In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify
the principal benefit-risk factors FDA considers during the reviews for premarket approval
applications and de novo classification requests. In addition to a detailed description of
benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a
factor that CDRH may consider in regulatory reviews. It underlined the need for developing
methods to measure patient preference and incorporate it into regulatory decision-making. The
purpose of this study is to advance methods for patient and community engagement in
patient-centered outcome research (PCOR) and has three objectives.
First, demonstrate good practices for patient and community involvement in PCOR projects by
applying principles of community-based participatory research (CBPR).
Second, address methodological gaps pertaining to the use of stated-preference methods in
studying priorities in PCOR. These include identifying the best methods for identifying
patient priorities and strategies for analyzing variation in priorities. The investigators
also seek to assess the relevance of stated-preference methods to patients and stakeholders
using both qualitative and quantitative methods.
Third, demonstrate good practices for applying stated-preference methods by studying the
priorities of patients with type II diabetes. While type II diabetes provides an important
case study, this research will advance approaches and methods that will be broadly
generalizable to other diseases, and to diverse patient and stakeholder groups.
This project will illustrate and advance methods for assessing the values of patients and
stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of
stated-preference methods in measuring the priorities of patients and stakeholders and
directing health care.