Adherence to CONSORT guidelines in selected general orthopaedic journals

Area of Science:

• Orthopaedic Surgery
• Clinical Trials Methodology

Background:

• Randomized controlled trials (RCTs) are crucial for evidence-based medicine in orthopaedics.
• The CONSORT (Consolidated Standards of Reporting Trials) guidelines aim to improve the quality and transparency of RCT reporting.
• Adherence to CONSORT guidelines ensures the reliability and reproducibility of research findings.

Purpose of the Study:

• To evaluate the adherence to the 2010 CONSORT guidelines in randomized controlled trials (RCTs) published in general orthopaedic and trauma journals.
• To identify specific areas of under-reporting within orthopaedic RCTs.
• To provide recommendations for improving reporting quality.

Main Methods:

• A systematic review of 100 RCTs published between January 2019 and November 2024 in four general orthopaedic and trauma journals.
• Assessment of adherence to 37 CONSORT checklist items by three independent reviewers.
• Calculation of adherence rates for each item and overall, with inter-rater reliability assessed using the intraclass correlation coefficient (ICC).

Main Results:

• Overall adherence to CONSORT guidelines averaged 86%, with 14 checklist items achieving perfect adherence.
• Significant deficiencies were observed in reporting randomization processes (17%), sharing original protocols (17%), and detailing reasons for losses/exclusions (62%).
• Adherence to reporting both absolute and relative effect sizes for binary outcomes was suboptimal at 52%.

Conclusions:

• While reporting quality in orthopaedic RCTs has improved, several critical methodological details remain under-reported.
• Enhanced enforcement and integration of CONSORT guidelines within the peer review process are necessary.
• Authors, editors, and reviewers must focus on improving transparency in data handling and methodological reporting for more reliable clinical evidence.