Reflections 1 year into the 21-center national institutes of health-funded wrist study: A primer on conducting a multicenter clinical trial

Journal of Hand Surgery

Volumn 38, Issue 6, 2013, Pages 1194-1201

  Chung, Kevin C ^a   Kim, H Myra ^a   Haase, Steven C ^a   Lawton, Jeffrey ^a   Ozer, Kagan ^a   Waljee, Jennifer F ^a   Nellans, Kate ^a   Malay, Sunitha ^a   Shauver, Melissa J ^a   Rozental, Tamara D ^a   Appleton, Paul ^a   Rodriguez, Edward ^a   Herder, Lindsay ^a   Wagner, Katiri ^a   Blazar, Philip ^a   Earp, Brandon ^a   Floyd, W Emerson ^a   Pico, Katherine S ^a   Richards, Marc J ^a   Ruch, David S ^a   Finley, Suzanne ^a   Kalliainen, Loree K ^a   Fletcher, James W ^a   Heinrich, Cherrie A ^a   Ward, Christian M ^a   Hill, Brian W ^a   Bamberger, Brent ^a   Robinson, Carla ^a   Palmer, Brandi ^a   Ring, David ^a   Jupiter, Jesse B ^a   Reddy, Rajesh ^a   Dennison, David ^a   Kakar, Sanjeev ^a   Shin, Alexander ^a   Scrabeck, Tyson ^a   Hoyen, Harry ^a   Malone, Kevin ^a   Sebastin, Sandeep ^a   Tay, Poh Ling ^a   Gaston, Glenn ^a   Connell, Benjamin ^a   Neumeister, Michael ^a   Berry, Nada N ^a   Bueno Jr , Reuben A ^a   McAndrew, Mark ^a   Koechle, Jennifer ^a   Perey, Bertrand ^a   Zomar, Mauri ^a   Wolf, Jennifer Moriatis ^a   Rodner, Craig M ^a   Cote, Mark ^a   Clark, Tod ^a   Lehman, Thomas ^a   Carl, Kathy ^a   Bozentka, David ^a   Levin, Scott ^a   Steinberg, David ^a   Horan, Annamarie ^a   Knox, Denise ^a   Hammert, Warren ^a   McIntyre, Allison W ^a   Friedrich, Jeffrey B ^a   Allan, Christopher H ^a   Hanel, Douglas P ^a   Huang, Jerry I ^a   Ko, Jason H ^a   Vedder, Nicholas B ^a   Boman, David ^a   Cooper, Claudette L ^a   Grewal, Ruby ^a   MacDermid, Joy ^a   Kelly, Kate ^a   Millman, Kristie ^a   Li, Zhongyu ^a   Koman, Andrew ^a   Smith, Beth ^a   Bullard, Debra ^a   more..

^a NONE

Author keywords

Distal radius fracture; multicenter trials; randomized clinical trials

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CLINICAL TRIAL (TOPIC); EVIDENCE BASED MEDICINE; FUNDING; HAND SURGERY; HUMAN; IMAGE PROCESSING; INFORMATION PROCESSING DEVICE; JOB EXPERIENCE; MONITORING; MULTICENTER STUDY (TOPIC); ONLINE SYSTEM; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; PUBLIC-PRIVATE PARTNERSHIP; PUBLISHING; QUALITY CONTROL; RADIUS FRACTURE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REFERENCE DATABASE; REIMBURSEMENT; RESEARCH SUBJECT; SCREENING; STANDARD; SYSTEMATIC REVIEW (TOPIC); THE WRIST AND RADIUS INJURY SURGERY TRIAL; X RAY;

COLLES' FRACTURE; HUMANS; MULTICENTER STUDIES AS TOPIC; NATIONAL INSTITUTES OF HEALTH (U.S.); PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RESEARCH SUPPORT AS TOPIC; UNITED STATES; WRIST INJURIES;

EID: 84878261730     PISSN: 03635023     EISSN: 15316564     Source Type: Journal    
DOI: 10.1016/j.jhsa.2013.02.027     Document Type: Article

References (33)

1. S.R. Cummings, D.M. Black, S.M. Rubin Lifetime risks of hip, Colles', or vertebral fracture and coronary heart disease among white postmenopausal women Arch Intern Med 149 11 1989 2445 2448
2. R. Arora, M. Gabl, M. Gschwentner, C. Deml, D. Krappinger, M. Lutz A comparative study of clinical and radiologic outcomes of unstable colles type distal radius fractures in patients older than 70 years: nonoperative treatment versus volar locking plating J Orthop Trauma 23 4 2009 237 242
3. A.J. Synn, E.C. Makhni, M.C. Makhni, T.D. Rozental, C.S. Day Distal radius fractures in older patients: is anatomic reduction necessary? Clin Orthop Relat Res 467 6 2009 1612 1620
4. P.M. Simic, A.J. Weiland Fractures of the distal aspect of the radius: changes in treatment over the past two decades Instr Course Lect 52 2003 185 195
5. R. Grewal, J.C. MacDermid The risk of adverse outcomes in extra-articular distal radius fractures is increased with malalignment in patients of all ages but mitigated in older patients J Hand Surg Am 32 7 2007 962 970
6. Z. Margaliot, S.C. Haase, S.V. Kotsis, H.M. Kim, K.C. Chung A meta-analysis of outcomes of external fixation versus plate osteosynthesis for unstable distal radius fractures J Hand Surg Am 30 6 2005 1185 1199
7. H.H. Handoll, J.S. Huntley, R. Madhok Different methods of external fixation for treating distal radial fractures in adults Cochrane Database Syst Rev 1 2008 CD006522
8. H.H. Handoll, R. Madhok Conservative interventions for treating distal radial fractures in adults Cochrane Database Syst Rev 2 2003 CD000314
9. H.H. Handoll, M.V. Vaghela, R. Madhok Percutaneous pinning for treating distal radial fractures in adults Cochrane Database Syst Rev 3 2007 CD006080
10. Surgeons AAoO The Treatment of Distal Radius Fractures 2009 American Academy of Orthopaedic Surgeons Rosemont, IL
11. K.C. Chung, M.J. Shauver, J.D. Birkmeyer Trends in the United States in the treatment of distal radial fractures in the elderly J Bone Joint Surg Am 91 8 Aug. 2009 1868 1873
12. K.C. Chung, M.J. Shauver, H. Yin, H.M. Kim, O. Baser, J.D. Birkmeyer National variations in the utilization of internal fixation techniques for distal radius fractures in the United States Medicare population J Bone Joint Surg Am 93 23 2011 2154 2162
13. K.C. Chung, P.B. Burns A guide to planning and executing a surgical randomized controlled trial J Hand Surg Am 33 3 2008 407 412
14. I. Boutron, D. Moher, P. Tugwell A checklist to evaluate a report of nonpharmacological trial (CLEAR NPT) was developed using consensus J Clin Epidemiol 58 12 2005 1233 1240
15. L.M. Herrick, G.R. Locke III, A.R. Zinsmeister, N.J. Talley Challenges and lessons learned in conducting comparative-effectiveness trials Am J Gastroenterol 107 5 2012 644 649
16. L.A. McNay, J.A. Tavel, K. Oseekey, C.M. McDermott, D. Mollerup, J.D. Bebchuk Regulatory approvals in a large multinational clinical trial: the ESPRIT experience Control Clin Trials 23 1 2002 59 66
17. I.B. Aban, G.I. Wolfe, G.R. Cutter The MGTX experience: challenges in planning and executing an international, multicenter clinical trial J Neuroimmunol 201-202 2008 80 84
18. L. Duley, K. Antman, J. Arena Specific barriers to the conduct of randomized trials Clin Trials 5 1 2008 40 48
19. M.K. Campbell, C. Snowdon, D. Francis Recruitment to randomised trials: strategies for trial enrollment and participation study: the STEPS study Health Technol Assess 11 48 2007 iii ix-105
20. G. Kaur, R.L. Smyth, P. Williamson Developing a survey of barriers and facilitators to recruitment in randomized controlled trials Trials 13 1 2012 218
21. L.C. Lovato, K. Hill, S. Hertert, D.B. Hunninghake, J.L. Probstfield Recruitment for controlled clinical trials: literature summary and annotated bibliography Control Clin Trials 18 4 1997 328 352
22. M.J. Shauver, H. Yin, M. Banerjee, K.C. Chung Current and future national costs to medicare for the treatment of distal radius fracture in the elderly J Hand Surg Am 36 8 2011 1282 1287
23. K.C. Chung, M.J. Shauver, H. Yin The relationship between ASSH membership and the treatment of distal radius fracture in the United States Medicare population J Hand Surg Am 36 8 2011 1288 1293
24. J. Oyen, G.E. Rohde, M. Hochberg, V. Johnsen, G. Haugeberg Low-energy distal radius fractures in middle-aged and elderly women-seasonal variations, prevalence of osteoporosis, and associates with fractures Osteoporos Int 21 7 2010 1247 1255
25. Z.A. Ralis Epidemic of fractures during period of snow and ice Br Med J (Clin Res Ed) 282 6264 1981 603 605
26. P.W. Thompson, J. Taylor, A. Dawson The annual incidence and seasonal variation of fractures of the distal radius in men and women over 25 years in Dorset, UK Injury 35 5 2004 462 466
27. S.J. Jacobsen, D.J. Sargent, E.J. Atkinson, W.M. O'Fallon, L.J. Melton III Contribution of weather to the seasonality of distal forearm fractures: a population-based study in Rochester, Minnesota Osteoporos Int 9 3 1999 254 259
28. T. Flinkkila, K. Sirnio, M. Hippi Epidemiology and seasonal variation of distal radius fractures in Oulu, Finland Osteoporos Int 22 8 2011 2307 2312
29. R.J. Hogg Trials and tribulations of multicenter studies: lessons learned from the experiences of the Southwest Pediatric Nephrology Study Group (SPNSG) Pediatr Nephrol 5 3 1991 348 351
30. I. Ridda, C.R. MacIntyre, R.I. Lindley, T.C. Tan Difficulties in recruiting older people in clinical trials: an examination of barriers and solutions Vaccine 28 4 2010 901 906
31. D.J. Cook, D. Blythe, A. Rischbieth Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers' experiences, beliefs, and practices Crit Care Med 36 7 2008 2100 2105
32. R. Harris, E. Dyson Recruitment of frail older people to research: lessons learnt through experience J Adv Nurs 36 5 2001 643 651
33. N. Dickert, E. Emanuel, C. Grady Paying research subjects: an analysis of current policies Ann Intern Med 136 5 2002 368 373