The Journal of Bone and Joint Surgery (American). 2008;90:1026-1033.
doi:10.2106/JBJS.G.00963
© 2008 The Journal of Bone and Joint Surgery, Inc.
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Blinding of Outcomes in Trials of Orthopaedic Trauma: An Opportunity to Enhance the Validity of Clinical Trials

Paul J. Karanicolas, MD1, Mohit Bhandari, MD, MSc1, Behzad Taromi, MD2, Elie A. Akl, MD, MPH3, Dirk Bassler, MD, MSc4, Pablo Alonso-Coello, MD5, David Rigau, MD5, Dianne Bryant, MSc, PhD1, Shona E. Smith, MD6, Stephen D. Walter, PhD1 and Gordon H. Guyatt, MD, MSc1

1 Department of Clinical Epidemiology and Biostatistics, McMaster University, 1200 Main Street West, Hamilton, ON L8N 3Z5, Canada. E-mail address for P.J. Karanicolas: karanipj{at}mcmaster.ca
2 Department of Surgery, McMaster University, Hamilton General Hospital, 7 North Suite 727, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada
3 Department of Medicine, State University of New York at Buffalo, ECMC, CC142, 642 Grider Street, Buffalo, NY 14215
4 Department of Neonatology, University Children's Hospital, Calwerstrasse 7, 72076 Tuebingen, Germany
5 Iberoamerican Cochrane Center-Department of Clinical Epidemiology and Public Health, CIBER de Epidemiología y Salud Pública (Hospital de Sant Pau), 08041 Barcelona, Spain
6 Department of Surgery, The University of Western Ontario, University Hospital, Room C8-114, 339 Windermere Road, London, ON N6A 5A5, Canada
Investigation performed at McMaster University, Hamilton, Ontario, Canada

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 in excess of $10,000 from the Orthopaedic Trauma Association (OTA) and the Association Internationale pour l'Ostéosynthèse Dynamique (AIOD) and one author holds a Canada Graduate Scholarship from the Canadian Institutes of Health Research (CIHR) in excess of $10,000. 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.

Background: Blinding personnel in randomized controlled trials is an important strategy to minimize bias and increase the validity of the results. Trials of surgical interventions present blinding challenges not seen in drug trials. How often orthopaedic trauma investigators undertake blinding, and the frequency with which they could potentially utilize blinding, remains uncertain.

Methods: We conducted a systematic review of all randomized controlled trials of orthopaedic trauma published from 1995 to 2004. Two reviewers assessed each trial for eligibility and extracted data regarding its characteristics, outcomes, reporting of blinding, and feasibility of blinding.

Results: We included 171 unique randomized controlled trials spanning a variety of body regions and interventions. The most commonly reported outcomes were clinical (e.g., mortality or wound infection; 91% of trials), radiographic (83%), patient-reported (66%), and physiological results (e.g., range of motion; 56%). Less than 10% of the trials in each category reported the use of blinded outcome assessors. This contrasted with blinding that investigators could have accomplished: blinding was feasible with use of simple methods such as independent assessors, concealed incisions, and masked radiographs for 89% of clinical assessors, 89% of radiographic assessors, 96% of physiological assessors, and 35% of patient-reported assessors.

Conclusions: Trials in orthopaedic trauma typically measure many outcomes requiring judgment, but the individuals assessing those outcomes are seldom blinded. Investigators have the opportunity to enhance the validity of future clinical trials by incorporating simple blinding techniques.


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