Trustworthiness assessment as an inclusion criterion for systematic reviews—What is the impact on results?

Jo Weeks · Anna Cuthbert · Žarko Alfirević

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Meta-analysis and systematic reviews Pharmaceutical industry and healthcare Delphi Technique in Research

Abstract

Background: There is increasing concern that a significant proportion of randomized controlled trials (RCTs) included in Cochrane reviews may not be trustworthy. Applying the Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool (CPC-TST) has already had a clinically important effect on several reviews published by the Cochrane Pregnancy and Childbirth Group. Objectives: We wanted to assess the impact of removing untrustworthy RCTs from already-published Cochrane reviews on a defined clinical area (antenatal and postnatal nutritional interventions). Methods: We applied the tool to 18 Cochrane reviews (374 RCTs). The tool had four domains: (i) is the research governance trustworthy; (ii) are the baseline characteristics trustworthy; (iii) is the study feasible; (iv) are the results plausible? When additional information was needed, authors were contacted using a standard template. At least two attempts were made to contact the authors. At the end of the evaluation process each study was classified as: (i) included (YES to all questions); (ii) excluded (retracted study); or (iii) awaiting classification (any NO to the questions). Results: Ninety-three out of 374 included studies (25%) were reclassified as "excluded" or "awaiting classification." The number of included RCTs was reduced in 14 out of 18 reviews. Six reviews (33%) were judged to require updating because of important differences in the Summary of Findings tables (direction and size of effects and/or GRADE ratings), conclusions, implication for practice, and/or implication for research. Conclusions: Formal assessment of trustworthiness, and inclusion only of studies that satisfy prespecified criteria for trustworthiness, affect conclusions in a relatively large number of Cochrane reviews, with potentially important clinical implications for practice and research.

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References

2017Data fabrication and other reasons for non‐random sampling in 5087 randomised, controlled trials in anaesthetic and general medical journals 2020False individual patient data and zombie randomised controlled trials submitted to Anaesthesia 2019Plagiarism and data falsification are the most common reasons for retracted publications in obstetrics and gynaecology 2021Methods to assess research misconduct in health-related research: A scoping review 2020A review of the current concerns about misconduct in medical sciences publications and the consequences

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2025Investigating the impact of trial retractions on the healthcare evidence ecosystem (VITALITY Study I): retrospective cohort study 2024Research Integrity in Guidelines and evIDence synthesis (RIGID): a framework for assessing research integrity in guideline development and evidence synthesis 2025Assessing the feasibility and impact of clinical trial trustworthiness checks via an application to Cochrane Reviews: Stage 2 of the INSPECT-SR project 2025INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials

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