water and on dry land. Arch Phys Med Rehabil. 2001;82(10):1446-1452.

8.    Eastlack RK, Hargens AR, Groppo ER, Steinbach GC, White KK, Pedowitz RA. Lower body positive-pressure exercise after knee surgery. Clin Orthop Rel Res. 2005;431:213-219.

9.    Cutuk A, Groppo ER, Quigley EJ, White KW, Pedowitz RA, Hargens AR. Ambulation in simulated fractional gravity using lower body positive pressure: cardiovascular safety and gait analyses. J Appl Physiol. 2006;101(3):771-777.

10.   Gojanovic B, Cutti P, Shultz R, Matheson GO. Maximal physiological parameters during partial body-weight support treadmill testing. Med Sci Sports Exerc. 2012;44(10):1935-1941.

11.  Figueroa MA, Manning J, Escamilla P. Physiological responses to the AlterG Anti-Gravity Treadmill. Int J Applied Sci Tech. 2011;1:92-97.

12.  Hoffman MD, Donaghe HE. Physiological responses to body weight-supported treadmill exercise in healthy adults. Arch Phys Med Rehabil. 2011;92(6):960-966.

13.  Kurz MJ, Corr B, Stuberg W, Volkman KG, Smith N. Evaluation of lower body positive pressure supported treadmill training for children with cerebral palsy. Pediatr Phys Ther. 2011;23(3):232-239.

14.  Christian M. Managing knee osteoarthritis: the effects of anti-gravity treadmill exercise on joint pain and physical function. Available at: http://mspace.lib.umanitoba.ca/handle/1993/8580. Accessed March 31, 2016.

15.  Wilk KE, Macrina LC, Reinhold MM. Rehabilitation following microfracture of the knee. Cartilage. 2010;1(2):96-107.

16.  Patil SS, Branovacki G, Martin MR, Pulido PA, Levy YD, Colwell CW Jr. 14-year median follow-up using the press-fit condylar sigma design for total knee arthroplasty. J Arthroplasty. 2013;28(8):1286-1290.

17.  Saxena A, Granot A. Use of an anti-gravity treadmill in the rehabilitation of the operated achilles tendon: a pilot study. J Foot Ankle Surg. 2011;50(5):558-561.

18.   Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version. Scand J Med Sci Sports. 1998;8(6):439-448.

19.  Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1:17.

20.  Timed Up and Go (TUG). Available at: http://www.rheumatology.org/I-Am-A/Rheumatologist/Research/Clinician-Researchers/Timed-Up-Go-TUG Accessed: March 15, 2016.

21.  Webber SC, Horvey KJ, Yurach Pikaluk MT, Butcher SJ. Cardiovascular responses in older adults with total knee arthroplasty at rest and with exercise on a positive pressure treadmill. Eur J Appl Physiol. 2014;114(3):653-662.

22.  Liebs TR, Herzberg W, Ruther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip and knee replacement surgery: a randomized control trial. J Bone Joint Surg Am. 2010;92(4):814-822.

23.  Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res. 2014;66(12):1856-1866.

24.  Skoffer B, Dalgas U, Mechlenburg I. Progressive resistance training before and after total hip and knee arthroplasty: a systematic review. Clin Rehabil. 2015;29(1):14-29.

Issue
The American Journal of Orthopedics - 45(4)
Issue
The American Journal of Orthopedics - 45(4)
Page Number
E167-E173
Page Number
E167-E173
Publications
Publications
Topics
Article Type
Display Headline
Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility
Display Headline
Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility
Legacy Keywords
anti-gravity, gravity, knee, knee replacement, replacement, rehabilitation, treadmill, total knee arthroplasty, TKA, physical therapy, study, bugbee, pulido, goldberg, d'lima
Legacy Keywords
anti-gravity, gravity, knee, knee replacement, replacement, rehabilitation, treadmill, total knee arthroplasty, TKA, physical therapy, study, bugbee, pulido, goldberg, d'lima
Sections
Article Source

PURLs Copyright

Inside the Article

Article PDF Media

Perspective on Opioid Prescribing

Article Type
Changed
Display Headline
The hospitalist perspective on opioid prescribing: A qualitative analysis

Pain is a frequent symptom among patients seen in the hospital.[1, 2, 3] Hospitalized patients often suffer before they come to the hospital and are commonly prescribed opioids in the months preceding their hospital stay.[4] Adequate pain control is important because uncontrolled pain is associated with higher levels of depression and anxiety among hospitalized patients.[5] In 2011, the Institute of Medicine called on healthcare providers to improve pain assessment and management in healthcare delivery.[6] Since then, pain management has become a key quality indicator for hospitals, and providers are encouraged to frequently assess and treat pain.[7, 8, 9, 10] Although the use of opioids for pain management among hospitalized patients is routine, the amount of opioids prescribed per patient varies widely between institutions.[11] In‐hospital guidelines for the optimal management of acute exacerbations of chronic pain are lacking.

Pain management also carries risks. Recently, the Centers for Disease Control and Prevention urged clinicians to prevent opioid overdoses by following best prescribing practices including screening patients for substance use disorders, mental health issues, and avoiding combinations of opioids and sedatives.[12, 13] These guidelines may be at odds with the priorities of current hospital care, which focus on patient‐perceived pain control rather than potential long‐term consequences of opioid use.[7, 8, 14] In light of the competing demands to provide adequate pain relief to hospitalized patients while optimally prescribing opioids, we sought to understand physicians' attitudes, beliefs, and experiences that inform opioid prescribing practices during hospitalization and at discharge.

METHODS

Study Design, Setting, and Participants

Between January 2015 and August 2015, we recruited a convenience sample via e‐mail solicitation from approximately 135 hospitalists practicing in Colorado and South Carolina.[15] Fifty‐three physicians responded. We conducted 25 in‐depth, semistructured interviews with physicians who represented the average hospitalist practicing in the United States in terms of years in practice and gender.[16] We enrolled physicians working in 4 distinct types of hospital settings, including 2 university hospitals, a safety‐net hospital, a Veterans Affairs hospital, and a private hospital. We used purposive sampling to achieve an even distribution with respect to gender and years in practice.[17] Interviews were either face‐to‐face (n = 16) or over the telephone (n = 9) and were performed outside of the physician's clinical shift. Informed consent was obtained from study participants, and the interview duration was approximately 1 hour. The study was approved by the Colorado Multiple Institutional Review Board.

Interview Guide Development and Content

Members of our multidisciplinary team (S.L.C., I.A.B., S.K.) developed an interview guide designed to explore hospitalists' attitudes and practices about opioid prescribing during hospitalization and at discharge (see Supporting Information, Appendix 1, in the online version of this article). Initial interview questions were developed with input from health sciences researchers (S.E.L., A.D.D., R.D.) and qualitative researchers (I.A.B., S.K.). During data collection, we occasionally edited or added questions to our guide to more fully explore new issues or information emerging from our interviews. Through open‐ended interviews, we sought to capture a qualitative narrative in which hospitalists would describe their attitudes and practices that may influence opioid prescribing within 3 major domains pertinent to clinical practice: patient factors,[18, 19, 20, 21, 22, 23] physician factors,[24, 25, 26, 27] and institutional factors.[27, 28, 29, 30, 31, 32] These domains were based on prior literature. All participants received a $25 gift card.

Data Analysis

Interview transcripts and a demographic survey were our primary data sources. Transcript files were entered into qualitative data analysis software (ATLAS.ti; Scientific Software Development GmbH, Berlin, Germany). We used a mixed inductive and deductive,[33] participatory, team‐based approach to explore patterns and themes related to attitudes and practices around opioid prescribing.[34, 35] A deductive or top‐down approach was used to link text to predefined codes and categories based on literature, prior knowledge, and our interview guide. An inductive or bottom‐up approach was used to identify new codes and categories that emerged from the data, including unanticipated information relevant to our research questions.

Team members included 2 hospitalists (S.L.C., A.D.D.), 2 research assistants with experience in qualitative methods (S.E.L., R.D.), an addiction medicine physician and researcher (I.A.B.), and a medical anthropologist (S.K.). S.L.C. performed initial coding using an a priori template that reflected the primary areas of interest in the study. The codes were categorized as patient, physician, and institutional factors. Using this template as a guide, 3 other team members (S.E.L., A.D.D., R.D.) independently coded 3 transcripts by assigning predefined codes to text and assigning new codes to emergent findings. Using this subset of 4 transcripts, the team reached a consensus on initial codes to be applied to the remaining transcripts. In weekly meetings, team members discussed and modified the codebook based on inconsistencies noted among team members to refine the coding scheme and to ensure consensus. Through group consensus, codes were condensed into a list of categories, subcategories, and emergent themes (ie, themes that did not originate from summarized answers to specific interview questions). The team identified emergent themes represented across all major domains (Table 1). Three of the most prevalent themes representing physicians' personal opioid prescribing practices are reported here. The study team determined that thematic saturation was reached after 25 interviews, as additional interview data created little change to the codebook and no new patterns or themes emerged.

A Complete List of Identified Emergent Themes With Hospitalist Physicians Regarding Opioid Prescribing Practices*
  • NOTE: *Discussed in the article.

Perceived success, satisfaction, comfort, and the use of opioids for pain management*
Professional experiences influenced opioid prescribing practices*
The use of opioids to improve efficiency*
Skepticism between other physician subspecialty types and opioid prescribing practices
Unintended consequences of patient‐perceived pain control metrics and opioid prescribing
Lack of trust with patients when reported pain level was not supported with objective data
Resident burnout contributed to a lack of empathy and undertreatment of pain
Limited perceived risk of personal opioid prescribing practices and patient overdose with short‐acting opioids
Unreal expectations by patients to have complete pain eradication contributes to overprescribing
Recognition that patient profiling impacts personal opioid‐prescribing practices

RESULTS

Of the 25 hospitalist participants who were all trained in internal medicine, 16 (64%) were women. The majority were non‐Hispanic white (21 [84%]). Nine physicians (36%) completed residency within the past 5 years, 12 (48%) completed residency within the past 5 to 10 years, and 4 (16%) completed residency >10 years ago. Sixteen (64%) hospitalists practiced medicine in Colorado, where 8 (32%) worked in a safety‐net hospital, 5 (20%) worked in a university hospital, and 3 (12%) worked in a Veterans Affairs hospital. Nine hospitalists (36%) practiced in South Carolina, where 2 (8%) worked in a university hospital and 7 (28%) worked in a private hospital (Table 2).

Participant Characteristics (N = 25)
Female, no. (%) 16 (64)
Race/ethnicity, no. (%)
White, non‐Hispanic 21 (84)
Asian, non‐Hispanic 4 (16)
Years postresidency, no. (%)
5 9 (36)
510 12 (48)
>10 4 (16)
State of practice, no. (%)
Colorado 16 (64)
South Carolina 9 (36)
Private hospital, no. (%) 7 (28)
Academic institution, no. (%)
Safety‐net hospital 8 (32)
Veteran Affairs hospital 3 (12)
University hospital 7 (28)

Emergent themes described here include: (1) hospitalists' perceived success, satisfaction, and comfort when prescribing opioids for their patients' pain management; (2) the influence of physicians' professional sentinel experiences on opioid prescribing practices; and (3) opioid prescribing as a tool to improve efficiency in the hospital. Additional quotations to support emergent themes are listed in Table 3.

Selected Emergent Themes With Illustrative Quotations
Theme Illustrative Quote
  • NOTE: Abbreviations: ER, emergency room; ERCPs, endoscopic retrograde cholangiopancreatographies.

Perceived success, satisfaction, comfort, and the use of opioids for pain management Acute pain: I'm more comfortable treating acute pain. With chronic pain, it depends on the circumstance. There are certain people who have objective reasons to have chronic pain, for instance they have severe degenerate disc disease, for example. With chronic painlet me just say, getting their pain under control is quite challenging. Acute pain is much more straight forward to treat.
Chronic pain; If I am treating an exacerbation of someone's chronic pain, it makes me a little less comfortable as far as sending people out on large doses of opioids because of the whole addiction thought behind it. And you don't want to start or feed people's addiction. Or, you know, lead them to it, in the future, requiring increased doses of opioids.
Chronic pain: I have a hard time feeling like I'm very successful with people who have chronic noncancer pain who come in for an exacerbation. Unless I can figure out clear reasons for that exacerbation, I feel I rarely succeed in having the patient, the providers, and the caregivers be happy. It is an unrewarding situation all around.
Chronic pain: I'm less comfortable treating chronic pain because we don't know the patients as well, I think, in the hospital, and you just worry about people abusing the system to get their needs met while they are in the hospital. We don't have much objective data in terms of assessing pain, and you know, they are on chronic narcotics, you don't really know what to believe, I guess.
Professional experiences that influenced opioid prescribing practices In the hospital: I had 1 horrible experience. I had a young woman who came in with chronic abdominal pain. She told me how much opioids she took. It was before there was a statewide database and I couldn't verify her doses. I gave her what she told me she was taking. I hadn't put a pulse ox on her which I always do now because it makes me feel better. Later the nurse called and said she wasn't responsive. I put her on Pulse Ox and she was sating 30% and blue. A code was called and we brought her back. That was in my mind for ever, I almost killed a 23 year old.
In the hospital: I think past experiences inform what I do now. I mean it's not that I've murdered anybody, but there was a time when I took over a patient and didn't realize that, while she had terrible pain from her restless leg syndrome, she also had severe pulmonary hypertension. I gave her 5 mg of oxycodone. She ended up somnolent with hypercarbic respiratory failure. I think that is something that will always stick in my head.
Discharge: When discussing what type of opioids prescribed at dischargeI worry about, not just deliberate diversion, but for the patient being robbed, for the type of opioid I might choose. So I might do oxycodone instead of Percocet. Percocet, itself, has a higher street value then oxycodone. That may be completely false, but I think of it as a name brand that people want.
Discharge: I think many providers, including myself, try to minimize the use of opiates when we can. I think we are all concerned every time we write, you know, our DEA #. Even when we have other providers ask us, you know, to prescribe opioids for their patients because they are out of the hospital or something like that, it is always a touchy subject. Because I think we all feel like our license is always at risk every time we are writing opioids.
Discharge: I give them what they need but I want them to be seen in follow‐up. I encourage that by giving them a shortened course. I'm more skeptical. I've seen people misuse, have bad side effects, and overdose on opioids. I worry about that, so I tend to prescribe shorter courses and less.
The use of opioids to improve efficiency There is always the group of patients [for whom] we've done everything we can. We set up follow‐up. If giving you a few days of Percocet is going to help you leave the hospital comfortably and stay out of the hospital for appropriate reasons, then we give them a few days. It's horrible but...
I'll give 4 or 6 weeks' worth of opioid medication to the chronic abdominal pain patients, the ones who have ERCPs scheduled for every 4 or 6 weeks. You sort of end up managing their chronic pain. It's the people that we know. If you don't give them a month's worth of pain meds, they are going to come back in to the hospital. Because they always come in when they run out.
I think physicians overprescribe opioids because we don't want people to bounce back to the hospital. We don't want them to have acute pain at home and have to go back to the ER to be readmitted. You don't want someone to be in pain. I think that sometimes people go overboard. I also think that sometimes physicians gauge like, oh, this person isn't a huge risk, and maybe give them more opioids than necessary.

Perceived Success, Satisfaction, and Comfort When Prescribing Opioids for Pain Management

Providing adequate pain control to their patients was of utmost importance to hospitalists and influenced opioid prescribing. Hospitalists felt confident in their ability to control acute pain using opioids, but notably perceived limited success in achieving adequate patient‐perceived pain control when treating acute exacerbations of chronic pain with opioids. A physician described his confidence in treating severe, acute pain:

If someone is dying of cancer, or if they have an acutely broken femur, I don't really care if they are actively in the 12‐Step Program or Narcotics Anonymous to stay sober. That pain is real and there is no effective pain medicine on earth except for opioids.

Managing exacerbations of chronic pain with increasing opioid doses left physicians feeling frustrated and uncomfortable, especially when they lacked objective findings to explain the reported pain. Physicians were concerned that, by increasing opioid doses, they may be contributing to opioid dependence or addiction. A physician explained his dilemma when treating chronic pain:

[I am uncomfortable treating] people that you classify with chronic pain syndrome. There is that terminology you use for people who have subjective pain, out of proportion to objective findings. In my experience it is a black hole. You never get an adequate level of pain control and you keep adding the doses up and they get habituated. An end point is very difficult to achieve. Not like with acute pain.

Hospitalists described awareness that patients' reports of pain management were part of the evaluation of their care, and expressed concern that these patient‐perceived pain control metrics for quality care were inappropriately applied to patients with chronic pain, and may even be unsafe. A physician explained his experience with chronic pain management among hospitalized patients:

All of these things you do for patient satisfaction set up people, who aren't ever going to be without pain, to fail. They have pain all the time, and now you are asking them about their pain. Well, of course their pain is not controlled, because their pain is never going to be less than 5 out of 10, period. And no opioid is going to get them there, unless they are unconscious.

Professional Experiences Influenced Opioid Prescribing Practices

Physicians reported little opioid‐specific training during residency, and so opioid prescribing practices were shaped by the physicians' clinical experiences. Hospitalists reflected on negative, sentinel events that shaped their opioid prescribing practices in the inpatient setting or led them to adopt risk‐modifying behaviors when prescribing opioids at hospital discharge. Negative experiences varied and included a fatal overdose and suspected diversion of opioids for sale. A physician reflected on an avoidable in‐hospital overdose which left her more guarded when prescribing opioids:

It is both your cumulative experience and, sometimes, when you've had a negative experience, it really biases how you think. I've had an experience where my patient actually overdosed. She crushed up the oxycodone we were giving her in the hospital and shot it up through her central line and died. We've all had experiences with opioids being abused. This just happened to be a very dramatic thing that happened right under my nose. It just makes me more guarded, in terms of my practice, and the lengths people will go through to do harm to themselves with opioids.

Hospitalists recognized that some of their patients had limited resources. They expressed suspicions that opioid prescriptions, in some cases, represented a form of currency for patients to supplement their income. A physician stated:

I think our population can divert quite a few meds. I think their financial situations can be really tenuous. Sometimes they sell pills to survive.

Physicians described past experiences with patients who were deceptive to get an opioid prescription, which left them much more reticent to prescribe the drugs. For example, a physician described how a patient altered her opioid prescription following hospital discharge:

I saw a patient who had her gallbladder removed. She asked for an opioid script until she could see her primary care physician, so I gave her a few days of opioids. I later found out she had forged my script and had changed it from 18 pills to 180 pills. She took it all over the state to try to fill. I got a call from the DEA [Drug Enforcement Administration] and had to write them a letter. I think she's in prison now.

These experiences inspired hospitalists to adopt strategies around opioid prescribing that would make it harder for a patient to misuse a prescription or to jeopardize their DEA license. A physician discussed her technique to prevent patients from selling their opioid prescriptions following discharge:

When I write the prescription, I put the name of the patient on the paper prescription with the patient's sticker on top. I don't want the patients to pull it off and sell the prescription, especially when it is my license.

Another physician described feeling reassured when she is able to verify a patient's opioid dose in a statewide prescription monitoring program:

Seeing they have filled opioids before supports your decision making. You just sort of cross your finger that this time my DEA number is not going to come up on the next drug bust!

The Use of Opioids to Improve Institutional Efficiency

Hospitalists felt institutional pressure to reduce hospital readmissions and to facilitate discharges. Pain was a common complaint among patients admitted to the hospital, and uncontrolled pain often prolonged a hospital stay. In these ways, physicians viewed opioid prescriptions as a tool to buffer against readmission or long hospital stays. A physician described his approach to more readily prescribed opioids when he felt it would prevent a patient from being rehospitalized:

If a patient tells you that they are in pain and they are receiving opioids in the hospital, and I have a strong sense that this is a person who comes back to the hospital easily and regularly if something is not right, I'm more likely to make sure that patient has adequate pain medicine for a reasonable duration of time to reduce the chance that they get readmitted just for pain alone.

Physicians used opioids as a tool to facilitate discharges and prevent readmissions; yet doing so sometimes left them feeling conflicted. On one hand, they felt pressured to maintain efficiency; on the other hand, they recognized it might not be in the patient's best interest to receive a higher than necessary quantity of opioids at discharge. A physician described his dilemma:

For the acute pain, I usually give them 15 to 20 [opioid pills]. For the chronics, maybe a little bit more like 30. A lot of them have told me they can just buy it off the street anyway. If we can help keep them out of the hospital, we are probably doing them a disservice [by prescribing more opioids], but we are also not clogging up our system.

Similarly, another hospitalist described opioid prescribing at discharge as a way to reduce hospital costs and prevent a readmission, despite feeling uncomfortable when a patient's diagnosis of pain was nebulous:

If the patient comes back and gets readmitted to the hospital when they don't have pain medicine, it's a $3,000.00, 2‐day stay in the hospital that was unnecessary. And when they have a prescription for a month of pain medicine, they stay out of the hospital. That is utterly pragmaticthere is no other way to do it and it's going to work. At other times, especially when a patient lacks a diagnosis which is known to cause pain, it can feel cheap and dirty.

DISCUSSION

To our knowledge, this is the first study to qualitatively explore the hospitalist perspective on opioid prescribing during hospitalization and at discharge. Hospitalists expressed discomfort and dissatisfaction when managing acute exacerbations of chronic pain with opioid medications. This stemmed from the discordance between the patients' expressed pain and the lack of objective clinical findings of pain, a perceived inability to adequately provide relief to patients with chronic pain, and a concern of contributing to future opioid dependence. Hospitalists identified negative professional experiences with opioid prescribing as a factor that influenced their opioid prescribing practices. Hospitalists also described using opioids as a tool to reduce readmissions and facilitate hospital discharges to contain healthcare costs. This sometimes left them feeling conflicted, especially when their patients lacked clear, pain‐related diagnoses.

Hospitalists were reluctant to increase patients' chronic opioid therapy doses, even when patients had acute exacerbations of chronic pain. Management of chronic pain presents a unique challenge to hospitalists. Existing clinical guidelines for chronic pain management are directed to the primary care physician.[36, 37] Acute exacerbations of chronic pain are commonly seen in hospitalized patients and should not be overlooked.[4] Management strategies that include in‐hospital, guideline‐based opioid dose adjustments are needed to address some of the concern hospitalists feel when managing chronic pain exacerbations. Involving the patient in the decision to temporarily increase their opioid dose may improve patient‐perceived pain control.[38] In addition, when possible, close communication between the hospitalist and the primary care physician may alleviate some of the uncertainty hospitalists feel when they prescribe an increased dose of chronic opioid therapy.[39, 40]

Opioid prescribing practices by hospitalists were influenced by past negative experiences. This principle, defined as negativity bias, refers to the notion that in most situations, negative events are more salient, potent, and dominant than positive events.[41, 42] Hospitalists recounted situations in which their patients overdosed on opioids in the hospital or forged an opioid prescription, which they perceived as jeopardizing their DEA licenses or reputations. They described concrete practice changes they made in an attempt to avoid these situations in the future. Whereas it is appropriate to critically assess practice behaviors that contribute to unanticipated patient outcomes, there may be unintended consequences when providers narrowly focus on the negative, including the undertreatment of pain. Focusing on successful outcomes associated with opioid prescribing, rather than negative outcomes, may lead to less restrictive and more thoughtful opioid prescribing practices. Furthermore, standardizing opioid prescribing to protect physicians from medicolegal consequences related to opioid diversion and fraud could lessen physicians' fears when prescribing opioids both during the hospitalization and at hospital discharge.

Hospitalists described prescribing opioids as a tool to improve efficiency in their practice, although at times it left them feeling conflicted. We interpreted this as a form of cognitive dissonance.[43] Hospitalists are acutely aware of the need to prevent costly hospital readmissions for their own success and longevity, which may lead them to become less judicious about how they prescribe opioids.[44, 45, 46] Our findings suggest a delicate balance between the potential benefits and drawbacks of using opioids to improve efficiency. Whereas it is important to provide pain relief to the patient, which can facilitate a discharge or delay time to next hospital admission, using opioids to smooth a difficult discharge may be detrimental to the patient. These findings highlight the competing pressures hospitalists face to deliver value‐based care[46, 47] while maintaining patient‐centered care.[48, 49]

This study has several limitations. First, qualitative data provide depth to the understanding of a behavior, but not breadth.[50, 51] Therefore, these results may not be generalizable to all hospitalists. We included a convenience sample of hospitalists who practiced in diverse settings including academic and private hospitals and the western and southern regions of the United States. The majority of the hospitalists interviewed had clinical experience less than 10 years. A national survey of hospitalists found the mean years of experience to be 6.9 years[16]; thus, the hospitalists we interviewed are likely representative of hospitalists nationally when considering clinical experience. Second, our interview guide was informed by prior literature and an a priori knowledge based on our experience as practicing hospitalist physicians. Interviews were conducted by 2 hospitalists who may have had similar experiences as those being described by the interviewees. Having shared experiences facilitated rapport and understating between the interviewers and participants; at the same time, however, shared experiences may have narrowed the focus of the interviews, eliminating themes that were already assumed. Lastly, hospitalists who chose to be interviewed may have participated because they felt strongly about the issues discussed and may not fully represent the population from which the sample was drawn.[15]

The development of evidence‐based strategies to promote optimal opioid prescribing for the management of acute exacerbations of chronic pain among hospitalized patients may benefit both hospital providers and patients who have a mutual goal for safe and effective pain relief. Methods to provide adequate pain relief to patients that allow hospitalists to maintain efficiency, while ensuring protection from medicolegal consequences related to opioid diversion or opioid overdose, are urgently needed.

Disclosures

This work was supported by the Denver Health Department of Medicine Small Grants Program, which was not involved in the design, conduct, or reporting of the study, or in the decision to submit the manuscript for publication. Dr. Binswanger was supported by the National Institute On Drug Abuse of the National Institutes of Health under award number R34DA035952. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors declare that they do not have any conflicts of interest.

Files
References
  1. Abbott FV, Gray‐Donald K, Sewitch MJ, Johnston CC, Edgar L, Jeans ME. The prevalence of pain in hospitalized patients and resolution over six months. Pain. 1992;50(1):1528.
  2. Marks RM, Sachar EJ. Undertreatment of medical inpatients with narcotic analgesics. Ann Intern Med. 1973;78(2):173181.
  3. Desbiens NA, Wu AW. Pain and suffering in seriously ill hospitalized patients. J Am Geriatr Soc. 2000;48(5 suppl):S183S186.
  4. Mosher HJ, Jiang L, Vaughan Sarrazin MS, Cram P, Kaboli PJ, Weg MW. Prevalence and characteristics of hospitalized adults on chronic opioid therapy. J Hosp Med. 2014;9(2):8287.
  5. Rockett MP, Simpson G, Crossley R, Blowey S. Characteristics of pain in hospitalized medical patients, surgical patients, and outpatients attending a pain management centre. Br J Anaesth. 2013;110(6):10171023.
  6. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academy of Sciences; 2011.
  7. Gupta A, Daigle S, Mojica J, Hurley RW. Patient perception of pain care in hospitals in the United States. J Pain Res. 2009;2:157164.
  8. Lanser P, Gesell S. Pain management: the fifth vital sign. Healthc Benchmarks. 2001;8(6):6870, 62.
  9. Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res. 2013;6:683689.
  10. Zgierska A, Rabago D, Miller MM. Impact of patient satisfaction ratings on physicians and clinical care. Patient Prefer Adherence. 2014;8:437446.
  11. Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid‐related adverse events in non‐surgical patients in U.S. hospitals. J Hosp Med. 2014;9(2):7381.
  12. Centers for Disease Control and Prevention. CDC grand rounds: prescription drug overdoses—a U.S. epidemic. MMWR Morb Mortal Wkly Rep. 2012;61(1):1013.
  13. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999–2010. MMWR Morb Mortal Wkly Rep. 2013;62(26):537542.
  14. Gupta A, Lee LK, Mojica JJ, Nairizi A, George SJ. Patient perception of pain care in the United States: a 5‐year comparative analysis of hospital consumer assessment of health care providers and systems. Pain Physician. 2014;17(5):369377.
  15. Cochran WG. Sampling Techniques. 3rd ed. New York, NY: Wiley; 1977.
  16. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  17. Patton MQ. Qualitative Evaluation and Research Methods. Thousand Oaks, CA: Sage; 1990.
  18. Fishbain DA, Cole B, Lewis J, Rosomoff HL, Rosomoff RS. What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug‐related behaviors? A structured evidence‐based review. Pain Med. 2008;9(4):444459.
  19. Manchikanti L, Cash KA, Damron KS, Manchukonda R, Pampati V, McManus CD. Controlled substance abuse and illicit drug use in chronic pain patients: an evaluation of multiple variables. Pain Physician. 2006;9(3):215225.
  20. Ives TJ, Chelminski PR, Hammett‐Stabler CA, et al. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006;6:46.
  21. Edlund MJ, Sullivan M, Steffick D, Harris KM, Wells KB. Do users of regularly prescribed opioids have higher rates of substance use problems than nonusers? Pain Med. 2007;8(8):647656.
  22. Silverberg MJ, Ray GT, Saunders K, et al. Prescription long‐term opioid use in HIV‐infected patients. Clin J Pain. 2012;28(1):3946.
  23. Green CR, Anderson KO, Baker TA, et al. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003;4(3):277294.
  24. Green CR, Wheeler JR, Marchant B, LaPorte F, Guerrero E. Analysis of the physician variable in pain management. Pain Med. 2001;2(4):317327.
  25. Hutchinson K, Moreland AM, de CWAC, Weinman J, Horne R. Exploring beliefs and practice of opioid prescribing for persistent non‐cancer pain by general practitioners. Eur J Pain. 2007;11(1):9398.
  26. Jamison RN, Sheehan KA, Scanlan E, Matthews M, Ross EL. Beliefs and attitudes about opioid prescribing and chronic pain management: survey of primary care providers. J Opioid Manag. 2014;10(6):375382.
  27. Nwokeji ED, Rascati KL, Brown CM, Eisenberg A. Influences of attitudes on family physicians' willingness to prescribe long‐acting opioid analgesics for patients with chronic nonmalignant pain. Clin Ther. 2007;29(suppl):25892602.
  28. Miller NS. Failure of enforcement controlled substance laws in health policy for prescribing opiate medications: a painful assessment of morbidity and mortality. Am J Ther. 2006;13(6):527533.
  29. Hoffmann DE, Tarzian AJ. Achieving the right balance in oversight of physician opioid prescribing for pain: the role of state medical boards. J Law Med Ethics. 2003;31(1):2140.
  30. Fishman SM, Papazian JS, Gonzalez S, Riches PS, Gilson A. Regulating opioid prescribing through prescription monitoring programs: balancing drug diversion and treatment of pain. Pain Med. 2004;5(3):309324.
  31. Miller J. The other side of trust in health care: prescribing drugs with the potential for abuse. Bioethics. 2007;21(1):5160.
  32. US Drug Enforcement Administration, Department of Justice. Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II. Fed Regist. 2014;79(163):4966149682.
  33. Fereday J, Muir‐Cochrane E. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods. 2008;5(1):8092.
  34. Bernard HR, Ryan GW. Analyzing Qualitative Data: Systematic Approaches. Thousand Oaks, CA: Sage; 2009.
  35. Patton MQ. Qualitative Research and Evaluation Methods, Third Edition. Thousand Oaks, CA: Sage; 2002.
  36. Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain—consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007;12(1):1321.
  37. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113130.
  38. Rao JK, Anderson LA, Inui TS, Frankel RM. Communication interventions make a difference in conversations between physicians and patients: a systematic review of the evidence. Med Care. 2007;45(4):340349.
  39. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314323.
  40. Sheu L, Fung K, Mourad M, Ranji S, Wu E. We need to talk: primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med. 2015;10(5):307310.
  41. Ito TA, Larsen JT, Smith NK, Cacioppo JT. Negative information weighs more heavily on the brain: the negativity bias in evaluative categorizations. J Pers Soc Psychol. 1998;75(4):887900.
  42. Carretie L, Mercado F, Tapia M, Hinojosa JA. Emotion, attention, and the ‘negativity bias’, studied through event‐related potentials. Int J Psychophysiol. 2001;41(1):7585.
  43. Harmon‐Jones E, Mills J. Cognitive Dissonance: Progress on a Pivotal Theory in Social Psychology. Washington, DC: American Psychological Association; 1999.
  44. Ahmad FS, Metlay JP, Barg FK, Henderson RR, Werner RM. Identifying hospital organizational strategies to reduce readmissions. Am J Med Qual. 2013;28(4):278285.
  45. Edwards PK, Levine M, Cullinan K, Newbern G, Barnes CL. Avoiding readmissions‐support systems required after discharge to continue rapid recovery? J Arthroplasty. 2015;30(4):527530.
  46. Elliott DJ, Young RS, Brice J, Aguiar R, Kolm P. Effect of hospitalist workload on the quality and efficiency of care. JAMA Intern Med. 2014;174(5):786793.
  47. Moriates C, Shah NT, Arora VM. A framework for the frontline: how hospitalists can improve healthcare value. J Hosp Med. 2016;11(4):297302.
  48. Chen LM, Birkmeyer JD, Saint S, Jha AK. Hospitalist staffing and patient satisfaction in the national Medicare population. J Hosp Med. 2013;8(3):126131.
  49. O'Leary KJ, Cyrus RM. Improving patient satisfaction: timely feedback to specific physicians is essential for success. J Hosp Med. 2015;10(8):555556.
  50. Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care B. What are the results and how do they help me care for my patients? Evidence‐Based Medicine Working Group. JAMA. 2000;284(4):478482.
  51. Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care A. Are the results of the study valid? Evidence‐Based Medicine Working Group. JAMA. 2000;284(3):357362.
Article PDF
Issue
Journal of Hospital Medicine - 11(8)
Page Number
536-542
Sections
Files
Files
Article PDF
Article PDF

Pain is a frequent symptom among patients seen in the hospital.[1, 2, 3] Hospitalized patients often suffer before they come to the hospital and are commonly prescribed opioids in the months preceding their hospital stay.[4] Adequate pain control is important because uncontrolled pain is associated with higher levels of depression and anxiety among hospitalized patients.[5] In 2011, the Institute of Medicine called on healthcare providers to improve pain assessment and management in healthcare delivery.[6] Since then, pain management has become a key quality indicator for hospitals, and providers are encouraged to frequently assess and treat pain.[7, 8, 9, 10] Although the use of opioids for pain management among hospitalized patients is routine, the amount of opioids prescribed per patient varies widely between institutions.[11] In‐hospital guidelines for the optimal management of acute exacerbations of chronic pain are lacking.

Pain management also carries risks. Recently, the Centers for Disease Control and Prevention urged clinicians to prevent opioid overdoses by following best prescribing practices including screening patients for substance use disorders, mental health issues, and avoiding combinations of opioids and sedatives.[12, 13] These guidelines may be at odds with the priorities of current hospital care, which focus on patient‐perceived pain control rather than potential long‐term consequences of opioid use.[7, 8, 14] In light of the competing demands to provide adequate pain relief to hospitalized patients while optimally prescribing opioids, we sought to understand physicians' attitudes, beliefs, and experiences that inform opioid prescribing practices during hospitalization and at discharge.

METHODS

Study Design, Setting, and Participants

Between January 2015 and August 2015, we recruited a convenience sample via e‐mail solicitation from approximately 135 hospitalists practicing in Colorado and South Carolina.[15] Fifty‐three physicians responded. We conducted 25 in‐depth, semistructured interviews with physicians who represented the average hospitalist practicing in the United States in terms of years in practice and gender.[16] We enrolled physicians working in 4 distinct types of hospital settings, including 2 university hospitals, a safety‐net hospital, a Veterans Affairs hospital, and a private hospital. We used purposive sampling to achieve an even distribution with respect to gender and years in practice.[17] Interviews were either face‐to‐face (n = 16) or over the telephone (n = 9) and were performed outside of the physician's clinical shift. Informed consent was obtained from study participants, and the interview duration was approximately 1 hour. The study was approved by the Colorado Multiple Institutional Review Board.

Interview Guide Development and Content

Members of our multidisciplinary team (S.L.C., I.A.B., S.K.) developed an interview guide designed to explore hospitalists' attitudes and practices about opioid prescribing during hospitalization and at discharge (see Supporting Information, Appendix 1, in the online version of this article). Initial interview questions were developed with input from health sciences researchers (S.E.L., A.D.D., R.D.) and qualitative researchers (I.A.B., S.K.). During data collection, we occasionally edited or added questions to our guide to more fully explore new issues or information emerging from our interviews. Through open‐ended interviews, we sought to capture a qualitative narrative in which hospitalists would describe their attitudes and practices that may influence opioid prescribing within 3 major domains pertinent to clinical practice: patient factors,[18, 19, 20, 21, 22, 23] physician factors,[24, 25, 26, 27] and institutional factors.[27, 28, 29, 30, 31, 32] These domains were based on prior literature. All participants received a $25 gift card.

Data Analysis

Interview transcripts and a demographic survey were our primary data sources. Transcript files were entered into qualitative data analysis software (ATLAS.ti; Scientific Software Development GmbH, Berlin, Germany). We used a mixed inductive and deductive,[33] participatory, team‐based approach to explore patterns and themes related to attitudes and practices around opioid prescribing.[34, 35] A deductive or top‐down approach was used to link text to predefined codes and categories based on literature, prior knowledge, and our interview guide. An inductive or bottom‐up approach was used to identify new codes and categories that emerged from the data, including unanticipated information relevant to our research questions.

Team members included 2 hospitalists (S.L.C., A.D.D.), 2 research assistants with experience in qualitative methods (S.E.L., R.D.), an addiction medicine physician and researcher (I.A.B.), and a medical anthropologist (S.K.). S.L.C. performed initial coding using an a priori template that reflected the primary areas of interest in the study. The codes were categorized as patient, physician, and institutional factors. Using this template as a guide, 3 other team members (S.E.L., A.D.D., R.D.) independently coded 3 transcripts by assigning predefined codes to text and assigning new codes to emergent findings. Using this subset of 4 transcripts, the team reached a consensus on initial codes to be applied to the remaining transcripts. In weekly meetings, team members discussed and modified the codebook based on inconsistencies noted among team members to refine the coding scheme and to ensure consensus. Through group consensus, codes were condensed into a list of categories, subcategories, and emergent themes (ie, themes that did not originate from summarized answers to specific interview questions). The team identified emergent themes represented across all major domains (Table 1). Three of the most prevalent themes representing physicians' personal opioid prescribing practices are reported here. The study team determined that thematic saturation was reached after 25 interviews, as additional interview data created little change to the codebook and no new patterns or themes emerged.

A Complete List of Identified Emergent Themes With Hospitalist Physicians Regarding Opioid Prescribing Practices*
  • NOTE: *Discussed in the article.

Perceived success, satisfaction, comfort, and the use of opioids for pain management*
Professional experiences influenced opioid prescribing practices*
The use of opioids to improve efficiency*
Skepticism between other physician subspecialty types and opioid prescribing practices
Unintended consequences of patient‐perceived pain control metrics and opioid prescribing
Lack of trust with patients when reported pain level was not supported with objective data
Resident burnout contributed to a lack of empathy and undertreatment of pain
Limited perceived risk of personal opioid prescribing practices and patient overdose with short‐acting opioids
Unreal expectations by patients to have complete pain eradication contributes to overprescribing
Recognition that patient profiling impacts personal opioid‐prescribing practices

RESULTS

Of the 25 hospitalist participants who were all trained in internal medicine, 16 (64%) were women. The majority were non‐Hispanic white (21 [84%]). Nine physicians (36%) completed residency within the past 5 years, 12 (48%) completed residency within the past 5 to 10 years, and 4 (16%) completed residency >10 years ago. Sixteen (64%) hospitalists practiced medicine in Colorado, where 8 (32%) worked in a safety‐net hospital, 5 (20%) worked in a university hospital, and 3 (12%) worked in a Veterans Affairs hospital. Nine hospitalists (36%) practiced in South Carolina, where 2 (8%) worked in a university hospital and 7 (28%) worked in a private hospital (Table 2).

Participant Characteristics (N = 25)
Female, no. (%) 16 (64)
Race/ethnicity, no. (%)
White, non‐Hispanic 21 (84)
Asian, non‐Hispanic 4 (16)
Years postresidency, no. (%)
5 9 (36)
510 12 (48)
>10 4 (16)
State of practice, no. (%)
Colorado 16 (64)
South Carolina 9 (36)
Private hospital, no. (%) 7 (28)
Academic institution, no. (%)
Safety‐net hospital 8 (32)
Veteran Affairs hospital 3 (12)
University hospital 7 (28)

Emergent themes described here include: (1) hospitalists' perceived success, satisfaction, and comfort when prescribing opioids for their patients' pain management; (2) the influence of physicians' professional sentinel experiences on opioid prescribing practices; and (3) opioid prescribing as a tool to improve efficiency in the hospital. Additional quotations to support emergent themes are listed in Table 3.

Selected Emergent Themes With Illustrative Quotations
Theme Illustrative Quote
  • NOTE: Abbreviations: ER, emergency room; ERCPs, endoscopic retrograde cholangiopancreatographies.

Perceived success, satisfaction, comfort, and the use of opioids for pain management Acute pain: I'm more comfortable treating acute pain. With chronic pain, it depends on the circumstance. There are certain people who have objective reasons to have chronic pain, for instance they have severe degenerate disc disease, for example. With chronic painlet me just say, getting their pain under control is quite challenging. Acute pain is much more straight forward to treat.
Chronic pain; If I am treating an exacerbation of someone's chronic pain, it makes me a little less comfortable as far as sending people out on large doses of opioids because of the whole addiction thought behind it. And you don't want to start or feed people's addiction. Or, you know, lead them to it, in the future, requiring increased doses of opioids.
Chronic pain: I have a hard time feeling like I'm very successful with people who have chronic noncancer pain who come in for an exacerbation. Unless I can figure out clear reasons for that exacerbation, I feel I rarely succeed in having the patient, the providers, and the caregivers be happy. It is an unrewarding situation all around.
Chronic pain: I'm less comfortable treating chronic pain because we don't know the patients as well, I think, in the hospital, and you just worry about people abusing the system to get their needs met while they are in the hospital. We don't have much objective data in terms of assessing pain, and you know, they are on chronic narcotics, you don't really know what to believe, I guess.
Professional experiences that influenced opioid prescribing practices In the hospital: I had 1 horrible experience. I had a young woman who came in with chronic abdominal pain. She told me how much opioids she took. It was before there was a statewide database and I couldn't verify her doses. I gave her what she told me she was taking. I hadn't put a pulse ox on her which I always do now because it makes me feel better. Later the nurse called and said she wasn't responsive. I put her on Pulse Ox and she was sating 30% and blue. A code was called and we brought her back. That was in my mind for ever, I almost killed a 23 year old.
In the hospital: I think past experiences inform what I do now. I mean it's not that I've murdered anybody, but there was a time when I took over a patient and didn't realize that, while she had terrible pain from her restless leg syndrome, she also had severe pulmonary hypertension. I gave her 5 mg of oxycodone. She ended up somnolent with hypercarbic respiratory failure. I think that is something that will always stick in my head.
Discharge: When discussing what type of opioids prescribed at dischargeI worry about, not just deliberate diversion, but for the patient being robbed, for the type of opioid I might choose. So I might do oxycodone instead of Percocet. Percocet, itself, has a higher street value then oxycodone. That may be completely false, but I think of it as a name brand that people want.
Discharge: I think many providers, including myself, try to minimize the use of opiates when we can. I think we are all concerned every time we write, you know, our DEA #. Even when we have other providers ask us, you know, to prescribe opioids for their patients because they are out of the hospital or something like that, it is always a touchy subject. Because I think we all feel like our license is always at risk every time we are writing opioids.
Discharge: I give them what they need but I want them to be seen in follow‐up. I encourage that by giving them a shortened course. I'm more skeptical. I've seen people misuse, have bad side effects, and overdose on opioids. I worry about that, so I tend to prescribe shorter courses and less.
The use of opioids to improve efficiency There is always the group of patients [for whom] we've done everything we can. We set up follow‐up. If giving you a few days of Percocet is going to help you leave the hospital comfortably and stay out of the hospital for appropriate reasons, then we give them a few days. It's horrible but...
I'll give 4 or 6 weeks' worth of opioid medication to the chronic abdominal pain patients, the ones who have ERCPs scheduled for every 4 or 6 weeks. You sort of end up managing their chronic pain. It's the people that we know. If you don't give them a month's worth of pain meds, they are going to come back in to the hospital. Because they always come in when they run out.
I think physicians overprescribe opioids because we don't want people to bounce back to the hospital. We don't want them to have acute pain at home and have to go back to the ER to be readmitted. You don't want someone to be in pain. I think that sometimes people go overboard. I also think that sometimes physicians gauge like, oh, this person isn't a huge risk, and maybe give them more opioids than necessary.

Perceived Success, Satisfaction, and Comfort When Prescribing Opioids for Pain Management

Providing adequate pain control to their patients was of utmost importance to hospitalists and influenced opioid prescribing. Hospitalists felt confident in their ability to control acute pain using opioids, but notably perceived limited success in achieving adequate patient‐perceived pain control when treating acute exacerbations of chronic pain with opioids. A physician described his confidence in treating severe, acute pain:

If someone is dying of cancer, or if they have an acutely broken femur, I don't really care if they are actively in the 12‐Step Program or Narcotics Anonymous to stay sober. That pain is real and there is no effective pain medicine on earth except for opioids.

Managing exacerbations of chronic pain with increasing opioid doses left physicians feeling frustrated and uncomfortable, especially when they lacked objective findings to explain the reported pain. Physicians were concerned that, by increasing opioid doses, they may be contributing to opioid dependence or addiction. A physician explained his dilemma when treating chronic pain:

[I am uncomfortable treating] people that you classify with chronic pain syndrome. There is that terminology you use for people who have subjective pain, out of proportion to objective findings. In my experience it is a black hole. You never get an adequate level of pain control and you keep adding the doses up and they get habituated. An end point is very difficult to achieve. Not like with acute pain.

Hospitalists described awareness that patients' reports of pain management were part of the evaluation of their care, and expressed concern that these patient‐perceived pain control metrics for quality care were inappropriately applied to patients with chronic pain, and may even be unsafe. A physician explained his experience with chronic pain management among hospitalized patients:

All of these things you do for patient satisfaction set up people, who aren't ever going to be without pain, to fail. They have pain all the time, and now you are asking them about their pain. Well, of course their pain is not controlled, because their pain is never going to be less than 5 out of 10, period. And no opioid is going to get them there, unless they are unconscious.

Professional Experiences Influenced Opioid Prescribing Practices

Physicians reported little opioid‐specific training during residency, and so opioid prescribing practices were shaped by the physicians' clinical experiences. Hospitalists reflected on negative, sentinel events that shaped their opioid prescribing practices in the inpatient setting or led them to adopt risk‐modifying behaviors when prescribing opioids at hospital discharge. Negative experiences varied and included a fatal overdose and suspected diversion of opioids for sale. A physician reflected on an avoidable in‐hospital overdose which left her more guarded when prescribing opioids:

It is both your cumulative experience and, sometimes, when you've had a negative experience, it really biases how you think. I've had an experience where my patient actually overdosed. She crushed up the oxycodone we were giving her in the hospital and shot it up through her central line and died. We've all had experiences with opioids being abused. This just happened to be a very dramatic thing that happened right under my nose. It just makes me more guarded, in terms of my practice, and the lengths people will go through to do harm to themselves with opioids.

Hospitalists recognized that some of their patients had limited resources. They expressed suspicions that opioid prescriptions, in some cases, represented a form of currency for patients to supplement their income. A physician stated:

I think our population can divert quite a few meds. I think their financial situations can be really tenuous. Sometimes they sell pills to survive.

Physicians described past experiences with patients who were deceptive to get an opioid prescription, which left them much more reticent to prescribe the drugs. For example, a physician described how a patient altered her opioid prescription following hospital discharge:

I saw a patient who had her gallbladder removed. She asked for an opioid script until she could see her primary care physician, so I gave her a few days of opioids. I later found out she had forged my script and had changed it from 18 pills to 180 pills. She took it all over the state to try to fill. I got a call from the DEA [Drug Enforcement Administration] and had to write them a letter. I think she's in prison now.

These experiences inspired hospitalists to adopt strategies around opioid prescribing that would make it harder for a patient to misuse a prescription or to jeopardize their DEA license. A physician discussed her technique to prevent patients from selling their opioid prescriptions following discharge:

When I write the prescription, I put the name of the patient on the paper prescription with the patient's sticker on top. I don't want the patients to pull it off and sell the prescription, especially when it is my license.

Another physician described feeling reassured when she is able to verify a patient's opioid dose in a statewide prescription monitoring program:

Seeing they have filled opioids before supports your decision making. You just sort of cross your finger that this time my DEA number is not going to come up on the next drug bust!

The Use of Opioids to Improve Institutional Efficiency

Hospitalists felt institutional pressure to reduce hospital readmissions and to facilitate discharges. Pain was a common complaint among patients admitted to the hospital, and uncontrolled pain often prolonged a hospital stay. In these ways, physicians viewed opioid prescriptions as a tool to buffer against readmission or long hospital stays. A physician described his approach to more readily prescribed opioids when he felt it would prevent a patient from being rehospitalized:

If a patient tells you that they are in pain and they are receiving opioids in the hospital, and I have a strong sense that this is a person who comes back to the hospital easily and regularly if something is not right, I'm more likely to make sure that patient has adequate pain medicine for a reasonable duration of time to reduce the chance that they get readmitted just for pain alone.

Physicians used opioids as a tool to facilitate discharges and prevent readmissions; yet doing so sometimes left them feeling conflicted. On one hand, they felt pressured to maintain efficiency; on the other hand, they recognized it might not be in the patient's best interest to receive a higher than necessary quantity of opioids at discharge. A physician described his dilemma:

For the acute pain, I usually give them 15 to 20 [opioid pills]. For the chronics, maybe a little bit more like 30. A lot of them have told me they can just buy it off the street anyway. If we can help keep them out of the hospital, we are probably doing them a disservice [by prescribing more opioids], but we are also not clogging up our system.

Similarly, another hospitalist described opioid prescribing at discharge as a way to reduce hospital costs and prevent a readmission, despite feeling uncomfortable when a patient's diagnosis of pain was nebulous:

If the patient comes back and gets readmitted to the hospital when they don't have pain medicine, it's a $3,000.00, 2‐day stay in the hospital that was unnecessary. And when they have a prescription for a month of pain medicine, they stay out of the hospital. That is utterly pragmaticthere is no other way to do it and it's going to work. At other times, especially when a patient lacks a diagnosis which is known to cause pain, it can feel cheap and dirty.

DISCUSSION

To our knowledge, this is the first study to qualitatively explore the hospitalist perspective on opioid prescribing during hospitalization and at discharge. Hospitalists expressed discomfort and dissatisfaction when managing acute exacerbations of chronic pain with opioid medications. This stemmed from the discordance between the patients' expressed pain and the lack of objective clinical findings of pain, a perceived inability to adequately provide relief to patients with chronic pain, and a concern of contributing to future opioid dependence. Hospitalists identified negative professional experiences with opioid prescribing as a factor that influenced their opioid prescribing practices. Hospitalists also described using opioids as a tool to reduce readmissions and facilitate hospital discharges to contain healthcare costs. This sometimes left them feeling conflicted, especially when their patients lacked clear, pain‐related diagnoses.

Hospitalists were reluctant to increase patients' chronic opioid therapy doses, even when patients had acute exacerbations of chronic pain. Management of chronic pain presents a unique challenge to hospitalists. Existing clinical guidelines for chronic pain management are directed to the primary care physician.[36, 37] Acute exacerbations of chronic pain are commonly seen in hospitalized patients and should not be overlooked.[4] Management strategies that include in‐hospital, guideline‐based opioid dose adjustments are needed to address some of the concern hospitalists feel when managing chronic pain exacerbations. Involving the patient in the decision to temporarily increase their opioid dose may improve patient‐perceived pain control.[38] In addition, when possible, close communication between the hospitalist and the primary care physician may alleviate some of the uncertainty hospitalists feel when they prescribe an increased dose of chronic opioid therapy.[39, 40]

Opioid prescribing practices by hospitalists were influenced by past negative experiences. This principle, defined as negativity bias, refers to the notion that in most situations, negative events are more salient, potent, and dominant than positive events.[41, 42] Hospitalists recounted situations in which their patients overdosed on opioids in the hospital or forged an opioid prescription, which they perceived as jeopardizing their DEA licenses or reputations. They described concrete practice changes they made in an attempt to avoid these situations in the future. Whereas it is appropriate to critically assess practice behaviors that contribute to unanticipated patient outcomes, there may be unintended consequences when providers narrowly focus on the negative, including the undertreatment of pain. Focusing on successful outcomes associated with opioid prescribing, rather than negative outcomes, may lead to less restrictive and more thoughtful opioid prescribing practices. Furthermore, standardizing opioid prescribing to protect physicians from medicolegal consequences related to opioid diversion and fraud could lessen physicians' fears when prescribing opioids both during the hospitalization and at hospital discharge.

Hospitalists described prescribing opioids as a tool to improve efficiency in their practice, although at times it left them feeling conflicted. We interpreted this as a form of cognitive dissonance.[43] Hospitalists are acutely aware of the need to prevent costly hospital readmissions for their own success and longevity, which may lead them to become less judicious about how they prescribe opioids.[44, 45, 46] Our findings suggest a delicate balance between the potential benefits and drawbacks of using opioids to improve efficiency. Whereas it is important to provide pain relief to the patient, which can facilitate a discharge or delay time to next hospital admission, using opioids to smooth a difficult discharge may be detrimental to the patient. These findings highlight the competing pressures hospitalists face to deliver value‐based care[46, 47] while maintaining patient‐centered care.[48, 49]

This study has several limitations. First, qualitative data provide depth to the understanding of a behavior, but not breadth.[50, 51] Therefore, these results may not be generalizable to all hospitalists. We included a convenience sample of hospitalists who practiced in diverse settings including academic and private hospitals and the western and southern regions of the United States. The majority of the hospitalists interviewed had clinical experience less than 10 years. A national survey of hospitalists found the mean years of experience to be 6.9 years[16]; thus, the hospitalists we interviewed are likely representative of hospitalists nationally when considering clinical experience. Second, our interview guide was informed by prior literature and an a priori knowledge based on our experience as practicing hospitalist physicians. Interviews were conducted by 2 hospitalists who may have had similar experiences as those being described by the interviewees. Having shared experiences facilitated rapport and understating between the interviewers and participants; at the same time, however, shared experiences may have narrowed the focus of the interviews, eliminating themes that were already assumed. Lastly, hospitalists who chose to be interviewed may have participated because they felt strongly about the issues discussed and may not fully represent the population from which the sample was drawn.[15]

The development of evidence‐based strategies to promote optimal opioid prescribing for the management of acute exacerbations of chronic pain among hospitalized patients may benefit both hospital providers and patients who have a mutual goal for safe and effective pain relief. Methods to provide adequate pain relief to patients that allow hospitalists to maintain efficiency, while ensuring protection from medicolegal consequences related to opioid diversion or opioid overdose, are urgently needed.

Disclosures

This work was supported by the Denver Health Department of Medicine Small Grants Program, which was not involved in the design, conduct, or reporting of the study, or in the decision to submit the manuscript for publication. Dr. Binswanger was supported by the National Institute On Drug Abuse of the National Institutes of Health under award number R34DA035952. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors declare that they do not have any conflicts of interest.

Pain is a frequent symptom among patients seen in the hospital.[1, 2, 3] Hospitalized patients often suffer before they come to the hospital and are commonly prescribed opioids in the months preceding their hospital stay.[4] Adequate pain control is important because uncontrolled pain is associated with higher levels of depression and anxiety among hospitalized patients.[5] In 2011, the Institute of Medicine called on healthcare providers to improve pain assessment and management in healthcare delivery.[6] Since then, pain management has become a key quality indicator for hospitals, and providers are encouraged to frequently assess and treat pain.[7, 8, 9, 10] Although the use of opioids for pain management among hospitalized patients is routine, the amount of opioids prescribed per patient varies widely between institutions.[11] In‐hospital guidelines for the optimal management of acute exacerbations of chronic pain are lacking.

Pain management also carries risks. Recently, the Centers for Disease Control and Prevention urged clinicians to prevent opioid overdoses by following best prescribing practices including screening patients for substance use disorders, mental health issues, and avoiding combinations of opioids and sedatives.[12, 13] These guidelines may be at odds with the priorities of current hospital care, which focus on patient‐perceived pain control rather than potential long‐term consequences of opioid use.[7, 8, 14] In light of the competing demands to provide adequate pain relief to hospitalized patients while optimally prescribing opioids, we sought to understand physicians' attitudes, beliefs, and experiences that inform opioid prescribing practices during hospitalization and at discharge.

METHODS

Study Design, Setting, and Participants

Between January 2015 and August 2015, we recruited a convenience sample via e‐mail solicitation from approximately 135 hospitalists practicing in Colorado and South Carolina.[15] Fifty‐three physicians responded. We conducted 25 in‐depth, semistructured interviews with physicians who represented the average hospitalist practicing in the United States in terms of years in practice and gender.[16] We enrolled physicians working in 4 distinct types of hospital settings, including 2 university hospitals, a safety‐net hospital, a Veterans Affairs hospital, and a private hospital. We used purposive sampling to achieve an even distribution with respect to gender and years in practice.[17] Interviews were either face‐to‐face (n = 16) or over the telephone (n = 9) and were performed outside of the physician's clinical shift. Informed consent was obtained from study participants, and the interview duration was approximately 1 hour. The study was approved by the Colorado Multiple Institutional Review Board.

Interview Guide Development and Content

Members of our multidisciplinary team (S.L.C., I.A.B., S.K.) developed an interview guide designed to explore hospitalists' attitudes and practices about opioid prescribing during hospitalization and at discharge (see Supporting Information, Appendix 1, in the online version of this article). Initial interview questions were developed with input from health sciences researchers (S.E.L., A.D.D., R.D.) and qualitative researchers (I.A.B., S.K.). During data collection, we occasionally edited or added questions to our guide to more fully explore new issues or information emerging from our interviews. Through open‐ended interviews, we sought to capture a qualitative narrative in which hospitalists would describe their attitudes and practices that may influence opioid prescribing within 3 major domains pertinent to clinical practice: patient factors,[18, 19, 20, 21, 22, 23] physician factors,[24, 25, 26, 27] and institutional factors.[27, 28, 29, 30, 31, 32] These domains were based on prior literature. All participants received a $25 gift card.

Data Analysis

Interview transcripts and a demographic survey were our primary data sources. Transcript files were entered into qualitative data analysis software (ATLAS.ti; Scientific Software Development GmbH, Berlin, Germany). We used a mixed inductive and deductive,[33] participatory, team‐based approach to explore patterns and themes related to attitudes and practices around opioid prescribing.[34, 35] A deductive or top‐down approach was used to link text to predefined codes and categories based on literature, prior knowledge, and our interview guide. An inductive or bottom‐up approach was used to identify new codes and categories that emerged from the data, including unanticipated information relevant to our research questions.

Team members included 2 hospitalists (S.L.C., A.D.D.), 2 research assistants with experience in qualitative methods (S.E.L., R.D.), an addiction medicine physician and researcher (I.A.B.), and a medical anthropologist (S.K.). S.L.C. performed initial coding using an a priori template that reflected the primary areas of interest in the study. The codes were categorized as patient, physician, and institutional factors. Using this template as a guide, 3 other team members (S.E.L., A.D.D., R.D.) independently coded 3 transcripts by assigning predefined codes to text and assigning new codes to emergent findings. Using this subset of 4 transcripts, the team reached a consensus on initial codes to be applied to the remaining transcripts. In weekly meetings, team members discussed and modified the codebook based on inconsistencies noted among team members to refine the coding scheme and to ensure consensus. Through group consensus, codes were condensed into a list of categories, subcategories, and emergent themes (ie, themes that did not originate from summarized answers to specific interview questions). The team identified emergent themes represented across all major domains (Table 1). Three of the most prevalent themes representing physicians' personal opioid prescribing practices are reported here. The study team determined that thematic saturation was reached after 25 interviews, as additional interview data created little change to the codebook and no new patterns or themes emerged.

A Complete List of Identified Emergent Themes With Hospitalist Physicians Regarding Opioid Prescribing Practices*
  • NOTE: *Discussed in the article.

Perceived success, satisfaction, comfort, and the use of opioids for pain management*
Professional experiences influenced opioid prescribing practices*
The use of opioids to improve efficiency*
Skepticism between other physician subspecialty types and opioid prescribing practices
Unintended consequences of patient‐perceived pain control metrics and opioid prescribing
Lack of trust with patients when reported pain level was not supported with objective data
Resident burnout contributed to a lack of empathy and undertreatment of pain
Limited perceived risk of personal opioid prescribing practices and patient overdose with short‐acting opioids
Unreal expectations by patients to have complete pain eradication contributes to overprescribing
Recognition that patient profiling impacts personal opioid‐prescribing practices

RESULTS

Of the 25 hospitalist participants who were all trained in internal medicine, 16 (64%) were women. The majority were non‐Hispanic white (21 [84%]). Nine physicians (36%) completed residency within the past 5 years, 12 (48%) completed residency within the past 5 to 10 years, and 4 (16%) completed residency >10 years ago. Sixteen (64%) hospitalists practiced medicine in Colorado, where 8 (32%) worked in a safety‐net hospital, 5 (20%) worked in a university hospital, and 3 (12%) worked in a Veterans Affairs hospital. Nine hospitalists (36%) practiced in South Carolina, where 2 (8%) worked in a university hospital and 7 (28%) worked in a private hospital (Table 2).

Participant Characteristics (N = 25)
Female, no. (%) 16 (64)
Race/ethnicity, no. (%)
White, non‐Hispanic 21 (84)
Asian, non‐Hispanic 4 (16)
Years postresidency, no. (%)
5 9 (36)
510 12 (48)
>10 4 (16)
State of practice, no. (%)
Colorado 16 (64)
South Carolina 9 (36)
Private hospital, no. (%) 7 (28)
Academic institution, no. (%)
Safety‐net hospital 8 (32)
Veteran Affairs hospital 3 (12)
University hospital 7 (28)

Emergent themes described here include: (1) hospitalists' perceived success, satisfaction, and comfort when prescribing opioids for their patients' pain management; (2) the influence of physicians' professional sentinel experiences on opioid prescribing practices; and (3) opioid prescribing as a tool to improve efficiency in the hospital. Additional quotations to support emergent themes are listed in Table 3.

Selected Emergent Themes With Illustrative Quotations
Theme Illustrative Quote
  • NOTE: Abbreviations: ER, emergency room; ERCPs, endoscopic retrograde cholangiopancreatographies.

Perceived success, satisfaction, comfort, and the use of opioids for pain management Acute pain: I'm more comfortable treating acute pain. With chronic pain, it depends on the circumstance. There are certain people who have objective reasons to have chronic pain, for instance they have severe degenerate disc disease, for example. With chronic painlet me just say, getting their pain under control is quite challenging. Acute pain is much more straight forward to treat.
Chronic pain; If I am treating an exacerbation of someone's chronic pain, it makes me a little less comfortable as far as sending people out on large doses of opioids because of the whole addiction thought behind it. And you don't want to start or feed people's addiction. Or, you know, lead them to it, in the future, requiring increased doses of opioids.
Chronic pain: I have a hard time feeling like I'm very successful with people who have chronic noncancer pain who come in for an exacerbation. Unless I can figure out clear reasons for that exacerbation, I feel I rarely succeed in having the patient, the providers, and the caregivers be happy. It is an unrewarding situation all around.
Chronic pain: I'm less comfortable treating chronic pain because we don't know the patients as well, I think, in the hospital, and you just worry about people abusing the system to get their needs met while they are in the hospital. We don't have much objective data in terms of assessing pain, and you know, they are on chronic narcotics, you don't really know what to believe, I guess.
Professional experiences that influenced opioid prescribing practices In the hospital: I had 1 horrible experience. I had a young woman who came in with chronic abdominal pain. She told me how much opioids she took. It was before there was a statewide database and I couldn't verify her doses. I gave her what she told me she was taking. I hadn't put a pulse ox on her which I always do now because it makes me feel better. Later the nurse called and said she wasn't responsive. I put her on Pulse Ox and she was sating 30% and blue. A code was called and we brought her back. That was in my mind for ever, I almost killed a 23 year old.
In the hospital: I think past experiences inform what I do now. I mean it's not that I've murdered anybody, but there was a time when I took over a patient and didn't realize that, while she had terrible pain from her restless leg syndrome, she also had severe pulmonary hypertension. I gave her 5 mg of oxycodone. She ended up somnolent with hypercarbic respiratory failure. I think that is something that will always stick in my head.
Discharge: When discussing what type of opioids prescribed at dischargeI worry about, not just deliberate diversion, but for the patient being robbed, for the type of opioid I might choose. So I might do oxycodone instead of Percocet. Percocet, itself, has a higher street value then oxycodone. That may be completely false, but I think of it as a name brand that people want.
Discharge: I think many providers, including myself, try to minimize the use of opiates when we can. I think we are all concerned every time we write, you know, our DEA #. Even when we have other providers ask us, you know, to prescribe opioids for their patients because they are out of the hospital or something like that, it is always a touchy subject. Because I think we all feel like our license is always at risk every time we are writing opioids.
Discharge: I give them what they need but I want them to be seen in follow‐up. I encourage that by giving them a shortened course. I'm more skeptical. I've seen people misuse, have bad side effects, and overdose on opioids. I worry about that, so I tend to prescribe shorter courses and less.
The use of opioids to improve efficiency There is always the group of patients [for whom] we've done everything we can. We set up follow‐up. If giving you a few days of Percocet is going to help you leave the hospital comfortably and stay out of the hospital for appropriate reasons, then we give them a few days. It's horrible but...
I'll give 4 or 6 weeks' worth of opioid medication to the chronic abdominal pain patients, the ones who have ERCPs scheduled for every 4 or 6 weeks. You sort of end up managing their chronic pain. It's the people that we know. If you don't give them a month's worth of pain meds, they are going to come back in to the hospital. Because they always come in when they run out.
I think physicians overprescribe opioids because we don't want people to bounce back to the hospital. We don't want them to have acute pain at home and have to go back to the ER to be readmitted. You don't want someone to be in pain. I think that sometimes people go overboard. I also think that sometimes physicians gauge like, oh, this person isn't a huge risk, and maybe give them more opioids than necessary.

Perceived Success, Satisfaction, and Comfort When Prescribing Opioids for Pain Management

Providing adequate pain control to their patients was of utmost importance to hospitalists and influenced opioid prescribing. Hospitalists felt confident in their ability to control acute pain using opioids, but notably perceived limited success in achieving adequate patient‐perceived pain control when treating acute exacerbations of chronic pain with opioids. A physician described his confidence in treating severe, acute pain:

If someone is dying of cancer, or if they have an acutely broken femur, I don't really care if they are actively in the 12‐Step Program or Narcotics Anonymous to stay sober. That pain is real and there is no effective pain medicine on earth except for opioids.

Managing exacerbations of chronic pain with increasing opioid doses left physicians feeling frustrated and uncomfortable, especially when they lacked objective findings to explain the reported pain. Physicians were concerned that, by increasing opioid doses, they may be contributing to opioid dependence or addiction. A physician explained his dilemma when treating chronic pain:

[I am uncomfortable treating] people that you classify with chronic pain syndrome. There is that terminology you use for people who have subjective pain, out of proportion to objective findings. In my experience it is a black hole. You never get an adequate level of pain control and you keep adding the doses up and they get habituated. An end point is very difficult to achieve. Not like with acute pain.

Hospitalists described awareness that patients' reports of pain management were part of the evaluation of their care, and expressed concern that these patient‐perceived pain control metrics for quality care were inappropriately applied to patients with chronic pain, and may even be unsafe. A physician explained his experience with chronic pain management among hospitalized patients:

All of these things you do for patient satisfaction set up people, who aren't ever going to be without pain, to fail. They have pain all the time, and now you are asking them about their pain. Well, of course their pain is not controlled, because their pain is never going to be less than 5 out of 10, period. And no opioid is going to get them there, unless they are unconscious.

Professional Experiences Influenced Opioid Prescribing Practices

Physicians reported little opioid‐specific training during residency, and so opioid prescribing practices were shaped by the physicians' clinical experiences. Hospitalists reflected on negative, sentinel events that shaped their opioid prescribing practices in the inpatient setting or led them to adopt risk‐modifying behaviors when prescribing opioids at hospital discharge. Negative experiences varied and included a fatal overdose and suspected diversion of opioids for sale. A physician reflected on an avoidable in‐hospital overdose which left her more guarded when prescribing opioids:

It is both your cumulative experience and, sometimes, when you've had a negative experience, it really biases how you think. I've had an experience where my patient actually overdosed. She crushed up the oxycodone we were giving her in the hospital and shot it up through her central line and died. We've all had experiences with opioids being abused. This just happened to be a very dramatic thing that happened right under my nose. It just makes me more guarded, in terms of my practice, and the lengths people will go through to do harm to themselves with opioids.

Hospitalists recognized that some of their patients had limited resources. They expressed suspicions that opioid prescriptions, in some cases, represented a form of currency for patients to supplement their income. A physician stated:

I think our population can divert quite a few meds. I think their financial situations can be really tenuous. Sometimes they sell pills to survive.

Physicians described past experiences with patients who were deceptive to get an opioid prescription, which left them much more reticent to prescribe the drugs. For example, a physician described how a patient altered her opioid prescription following hospital discharge:

I saw a patient who had her gallbladder removed. She asked for an opioid script until she could see her primary care physician, so I gave her a few days of opioids. I later found out she had forged my script and had changed it from 18 pills to 180 pills. She took it all over the state to try to fill. I got a call from the DEA [Drug Enforcement Administration] and had to write them a letter. I think she's in prison now.

These experiences inspired hospitalists to adopt strategies around opioid prescribing that would make it harder for a patient to misuse a prescription or to jeopardize their DEA license. A physician discussed her technique to prevent patients from selling their opioid prescriptions following discharge:

When I write the prescription, I put the name of the patient on the paper prescription with the patient's sticker on top. I don't want the patients to pull it off and sell the prescription, especially when it is my license.

Another physician described feeling reassured when she is able to verify a patient's opioid dose in a statewide prescription monitoring program:

Seeing they have filled opioids before supports your decision making. You just sort of cross your finger that this time my DEA number is not going to come up on the next drug bust!

The Use of Opioids to Improve Institutional Efficiency

Hospitalists felt institutional pressure to reduce hospital readmissions and to facilitate discharges. Pain was a common complaint among patients admitted to the hospital, and uncontrolled pain often prolonged a hospital stay. In these ways, physicians viewed opioid prescriptions as a tool to buffer against readmission or long hospital stays. A physician described his approach to more readily prescribed opioids when he felt it would prevent a patient from being rehospitalized:

If a patient tells you that they are in pain and they are receiving opioids in the hospital, and I have a strong sense that this is a person who comes back to the hospital easily and regularly if something is not right, I'm more likely to make sure that patient has adequate pain medicine for a reasonable duration of time to reduce the chance that they get readmitted just for pain alone.

Physicians used opioids as a tool to facilitate discharges and prevent readmissions; yet doing so sometimes left them feeling conflicted. On one hand, they felt pressured to maintain efficiency; on the other hand, they recognized it might not be in the patient's best interest to receive a higher than necessary quantity of opioids at discharge. A physician described his dilemma:

For the acute pain, I usually give them 15 to 20 [opioid pills]. For the chronics, maybe a little bit more like 30. A lot of them have told me they can just buy it off the street anyway. If we can help keep them out of the hospital, we are probably doing them a disservice [by prescribing more opioids], but we are also not clogging up our system.

Similarly, another hospitalist described opioid prescribing at discharge as a way to reduce hospital costs and prevent a readmission, despite feeling uncomfortable when a patient's diagnosis of pain was nebulous:

If the patient comes back and gets readmitted to the hospital when they don't have pain medicine, it's a $3,000.00, 2‐day stay in the hospital that was unnecessary. And when they have a prescription for a month of pain medicine, they stay out of the hospital. That is utterly pragmaticthere is no other way to do it and it's going to work. At other times, especially when a patient lacks a diagnosis which is known to cause pain, it can feel cheap and dirty.

DISCUSSION

To our knowledge, this is the first study to qualitatively explore the hospitalist perspective on opioid prescribing during hospitalization and at discharge. Hospitalists expressed discomfort and dissatisfaction when managing acute exacerbations of chronic pain with opioid medications. This stemmed from the discordance between the patients' expressed pain and the lack of objective clinical findings of pain, a perceived inability to adequately provide relief to patients with chronic pain, and a concern of contributing to future opioid dependence. Hospitalists identified negative professional experiences with opioid prescribing as a factor that influenced their opioid prescribing practices. Hospitalists also described using opioids as a tool to reduce readmissions and facilitate hospital discharges to contain healthcare costs. This sometimes left them feeling conflicted, especially when their patients lacked clear, pain‐related diagnoses.

Hospitalists were reluctant to increase patients' chronic opioid therapy doses, even when patients had acute exacerbations of chronic pain. Management of chronic pain presents a unique challenge to hospitalists. Existing clinical guidelines for chronic pain management are directed to the primary care physician.[36, 37] Acute exacerbations of chronic pain are commonly seen in hospitalized patients and should not be overlooked.[4] Management strategies that include in‐hospital, guideline‐based opioid dose adjustments are needed to address some of the concern hospitalists feel when managing chronic pain exacerbations. Involving the patient in the decision to temporarily increase their opioid dose may improve patient‐perceived pain control.[38] In addition, when possible, close communication between the hospitalist and the primary care physician may alleviate some of the uncertainty hospitalists feel when they prescribe an increased dose of chronic opioid therapy.[39, 40]

Opioid prescribing practices by hospitalists were influenced by past negative experiences. This principle, defined as negativity bias, refers to the notion that in most situations, negative events are more salient, potent, and dominant than positive events.[41, 42] Hospitalists recounted situations in which their patients overdosed on opioids in the hospital or forged an opioid prescription, which they perceived as jeopardizing their DEA licenses or reputations. They described concrete practice changes they made in an attempt to avoid these situations in the future. Whereas it is appropriate to critically assess practice behaviors that contribute to unanticipated patient outcomes, there may be unintended consequences when providers narrowly focus on the negative, including the undertreatment of pain. Focusing on successful outcomes associated with opioid prescribing, rather than negative outcomes, may lead to less restrictive and more thoughtful opioid prescribing practices. Furthermore, standardizing opioid prescribing to protect physicians from medicolegal consequences related to opioid diversion and fraud could lessen physicians' fears when prescribing opioids both during the hospitalization and at hospital discharge.

Hospitalists described prescribing opioids as a tool to improve efficiency in their practice, although at times it left them feeling conflicted. We interpreted this as a form of cognitive dissonance.[43] Hospitalists are acutely aware of the need to prevent costly hospital readmissions for their own success and longevity, which may lead them to become less judicious about how they prescribe opioids.[44, 45, 46] Our findings suggest a delicate balance between the potential benefits and drawbacks of using opioids to improve efficiency. Whereas it is important to provide pain relief to the patient, which can facilitate a discharge or delay time to next hospital admission, using opioids to smooth a difficult discharge may be detrimental to the patient. These findings highlight the competing pressures hospitalists face to deliver value‐based care[46, 47] while maintaining patient‐centered care.[48, 49]

This study has several limitations. First, qualitative data provide depth to the understanding of a behavior, but not breadth.[50, 51] Therefore, these results may not be generalizable to all hospitalists. We included a convenience sample of hospitalists who practiced in diverse settings including academic and private hospitals and the western and southern regions of the United States. The majority of the hospitalists interviewed had clinical experience less than 10 years. A national survey of hospitalists found the mean years of experience to be 6.9 years[16]; thus, the hospitalists we interviewed are likely representative of hospitalists nationally when considering clinical experience. Second, our interview guide was informed by prior literature and an a priori knowledge based on our experience as practicing hospitalist physicians. Interviews were conducted by 2 hospitalists who may have had similar experiences as those being described by the interviewees. Having shared experiences facilitated rapport and understating between the interviewers and participants; at the same time, however, shared experiences may have narrowed the focus of the interviews, eliminating themes that were already assumed. Lastly, hospitalists who chose to be interviewed may have participated because they felt strongly about the issues discussed and may not fully represent the population from which the sample was drawn.[15]

The development of evidence‐based strategies to promote optimal opioid prescribing for the management of acute exacerbations of chronic pain among hospitalized patients may benefit both hospital providers and patients who have a mutual goal for safe and effective pain relief. Methods to provide adequate pain relief to patients that allow hospitalists to maintain efficiency, while ensuring protection from medicolegal consequences related to opioid diversion or opioid overdose, are urgently needed.

Disclosures

This work was supported by the Denver Health Department of Medicine Small Grants Program, which was not involved in the design, conduct, or reporting of the study, or in the decision to submit the manuscript for publication. Dr. Binswanger was supported by the National Institute On Drug Abuse of the National Institutes of Health under award number R34DA035952. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors declare that they do not have any conflicts of interest.

References
  1. Abbott FV, Gray‐Donald K, Sewitch MJ, Johnston CC, Edgar L, Jeans ME. The prevalence of pain in hospitalized patients and resolution over six months. Pain. 1992;50(1):1528.
  2. Marks RM, Sachar EJ. Undertreatment of medical inpatients with narcotic analgesics. Ann Intern Med. 1973;78(2):173181.
  3. Desbiens NA, Wu AW. Pain and suffering in seriously ill hospitalized patients. J Am Geriatr Soc. 2000;48(5 suppl):S183S186.
  4. Mosher HJ, Jiang L, Vaughan Sarrazin MS, Cram P, Kaboli PJ, Weg MW. Prevalence and characteristics of hospitalized adults on chronic opioid therapy. J Hosp Med. 2014;9(2):8287.
  5. Rockett MP, Simpson G, Crossley R, Blowey S. Characteristics of pain in hospitalized medical patients, surgical patients, and outpatients attending a pain management centre. Br J Anaesth. 2013;110(6):10171023.
  6. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academy of Sciences; 2011.
  7. Gupta A, Daigle S, Mojica J, Hurley RW. Patient perception of pain care in hospitals in the United States. J Pain Res. 2009;2:157164.
  8. Lanser P, Gesell S. Pain management: the fifth vital sign. Healthc Benchmarks. 2001;8(6):6870, 62.
  9. Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res. 2013;6:683689.
  10. Zgierska A, Rabago D, Miller MM. Impact of patient satisfaction ratings on physicians and clinical care. Patient Prefer Adherence. 2014;8:437446.
  11. Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid‐related adverse events in non‐surgical patients in U.S. hospitals. J Hosp Med. 2014;9(2):7381.
  12. Centers for Disease Control and Prevention. CDC grand rounds: prescription drug overdoses—a U.S. epidemic. MMWR Morb Mortal Wkly Rep. 2012;61(1):1013.
  13. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999–2010. MMWR Morb Mortal Wkly Rep. 2013;62(26):537542.
  14. Gupta A, Lee LK, Mojica JJ, Nairizi A, George SJ. Patient perception of pain care in the United States: a 5‐year comparative analysis of hospital consumer assessment of health care providers and systems. Pain Physician. 2014;17(5):369377.
  15. Cochran WG. Sampling Techniques. 3rd ed. New York, NY: Wiley; 1977.
  16. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  17. Patton MQ. Qualitative Evaluation and Research Methods. Thousand Oaks, CA: Sage; 1990.
  18. Fishbain DA, Cole B, Lewis J, Rosomoff HL, Rosomoff RS. What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug‐related behaviors? A structured evidence‐based review. Pain Med. 2008;9(4):444459.
  19. Manchikanti L, Cash KA, Damron KS, Manchukonda R, Pampati V, McManus CD. Controlled substance abuse and illicit drug use in chronic pain patients: an evaluation of multiple variables. Pain Physician. 2006;9(3):215225.
  20. Ives TJ, Chelminski PR, Hammett‐Stabler CA, et al. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006;6:46.
  21. Edlund MJ, Sullivan M, Steffick D, Harris KM, Wells KB. Do users of regularly prescribed opioids have higher rates of substance use problems than nonusers? Pain Med. 2007;8(8):647656.
  22. Silverberg MJ, Ray GT, Saunders K, et al. Prescription long‐term opioid use in HIV‐infected patients. Clin J Pain. 2012;28(1):3946.
  23. Green CR, Anderson KO, Baker TA, et al. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003;4(3):277294.
  24. Green CR, Wheeler JR, Marchant B, LaPorte F, Guerrero E. Analysis of the physician variable in pain management. Pain Med. 2001;2(4):317327.
  25. Hutchinson K, Moreland AM, de CWAC, Weinman J, Horne R. Exploring beliefs and practice of opioid prescribing for persistent non‐cancer pain by general practitioners. Eur J Pain. 2007;11(1):9398.
  26. Jamison RN, Sheehan KA, Scanlan E, Matthews M, Ross EL. Beliefs and attitudes about opioid prescribing and chronic pain management: survey of primary care providers. J Opioid Manag. 2014;10(6):375382.
  27. Nwokeji ED, Rascati KL, Brown CM, Eisenberg A. Influences of attitudes on family physicians' willingness to prescribe long‐acting opioid analgesics for patients with chronic nonmalignant pain. Clin Ther. 2007;29(suppl):25892602.
  28. Miller NS. Failure of enforcement controlled substance laws in health policy for prescribing opiate medications: a painful assessment of morbidity and mortality. Am J Ther. 2006;13(6):527533.
  29. Hoffmann DE, Tarzian AJ. Achieving the right balance in oversight of physician opioid prescribing for pain: the role of state medical boards. J Law Med Ethics. 2003;31(1):2140.
  30. Fishman SM, Papazian JS, Gonzalez S, Riches PS, Gilson A. Regulating opioid prescribing through prescription monitoring programs: balancing drug diversion and treatment of pain. Pain Med. 2004;5(3):309324.
  31. Miller J. The other side of trust in health care: prescribing drugs with the potential for abuse. Bioethics. 2007;21(1):5160.
  32. US Drug Enforcement Administration, Department of Justice. Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II. Fed Regist. 2014;79(163):4966149682.
  33. Fereday J, Muir‐Cochrane E. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods. 2008;5(1):8092.
  34. Bernard HR, Ryan GW. Analyzing Qualitative Data: Systematic Approaches. Thousand Oaks, CA: Sage; 2009.
  35. Patton MQ. Qualitative Research and Evaluation Methods, Third Edition. Thousand Oaks, CA: Sage; 2002.
  36. Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain—consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007;12(1):1321.
  37. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113130.
  38. Rao JK, Anderson LA, Inui TS, Frankel RM. Communication interventions make a difference in conversations between physicians and patients: a systematic review of the evidence. Med Care. 2007;45(4):340349.
  39. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314323.
  40. Sheu L, Fung K, Mourad M, Ranji S, Wu E. We need to talk: primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med. 2015;10(5):307310.
  41. Ito TA, Larsen JT, Smith NK, Cacioppo JT. Negative information weighs more heavily on the brain: the negativity bias in evaluative categorizations. J Pers Soc Psychol. 1998;75(4):887900.
  42. Carretie L, Mercado F, Tapia M, Hinojosa JA. Emotion, attention, and the ‘negativity bias’, studied through event‐related potentials. Int J Psychophysiol. 2001;41(1):7585.
  43. Harmon‐Jones E, Mills J. Cognitive Dissonance: Progress on a Pivotal Theory in Social Psychology. Washington, DC: American Psychological Association; 1999.
  44. Ahmad FS, Metlay JP, Barg FK, Henderson RR, Werner RM. Identifying hospital organizational strategies to reduce readmissions. Am J Med Qual. 2013;28(4):278285.
  45. Edwards PK, Levine M, Cullinan K, Newbern G, Barnes CL. Avoiding readmissions‐support systems required after discharge to continue rapid recovery? J Arthroplasty. 2015;30(4):527530.
  46. Elliott DJ, Young RS, Brice J, Aguiar R, Kolm P. Effect of hospitalist workload on the quality and efficiency of care. JAMA Intern Med. 2014;174(5):786793.
  47. Moriates C, Shah NT, Arora VM. A framework for the frontline: how hospitalists can improve healthcare value. J Hosp Med. 2016;11(4):297302.
  48. Chen LM, Birkmeyer JD, Saint S, Jha AK. Hospitalist staffing and patient satisfaction in the national Medicare population. J Hosp Med. 2013;8(3):126131.
  49. O'Leary KJ, Cyrus RM. Improving patient satisfaction: timely feedback to specific physicians is essential for success. J Hosp Med. 2015;10(8):555556.
  50. Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care B. What are the results and how do they help me care for my patients? Evidence‐Based Medicine Working Group. JAMA. 2000;284(4):478482.
  51. Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care A. Are the results of the study valid? Evidence‐Based Medicine Working Group. JAMA. 2000;284(3):357362.
References
  1. Abbott FV, Gray‐Donald K, Sewitch MJ, Johnston CC, Edgar L, Jeans ME. The prevalence of pain in hospitalized patients and resolution over six months. Pain. 1992;50(1):1528.
  2. Marks RM, Sachar EJ. Undertreatment of medical inpatients with narcotic analgesics. Ann Intern Med. 1973;78(2):173181.
  3. Desbiens NA, Wu AW. Pain and suffering in seriously ill hospitalized patients. J Am Geriatr Soc. 2000;48(5 suppl):S183S186.
  4. Mosher HJ, Jiang L, Vaughan Sarrazin MS, Cram P, Kaboli PJ, Weg MW. Prevalence and characteristics of hospitalized adults on chronic opioid therapy. J Hosp Med. 2014;9(2):8287.
  5. Rockett MP, Simpson G, Crossley R, Blowey S. Characteristics of pain in hospitalized medical patients, surgical patients, and outpatients attending a pain management centre. Br J Anaesth. 2013;110(6):10171023.
  6. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academy of Sciences; 2011.
  7. Gupta A, Daigle S, Mojica J, Hurley RW. Patient perception of pain care in hospitals in the United States. J Pain Res. 2009;2:157164.
  8. Lanser P, Gesell S. Pain management: the fifth vital sign. Healthc Benchmarks. 2001;8(6):6870, 62.
  9. Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res. 2013;6:683689.
  10. Zgierska A, Rabago D, Miller MM. Impact of patient satisfaction ratings on physicians and clinical care. Patient Prefer Adherence. 2014;8:437446.
  11. Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid‐related adverse events in non‐surgical patients in U.S. hospitals. J Hosp Med. 2014;9(2):7381.
  12. Centers for Disease Control and Prevention. CDC grand rounds: prescription drug overdoses—a U.S. epidemic. MMWR Morb Mortal Wkly Rep. 2012;61(1):1013.
  13. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers and other drugs among women—United States, 1999–2010. MMWR Morb Mortal Wkly Rep. 2013;62(26):537542.
  14. Gupta A, Lee LK, Mojica JJ, Nairizi A, George SJ. Patient perception of pain care in the United States: a 5‐year comparative analysis of hospital consumer assessment of health care providers and systems. Pain Physician. 2014;17(5):369377.
  15. Cochran WG. Sampling Techniques. 3rd ed. New York, NY: Wiley; 1977.
  16. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 2012;27(1):2836.
  17. Patton MQ. Qualitative Evaluation and Research Methods. Thousand Oaks, CA: Sage; 1990.
  18. Fishbain DA, Cole B, Lewis J, Rosomoff HL, Rosomoff RS. What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug‐related behaviors? A structured evidence‐based review. Pain Med. 2008;9(4):444459.
  19. Manchikanti L, Cash KA, Damron KS, Manchukonda R, Pampati V, McManus CD. Controlled substance abuse and illicit drug use in chronic pain patients: an evaluation of multiple variables. Pain Physician. 2006;9(3):215225.
  20. Ives TJ, Chelminski PR, Hammett‐Stabler CA, et al. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006;6:46.
  21. Edlund MJ, Sullivan M, Steffick D, Harris KM, Wells KB. Do users of regularly prescribed opioids have higher rates of substance use problems than nonusers? Pain Med. 2007;8(8):647656.
  22. Silverberg MJ, Ray GT, Saunders K, et al. Prescription long‐term opioid use in HIV‐infected patients. Clin J Pain. 2012;28(1):3946.
  23. Green CR, Anderson KO, Baker TA, et al. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003;4(3):277294.
  24. Green CR, Wheeler JR, Marchant B, LaPorte F, Guerrero E. Analysis of the physician variable in pain management. Pain Med. 2001;2(4):317327.
  25. Hutchinson K, Moreland AM, de CWAC, Weinman J, Horne R. Exploring beliefs and practice of opioid prescribing for persistent non‐cancer pain by general practitioners. Eur J Pain. 2007;11(1):9398.
  26. Jamison RN, Sheehan KA, Scanlan E, Matthews M, Ross EL. Beliefs and attitudes about opioid prescribing and chronic pain management: survey of primary care providers. J Opioid Manag. 2014;10(6):375382.
  27. Nwokeji ED, Rascati KL, Brown CM, Eisenberg A. Influences of attitudes on family physicians' willingness to prescribe long‐acting opioid analgesics for patients with chronic nonmalignant pain. Clin Ther. 2007;29(suppl):25892602.
  28. Miller NS. Failure of enforcement controlled substance laws in health policy for prescribing opiate medications: a painful assessment of morbidity and mortality. Am J Ther. 2006;13(6):527533.
  29. Hoffmann DE, Tarzian AJ. Achieving the right balance in oversight of physician opioid prescribing for pain: the role of state medical boards. J Law Med Ethics. 2003;31(1):2140.
  30. Fishman SM, Papazian JS, Gonzalez S, Riches PS, Gilson A. Regulating opioid prescribing through prescription monitoring programs: balancing drug diversion and treatment of pain. Pain Med. 2004;5(3):309324.
  31. Miller J. The other side of trust in health care: prescribing drugs with the potential for abuse. Bioethics. 2007;21(1):5160.
  32. US Drug Enforcement Administration, Department of Justice. Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II. Fed Regist. 2014;79(163):4966149682.
  33. Fereday J, Muir‐Cochrane E. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods. 2008;5(1):8092.
  34. Bernard HR, Ryan GW. Analyzing Qualitative Data: Systematic Approaches. Thousand Oaks, CA: Sage; 2009.
  35. Patton MQ. Qualitative Research and Evaluation Methods, Third Edition. Thousand Oaks, CA: Sage; 2002.
  36. Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain—consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007;12(1):1321.
  37. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113130.
  38. Rao JK, Anderson LA, Inui TS, Frankel RM. Communication interventions make a difference in conversations between physicians and patients: a systematic review of the evidence. Med Care. 2007;45(4):340349.
  39. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med. 2007;2(5):314323.
  40. Sheu L, Fung K, Mourad M, Ranji S, Wu E. We need to talk: primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med. 2015;10(5):307310.
  41. Ito TA, Larsen JT, Smith NK, Cacioppo JT. Negative information weighs more heavily on the brain: the negativity bias in evaluative categorizations. J Pers Soc Psychol. 1998;75(4):887900.
  42. Carretie L, Mercado F, Tapia M, Hinojosa JA. Emotion, attention, and the ‘negativity bias’, studied through event‐related potentials. Int J Psychophysiol. 2001;41(1):7585.
  43. Harmon‐Jones E, Mills J. Cognitive Dissonance: Progress on a Pivotal Theory in Social Psychology. Washington, DC: American Psychological Association; 1999.
  44. Ahmad FS, Metlay JP, Barg FK, Henderson RR, Werner RM. Identifying hospital organizational strategies to reduce readmissions. Am J Med Qual. 2013;28(4):278285.
  45. Edwards PK, Levine M, Cullinan K, Newbern G, Barnes CL. Avoiding readmissions‐support systems required after discharge to continue rapid recovery? J Arthroplasty. 2015;30(4):527530.
  46. Elliott DJ, Young RS, Brice J, Aguiar R, Kolm P. Effect of hospitalist workload on the quality and efficiency of care. JAMA Intern Med. 2014;174(5):786793.
  47. Moriates C, Shah NT, Arora VM. A framework for the frontline: how hospitalists can improve healthcare value. J Hosp Med. 2016;11(4):297302.
  48. Chen LM, Birkmeyer JD, Saint S, Jha AK. Hospitalist staffing and patient satisfaction in the national Medicare population. J Hosp Med. 2013;8(3):126131.
  49. O'Leary KJ, Cyrus RM. Improving patient satisfaction: timely feedback to specific physicians is essential for success. J Hosp Med. 2015;10(8):555556.
  50. Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care B. What are the results and how do they help me care for my patients? Evidence‐Based Medicine Working Group. JAMA. 2000;284(4):478482.
  51. Giacomini MK, Cook DJ. Users' guides to the medical literature: XXIII. Qualitative research in health care A. Are the results of the study valid? Evidence‐Based Medicine Working Group. JAMA. 2000;284(3):357362.
Issue
Journal of Hospital Medicine - 11(8)
Issue
Journal of Hospital Medicine - 11(8)
Page Number
536-542
Page Number
536-542
Article Type
Display Headline
The hospitalist perspective on opioid prescribing: A qualitative analysis
Display Headline
The hospitalist perspective on opioid prescribing: A qualitative analysis
Sections
Article Source
© 2016 Society of Hospital Medicine
Disallow All Ads
Correspondence Location
Address for correspondence and reprint requests: Susan Calcaterra, MD, 1216 Race Street, Denver, CO 8020; Telephone: 248‐703‐5947; Fax: 303‐602‐5056; E‐mail: [email protected]
Content Gating
Gated (full article locked unless allowed per User)
Gating Strategy
First Peek Free
Article PDF Media
Media Files