title: Improving the relevance and consistency of outcomes in comparative effectiveness research.
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.
authors.affiliation: Center for Medical Technology Policy, Baltimore, MD 21202, USA.
authors.forename: Sean R
authors.initials: SR
authors.lastname: Tunis
authors.affiliation: Centre for Public Health, Queen's University Belfast, Belfast, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Gorst
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Gargon
authors.affiliation: School of Social & Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods*; D003695:Delivery of Health Care; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D012107:Research Design
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