Estimating the Placebo Effect on Patient-Reported Outcomes in Sham-controlled Device Trials: Insights from REDUCE LAP-HF II.

ABSTRACT:

Background

Patient-reported outcomes (PROs) are increasingly used as endpoints in clinical trials. However, the magnitude of observed changes in control arms attributable to placebo effects, as compared with other benefits of trial participation, has not been described.This study seeks to estimate the magnitude of the placebo effect by calculating changes in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) scores, which quantify the impact of heart failure on patients' symptoms, function, and quality of life, after participants were unblinded to treatment.

Methods

REDUCE LAP-HF II randomized participants to atrial shunt or sham procedure, with unblinding after 2 years. The KCCQ was collected at baseline, 2, and 3 years after randomization. KCCQ-OS change fr

SUBMITTER: Girard AA 

PROVIDER: S-EPMC12811010 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature