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The Quality of Reporting of Orthopaedic Randomized Trials with Use of a Checklist for Nonpharmacological Therapies
Simon Chan, BSc1; Mohit Bhandari, MD1
1 Hamilton Health Sciences-General Hospital, 237 Barton Street East, 7 North Wing, Suite 727, Hamilton, ON L8L 2X2, Canada. E-mail address for M. Bhandari: bhandam@mcmaster.ca
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Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants of less than $10,000 from the Canadian Institutes of Health Research and of more than $10,000 from a Canada Research Chair and McMaster University. Neither they nor a member of their immediate families received 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, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Investigation performed at the Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2007 Sep 01;89(9):1970-1978. doi: 10.2106/JBJS.F.01591
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Abstract

Background: The Consolidated Standards of Reporting Trials statement for the reporting of randomized controlled trials has been limited by its applicability to surgical trials. In response, a Checklist to Evaluate a Report of a Nonpharmacological Trial was recently developed by the Consolidated Standards of Reporting Trials group to address reporting issues in surgical trials. We aimed (1) to apply the checklist for nonpharmacological therapies to orthopaedic randomized controlled trials across multiple journals from 2004 through 2005, and (2) to survey authors when methodological safeguards itemized in the checklist were not reported to determine whether they actually had been performed. We hypothesized that lack of reporting of a methodological safeguard did not necessarily mean it had not been conducted.

Methods: We searched for relevant orthopaedic randomized controlled trials across eight journals in the period from January 2004 through December 2005. We applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to all eligible studies. We contacted authors to determine what methodological safeguards were actually used, especially when details remained unclear from the publication.

Results: We included eighty-seven randomized controlled trials from eighty-five scientific reports. In assessing the randomized controlled trials with the checklist for nonpharmacological therapies, seventy-three studies (84%) had unclear reporting of treatment allocation concealment. Only seventeen studies (20%) mentioned surgeon skill or experience. The blinding of patients, ward staff, rehabilitation staff, clinical outcome assessors, and nonclinical outcome assessors was unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%), and thirty-three studies (38%), respectively. Authors from forty-three randomized controlled trials responded to our survey. The results of the survey showed that 41% (95% confidence interval, 25% to 58%) of the trials had adequate allocation concealment when this had been unclear from the report. Although the surgical experience of the investigators was rarely reported, most authors (70%) acknowledged that they had defined "surgical expertise criteria" such as minimum case criteria, specialized training, and clinical performance. The survey also showed that 28% to 40% of the trials had blinding of relevant groups despite the fact that the reporting of such blinding had been unclear in the publications.

Conclusions: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias-reducing safeguards that were not reported in a randomized controlled trial did not occur. Our study reinforces the need for the consistent use of a tool like the Checklist to Evaluate a Report of a Nonpharmacological Trial to assess the methodology of surgical trials.

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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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