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

Journal of Clinical Epidemiology
Jeffrey N KatzElena Losina

Abstract

To assess the impact of selective enrollment on the results of randomized controlled trials (RCTs). We simulated an RCT of arthroscopic partial meniscectomy vs. nonoperative therapy in patients with meniscal tear and osteoarthritis (OA). We estimated efficacy with the risk ratio (RR) comparing the likelihood of clinically important improvement after surgery with that after nonoperative therapy. We assumed that efficacy differs by extent of OA. We simulated four scenarios: (1) nonselective enrollment; (2) higher likelihood of enrolling subjects with mild OA; (3) higher likelihood of enrolling subjects with severe OA; (4) much higher likelihood of enrolling subjects with severe OA. For each scenario, we simulated 100 trials with sample size 340. With nonselective enrollment, reflecting community equipoise, the results in 100 trials were consistent with those in the underlying population (mean RR: 1.87; 95% confidence interval [95% CI]: 1.57, 2.14). Selective enrollment of subjects with much higher likelihood of severe OA resulted in 28% lower efficacy of surgery (mean RR: 1.34; 95% CI: 0.93, 2.15), with 95% CI containing the true efficacy in just 25% of trials and empirical power of 44%. Selective enrollment with respect to facto...Continue Reading

Citations

Feb 2, 2013·HSS Journal : the Musculoskeletal Journal of Hospital for Special Surgery·Jeffrey N Katz
Mar 20, 2013·The New England Journal of Medicine·Jeffrey N KatzElena Losina
Jan 15, 2013·Sports Medicine and Arthroscopy Review·Aaron J KrychBruce A Levy
Apr 8, 2011·The Journal of Bone and Joint Surgery. American Volume·Jeffrey N KatzElena Losina
Sep 13, 2012·Contemporary Clinical Trials·Jeffrey N KatzElena Losina
Nov 7, 2016·Arthroscopy : the Journal of Arthroscopic & Related Surgery : Official Publication of the Arthroscopy Association of North America and the International Arthroscopy Association·James H LubowitzJefferson C Brand
Feb 23, 2020·The Journal of Bone and Joint Surgery. American Volume·C Thomas VangsnessMichael J Daley
Aug 5, 2016·The Journal of Bone and Joint Surgery. American Volume·Stephen LymanJack Farr
Nov 3, 2011·Journal of Neuro-oncology·Derek R Johnson, Brian Patrick O'Neill

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