Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

Research output: Contribution to journalArticle

Authors

  • Rebecca Mercieca-Bebber
  • Julie Rouette
  • Melanie Calvert
  • Madeleine T King
  • Lori McLeod
  • Patricia Holch
  • Michael J Palmer
  • Michael Brundage
  • International Society for Quality of Life Research (ISOQOL) Best Practice for PROs—Reporting Taskforce

Colleges, School and Institutes

External organisations

  • Central Clinical School, Sydney Medical School, University of Sydney, Quality of Life Office, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia. Rebecca.Mercieca@sydney.edu.au.
  • Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, Kingston, ON, K7L 3N6, Canada.
  • Central Clinical School, Sydney Medical School, University of Sydney, Quality of Life Office, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia.
  • RTI Health Solutions, Research Triangle Park, NC, University of North Carolina, Chapel Hill, NC, 27709, USA.
  • Leeds Beckett University

Abstract

PURPOSE: This study assessed the uptake of the CONsolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO) statement; determined if use of CONSORT-PRO was associated with more complete reporting of PRO endpoints in randomised controlled trials (RCTs) and identified the extent to which high-impact journals publishing RCTs with PRO endpoints endorse CONSORT-PRO.

METHODS: CONSORT-PRO citations were identified by systematically searching Medline, EMBASE and Google from 2013 (year CONSORT-PRO released) to 17 December 2015. RCTs that cited CONSORT-PRO (cases) were compared to a comparable control sample of RCTs in terms of adherence to CONSORT-PRO using t tests. General linear models assessed the relationship between CONSORT-PRO score and key, pre-specified variables. The 100 highest-impact journals that published RCTs with PRO endpoints (2014-2015) were identified via a systematic Medline search. Instructions for authors were reviewed to determine whether journals endorsed CONSORT-PRO.

RESULTS: Total CONSORT-PRO scores ranged from 47 to 100% for cases and 25-96% for controls. Cases had significantly higher total CONSORT-PRO scores compared to controls: t = 2.64, p = 0.01. 'Citing CONSORT-PRO', 'journal endorsing CONSORT-PRO' and 'dedicated PRO paper' were significant predictors of higher CONSORT-PRO adherence score: R (2) = 0.48, p < 0.001. 11/100 top-ranked journals endorsed CONSORT-PRO in their instructions to authors, seven of these journals published RCTs included as cases in this study.

CONCLUSION: This study demonstrated improved PRO reporting associated with journal endorsement and author use of the CONSORT-PRO extension. Despite growing awareness, more work is needed to promote appropriate use of CONSORT-PRO to improve completeness of reporting; in particular, stronger journal endorsement of CONSORT-PRO.

Details

Original languageEnglish
Number of pages11
JournalQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
Early online date7 Feb 2017
Publication statusE-pub ahead of print - 7 Feb 2017