Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 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

Robert Goldberg  1 , Joel M Gore  2 , Bruce Barton  3 , Jerry Gurwitz  4
Affiliations
Review

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

Robert Goldberg et al. Am J Med. 2014 May.

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Statement: There are no conflicts of interest for any of the authors. All authors had access to the data and a role in writing this manuscript.

References

    1. Begg CB, Cho MK, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637–639. - PubMed
    1. Collins R, MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: Clinical trials. Lancet. 2001;357:373–380. - PubMed
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet. 2001;357:1191–1194. - PubMed
    1. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–1632. - PubMed
    1. Head SJ, Kaul S, Bogers AJ, Kappetein AP. Non-inferiority study design: lessons to be learned from cardiovascular trials. Eur Heart J. 2012;33:1318–1324. - PubMed

Publication types