INSPECT-SR tool for assessing trustworthiness of randomised controlled trials

The integrity of evidence synthesis is threatened by problematic randomised controlled trials, where there are serious concerns about the trustworthiness of the data or findings. Such concerns could be due to research misconduct, including fraud, or due to honest critical errors. If these trials are not detected, they may be inadvertently included in systematic reviews and guidelines, potentially distorting their results. To resolve this problem, the INSPECT-SR (Investigating Problematic Clinical Trials in Systematic Reviews) tool has been developed to assess the trustworthiness of randomised controlled trials. This tool will help researchers to identify and exclude problematic trials from systematic reviews. This article describes the development of INSPECT-SR and presents the tool and an associated guidance document.