Disparity between statistical significance and clinical importance in published randomised controlled trials: a methodological study.

ABSTRACT:

Objectives

We estimated the extent of the disparity between statistical significance and clinical importance in published randomised controlled trials (RCTs), and explored factors associated with this disparity.

Design

A methodological study of trials published between 2018 and 2022 and indexed in PubMed was conducted. Primary reports of two-arm, phase three, superiority trials of human health interventions were included. Pharmacokinetic studies and pilot trials were excluded. The relationship between the specified delta value or minimum clinically important difference (as specified in the sample size calculation) and the effect size determined the clinical importance of the trial results. Studies where the clinical importance was at least possible, with no statistical signi

SUBMITTER: Esterhuizen TM 

PROVIDER: S-EPMC12414192 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature