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
. 2016 Mar;5(2):193-205.
doi: 10.2217/cer-2015-0007. Epub 2016 Mar 1.

Improving the relevance and consistency of outcomes in comparative effectiveness research

Sean R Tunis  1 , Mike Clarke  2 , Sarah L Gorst  3 , Elizabeth Gargon  3 , Jane M Blazeby  4 , Douglas G Altman  5 , Paula R Williamson  3
Affiliations
Review

Improving the relevance and consistency of outcomes in comparative effectiveness research

Sean R Tunis et al. J Comp Eff Res. 2016 Mar.

Abstract

Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues.

Keywords: clinical trials; clinician-reported outcomes; comparative effectiveness; patient-centered outcomes; patient-reported outcomes; quality of life; reimbursement science; research methods; research standards; research waste.

PubMed Disclaimer

Conflict of interest statement

Financial & competing interests disclosure This work was supported in part by a Eugene Washington Engagement Award from the Patient Centered Outcomes Research Institute. This work was also funded in part by the MRC MRP (Medical Research Council Methodology Research Panel), grant number MR/J004847/1; and European Union Seventh Framework Programme ([FP7/2007-2013] [FP7/2007-2011]) under grant agreement number 305081. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Figures

<b>Figure 1.</b>
Figure 1.. Year of first publication of each core outcome sets study (n = 227).
COS: Core outcome sets.
<b>Figure 2.</b>
Figure 2.. Number of core outcome sets developed in each disease category (n = 305).
†Studies we are aware have been published since December 2014. COS: Core outcome sets; N/A: Not applicable.
See this image and copyright information in PMC

References

    1. Orszag PR, Ellis P. Addressing rising health care costs – a view from the Congressional Budget Office. N. Engl. J. Med. 2007;357(19):1885–1887. - PubMed
    1. Gabriel SE, Normand SL. Getting the methods right – the foundation of patient-centered outcomes research. N. Engl. J. Med. 2012;367(9):787–790. - PubMed
    1. Sox HC, Greenfield S. Comparative effectiveness research: a report from the Institute of Medicine. Ann. Intern. Med. 2009;151(3):203–205. - PubMed
    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86–89. - PubMed
    1. Qaseem A, Snow V, Cross JT, Jr, et al. Current pharmacologic treatment of dementia: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann. Intern. Med. 2008;148(5):370–378. - PubMed

Publication types

MeSH terms

LinkOut - more resources