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Letters |21 April 2009

Composite Outcomes Can Distort the Nature and Magnitude of Treatment Benefits in Clinical Trials

Ignacio Ferreira-Gonzalez, MD, PhD; Gaieta Permanyer-Miralda, MD, PhD; Jason W. Busse, MSc; P. J. Devereaux, MD, BSc, PhD; Gordon H. Guyatt, MD, MSc; Pablo Alonso-Coello, MD; Victor M. Montori, MD, MSc

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Author, Article, and Disclosure Information
Potential Financial Conflicts of Interest: None disclosed.
  • From Vall d'Hebron Hospital, CIBER de Epidemiología y Salud Pública, 08035 Barcelona, Spain; McMaster University, Hamilton, Ontario L8N 3Z5, Canada; Iberoamerican Cochrane Center, Hospital de la Santa Creu i Sant Pau, CIBER de Epidemiología y Salud Pública, 08025 Barcelona, Spain; and Mayo Clinic, Rochester, MN 55905.
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Potential Financial Conflicts of Interest: None disclosed.
TO THE EDITOR:
In their article, Lim and colleagues (1) contribute important insights into the use of composite outcomes in clinical trials. Their article contributes to a debate initiated a few years ago (2–6). Confirming our earlier work (5), the study by Lim and colleagues shows that composite outcomes in cardiovascular trials are common, components usually vary in importance to patients, events occur more frequently in the less important components than in the most important ones, and less important outcomes (such as angina) usually drive the effect of the therapy on the composite.
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Ferreira-Gonzalez I, Permanyer-Miralda G, Busse JW, Devereaux PJ, Guyatt GH, Alonso-Coello P, et al. Composite Outcomes Can Distort the Nature and Magnitude of Treatment Benefits in Clinical Trials. Ann Intern Med. ;150:566–567. doi: 10.7326/0003-4819-150-8-200904210-00016

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Published: Ann Intern Med. 2009;150(8):566-567.

DOI: 10.7326/0003-4819-150-8-200904210-00016

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