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Screw Fixation Without Bone Grafting for Delayed Unions and Nonunions of Minimally Displaced Scaphoids
ABSTRACT
Delayed unions and nonunions of the scaphoid are most often treated by open reduction and internal fixation with bone grafting. We sought to evaluate a large consecutive series of nondisplaced or minimally displaced scaphoid nonunions and delayed unions treated by a compression screw without bone grafting by 2 fellowship trained hand surgeons. A total of 23 patients (19 males, 4 females) were identified who had fractures located at the distal third (2), the waist (18), and the proximal third (3). Of the 23 patients, 19 had a complete follow-up (mean follow-up period, 5.2 months) with evidence of radiographic union. There were no radiographic signs of arthrosis, osteonecrosis of the scaphoid, hardware-related complications, or reported revision surgeries. In conclusion, nonunions and delayed unions in nondisplaced or minimally displaced scaphoids without carpal malalignment can be successfully treated using compression screw fixation without bone grafting.
Continued to: Scaphoid nonunions or delayed unions with displacement...
Scaphoid nonunions or delayed unions with displacement, humpback deformities, or dorsal intercalated segmental instability deformities require open exposure with reduction of the fracture and autogenous bone grafting (structural or nonstructural and vascularized or nonvascularized).1,2 However, in the absence of displacement or deformity, compression and internal fixation without bone grafting may be sufficient to achieve union.
Several reports have described the use of internal fixation alone in the management of scaphoid nonunions with both minimal and extensive bone loss.3-7 These studies have shown that screw fixation alone affords less morbidity to the patient while allowing high rates of union.
Previous reports of internal fixation alone included limited numbers of patients for review. Therefore, we aim to review a large consecutive series of scaphoid delayed unions and nonunions without osteonecrosis or deformity managed by only internal fixation. Our hypothesis is that drilling combined with compression and rigid stabilization would allow for bony union in these cases
MATERIALS AND METHODS
After Institutional Review Board approval was obtained, a retrospective review of prospectively collected data was performed on consecutive patients with a delayed union or nonunion of the scaphoid. All injuries had failed conservative treatment of casting for at least 12 weeks and ultrasound stimulation, and were subsequently treated by compression screw fixation by 1 of 2 fellowship trained hand surgeons. The database comprised the data of patients who presented to a single, Level 1 trauma center between 2000 and 2012.
Delayed unions and nonunions were defined as a lack of radiographic trabecular bridging and pain on clinical examination at 3 and 6 months, respectively. All fractures were nondisplaced or minimally displaced (<2 mm), and patients with carpal malalignment or humpback deformity (based on scapholunate angle on plain radiographs) were excluded. Clinical outcome measures included evidence of radiographic union, revision surgery, pain, and reported complications.
Continue to: Inclusion criteria were all patients who sustained...
Inclusion criteria were all patients who sustained a minimally displaced scaphoid fracture and were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions.
Patients younger than age 18 years or with radiographic evidence of arthrosis or humpback deformity were excluded. Any fracture with >2 mm of gapping on original injury radiographs was not considered as minimally displaced and was also excluded. Furthermore, patients with a previous ipsilateral scaphoid injury or hand surgery were also excluded.
Compression screw placement was recorded as being either central or eccentric based on Trumble and colleagues’8 criteria. Posteroanterior (PA), lateral, and scaphoid view radiographs were reviewed by the first author (DS) and the treating hand surgeon (AS). Central screw placement was substantiated if the screw was in the middle third of the proximal pole in all 3 views.
The final set of postoperative radiographs was reviewed for unions. Union was defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views. Computerized tomography (CT) was performed at the discretion of the treating surgeon, and its use was not required if there was near obliteration of the fracture line on the 3-view radiographs and in the absence of patient-reported pain. Patients with bone loss or sclerosis were included as long as no deformity existed.
After surgical intervention, a short-arm cast was applied for 6 weeks, followed by a wrist splint for 4 to 8 weeks depending on patient comfort.
Continue to: SURGICAL TECHNIQUE...
SURGICAL TECHNIQUE
Either a 1-cm to 2-cm transverse incision distal to Lister’s tubercle or a longitudinal incision just ulnar was utilized. The extensor pollicis longus was identified and retracted. A longitudinal or an L-shaped capsulotomy was made to identify the proximal pole of the scaphoid. With the wrist flexed, a guide wire was inserted down the central axis of the scaphoid and confirmed by fluoroscopy. The measurement was made off the guidewire and 4 to 6 mm was subtracted. The scaphoid was then drilled, and the variable pitch compression screw (Acutrak Headless Compression Screw, Acumed) was inserted. Compression and position of the screw were confirmed by fluoroscopy before closure.
RESULTS
A total of 23 patients (19 males, 4 females) with acute scaphoid fractures who were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions were identified in this study. The ages of the patients ranged from 19 to 50 years. Of the 23 patients, 6 were smokers. The majority of patients sustained fractures in the scaphoid waist (18 patients) (Figure 1). Two patients had distal third fractures, and 3 had proximal third fractures.
The average time from the sustained injury to the surgical intervention was 8.2 months (range, 3.1-27.6 months). There were no patients with delayed diagnoses. Three fractures were identified as delayed unions with failure of union and pain after 3 months of conservative treatment, whereas the other 20 were identified as nonunions with at least 6 months of failed conservative treatment.

Of the 23 patients, 21 were found to have centrally placed variable compression screws based on Trumble and colleagues’8 criteria. Of the 23 patients, 19 had a complete follow-up course with radiographs at 6 months after surgery. All of these 19 patients had evidence of radiographic union defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views (Figure 2). Of the 6 smokers, 5 progressed to radiographic union and 1 patient had <6 months of postoperative return visits and could not be contacted. At the final clinic visit, all of the 19 patients denied wrist pain on direct palpation over the scaphoid tubercle, and no complications were reported. There were no repeat or revision surgical interventions.
Four patients had limited follow-up with <6 months of postoperative return visits. Their final set of radiographs did not demonstrate complete bridging trabeculation. One patient who moved away from the area was lost to follow-up but was contacted. The patient stated that he had a pain-free wrist with no further surgical interventions on his scaphoid. The other 3 patients could not be contacted.

DISCUSSION
The management of scaphoid nonunions and delayed unions has dramatically evolved over the past 20 years.1,3-8 Historically, semi-rigid stabilization using Kirschner wires and casting afforded a 77% union rate in these cases.9 More recently, several authors have reported that stabilization without bone grafting can predictably unite scaphoid nonunions. Treating patients with uncomplicated scaphoid nonunions and delayed unions by internal fixation alone may be all that is required to achieve union.
The definitions of a scaphoid nonunion and delayed union are complex. The exact time when a scaphoid fracture heals varies between patients.2,5,10 However, the majority of hand surgeons believe that failure to see clear signs of healing (in waist fractures) after 3 months from the injury would suggest a failure to heal and a “delayed” union, whereas failure after 6 months from the injury and without clear signs of healing indicate a nonunion.5,6,10,11 Any resorption at the fracture site suggests that the fracture will not heal by continued immobilization alone and will require surgery.10
Continue to: Hand surgeons have several surgical options...
Hand surgeons have several surgical options when managing scaphoid injuries. Mahmoud and Koptan4 used a volar approach to percutaneously deliver a headless compression screw into 27 nonunions. Postoperative CT scans demonstrated fracture union in all 27 patients, and no patient underwent revision surgery. Interestingly, 14 of their patients had extensive preoperative resorption (but no deformity) of >5 mm.
Although volar percutaneous approaches for internal fixation have been cited to provide high rates of union and high patient satisfaction in acute scaphoid fracture fixation, this study utilized a dorsal approach. Both Wozasek and Moser12 and Haddad and Goddard13 reported excellent results and high union rates using a volar approach in consecutive acute scaphoid fractures. Despite these results, there are concerns that using a volar approach may damage the scaphotrapezial joint and may be prone to eccentric placement of compression screws.8,14
Slade and colleagues3 did utilize the dorsal approach with arthroscopic assistance to deliver a compression screw into scaphoid nonunions in 15 consecutive patients without any evidence of deformity, sclerosis, or resorption. Similar to our investigation, they treated patients with both delayed unions and nonunions. CT scans were used to confirm unions in all their patients. Using a dorsal approach, Yassaee and Yang15 treated 9 consecutive patients using a compression screw without bone grafting for both delayed and nonunion scaphoid injuries. Other authors have used both volar and dorsal approaches in 12 consecutive delayed and nonunion scaphoid injuries and found that 11 of the 12 injuries progressed to unions.6
Although these authors and several others advocate the use of CT scans to assess unions, our investigation used bridging trabeculation obliteration of the fracture line on 3 standard radiographic views to confirm unions in addition to the absence of pain clinically.16,17 CT scans expose the patient to increased radiation that, in our experience, does not alter the postoperative clinical course.18 If there is clear evidence of bridged callus and no pain on physical examination, a CT scan performed to reconfirm the union affords little benefit to clinical management.19
Continue to: All these previous studies have demonstrated...
All these previous studies have demonstrated excellent union rates but using a limited series of patients. We reviewed a large number of consecutive patients with scaphoid delayed unions and nonunions treated by screw fixation without bone grafting. Our hospital is a safety net institution for a large urban catchment area and had complete radiographic and clinical data for 19 of our 23 patients. One patient was contacted by telephone and he reported no pain and no revision surgical interventions.
The limitations of this study include not only its retrospective design but also its limited secondary outcome measures. However, our primary outcomes of union, pain, and complications are of utmost importance to clinicians and patients alike. Similar to other authors, we used radiographs to confirm unions. Although bridging trabeculation in radiographs has been demonstrated as soon as 1 month after the injury, there may be problems with interobserver reliability.4,13,15,20,21
Patients being lost to follow-up is not uncommon in the orthopedic trauma literature and can influence results.22,23 It is speculative to infer that the 3 patients who did not complete a follow-up course did not return because their pain had mitigated.
CONCLUSION
Like several fractures, the lack of stability and the absence of micro-motion are believed to contribute to fibrous nonunions in scaphoid fractures.13 This study provides a large consecutive cohort of patients with minimally displaced scaphoid delayed unions and nonunions that were successfully treated by rigid internal fixation without bone grafting. These results confirm previous reports that bone grafting is not required to provide predictable unions for the majority of scaphoid nonunions.
This paper will be judged for the Resident Writer’s Award.
1. Trumble TE, Salas P, Barthel T, Robert KQ 3rd. Management of scaphoid nonunions. J Am Acad Orthop Surg. 2003;11(6):380-391. doi:10.1016/j.jhsa.2012.03.002.
2. Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004;75(5):618-629. doi:10.1080/00016470410001529.
3. Slade JF 3rd, Geissler WB, Gutow AP, Merrell GA. Percutaneous internal fixation of selected scaphoid nonunions with an arthroscopically assisted dorsal approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:20-32.
4. Mahmoud M, Koptan W. Percutaneous screw fixation without bone grafting for established scaphoid nonunion with substantial bone loss. J Bone Joint Surg Br. 2011;93(7):932-936. doi:10.1302/0301-620X.93B7.25418.
5. Inaparthy PK, Nicholl JE. Treatment of delayed/nonunion of scaphoid waist with Synthes cannulated scaphoid screw and bone graft. Hand N Y N. 2008;3(4):292-296. doi:10.1007/s11552-008-9112-4.
6. Capo JT, Shamian B, Rizzo M. Percutaneous screw fixation without bone grafting of scaphoid non-union. Isr Med Assoc J. 2012;14(12):729-732.
7. Kim JK, Kim JO, Lee SY. Volar percutaneous screw fixation for scaphoid waist delayed union. Clin Orthop Relat Res. 2010;468(4):1066-1071. doi:10.1007/s11999-009-1032-2.
8. Trumble TE, Clarke T, Kreder HJ. Non-union of the scaphoid. Treatment with cannulated screws compared with treatment with Herbert screws. J Bone Joint Surg Am. 1996;78(12):1829-1837.
9. Cosio MQ, Camp RA. Percutaneous pinning of symptomatic scaphoid nonunions. J Hand Surg. 1986;11(3):350-355. doi:10.1016/S0363-5023(86)80141-1.
10. Steinmann SP, Adams JE. Scaphoid fractures and nonunions: diagnosis and treatment. J Orthop Sci. 2006;11(4):424-431. doi:10.1007/s00776-006-1025-x.
11. Zarezadeh A, Moezi M, Rastegar S, Motififard M, Foladi A, Daneshpajouhnejad P. Scaphoid nonunion fracture and results of the modified Matti-Russe technique. Adv Biomed Res. 2015;4:39. doi:10.4103/2277-9175.151248.
12. Wozasek GE, Moser KD. Percutaneous screw fixation for fractures of the scaphoid. J Bone Joint Surg Br. 1991;73(1):138-142. doi:10.3928/01477447-20170509-04.
13. Haddad FS, Goddard NJ. Acute percutaneous scaphoid fixation. A pilot study. J Bone Joint Surg Br. 1998;80(1):95-99. doi:10.1302/0301-620X.80B1.8076.
14. Yip HSF, Wu WC, Chang RYP, So TYC. Percutaneous cannulated screw fixation of acute scaphoid waist fracture. J Hand Surg Br. 2002;27(1):42-46. doi:10.1054/jhsb.2001.0690.
15. Yassaee F, Yang SS. Mini-incision fixation of nondisplaced scaphoid fracture nonunions. J Hand Surg. 2008;33(7):1116-1120. doi:10.1016/j.jhsa.2008.03.004.
16. Slade JF 3rd, Gillon T. Retrospective review of 234 scaphoid fractures and nonunions treated with arthroscopy for union and complications. Scand J Surg. 2008;97(4):280-289. doi:10.1177/145749690809700402
17. Geoghegan JM, Woodruff MJ, Bhatia R, et al. Undisplaced scaphoid waist fractures: is 4 weeks’ immobilisation in a below-elbow cast sufficient if a week 4 CT scan suggests fracture union? J Hand Surg Eur Vol. 2009;34(5):631-637. doi:10.1177/1753193409105189.
18. Biswas D, Bible JE, Bohan M, Simpson AK, Whang PG, Grauer JN. Radiation exposure from musculoskeletal computerized tomographic scans. J Bone Joint Surg Am. 2009;91(8):1882-1889. doi:10.2106/JBJS.H.01199.
19. Dias JJ, Taylor M, Thompson J, Brenkel IJ, Gregg PJ. Radiographic signs of union of scaphoid fractures. An analysis of inter-observer agreement and reproducibility. J Bone Joint Surg Br. 1988;70(2):299-301. doi:10.1302/0301-620X.70B2.3346310.
20. Martus JE, Bedi A, Jebson PJL. Cannulated variable pitch compression screw fixation of scaphoid fractures using a limited dorsal approach. Tech Hand Up Extrem Surg. 2005;9(4):202-206. doi:10.1097/01.bth.0000191422.26565.25.
21. Clay NR, Dias JJ, Costigan PS, Gregg PJ, Barton NJ. Need the thumb be immobilised in scaphoid fractures? A randomised prospective trial. J Bone Joint Surg Br. 1991;73(5):828-832. doi:10.1302/0301-620X.73B5.1894676.
22. Zelle BA, Bhandari M, Sanchez AI, Probst C, Pape HC. Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013;27(3):177-181. doi:10.1097/BOT.0b013e31825cf367.
23. Sprague S, Leece P, Bhandari M, et al. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials. 2003;24(6):719-725. doi:10.1016/j.cct.2003.08.012.
ABSTRACT
Delayed unions and nonunions of the scaphoid are most often treated by open reduction and internal fixation with bone grafting. We sought to evaluate a large consecutive series of nondisplaced or minimally displaced scaphoid nonunions and delayed unions treated by a compression screw without bone grafting by 2 fellowship trained hand surgeons. A total of 23 patients (19 males, 4 females) were identified who had fractures located at the distal third (2), the waist (18), and the proximal third (3). Of the 23 patients, 19 had a complete follow-up (mean follow-up period, 5.2 months) with evidence of radiographic union. There were no radiographic signs of arthrosis, osteonecrosis of the scaphoid, hardware-related complications, or reported revision surgeries. In conclusion, nonunions and delayed unions in nondisplaced or minimally displaced scaphoids without carpal malalignment can be successfully treated using compression screw fixation without bone grafting.
Continued to: Scaphoid nonunions or delayed unions with displacement...
Scaphoid nonunions or delayed unions with displacement, humpback deformities, or dorsal intercalated segmental instability deformities require open exposure with reduction of the fracture and autogenous bone grafting (structural or nonstructural and vascularized or nonvascularized).1,2 However, in the absence of displacement or deformity, compression and internal fixation without bone grafting may be sufficient to achieve union.
Several reports have described the use of internal fixation alone in the management of scaphoid nonunions with both minimal and extensive bone loss.3-7 These studies have shown that screw fixation alone affords less morbidity to the patient while allowing high rates of union.
Previous reports of internal fixation alone included limited numbers of patients for review. Therefore, we aim to review a large consecutive series of scaphoid delayed unions and nonunions without osteonecrosis or deformity managed by only internal fixation. Our hypothesis is that drilling combined with compression and rigid stabilization would allow for bony union in these cases
MATERIALS AND METHODS
After Institutional Review Board approval was obtained, a retrospective review of prospectively collected data was performed on consecutive patients with a delayed union or nonunion of the scaphoid. All injuries had failed conservative treatment of casting for at least 12 weeks and ultrasound stimulation, and were subsequently treated by compression screw fixation by 1 of 2 fellowship trained hand surgeons. The database comprised the data of patients who presented to a single, Level 1 trauma center between 2000 and 2012.
Delayed unions and nonunions were defined as a lack of radiographic trabecular bridging and pain on clinical examination at 3 and 6 months, respectively. All fractures were nondisplaced or minimally displaced (<2 mm), and patients with carpal malalignment or humpback deformity (based on scapholunate angle on plain radiographs) were excluded. Clinical outcome measures included evidence of radiographic union, revision surgery, pain, and reported complications.
Continue to: Inclusion criteria were all patients who sustained...
Inclusion criteria were all patients who sustained a minimally displaced scaphoid fracture and were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions.
Patients younger than age 18 years or with radiographic evidence of arthrosis or humpback deformity were excluded. Any fracture with >2 mm of gapping on original injury radiographs was not considered as minimally displaced and was also excluded. Furthermore, patients with a previous ipsilateral scaphoid injury or hand surgery were also excluded.
Compression screw placement was recorded as being either central or eccentric based on Trumble and colleagues’8 criteria. Posteroanterior (PA), lateral, and scaphoid view radiographs were reviewed by the first author (DS) and the treating hand surgeon (AS). Central screw placement was substantiated if the screw was in the middle third of the proximal pole in all 3 views.
The final set of postoperative radiographs was reviewed for unions. Union was defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views. Computerized tomography (CT) was performed at the discretion of the treating surgeon, and its use was not required if there was near obliteration of the fracture line on the 3-view radiographs and in the absence of patient-reported pain. Patients with bone loss or sclerosis were included as long as no deformity existed.
After surgical intervention, a short-arm cast was applied for 6 weeks, followed by a wrist splint for 4 to 8 weeks depending on patient comfort.
Continue to: SURGICAL TECHNIQUE...
SURGICAL TECHNIQUE
Either a 1-cm to 2-cm transverse incision distal to Lister’s tubercle or a longitudinal incision just ulnar was utilized. The extensor pollicis longus was identified and retracted. A longitudinal or an L-shaped capsulotomy was made to identify the proximal pole of the scaphoid. With the wrist flexed, a guide wire was inserted down the central axis of the scaphoid and confirmed by fluoroscopy. The measurement was made off the guidewire and 4 to 6 mm was subtracted. The scaphoid was then drilled, and the variable pitch compression screw (Acutrak Headless Compression Screw, Acumed) was inserted. Compression and position of the screw were confirmed by fluoroscopy before closure.
RESULTS
A total of 23 patients (19 males, 4 females) with acute scaphoid fractures who were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions were identified in this study. The ages of the patients ranged from 19 to 50 years. Of the 23 patients, 6 were smokers. The majority of patients sustained fractures in the scaphoid waist (18 patients) (Figure 1). Two patients had distal third fractures, and 3 had proximal third fractures.
The average time from the sustained injury to the surgical intervention was 8.2 months (range, 3.1-27.6 months). There were no patients with delayed diagnoses. Three fractures were identified as delayed unions with failure of union and pain after 3 months of conservative treatment, whereas the other 20 were identified as nonunions with at least 6 months of failed conservative treatment.

Of the 23 patients, 21 were found to have centrally placed variable compression screws based on Trumble and colleagues’8 criteria. Of the 23 patients, 19 had a complete follow-up course with radiographs at 6 months after surgery. All of these 19 patients had evidence of radiographic union defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views (Figure 2). Of the 6 smokers, 5 progressed to radiographic union and 1 patient had <6 months of postoperative return visits and could not be contacted. At the final clinic visit, all of the 19 patients denied wrist pain on direct palpation over the scaphoid tubercle, and no complications were reported. There were no repeat or revision surgical interventions.
Four patients had limited follow-up with <6 months of postoperative return visits. Their final set of radiographs did not demonstrate complete bridging trabeculation. One patient who moved away from the area was lost to follow-up but was contacted. The patient stated that he had a pain-free wrist with no further surgical interventions on his scaphoid. The other 3 patients could not be contacted.

DISCUSSION
The management of scaphoid nonunions and delayed unions has dramatically evolved over the past 20 years.1,3-8 Historically, semi-rigid stabilization using Kirschner wires and casting afforded a 77% union rate in these cases.9 More recently, several authors have reported that stabilization without bone grafting can predictably unite scaphoid nonunions. Treating patients with uncomplicated scaphoid nonunions and delayed unions by internal fixation alone may be all that is required to achieve union.
The definitions of a scaphoid nonunion and delayed union are complex. The exact time when a scaphoid fracture heals varies between patients.2,5,10 However, the majority of hand surgeons believe that failure to see clear signs of healing (in waist fractures) after 3 months from the injury would suggest a failure to heal and a “delayed” union, whereas failure after 6 months from the injury and without clear signs of healing indicate a nonunion.5,6,10,11 Any resorption at the fracture site suggests that the fracture will not heal by continued immobilization alone and will require surgery.10
Continue to: Hand surgeons have several surgical options...
Hand surgeons have several surgical options when managing scaphoid injuries. Mahmoud and Koptan4 used a volar approach to percutaneously deliver a headless compression screw into 27 nonunions. Postoperative CT scans demonstrated fracture union in all 27 patients, and no patient underwent revision surgery. Interestingly, 14 of their patients had extensive preoperative resorption (but no deformity) of >5 mm.
Although volar percutaneous approaches for internal fixation have been cited to provide high rates of union and high patient satisfaction in acute scaphoid fracture fixation, this study utilized a dorsal approach. Both Wozasek and Moser12 and Haddad and Goddard13 reported excellent results and high union rates using a volar approach in consecutive acute scaphoid fractures. Despite these results, there are concerns that using a volar approach may damage the scaphotrapezial joint and may be prone to eccentric placement of compression screws.8,14
Slade and colleagues3 did utilize the dorsal approach with arthroscopic assistance to deliver a compression screw into scaphoid nonunions in 15 consecutive patients without any evidence of deformity, sclerosis, or resorption. Similar to our investigation, they treated patients with both delayed unions and nonunions. CT scans were used to confirm unions in all their patients. Using a dorsal approach, Yassaee and Yang15 treated 9 consecutive patients using a compression screw without bone grafting for both delayed and nonunion scaphoid injuries. Other authors have used both volar and dorsal approaches in 12 consecutive delayed and nonunion scaphoid injuries and found that 11 of the 12 injuries progressed to unions.6
Although these authors and several others advocate the use of CT scans to assess unions, our investigation used bridging trabeculation obliteration of the fracture line on 3 standard radiographic views to confirm unions in addition to the absence of pain clinically.16,17 CT scans expose the patient to increased radiation that, in our experience, does not alter the postoperative clinical course.18 If there is clear evidence of bridged callus and no pain on physical examination, a CT scan performed to reconfirm the union affords little benefit to clinical management.19
Continue to: All these previous studies have demonstrated...
All these previous studies have demonstrated excellent union rates but using a limited series of patients. We reviewed a large number of consecutive patients with scaphoid delayed unions and nonunions treated by screw fixation without bone grafting. Our hospital is a safety net institution for a large urban catchment area and had complete radiographic and clinical data for 19 of our 23 patients. One patient was contacted by telephone and he reported no pain and no revision surgical interventions.
The limitations of this study include not only its retrospective design but also its limited secondary outcome measures. However, our primary outcomes of union, pain, and complications are of utmost importance to clinicians and patients alike. Similar to other authors, we used radiographs to confirm unions. Although bridging trabeculation in radiographs has been demonstrated as soon as 1 month after the injury, there may be problems with interobserver reliability.4,13,15,20,21
Patients being lost to follow-up is not uncommon in the orthopedic trauma literature and can influence results.22,23 It is speculative to infer that the 3 patients who did not complete a follow-up course did not return because their pain had mitigated.
CONCLUSION
Like several fractures, the lack of stability and the absence of micro-motion are believed to contribute to fibrous nonunions in scaphoid fractures.13 This study provides a large consecutive cohort of patients with minimally displaced scaphoid delayed unions and nonunions that were successfully treated by rigid internal fixation without bone grafting. These results confirm previous reports that bone grafting is not required to provide predictable unions for the majority of scaphoid nonunions.
This paper will be judged for the Resident Writer’s Award.
ABSTRACT
Delayed unions and nonunions of the scaphoid are most often treated by open reduction and internal fixation with bone grafting. We sought to evaluate a large consecutive series of nondisplaced or minimally displaced scaphoid nonunions and delayed unions treated by a compression screw without bone grafting by 2 fellowship trained hand surgeons. A total of 23 patients (19 males, 4 females) were identified who had fractures located at the distal third (2), the waist (18), and the proximal third (3). Of the 23 patients, 19 had a complete follow-up (mean follow-up period, 5.2 months) with evidence of radiographic union. There were no radiographic signs of arthrosis, osteonecrosis of the scaphoid, hardware-related complications, or reported revision surgeries. In conclusion, nonunions and delayed unions in nondisplaced or minimally displaced scaphoids without carpal malalignment can be successfully treated using compression screw fixation without bone grafting.
Continued to: Scaphoid nonunions or delayed unions with displacement...
Scaphoid nonunions or delayed unions with displacement, humpback deformities, or dorsal intercalated segmental instability deformities require open exposure with reduction of the fracture and autogenous bone grafting (structural or nonstructural and vascularized or nonvascularized).1,2 However, in the absence of displacement or deformity, compression and internal fixation without bone grafting may be sufficient to achieve union.
Several reports have described the use of internal fixation alone in the management of scaphoid nonunions with both minimal and extensive bone loss.3-7 These studies have shown that screw fixation alone affords less morbidity to the patient while allowing high rates of union.
Previous reports of internal fixation alone included limited numbers of patients for review. Therefore, we aim to review a large consecutive series of scaphoid delayed unions and nonunions without osteonecrosis or deformity managed by only internal fixation. Our hypothesis is that drilling combined with compression and rigid stabilization would allow for bony union in these cases
MATERIALS AND METHODS
After Institutional Review Board approval was obtained, a retrospective review of prospectively collected data was performed on consecutive patients with a delayed union or nonunion of the scaphoid. All injuries had failed conservative treatment of casting for at least 12 weeks and ultrasound stimulation, and were subsequently treated by compression screw fixation by 1 of 2 fellowship trained hand surgeons. The database comprised the data of patients who presented to a single, Level 1 trauma center between 2000 and 2012.
Delayed unions and nonunions were defined as a lack of radiographic trabecular bridging and pain on clinical examination at 3 and 6 months, respectively. All fractures were nondisplaced or minimally displaced (<2 mm), and patients with carpal malalignment or humpback deformity (based on scapholunate angle on plain radiographs) were excluded. Clinical outcome measures included evidence of radiographic union, revision surgery, pain, and reported complications.
Continue to: Inclusion criteria were all patients who sustained...
Inclusion criteria were all patients who sustained a minimally displaced scaphoid fracture and were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions.
Patients younger than age 18 years or with radiographic evidence of arthrosis or humpback deformity were excluded. Any fracture with >2 mm of gapping on original injury radiographs was not considered as minimally displaced and was also excluded. Furthermore, patients with a previous ipsilateral scaphoid injury or hand surgery were also excluded.
Compression screw placement was recorded as being either central or eccentric based on Trumble and colleagues’8 criteria. Posteroanterior (PA), lateral, and scaphoid view radiographs were reviewed by the first author (DS) and the treating hand surgeon (AS). Central screw placement was substantiated if the screw was in the middle third of the proximal pole in all 3 views.
The final set of postoperative radiographs was reviewed for unions. Union was defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views. Computerized tomography (CT) was performed at the discretion of the treating surgeon, and its use was not required if there was near obliteration of the fracture line on the 3-view radiographs and in the absence of patient-reported pain. Patients with bone loss or sclerosis were included as long as no deformity existed.
After surgical intervention, a short-arm cast was applied for 6 weeks, followed by a wrist splint for 4 to 8 weeks depending on patient comfort.
Continue to: SURGICAL TECHNIQUE...
SURGICAL TECHNIQUE
Either a 1-cm to 2-cm transverse incision distal to Lister’s tubercle or a longitudinal incision just ulnar was utilized. The extensor pollicis longus was identified and retracted. A longitudinal or an L-shaped capsulotomy was made to identify the proximal pole of the scaphoid. With the wrist flexed, a guide wire was inserted down the central axis of the scaphoid and confirmed by fluoroscopy. The measurement was made off the guidewire and 4 to 6 mm was subtracted. The scaphoid was then drilled, and the variable pitch compression screw (Acutrak Headless Compression Screw, Acumed) was inserted. Compression and position of the screw were confirmed by fluoroscopy before closure.
RESULTS
A total of 23 patients (19 males, 4 females) with acute scaphoid fractures who were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions were identified in this study. The ages of the patients ranged from 19 to 50 years. Of the 23 patients, 6 were smokers. The majority of patients sustained fractures in the scaphoid waist (18 patients) (Figure 1). Two patients had distal third fractures, and 3 had proximal third fractures.
The average time from the sustained injury to the surgical intervention was 8.2 months (range, 3.1-27.6 months). There were no patients with delayed diagnoses. Three fractures were identified as delayed unions with failure of union and pain after 3 months of conservative treatment, whereas the other 20 were identified as nonunions with at least 6 months of failed conservative treatment.

Of the 23 patients, 21 were found to have centrally placed variable compression screws based on Trumble and colleagues’8 criteria. Of the 23 patients, 19 had a complete follow-up course with radiographs at 6 months after surgery. All of these 19 patients had evidence of radiographic union defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views (Figure 2). Of the 6 smokers, 5 progressed to radiographic union and 1 patient had <6 months of postoperative return visits and could not be contacted. At the final clinic visit, all of the 19 patients denied wrist pain on direct palpation over the scaphoid tubercle, and no complications were reported. There were no repeat or revision surgical interventions.
Four patients had limited follow-up with <6 months of postoperative return visits. Their final set of radiographs did not demonstrate complete bridging trabeculation. One patient who moved away from the area was lost to follow-up but was contacted. The patient stated that he had a pain-free wrist with no further surgical interventions on his scaphoid. The other 3 patients could not be contacted.

DISCUSSION
The management of scaphoid nonunions and delayed unions has dramatically evolved over the past 20 years.1,3-8 Historically, semi-rigid stabilization using Kirschner wires and casting afforded a 77% union rate in these cases.9 More recently, several authors have reported that stabilization without bone grafting can predictably unite scaphoid nonunions. Treating patients with uncomplicated scaphoid nonunions and delayed unions by internal fixation alone may be all that is required to achieve union.
The definitions of a scaphoid nonunion and delayed union are complex. The exact time when a scaphoid fracture heals varies between patients.2,5,10 However, the majority of hand surgeons believe that failure to see clear signs of healing (in waist fractures) after 3 months from the injury would suggest a failure to heal and a “delayed” union, whereas failure after 6 months from the injury and without clear signs of healing indicate a nonunion.5,6,10,11 Any resorption at the fracture site suggests that the fracture will not heal by continued immobilization alone and will require surgery.10
Continue to: Hand surgeons have several surgical options...
Hand surgeons have several surgical options when managing scaphoid injuries. Mahmoud and Koptan4 used a volar approach to percutaneously deliver a headless compression screw into 27 nonunions. Postoperative CT scans demonstrated fracture union in all 27 patients, and no patient underwent revision surgery. Interestingly, 14 of their patients had extensive preoperative resorption (but no deformity) of >5 mm.
Although volar percutaneous approaches for internal fixation have been cited to provide high rates of union and high patient satisfaction in acute scaphoid fracture fixation, this study utilized a dorsal approach. Both Wozasek and Moser12 and Haddad and Goddard13 reported excellent results and high union rates using a volar approach in consecutive acute scaphoid fractures. Despite these results, there are concerns that using a volar approach may damage the scaphotrapezial joint and may be prone to eccentric placement of compression screws.8,14
Slade and colleagues3 did utilize the dorsal approach with arthroscopic assistance to deliver a compression screw into scaphoid nonunions in 15 consecutive patients without any evidence of deformity, sclerosis, or resorption. Similar to our investigation, they treated patients with both delayed unions and nonunions. CT scans were used to confirm unions in all their patients. Using a dorsal approach, Yassaee and Yang15 treated 9 consecutive patients using a compression screw without bone grafting for both delayed and nonunion scaphoid injuries. Other authors have used both volar and dorsal approaches in 12 consecutive delayed and nonunion scaphoid injuries and found that 11 of the 12 injuries progressed to unions.6
Although these authors and several others advocate the use of CT scans to assess unions, our investigation used bridging trabeculation obliteration of the fracture line on 3 standard radiographic views to confirm unions in addition to the absence of pain clinically.16,17 CT scans expose the patient to increased radiation that, in our experience, does not alter the postoperative clinical course.18 If there is clear evidence of bridged callus and no pain on physical examination, a CT scan performed to reconfirm the union affords little benefit to clinical management.19
Continue to: All these previous studies have demonstrated...
All these previous studies have demonstrated excellent union rates but using a limited series of patients. We reviewed a large number of consecutive patients with scaphoid delayed unions and nonunions treated by screw fixation without bone grafting. Our hospital is a safety net institution for a large urban catchment area and had complete radiographic and clinical data for 19 of our 23 patients. One patient was contacted by telephone and he reported no pain and no revision surgical interventions.
The limitations of this study include not only its retrospective design but also its limited secondary outcome measures. However, our primary outcomes of union, pain, and complications are of utmost importance to clinicians and patients alike. Similar to other authors, we used radiographs to confirm unions. Although bridging trabeculation in radiographs has been demonstrated as soon as 1 month after the injury, there may be problems with interobserver reliability.4,13,15,20,21
Patients being lost to follow-up is not uncommon in the orthopedic trauma literature and can influence results.22,23 It is speculative to infer that the 3 patients who did not complete a follow-up course did not return because their pain had mitigated.
CONCLUSION
Like several fractures, the lack of stability and the absence of micro-motion are believed to contribute to fibrous nonunions in scaphoid fractures.13 This study provides a large consecutive cohort of patients with minimally displaced scaphoid delayed unions and nonunions that were successfully treated by rigid internal fixation without bone grafting. These results confirm previous reports that bone grafting is not required to provide predictable unions for the majority of scaphoid nonunions.
This paper will be judged for the Resident Writer’s Award.
1. Trumble TE, Salas P, Barthel T, Robert KQ 3rd. Management of scaphoid nonunions. J Am Acad Orthop Surg. 2003;11(6):380-391. doi:10.1016/j.jhsa.2012.03.002.
2. Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004;75(5):618-629. doi:10.1080/00016470410001529.
3. Slade JF 3rd, Geissler WB, Gutow AP, Merrell GA. Percutaneous internal fixation of selected scaphoid nonunions with an arthroscopically assisted dorsal approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:20-32.
4. Mahmoud M, Koptan W. Percutaneous screw fixation without bone grafting for established scaphoid nonunion with substantial bone loss. J Bone Joint Surg Br. 2011;93(7):932-936. doi:10.1302/0301-620X.93B7.25418.
5. Inaparthy PK, Nicholl JE. Treatment of delayed/nonunion of scaphoid waist with Synthes cannulated scaphoid screw and bone graft. Hand N Y N. 2008;3(4):292-296. doi:10.1007/s11552-008-9112-4.
6. Capo JT, Shamian B, Rizzo M. Percutaneous screw fixation without bone grafting of scaphoid non-union. Isr Med Assoc J. 2012;14(12):729-732.
7. Kim JK, Kim JO, Lee SY. Volar percutaneous screw fixation for scaphoid waist delayed union. Clin Orthop Relat Res. 2010;468(4):1066-1071. doi:10.1007/s11999-009-1032-2.
8. Trumble TE, Clarke T, Kreder HJ. Non-union of the scaphoid. Treatment with cannulated screws compared with treatment with Herbert screws. J Bone Joint Surg Am. 1996;78(12):1829-1837.
9. Cosio MQ, Camp RA. Percutaneous pinning of symptomatic scaphoid nonunions. J Hand Surg. 1986;11(3):350-355. doi:10.1016/S0363-5023(86)80141-1.
10. Steinmann SP, Adams JE. Scaphoid fractures and nonunions: diagnosis and treatment. J Orthop Sci. 2006;11(4):424-431. doi:10.1007/s00776-006-1025-x.
11. Zarezadeh A, Moezi M, Rastegar S, Motififard M, Foladi A, Daneshpajouhnejad P. Scaphoid nonunion fracture and results of the modified Matti-Russe technique. Adv Biomed Res. 2015;4:39. doi:10.4103/2277-9175.151248.
12. Wozasek GE, Moser KD. Percutaneous screw fixation for fractures of the scaphoid. J Bone Joint Surg Br. 1991;73(1):138-142. doi:10.3928/01477447-20170509-04.
13. Haddad FS, Goddard NJ. Acute percutaneous scaphoid fixation. A pilot study. J Bone Joint Surg Br. 1998;80(1):95-99. doi:10.1302/0301-620X.80B1.8076.
14. Yip HSF, Wu WC, Chang RYP, So TYC. Percutaneous cannulated screw fixation of acute scaphoid waist fracture. J Hand Surg Br. 2002;27(1):42-46. doi:10.1054/jhsb.2001.0690.
15. Yassaee F, Yang SS. Mini-incision fixation of nondisplaced scaphoid fracture nonunions. J Hand Surg. 2008;33(7):1116-1120. doi:10.1016/j.jhsa.2008.03.004.
16. Slade JF 3rd, Gillon T. Retrospective review of 234 scaphoid fractures and nonunions treated with arthroscopy for union and complications. Scand J Surg. 2008;97(4):280-289. doi:10.1177/145749690809700402
17. Geoghegan JM, Woodruff MJ, Bhatia R, et al. Undisplaced scaphoid waist fractures: is 4 weeks’ immobilisation in a below-elbow cast sufficient if a week 4 CT scan suggests fracture union? J Hand Surg Eur Vol. 2009;34(5):631-637. doi:10.1177/1753193409105189.
18. Biswas D, Bible JE, Bohan M, Simpson AK, Whang PG, Grauer JN. Radiation exposure from musculoskeletal computerized tomographic scans. J Bone Joint Surg Am. 2009;91(8):1882-1889. doi:10.2106/JBJS.H.01199.
19. Dias JJ, Taylor M, Thompson J, Brenkel IJ, Gregg PJ. Radiographic signs of union of scaphoid fractures. An analysis of inter-observer agreement and reproducibility. J Bone Joint Surg Br. 1988;70(2):299-301. doi:10.1302/0301-620X.70B2.3346310.
20. Martus JE, Bedi A, Jebson PJL. Cannulated variable pitch compression screw fixation of scaphoid fractures using a limited dorsal approach. Tech Hand Up Extrem Surg. 2005;9(4):202-206. doi:10.1097/01.bth.0000191422.26565.25.
21. Clay NR, Dias JJ, Costigan PS, Gregg PJ, Barton NJ. Need the thumb be immobilised in scaphoid fractures? A randomised prospective trial. J Bone Joint Surg Br. 1991;73(5):828-832. doi:10.1302/0301-620X.73B5.1894676.
22. Zelle BA, Bhandari M, Sanchez AI, Probst C, Pape HC. Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013;27(3):177-181. doi:10.1097/BOT.0b013e31825cf367.
23. Sprague S, Leece P, Bhandari M, et al. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials. 2003;24(6):719-725. doi:10.1016/j.cct.2003.08.012.
1. Trumble TE, Salas P, Barthel T, Robert KQ 3rd. Management of scaphoid nonunions. J Am Acad Orthop Surg. 2003;11(6):380-391. doi:10.1016/j.jhsa.2012.03.002.
2. Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004;75(5):618-629. doi:10.1080/00016470410001529.
3. Slade JF 3rd, Geissler WB, Gutow AP, Merrell GA. Percutaneous internal fixation of selected scaphoid nonunions with an arthroscopically assisted dorsal approach. J Bone Joint Surg Am. 2003;85-A Suppl 4:20-32.
4. Mahmoud M, Koptan W. Percutaneous screw fixation without bone grafting for established scaphoid nonunion with substantial bone loss. J Bone Joint Surg Br. 2011;93(7):932-936. doi:10.1302/0301-620X.93B7.25418.
5. Inaparthy PK, Nicholl JE. Treatment of delayed/nonunion of scaphoid waist with Synthes cannulated scaphoid screw and bone graft. Hand N Y N. 2008;3(4):292-296. doi:10.1007/s11552-008-9112-4.
6. Capo JT, Shamian B, Rizzo M. Percutaneous screw fixation without bone grafting of scaphoid non-union. Isr Med Assoc J. 2012;14(12):729-732.
7. Kim JK, Kim JO, Lee SY. Volar percutaneous screw fixation for scaphoid waist delayed union. Clin Orthop Relat Res. 2010;468(4):1066-1071. doi:10.1007/s11999-009-1032-2.
8. Trumble TE, Clarke T, Kreder HJ. Non-union of the scaphoid. Treatment with cannulated screws compared with treatment with Herbert screws. J Bone Joint Surg Am. 1996;78(12):1829-1837.
9. Cosio MQ, Camp RA. Percutaneous pinning of symptomatic scaphoid nonunions. J Hand Surg. 1986;11(3):350-355. doi:10.1016/S0363-5023(86)80141-1.
10. Steinmann SP, Adams JE. Scaphoid fractures and nonunions: diagnosis and treatment. J Orthop Sci. 2006;11(4):424-431. doi:10.1007/s00776-006-1025-x.
11. Zarezadeh A, Moezi M, Rastegar S, Motififard M, Foladi A, Daneshpajouhnejad P. Scaphoid nonunion fracture and results of the modified Matti-Russe technique. Adv Biomed Res. 2015;4:39. doi:10.4103/2277-9175.151248.
12. Wozasek GE, Moser KD. Percutaneous screw fixation for fractures of the scaphoid. J Bone Joint Surg Br. 1991;73(1):138-142. doi:10.3928/01477447-20170509-04.
13. Haddad FS, Goddard NJ. Acute percutaneous scaphoid fixation. A pilot study. J Bone Joint Surg Br. 1998;80(1):95-99. doi:10.1302/0301-620X.80B1.8076.
14. Yip HSF, Wu WC, Chang RYP, So TYC. Percutaneous cannulated screw fixation of acute scaphoid waist fracture. J Hand Surg Br. 2002;27(1):42-46. doi:10.1054/jhsb.2001.0690.
15. Yassaee F, Yang SS. Mini-incision fixation of nondisplaced scaphoid fracture nonunions. J Hand Surg. 2008;33(7):1116-1120. doi:10.1016/j.jhsa.2008.03.004.
16. Slade JF 3rd, Gillon T. Retrospective review of 234 scaphoid fractures and nonunions treated with arthroscopy for union and complications. Scand J Surg. 2008;97(4):280-289. doi:10.1177/145749690809700402
17. Geoghegan JM, Woodruff MJ, Bhatia R, et al. Undisplaced scaphoid waist fractures: is 4 weeks’ immobilisation in a below-elbow cast sufficient if a week 4 CT scan suggests fracture union? J Hand Surg Eur Vol. 2009;34(5):631-637. doi:10.1177/1753193409105189.
18. Biswas D, Bible JE, Bohan M, Simpson AK, Whang PG, Grauer JN. Radiation exposure from musculoskeletal computerized tomographic scans. J Bone Joint Surg Am. 2009;91(8):1882-1889. doi:10.2106/JBJS.H.01199.
19. Dias JJ, Taylor M, Thompson J, Brenkel IJ, Gregg PJ. Radiographic signs of union of scaphoid fractures. An analysis of inter-observer agreement and reproducibility. J Bone Joint Surg Br. 1988;70(2):299-301. doi:10.1302/0301-620X.70B2.3346310.
20. Martus JE, Bedi A, Jebson PJL. Cannulated variable pitch compression screw fixation of scaphoid fractures using a limited dorsal approach. Tech Hand Up Extrem Surg. 2005;9(4):202-206. doi:10.1097/01.bth.0000191422.26565.25.
21. Clay NR, Dias JJ, Costigan PS, Gregg PJ, Barton NJ. Need the thumb be immobilised in scaphoid fractures? A randomised prospective trial. J Bone Joint Surg Br. 1991;73(5):828-832. doi:10.1302/0301-620X.73B5.1894676.
22. Zelle BA, Bhandari M, Sanchez AI, Probst C, Pape HC. Loss of follow-up in orthopaedic trauma: is 80% follow-up still acceptable? J Orthop Trauma. 2013;27(3):177-181. doi:10.1097/BOT.0b013e31825cf367.
23. Sprague S, Leece P, Bhandari M, et al. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials. 2003;24(6):719-725. doi:10.1016/j.cct.2003.08.012.
TAKE-HOME POINTS
- Scaphoid nonunions can occur in minimally displaced fractures.
- If there is no deformity of the scaphoid delayed or nonunion, then a percutaneous screw fixation without bone grafting can reliably lead to bony union.
- Not all scaphoid delayed unions and nonunions require bone grafting.
Score predicts 3-month mortality in malignant pleural effusion
A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.
The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.
They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.
The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.
The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.
The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.
“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.
For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.
“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”
The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.
SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.
Around 50% of patients with a malignancy will present with dyspnea – mostly those with advanced disease. The scientific literature suggests pleurodesis is effective in around 70% of those who undergo the treatment but in real life the proportion can be much lower.
While this study is to be congratulated for introducing a new scoring system to predict survival in malignant pleural effusion, the model did not seem to be able to predict the success of pleurodesis.
The search for predictive markers for successful pleurodesis was one of the most interesting goals of this study, but despite a rigorous analysis of many pleural fluid samples, these markers proved elusive. It may be that identifying even one predictive marker in such a heterogeneous group of primary malignancies is going to be a challenge.
Paul Baas, MD, and Sjaak Burgers, MD, are in the department of thoracic oncology at The Netherlands Cancer Institute in Amsterdam. These comments are taken from their editorial (Lancet Oncol. 2018 Jun 12. doi: 10.1016/S1470-2045(18)30361-9). No conflicts of interest were declared.
Around 50% of patients with a malignancy will present with dyspnea – mostly those with advanced disease. The scientific literature suggests pleurodesis is effective in around 70% of those who undergo the treatment but in real life the proportion can be much lower.
While this study is to be congratulated for introducing a new scoring system to predict survival in malignant pleural effusion, the model did not seem to be able to predict the success of pleurodesis.
The search for predictive markers for successful pleurodesis was one of the most interesting goals of this study, but despite a rigorous analysis of many pleural fluid samples, these markers proved elusive. It may be that identifying even one predictive marker in such a heterogeneous group of primary malignancies is going to be a challenge.
Paul Baas, MD, and Sjaak Burgers, MD, are in the department of thoracic oncology at The Netherlands Cancer Institute in Amsterdam. These comments are taken from their editorial (Lancet Oncol. 2018 Jun 12. doi: 10.1016/S1470-2045(18)30361-9). No conflicts of interest were declared.
Around 50% of patients with a malignancy will present with dyspnea – mostly those with advanced disease. The scientific literature suggests pleurodesis is effective in around 70% of those who undergo the treatment but in real life the proportion can be much lower.
While this study is to be congratulated for introducing a new scoring system to predict survival in malignant pleural effusion, the model did not seem to be able to predict the success of pleurodesis.
The search for predictive markers for successful pleurodesis was one of the most interesting goals of this study, but despite a rigorous analysis of many pleural fluid samples, these markers proved elusive. It may be that identifying even one predictive marker in such a heterogeneous group of primary malignancies is going to be a challenge.
Paul Baas, MD, and Sjaak Burgers, MD, are in the department of thoracic oncology at The Netherlands Cancer Institute in Amsterdam. These comments are taken from their editorial (Lancet Oncol. 2018 Jun 12. doi: 10.1016/S1470-2045(18)30361-9). No conflicts of interest were declared.
A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.
The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.
They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.
The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.
The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.
The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.
“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.
For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.
“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”
The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.
SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.
A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.
The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.
They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.
The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.
The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.
The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.
“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.
For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.
“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”
The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.
SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.
FROM THE LANCET ONCOLOGY
Key clinical point: Clinical and biological markers predict 3-month mortality in malignant pleural effusion.
Major finding: The PROMISE score shows good discrimination between high and low risk of death in malignant pleural effusion.
Study details: Development and validation of markers in multicohort study.
Disclosures: The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding–University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.
Source: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.
New chronic lymphocytic leukemia guidelines from the UK
Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.
The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.
Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.
While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.
Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.
All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.
With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”
Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.
“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.
Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.
The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.
In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.
The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.
SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.
Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.
The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.
Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.
While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.
Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.
All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.
With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”
Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.
“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.
Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.
The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.
In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.
The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.
SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.
Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.
The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.
Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.
While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.
Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.
All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.
With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”
Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.
“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.
Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.
The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.
In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.
The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.
SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.
FROM THE BRITISH JOURNAL OF HAEMATOLOGY
Key clinical point:
Major finding: All patients diagnosed with CLL should be tested for TP53 disruption.
Study details: A guideline developed by the British Society for Haematology offering recommendations for CLL treatment outside clinical trials.
Disclosures: The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.
Source: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.
FDA approves mogamulizumab for MF, SS
The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.
The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.
Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.
Baseline characteristics were similar between the treatment arms.
The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).
For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.
After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.
For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:
- Infusion-related reactions (33.2% vs 0.5%)
- Drug eruptions (23.9% vs 0.5%)
- Diarrhea (23.4% vs 61.8%)
- Nausea (15.2% vs 42.5%)
- Thrombocytopenia (11.4% vs 30.6%)
- Dysgeusia (3.3% vs 28.0%)
- Increased blood creatinine (3.3% vs 28.0%)
- Decreased appetite (7.6% vs 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).
The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.
The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.
Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.
Baseline characteristics were similar between the treatment arms.
The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).
For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.
After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.
For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:
- Infusion-related reactions (33.2% vs 0.5%)
- Drug eruptions (23.9% vs 0.5%)
- Diarrhea (23.4% vs 61.8%)
- Nausea (15.2% vs 42.5%)
- Thrombocytopenia (11.4% vs 30.6%)
- Dysgeusia (3.3% vs 28.0%)
- Increased blood creatinine (3.3% vs 28.0%)
- Decreased appetite (7.6% vs 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).
The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.
The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.
Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.
Baseline characteristics were similar between the treatment arms.
The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).
For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.
After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.
For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:
- Infusion-related reactions (33.2% vs 0.5%)
- Drug eruptions (23.9% vs 0.5%)
- Diarrhea (23.4% vs 61.8%)
- Nausea (15.2% vs 42.5%)
- Thrombocytopenia (11.4% vs 30.6%)
- Dysgeusia (3.3% vs 28.0%)
- Increased blood creatinine (3.3% vs 28.0%)
- Decreased appetite (7.6% vs 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).
Judge seeks replication of efforts to support people with SMI
Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.
“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.
Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.
In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.
Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”
Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.
The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.
Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).
Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.
Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.
Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.
Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.
“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.
Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.
In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.
Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”
Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.
The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.
Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).
Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.
Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.
Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.
Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.
“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.
Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.
In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.
Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”
Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.
The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.
Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).
Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.
Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.
Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.
REPORTING FROM AN NIMH CONFERENCE
Discharge opioid prescriptions for many surgical hospitalizations may be unnecessary
Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.
Study design: Cross-sectional study.
Setting: Two Boston-area acute care hospitals from May 2014 to September 2016.
Synopsis: The authors identified 6,548 inpatient surgical hospitalizations lasting longer than 1 day with a discharge to home in which the patient used no opioid medications in the final 24 hours prior to discharge. Of these, 43.7% received an opioid prescription at discharge. The mean prescription morphine milligram equivalents (MME) provided to this group was 343. The authors identified these cases as instances in which overprescription of opiates may have occurred. Surgical services that tended to have more patients still using opioids at the time of discharge had a higher likelihood of potential overprescription. For patients who used opioids during the final 24 hours of their hospitalization and received an opioid prescription at discharge, inpatient MME use and prescription MME were only weakly correlated (R2 = 0.112). The retrospective two-site design of this study may limit its generalizability.
Bottom line: In postoperative surgical patients, overprescription of opioid medications may occur frequently.
Citation: Chen EY et al. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg. 2018;153(2):e174859.
Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.
Study design: Cross-sectional study.
Setting: Two Boston-area acute care hospitals from May 2014 to September 2016.
Synopsis: The authors identified 6,548 inpatient surgical hospitalizations lasting longer than 1 day with a discharge to home in which the patient used no opioid medications in the final 24 hours prior to discharge. Of these, 43.7% received an opioid prescription at discharge. The mean prescription morphine milligram equivalents (MME) provided to this group was 343. The authors identified these cases as instances in which overprescription of opiates may have occurred. Surgical services that tended to have more patients still using opioids at the time of discharge had a higher likelihood of potential overprescription. For patients who used opioids during the final 24 hours of their hospitalization and received an opioid prescription at discharge, inpatient MME use and prescription MME were only weakly correlated (R2 = 0.112). The retrospective two-site design of this study may limit its generalizability.
Bottom line: In postoperative surgical patients, overprescription of opioid medications may occur frequently.
Citation: Chen EY et al. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg. 2018;153(2):e174859.
Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.
Study design: Cross-sectional study.
Setting: Two Boston-area acute care hospitals from May 2014 to September 2016.
Synopsis: The authors identified 6,548 inpatient surgical hospitalizations lasting longer than 1 day with a discharge to home in which the patient used no opioid medications in the final 24 hours prior to discharge. Of these, 43.7% received an opioid prescription at discharge. The mean prescription morphine milligram equivalents (MME) provided to this group was 343. The authors identified these cases as instances in which overprescription of opiates may have occurred. Surgical services that tended to have more patients still using opioids at the time of discharge had a higher likelihood of potential overprescription. For patients who used opioids during the final 24 hours of their hospitalization and received an opioid prescription at discharge, inpatient MME use and prescription MME were only weakly correlated (R2 = 0.112). The retrospective two-site design of this study may limit its generalizability.
Bottom line: In postoperative surgical patients, overprescription of opioid medications may occur frequently.
Citation: Chen EY et al. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg. 2018;153(2):e174859.
Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Not all drugs are created equal in the U.S. drug crisis
Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.
“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.
Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.
The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.
Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.
“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.
Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.
Click here to read the Forbes article.
Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.
“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.
Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.
The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.
Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.
“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.
Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.
Click here to read the Forbes article.
Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.
“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.
Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.
The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.
Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.
“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.
Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.
Click here to read the Forbes article.
CUBE-C initiative aims to educate about atopic dermatitis
WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.
In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”
She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”
Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.
More information on CUBE-C is available on the NEA website.
The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.
In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”
She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”
Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.
More information on CUBE-C is available on the NEA website.
The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.
In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”
She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”
Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.
More information on CUBE-C is available on the NEA website.
The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
Parents’ religiosity tied to reduced suicide risk in girls
Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.
Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.
The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).
A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.
“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.
Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.
“,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”
Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.
Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.
Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.
The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).
A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.
“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.
Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.
“,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”
Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.
Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.
Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.
The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).
A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.
“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.
Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.
“,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”
Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.
FROM JAMA PSYCHIATRY
Making the referral and navigating care
Be familiar with local post-acute care resources
Presenter
Elisabeth Schainker, MD, MSc
Session title
Making the referral and navigating “A Whole New World” of care
Session summary
By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.
With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.
Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.
Key takeaways for HM
1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.
2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.
3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.
Be familiar with local post-acute care resources
Be familiar with local post-acute care resources
Presenter
Elisabeth Schainker, MD, MSc
Session title
Making the referral and navigating “A Whole New World” of care
Session summary
By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.
With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.
Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.
Key takeaways for HM
1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.
2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.
3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.
Presenter
Elisabeth Schainker, MD, MSc
Session title
Making the referral and navigating “A Whole New World” of care
Session summary
By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.
With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.
Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.
Key takeaways for HM
1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.
2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.
3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.




