title: A model for incorporating patient and stakeholder voices in a learning health care network: Washington State's Comparative Effectiveness Research Translation Network.
abstract: OBJECTIVE
  To describe the inaugural comparative effectiveness research (CER) cohort study of Washington State's Comparative Effectiveness Research Translation Network (CERTAIN), which compares invasive with noninvasive treatments for peripheral artery disease, and to focus on the patient centeredness of this cohort study by describing it within the context of a newly published conceptual framework for patient-centered outcomes research (PCOR).
  
  
  METHODS
  The peripheral artery disease study was selected because of clinician-identified uncertainty in treatment selection and differences in desired outcomes between patients and clinicians. Patient centeredness is achieved through the "Patient Voices Project," a CERTAIN initiative through which patient-reported outcome (PRO) instruments are administered for research and clinical purposes, and a study-specific patient advisory group where patients are meaningfully engaged throughout the life cycle of the study. A clinician-led research advisory panel follows in parallel.
  
  
  RESULTS
  Primary outcomes are PRO instruments that measure function, health-related quality of life, and symptoms, the latter developed with input from the patients. Input from the patient advisory group led to revised retention procedures, which now focus on short-term (3-6 months) follow-up. The research advisory panel is piloting a point-of-care, patient assessment checklist, thereby returning study results to practice. The cohort study is aligned with the tenets of one of the new conceptual frameworks for conducting PCOR.
  
  
  CONCLUSIONS
  The CERTAIN's inaugural cohort study may serve as a useful model for conducting PCOR and creating a learning health care network.
authors.affiliation: Pharmaceutical Outcome Research and Policy Program, University of Washington, Seattle, WA, USA. bdevine@uw.edu
authors.forename: Emily Beth
authors.initials: EB
authors.lastname: Devine
authors.forename: Rafael
authors.initials: R
authors.lastname: Alfonso-Cristancho
authors.forename: Allison
authors.initials: A
authors.lastname: Devlin
authors.forename: Todd C
authors.initials: TC
authors.lastname: Edwards
authors.forename: Ellen T
authors.initials: ET
authors.lastname: Farrokhi
authors.forename: Larry
authors.initials: L
authors.lastname: Kessler
authors.forename: Danielle C
authors.initials: DC
authors.lastname: Lavallee
authors.forename: Donald L
authors.initials: DL
authors.lastname: Patrick
authors.forename: Sean D
authors.initials: SD
authors.lastname: Sullivan
authors.forename: Peter
authors.initials: P
authors.lastname: Tarczy-Hornoch
authors.forename: N David
authors.initials: ND
authors.lastname: Yanez
authors.forename: David R
authors.initials: DR
authors.lastname: Flum
mesh_terms: D026683:Advisory Committees; D015331:Cohort Studies; D057186:Comparative Effectiveness Research / Q000379:methods* / Q000458:organization & administration; D003625:Data Collection; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy; D008962:Models, Theoretical; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010358:Patient Participation / Q000379:methods*; D017060:Patient Satisfaction; D018802:Patient-Centered Care / Q000458:organization & administration; D058729:Peripheral Arterial Disease / Q000628:therapy*; D057170:Translational Research, Biomedical / Q000379:methods* / Q000458:organization & administration; D014861:Washington
keywords: Comparative effectiveness research; Patient-centered outcomes research; Patient-reported outcomes; Peripheral artery disease; Research infrastructure; Stakeholders