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



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.



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: R2= 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.



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.
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.|Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia. Rebecca.Mercieca@sydney.edu.au.
Rebecca
0000-0003-3708-9099
R
Mercieca-Bebber
Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, Kingston, ON, K7L 3N6, Canada.
Julie
J
Rouette
Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Melanie
M
Calvert
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.|Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia.
Madeleine T
MT
King
RTI Health Solutions, Research Triangle Park, NC, University of North Carolina, Chapel Hill, NC, 27709, USA.
Lori
L
McLeod
Psychology, School of Social Sciences, Faculty of Health and Social Sciences, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK.|Patient Reported Outcomes Research Group, Leeds Institute of Cancer Studies and Pathology, Bexley Wing, St James's Hospital, University of Leeds, Beckett Street, Leeds, LS9 7TF, UK.
Patricia
P
Holch
Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, Kingston, ON, K7L 3N6, Canada.
Michael J
MJ
Palmer
Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, Kingston, ON, K7L 3N6, Canada.
Michael
M
Brundage
D023381:Endpoint Determination / Q000379:methods / Q000592:standards; D006801:Humans; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*
CONSORT-PRO; Patient-reported outcome; Quality of Life; Reporting standards