Comprehensive review of statistical methods for analysing patient-reported outcomes (PROs) used as primary outcomes in randomised controlled trials (RCTs) published by the UK's Health Technology Assessment (HTA) journal (1997-2020).

ABSTRACT:

Objectives

To identify how frequently patient-reported outcomes (PROs) are used as primary and/or secondary outcomes in randomised controlled trials (RCTs) and to summarise what statistical methods are used for the analysis of PROs.

Design

Comprehensive review.

Setting

RCTs funded and published by the United Kingdom's (UK) National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.

Data sources and eligibility

HTA reports of RCTs published between January 1997 and December 2020 were reviewed.

Data extraction

Information relating to PRO use and analysis methods was extracted.

Primary and secondary outcome measures

The frequency of using PROs as primary and/or secondary outcomes; statistical methods that were used for

SUBMITTER: Qian Y 

PROVIDER: S-EPMC8422492 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature