Risk Factors for Early Readmission After Anatomical or Reverse Total Shoulder Arthroplasty

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Risk Factors for Early Readmission After Anatomical or Reverse Total Shoulder Arthroplasty

Hospital readmissions are undesirable and expensive.1 The Centers for Medicare & Medicaid Services (CMS) use hospital readmission rates as one measure of healthcare quality and hospital performance.2 In addition, the Patient Protection and Affordable Care Act of 2010 established a provision that decreases payments to hospitals with above-average readmission rates.3 Total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) are among the most common surgical procedures leading to readmission and cost almost $20 billion dollars annually in the Medicare population alone.1 Identifying factors that lead to readmissions after certain popular procedures may be a way to improve healthcare quality and outcomes while decreasing costs.

One such operation is shoulder arthroplasty (SA), which has surged in popularity over the past decade and is projected to increase faster than TKAs and THAs.4-6 SA is used to treat a variety of shoulder conditions, including osteoarthritis, inflammatory arthritis, severe proximal humeral fracture, avascular necrosis, and rotator cuff tear arthropathy.7-12 Much as with knee and hip arthroplasty, good outcomes have been reported with SA: decreased pain, improved range of motion, and high patient satisfaction.10,13 However, there have been few studies of rates of readmission after SA and the associated risk factors.3,14,15 The reported rates of early readmission after SA have ranged from 5.6% to 7.3%.3,14,15 These rates are comparable to rates of readmission after TKA (4.0%-6.6%) and THA (3.5%-8.4%).15-17Recently, CMS introduced legislation to void payments for hospital-acquired conditions (HACs), preventable medical conditions that patients develop during or as a result of their hospital care and that were not present on admission.18 Although many factors contribute to readmission, a recent study regarding all-cause readmission during the first 30 days after discharge found that almost 50% of 30-day readmissions after knee and hip replacements were potentially preventable.19 HACs resulting in readmission after SAs make up 9.3% to 34.5% of all readmissions, after anatomical total shoulder arthroplasties (ATSAs) and reverse total shoulder arthroplasties (RTSAs).3,14 The most common HACs include retained foreign body after surgery, air embolism, falls and trauma, catheter-associated urinary tract infection (CAUTI), surgical-site infection, deep vein thrombosis (DVT), and pulmonary embolism (PE).18 Raines and colleagues16 found that HACs accounted for 41.7% of all complications in knee or hip arthroplasty and that HACs were the greatest predictors of early readmission after both procedures.

We conducted a study to evaluate rates of readmission within 30 days after ATSA and RTSA and to describe the independent risk factors for readmission. We hypothesized that the rate of readmission after SA would be similar to the rate after knee and hip arthroplasty and that readmission risk factors would be similar. Elucidating these rates and associated risk factors may ultimately help to minimize the burden of disability on patients and the burden of financial costs on healthcare institutions.

Materials and Methods

Institutional Review Board approval was not required for this study, and all data used were de-identified to Health Insurance Portability and Accountability Act (HIPAA) standards. We used the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database for this study. The NSQIP was developed in the 1990s to improve surgical quality in the Veterans Health Administration and was later adapted by the ACS.20 NSQIP follows patients for 30 days after operations and provides clinical data and outcome measures that are closely regulated and internally audited.21 The program has continued to expand and now includes more than 400 institutions. The NSQIP database has been validated as a reliable source of surgical outcomes data, including outcomes data for orthopedic procedures, and has been used in other studies of readmissions.17,22

In the present study, the ACS-NSQIP files for the period 2011-2013 were queried for all total shoulder arthroplasties (TSAs) (Current Procedural Terminology [CPT] code 23472, which includes ATSA and RTSA). Descriptive analysis was performed to determine the overall readmission rate as well as the percentages of readmissions for medical and surgical complications. Reasons for readmission were collected from 2012 and 2013 (information from 2011 was absent).

The various patient parameters compiled within the database were examined in a review of ATSAs and RTSAs. Demographics, comorbidities, operative characteristics, and predischarge complications were amassed from these data. Demographics included age, sex, race, body mass index, smoking status, preoperative functional health status, and American Society of Anesthesiologists (ASA) score. Comorbidities included diabetes mellitus, hypertension, chronic corticosteroid use, coagulation disorder, peripheral vascular disease, chronic obstructive pulmonary disease (COPD), cardiac comorbidity (including congestive heart failure, history of myocardial infarction, previous coronary intervention or cardiac surgery, and angina), renal comorbidity (including acute renal failure and preoperative dialysis), neurologic comorbidity (including impaired sensorium, hemiplegia, history of transient ischemic attack, and history of cerebrovascular accident with or without residual deficit), and preoperative blood transfusion. Operative characteristics included resident involvement, operative time more than 1 SD from the mean (>164.4 minutes), intraoperative blood transfusion, and revision surgery. Predischarge complications included pneumonia, CAUTI, DVT, PE, postoperative bleeding that required transfusion, cerebrovascular accident, myocardial infarction, and sepsis. Surgical-site infection, CAUTI, DVT, and PE were selected for analysis because these HACs are common in our cohort.

After the data on these characteristics were collected, univariate analysis was performed to determine association with any readmission. Factors with P < .20 were then entered into multivariate analysis to determine independent risk factors for readmission. This P value was selected to make the model inclusive of any potentially important predictor. Univariate analysis was performed using the Fisher exact test. Multivariate analysis was performed using backward conditional binary logistic regression. Statistical significance was set at P < .05. All analysis was performed with SPSS Version 22.0 (SPSS).

 

 

Results

This study included a combined total of 3501 ATSAs and RTSAs performed between 2011 and 2013. The overall readmission rate was 2.7%. The associated diagnosis for readmission was available for 54% of the readmitted patients. Of the known readmission diagnoses, 33% were secondary to HACs.

Three independent risk factors for readmission were identified: revision surgery (odds ratio [OR], 2.59), 3 or more comorbidities (OR, 2.02), and extended length of stay (LOS, >4.3 days) during index admission (OR, 2.48). These factors, plus P values and ORs, are listed in Table 1.

Of the 51 readmissions, 34 (67%) were for medical complications, and 17 (33%) were for surgical complications. Pneumonia was the most common medical complication (11.8%), followed by UTI (7.8%), DVT (5.9%), PE (5.9%), and renal insufficiency (3.9%). Surgical-site infection was the most common surgical complication (13.7%), followed by prosthetic joint dislocation (9.8%) and hematoma (3.9%).

Of the HACs, 41.2% were surgical-site infections, 23.5% were CAUTIs, 17.6% were DVTs, and 17.6% were PEs (Table 2).

Other risk factors significantly (P < .05) associated with readmission were age over 75 years, dependent functional status, ASA score of 4 or higher, cardiac comorbidity, 2 or more comorbidities, postoperative CAUTI, extended LOS, and revision surgery (Table 3).
The most common comorbidities were hypertension (67.8%), diabetes (16.6%), and COPD (6.3%). Readmitted patients were more likely to be female (56.3%) than male (43.6%). The majority of patients were white (86.1%), and 48.1% were obese (body mass index, >30). In addition, 16.9% of readmissions had resident involvement in the operation, and 13.2% of readmissions had an operative time >164.4 minutes. Of readmitted patients, 3.8% required a postoperative blood transfusion (Table 4).

Discussion

Hospital readmissions are important because they represent quality of care and play a role in patient outcomes. Arthroplasty research has focused mainly on readmissions after primary knee and hip replacements.23-25

Given the increasing popularity of SAs, we initiated the present study to quantify short-term rates of readmission after ATSAs and RTSAs and to determine independent risk factors for readmission based on data from a national database. The results identified a 30-day readmission rate of 2.7%. Risk factors for readmission included revision surgery, 3 or more comorbidities, and extended LOS during the index admission.

Historical rates of early readmission after SA14 are comparable to those found in our study. Previously identified risk factors have included increasing age, Medicaid insurance status, low-volume surgical centers, and SA type.3 Mahoney and colleagues14 reported a 90-day readmission rate of 5.9%, but, when they removed hemiarthroplasty replacement from the analysis and shortened the readmission timeline to 30 days, the readmission rate was identical to the 2.7% rate in the present study. In their series from a single high-volume institution, the highest 90-day readmission rate was found for hemiarthroplasty (8.8%), followed by RTSA (6.6%) and ATSA (4.5%). In a study by Schairer and colleagues,3 the readmission rate was also influenced by replacement type, but their results differed from those of Mahoney and colleagues.14 Schairer and colleagues3 analyzed data from 7 state inpatient databases and found that the highest readmission rate was associated with RTSA (11.2%), followed by hemiarthroplasty (8.2%) and ATSA (6.0%). In both series, RTSA readmission rates were higher than ATSA readmission rates—consistent with the complication profiles of these procedures, with RTSA often provided as a surgery of last resort, after failure of other procedures, including ATSA.26 The lower 30-day readmission rate in the present study may be attributable to the fact that some surgical and medical complications may not have developed within this short time. Nonetheless, the majority of readmissions typically present within the first 30 days after SA.14,15 Other factors, including hospital volume, surgeon volume, race, and hospital type, may also influence readmission rates but could not be compared between studies.27,28

The present study found that revision surgery, 3 or more comorbidities, and extended LOS (>4.3 days) more than doubled the risk of readmission. Published SA revision rates range from 5% to 42%, with most revisions performed for instability, dislocation, infection, and component loosening.6,29 Complication rates are higher for revision SA than for primary SA, which may explain why revisions predispose patients to readmission.30 Compared with primary SAs, revision SAs are also more likely to be RTSAs, and these salvage procedures have been found to have high complication rates.31 In the present study, the most common comorbidities were hypertension, diabetes, and COPD; the literature supports these as some of the most common comorbid medical conditions in patients who undergo ATSA or RTSA.5,26,32 Furthermore, all 3 of these comorbidities have been shown to be independent predictors of increased postoperative complications in patients who undergo SA, which ultimately would increase the risk of readmission.3,26,33,34 Last, extended LOS has also been shown to increase the risk of unplanned readmissions after orthopedic procedures.35 Risk factors associated with increased LOS after ATSA or RTSA include female sex, advanced age, multiple comorbidities, and postoperative complications.32Several other factors must be noted with respect to individual risk for readmission. In the present study, age over 75 years, dependent functional status, ASA score of 4 or higher, and cardiac comorbidity were found to have a significant association with readmission. Increased age is a risk factor for increased postoperative complications, more medical comorbidities, and increased LOS.34,36 Older people are at higher risk of developing osteoarthritis and rotator cuff tear arthropathy and are more likely to undergo SA.5,6 Older people also are more likely to be dependent, which itself is a risk factor for readmission.19 An ASA score of 3 or 4 has been found to be associated with increased LOS and complications after SA, and cardiac comorbidities predispose patients to a variety of complications.34,36,37In studies that have combined surgical and medical factors, rates of complications early after ATSA and RTSA have ranged from 3.6% to 17.8%.26,38,39 After SAs, medical complications (80%) are more common than surgical complications (20%).39 In the present cohort, many more readmissions were for medical complications (67%) than for surgical complications (33%). In addition, Schairer and colleagues3 found medical complications associated with more than 80% of readmissions after SA.3 Infection was the most common medical reason (pneumonia) and surgical reason (surgical-site infection) for readmission—consistent with findings of other studies.3,35,40 Infection has accounted for 9.4% to 41.4% of readmissions after ATSA and RTSA.3,14In joint arthroplasty, infection occurs more often in patients with coexisting medical comorbidities, leading to higher mortality and increased LOS.41 Prosthetic joint dislocation was common as well—similar to findings in other studies.3,10In the present study, 33% of known readmission diagnoses were secondary to HACs. Surgical-site infection was the most common, followed by CAUTI, DVT, and PE. In another study, of knee and hip arthroplasties, HACs accounted for more than 40% of all complications and were the strongest predictor of early readmission.16 In SA studies, HACs were responsible for 9.3% to 34.5% of readmissions after ATSA and RTSA.3,14 Our finding (33%) is more in line with Mahoney and colleagues14 (34.5%) than Schairer and colleagues3 (9.3%). One explanation for the large discrepancy with Schairer and colleagues3 is that UTI was not among the medical reasons for readmission in their study, but it was in ours. Another difference is that we used a database that included data from multiple institutions. Last, Schairer and colleagues3 excluded revision SAs from their analysis (complication rates are higher for revision SAs than for primary SAs30). They also excluded cases of SA used for fracture (shown to increase the risk for PE42). The US Department of Health and Human Services estimated that patients experienced 1.3 million fewer HACs during the period 2010-2013, corresponding to a 17% decline over the 3 years.43 This translates to an estimated 50,000 fewer mortalities, and $12 billion saved in healthcare costs, over the same period.43 Preventing HACs helps reduce readmission rates while improving patient outcomes and decreasing healthcare costs.

This study had several limitations. We could not differentiate between ATSA and RTSA readmission rates because, for the study period, these procedures are collectively organized under a common CPT code in the NSQIP database. Readmission and complication rates are higher for RTSAs than for ATSAs.3,14 In addition, our data were limited to hospitals that were participating in NSQIP, which could lead to selection bias. We studied rates of only those readmissions and complications that occurred within 30 days, but many complications develop after 30 days, and these increase the readmission rate. Last, reasons for readmission were not recorded for 2011, so this information was available only for the final 2 years of the study. Despite these limitations, NSQIP still allows for a powerful study, as it includes multiple institutions and a very large cohort.

 

 

Conclusion

With medical costs increasing, focus has shifted to quality care and good outcomes with the goal of reducing readmissions and complications after various procedures. SA has recently become more popular because of its multiple indications, and this trend will continue. In the present study, the rate of readmission within 30 days after ATSA or RTSA was 2.7%. Revision surgery, 3 or more comorbidities, and extended LOS were independent risk factors that more than doubled the risk of readmission. Understanding the risk factors for short-term readmission will allow for better patient care and decreased costs, and will benefit the healthcare system as a whole.

Am J Orthop. 2016;45(6):E386-E392. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

References

1. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428.

2. Axon RN, Williams MV. Hospital readmission as an accountability measure. JAMA. 2011;305(5):504-505.

3. Schairer WW, Zhang AL, Feeley BT. Hospital readmissions after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(9):1349-1355.

4. Day JS, Lau E, Ong KL, Williams GR, Ramsey ML, Kurtz SM. Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015. J Shoulder Elbow Surg. 2010;19(8):1115-1120.

5. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254.

6. Jain NB, Yamaguchi K. The contribution of reverse shoulder arthroplasty to utilization of primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(12):1905-1912.

7. Bartelt R, Sperling JW, Schleck CD, Cofield RH. Shoulder arthroplasty in patients aged fifty-five years or younger with osteoarthritis. J Shoulder Elbow Surg. 2011;20(1):123-130.

8. Chalmers PN, Slikker W 3rd, Mall NA, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction–internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014;23(2):197-204.

9. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.

10. 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.

11. Fevang BT, Lygre SH, Bertelsen G, Skredderstuen A, Havelin LI, Furnes O. Good function after shoulder arthroplasty. Acta Orthop. 2012;83(5):467-473.

12. Orfaly RM, Rockwood CA Jr, Esenyel CZ, Wirth MA. Shoulder arthroplasty in cases with avascular necrosis of the humeral head. J Shoulder Elbow Surg. 2007;16(3 suppl):S27-S32.

13. Sperling JW, Cofield RH, Rowland CM. Minimum fifteen-year follow-up of Neer hemiarthroplasty and total shoulder arthroplasty in patients aged fifty years or younger. J Shoulder Elbow Surg. 2004;13(6):604-613.

14. Mahoney A, Bosco JA 3rd, Zuckerman JD. Readmission after shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(3):377-381.

15. Fehringer EV, Mikuls TR, Michaud KD, Henderson WG, O’Dell JR. Shoulder arthroplasties have fewer complications than hip or knee arthroplasties in US veterans. Clin Orthop Relat Res. 2010;468(3):717-722.

16. Raines BT, Ponce BA, Reed RD, Richman JS, Hawn MT. Hospital acquired conditions are the strongest predictor for early readmission: an analysis of 26,710 arthroplasties. J Arthroplasty. 2015;30(8):1299-1307.

17. Pugely AJ, Callaghan JJ, Martin CT, Cram P, Gao Y. Incidence of and risk factors for 30-day readmission following elective primary total joint arthroplasty: analysis from the ACS-NSQIP. J Arthroplasty. 2013;28(9):1499-1504.

18. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html. Published 2014. Accessed May 21, 2015.

19. Feigenbaum P, Neuwirth E, Trowbridge L, et al. Factors contributing to all-cause 30-day readmissions: a structured case series across 18 hospitals. Med Care. 2012;50(7):599-605.

20. Hall BL, Hamilton BH, Richards K, Bilimoria KY, Cohen ME, Ko CY. Does surgical quality improve in the American College of Surgeons National Surgical Quality Improvement Program: an evaluation of all participating hospitals. Ann Surg. 2009;250(3):363-376.

21. American College of Surgeons. About ACS NSQIP. http://www.facs.org/quality-programs/acs-nsqip/about. Published 2015. Accessed June 14, 2015.

22. Shiloach M, Frencher SK Jr, Steeger JE, et al. Toward robust information: data quality and inter-rater reliability in the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;210(1):6-16.

23. Bini SA, Fithian DC, Paxton LW, Khatod MX, Inacio MC, Namba RS. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25(1):114-117.

24. Husted H, Otte KS, Kristensen BB, Orsnes T, Kehlet H. Readmissions after fast-track hip and knee arthroplasty. Arch Orthop Trauma Surg. 2010;130(9):1185-1191.

25. Vorhies JS, Wang Y, Herndon J, Maloney WJ, Huddleston JI. Readmission and length of stay after total hip arthroplasty in a national Medicare sample. J Arthroplasty. 2011;26(6 suppl):119-123.

26. Ponce BA, Oladeji LO, Rogers ME, Menendez ME. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460-467.

27. Bozic KJ, Maselli J, Pekow PS, Lindenauer PK, Vail TP, Auerbach AD. The influence of procedure volumes and standardization of care on quality and efficiency in total joint replacement surgery. J Bone Joint Surg Am. 2010;92(16):2643-2652.

28. Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day readmission rates for Medicare beneficiaries by race and site of care. Ann Surg. 2014;259(6):1086-1090.

29. Bohsali KI, Wirth MA, Rockwood CA Jr. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292.

30. Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1647-1654.

31. Black EM, Roberts SM, Siegel E, Yannopoulos P, Higgins LD, Warner JJ. Reverse shoulder arthroplasty as salvage for failed prior arthroplasty in patients 65 years of age or younger. J Shoulder Elbow Surg. 2014;23(7):1036-1042.

32. Menendez ME, Baker DK, Fryberger CT, Ponce BA. Predictors of extended length of stay after elective shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):1527-1533.

33. Jain NB, Guller U, Pietrobon R, Bond TK, Higgins LD. Comorbidities increase complication rates in patients having arthroplasty. Clin Orthop Relat Res. 2005;(435):232-238.

34. Martin CT, Gao Y, Pugely AJ, Wolf BR. 30-day morbidity and mortality after elective shoulder arthroscopy: a review of 9410 cases. J Shoulder Elbow Surg. 2013;22(12):1667-1675.e1.

35. Dailey EA, Cizik A, Kasten J, Chapman JR, Lee MJ. Risk factors for readmission of orthopaedic surgical patients. J Bone Joint Surg Am. 2013;95(11):1012-1019.

36. Dunn JC, Lanzi J, Kusnezov N, Bader J, Waterman BR, Belmont PJ Jr. Predictors of length of stay after elective total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(5):754-759.

37. Maile MD, Engoren MC, Tremper KK, Jewell E, Kheterpal S. Worsening preoperative heart failure is associated with mortality and noncardiac complications, but not myocardial infarction after noncardiac surgery: a retrospective cohort study. Anesth Analg. 2014;119(3):522-532.

38. Farng E, Zingmond D, Krenek L, Soohoo NF. Factors predicting complication rates after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(4):557-563.

39. Waterman BR, Dunn JC, Bader J, Urrea L, Schoenfeld AJ, Belmont PJ Jr. Thirty-day morbidity and mortality after elective total shoulder arthroplasty: patient-based and surgical risk factors. J Shoulder Elbow Surg. 2015;24(1):24-30.

40. Kassin MT, Owen RM, Perez SD, et al. Risk factors for 30-day hospital readmission among general surgery patients. J Am Coll Surg. 2012;215(3):322-330.

41. Poultsides LA, Ma Y, Della Valle AG, Chiu YL, Sculco TP, Memtsoudis SG. In-hospital surgical site infections after primary hip and knee arthroplasty—incidence and risk factors. J Arthroplasty. 2013;28(3):385-389.

42. Young BL, Menendez ME, Baker DK, Ponce BA. Factors associated with in-hospital pulmonary embolism after shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):e271-e278.

43. US Department of Health and Human Services. Efforts to improve patient safety result in 1.3 million fewer patient harms, 50,000 lives saved and $12 billion in health spending avoided [press release]. http://www.hhs.gov/news/press/2014pres/12/20141202a.html. Published December 2, 2014. Accessed May 25, 2015.

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Hospital readmissions are undesirable and expensive.1 The Centers for Medicare & Medicaid Services (CMS) use hospital readmission rates as one measure of healthcare quality and hospital performance.2 In addition, the Patient Protection and Affordable Care Act of 2010 established a provision that decreases payments to hospitals with above-average readmission rates.3 Total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) are among the most common surgical procedures leading to readmission and cost almost $20 billion dollars annually in the Medicare population alone.1 Identifying factors that lead to readmissions after certain popular procedures may be a way to improve healthcare quality and outcomes while decreasing costs.

One such operation is shoulder arthroplasty (SA), which has surged in popularity over the past decade and is projected to increase faster than TKAs and THAs.4-6 SA is used to treat a variety of shoulder conditions, including osteoarthritis, inflammatory arthritis, severe proximal humeral fracture, avascular necrosis, and rotator cuff tear arthropathy.7-12 Much as with knee and hip arthroplasty, good outcomes have been reported with SA: decreased pain, improved range of motion, and high patient satisfaction.10,13 However, there have been few studies of rates of readmission after SA and the associated risk factors.3,14,15 The reported rates of early readmission after SA have ranged from 5.6% to 7.3%.3,14,15 These rates are comparable to rates of readmission after TKA (4.0%-6.6%) and THA (3.5%-8.4%).15-17Recently, CMS introduced legislation to void payments for hospital-acquired conditions (HACs), preventable medical conditions that patients develop during or as a result of their hospital care and that were not present on admission.18 Although many factors contribute to readmission, a recent study regarding all-cause readmission during the first 30 days after discharge found that almost 50% of 30-day readmissions after knee and hip replacements were potentially preventable.19 HACs resulting in readmission after SAs make up 9.3% to 34.5% of all readmissions, after anatomical total shoulder arthroplasties (ATSAs) and reverse total shoulder arthroplasties (RTSAs).3,14 The most common HACs include retained foreign body after surgery, air embolism, falls and trauma, catheter-associated urinary tract infection (CAUTI), surgical-site infection, deep vein thrombosis (DVT), and pulmonary embolism (PE).18 Raines and colleagues16 found that HACs accounted for 41.7% of all complications in knee or hip arthroplasty and that HACs were the greatest predictors of early readmission after both procedures.

We conducted a study to evaluate rates of readmission within 30 days after ATSA and RTSA and to describe the independent risk factors for readmission. We hypothesized that the rate of readmission after SA would be similar to the rate after knee and hip arthroplasty and that readmission risk factors would be similar. Elucidating these rates and associated risk factors may ultimately help to minimize the burden of disability on patients and the burden of financial costs on healthcare institutions.

Materials and Methods

Institutional Review Board approval was not required for this study, and all data used were de-identified to Health Insurance Portability and Accountability Act (HIPAA) standards. We used the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database for this study. The NSQIP was developed in the 1990s to improve surgical quality in the Veterans Health Administration and was later adapted by the ACS.20 NSQIP follows patients for 30 days after operations and provides clinical data and outcome measures that are closely regulated and internally audited.21 The program has continued to expand and now includes more than 400 institutions. The NSQIP database has been validated as a reliable source of surgical outcomes data, including outcomes data for orthopedic procedures, and has been used in other studies of readmissions.17,22

In the present study, the ACS-NSQIP files for the period 2011-2013 were queried for all total shoulder arthroplasties (TSAs) (Current Procedural Terminology [CPT] code 23472, which includes ATSA and RTSA). Descriptive analysis was performed to determine the overall readmission rate as well as the percentages of readmissions for medical and surgical complications. Reasons for readmission were collected from 2012 and 2013 (information from 2011 was absent).

The various patient parameters compiled within the database were examined in a review of ATSAs and RTSAs. Demographics, comorbidities, operative characteristics, and predischarge complications were amassed from these data. Demographics included age, sex, race, body mass index, smoking status, preoperative functional health status, and American Society of Anesthesiologists (ASA) score. Comorbidities included diabetes mellitus, hypertension, chronic corticosteroid use, coagulation disorder, peripheral vascular disease, chronic obstructive pulmonary disease (COPD), cardiac comorbidity (including congestive heart failure, history of myocardial infarction, previous coronary intervention or cardiac surgery, and angina), renal comorbidity (including acute renal failure and preoperative dialysis), neurologic comorbidity (including impaired sensorium, hemiplegia, history of transient ischemic attack, and history of cerebrovascular accident with or without residual deficit), and preoperative blood transfusion. Operative characteristics included resident involvement, operative time more than 1 SD from the mean (>164.4 minutes), intraoperative blood transfusion, and revision surgery. Predischarge complications included pneumonia, CAUTI, DVT, PE, postoperative bleeding that required transfusion, cerebrovascular accident, myocardial infarction, and sepsis. Surgical-site infection, CAUTI, DVT, and PE were selected for analysis because these HACs are common in our cohort.

After the data on these characteristics were collected, univariate analysis was performed to determine association with any readmission. Factors with P < .20 were then entered into multivariate analysis to determine independent risk factors for readmission. This P value was selected to make the model inclusive of any potentially important predictor. Univariate analysis was performed using the Fisher exact test. Multivariate analysis was performed using backward conditional binary logistic regression. Statistical significance was set at P < .05. All analysis was performed with SPSS Version 22.0 (SPSS).

 

 

Results

This study included a combined total of 3501 ATSAs and RTSAs performed between 2011 and 2013. The overall readmission rate was 2.7%. The associated diagnosis for readmission was available for 54% of the readmitted patients. Of the known readmission diagnoses, 33% were secondary to HACs.

Three independent risk factors for readmission were identified: revision surgery (odds ratio [OR], 2.59), 3 or more comorbidities (OR, 2.02), and extended length of stay (LOS, >4.3 days) during index admission (OR, 2.48). These factors, plus P values and ORs, are listed in Table 1.

Of the 51 readmissions, 34 (67%) were for medical complications, and 17 (33%) were for surgical complications. Pneumonia was the most common medical complication (11.8%), followed by UTI (7.8%), DVT (5.9%), PE (5.9%), and renal insufficiency (3.9%). Surgical-site infection was the most common surgical complication (13.7%), followed by prosthetic joint dislocation (9.8%) and hematoma (3.9%).

Of the HACs, 41.2% were surgical-site infections, 23.5% were CAUTIs, 17.6% were DVTs, and 17.6% were PEs (Table 2).

Other risk factors significantly (P < .05) associated with readmission were age over 75 years, dependent functional status, ASA score of 4 or higher, cardiac comorbidity, 2 or more comorbidities, postoperative CAUTI, extended LOS, and revision surgery (Table 3).
The most common comorbidities were hypertension (67.8%), diabetes (16.6%), and COPD (6.3%). Readmitted patients were more likely to be female (56.3%) than male (43.6%). The majority of patients were white (86.1%), and 48.1% were obese (body mass index, >30). In addition, 16.9% of readmissions had resident involvement in the operation, and 13.2% of readmissions had an operative time >164.4 minutes. Of readmitted patients, 3.8% required a postoperative blood transfusion (Table 4).

Discussion

Hospital readmissions are important because they represent quality of care and play a role in patient outcomes. Arthroplasty research has focused mainly on readmissions after primary knee and hip replacements.23-25

Given the increasing popularity of SAs, we initiated the present study to quantify short-term rates of readmission after ATSAs and RTSAs and to determine independent risk factors for readmission based on data from a national database. The results identified a 30-day readmission rate of 2.7%. Risk factors for readmission included revision surgery, 3 or more comorbidities, and extended LOS during the index admission.

Historical rates of early readmission after SA14 are comparable to those found in our study. Previously identified risk factors have included increasing age, Medicaid insurance status, low-volume surgical centers, and SA type.3 Mahoney and colleagues14 reported a 90-day readmission rate of 5.9%, but, when they removed hemiarthroplasty replacement from the analysis and shortened the readmission timeline to 30 days, the readmission rate was identical to the 2.7% rate in the present study. In their series from a single high-volume institution, the highest 90-day readmission rate was found for hemiarthroplasty (8.8%), followed by RTSA (6.6%) and ATSA (4.5%). In a study by Schairer and colleagues,3 the readmission rate was also influenced by replacement type, but their results differed from those of Mahoney and colleagues.14 Schairer and colleagues3 analyzed data from 7 state inpatient databases and found that the highest readmission rate was associated with RTSA (11.2%), followed by hemiarthroplasty (8.2%) and ATSA (6.0%). In both series, RTSA readmission rates were higher than ATSA readmission rates—consistent with the complication profiles of these procedures, with RTSA often provided as a surgery of last resort, after failure of other procedures, including ATSA.26 The lower 30-day readmission rate in the present study may be attributable to the fact that some surgical and medical complications may not have developed within this short time. Nonetheless, the majority of readmissions typically present within the first 30 days after SA.14,15 Other factors, including hospital volume, surgeon volume, race, and hospital type, may also influence readmission rates but could not be compared between studies.27,28

The present study found that revision surgery, 3 or more comorbidities, and extended LOS (>4.3 days) more than doubled the risk of readmission. Published SA revision rates range from 5% to 42%, with most revisions performed for instability, dislocation, infection, and component loosening.6,29 Complication rates are higher for revision SA than for primary SA, which may explain why revisions predispose patients to readmission.30 Compared with primary SAs, revision SAs are also more likely to be RTSAs, and these salvage procedures have been found to have high complication rates.31 In the present study, the most common comorbidities were hypertension, diabetes, and COPD; the literature supports these as some of the most common comorbid medical conditions in patients who undergo ATSA or RTSA.5,26,32 Furthermore, all 3 of these comorbidities have been shown to be independent predictors of increased postoperative complications in patients who undergo SA, which ultimately would increase the risk of readmission.3,26,33,34 Last, extended LOS has also been shown to increase the risk of unplanned readmissions after orthopedic procedures.35 Risk factors associated with increased LOS after ATSA or RTSA include female sex, advanced age, multiple comorbidities, and postoperative complications.32Several other factors must be noted with respect to individual risk for readmission. In the present study, age over 75 years, dependent functional status, ASA score of 4 or higher, and cardiac comorbidity were found to have a significant association with readmission. Increased age is a risk factor for increased postoperative complications, more medical comorbidities, and increased LOS.34,36 Older people are at higher risk of developing osteoarthritis and rotator cuff tear arthropathy and are more likely to undergo SA.5,6 Older people also are more likely to be dependent, which itself is a risk factor for readmission.19 An ASA score of 3 or 4 has been found to be associated with increased LOS and complications after SA, and cardiac comorbidities predispose patients to a variety of complications.34,36,37In studies that have combined surgical and medical factors, rates of complications early after ATSA and RTSA have ranged from 3.6% to 17.8%.26,38,39 After SAs, medical complications (80%) are more common than surgical complications (20%).39 In the present cohort, many more readmissions were for medical complications (67%) than for surgical complications (33%). In addition, Schairer and colleagues3 found medical complications associated with more than 80% of readmissions after SA.3 Infection was the most common medical reason (pneumonia) and surgical reason (surgical-site infection) for readmission—consistent with findings of other studies.3,35,40 Infection has accounted for 9.4% to 41.4% of readmissions after ATSA and RTSA.3,14In joint arthroplasty, infection occurs more often in patients with coexisting medical comorbidities, leading to higher mortality and increased LOS.41 Prosthetic joint dislocation was common as well—similar to findings in other studies.3,10In the present study, 33% of known readmission diagnoses were secondary to HACs. Surgical-site infection was the most common, followed by CAUTI, DVT, and PE. In another study, of knee and hip arthroplasties, HACs accounted for more than 40% of all complications and were the strongest predictor of early readmission.16 In SA studies, HACs were responsible for 9.3% to 34.5% of readmissions after ATSA and RTSA.3,14 Our finding (33%) is more in line with Mahoney and colleagues14 (34.5%) than Schairer and colleagues3 (9.3%). One explanation for the large discrepancy with Schairer and colleagues3 is that UTI was not among the medical reasons for readmission in their study, but it was in ours. Another difference is that we used a database that included data from multiple institutions. Last, Schairer and colleagues3 excluded revision SAs from their analysis (complication rates are higher for revision SAs than for primary SAs30). They also excluded cases of SA used for fracture (shown to increase the risk for PE42). The US Department of Health and Human Services estimated that patients experienced 1.3 million fewer HACs during the period 2010-2013, corresponding to a 17% decline over the 3 years.43 This translates to an estimated 50,000 fewer mortalities, and $12 billion saved in healthcare costs, over the same period.43 Preventing HACs helps reduce readmission rates while improving patient outcomes and decreasing healthcare costs.

This study had several limitations. We could not differentiate between ATSA and RTSA readmission rates because, for the study period, these procedures are collectively organized under a common CPT code in the NSQIP database. Readmission and complication rates are higher for RTSAs than for ATSAs.3,14 In addition, our data were limited to hospitals that were participating in NSQIP, which could lead to selection bias. We studied rates of only those readmissions and complications that occurred within 30 days, but many complications develop after 30 days, and these increase the readmission rate. Last, reasons for readmission were not recorded for 2011, so this information was available only for the final 2 years of the study. Despite these limitations, NSQIP still allows for a powerful study, as it includes multiple institutions and a very large cohort.

 

 

Conclusion

With medical costs increasing, focus has shifted to quality care and good outcomes with the goal of reducing readmissions and complications after various procedures. SA has recently become more popular because of its multiple indications, and this trend will continue. In the present study, the rate of readmission within 30 days after ATSA or RTSA was 2.7%. Revision surgery, 3 or more comorbidities, and extended LOS were independent risk factors that more than doubled the risk of readmission. Understanding the risk factors for short-term readmission will allow for better patient care and decreased costs, and will benefit the healthcare system as a whole.

Am J Orthop. 2016;45(6):E386-E392. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Hospital readmissions are undesirable and expensive.1 The Centers for Medicare & Medicaid Services (CMS) use hospital readmission rates as one measure of healthcare quality and hospital performance.2 In addition, the Patient Protection and Affordable Care Act of 2010 established a provision that decreases payments to hospitals with above-average readmission rates.3 Total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) are among the most common surgical procedures leading to readmission and cost almost $20 billion dollars annually in the Medicare population alone.1 Identifying factors that lead to readmissions after certain popular procedures may be a way to improve healthcare quality and outcomes while decreasing costs.

One such operation is shoulder arthroplasty (SA), which has surged in popularity over the past decade and is projected to increase faster than TKAs and THAs.4-6 SA is used to treat a variety of shoulder conditions, including osteoarthritis, inflammatory arthritis, severe proximal humeral fracture, avascular necrosis, and rotator cuff tear arthropathy.7-12 Much as with knee and hip arthroplasty, good outcomes have been reported with SA: decreased pain, improved range of motion, and high patient satisfaction.10,13 However, there have been few studies of rates of readmission after SA and the associated risk factors.3,14,15 The reported rates of early readmission after SA have ranged from 5.6% to 7.3%.3,14,15 These rates are comparable to rates of readmission after TKA (4.0%-6.6%) and THA (3.5%-8.4%).15-17Recently, CMS introduced legislation to void payments for hospital-acquired conditions (HACs), preventable medical conditions that patients develop during or as a result of their hospital care and that were not present on admission.18 Although many factors contribute to readmission, a recent study regarding all-cause readmission during the first 30 days after discharge found that almost 50% of 30-day readmissions after knee and hip replacements were potentially preventable.19 HACs resulting in readmission after SAs make up 9.3% to 34.5% of all readmissions, after anatomical total shoulder arthroplasties (ATSAs) and reverse total shoulder arthroplasties (RTSAs).3,14 The most common HACs include retained foreign body after surgery, air embolism, falls and trauma, catheter-associated urinary tract infection (CAUTI), surgical-site infection, deep vein thrombosis (DVT), and pulmonary embolism (PE).18 Raines and colleagues16 found that HACs accounted for 41.7% of all complications in knee or hip arthroplasty and that HACs were the greatest predictors of early readmission after both procedures.

We conducted a study to evaluate rates of readmission within 30 days after ATSA and RTSA and to describe the independent risk factors for readmission. We hypothesized that the rate of readmission after SA would be similar to the rate after knee and hip arthroplasty and that readmission risk factors would be similar. Elucidating these rates and associated risk factors may ultimately help to minimize the burden of disability on patients and the burden of financial costs on healthcare institutions.

Materials and Methods

Institutional Review Board approval was not required for this study, and all data used were de-identified to Health Insurance Portability and Accountability Act (HIPAA) standards. We used the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database for this study. The NSQIP was developed in the 1990s to improve surgical quality in the Veterans Health Administration and was later adapted by the ACS.20 NSQIP follows patients for 30 days after operations and provides clinical data and outcome measures that are closely regulated and internally audited.21 The program has continued to expand and now includes more than 400 institutions. The NSQIP database has been validated as a reliable source of surgical outcomes data, including outcomes data for orthopedic procedures, and has been used in other studies of readmissions.17,22

In the present study, the ACS-NSQIP files for the period 2011-2013 were queried for all total shoulder arthroplasties (TSAs) (Current Procedural Terminology [CPT] code 23472, which includes ATSA and RTSA). Descriptive analysis was performed to determine the overall readmission rate as well as the percentages of readmissions for medical and surgical complications. Reasons for readmission were collected from 2012 and 2013 (information from 2011 was absent).

The various patient parameters compiled within the database were examined in a review of ATSAs and RTSAs. Demographics, comorbidities, operative characteristics, and predischarge complications were amassed from these data. Demographics included age, sex, race, body mass index, smoking status, preoperative functional health status, and American Society of Anesthesiologists (ASA) score. Comorbidities included diabetes mellitus, hypertension, chronic corticosteroid use, coagulation disorder, peripheral vascular disease, chronic obstructive pulmonary disease (COPD), cardiac comorbidity (including congestive heart failure, history of myocardial infarction, previous coronary intervention or cardiac surgery, and angina), renal comorbidity (including acute renal failure and preoperative dialysis), neurologic comorbidity (including impaired sensorium, hemiplegia, history of transient ischemic attack, and history of cerebrovascular accident with or without residual deficit), and preoperative blood transfusion. Operative characteristics included resident involvement, operative time more than 1 SD from the mean (>164.4 minutes), intraoperative blood transfusion, and revision surgery. Predischarge complications included pneumonia, CAUTI, DVT, PE, postoperative bleeding that required transfusion, cerebrovascular accident, myocardial infarction, and sepsis. Surgical-site infection, CAUTI, DVT, and PE were selected for analysis because these HACs are common in our cohort.

After the data on these characteristics were collected, univariate analysis was performed to determine association with any readmission. Factors with P < .20 were then entered into multivariate analysis to determine independent risk factors for readmission. This P value was selected to make the model inclusive of any potentially important predictor. Univariate analysis was performed using the Fisher exact test. Multivariate analysis was performed using backward conditional binary logistic regression. Statistical significance was set at P < .05. All analysis was performed with SPSS Version 22.0 (SPSS).

 

 

Results

This study included a combined total of 3501 ATSAs and RTSAs performed between 2011 and 2013. The overall readmission rate was 2.7%. The associated diagnosis for readmission was available for 54% of the readmitted patients. Of the known readmission diagnoses, 33% were secondary to HACs.

Three independent risk factors for readmission were identified: revision surgery (odds ratio [OR], 2.59), 3 or more comorbidities (OR, 2.02), and extended length of stay (LOS, >4.3 days) during index admission (OR, 2.48). These factors, plus P values and ORs, are listed in Table 1.

Of the 51 readmissions, 34 (67%) were for medical complications, and 17 (33%) were for surgical complications. Pneumonia was the most common medical complication (11.8%), followed by UTI (7.8%), DVT (5.9%), PE (5.9%), and renal insufficiency (3.9%). Surgical-site infection was the most common surgical complication (13.7%), followed by prosthetic joint dislocation (9.8%) and hematoma (3.9%).

Of the HACs, 41.2% were surgical-site infections, 23.5% were CAUTIs, 17.6% were DVTs, and 17.6% were PEs (Table 2).

Other risk factors significantly (P < .05) associated with readmission were age over 75 years, dependent functional status, ASA score of 4 or higher, cardiac comorbidity, 2 or more comorbidities, postoperative CAUTI, extended LOS, and revision surgery (Table 3).
The most common comorbidities were hypertension (67.8%), diabetes (16.6%), and COPD (6.3%). Readmitted patients were more likely to be female (56.3%) than male (43.6%). The majority of patients were white (86.1%), and 48.1% were obese (body mass index, >30). In addition, 16.9% of readmissions had resident involvement in the operation, and 13.2% of readmissions had an operative time >164.4 minutes. Of readmitted patients, 3.8% required a postoperative blood transfusion (Table 4).

Discussion

Hospital readmissions are important because they represent quality of care and play a role in patient outcomes. Arthroplasty research has focused mainly on readmissions after primary knee and hip replacements.23-25

Given the increasing popularity of SAs, we initiated the present study to quantify short-term rates of readmission after ATSAs and RTSAs and to determine independent risk factors for readmission based on data from a national database. The results identified a 30-day readmission rate of 2.7%. Risk factors for readmission included revision surgery, 3 or more comorbidities, and extended LOS during the index admission.

Historical rates of early readmission after SA14 are comparable to those found in our study. Previously identified risk factors have included increasing age, Medicaid insurance status, low-volume surgical centers, and SA type.3 Mahoney and colleagues14 reported a 90-day readmission rate of 5.9%, but, when they removed hemiarthroplasty replacement from the analysis and shortened the readmission timeline to 30 days, the readmission rate was identical to the 2.7% rate in the present study. In their series from a single high-volume institution, the highest 90-day readmission rate was found for hemiarthroplasty (8.8%), followed by RTSA (6.6%) and ATSA (4.5%). In a study by Schairer and colleagues,3 the readmission rate was also influenced by replacement type, but their results differed from those of Mahoney and colleagues.14 Schairer and colleagues3 analyzed data from 7 state inpatient databases and found that the highest readmission rate was associated with RTSA (11.2%), followed by hemiarthroplasty (8.2%) and ATSA (6.0%). In both series, RTSA readmission rates were higher than ATSA readmission rates—consistent with the complication profiles of these procedures, with RTSA often provided as a surgery of last resort, after failure of other procedures, including ATSA.26 The lower 30-day readmission rate in the present study may be attributable to the fact that some surgical and medical complications may not have developed within this short time. Nonetheless, the majority of readmissions typically present within the first 30 days after SA.14,15 Other factors, including hospital volume, surgeon volume, race, and hospital type, may also influence readmission rates but could not be compared between studies.27,28

The present study found that revision surgery, 3 or more comorbidities, and extended LOS (>4.3 days) more than doubled the risk of readmission. Published SA revision rates range from 5% to 42%, with most revisions performed for instability, dislocation, infection, and component loosening.6,29 Complication rates are higher for revision SA than for primary SA, which may explain why revisions predispose patients to readmission.30 Compared with primary SAs, revision SAs are also more likely to be RTSAs, and these salvage procedures have been found to have high complication rates.31 In the present study, the most common comorbidities were hypertension, diabetes, and COPD; the literature supports these as some of the most common comorbid medical conditions in patients who undergo ATSA or RTSA.5,26,32 Furthermore, all 3 of these comorbidities have been shown to be independent predictors of increased postoperative complications in patients who undergo SA, which ultimately would increase the risk of readmission.3,26,33,34 Last, extended LOS has also been shown to increase the risk of unplanned readmissions after orthopedic procedures.35 Risk factors associated with increased LOS after ATSA or RTSA include female sex, advanced age, multiple comorbidities, and postoperative complications.32Several other factors must be noted with respect to individual risk for readmission. In the present study, age over 75 years, dependent functional status, ASA score of 4 or higher, and cardiac comorbidity were found to have a significant association with readmission. Increased age is a risk factor for increased postoperative complications, more medical comorbidities, and increased LOS.34,36 Older people are at higher risk of developing osteoarthritis and rotator cuff tear arthropathy and are more likely to undergo SA.5,6 Older people also are more likely to be dependent, which itself is a risk factor for readmission.19 An ASA score of 3 or 4 has been found to be associated with increased LOS and complications after SA, and cardiac comorbidities predispose patients to a variety of complications.34,36,37In studies that have combined surgical and medical factors, rates of complications early after ATSA and RTSA have ranged from 3.6% to 17.8%.26,38,39 After SAs, medical complications (80%) are more common than surgical complications (20%).39 In the present cohort, many more readmissions were for medical complications (67%) than for surgical complications (33%). In addition, Schairer and colleagues3 found medical complications associated with more than 80% of readmissions after SA.3 Infection was the most common medical reason (pneumonia) and surgical reason (surgical-site infection) for readmission—consistent with findings of other studies.3,35,40 Infection has accounted for 9.4% to 41.4% of readmissions after ATSA and RTSA.3,14In joint arthroplasty, infection occurs more often in patients with coexisting medical comorbidities, leading to higher mortality and increased LOS.41 Prosthetic joint dislocation was common as well—similar to findings in other studies.3,10In the present study, 33% of known readmission diagnoses were secondary to HACs. Surgical-site infection was the most common, followed by CAUTI, DVT, and PE. In another study, of knee and hip arthroplasties, HACs accounted for more than 40% of all complications and were the strongest predictor of early readmission.16 In SA studies, HACs were responsible for 9.3% to 34.5% of readmissions after ATSA and RTSA.3,14 Our finding (33%) is more in line with Mahoney and colleagues14 (34.5%) than Schairer and colleagues3 (9.3%). One explanation for the large discrepancy with Schairer and colleagues3 is that UTI was not among the medical reasons for readmission in their study, but it was in ours. Another difference is that we used a database that included data from multiple institutions. Last, Schairer and colleagues3 excluded revision SAs from their analysis (complication rates are higher for revision SAs than for primary SAs30). They also excluded cases of SA used for fracture (shown to increase the risk for PE42). The US Department of Health and Human Services estimated that patients experienced 1.3 million fewer HACs during the period 2010-2013, corresponding to a 17% decline over the 3 years.43 This translates to an estimated 50,000 fewer mortalities, and $12 billion saved in healthcare costs, over the same period.43 Preventing HACs helps reduce readmission rates while improving patient outcomes and decreasing healthcare costs.

This study had several limitations. We could not differentiate between ATSA and RTSA readmission rates because, for the study period, these procedures are collectively organized under a common CPT code in the NSQIP database. Readmission and complication rates are higher for RTSAs than for ATSAs.3,14 In addition, our data were limited to hospitals that were participating in NSQIP, which could lead to selection bias. We studied rates of only those readmissions and complications that occurred within 30 days, but many complications develop after 30 days, and these increase the readmission rate. Last, reasons for readmission were not recorded for 2011, so this information was available only for the final 2 years of the study. Despite these limitations, NSQIP still allows for a powerful study, as it includes multiple institutions and a very large cohort.

 

 

Conclusion

With medical costs increasing, focus has shifted to quality care and good outcomes with the goal of reducing readmissions and complications after various procedures. SA has recently become more popular because of its multiple indications, and this trend will continue. In the present study, the rate of readmission within 30 days after ATSA or RTSA was 2.7%. Revision surgery, 3 or more comorbidities, and extended LOS were independent risk factors that more than doubled the risk of readmission. Understanding the risk factors for short-term readmission will allow for better patient care and decreased costs, and will benefit the healthcare system as a whole.

Am J Orthop. 2016;45(6):E386-E392. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

References

1. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428.

2. Axon RN, Williams MV. Hospital readmission as an accountability measure. JAMA. 2011;305(5):504-505.

3. Schairer WW, Zhang AL, Feeley BT. Hospital readmissions after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(9):1349-1355.

4. Day JS, Lau E, Ong KL, Williams GR, Ramsey ML, Kurtz SM. Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015. J Shoulder Elbow Surg. 2010;19(8):1115-1120.

5. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254.

6. Jain NB, Yamaguchi K. The contribution of reverse shoulder arthroplasty to utilization of primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(12):1905-1912.

7. Bartelt R, Sperling JW, Schleck CD, Cofield RH. Shoulder arthroplasty in patients aged fifty-five years or younger with osteoarthritis. J Shoulder Elbow Surg. 2011;20(1):123-130.

8. Chalmers PN, Slikker W 3rd, Mall NA, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction–internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014;23(2):197-204.

9. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.

10. 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.

11. Fevang BT, Lygre SH, Bertelsen G, Skredderstuen A, Havelin LI, Furnes O. Good function after shoulder arthroplasty. Acta Orthop. 2012;83(5):467-473.

12. Orfaly RM, Rockwood CA Jr, Esenyel CZ, Wirth MA. Shoulder arthroplasty in cases with avascular necrosis of the humeral head. J Shoulder Elbow Surg. 2007;16(3 suppl):S27-S32.

13. Sperling JW, Cofield RH, Rowland CM. Minimum fifteen-year follow-up of Neer hemiarthroplasty and total shoulder arthroplasty in patients aged fifty years or younger. J Shoulder Elbow Surg. 2004;13(6):604-613.

14. Mahoney A, Bosco JA 3rd, Zuckerman JD. Readmission after shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(3):377-381.

15. Fehringer EV, Mikuls TR, Michaud KD, Henderson WG, O’Dell JR. Shoulder arthroplasties have fewer complications than hip or knee arthroplasties in US veterans. Clin Orthop Relat Res. 2010;468(3):717-722.

16. Raines BT, Ponce BA, Reed RD, Richman JS, Hawn MT. Hospital acquired conditions are the strongest predictor for early readmission: an analysis of 26,710 arthroplasties. J Arthroplasty. 2015;30(8):1299-1307.

17. Pugely AJ, Callaghan JJ, Martin CT, Cram P, Gao Y. Incidence of and risk factors for 30-day readmission following elective primary total joint arthroplasty: analysis from the ACS-NSQIP. J Arthroplasty. 2013;28(9):1499-1504.

18. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html. Published 2014. Accessed May 21, 2015.

19. Feigenbaum P, Neuwirth E, Trowbridge L, et al. Factors contributing to all-cause 30-day readmissions: a structured case series across 18 hospitals. Med Care. 2012;50(7):599-605.

20. Hall BL, Hamilton BH, Richards K, Bilimoria KY, Cohen ME, Ko CY. Does surgical quality improve in the American College of Surgeons National Surgical Quality Improvement Program: an evaluation of all participating hospitals. Ann Surg. 2009;250(3):363-376.

21. American College of Surgeons. About ACS NSQIP. http://www.facs.org/quality-programs/acs-nsqip/about. Published 2015. Accessed June 14, 2015.

22. Shiloach M, Frencher SK Jr, Steeger JE, et al. Toward robust information: data quality and inter-rater reliability in the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;210(1):6-16.

23. Bini SA, Fithian DC, Paxton LW, Khatod MX, Inacio MC, Namba RS. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25(1):114-117.

24. Husted H, Otte KS, Kristensen BB, Orsnes T, Kehlet H. Readmissions after fast-track hip and knee arthroplasty. Arch Orthop Trauma Surg. 2010;130(9):1185-1191.

25. Vorhies JS, Wang Y, Herndon J, Maloney WJ, Huddleston JI. Readmission and length of stay after total hip arthroplasty in a national Medicare sample. J Arthroplasty. 2011;26(6 suppl):119-123.

26. Ponce BA, Oladeji LO, Rogers ME, Menendez ME. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460-467.

27. Bozic KJ, Maselli J, Pekow PS, Lindenauer PK, Vail TP, Auerbach AD. The influence of procedure volumes and standardization of care on quality and efficiency in total joint replacement surgery. J Bone Joint Surg Am. 2010;92(16):2643-2652.

28. Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day readmission rates for Medicare beneficiaries by race and site of care. Ann Surg. 2014;259(6):1086-1090.

29. Bohsali KI, Wirth MA, Rockwood CA Jr. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292.

30. Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1647-1654.

31. Black EM, Roberts SM, Siegel E, Yannopoulos P, Higgins LD, Warner JJ. Reverse shoulder arthroplasty as salvage for failed prior arthroplasty in patients 65 years of age or younger. J Shoulder Elbow Surg. 2014;23(7):1036-1042.

32. Menendez ME, Baker DK, Fryberger CT, Ponce BA. Predictors of extended length of stay after elective shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):1527-1533.

33. Jain NB, Guller U, Pietrobon R, Bond TK, Higgins LD. Comorbidities increase complication rates in patients having arthroplasty. Clin Orthop Relat Res. 2005;(435):232-238.

34. Martin CT, Gao Y, Pugely AJ, Wolf BR. 30-day morbidity and mortality after elective shoulder arthroscopy: a review of 9410 cases. J Shoulder Elbow Surg. 2013;22(12):1667-1675.e1.

35. Dailey EA, Cizik A, Kasten J, Chapman JR, Lee MJ. Risk factors for readmission of orthopaedic surgical patients. J Bone Joint Surg Am. 2013;95(11):1012-1019.

36. Dunn JC, Lanzi J, Kusnezov N, Bader J, Waterman BR, Belmont PJ Jr. Predictors of length of stay after elective total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(5):754-759.

37. Maile MD, Engoren MC, Tremper KK, Jewell E, Kheterpal S. Worsening preoperative heart failure is associated with mortality and noncardiac complications, but not myocardial infarction after noncardiac surgery: a retrospective cohort study. Anesth Analg. 2014;119(3):522-532.

38. Farng E, Zingmond D, Krenek L, Soohoo NF. Factors predicting complication rates after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(4):557-563.

39. Waterman BR, Dunn JC, Bader J, Urrea L, Schoenfeld AJ, Belmont PJ Jr. Thirty-day morbidity and mortality after elective total shoulder arthroplasty: patient-based and surgical risk factors. J Shoulder Elbow Surg. 2015;24(1):24-30.

40. Kassin MT, Owen RM, Perez SD, et al. Risk factors for 30-day hospital readmission among general surgery patients. J Am Coll Surg. 2012;215(3):322-330.

41. Poultsides LA, Ma Y, Della Valle AG, Chiu YL, Sculco TP, Memtsoudis SG. In-hospital surgical site infections after primary hip and knee arthroplasty—incidence and risk factors. J Arthroplasty. 2013;28(3):385-389.

42. Young BL, Menendez ME, Baker DK, Ponce BA. Factors associated with in-hospital pulmonary embolism after shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):e271-e278.

43. US Department of Health and Human Services. Efforts to improve patient safety result in 1.3 million fewer patient harms, 50,000 lives saved and $12 billion in health spending avoided [press release]. http://www.hhs.gov/news/press/2014pres/12/20141202a.html. Published December 2, 2014. Accessed May 25, 2015.

References

1. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428.

2. Axon RN, Williams MV. Hospital readmission as an accountability measure. JAMA. 2011;305(5):504-505.

3. Schairer WW, Zhang AL, Feeley BT. Hospital readmissions after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(9):1349-1355.

4. Day JS, Lau E, Ong KL, Williams GR, Ramsey ML, Kurtz SM. Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015. J Shoulder Elbow Surg. 2010;19(8):1115-1120.

5. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254.

6. Jain NB, Yamaguchi K. The contribution of reverse shoulder arthroplasty to utilization of primary shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(12):1905-1912.

7. Bartelt R, Sperling JW, Schleck CD, Cofield RH. Shoulder arthroplasty in patients aged fifty-five years or younger with osteoarthritis. J Shoulder Elbow Surg. 2011;20(1):123-130.

8. Chalmers PN, Slikker W 3rd, Mall NA, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction–internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014;23(2):197-204.

9. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002;11(2):130-135.

10. 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.

11. Fevang BT, Lygre SH, Bertelsen G, Skredderstuen A, Havelin LI, Furnes O. Good function after shoulder arthroplasty. Acta Orthop. 2012;83(5):467-473.

12. Orfaly RM, Rockwood CA Jr, Esenyel CZ, Wirth MA. Shoulder arthroplasty in cases with avascular necrosis of the humeral head. J Shoulder Elbow Surg. 2007;16(3 suppl):S27-S32.

13. Sperling JW, Cofield RH, Rowland CM. Minimum fifteen-year follow-up of Neer hemiarthroplasty and total shoulder arthroplasty in patients aged fifty years or younger. J Shoulder Elbow Surg. 2004;13(6):604-613.

14. Mahoney A, Bosco JA 3rd, Zuckerman JD. Readmission after shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(3):377-381.

15. Fehringer EV, Mikuls TR, Michaud KD, Henderson WG, O’Dell JR. Shoulder arthroplasties have fewer complications than hip or knee arthroplasties in US veterans. Clin Orthop Relat Res. 2010;468(3):717-722.

16. Raines BT, Ponce BA, Reed RD, Richman JS, Hawn MT. Hospital acquired conditions are the strongest predictor for early readmission: an analysis of 26,710 arthroplasties. J Arthroplasty. 2015;30(8):1299-1307.

17. Pugely AJ, Callaghan JJ, Martin CT, Cram P, Gao Y. Incidence of and risk factors for 30-day readmission following elective primary total joint arthroplasty: analysis from the ACS-NSQIP. J Arthroplasty. 2013;28(9):1499-1504.

18. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html. Published 2014. Accessed May 21, 2015.

19. Feigenbaum P, Neuwirth E, Trowbridge L, et al. Factors contributing to all-cause 30-day readmissions: a structured case series across 18 hospitals. Med Care. 2012;50(7):599-605.

20. Hall BL, Hamilton BH, Richards K, Bilimoria KY, Cohen ME, Ko CY. Does surgical quality improve in the American College of Surgeons National Surgical Quality Improvement Program: an evaluation of all participating hospitals. Ann Surg. 2009;250(3):363-376.

21. American College of Surgeons. About ACS NSQIP. http://www.facs.org/quality-programs/acs-nsqip/about. Published 2015. Accessed June 14, 2015.

22. Shiloach M, Frencher SK Jr, Steeger JE, et al. Toward robust information: data quality and inter-rater reliability in the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;210(1):6-16.

23. Bini SA, Fithian DC, Paxton LW, Khatod MX, Inacio MC, Namba RS. Does discharge disposition after primary total joint arthroplasty affect readmission rates? J Arthroplasty. 2010;25(1):114-117.

24. Husted H, Otte KS, Kristensen BB, Orsnes T, Kehlet H. Readmissions after fast-track hip and knee arthroplasty. Arch Orthop Trauma Surg. 2010;130(9):1185-1191.

25. Vorhies JS, Wang Y, Herndon J, Maloney WJ, Huddleston JI. Readmission and length of stay after total hip arthroplasty in a national Medicare sample. J Arthroplasty. 2011;26(6 suppl):119-123.

26. Ponce BA, Oladeji LO, Rogers ME, Menendez ME. Comparative analysis of anatomic and reverse total shoulder arthroplasty: in-hospital outcomes and costs. J Shoulder Elbow Surg. 2015;24(3):460-467.

27. Bozic KJ, Maselli J, Pekow PS, Lindenauer PK, Vail TP, Auerbach AD. The influence of procedure volumes and standardization of care on quality and efficiency in total joint replacement surgery. J Bone Joint Surg Am. 2010;92(16):2643-2652.

28. Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day readmission rates for Medicare beneficiaries by race and site of care. Ann Surg. 2014;259(6):1086-1090.

29. Bohsali KI, Wirth MA, Rockwood CA Jr. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292.

30. Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1647-1654.

31. Black EM, Roberts SM, Siegel E, Yannopoulos P, Higgins LD, Warner JJ. Reverse shoulder arthroplasty as salvage for failed prior arthroplasty in patients 65 years of age or younger. J Shoulder Elbow Surg. 2014;23(7):1036-1042.

32. Menendez ME, Baker DK, Fryberger CT, Ponce BA. Predictors of extended length of stay after elective shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):1527-1533.

33. Jain NB, Guller U, Pietrobon R, Bond TK, Higgins LD. Comorbidities increase complication rates in patients having arthroplasty. Clin Orthop Relat Res. 2005;(435):232-238.

34. Martin CT, Gao Y, Pugely AJ, Wolf BR. 30-day morbidity and mortality after elective shoulder arthroscopy: a review of 9410 cases. J Shoulder Elbow Surg. 2013;22(12):1667-1675.e1.

35. Dailey EA, Cizik A, Kasten J, Chapman JR, Lee MJ. Risk factors for readmission of orthopaedic surgical patients. J Bone Joint Surg Am. 2013;95(11):1012-1019.

36. Dunn JC, Lanzi J, Kusnezov N, Bader J, Waterman BR, Belmont PJ Jr. Predictors of length of stay after elective total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015;24(5):754-759.

37. Maile MD, Engoren MC, Tremper KK, Jewell E, Kheterpal S. Worsening preoperative heart failure is associated with mortality and noncardiac complications, but not myocardial infarction after noncardiac surgery: a retrospective cohort study. Anesth Analg. 2014;119(3):522-532.

38. Farng E, Zingmond D, Krenek L, Soohoo NF. Factors predicting complication rates after primary shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(4):557-563.

39. Waterman BR, Dunn JC, Bader J, Urrea L, Schoenfeld AJ, Belmont PJ Jr. Thirty-day morbidity and mortality after elective total shoulder arthroplasty: patient-based and surgical risk factors. J Shoulder Elbow Surg. 2015;24(1):24-30.

40. Kassin MT, Owen RM, Perez SD, et al. Risk factors for 30-day hospital readmission among general surgery patients. J Am Coll Surg. 2012;215(3):322-330.

41. Poultsides LA, Ma Y, Della Valle AG, Chiu YL, Sculco TP, Memtsoudis SG. In-hospital surgical site infections after primary hip and knee arthroplasty—incidence and risk factors. J Arthroplasty. 2013;28(3):385-389.

42. Young BL, Menendez ME, Baker DK, Ponce BA. Factors associated with in-hospital pulmonary embolism after shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):e271-e278.

43. US Department of Health and Human Services. Efforts to improve patient safety result in 1.3 million fewer patient harms, 50,000 lives saved and $12 billion in health spending avoided [press release]. http://www.hhs.gov/news/press/2014pres/12/20141202a.html. Published December 2, 2014. Accessed May 25, 2015.

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Keeping Watch for Sepsis

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CDC study suggests that health care facilities can play a major role in preventing sepsis for at-risk individuals.

Sepsis begins outside the hospital for 80% of patients, according to a recent CDC evaluation, reported in Vital Signs. CDC researchers who reviewed medical records of 246 adults and 79 children at 4 New York hospitals in Albany and Rochester found that 7 in 10 patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

Related: The Role of Procalcitonin in the Management of Infectious Diseases

Sepsis is most common in adults aged ≥ 65 years, infants < 1 year, people with weakened immune systems, or people with chronic conditions, such as diabetes. Nearly all the adults (97%) had at least 1 comorbidity, and 70% of children who developed sepsis had a health condition that may have put them at risk.

Although multiple infections and organisms were implicated, Staphylococcus aureus, Escherichia coli, and some types of Streptococcus were identified most often. Among adults with sepsis, 35% had a lung infection, 25% had a urinary tract infection, 11% had a gastrointestinal infection, and 11% had a skin infection.

Related: Mass Transit for Viruses

Most of the patients had recent interactions with the health care system before admission with sepsis, which likely reflects their vulnerability to infection, the researchers say, “it also suggests that health care facilities and providers could play a central role in sepsis prevention.” The CDC report advises the following for health care providers:

  • Follow infection control requirements;
  • Ensure that patients receive recommended vaccines (such as flu and pneumococcal);
  • Educate patients and families, stressing the need to seek care if they see signs of severe infection or sepsis;
  • “Think sepsis”—know the signs and symptoms and treat them early;
  • Act fast—order tests to identify infection, start antibiotics and other care immediately; document dose, duration, and purpose; and
  • Check patient progress frequently; reassess antibiotic therapy at 24 to 48 hours or sooner to change therapy if needed
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CDC study suggests that health care facilities can play a major role in preventing sepsis for at-risk individuals.
CDC study suggests that health care facilities can play a major role in preventing sepsis for at-risk individuals.

Sepsis begins outside the hospital for 80% of patients, according to a recent CDC evaluation, reported in Vital Signs. CDC researchers who reviewed medical records of 246 adults and 79 children at 4 New York hospitals in Albany and Rochester found that 7 in 10 patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

Related: The Role of Procalcitonin in the Management of Infectious Diseases

Sepsis is most common in adults aged ≥ 65 years, infants < 1 year, people with weakened immune systems, or people with chronic conditions, such as diabetes. Nearly all the adults (97%) had at least 1 comorbidity, and 70% of children who developed sepsis had a health condition that may have put them at risk.

Although multiple infections and organisms were implicated, Staphylococcus aureus, Escherichia coli, and some types of Streptococcus were identified most often. Among adults with sepsis, 35% had a lung infection, 25% had a urinary tract infection, 11% had a gastrointestinal infection, and 11% had a skin infection.

Related: Mass Transit for Viruses

Most of the patients had recent interactions with the health care system before admission with sepsis, which likely reflects their vulnerability to infection, the researchers say, “it also suggests that health care facilities and providers could play a central role in sepsis prevention.” The CDC report advises the following for health care providers:

  • Follow infection control requirements;
  • Ensure that patients receive recommended vaccines (such as flu and pneumococcal);
  • Educate patients and families, stressing the need to seek care if they see signs of severe infection or sepsis;
  • “Think sepsis”—know the signs and symptoms and treat them early;
  • Act fast—order tests to identify infection, start antibiotics and other care immediately; document dose, duration, and purpose; and
  • Check patient progress frequently; reassess antibiotic therapy at 24 to 48 hours or sooner to change therapy if needed

Sepsis begins outside the hospital for 80% of patients, according to a recent CDC evaluation, reported in Vital Signs. CDC researchers who reviewed medical records of 246 adults and 79 children at 4 New York hospitals in Albany and Rochester found that 7 in 10 patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

Related: The Role of Procalcitonin in the Management of Infectious Diseases

Sepsis is most common in adults aged ≥ 65 years, infants < 1 year, people with weakened immune systems, or people with chronic conditions, such as diabetes. Nearly all the adults (97%) had at least 1 comorbidity, and 70% of children who developed sepsis had a health condition that may have put them at risk.

Although multiple infections and organisms were implicated, Staphylococcus aureus, Escherichia coli, and some types of Streptococcus were identified most often. Among adults with sepsis, 35% had a lung infection, 25% had a urinary tract infection, 11% had a gastrointestinal infection, and 11% had a skin infection.

Related: Mass Transit for Viruses

Most of the patients had recent interactions with the health care system before admission with sepsis, which likely reflects their vulnerability to infection, the researchers say, “it also suggests that health care facilities and providers could play a central role in sepsis prevention.” The CDC report advises the following for health care providers:

  • Follow infection control requirements;
  • Ensure that patients receive recommended vaccines (such as flu and pneumococcal);
  • Educate patients and families, stressing the need to seek care if they see signs of severe infection or sepsis;
  • “Think sepsis”—know the signs and symptoms and treat them early;
  • Act fast—order tests to identify infection, start antibiotics and other care immediately; document dose, duration, and purpose; and
  • Check patient progress frequently; reassess antibiotic therapy at 24 to 48 hours or sooner to change therapy if needed
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The Highs and Lows of Medical Marijuana

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The Highs and Lows of Medical Marijuana

Marijuana has been used medicinally worldwide for thousands of years.1,2 In the early 1990s, the discovery of cannabinoid receptors in the central and peripheral nervous systems began to propagate interest in other potential therapeutic values of marijuana.3 Since then, marijuana has been used by patients experiencing chemotherapy-induced anorexia, nausea and vomiting, pain, and forms of spasticity. Use among patients with glaucoma and HIV/AIDS has also been widely reported.

In light of this—and of increasing efforts to legalize medical marijuana use across the United States—clinicians should be cognizant of the substance’s negative effects, as well as its potential health benefits. Marijuana has significant systemic effects and associated risks of which patients and health care providers should be aware. Questions remain regarding the safety, efficacy, and long-term impact of use. Use of marijuana for medical purposes requires a careful examination of the risks and benefits.

PHARMACOKINETICS

Marijuana contains approximately 60 cannabinoids, two of which have been specifically identified as primary components. The first, delta-9 tetrahydrocannabinol (THC), is believed to be the most psychoactive.4,5 THC was identified in 1964 and is responsible for the well-documented symptoms of euphoria, appetite stimulation, impaired memory and cognition, and analgesia. The THC content in marijuana products varies widely and has increased over time, complicating research on the long-term effects of marijuana use.5,6

The second compound, cannabidiol (CBD), is a serotonin receptor agonist that lacks psychoactive effects. Potential benefits of CBD include antiemetic and anxiolytic properties, as well as anti-inflammatory effects. There is some evidence to suggest that CBD might also have antipsychotic properties.1,4

AVAILABLE FORMULATIONS

Two synthetic forms of THC have been approved by the FDA since 1985 for medicinal use: nabilone (categorized as a Schedule II drug) and dronabinol (Schedule III). Both are cannabinoid receptor agonists approved for treating chemotherapy-induced nausea and vomiting. They are recommended for use after failure of standard therapies, such as 5-HT3 receptor antagonists, but overall interest has decreased since the advent of agents such as ondansetron.2,4

Nabiximols, an oral buccal spray, is a combination of THC and CBD.  It was approved in Canada in 2005 for pain management in cancer patients and for multiple sclerosis–related pain and spasticity. It is not currently available in the US.2,4

Marijuana use is currently legal in 25 states and the District of Columbia.7,8 However, state laws regarding the criteria for medical use are vague and varied. For example, not all states require that clinicians review risks and benefits of marijuana use with patients. Even for those that do, the lack of clinical trials on the safety and efficacy of marijuana make it difficult for clinicians to properly educate themselves and their patients.9

LIMITATIONS OF RESEARCH

Why the lack of data? In 1937, a federal tax restricted marijuana prescription in the US, and in 1942, marijuana was removed from the US Pharmacopeia.2,4 The Controlled Substances Act in 1970 designated marijuana as a Schedule I drug, a categorization for drugs with high potential for abuse and no currently accepted medical use.9 Following this designation, research on marijuana was nearly halted in the US. Several medical organizations have subsequently called for reclassification to Schedule II in order to facilitate scientific research into marijuana’s medicinal benefits and risks.

Research is also limited due to the comorbid use of tobacco and other drugs in study subjects, the variation of cannabinoid levels among products, and differences in the route of administration—particularly smoking versus oral or buccal routes.5 Conducting marijuana research in a fashion similar to pharmaceuticals would not only serve the medical community but also the legislative faction.

Despite these obstacles, there is some available evidence on medical use of marijuana. A review of the associated risks and potential uses for the substance follows.

 

 

RISKS ASSOCIATED WITH MARIJUANA USE

Acute effects

Most symptoms of marijuana intoxication are attributed to the THC component and occur due to the presence of cannabinoid receptors in the central nervous system (see Table 1).5,10 Additional objective signs of acute or chronic intoxication include conjunctival injection, tachycardia, cannabis odor, yellowing of fingertips (from smoking), cough, and food cravings.10

A more recently identified effect of long-term marijuana use is a paradoxical hyperemesis syndrome, in which individuals experience nausea, vomiting, and abdominal pain. They obtain relief with hot showers or baths.6,8

Since there is a near absence of cannabinoid receptors in the brain stem, marijuana does not stimulate the autonomic nervous system. It is therefore believed that marijuana use cannot be fatal. Corroborating this theory, no deaths have been reported from marijuana overdose.2,11

Withdrawal symptoms

Approximately 10% of regular marijuana users become physically and psychologically dependent on the substance. Once tolerance develops, withdrawal symptoms occur with cessation of use (see Table 2).2,5,10 Symptoms peak within the first week following cessation and may last up to two weeks. Sleep disturbances may occur for more than one month.10

Unlike with other substances of abuse, there are no pharmaceutical agents to treat marijuana withdrawal; rather, treatment is supportive. Marijuana users often resume use following a period of cessation in order to avoid withdrawal.

 

 

Chronic effects

Dental/oral. Smoking marijuana is associated with an increased risk for dental caries, periodontal disease, and oral infections.1 Premalignant oral lesions, such as leukoplakia and erythroplakia, have also been reported. Patient education on the risks and need for proper oral hygiene is vital, as are regular dental examinations.

Respiratory. There are several known pulmonary implications of smoking marijuana, and therefore, this route of administration is not recommended for medicinal use. Respiratory effects of marijuana smoke are similar to those seen with tobacco: cough, dyspnea, sputum production, wheezing, bronchitis, pharyngitis, and hoarseness.4 Increased rates of pneumonia and other respiratory infections have also been identified.6 Research on long-term marijuana smoking has revealed hyperinflation and airway resistance.6 At this time, evidence is inconclusive as to whether smoking marijuana leads to chronic obstructive pulmonary disease.1

Studies have compared the chemical content of tobacco and marijuana and found similar components, including carcinogens, but data regarding concentrations of these chemicals are conflicting.1,4 It is unknown whether vaping (a trending practice in which a device is used to heat the substance prior to inhalation) reduces this risk.4

Unfortunately, data regarding the carcinogenic effects of long-term marijuana smoking are inconclusive; some studies have shown potential protective effects.4-6 Other evidence suggests that the risk is lower in comparison to tobacco smoking.6 

Cardiovascular. The effects of marijuana on the cardiovascular system are not fully understood. Known symptoms include tachycardia, peripheral vasodilation, hypotension, and syncope.4 There is some evidence that marijuana use carries an increased risk for angina in patients with previously established heart disease.5 Patients, especially those with known cardiovascular disease, should be educated about these risks.

Reproductive. There are several identified reproductive consequences of marijuana use. Research has found decreased sperm count and gynecomastia in men and impaired ovulation in women.4 Studies on marijuana use in pregnancy consistently reveal low birth weight—this effect is, however, less than that seen with tobacco smoking.5 Other complications or developmental abnormalities may occur, but there is currently a lack of evidence to support further conclusions.

Neurologic. The use of marijuana results in short-term memory loss and other cognitive impairments. There is conflicting evidence as to whether long-term effects remain after cessation.5,6 Because acute intoxication impairs motor skills, it is associated with increased rates of motor vehicle accidents.6 Driving while under the influence of marijuana should be cautioned against.

Psychiatric. Marijuana use is associated with the onset and exacerbation of acute psychosis. However, its role as a causal factor in schizophrenia has not been established.4,10 There is some evidence to suggest that CBD has antipsychotic properties, warranting further research. An amotivational syndrome has also been affiliated with chronic marijuana use; affected individuals exhibit a lack of goal-directed behavior, which may result in work or school dysfunction.10 Several studies have supported an association between marijuana use and risk for depression and anxiety. Due to the extensive risk factors for these disorders, including genetic and environmental, causality has yet to be established.5,6

 

 

Conditions for Which Marijuana May Offer Therapeutic Benefits

Glaucoma

Research has demonstrated that marijuana decreases intraocular pressure, and many patients with glaucoma use marijuana. However, it is not recommended as firstline treatment.

The beneficial effects of smoked marijuana are short-lived, requiring patients to dose repeatedly throughout the day. Use is also often discontinued due to adverse effects including dry mouth, dizziness, confusion, and anxiety.8

Topical preparations of THC have not been successfully developed due to the low water solubility of cannabis and minimal penetration through the cornea to the intraocular space.8 Standard treatments available for glaucoma are more effective and without obvious psychoactive effects.

Nausea

One of the first medical uses of marijuana was for nausea. Due to the presence of cannabinoid receptors that govern food intake, marijuana is known to stimulate appetite, making its use in reducing chemotherapy-associated nausea and vomiting widespread.2,6 Despite the variation in state laws regarding medical use of marijuana, cancer is included as a qualifying illness in every state that allows it.8 Cannabis-based medications may be useful for treating refractory nausea secondary to chemotherapy; however, dronabinol and nabilone are not recommended as firstline therapies.12

HIV/AIDS

Short-term evidence suggests that patients with HIV and/or AIDS benefit from marijuana use through improved appetite, weight gain, lessened pain, and improved quality of life.6,13 Studies with small sample sizes have been conducted using smoked marijuana and dronabinol.8 Long-term studies are needed to compare the use of marijuana with other nutritional and caloric supplements. Overall, reliable research regarding the therapeutic value of marijuana in these patients is inconclusive, and therefore no recommendations for incorporating marijuana into the treatment regimen have been made.8

 

 

Multiple sclerosis

For centuries, marijuana has been used for pain relief. The discovery of cannabinoid receptors in high concentrations throughout pain pathways of the brain supports the notion that marijuana plays a role in analgesia. While response to acute pain is poor, there is evidence to suggest that various cannabis formulations relieve chronic neuropathic pain and spasticity, as seen in multiple sclerosis.3,6

Subjective improvements in pain and spasticity were seen with the use of oral cannabis extract, THC, and nabiximols.11 Smoked marijuana is of uncertain efficacy and is not recommended for use in this patient population; it has been shown to potentially worsen cognition.8,11

Seizures

Research into the role of marijuana in decreasing seizure frequency is inconclusive.11 Large studies with human subjects are lacking, and most data thus far have come from animals and case studies.8 Some case reports have suggested a decrease in seizures with marijuana use, but further investigation is needed.6

At this time, it is not appropriate to recommend marijuana for patients with seizure disorders, but the use of cannabidiol might be more promising. Studies are ongoing.14

Alzheimer disease

Alzheimer disease is the most common cause of dementia.8 Despite known adverse effects on memory and cognition with acute use, studies have shown that marijuana might inhibit the development of amyloid beta plaques in Alzheimer disease.4 Further research on dronabinol has not provided sufficient data to support its use, and no studies utilizing smoked marijuana have been performed.8 Therefore, no recommendations exist for the use of marijuana in this patient population, and further research is warranted. 

Ongoing research

There are some additional areas of potential therapeutic use of marijuana. Limited evidence has revealed that marijuana has anti-inflammatory properties, leading researchers to examine its use for autoimmune diseases, such as rheumatoid arthritis and Crohn disease. Studies investigating marijuana’s potential ability to inhibit cancer growth and metastasis are ongoing.

Unfortunately, research in patients with Parkinson disease has not shown improvement in dyskinesias.11 Studies on other movement disorders, such as Tourette syndrome and Huntington disease, have not shown symptom improvement with marijuana use. Research on these conditions and others is ongoing.

CONCLUSION

Marijuana use has negative effects on a variety of body systems, but it also may provide therapeutic benefit in certain patient populations. Clinicians and patients are currently hampered by the dearth of reliable information on its safety and efficacy (resulting from federal restrictions and other factors). Comparative studies between marijuana and established standards of care are needed, as is additional research to identify therapeutic effects that could be maximized and ways to minimize or eliminate negative sequelae.

References

1.  Greydanus DE, Hawver EK, Greydanus MM, Merrick J. Cannabis: effective and safe analgesic? J Pain Manage. 2014;7(3):209-233.
2.  Bostwick JM. Blurred boundaries: the therapeutics and politics of medical marijuana. Mayo Clin Proc. 2012;87(2):172-186.
3.  Karst M, Wippermann S, Ahrens J. Role of cannabinoids in the treatment of pain and (painful) spasticity. Drugs. 2010;70(18):2409-2438.
4.  Owen KP, Sutter ME, Albertson TE. Marijuana: respiratory tract effects. Clin Rev Allergy Immunol. 2014;46(1):65-81.
5.  Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet. 2009;374(9698):1383-1391.
6.  Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219-2227.
7.  National Conference of State Legislatures. State medical marijuana laws (updated 7/20/2016). www.ncsl.org/research/health/state-medical-marijuana-laws.aspx. Accessed September 7, 2016.
8.  Belendiuk KA, Baldini LL, Bonn-Miller MO. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders. Addict Sci Clin Pract. 2015;10(1):1-10.
9.  Hoffmann DE, Weber E. Medical marijuana and the law. N Engl J Med. 2010;362(16):1453-1457.
10.  American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
11.  Koppel B, Brust J, Fife T, et al. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders. Neurology. 2014; 82(17):1556-1563.
12.  Smith LA, Azariah F, Lavender VT, Stoner NS, Bettiol S. Cannabinoids for nausea and vomiting in adults with cancer receiving chemotherapy. Cochrane Database Syst Rev. 2015;(11):CD009464.
13.  Lutge EE, Gray A, Siegfried N. The medical use of cannabis for reducing morbidity and mortality in patients with HIV/AIDS. Cochrane Database Syst Rev. 2013;(4):CD005175.
14.  Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database Syst Rev. 2012;(6):CD009270.

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Marijuana has been used medicinally worldwide for thousands of years.1,2 In the early 1990s, the discovery of cannabinoid receptors in the central and peripheral nervous systems began to propagate interest in other potential therapeutic values of marijuana.3 Since then, marijuana has been used by patients experiencing chemotherapy-induced anorexia, nausea and vomiting, pain, and forms of spasticity. Use among patients with glaucoma and HIV/AIDS has also been widely reported.

In light of this—and of increasing efforts to legalize medical marijuana use across the United States—clinicians should be cognizant of the substance’s negative effects, as well as its potential health benefits. Marijuana has significant systemic effects and associated risks of which patients and health care providers should be aware. Questions remain regarding the safety, efficacy, and long-term impact of use. Use of marijuana for medical purposes requires a careful examination of the risks and benefits.

PHARMACOKINETICS

Marijuana contains approximately 60 cannabinoids, two of which have been specifically identified as primary components. The first, delta-9 tetrahydrocannabinol (THC), is believed to be the most psychoactive.4,5 THC was identified in 1964 and is responsible for the well-documented symptoms of euphoria, appetite stimulation, impaired memory and cognition, and analgesia. The THC content in marijuana products varies widely and has increased over time, complicating research on the long-term effects of marijuana use.5,6

The second compound, cannabidiol (CBD), is a serotonin receptor agonist that lacks psychoactive effects. Potential benefits of CBD include antiemetic and anxiolytic properties, as well as anti-inflammatory effects. There is some evidence to suggest that CBD might also have antipsychotic properties.1,4

AVAILABLE FORMULATIONS

Two synthetic forms of THC have been approved by the FDA since 1985 for medicinal use: nabilone (categorized as a Schedule II drug) and dronabinol (Schedule III). Both are cannabinoid receptor agonists approved for treating chemotherapy-induced nausea and vomiting. They are recommended for use after failure of standard therapies, such as 5-HT3 receptor antagonists, but overall interest has decreased since the advent of agents such as ondansetron.2,4

Nabiximols, an oral buccal spray, is a combination of THC and CBD.  It was approved in Canada in 2005 for pain management in cancer patients and for multiple sclerosis–related pain and spasticity. It is not currently available in the US.2,4

Marijuana use is currently legal in 25 states and the District of Columbia.7,8 However, state laws regarding the criteria for medical use are vague and varied. For example, not all states require that clinicians review risks and benefits of marijuana use with patients. Even for those that do, the lack of clinical trials on the safety and efficacy of marijuana make it difficult for clinicians to properly educate themselves and their patients.9

LIMITATIONS OF RESEARCH

Why the lack of data? In 1937, a federal tax restricted marijuana prescription in the US, and in 1942, marijuana was removed from the US Pharmacopeia.2,4 The Controlled Substances Act in 1970 designated marijuana as a Schedule I drug, a categorization for drugs with high potential for abuse and no currently accepted medical use.9 Following this designation, research on marijuana was nearly halted in the US. Several medical organizations have subsequently called for reclassification to Schedule II in order to facilitate scientific research into marijuana’s medicinal benefits and risks.

Research is also limited due to the comorbid use of tobacco and other drugs in study subjects, the variation of cannabinoid levels among products, and differences in the route of administration—particularly smoking versus oral or buccal routes.5 Conducting marijuana research in a fashion similar to pharmaceuticals would not only serve the medical community but also the legislative faction.

Despite these obstacles, there is some available evidence on medical use of marijuana. A review of the associated risks and potential uses for the substance follows.

 

 

RISKS ASSOCIATED WITH MARIJUANA USE

Acute effects

Most symptoms of marijuana intoxication are attributed to the THC component and occur due to the presence of cannabinoid receptors in the central nervous system (see Table 1).5,10 Additional objective signs of acute or chronic intoxication include conjunctival injection, tachycardia, cannabis odor, yellowing of fingertips (from smoking), cough, and food cravings.10

A more recently identified effect of long-term marijuana use is a paradoxical hyperemesis syndrome, in which individuals experience nausea, vomiting, and abdominal pain. They obtain relief with hot showers or baths.6,8

Since there is a near absence of cannabinoid receptors in the brain stem, marijuana does not stimulate the autonomic nervous system. It is therefore believed that marijuana use cannot be fatal. Corroborating this theory, no deaths have been reported from marijuana overdose.2,11

Withdrawal symptoms

Approximately 10% of regular marijuana users become physically and psychologically dependent on the substance. Once tolerance develops, withdrawal symptoms occur with cessation of use (see Table 2).2,5,10 Symptoms peak within the first week following cessation and may last up to two weeks. Sleep disturbances may occur for more than one month.10

Unlike with other substances of abuse, there are no pharmaceutical agents to treat marijuana withdrawal; rather, treatment is supportive. Marijuana users often resume use following a period of cessation in order to avoid withdrawal.

 

 

Chronic effects

Dental/oral. Smoking marijuana is associated with an increased risk for dental caries, periodontal disease, and oral infections.1 Premalignant oral lesions, such as leukoplakia and erythroplakia, have also been reported. Patient education on the risks and need for proper oral hygiene is vital, as are regular dental examinations.

Respiratory. There are several known pulmonary implications of smoking marijuana, and therefore, this route of administration is not recommended for medicinal use. Respiratory effects of marijuana smoke are similar to those seen with tobacco: cough, dyspnea, sputum production, wheezing, bronchitis, pharyngitis, and hoarseness.4 Increased rates of pneumonia and other respiratory infections have also been identified.6 Research on long-term marijuana smoking has revealed hyperinflation and airway resistance.6 At this time, evidence is inconclusive as to whether smoking marijuana leads to chronic obstructive pulmonary disease.1

Studies have compared the chemical content of tobacco and marijuana and found similar components, including carcinogens, but data regarding concentrations of these chemicals are conflicting.1,4 It is unknown whether vaping (a trending practice in which a device is used to heat the substance prior to inhalation) reduces this risk.4

Unfortunately, data regarding the carcinogenic effects of long-term marijuana smoking are inconclusive; some studies have shown potential protective effects.4-6 Other evidence suggests that the risk is lower in comparison to tobacco smoking.6 

Cardiovascular. The effects of marijuana on the cardiovascular system are not fully understood. Known symptoms include tachycardia, peripheral vasodilation, hypotension, and syncope.4 There is some evidence that marijuana use carries an increased risk for angina in patients with previously established heart disease.5 Patients, especially those with known cardiovascular disease, should be educated about these risks.

Reproductive. There are several identified reproductive consequences of marijuana use. Research has found decreased sperm count and gynecomastia in men and impaired ovulation in women.4 Studies on marijuana use in pregnancy consistently reveal low birth weight—this effect is, however, less than that seen with tobacco smoking.5 Other complications or developmental abnormalities may occur, but there is currently a lack of evidence to support further conclusions.

Neurologic. The use of marijuana results in short-term memory loss and other cognitive impairments. There is conflicting evidence as to whether long-term effects remain after cessation.5,6 Because acute intoxication impairs motor skills, it is associated with increased rates of motor vehicle accidents.6 Driving while under the influence of marijuana should be cautioned against.

Psychiatric. Marijuana use is associated with the onset and exacerbation of acute psychosis. However, its role as a causal factor in schizophrenia has not been established.4,10 There is some evidence to suggest that CBD has antipsychotic properties, warranting further research. An amotivational syndrome has also been affiliated with chronic marijuana use; affected individuals exhibit a lack of goal-directed behavior, which may result in work or school dysfunction.10 Several studies have supported an association between marijuana use and risk for depression and anxiety. Due to the extensive risk factors for these disorders, including genetic and environmental, causality has yet to be established.5,6

 

 

Conditions for Which Marijuana May Offer Therapeutic Benefits

Glaucoma

Research has demonstrated that marijuana decreases intraocular pressure, and many patients with glaucoma use marijuana. However, it is not recommended as firstline treatment.

The beneficial effects of smoked marijuana are short-lived, requiring patients to dose repeatedly throughout the day. Use is also often discontinued due to adverse effects including dry mouth, dizziness, confusion, and anxiety.8

Topical preparations of THC have not been successfully developed due to the low water solubility of cannabis and minimal penetration through the cornea to the intraocular space.8 Standard treatments available for glaucoma are more effective and without obvious psychoactive effects.

Nausea

One of the first medical uses of marijuana was for nausea. Due to the presence of cannabinoid receptors that govern food intake, marijuana is known to stimulate appetite, making its use in reducing chemotherapy-associated nausea and vomiting widespread.2,6 Despite the variation in state laws regarding medical use of marijuana, cancer is included as a qualifying illness in every state that allows it.8 Cannabis-based medications may be useful for treating refractory nausea secondary to chemotherapy; however, dronabinol and nabilone are not recommended as firstline therapies.12

HIV/AIDS

Short-term evidence suggests that patients with HIV and/or AIDS benefit from marijuana use through improved appetite, weight gain, lessened pain, and improved quality of life.6,13 Studies with small sample sizes have been conducted using smoked marijuana and dronabinol.8 Long-term studies are needed to compare the use of marijuana with other nutritional and caloric supplements. Overall, reliable research regarding the therapeutic value of marijuana in these patients is inconclusive, and therefore no recommendations for incorporating marijuana into the treatment regimen have been made.8

 

 

Multiple sclerosis

For centuries, marijuana has been used for pain relief. The discovery of cannabinoid receptors in high concentrations throughout pain pathways of the brain supports the notion that marijuana plays a role in analgesia. While response to acute pain is poor, there is evidence to suggest that various cannabis formulations relieve chronic neuropathic pain and spasticity, as seen in multiple sclerosis.3,6

Subjective improvements in pain and spasticity were seen with the use of oral cannabis extract, THC, and nabiximols.11 Smoked marijuana is of uncertain efficacy and is not recommended for use in this patient population; it has been shown to potentially worsen cognition.8,11

Seizures

Research into the role of marijuana in decreasing seizure frequency is inconclusive.11 Large studies with human subjects are lacking, and most data thus far have come from animals and case studies.8 Some case reports have suggested a decrease in seizures with marijuana use, but further investigation is needed.6

At this time, it is not appropriate to recommend marijuana for patients with seizure disorders, but the use of cannabidiol might be more promising. Studies are ongoing.14

Alzheimer disease

Alzheimer disease is the most common cause of dementia.8 Despite known adverse effects on memory and cognition with acute use, studies have shown that marijuana might inhibit the development of amyloid beta plaques in Alzheimer disease.4 Further research on dronabinol has not provided sufficient data to support its use, and no studies utilizing smoked marijuana have been performed.8 Therefore, no recommendations exist for the use of marijuana in this patient population, and further research is warranted. 

Ongoing research

There are some additional areas of potential therapeutic use of marijuana. Limited evidence has revealed that marijuana has anti-inflammatory properties, leading researchers to examine its use for autoimmune diseases, such as rheumatoid arthritis and Crohn disease. Studies investigating marijuana’s potential ability to inhibit cancer growth and metastasis are ongoing.

Unfortunately, research in patients with Parkinson disease has not shown improvement in dyskinesias.11 Studies on other movement disorders, such as Tourette syndrome and Huntington disease, have not shown symptom improvement with marijuana use. Research on these conditions and others is ongoing.

CONCLUSION

Marijuana use has negative effects on a variety of body systems, but it also may provide therapeutic benefit in certain patient populations. Clinicians and patients are currently hampered by the dearth of reliable information on its safety and efficacy (resulting from federal restrictions and other factors). Comparative studies between marijuana and established standards of care are needed, as is additional research to identify therapeutic effects that could be maximized and ways to minimize or eliminate negative sequelae.

Marijuana has been used medicinally worldwide for thousands of years.1,2 In the early 1990s, the discovery of cannabinoid receptors in the central and peripheral nervous systems began to propagate interest in other potential therapeutic values of marijuana.3 Since then, marijuana has been used by patients experiencing chemotherapy-induced anorexia, nausea and vomiting, pain, and forms of spasticity. Use among patients with glaucoma and HIV/AIDS has also been widely reported.

In light of this—and of increasing efforts to legalize medical marijuana use across the United States—clinicians should be cognizant of the substance’s negative effects, as well as its potential health benefits. Marijuana has significant systemic effects and associated risks of which patients and health care providers should be aware. Questions remain regarding the safety, efficacy, and long-term impact of use. Use of marijuana for medical purposes requires a careful examination of the risks and benefits.

PHARMACOKINETICS

Marijuana contains approximately 60 cannabinoids, two of which have been specifically identified as primary components. The first, delta-9 tetrahydrocannabinol (THC), is believed to be the most psychoactive.4,5 THC was identified in 1964 and is responsible for the well-documented symptoms of euphoria, appetite stimulation, impaired memory and cognition, and analgesia. The THC content in marijuana products varies widely and has increased over time, complicating research on the long-term effects of marijuana use.5,6

The second compound, cannabidiol (CBD), is a serotonin receptor agonist that lacks psychoactive effects. Potential benefits of CBD include antiemetic and anxiolytic properties, as well as anti-inflammatory effects. There is some evidence to suggest that CBD might also have antipsychotic properties.1,4

AVAILABLE FORMULATIONS

Two synthetic forms of THC have been approved by the FDA since 1985 for medicinal use: nabilone (categorized as a Schedule II drug) and dronabinol (Schedule III). Both are cannabinoid receptor agonists approved for treating chemotherapy-induced nausea and vomiting. They are recommended for use after failure of standard therapies, such as 5-HT3 receptor antagonists, but overall interest has decreased since the advent of agents such as ondansetron.2,4

Nabiximols, an oral buccal spray, is a combination of THC and CBD.  It was approved in Canada in 2005 for pain management in cancer patients and for multiple sclerosis–related pain and spasticity. It is not currently available in the US.2,4

Marijuana use is currently legal in 25 states and the District of Columbia.7,8 However, state laws regarding the criteria for medical use are vague and varied. For example, not all states require that clinicians review risks and benefits of marijuana use with patients. Even for those that do, the lack of clinical trials on the safety and efficacy of marijuana make it difficult for clinicians to properly educate themselves and their patients.9

LIMITATIONS OF RESEARCH

Why the lack of data? In 1937, a federal tax restricted marijuana prescription in the US, and in 1942, marijuana was removed from the US Pharmacopeia.2,4 The Controlled Substances Act in 1970 designated marijuana as a Schedule I drug, a categorization for drugs with high potential for abuse and no currently accepted medical use.9 Following this designation, research on marijuana was nearly halted in the US. Several medical organizations have subsequently called for reclassification to Schedule II in order to facilitate scientific research into marijuana’s medicinal benefits and risks.

Research is also limited due to the comorbid use of tobacco and other drugs in study subjects, the variation of cannabinoid levels among products, and differences in the route of administration—particularly smoking versus oral or buccal routes.5 Conducting marijuana research in a fashion similar to pharmaceuticals would not only serve the medical community but also the legislative faction.

Despite these obstacles, there is some available evidence on medical use of marijuana. A review of the associated risks and potential uses for the substance follows.

 

 

RISKS ASSOCIATED WITH MARIJUANA USE

Acute effects

Most symptoms of marijuana intoxication are attributed to the THC component and occur due to the presence of cannabinoid receptors in the central nervous system (see Table 1).5,10 Additional objective signs of acute or chronic intoxication include conjunctival injection, tachycardia, cannabis odor, yellowing of fingertips (from smoking), cough, and food cravings.10

A more recently identified effect of long-term marijuana use is a paradoxical hyperemesis syndrome, in which individuals experience nausea, vomiting, and abdominal pain. They obtain relief with hot showers or baths.6,8

Since there is a near absence of cannabinoid receptors in the brain stem, marijuana does not stimulate the autonomic nervous system. It is therefore believed that marijuana use cannot be fatal. Corroborating this theory, no deaths have been reported from marijuana overdose.2,11

Withdrawal symptoms

Approximately 10% of regular marijuana users become physically and psychologically dependent on the substance. Once tolerance develops, withdrawal symptoms occur with cessation of use (see Table 2).2,5,10 Symptoms peak within the first week following cessation and may last up to two weeks. Sleep disturbances may occur for more than one month.10

Unlike with other substances of abuse, there are no pharmaceutical agents to treat marijuana withdrawal; rather, treatment is supportive. Marijuana users often resume use following a period of cessation in order to avoid withdrawal.

 

 

Chronic effects

Dental/oral. Smoking marijuana is associated with an increased risk for dental caries, periodontal disease, and oral infections.1 Premalignant oral lesions, such as leukoplakia and erythroplakia, have also been reported. Patient education on the risks and need for proper oral hygiene is vital, as are regular dental examinations.

Respiratory. There are several known pulmonary implications of smoking marijuana, and therefore, this route of administration is not recommended for medicinal use. Respiratory effects of marijuana smoke are similar to those seen with tobacco: cough, dyspnea, sputum production, wheezing, bronchitis, pharyngitis, and hoarseness.4 Increased rates of pneumonia and other respiratory infections have also been identified.6 Research on long-term marijuana smoking has revealed hyperinflation and airway resistance.6 At this time, evidence is inconclusive as to whether smoking marijuana leads to chronic obstructive pulmonary disease.1

Studies have compared the chemical content of tobacco and marijuana and found similar components, including carcinogens, but data regarding concentrations of these chemicals are conflicting.1,4 It is unknown whether vaping (a trending practice in which a device is used to heat the substance prior to inhalation) reduces this risk.4

Unfortunately, data regarding the carcinogenic effects of long-term marijuana smoking are inconclusive; some studies have shown potential protective effects.4-6 Other evidence suggests that the risk is lower in comparison to tobacco smoking.6 

Cardiovascular. The effects of marijuana on the cardiovascular system are not fully understood. Known symptoms include tachycardia, peripheral vasodilation, hypotension, and syncope.4 There is some evidence that marijuana use carries an increased risk for angina in patients with previously established heart disease.5 Patients, especially those with known cardiovascular disease, should be educated about these risks.

Reproductive. There are several identified reproductive consequences of marijuana use. Research has found decreased sperm count and gynecomastia in men and impaired ovulation in women.4 Studies on marijuana use in pregnancy consistently reveal low birth weight—this effect is, however, less than that seen with tobacco smoking.5 Other complications or developmental abnormalities may occur, but there is currently a lack of evidence to support further conclusions.

Neurologic. The use of marijuana results in short-term memory loss and other cognitive impairments. There is conflicting evidence as to whether long-term effects remain after cessation.5,6 Because acute intoxication impairs motor skills, it is associated with increased rates of motor vehicle accidents.6 Driving while under the influence of marijuana should be cautioned against.

Psychiatric. Marijuana use is associated with the onset and exacerbation of acute psychosis. However, its role as a causal factor in schizophrenia has not been established.4,10 There is some evidence to suggest that CBD has antipsychotic properties, warranting further research. An amotivational syndrome has also been affiliated with chronic marijuana use; affected individuals exhibit a lack of goal-directed behavior, which may result in work or school dysfunction.10 Several studies have supported an association between marijuana use and risk for depression and anxiety. Due to the extensive risk factors for these disorders, including genetic and environmental, causality has yet to be established.5,6

 

 

Conditions for Which Marijuana May Offer Therapeutic Benefits

Glaucoma

Research has demonstrated that marijuana decreases intraocular pressure, and many patients with glaucoma use marijuana. However, it is not recommended as firstline treatment.

The beneficial effects of smoked marijuana are short-lived, requiring patients to dose repeatedly throughout the day. Use is also often discontinued due to adverse effects including dry mouth, dizziness, confusion, and anxiety.8

Topical preparations of THC have not been successfully developed due to the low water solubility of cannabis and minimal penetration through the cornea to the intraocular space.8 Standard treatments available for glaucoma are more effective and without obvious psychoactive effects.

Nausea

One of the first medical uses of marijuana was for nausea. Due to the presence of cannabinoid receptors that govern food intake, marijuana is known to stimulate appetite, making its use in reducing chemotherapy-associated nausea and vomiting widespread.2,6 Despite the variation in state laws regarding medical use of marijuana, cancer is included as a qualifying illness in every state that allows it.8 Cannabis-based medications may be useful for treating refractory nausea secondary to chemotherapy; however, dronabinol and nabilone are not recommended as firstline therapies.12

HIV/AIDS

Short-term evidence suggests that patients with HIV and/or AIDS benefit from marijuana use through improved appetite, weight gain, lessened pain, and improved quality of life.6,13 Studies with small sample sizes have been conducted using smoked marijuana and dronabinol.8 Long-term studies are needed to compare the use of marijuana with other nutritional and caloric supplements. Overall, reliable research regarding the therapeutic value of marijuana in these patients is inconclusive, and therefore no recommendations for incorporating marijuana into the treatment regimen have been made.8

 

 

Multiple sclerosis

For centuries, marijuana has been used for pain relief. The discovery of cannabinoid receptors in high concentrations throughout pain pathways of the brain supports the notion that marijuana plays a role in analgesia. While response to acute pain is poor, there is evidence to suggest that various cannabis formulations relieve chronic neuropathic pain and spasticity, as seen in multiple sclerosis.3,6

Subjective improvements in pain and spasticity were seen with the use of oral cannabis extract, THC, and nabiximols.11 Smoked marijuana is of uncertain efficacy and is not recommended for use in this patient population; it has been shown to potentially worsen cognition.8,11

Seizures

Research into the role of marijuana in decreasing seizure frequency is inconclusive.11 Large studies with human subjects are lacking, and most data thus far have come from animals and case studies.8 Some case reports have suggested a decrease in seizures with marijuana use, but further investigation is needed.6

At this time, it is not appropriate to recommend marijuana for patients with seizure disorders, but the use of cannabidiol might be more promising. Studies are ongoing.14

Alzheimer disease

Alzheimer disease is the most common cause of dementia.8 Despite known adverse effects on memory and cognition with acute use, studies have shown that marijuana might inhibit the development of amyloid beta plaques in Alzheimer disease.4 Further research on dronabinol has not provided sufficient data to support its use, and no studies utilizing smoked marijuana have been performed.8 Therefore, no recommendations exist for the use of marijuana in this patient population, and further research is warranted. 

Ongoing research

There are some additional areas of potential therapeutic use of marijuana. Limited evidence has revealed that marijuana has anti-inflammatory properties, leading researchers to examine its use for autoimmune diseases, such as rheumatoid arthritis and Crohn disease. Studies investigating marijuana’s potential ability to inhibit cancer growth and metastasis are ongoing.

Unfortunately, research in patients with Parkinson disease has not shown improvement in dyskinesias.11 Studies on other movement disorders, such as Tourette syndrome and Huntington disease, have not shown symptom improvement with marijuana use. Research on these conditions and others is ongoing.

CONCLUSION

Marijuana use has negative effects on a variety of body systems, but it also may provide therapeutic benefit in certain patient populations. Clinicians and patients are currently hampered by the dearth of reliable information on its safety and efficacy (resulting from federal restrictions and other factors). Comparative studies between marijuana and established standards of care are needed, as is additional research to identify therapeutic effects that could be maximized and ways to minimize or eliminate negative sequelae.

References

1.  Greydanus DE, Hawver EK, Greydanus MM, Merrick J. Cannabis: effective and safe analgesic? J Pain Manage. 2014;7(3):209-233.
2.  Bostwick JM. Blurred boundaries: the therapeutics and politics of medical marijuana. Mayo Clin Proc. 2012;87(2):172-186.
3.  Karst M, Wippermann S, Ahrens J. Role of cannabinoids in the treatment of pain and (painful) spasticity. Drugs. 2010;70(18):2409-2438.
4.  Owen KP, Sutter ME, Albertson TE. Marijuana: respiratory tract effects. Clin Rev Allergy Immunol. 2014;46(1):65-81.
5.  Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet. 2009;374(9698):1383-1391.
6.  Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219-2227.
7.  National Conference of State Legislatures. State medical marijuana laws (updated 7/20/2016). www.ncsl.org/research/health/state-medical-marijuana-laws.aspx. Accessed September 7, 2016.
8.  Belendiuk KA, Baldini LL, Bonn-Miller MO. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders. Addict Sci Clin Pract. 2015;10(1):1-10.
9.  Hoffmann DE, Weber E. Medical marijuana and the law. N Engl J Med. 2010;362(16):1453-1457.
10.  American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
11.  Koppel B, Brust J, Fife T, et al. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders. Neurology. 2014; 82(17):1556-1563.
12.  Smith LA, Azariah F, Lavender VT, Stoner NS, Bettiol S. Cannabinoids for nausea and vomiting in adults with cancer receiving chemotherapy. Cochrane Database Syst Rev. 2015;(11):CD009464.
13.  Lutge EE, Gray A, Siegfried N. The medical use of cannabis for reducing morbidity and mortality in patients with HIV/AIDS. Cochrane Database Syst Rev. 2013;(4):CD005175.
14.  Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database Syst Rev. 2012;(6):CD009270.

References

1.  Greydanus DE, Hawver EK, Greydanus MM, Merrick J. Cannabis: effective and safe analgesic? J Pain Manage. 2014;7(3):209-233.
2.  Bostwick JM. Blurred boundaries: the therapeutics and politics of medical marijuana. Mayo Clin Proc. 2012;87(2):172-186.
3.  Karst M, Wippermann S, Ahrens J. Role of cannabinoids in the treatment of pain and (painful) spasticity. Drugs. 2010;70(18):2409-2438.
4.  Owen KP, Sutter ME, Albertson TE. Marijuana: respiratory tract effects. Clin Rev Allergy Immunol. 2014;46(1):65-81.
5.  Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet. 2009;374(9698):1383-1391.
6.  Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219-2227.
7.  National Conference of State Legislatures. State medical marijuana laws (updated 7/20/2016). www.ncsl.org/research/health/state-medical-marijuana-laws.aspx. Accessed September 7, 2016.
8.  Belendiuk KA, Baldini LL, Bonn-Miller MO. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders. Addict Sci Clin Pract. 2015;10(1):1-10.
9.  Hoffmann DE, Weber E. Medical marijuana and the law. N Engl J Med. 2010;362(16):1453-1457.
10.  American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
11.  Koppel B, Brust J, Fife T, et al. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders. Neurology. 2014; 82(17):1556-1563.
12.  Smith LA, Azariah F, Lavender VT, Stoner NS, Bettiol S. Cannabinoids for nausea and vomiting in adults with cancer receiving chemotherapy. Cochrane Database Syst Rev. 2015;(11):CD009464.
13.  Lutge EE, Gray A, Siegfried N. The medical use of cannabis for reducing morbidity and mortality in patients with HIV/AIDS. Cochrane Database Syst Rev. 2013;(4):CD005175.
14.  Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database Syst Rev. 2012;(6):CD009270.

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No rise in complications with concomitant gynecologic cancer, PFD surgery

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– Concomitantly treating pelvic floor disorders during surgery for gynecologic cancer does not increase the risk of postoperative complications, according to an analysis of 4 years of data from the American College of Surgeons’ National Surgical Quality Improvement Program.

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– Concomitantly treating pelvic floor disorders during surgery for gynecologic cancer does not increase the risk of postoperative complications, according to an analysis of 4 years of data from the American College of Surgeons’ National Surgical Quality Improvement Program.

 

– Concomitantly treating pelvic floor disorders during surgery for gynecologic cancer does not increase the risk of postoperative complications, according to an analysis of 4 years of data from the American College of Surgeons’ National Surgical Quality Improvement Program.

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Key clinical point: Treating pelvic floor disorders during gynecologic cancer surgery does not appear to increase the risk of postoperative complications.

Major finding: Women who underwent concomitant surgeries had similar rates of infectious, pulmonary, and cardiac complications as those who underwent surgery only for gynecologic cancer, with all P-values exceeding .05.

Data source: A study of 23,501 gynecologic cancer patients in the ACS National Surgical Quality Improvement Program dataset.

Disclosures: Dr. Bochenska and her associates did not report information on funding sources or financial disclosures.

Novel device provides real-time glucose monitoring of critically ill

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WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.

“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.

Dr. Grant V. Bochicchio
He presented results from a trial that evaluated the safety and accuracy of a continuous inline glucose monitor in 200 critically ill and trauma patients. The OptiScanner, an investigational device manufactured by OptiScan Biomedical, automatically measures plasma-based glucose levels to enable early detection of hypoglycemia, hyperglycemia, or glucose variability. The OptiScanner has yet to be cleared by the Food and Drug Administration, but Dr. Bochicchio said that he expects a decision from the agency in the next several months.

The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”

The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.

The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.

The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”

The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.

 

 

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WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.

“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.

Dr. Grant V. Bochicchio
He presented results from a trial that evaluated the safety and accuracy of a continuous inline glucose monitor in 200 critically ill and trauma patients. The OptiScanner, an investigational device manufactured by OptiScan Biomedical, automatically measures plasma-based glucose levels to enable early detection of hypoglycemia, hyperglycemia, or glucose variability. The OptiScanner has yet to be cleared by the Food and Drug Administration, but Dr. Bochicchio said that he expects a decision from the agency in the next several months.

The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”

The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.

The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.

The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”

The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.

 

 

 

WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.

“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.

Dr. Grant V. Bochicchio
He presented results from a trial that evaluated the safety and accuracy of a continuous inline glucose monitor in 200 critically ill and trauma patients. The OptiScanner, an investigational device manufactured by OptiScan Biomedical, automatically measures plasma-based glucose levels to enable early detection of hypoglycemia, hyperglycemia, or glucose variability. The OptiScanner has yet to be cleared by the Food and Drug Administration, but Dr. Bochicchio said that he expects a decision from the agency in the next several months.

The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”

The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.

The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.

The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”

The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.

 

 

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Key clinical point: The first inline continuous glucose monitor is safe and accurate for use in critically ill surgical patients.

Major finding: An analysis of 3,735 paired readings revealed that the mean absolute relative deviation (MARD) was 7.6%, which achieved the primary endpoint for accuracy.

Data source: A trial which set out to evaluate the safety and accuracy of the OptiScanner in 200 patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring.

Disclosures: The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.

VIDEO: Harvoni shows safety, efficacy in adolescents for hepatitis C

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– One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.

“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.

Dr. Karen F. Murray speaking from the podium at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition
Mitchel L. Zoler/Frontline Medical News
Dr. Karen F. Murray
Beyond the coverage and labeling issues, the results from this 100-patient, open-label study are important because “children’s metabolisms are different and you can see toxicities that you don’t see in adults from this novel set of drugs,” said Dr. Murray, chief of gastroenterology and hepatology at Seattle Children’s Hospital and professor of medicine at the University of Washington.

The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.

Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.

The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.

Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.

Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.

“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.

“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.

Dr. Karen F. Murray speaking from the podium at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition
Mitchel L. Zoler/Frontline Medical News
Dr. Karen F. Murray
Beyond the coverage and labeling issues, the results from this 100-patient, open-label study are important because “children’s metabolisms are different and you can see toxicities that you don’t see in adults from this novel set of drugs,” said Dr. Murray, chief of gastroenterology and hepatology at Seattle Children’s Hospital and professor of medicine at the University of Washington.

The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.

Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.

The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.

Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.

Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.

“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.

“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.

Dr. Karen F. Murray speaking from the podium at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition
Mitchel L. Zoler/Frontline Medical News
Dr. Karen F. Murray
Beyond the coverage and labeling issues, the results from this 100-patient, open-label study are important because “children’s metabolisms are different and you can see toxicities that you don’t see in adults from this novel set of drugs,” said Dr. Murray, chief of gastroenterology and hepatology at Seattle Children’s Hospital and professor of medicine at the University of Washington.

The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.

Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.

The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.

Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.

Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.

“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Key clinical point: Twelve weeks of treatment with standard-dose ledipasvir/sofosbuvir safely produced sustained virologic response in 98% of patients.

Major finding: Hepatitis C virus was undetectable after 12 weeks of treatment in 98%; the remaining two patients were lost to follow-up.

Data source: A multicenter, open-label study with 100 patients, aged 12-17 years old, and chronically infected with hepatitis C genotype 1.

Disclosures: The study was sponsored by Gilead, the company that markets ledipasvir/sofosbuvir (Harvoni). Dr. Murray has received research support from Gilead and is a shareholder in Merck.

POP severity not linked to risk of de novo stress urinary incontinence

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– Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.

But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.

Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.

A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).

Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).

The researchers did not report information on funding sources or financial disclosures.

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– Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.

But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.

Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.

A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).

Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).

The researchers did not report information on funding sources or financial disclosures.

 

– Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.

But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.

Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.

A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).

Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).

The researchers did not report information on funding sources or financial disclosures.

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Key clinical point: The severity of pelvic organ prolapse does not seem to be factor in the risk of de novo stress urinary incontinence.

Major finding: Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).

Data source: A single-center retrospective study of 206 patients who underwent surgical correction of POP and had no objective evidence of SUI at baseline.

Disclosures: The researchers did not report information on funding sources or financial disclosures.

Severe joint pain in adults with arthritis continues to rise

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The prevalence of severe joint pain among adults with diagnosed arthritis continues to increase, researchers from the Centers for Disease Control and Prevention reported in the Oct. 7 Morbidity and Mortality Weekly Report.

In 2014, more than one-fourth of adults with arthritis had severe joint pain. That is about 14.6 million Americans with severe joint pain, a significant increase from 2002 when there were an estimated 10.5 million adults with severe joint pain, according to Kamil E. Barbour, PhD, and his associates from the National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 7;65[39]:1052-6).

An analysis of data collected from the National Health Interview Survey revealed that severe joint pain disproportionately affects persons aged 45-64 years. After researchers adjusted for age, they identified women, non-Hispanic blacks, Hispanics, those with a disability, those with less than a high school education, and those unable to work as the demographic groups with the highest prevalence of severe joint pain.

Severe joint pain was also more prevalent among patients with overall fair or poor health who were obese or had heart disease, diabetes, or serious psychological distress, the investigators reported.

The investigators defined people with arthritis as those who had “been told by a doctor or other health professional” that they have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Severe joint pain was defined as a response of 7 or higher on a scale of 0-10 for rating joint pain on average over the past 30 days.

Recently, the U.S. Department of Health & Human Services released its National Pain Strategy, the nation’s first broad, federal effort aimed at developing strategies to reduce the burden of pain among Americans. The initiatives major objectives are to take steps to reduce barriers to pain care, and to increase patient knowledge of treatment options and risks, Dr. Barbour and his associates wrote.

“Health care providers and public health practitioners can begin to implement the recommendations [from the National Pain Strategy] and improve pain care among adults with arthritis and [severe joint pain] by prioritizing self-management education and appropriate physical activity interventions as effective nonpharmacologic ways to reduce pain and improve health outcomes,” the researchers added.
 

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The prevalence of severe joint pain among adults with diagnosed arthritis continues to increase, researchers from the Centers for Disease Control and Prevention reported in the Oct. 7 Morbidity and Mortality Weekly Report.

In 2014, more than one-fourth of adults with arthritis had severe joint pain. That is about 14.6 million Americans with severe joint pain, a significant increase from 2002 when there were an estimated 10.5 million adults with severe joint pain, according to Kamil E. Barbour, PhD, and his associates from the National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 7;65[39]:1052-6).

An analysis of data collected from the National Health Interview Survey revealed that severe joint pain disproportionately affects persons aged 45-64 years. After researchers adjusted for age, they identified women, non-Hispanic blacks, Hispanics, those with a disability, those with less than a high school education, and those unable to work as the demographic groups with the highest prevalence of severe joint pain.

Severe joint pain was also more prevalent among patients with overall fair or poor health who were obese or had heart disease, diabetes, or serious psychological distress, the investigators reported.

The investigators defined people with arthritis as those who had “been told by a doctor or other health professional” that they have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Severe joint pain was defined as a response of 7 or higher on a scale of 0-10 for rating joint pain on average over the past 30 days.

Recently, the U.S. Department of Health & Human Services released its National Pain Strategy, the nation’s first broad, federal effort aimed at developing strategies to reduce the burden of pain among Americans. The initiatives major objectives are to take steps to reduce barriers to pain care, and to increase patient knowledge of treatment options and risks, Dr. Barbour and his associates wrote.

“Health care providers and public health practitioners can begin to implement the recommendations [from the National Pain Strategy] and improve pain care among adults with arthritis and [severe joint pain] by prioritizing self-management education and appropriate physical activity interventions as effective nonpharmacologic ways to reduce pain and improve health outcomes,” the researchers added.
 

 

The prevalence of severe joint pain among adults with diagnosed arthritis continues to increase, researchers from the Centers for Disease Control and Prevention reported in the Oct. 7 Morbidity and Mortality Weekly Report.

In 2014, more than one-fourth of adults with arthritis had severe joint pain. That is about 14.6 million Americans with severe joint pain, a significant increase from 2002 when there were an estimated 10.5 million adults with severe joint pain, according to Kamil E. Barbour, PhD, and his associates from the National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 7;65[39]:1052-6).

An analysis of data collected from the National Health Interview Survey revealed that severe joint pain disproportionately affects persons aged 45-64 years. After researchers adjusted for age, they identified women, non-Hispanic blacks, Hispanics, those with a disability, those with less than a high school education, and those unable to work as the demographic groups with the highest prevalence of severe joint pain.

Severe joint pain was also more prevalent among patients with overall fair or poor health who were obese or had heart disease, diabetes, or serious psychological distress, the investigators reported.

The investigators defined people with arthritis as those who had “been told by a doctor or other health professional” that they have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia. Severe joint pain was defined as a response of 7 or higher on a scale of 0-10 for rating joint pain on average over the past 30 days.

Recently, the U.S. Department of Health & Human Services released its National Pain Strategy, the nation’s first broad, federal effort aimed at developing strategies to reduce the burden of pain among Americans. The initiatives major objectives are to take steps to reduce barriers to pain care, and to increase patient knowledge of treatment options and risks, Dr. Barbour and his associates wrote.

“Health care providers and public health practitioners can begin to implement the recommendations [from the National Pain Strategy] and improve pain care among adults with arthritis and [severe joint pain] by prioritizing self-management education and appropriate physical activity interventions as effective nonpharmacologic ways to reduce pain and improve health outcomes,” the researchers added.
 

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Key clinical point: The incidence of severe joint pain in U.S. adults with diagnosed arthritis continues to increase.

Major finding: The estimated number of U.S. adults with severe joint pain rose from 10.5 million in 2002 to 14.6 million in 2014.

Data source: Analysis of data from the National Health Interview Survey in 2002, 2003, 2006, 2009, and 2014.

Disclosures: The authors are federal government employees and have no financial disclosures.

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FDA reaffirms rivaroxaban’s atrial fib efficacy in ROCKET AF

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The Food and Drug Administration reaffirmed its confidence in the data supporting the claim that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin for preventing strokes and blood clots in patients with nonvalvular atrial fibrillation.

“The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation,” the agency said in a statement released on Oct. 11.

Questions arose about the validity of the data collected in the pivotal trial that supported this indication for rivaroxaban, the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) study, because the Alere INRatio device used to monitor warfarin levels in the trial was subsequently found faulty and recalled by its manufacturer in July 2016.

In response to these events the FDA “completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET AF study results. The agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal,” the agency said in its statement.

Researchers associated with ROCKET AF published their own analysis of the impact of the faulty device on bleeding rates among patients treated with warfarin in the trial and concluded that device malfunction did not appear to influence the results (N Engl J Med. 2016 Feb 25;374[8]:785-8).

Rivaroxaban is one of four new oral anticoagulants (NOACs) on the U.S. market that are alternatives to warfarin for stroke and clot prevention in patients with nonvalvular atrial fibrillation. An analysis of 2014 data on U.S. office-based prescriptions for NOACs in atrial fibrillation patients showed that rivaroxaban was by far the most commonly prescribed drug in the class, prescribed for patients during 48% of physician office visits that led to a NOAC prescription (Am J Med. 2015 Dec;128[12]:1300-5).

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The Food and Drug Administration reaffirmed its confidence in the data supporting the claim that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin for preventing strokes and blood clots in patients with nonvalvular atrial fibrillation.

“The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation,” the agency said in a statement released on Oct. 11.

Questions arose about the validity of the data collected in the pivotal trial that supported this indication for rivaroxaban, the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) study, because the Alere INRatio device used to monitor warfarin levels in the trial was subsequently found faulty and recalled by its manufacturer in July 2016.

In response to these events the FDA “completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET AF study results. The agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal,” the agency said in its statement.

Researchers associated with ROCKET AF published their own analysis of the impact of the faulty device on bleeding rates among patients treated with warfarin in the trial and concluded that device malfunction did not appear to influence the results (N Engl J Med. 2016 Feb 25;374[8]:785-8).

Rivaroxaban is one of four new oral anticoagulants (NOACs) on the U.S. market that are alternatives to warfarin for stroke and clot prevention in patients with nonvalvular atrial fibrillation. An analysis of 2014 data on U.S. office-based prescriptions for NOACs in atrial fibrillation patients showed that rivaroxaban was by far the most commonly prescribed drug in the class, prescribed for patients during 48% of physician office visits that led to a NOAC prescription (Am J Med. 2015 Dec;128[12]:1300-5).


The Food and Drug Administration reaffirmed its confidence in the data supporting the claim that rivaroxaban (Xarelto) is a safe and effective alternative to warfarin for preventing strokes and blood clots in patients with nonvalvular atrial fibrillation.

“The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation,” the agency said in a statement released on Oct. 11.

Questions arose about the validity of the data collected in the pivotal trial that supported this indication for rivaroxaban, the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) study, because the Alere INRatio device used to monitor warfarin levels in the trial was subsequently found faulty and recalled by its manufacturer in July 2016.

In response to these events the FDA “completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET AF study results. The agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal,” the agency said in its statement.

Researchers associated with ROCKET AF published their own analysis of the impact of the faulty device on bleeding rates among patients treated with warfarin in the trial and concluded that device malfunction did not appear to influence the results (N Engl J Med. 2016 Feb 25;374[8]:785-8).

Rivaroxaban is one of four new oral anticoagulants (NOACs) on the U.S. market that are alternatives to warfarin for stroke and clot prevention in patients with nonvalvular atrial fibrillation. An analysis of 2014 data on U.S. office-based prescriptions for NOACs in atrial fibrillation patients showed that rivaroxaban was by far the most commonly prescribed drug in the class, prescribed for patients during 48% of physician office visits that led to a NOAC prescription (Am J Med. 2015 Dec;128[12]:1300-5).

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Hanging on as small practices slowly die

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I’ve had to skip several paychecks this year to keep my practice afloat. That makes it hard to pay for my routine personal expenses, like a mortgage, so I have to take the money out of my family’s “rainy day” savings.

This gets old after a few years of the same cycle. I’m pretty sick of it.

Granted, I chose this path. Solo practice suits me. I’ve been in a large group, and it took me roughly 2 years to realize it was a poor fit for me. I’ve been on my own since 2000 and been pretty happy here.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block


I’ve come to accept that taking a vacation means a temporary drop in salary down the road. My family is important to me, and I don’t want them to remember me as the never-home father immortalized by Harry Chapin’s “Cat’s in the Cradle.”

Trouble is this: What if you still work hard, and find your income falling? I see patients from 8 to 4 most days, with a full schedule, but reimbursements keep dropping and costs keep climbing. Isn’t the idea that hard work will bring success central to the American Dream? Especially when you toss in 9 years of medical school and residency? Apparently not. The American Dream, whatever it is, is pretty much dead for most small-practice doctors.

These are tough times for solo docs, regardless of field. I’ve seen several posts on sites such as Sermo that show I’m not the only one in this boat, skipping paychecks to keep the door open and lights on. Most small practices are running into the same issue. Some, like me, are slugging it out and hoping things get better. Others are folding up and moving, or joining large groups, or signing up with a hospital system.

I’m not sure those last two are options I want. Most of the docs I know who’ve joined hospital outpatient systems are pretty unhappy with them, too. They talk about computer systems designed for billing rather than patient care; unrealistic amounts of time allotted to each patient by a nonmedical person; and jumping through hoops to get certain tests or treatments done.

I suspect it’s a combination of factors, though others see more sinister forces at work. Some posts I read suggest that it’s part of a government and/or insurance conspiracy to destroy small practices.

Regardless, it seems to be succeeding. Small practices are in crisis. Doctor suicides are up. And solo practice has been found to be a risk factor for suicide. There are days when I can see how that seems like the only way out for those who came here just to care for people, and now find that economic circumstances won’t let them.

I don’t have a castle, or drive a Rolls-Royce, or send my kids to private school. We live fairly modestly, but even then it’s getting hard to keep up with costs.

We’re in an election year, and, as always, medical care is bandied about by both parties as a bargaining chip to get votes. But I haven’t heard either side talk about this, nor do I get the impression that either major candidate really cares. Both of them, and members of Congress, get pretty top-notch care without having to worry about cost. This isn’t reassuring to me and all the other solo docs hanging on by our fingernails and trying to practice ethical, honest medicine.

I’m sure some will say it’s progress, but I think the gradual death of the American small and solo practice is sad. It’s a model that’s been the backbone of Western medicine for a few hundred years now, caring for people in big cities, small towns, and everywhere in between. Portrayed in fiction as Marcus Welby, Michaela Quinn, Joel Fleischman, and (my favorite, from Willa Cather’s “Neighbour Rosicky”) Ed Burleigh. Sometimes brilliant, sometimes quirky, sometimes all-too-human ... but still doctors, caring for their patients and communities.

Like the unnamed protagonist in Dr. Seuss’ “I Had Trouble in getting to Solla Sollew,” I tend to find that no matter where you go there will be troubles, and sometimes you’re best off staying in one place and fighting the ones you know.

And, for now, that’s where I am and hope to stay. But I’m scared.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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I’ve had to skip several paychecks this year to keep my practice afloat. That makes it hard to pay for my routine personal expenses, like a mortgage, so I have to take the money out of my family’s “rainy day” savings.

This gets old after a few years of the same cycle. I’m pretty sick of it.

Granted, I chose this path. Solo practice suits me. I’ve been in a large group, and it took me roughly 2 years to realize it was a poor fit for me. I’ve been on my own since 2000 and been pretty happy here.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block


I’ve come to accept that taking a vacation means a temporary drop in salary down the road. My family is important to me, and I don’t want them to remember me as the never-home father immortalized by Harry Chapin’s “Cat’s in the Cradle.”

Trouble is this: What if you still work hard, and find your income falling? I see patients from 8 to 4 most days, with a full schedule, but reimbursements keep dropping and costs keep climbing. Isn’t the idea that hard work will bring success central to the American Dream? Especially when you toss in 9 years of medical school and residency? Apparently not. The American Dream, whatever it is, is pretty much dead for most small-practice doctors.

These are tough times for solo docs, regardless of field. I’ve seen several posts on sites such as Sermo that show I’m not the only one in this boat, skipping paychecks to keep the door open and lights on. Most small practices are running into the same issue. Some, like me, are slugging it out and hoping things get better. Others are folding up and moving, or joining large groups, or signing up with a hospital system.

I’m not sure those last two are options I want. Most of the docs I know who’ve joined hospital outpatient systems are pretty unhappy with them, too. They talk about computer systems designed for billing rather than patient care; unrealistic amounts of time allotted to each patient by a nonmedical person; and jumping through hoops to get certain tests or treatments done.

I suspect it’s a combination of factors, though others see more sinister forces at work. Some posts I read suggest that it’s part of a government and/or insurance conspiracy to destroy small practices.

Regardless, it seems to be succeeding. Small practices are in crisis. Doctor suicides are up. And solo practice has been found to be a risk factor for suicide. There are days when I can see how that seems like the only way out for those who came here just to care for people, and now find that economic circumstances won’t let them.

I don’t have a castle, or drive a Rolls-Royce, or send my kids to private school. We live fairly modestly, but even then it’s getting hard to keep up with costs.

We’re in an election year, and, as always, medical care is bandied about by both parties as a bargaining chip to get votes. But I haven’t heard either side talk about this, nor do I get the impression that either major candidate really cares. Both of them, and members of Congress, get pretty top-notch care without having to worry about cost. This isn’t reassuring to me and all the other solo docs hanging on by our fingernails and trying to practice ethical, honest medicine.

I’m sure some will say it’s progress, but I think the gradual death of the American small and solo practice is sad. It’s a model that’s been the backbone of Western medicine for a few hundred years now, caring for people in big cities, small towns, and everywhere in between. Portrayed in fiction as Marcus Welby, Michaela Quinn, Joel Fleischman, and (my favorite, from Willa Cather’s “Neighbour Rosicky”) Ed Burleigh. Sometimes brilliant, sometimes quirky, sometimes all-too-human ... but still doctors, caring for their patients and communities.

Like the unnamed protagonist in Dr. Seuss’ “I Had Trouble in getting to Solla Sollew,” I tend to find that no matter where you go there will be troubles, and sometimes you’re best off staying in one place and fighting the ones you know.

And, for now, that’s where I am and hope to stay. But I’m scared.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

I’ve had to skip several paychecks this year to keep my practice afloat. That makes it hard to pay for my routine personal expenses, like a mortgage, so I have to take the money out of my family’s “rainy day” savings.

This gets old after a few years of the same cycle. I’m pretty sick of it.

Granted, I chose this path. Solo practice suits me. I’ve been in a large group, and it took me roughly 2 years to realize it was a poor fit for me. I’ve been on my own since 2000 and been pretty happy here.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block


I’ve come to accept that taking a vacation means a temporary drop in salary down the road. My family is important to me, and I don’t want them to remember me as the never-home father immortalized by Harry Chapin’s “Cat’s in the Cradle.”

Trouble is this: What if you still work hard, and find your income falling? I see patients from 8 to 4 most days, with a full schedule, but reimbursements keep dropping and costs keep climbing. Isn’t the idea that hard work will bring success central to the American Dream? Especially when you toss in 9 years of medical school and residency? Apparently not. The American Dream, whatever it is, is pretty much dead for most small-practice doctors.

These are tough times for solo docs, regardless of field. I’ve seen several posts on sites such as Sermo that show I’m not the only one in this boat, skipping paychecks to keep the door open and lights on. Most small practices are running into the same issue. Some, like me, are slugging it out and hoping things get better. Others are folding up and moving, or joining large groups, or signing up with a hospital system.

I’m not sure those last two are options I want. Most of the docs I know who’ve joined hospital outpatient systems are pretty unhappy with them, too. They talk about computer systems designed for billing rather than patient care; unrealistic amounts of time allotted to each patient by a nonmedical person; and jumping through hoops to get certain tests or treatments done.

I suspect it’s a combination of factors, though others see more sinister forces at work. Some posts I read suggest that it’s part of a government and/or insurance conspiracy to destroy small practices.

Regardless, it seems to be succeeding. Small practices are in crisis. Doctor suicides are up. And solo practice has been found to be a risk factor for suicide. There are days when I can see how that seems like the only way out for those who came here just to care for people, and now find that economic circumstances won’t let them.

I don’t have a castle, or drive a Rolls-Royce, or send my kids to private school. We live fairly modestly, but even then it’s getting hard to keep up with costs.

We’re in an election year, and, as always, medical care is bandied about by both parties as a bargaining chip to get votes. But I haven’t heard either side talk about this, nor do I get the impression that either major candidate really cares. Both of them, and members of Congress, get pretty top-notch care without having to worry about cost. This isn’t reassuring to me and all the other solo docs hanging on by our fingernails and trying to practice ethical, honest medicine.

I’m sure some will say it’s progress, but I think the gradual death of the American small and solo practice is sad. It’s a model that’s been the backbone of Western medicine for a few hundred years now, caring for people in big cities, small towns, and everywhere in between. Portrayed in fiction as Marcus Welby, Michaela Quinn, Joel Fleischman, and (my favorite, from Willa Cather’s “Neighbour Rosicky”) Ed Burleigh. Sometimes brilliant, sometimes quirky, sometimes all-too-human ... but still doctors, caring for their patients and communities.

Like the unnamed protagonist in Dr. Seuss’ “I Had Trouble in getting to Solla Sollew,” I tend to find that no matter where you go there will be troubles, and sometimes you’re best off staying in one place and fighting the ones you know.

And, for now, that’s where I am and hope to stay. But I’m scared.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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