title: A CTSA agenda to advance methods for comparative effectiveness research.
abstract: Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient-centered outcomes, compare viable alternatives, and be responsive to individual patients' preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness research (CER) fundamentally patient-centered, challenge researchers to adopt or develop methods that improve the timeliness, relevance, and practical application of clinical studies. In this paper, we describe 10 priority areas that address 3 critical needs for research on patient-centered outcomes (PCOR): (1) developing and testing trustworthy methods to identify and prioritize important questions for research; (2) improving the design, conduct, and analysis of clinical research studies; and (3) linking the process and outcomes of actual practice to priorities for research on patient-centered outcomes. We argue that the National Institutes of Health, through its clinical and translational research program, should accelerate the development and refinement of methods for CER by linking a program of methods research to the broader portfolio of large, prospective clinical and health system studies it supports. Insights generated by this work should be of enormous value to PCORI and to the broad range of organizations that will be funding and implementing CER.
authors.affiliation: Oregon Clinical & Translational Research Center, Oregon Health & Sciences University, and Department of Hospital and Specialty Medicine, The Portland VA Medical Center, Portland, OR, USA. helfand@ohsu.edu
authors.forename: Mark
authors.initials: M
authors.lastname: Helfand
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
authors.forename: Evelyn P
authors.initials: EP
authors.lastname: Whitlock
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Pauker
authors.forename: Anirban
authors.initials: A
authors.lastname: Basu
authors.forename: Jon
authors.initials: J
authors.lastname: Chilingerian
authors.forename: Frank E
authors.initials: FE
authors.lastname: Harrell
authors.forename: David O
authors.initials: DO
authors.lastname: Meltzer
authors.forename: Victor M
authors.initials: VM
authors.lastname: Montori
authors.forename: Donald S
authors.initials: DS
authors.lastname: Shepard
authors.forename: David M
authors.initials: DM
authors.lastname: Kent
mesh_terms: D002986:Clinical Trials as Topic; D057186:Comparative Effectiveness Research / Q000379:methods*; D006801:Humans; D009316:National Institutes of Health (U.S.); D017063:Outcome Assessment, Health Care; D018802:Patient-Centered Care; D016730:Program Development; D015397:Program Evaluation; D012107:Research Design; D057170:Translational Research, Biomedical / Q000379:methods / Q000639:trends*; D016896:Treatment Outcome; D014481:United States