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Am J Med. 2014 May;127(5):379-84. doi: 10.1016/j.amjmed.2014.01.011. Epub 2014 Jan 28.

Individual and composite study endpoints: separating the wheat from the chaff.

Author information

1
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Mass; Meyers Primary Care Institute, Worcester, Mass. Electronic address: Robert.Goldberg@umassmed.edu.
2
Department of Medicine, University of Massachusetts Medical School, Worcester, Mass.
3
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Mass.
4
Meyers Primary Care Institute, Worcester, Mass; Department of Medicine, University of Massachusetts Medical School, Worcester, Mass.

Abstract

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.

KEYWORDS:

Clinical epidemiology; Study design; Study outcomes and endpoints

PMID:
24486289
PMCID:
PMC4019929
DOI:
10.1016/j.amjmed.2014.01.011
[Indexed for MEDLINE]
Free PMC Article

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