Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension
Abstract
PurposeThis 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.MethodsCONSORT-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.ResultsTotal 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…
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