Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in...

Area of Science:

• Medical Research Integrity
• Evidence Synthesis Methodology
• Clinical Trial Evaluation

Background:

• Evidence synthesis relies on the integrity of included studies.
• Problematic studies (misconduct, poor practice, error) can distort findings.
• Transparent methods are needed to identify and manage such studies.

Purpose of the Study:

• To develop and apply a Research Integrity Assessment (RIA) tool for randomized controlled trials.
• To address the challenge of problematic studies in evidence synthesis, using the Cochrane ivermectin review as a case study.

Main Methods:

• Developed a RIA tool assessing six criteria: retraction, registration, ethics, author group, methods plausibility, and results plausibility.
• Applied the RIA tool during the eligibility check in the Cochrane review.
• Decisions were made independently by two authors and reported transparently.

Main Results:

• The RIA tool identified numerous studies with issues in research integrity and regulatory compliance.
• Over 40% of studies were excluded in the first update of the Cochrane ivermectin review due to RIA findings.
• Problematic studies were excluded, and uncertain ones were held for clarification.

Conclusions:

• The RIA tool is effective in identifying and managing problematic studies prior to 'Risk of Bias' assessment.
• It enhances the integrity and authenticity of studies included in evidence synthesis.
• There is a need for a standardized approach to assessing research integrity in scientific literature.