Mercieca-Bebber R, Rouette J, Calvert M, King MT, McLeod L, Holch P, Palmer MJ, Brundage M, ISOQOL Best Practice for PROs-Reporting Task Force. Preliminary evidence on the uptake, use, and benefits of the CONSORT-PRO extension. Qual Life Res. 2017 Jun;26(6):1427-37. doi: 10.1007/s11136-017-1508-6

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 CONSORTPRO adherence score: R² = 0.48, p < 0.001. 11/100 topranked 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.