Five good reasons to be disappointed with randomized trials

摘要

Randomized controlled trials (RCTs) are recognized to exhibit very high levels of evidence, representing a coveted position near the top of the evidence- based pyramid [1]. Both authors of this editorial have been part of small to large-scale RCTs and support the need for this form of research design. Yet, few things annoy us more than the deification that clinicians and selected researchers have given to randomize controlled trials. Yes, RCTs are useful in testing the efficacy and effectiveness of interven- tions between groups; essentially, identifying which treatment intervention is superior between two or more unique groups [2]. Moreover, RCTs are neces- sary to reduce bias and confounding and are per- ceived to yield causal inferences [3]. However (and we can’t emphasize this enough), it is our impres- sion that few understand the noteworthy limitations of RCTs, and even fewer are able to extrapolate how these limitations influence clinical practice. Our experiences with these misunderstandings have prompted us to outline some (trust us, there are more) of the limitations of RCTs, specifically those that might influence clinical practice in an orthope- dic setting.