INSPECT-SR tool for assessing trustworthiness of randomised controlled trials

Systematic reviews of randomised controlled trials (RCTs) typically involve identifying eligible trials, appraising them using risk of bias tools, and synthesising results. This process is threatened by the presence of problematic studies in the literature. As defined by Cochrane, these are studies "where there are serious questions about the trustworthiness of the data or findings." Problematic studies can result from research misconduct, such as plagiarism, falsification, or fabrication of data or methods. They can also arise from critical errors in study conduct that would not be flagged by risk of bias tools. If these untrustworthy studies are not identified, they may inadvertently be included in evidence synthesis. This can lead to misleading or even actively harmful treatment recommendations. Identifying many of these studies is difficult.