Completeness of reporting of randomised controlled trials including people with transient ischaemic attack or stroke: A systematic review

Abstract

Purpose To assess the adherence of stroke randomised controlled trials to Consolidated Standards Of Reporting Trials reporting guidelines and investigate the factors that are associated with completeness of reporting. Method We took a random sample from the Cochrane Stroke Group's Trial Register of transient ischaemic attack or stroke randomised controlled trials, published in English in 1997–2016 inclusive. Two reviewers assessed the published report of the final primary results of stroke randomised controlled trials with a 10-point truncated Consolidated Standards Of Reporting Trials reporting checklist to investigate adherence over time, univariable associations and independent associations with total Consolidated Standards Of Reporting Trials reporting score in a multiple linear regression model. Findings In this random sample of 177 stroke randomised controlled trials, the mean score on the truncated Consolidated Standards Of Reporting Trials checklist was 5.8 (SD 2.2); reporting improved from 1997–2000 (4.9 SD 2.0) to 2001–2009 (5.8 SD 2.1) and to 2010–2016 (6.8 SD 2.1). A higher Consolidated Standards Of Reporting Trials score was independently associated with publication during epochs following a revision of Consolidated Standards Of Reporting Trials reporting guidelines (p < 0.001), journal endorsement of the Consolidated Standards Of Reporting Trials reporting guideline at the time of randomised controlled trial publication (p < 0.001) and modified journal impact factor using median citation distribution (p = 0.012). Discussion Stroke randomised controlled trial reporting to Consolidated Standards Of Reporting Trials standards has improved over time, but could be better. Conclusion Journal endorsement and enforcement of Consolidated Standards Of Reporting Trials reporting guidelines could further improve the reporting of stroke randomised controlled trials. Systematic review registration: Registered with PROSPERO (CRD42017072193).