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Impact of a Research Integrity Assessment (RIA) of Randomized Controlled Trials Included in Interventional COVID-19
Stephanie Weibel1, Patrick Meybohm1, Annika Oeser2
1Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital Würzburg Würzburg Germany.
Cochrane Evidence Synthesis and Methods
|April 27, 2026
Summary
The Research Integrity Assessment (RIA) tool identified widespread integrity concerns in COVID-19 randomized controlled trials (RCTs), with 29% excluded. Applying RIA requires expertise and resources but enhances the trustworthiness of clinical evidence.
Area of Science:
- Clinical Research Methodology
- Evidence Synthesis
- Research Integrity
Background:
- Systematic reviews rely on the quality of included randomized controlled trials (RCTs).
- Assessing research integrity is crucial for trustworthy evidence synthesis.
- The Research Integrity Assessment (RIA) tool offers a structured approach to evaluate RCTs.
Purpose of the Study:
- To evaluate the feasibility, reliability, and impact of the RIA tool on RCTs within systematic reviews.
- To identify RCTs with potential research integrity issues.
- To assess the effect of excluding low-integrity RCTs on meta-analytic findings.
Main Methods:
- A meta-epidemiological study design was employed.
- RCTs from COVID-19 systematic reviews were assessed using the RIA tool by two independent reviewers.
- Sensitivity analyses were conducted to determine the impact of RIA exclusions on meta-analytic results.
Main Results:
- Out of 206 RCTs, 29% were excluded due to integrity concerns, primarily related to trial registration and ethics approval.
- Interrater reliability was moderate (κ=0.5), with higher agreement in objective domains.
- Excluding RCTs failing RIA reduced the number of eligible studies by 60%, widening confidence intervals and decreasing conclusion certainty.
Conclusions:
- Integrity checks using the RIA tool are feasible but demand expertise, adjudication, and resources.
- Widespread integrity concerns were found in COVID-19 RCTs.
- Incorporating RIA into review methodology can improve the trustworthiness of clinical evidence and patient safety.
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