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

  1. Ignacio Ferreira-Gonzalez, MD, PhD;
  2. Gaieta Permanyer-Miralda, MD, PhD;
  3. Jason W. Busse, MSc;
  4. P. J. Devereaux, MD, BSc, PhD;
  5. Gordon H. Guyatt, MD, MSc;
  6. Pablo Alonso-Coello, MD; and
  7. Victor M. Montori, MD, MSc
  1. 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.

    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 …

    This 100-word excerpt has been provided in the absence of an abstract.

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