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

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).