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Use and Interpretation of Composite End Points in Orthopaedic Trials
Jason W. Busse, DC, PhD1; Mohit Bhandari, MD, PhD, FRCSC2; Ignacio Ferreira-González, MD, PhD3; Victor M. Montori, MD, MSc4; Gordon H. Guyatt, MD, MSc5
1 Institute for Work & Health, 481 University Avenue, Suite #800, Toronto, ON M5G 2E9, Canada. E-mail address: jbusse@iwh.on.ca
2 CLARITY Research Group, Department of Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada
3 Cardiology Department, Vall d’Hebron Hospital and CIBER de Epidemiología y Salud Pública (CIBERESP), Passeig Vall d’Hebron 119-129, 08035, Barcelona, Spain
4 Knowledge and Evaluation Research Unit, Department of Medicine, Mayo Clinic, Plummer 3-35, 200 First Street S.W., Rochester, MN 55905
5 CLARITY Research Group, McMaster University, 1280 Main Street West, Room 2C12, Hamilton, ON L8S 4K1, Canada
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at the Institute for Work & Health, Toronto, Ontario, Canada

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 18;94(Suppl 1(E)):65-69. doi: 10.2106/JBJS.K.01287
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Randomized controlled trials in orthopaedics are often underpowered to detect important differences in outcomes. Composite end points (CEPs) hold promise as a strategy to address this issue by combining multiple end points into one summary measure, thus increasing the observed event rate. The use of CEPs by trialists, however, can be problematic when they include components that vary greatly in importance to patients and when differences in apparent effect between components are large. We present an overview of CEPs with a focus on appropriate design and interpretation of results.

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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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