4.6 Review

Individual and Composite Study Endpoints: Separating the Wheat from the Chaff

Journal

AMERICAN JOURNAL OF MEDICINE
Volume 127, Issue 5, Pages 379-384

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.amjmed.2014.01.011

Keywords

Clinical epidemiology; Study design; Study outcomes and endpoints

Funding

  1. National Institutes of Health [RO1 HL35434, 1U01HL105268]
  2. National Center for Advancing Translational Sciences of the National Institutes of Health [UL1TR000161]

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We provide an overview of the individual and combined clinical endpoints and patient-reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. (c) 2014 Elsevier Inc. All rights reserved.

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