Adherence to Complication Reporting for Randomized Controlled Trials Contained in Clinical Practice Guidelines for the Management of Carpal Tunnel Syndrome

Yagiz Ozdag; Daniel S Hayes; Clarice Callahan; Jad El Koussaify; Eugene P Warnick; Brian K Foster; Joel C Klena; Louis C Grandizio

doi:10.1016/j.jhsg.2023.06.004

Adherence to Complication Reporting for Randomized Controlled Trials Contained in Clinical Practice Guidelines for the Management of Carpal Tunnel Syndrome

J Hand Surg Glob Online. 2023 Jul 22;5(6):779-783. doi: 10.1016/j.jhsg.2023.06.004. eCollection 2023 Nov.

Authors

Yagiz Ozdag¹, Daniel S Hayes¹, Clarice Callahan¹, Jad El Koussaify¹, Eugene P Warnick¹, Brian K Foster¹, Joel C Klena¹, Louis C Grandizio¹

Affiliation

¹ Department of Orthopaedic Surgery, Geisinger Commonwealth School of Medicine, Geisinger Musculoskeletal Institute, Danville, PA.

Abstract

Purpose: Randomized controlled trials (RCTs) are frequently used in creating recommendations contained within clinical practice guidelines (CPGs). However, investigations outside of hand surgery have reported that RCTs within CPGs infrequently report complications and harms-related data. Our purpose was to assess adherence to complication reporting and harms-related outcomes contained in the Consolidated Standards for Reporting (CONSORT) Extension of Harms and Standards for Reporting of Diagnostic Accuracy Studies (STARD) reporting checklists for RCTs within the American Academy of Orthopaedic Surgery (AAOS) CPGs for carpal tunnel syndrome (CTS).

Methods: We identified all RCTs within the AAOS CTS CPGs. All therapeutic RCTs and diagnostic studies were included. We used the CONSORT Harms Checklist criteria to assess adherence to the reporting of adverse events for therapeutic RCTs and the STARD criteria to assess the diagnostic accuracy of the articles. We defined adequate compliance as adherence to ≥50% of the checklist items.

Results: We identified 82 therapeutic RCTs and 90 diagnostic accuracy articles within the AAOS CTS CPG. For therapeutic RCTs, we found that the average compliance with the published checklists was 19%. For diagnostic studies, the average compliance with checklists was found to be 55%. Eleven therapeutic RCTs (13%) and 60 diagnostic studies (67%) were determined to have adequate compliance for the CONSORT and STARD checklists, respectively.

Conclusions: Randomized controlled trials in the AAOS CPGs for CTS have low compliance with the CONSORT Extension for Harms Checklist. Although the overall adherence to the items published in the STARD statement for diagnostic accuracy evaluation remains higher, future efforts should be made to improve the adherence rates to both checklists.

Clinical relevance: Improved standardization of complication reporting may aid in comparing outcomes across multiple clinical investigations of upper-extremity procedures.

Keywords: Carpal tunnel syndrome; Clinical practice guidelines; Complications; Hand surgery; Systematic review.