Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment

The integrity of randomized clinical trials (RCT) has become a concern owing to a recent rise in the number of retractions and the repercussions this has for evidence-based patient care. However, there is little research on the subject of RCT integrity assessment. Recent literature reviews have revealed that journals' authors' instructions concerning integrity and their investigation policies concerning allegations of misconduct are heterogeneous. The judicious use of integrity tests applied to RCT manuscripts is hampered by an absence of data concerning misconduct prevalence (pre-test probability), a failure to evaluate test performance (validity) and a lack of consensus over a gold standard (against which test accuracy can be evaluated). These deficiencies hinder the post-publication correction of RCT records, the integrity evaluations in systematic reviews of RCTs and the prospective application of preventive solutions in RCT peer-review and preprint assessment. Dealing with the current controversy about trustworthiness of RCT evidence requires a strong investment in research, reform and education concerning research integrity. The purpose of this review article is to highlight the current limitations in dealing with trial integrity-related concerns and to propose solutions to some of these issues.

Automated summary

The rise in retractions of randomized clinical trials (RCTs) and the lack of research on RCT integrity assessment have raised concerns about evidence-based patient care. Recent literature reviews have found inconsistencies in journals' authors' instructions regarding integrity and their policies for investigating misconduct allegations. The limited data on misconduct prevalence, test performance evaluation, and a lack of consensus on a gold standard hinder the use of integrity tests for RCT manuscripts. These deficiencies also impede the correction of RCT records, integrity evaluations in systematic reviews, and the application of preventive solutions in RCT peer-review and preprint assessment. Addressing the trustworthiness of RCT evidence requires investment in research, reform, and education on research integrity.