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Outcome reporting bias in ophthalmology clinical trials between 2014 and 2023
Xiaole Li1, Marko Tien1, Ryan S Huang1
1Faculty of Medicine, University of Toronto Temerty, Toronto, Ontario, Canada.
Outcome-reporting bias is common in ophthalmic trials, with unfavorable results more likely to be omitted. Improving protocol adherence and transparency is crucial for accurate medical research.
Area of Science:
- Ophthalmology
- Clinical Trials
- Research Integrity
Background:
- Outcome-reporting bias (ORB) can skew intervention effectiveness and safety data.
- Selective reporting of outcomes in clinical trials compromises evidence-based medicine.
- Prevalence of ORB in ophthalmic randomized controlled trials (RCTs) requires investigation.
Purpose of the Study:
- To determine the prevalence and extent of outcome-reporting bias in ophthalmic RCTs.
- To identify factors associated with incomplete or unreported outcomes in ophthalmic research.
- To examine discrepancies between prespecified and published outcomes in ophthalmic trials.
Main Methods:
- Systematic search of Embase, MEDLINE, and CENTRAL for ophthalmic RCTs (2014-2023).
- Defined incompletely reported outcomes (lacking meta-analysis data) and unreported outcomes (absent from publication).
- Used logistic regression and meta-analysis to assess ORB prevalence, associated factors, and outcome unfavorability.
Main Results:
- 64.2% of 260 ophthalmic RCTs had incompletely reported outcomes; 47.7% had unreported outcomes.
- Unreported outcomes linked to lower journal impact factor and industry funding.
- Unfavorable outcomes were 3.31 times more likely to be incompletely reported (p<0.001).
Conclusions:
- Outcome-reporting bias is highly prevalent in ophthalmic RCTs.
- Incomplete reporting is associated with unfavorable results and specific trial characteristics.
- Enhanced adherence to protocols and reporting transparency are vital for reliable ophthalmic research.
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