Responder Analyses: A Methodological Mess

Abstract

SYNOPSIS: Responder analyses are methods for analyzing randomized controlled trials, which purport to identify individuals or subgroups of study participants who experienced a "clinically meaningful" improvement from a treatment. Unfortunately, responder analyses have numerous methodological shortcomings, which preclude inferences concerning individual response to treatments and, thus, adoption into clinical practice. In this Viewpoint, we summarize 2 major limitations of responder analyses: (1) their thresholds of success involve arbitrary criteria and (2) responder analyses do not capture true individual treatment effects. J Orthop Sports Phys Ther 2023;53(XX):1-3. Epub: 20 June 2023. doi:10.2519/jospt.2023.11853.

Keywords: minimal clinically important difference; randomized controlled trial; responder analyses.