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Special Communication
November 2017

Incorporating Patient and Caregiver Experiences Into Cardiovascular Clinical Trial Design

Author Affiliations
  • 1Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
  • 2Department of Emergency Medicine, Wayne State University, Detroit, Michigan
  • 3Institute for Public Health and Medicine, Northwestern University, Chicago, Illinois
  • 4Division of Cardiovascular Medicine, Stony Brook University, Stony Brook, New York
  • 5American Heart Association/American Stroke Association, Dallas, Texas
  • 6Institute for Medicine and Public Health, Vanderbilt University Medical Center, Nashville, Tennessee
  • 7Ronald Reagan Medical Center, Division of Cardiovascular Medicine, University of California Los Angeles, Los Angeles
  • 8American Heart Association–Patient-Centered Outcomes Research Institute Ambassador/Citizen Scientist and Patient ADAPTOR, University of California Los Angeles, Los Angeles
  • 9American Heart Association Volunteer Stroke Survivor/Citizen Scientist and University of Wisconsin Patient & Family Advisor, Madison
  • 10Public Health and Epidemiology Consultant, Dallas, Texas
  • 11Division of Cardiovascular Medicine, Northwestern University, Chicago, Illinois
  • 12Deputy Editor, JAMA Cardiology
  • 13Section Editor, JAMA Cardiology
JAMA Cardiol. 2017;2(11):1263-1269. doi:10.1001/jamacardio.2017.3606

Patient centeredness is a concept that is increasingly being viewed as essential for clinical research. A core principle involves a comprehensive assessment and integration of patient and caregiver perspectives into trial design. Importantly, this involves more than just soliciting feedback. Patients and caregivers are now considered vital members of the study team, even serving as coinvestigators who may help to conceive, plan, and develop the study; continue to direct the day-to-day conduct of the study; and fully participate in the dissemination of the study results. The Patient-Centered Outcomes Research Institute offers substantial funding to support this approach, but getting started, particularly at institutions that lack a robust community engagement infrastructure, can be daunting. In this Special Communication, successful methods that have been used by researchers to engage patients, caregivers, and the broader health care community in the research process are outlined, and examples of currently funded studies that have fully engaged key stakeholders are described. Although trials are designed to assess efficacy and effectiveness and inform future implementation and dissemination, this Special Communication emphasizes methods to ensure trial results are relevant to and understood by the individuals and groups that they are intended to impact. Critical next steps in this new research approach are also discussed. In doing so, this will inspire future cardiovascular research that evaluates not only traditional end points, such as mortality and readmission, but also emphasizes true patient-centered outcomes, including quality of life, knowledge and satisfaction, caregiver burden, time tradeoffs, and out-of-pocket costs.