Individual and composite study endpoints: separating the wheat from the chaff.
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.
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Mass; Meyers Primary Care Institute, Worcester, Mass. Electronic address: Robert.Goldberg@umassmed.edu.
Robert
R
Goldberg
Department of Medicine, University of Massachusetts Medical School, Worcester, Mass.
Joel M
JM
Gore
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Mass.
Bruce
B
Barton
Meyers Primary Care Institute, Worcester, Mass; Department of Medicine, University of Massachusetts Medical School, Worcester, Mass.
Jerry
J
Gurwitz
D002986:Clinical Trials as Topic / Q000592:standards / Q000639:trends; D003362:Cost-Benefit Analysis; D023381:Endpoint Determination; D006801:Humans; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome
Clinical epidemiology; Study design; Study outcomes and endpoints