A tool for assessing the trustworthiness of randomized controlled trials (RCTs) has been published today in The BMJ, giving researchers a structured way to identify problematic studies before they're included in systematic reviews.
What is INSPECT-SR?
The INSPECT-SR tool (INveStigating ProblEmatic Clinical Trials in Systematic Reviews) was created by an international group of researchers to address the risks posed by untrustworthy RCTs.
Problematic studies, including those affected by human error or research misconduct, can distort the evidence that systematic reviews rely on, and in turn influence treatment guidelines. This can lead to inaccurate or even harmful recommendations. A recent example of problematic studies included in systematic reviews was a review on ivermectin for the treatment of COVID-19. Some of the trials used in the systematic reviews were not authentic, according to health authorities in the US, UK and EU. Subsequent high-quality trials suggested little or no benefit.
Problems with a trial can go unrecognized for years, and many are never formally retracted at all, which makes the true scale of the issue hard to pin down. Reviewers have historically had only limited, inconsistent ways to assess trial trustworthiness. The INSPECT-SR tool fills that gap with a rigorously developed, systematic, and transparent method.
How will INSPECT-SR be used?
Developed by researchers at the University of Manchester, Cochrane, and University of Colorado, in collaboration with more than 40 institutions worldwide, INSPECT-SR guides reviewers through 21 structured checks across four domains: post-publication notices, study conduct, governance and transparency, text and figures, and study results.
Dr Jack Wilkinson, lead researcher, said: “More than 150 integrity and health research experts from around the world have contributed to the development of INSPECT-SR. Researchers can use this tool to assess the trustworthiness of randomized controlled trials and to identify problematic studies, knowing that it has the backing of the systematic review community."
Unlike tools that assess risk of bias or methodological quality, INSPECT-SR focuses specifically on the trustworthiness of trial data. The framework does not assume misconduct or imply deliberate wrongdoing, but will enable identification of fraudulent studies among other problematic trials. The research team encourages reviewers, guideline developers, and publishers to adopt INSPECT-SR, and anticipates that it will become the standard for assessing the trustworthiness of RCTs.
“Systematic reviews are only as credible as the studies they include,” said Lisa Bero, fellow author from the University of Colorado and Cochrane Senior Research Integrity Editor. “INSPECT-SR gives reviewers a rigourous, thoroughly-tested, transparent way to detect problematic trials, helping to safeguard the integrity of evidence that informs patients, clinicians, and policymakers.”
INSPECT-SR is freely available for anyone to use from launch. It has already been endorsed for use in Cochrane reviews, and has been added to the resources Cochrane review teams draw on when assessing whether included studies raise integrity concerns.
