Patient-Reported Outcome Measures
in PAD (PROM-PAD)
Vascular Cures is launching an initiative to advance the use of patient-reported outcomes measures in clinical care and research for peripheral artery disease (PAD). Patient-reported outcomes are health information directly from patients themselves instead of from doctors or medical tests. We are bringing together a multi-stakeholder group of participants which will include the FDA, CMS, multiple vascular specialties, patients, and biopharma and medical device companies. The working group will be a transparent, non-competitive approach to developing consensus views and actionable strategies for advancing the use of patient-report outcome measures across all sectors.
The program is an outgrowth of our 2018 Vascular Research Summit, at which 60+ leaders from over 30 organizations prioritized unmet needs to improve vascular outcomes. These included the need to define consistent patient-reported outcome measures in PAD clinical research and care. The implementation challenges to overcome were:
- Priority measures vary across specialties, regulators, payers and industry
- Methods and tools to gather data are not yet validated
- Varying guidelines among professional societies make it difficult to manage value creation
Our hope is that this key combination of perspectives and expertise will lead to a clear set of activities that generate long-term benefit for PAD patients.
The working group is co-chaired by Michael S. Conte MD, Chief Medical Officer of Vascular Cures and Chief of the Division of Vascular and Endovascular Surgery at UCSF; and Manesh R. Patel, MD, Chief of the Division of Cardiology and Co-Director Heart Center, Duke University Health System.