Scientific Articles   |    
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; 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@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
View Disclosures and Other Information
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.
Investigation performed at McMaster University, Hamilton, Ontario, Canada

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2008 May 01;90(5):1026-1033. doi: 10.2106/JBJS.G.00963
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case


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.

Figures in this Article
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org


    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.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe

    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    PubMed Articles
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    Illinois - Hinsdale Orthopaedics
    Oregon - The Center - Orthopedic and Neurosurgical Care and Research
    IL - Hinsdale Orthopaedics