Research Integrity Assessment (RIA) Tool for RCTs in evidence synthesis

Brief summary: Potentially eligible RCTs identified during screening should be assessed for research integrity hierarchically considering domain 1 to 6. Retraction, lack of prospective registration, lack of adequate ethical approval with informed written consent, inconsistencies in the author group and the location of the study, lack of proper randomization, implausible study results should lead to exclusion of a RCT.

Concerns with the RCT in any domain put the study in ‘awaiting classification’ and should lead to further investigations. If no concerns appear through all domains or could be clarified, e.g. in correspondence with study authors, the RCT meets criteria for inclusion in the review and can be processed further. In living systematic reviews, included RCTs and RCTs ‘awaiting classification’ must be reassessed for retraction notices.