Harms Reporting in the RCTs Underpinning the AAOS Clinical Practice Guidelines for Clavicle Fractures.

Abstract

The American Academy of Orthopaedic Surgeons (AAOS) publishes clinical practice guidelines (CPGs) for various pathologies. An extension to the Consolidated Standards for Reporting (CONSORT) checklist provides authors with a framework for reporting harms in randomized controlled trials (RCTs). The purpose of this study was to measure harms reporting among RCTs cited as supporting evidence for the AAOS CPG on the treatment of clavicle fractures. This study also sought to determine whether these reporting rates changed over time. Adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we used the AAOS CPG for clavicle fractures and conducted a linear regression analysis to model the relationship between the year of publication and the total CONSORT checklist percentage adherence over time. There were 28 RCTs cited as supporting evidence for the clavicle fractures CPG included in the final sample. The average number of the 18 CONSORT Extension for Harms items appropriately reported across all included RCTs was 9.32 (51.8%). Nine checklist items had more than 50% compliance (50%), 3 items had between 20% and 50% compliance (16.7%), and 6 items had less than 20% compliance (33.3%). The linear regression model demonstrated no significant improvement in CONSORT Harms reporting over time. Adverse events are inadequately reported in RCTs cited as supporting evidence for the AAOS <i>Treatment of Clavicle Fractures</i> CPGs. We recommend the utilization of standardized adverse event reporting tools specific to orthopedic trauma literature to facilitate ease in adverse event reporting among RCTs.