Scientific Article   |    
The Quality of Reporting of Randomized Trials in The Journal of Bone and Joint Surgery from 1988 through 2000
Mohit Bhandari, MD, MSc; Robin R. Richards, MD, FRCSC; Sheila Sprague, BSc; Emil H. Schemitsch, MD, FRCSC
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Investigation performed at the Department of Clinical Epidemiology and Biostatistics, McMaster University Health Sciences Centre, Hamilton, Ontario, Canada

Mohit Bhandari, MD, MSc
Sheila Sprague, BSc
Department of Clinical Epidemiology and Biostatistics, McMaster University Health Sciences Centre, Room 2C12, 1200 Main Street West, Hamilton, ON L8N 3Z5, Canada. E-mail address for M. Bhandari: bhandari@sympatico.ca

Robin R. Richards, MD, FRCSC
Emil H. Schemitsch, MD, FRCSC
Division of Orthopaedic Surgery, Department of Surgery, St. Michael’s Hospital, 55 Queen Street East, Suite 800, Toronto, ON M5C 1R6, Canada

The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated. Dr. Bhandari was supported, in part, by a Clinical Scientist Fellowship, Department of Clinical Epidemiology and Biostatistics, McMaster University. Sheila Sprague was supported by the Surgical Outcomes Research Centre, Hamilton, Ontario.

J Bone Joint Surg Am, 2002 Mar 01;84(3):388-396
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Background: The purpose of this study was threefold: (1) to determine the scientific quality of published randomized trials in the American Volume of The Journal of Bone and Joint Surgery from 1988 through 2000, (2) to identify predictors of study quality, and (3) to evaluate inter-rater agreement in the scoring of study quality with use of a simple scale.

Methods: Hand searches of The Journal of Bone and Joint Surgery were conducted in duplicate to identify randomized clinical trials. Of 2468 studies identified, seventy-two (2.9%) met all eligibility criteria. Two investigators each assessed the quality of the study under blinded conditions and abstracted relevant data.

Results: The mean score (and standard error) for the quality of the seventy-two randomized trials was 68.1% ± 1.6%; 60% (forty-three) scored <75%. Drug trials had a significantly higher mean quality score than did surgical trials (72.8% compared with 63.9%, p < 0.05). Regression analysis revealed that cited affiliation with an epidemiology department and cited funding were associated with higher quality scores. Failure to conceal randomization, to blind outcome assessors, and to describe why patients were excluded resulted in significantly lower quality scores (p < 0.05), more than the 5% decrease expected by removal of each item. A priori calculations of sample size were rarely performed in the reviewed studies, and only 2% of the studies with negative results included a post hoc power analysis. The Detsky quality scale met accepted standards of interobserver reliability (kappa, 0.87; 95% confidence interval, 0.70 to 0.95).

Conclusions: Few studies published in The Journal of Bone and Joint Surgery were randomized trials. More than half of the trials were limited by a lack of concealed randomization, lack of blinding of outcome assessors, or failure to report reasons for excluding patients. Application of standardized guidelines for the reporting of clinical trials in orthopaedics should improve quality.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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