Transparency Matters: Assessing Harms Reporting Compliance in Randomized Controlled Trials Underpinning the AAOS Clinical Practice Guideline for Anterior Cruciate Ligament Injuries.

BACKGROUND

The American Academy of Orthopaedic Surgeons (AAOS) has developed a clinical practice guideline (CPG) for management of anterior cruciate ligament (ACL) injuries. Primary studies such as randomized controlled trials (RCTs) are cited as evidence for the guidelines. Given the influence that these trials have on patient care, adherence to standardized protocols for conducting and reporting RCTs is essential.

PURPOSE

To evaluate the CONSORT (Consolidated Standards of Reporting Trials) Extension for Harms-related reporting of RCTs cited as supporting evidence for the AAOS CPG on the management of ACL tears.

STUDY DESIGN

Cross-sectional study.

METHODS

The reference section of the AAOS guideline for ACL tears was first screened for RCTs cited in the CPG. Next, each RCT was evaluated for adherence to the CONSORT Extension for Harms checklist. Both identification of RCTs and assessment of adherence were performed in a masked and duplicate process. Descriptive statistics were used to summarize adherence to CONSORT Extension for Harms items. A Pearson correlation test was conducted to assess the relationship between the year of publication and adherence to CONSORT harms reporting.

RESULTS

The sample included 113 RCTs, of which 16 (14.2%) were published before the CONSORT Extension for Harms was implemented in 2004. Sample sizes ranged from 24 to 4564 participants, with a mean of 228. None of the included RCTs included all 18 items in the CONSORT Extension for Harms checklist. The mean number of checklist items reported was 4 (of 18; 22.2%). A moderate, positive, and statistically significant correlation was found between the RCT publication year and the adherence with reporting of the CONSORT Extension for Harms ( = 3.54; < .001) ( = 0.32; 95% CI, 0.14-0.47).

CONCLUSION

Harms were infrequently reported in RCTs cited as supporting evidence in the AAOS CPG for the management of ACL tears. One encouraging finding was the positive correlation between the year when RCTs were published and how well they adhered to reporting harms. Efforts to improve adverse event reporting are warranted, as RCTs are commonly used to make clinical decisions in orthopaedic surgery.