Patient reported outcome measures in clinical trials should be initially analyzed as continuous outcomes for statistical significance and responder analyses should be reserved as secondary analyses

OBJECTIVE: To evaluate the power of responder analyses in a randomized controlled trial. STUDY DESIGN AND SETTING: Simulations were based on the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST), which compared sertraline to placebo for the treatment of depression in kidney disease. Baseline disease severity, placebo response, effect size, and the proportion of responders were varied across 72 scenarios. Power was assessed using a …