Comparison of statistical methods for the analysis of patient-reported outcomes (PROs), particularly the Short-Form 36 (SF-36), in randomised controlled trials (RCTs) using standardised effect size (SES): an empirical analysis.

ABSTRACT:

Background

The Short-Form 36 (SF-36), a widely used patient-reported outcome (PRO), is a questionnaire completed by patients measuring health outcomes in clinical trials. The PRO scores can be discrete, bounded, and skewed. Various statistical methods have been suggested to analyse PRO data, but their results may not be presented on the same scale as the original score, making it difficult to interpret and compare different approaches. This study aims to unify and compare the estimates from different statistical methods for analysing PROs, particularly the SF-36, in randomised controlled trials (RCTs), using standardised effect size (SES) summary measure.

Methods

SF-36 outcomes were analysed using ten statistical methods: multiple linear regression (MLR), median regression (

SUBMITTER: Qian Y 

PROVIDER: S-EPMC12042522 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature