Harms Reporting in Randomized Controlled Trials Underpinning the American Academy of Orthopaedic Surgeons Clinical Practice Guidelines for Distal Radius Fractures.

Purpose: The purpose of this study was to measure the harms-related reporting among randomized controlled trials (RCTs) cited as supporting evidence for the American Academy of Orthopaedic Surgeons clinical practice guidelines regarding the management of distal radius fractures.

Methods: We adhered to the guidance for reporting metaresearch and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines throughout the course of this investigation. We used the American Academy of Orthopaedic Surgeons clinical practice guidelines for distal radius fractures available on Orthoguidelines.org. A linear regression analysis was conducted to model the relationship between the year of publication and the total Consolidated Standards of Reporting Trials percentage adherence over time.

Results: Thirty-five RCTs were included in the final sample. The average number of Consolidated Standards of Reporting Trials Extension for Harms items adequately reported across all included RCTs was 9.2 (9.2/18, 50.9%). None of the included trials adequately reported all 18 items. Ten items had a compliance of more than 50% (10/18, 55.6%), 4 items had a compliance of 20%-50% (4/18, 22.2%), and 4 items had a compliance of less than 20% (4/18, 22.2%). The results of the linear regression model showed no significant improvement in Consolidated Standards of Reporting Trials Harms reporting over time.

Conclusions: Adverse events are incompletely reported among RCTs cited as supporting evidence for American Academy of Orthopaedic Surgeons clinical practice guidelines for the management of distal radius fractures.

Clinical Relevance: Given our findings, specific attention should be paid to improving the standardization of the classification of adverse events to facilitate ease in the reporting process.