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).
Study design and setting: 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.
Conclusion: The CERTAIN's inaugural cohort study may serve as a useful model for conducting PCOR and creating a learning health care network.
Keywords: Comparative effectiveness research; Patient-centered outcomes research; Patient-reported outcomes; Peripheral artery disease; Research infrastructure; Stakeholders.
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