Departures from community equipoise may lead to incorrect inference in randomized trials

Journal of Clinical Epidemiology

Volumn 64, Issue 3, 2011, Pages 280-285

  Katz, Jeffrey N ^a,b   Wright, John ^a   Levy, Bruce A ^c   Baron, John A ^d   Losina, Elena ^a,e  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c MAYO CLINIC   (United States)

^d DARTMOUTH MEDICAL SCHOOL   (United States)

^e BOSTON UNIVERSITY   (United States)

Author keywords

Arthroscopy; Equipoise; Generalizability; Meniscectomy; Randomized controlled trial; Selection bias; Simulation

Indexed keywords

ACCURACY; ARTHROSCOPIC SURGERY; ARTICLE; CONSERVATIVE TREATMENT; EQUIPOISE; INFERENTIAL STATISTICS; MENISCECTOMY; OSTEOARTHRITIS; OUTCOME ASSESSMENT; PATIENT PARTICIPATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT; SAMPLE SIZE; SAMPLING ERROR; SELECTIVE ENROLLMENT; SIMULATION;

ARTHROSCOPY; ATTITUDE OF HEALTH PERSONNEL; CONFIDENCE INTERVALS; FEMALE; HUMANS; MALE; MENISCI, TIBIAL; OSTEOARTHRITIS, KNEE; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; SELECTION BIAS; THERAPEUTIC EQUIPOISE;

EID: 78751647894     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2010.04.008     Document Type: Article

References (17)

1. P. Alderson Equipoise as a means of managing uncertainty: personal, communal and proxy J Med Ethics 22 1996 135 139
2. J.A. Chard, and R.J. Lilford The use of equipoise in clinical trials Soc Sci Med 47 1998 891 898
3. B. Freedman Equipoise and the ethics of clinical research N Engl J Med 317 1987 141 145
4. R.M. Veatch Indifference of subjects: an alternative to equipoise in randomized clinical trials Soc Philos Policy 19 2002 295 323
5. R.M. Veatch The irrelevance of equipoise J Med Philos 32 2007 167 183
6. S. Herrlin, M. Hallander, P. Wange, L. Weidenhielm, and S. Werner Arthroscopic or conservative treatment of degenerative medial meniscal tears: a prospective randomised trial Knee Surg Sports Traumatol Arthrosc 15 2007 393 401
7. E.C. Merchan, and E. Galindo Arthroscope-guided surgery versus nonoperative treatment for limited degenerative osteoarthritis of the femorotibial joint in patients over 50 years of age: a prospective comparative study Arthroscopy 9 1993 663 667
8. D.S. Meredith, E. Losina, N.N. Mahomed, J. Wright, and J.N. Katz Factors predicting functional and radiographic outcomes after arthroscopic partial meniscectomy: a review of the literature Arthroscopy 21 2005 211 223
9. A. Guermazi, D.J. Hunter, and F.W. Roemer Plain radiography and magnetic resonance imaging diagnostics in osteoarthritis: validated staging and scoring J Bone Joint Surg Am 91 Suppl. 1 2009 54 62
10. N. Bellamy, W.W. Buchanan, C.H. Goldsmith, J. Campbell, and L.W. Stitt Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee J Rheumatol 15 1988 1833 1840
11. F. Angst, A. Aeschlimann, and G. Stucki Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities Arthritis Rheum 45 2001 384 391
12. M. Englund, A. Guermazi, D. Gale, D.J. Hunter, P. Aliabadi, and M. Clancy Incidental meniscal findings on knee MRI in middle-aged and elderly persons N Engl J Med 359 2008 1108 1115
13. C. Warlow Advanced issues in the design and conduct of randomized clinical trials: the bigger the better? Stat Med 21 2002 2797 2805
14. J. Concato, and R.I. Horwitz Beyond randomised versus observational studies Lancet 363 2004 1660 1661
15. D. Marquis How to resolve an ethical dilemma concerning randomized clinical trials N Engl J Med 341 1999 691 693
16. P.B. Miller, and C. Weijer Rehabilitating equipoise Kennedy Inst Ethics J 13 2003 93 118
17. N. Freemantle, J.M. Mason, A. Haines, and M.P. Eccles CONSORT: an important step toward evidence-based health care. Consolidated Standards of Reporting Trials Ann Intern Med 126 1997 81 83