Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis
Stephanie Weibel,
Maria Popp,
Stefanie Reis,
Nicole Skoetz,
Paul Garner,
Emma Sydenham
First published: 29 August 2022
https://doi.org/10.1002/jrsm.1599
Abstract
Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false. Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms to identify and manage problematic studies to avoid misleading findings. As evidence synthesis authors of the Cochrane COVID-19 review on ivermectin, we identified many problematic studies in terms of research integrity and regulatory compliance. Through iterative discussion, we developed a research integrity assessment (RIA) tool for randomized controlled trials for the update of this Cochrane review. In this paper, we explain the rationale and application of the RIA tool in this case study.