Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions. The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

Declaration of interests JW, CH, GA, LB, JJK declare funding from NIHR (NIHR203568) in relation to this work. LB additionally declares The University of Colorado receives remuneration for service as Senior Research Integrity Editor, Cochrane. WL, ALS, and RW declare funding from Australian National Health and Medical Research Council Investigator Grants (GNT2016729, GNT2009432, GNT2009767). EF, SG, TLa declare employment by Cochrane. Tla additionally declares authorship of a chapter in the Cochrane Handbook for Systematic Reviews of Interventions and that he is a developer of standards for Cochrane intervention reviews (MECIR). ES declares that she was a member of the Cochrane scientific misconduct policy advisory group. ZA declares he is a member of the Cochrane Library Editorial Board, and PI on a grant from Children Investment Foundation Fund to University of Liverpool to investigate research integrity of clinical trials related to nutritional supplements in pregnancy. TLi is supported by grant UG1 EY020522 from the National Eye Institute, National Institutes of Health. MC declares that he is Co-ordinating Editor for the Cochrane Methodology Review Group. AA declares that The Health Services Research Unit, University of Aberdeen, is funded by the Health and Social Care Directorates of the Scottish Government.