An assessment of the quality of rotator cuff randomized controlled trials: utilizing the Jadad score and CONSORT criteria.

Abstract

The AAOS's Clinical Practice Guideline on "Optimizing Care of Rotator Cuff Problems" suggested a lack of high-quality data. Our purpose is to quantify the quality of randomized controlled trials of rotator cuff disorders via the Jadad score, and to apply the 2010 Consolidated Standards of Reporting Trials CONSORT Criteria to determine factors associated with high Jadad scores and areas for improvement. A systematic review using PRISMA guidelines was performed. Utilizing an iterative search strategy of the top 6 impact factor orthopaedic journals from 2001 to 2011, all randomized controlled studies involving rotator cuff disorders were identified and scored in a systematic, blinded fashion. Each study received a Jadad score. Adherence to CONSORT criteria was quantified and linked to the Jadad score via linear regression. Common deficiencies were described. A total of 129 manuscripts were identified; 54 met inclusion criteria: total patients n = 4099; mean patients per article = 76; range, 16-660. The mean Jadad score was 3.0. Sixty-six percent (35/53) of studies were high quality (high quality: >3). Among these, the majority (63%, 22/35) were nonoperative trials. Adherence to CONSORT Criteria was associated with higher Jadad scores (R(2) = 0.3). The most common deficient CONSORT Criteria were: trial design descriptions (66%; 36/54 studies), descriptions of randomization type (65%; 35/54), and power analysis (46%; 25/54). The majority of randomized controlled trials of rotator cuff pathology are high-quality studies based on the Jadad score. Adherence to CONSORT criteria is linked to high-quality scores. Future studies should use full CONSORT Criteria.