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

Robert Goldberg; Joel M Gore; Bruce Barton; Jerry Gurwitz

doi:10.1016/j.amjmed.2014.01.011

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

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

Authors

Robert Goldberg¹, Joel M Gore², Bruce Barton³, Jerry Gurwitz⁴

Affiliations

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.

Publication types

Research Support, N.I.H., Extramural
Review

MeSH terms

Clinical Trials as Topic* / standards
Clinical Trials as Topic* / trends
Cost-Benefit Analysis
Endpoint Determination*
Humans
Outcome Assessment, Health Care*
Prospective Studies
Research Design*
Sample Size
Treatment Outcome

Abstract

Publication types

MeSH terms

Grants and funding