Identifying and handling potentially untrustworthy trials in Pregnancy and Childbirth Cochrane Reviews

Cochrane’s mission is to promote evidence-informed health decision-making by producing high-quality, relevant, and accessible systematic reviews.  We are increasingly being made aware of the publication of untrustworthy and potentially fraudulent trials in a number of journals within our specialty. Including such trials in our Cochrane Reviews has serious implications – not only for the reputation of Cochrane, our group, and our review authors, but also for the impact on pregnant women and their babies as a result of healthcare decisions informed by our Cochrane Review evidence.

We acknowledge the guidance available to date in the Cochrane Handbook1 and the Committee on Publication Ethics (COPE) guidelines regarding a journal’s responsibilities for retracting fraudulent reports2Cochrane have also recently introduced a new policy for managing potentially problematic studies in systematic reviews – and implementation guidance.

We have developed our own process for identifying untrustworthy (potentially fraudulent) trials, and how to handle them in our Pregnancy and Childbirth Cochrane Reviews. This includes the Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool (CPC-TST). We have also incorporated the CPC-TST into our Group’s data extraction template.

Our proposed tool for assessing the trustworthiness of trials follows a clearly-defined process and will ensure that only studies whose data can be trusted are included in our Group’s Cochrane Reviews.  All new and updated Cochrane Pregnancy and Childbirth reviews will now incorporate the CPC-TST methods. 

References

1 Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Chapter 4.4.6. Cochrane, 2019. Available from www.training.cochrane.org/handbook

2 COPE. Guidelines: Retraction guidelines 2019. Committee on Publication Ethics, Hampshire, UK. Available at https://publicationethics.org/files/retraction-guidelines.pdf, accessed 13 December 2019