Background: Randomized controlled trials (RCTs) have been shown to influence clinical decision-making and health policy. Therefore, it is essential that trial outcomes—including harms—are completely reported.
Methods: We included all RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee, Osteoarthritis of the Knee, and Osteoarthritis of the Hip Clinical Practice Guideline recommendations. Manuscripts were analyzed for compliance with the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms items. We determined the Extension for Harms' influence on harms reporting by comparing RCTs published before and after the extension's release.
Results: One hundred and seventy-three RCTs were included, of which 81 (47%) adequately reported ≥50% of the checklist and 75 (43%) reported ≤33% of the checklist items. The mean number of checklist items reported was 8 items (of 18; 45%). Our interrupted time-series analysis suggests the implementation of the CONSORT Extension for Harms did not have a statistically significant effect on the completeness of harms reporting (P = .35; 95% Confidence interval = −0.0041 to 0.0014).
Conclusion: Harms-related data are poorly reported within RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons management for hip and knee OA Clinical Practice Guideline. Our time series analysis illustrates the failure of the CONSORT Extension for Harms on improving the reporting of harms-related data. Future efforts to improve the quality of harms reporting is crucial for patients, clinicians, and policy makers to perform thorough risk-benefit appraisals as RCT results directly influence clinical decision-making in orthopaedic surgery.
- CONSORT harms
- adverse events
- clinical trials
- harms reporting