Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials

Journal of Clinical Epidemiology - Tập 62 - Trang 609-616 - 2009
Ruth Tsang1, Lindsey Colley2,3, Larry D. Lynd2,3
1Vancouver General Hospital, Vancouver, British Columbia, Canada
2Centre for Health Evaluation and Outcome Sciences, Providence Health Research Institute, Vancouver, British Columbia, Canada
3Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada

Tài liệu tham khảo

Freiman, 1978, The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials, N Engl J Med, 299, 690, 10.1056/NEJM197809282991304 Chung, 1998, Type II (beta) errors in the hand literature: the importance of power, J Hand Surg [Am], 23, 20, 10.1016/S0363-5023(98)80083-X Bailey, 2004, Type II error in the spine surgical literature, Spine, 29, 1146, 10.1097/00007632-200405150-00018 Brown, 1987, The beta error and sample size determination in clinical trials in emergency medicine, Ann Emerg Med, 16, 183, 10.1016/S0196-0644(87)80013-6 Edlund, 1985, Beta, or type II error in psychiatric controlled clinical trials, J Psychiatr Res, 19, 563, 10.1016/0022-3956(85)90074-3 Hall, 1982, The other side of statistical significance: a review of type II errors in the Australian medical literature, Aust N Z J Med, 12, 7, 10.1111/j.1445-5994.1982.tb02415.x Williams, 1997, Low power, type II errors, and other statistical problems in recent cardiovascular research, Am J Physiol, 273, H487 Dimick, 2001, Negative results of randomized clinical trials published in the surgical literature: equivalency or error?, Arch Surg, 136, 796, 10.1001/archsurg.136.7.796 Fox, 1997, Empowering research: statistical power in general practice research, Fam Pract, 14, 324, 10.1093/fampra/14.4.324 Freedman, 1999, Sample size and statistical power in clinical orthopaedic research, J Bone Joint Surg Am, 81, 1454, 10.2106/00004623-199910000-00011 Lochner, 2001, Type-II error rates (beta errors) of randomized trials in orthopaedic trauma, J Bone Joint Surg Am, 83, 1650, 10.2106/00004623-200111000-00005 Mittendorf, 1995, The problem of the type II statistical error, Obstet Gynecol, 86, 857, 10.1016/0029-7844(95)00251-L Moher, 1994, Statistical power, sample size, and their reporting in randomized controlled trials, JAMA, 272, 122, 10.1001/jama.272.2.122 Sundaresan, 1981, Hypothesis testing in neurosurgical trials, J Neurosurg, 54, 468, 10.3171/jns.1981.54.4.0468 Williams, 1993, Inadequate size of “negative” clinical trials in dermatology, Br J Dermatol, 128, 317, 10.1111/j.1365-2133.1993.tb00178.x World Health Organization, 2002 Connolly, 2006, Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial, JAMA, 295, 165, 10.1001/jama.295.2.165 Kearon, 2006, Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism, JAMA, 296, 935, 10.1001/jama.296.8.935 Kremer, 2006, Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial, Ann Intern Med, 144, 865, 10.7326/0003-4819-144-12-200606200-00003 Armstrong, 2006, Intraperitoneal cisplatin and paclitaxel in ovarian cancer, N Engl J Med, 354, 34, 10.1056/NEJMoa052985 Legro, 2007, Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome, N Engl J Med, 356, 551, 10.1056/NEJMoa063971 Palumbo, 2006, Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial, Lancet, 367, 825, 10.1016/S0140-6736(06)68338-4 Myers, 2005, Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial, Contemp Clin Trials, 26, 271, 10.1016/j.cct.2005.01.006 Agresti, 2002 Martin, 1995, The Wilcoxon, Spearman, Fisher, #2-, student and Pearson tests and 2x2 tables, Statistician, 44, 441, 10.2307/2348893 National Cancer Institute. Common toxicity criteria v.2. NCI; 1999 [updated 1999. Available at: http://ctep.cancer.gov/forms/CTCv20_4-30-992.pdf. [Accessed 2008 February 20]. April 30, 1999; Christensen R, Kristensen PK, Bartels EM, Bliddal H, Astrup A. Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials. Lancet; 370(): 1706–1713. Bongartz, 2006, Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials, JAMA, 295, 2275, 10.1001/jama.295.19.2275 Nissen, 2007, Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, N Engl J Med, 356, 2457, 10.1056/NEJMoa072761 Lynd, 2004, Advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis, J Clin Epidemiol, 57, 795, 10.1016/j.jclinepi.2003.12.012 Sterne, 2001, Sifting the evidence{–}what's wrong with significance tests? Another comment on the role of statistical methods, BMJ, 322, 226, 10.1136/bmj.322.7280.226 Loke, 2001, Reporting of adverse drug reactions in randomised controlled trials—a systematic survey, BMC Clin Pharmacol, 1, 3, 10.1186/1472-6904-1-3