Background: Today, researchers and health care providers collect varied measures in studies and care that often are not aligned with each other, nor with what is most important to patients about disease and treatments’ impacts on a patient’s life. This haphazard approach leads to confusion, inefficiency, and the question: what are the impacts most important to patients that should be measured? The project team proposes that the solution is patient-centered core impact sets (PC-CIS), a patient-prioritized list of impacts a disease and/or its treatments have on patients and families (e.g., career stress, out-of-pocket costs, work loss). PC-CIS could be a resource for researchers and care providers, but they do not exist and must be developed. In response, the NHC is spearheading an initiative to develop a Blueprint for patient groups and others to develop PC-CIS for a disease, group of diseases, or population. The project team believes patient groups should take a leadership role, ensuring patient centricity. The PC-CIS Blueprint, along with a supporting toolbox, will help them do so.
Proposed Solution to the Problem: In 2022 the project team will socialize the concept of PC-CIS and conduct public review and vetting of the PC-CIS Blueprint, which includes a public comment period. A public Dialogue Meeting held during the comment period will support socializing the PC-CIS concept and the project team’s understanding of prospective users’ views on Blueprint strengths and challenges.
Objectives: Hold a Summer 2022 public, multi-stakeholder Dialogue Meeting to further socialize PC-CIS as part of the project team’s efforts to refine the PC-CIS Blueprint and concept through a public comment period, which will be open and timed to be concurrent with the meeting.
Activities: The project team will leverage the advice of a planning committee, conduct preparatory sessions with stakeholders to ensure the concept of PC-CIS is well understood, encourage submission of comments during the comment period, encourage attendance at the Dialogue meeting, and prepare the meeting agenda and speakers. The Dialogue will be held during the third week of the 30-day comment period (expected August 1-30, 2022).
Projected Outcomes and Outputs:
Short-term outcomes during the project period include:
- Socialization of the PC-CIS concept
- Development of a PC-CIS Blueprint with multi-stakeholder input
Medium-term outcomes (0-2 years post-project period) include:
- Refinement of the Blueprint based on stakeholder feedback from Dialogue meeting
- Further socialization of concept through completed pilot and disease-specific case studies using the Blueprint
Long-term outcomes (3+ years post-project period) include:
- Frequent adoption of PC-CIS Blueprint and learnings from PC-CIS studies by medical product manufacturers, academics, patient advocacy groups, value assessors and others.
Patient and Stakeholder Engagement Plan: This project is patient-group led through the NHC patient-group membership. The concept of PC-CIS originated with patient groups. The project team is committed to patient governance, co-development, and continuous input. The project team envisions patient groups as the primary audience for the PC-CIS Blueprint; they will partner with all needed stakeholders to form collaboratives and consortia for developing PC-CIS. Thus, the project’s Advisory Committee includes a range of stakeholders who are prospective users and sponsors of the ongoing work, along with other potential users and co-developers: real-world evidence, health economic, core outcome set, and patient-reported outcome researchers. The project team is working with payers, employers, and specialty societies to interest them in the effort.
Patient groups will be encouraged to disseminate information about the comment period and meeting attendance opportunities to their patient, family, and caregiver constituents. When announcing both the public comment period and the meeting availability, the project’s communications team will use its usual mechanisms and mailing lists to disseminate the information broadly, including to patient groups, individual patients, and other stakeholders.
Project Collaborators: The project is led by the NHC with support from patient engagement experts Suz Schrandt and Eleanor Perfetto, PhD, MS. Stakeholders from across health care including patient groups, HTA bodies, industry, professional societies, and employer groups are already engaged in the development of the Blueprint.
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Project Resource: Project Website