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

ABSTRACT:

Objective

To assess the impact of selective enrollment on the results of randomized controlled trials (RCTs).

Study design and setting

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 3

SUBMITTER: Katz JN 

PROVIDER: S-EPMC2958234 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature