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

Abstract

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. 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. 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. 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. 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.