Advancing the Development of Patient-Centered Core Impact Sets (PC-CIS) Blueprint

The National Health Council (NHC) aspires to ensure patient centricity in our health care ecosystem by Advancing the Development of Patient-Centered Core Impact Sets. A PC-CIS is a recognized set of standardized impacts from a disease and/or its treatment that patients report as important to them. The term “impacts” includes health outcomes, such as what would be found in a core outcome set, and any other patient experience information (e.g., financial- or caregiver-related burdens) patients might report as important.  

As a result of this initiative, the NHC will produce a publicly available Blueprint, which will:   

  • Outline the intent and purposes of PC-CIS;  
  • Offer best practices for development and use of PC-CIS;  
  • Describe needed and existing tools to support development of PC-CIS; and  
  • Socialize the idea of collaborative development of PC-CIS   

A consensus-based, common Blueprint will establish standardized approaches and methods for developing PC-CIS, highlight good practices and potential applications, and identify needed or existing support tools. 

  • Heather Black, Merck
  • Jennifer Bright, Innovation and Value Initiative 
  • Nicholas Brooke, Patient Focused Medicines Development
  • Laurie Burke, LORA Group, LLC
  • Tim Coetzee, National Multiple Sclerosis Society
  • Maarten de Wit, OMERACT
  • J. Samantha Dougherty, PhRMA
  • Rosalind Fabunmi, Edwards Lifesciences
  • Ryan Fischer, Parent Project Muscular Dystrophy
  • Annie Kennedy, EveryLife Foundation for Rare Diseases
  • Pauline McNulty, Janssen
  • Donna Messner, Formerly at Center for Medical Technology Policy
  • John Schall, Caregiver Action Network
  • Jason Spangler, Amgen
  • Neo Tapela, ICHOM – International Consortium for Health Outcomes Measurement 
  • Patrick Wildman, Lupus Foundation of America
  • Paula Williamson, COMET
  • Leonard Valentino, National Hemophilia Foundation
  • Susan Vallow, Novartis Pharmaceuticals Corporation
  • Yvette Venable, Institute for Clinical and Economic Review
  • Robyn Bent, US Food and Drug Administration
  • Kristin L. Carman, Patient Centered Outcomes Research Institute
  • Andrew Cleeland, Fogarty Institute of Innovation
  • Kathryn Davidson, Center for Medicare and Medicaid Innovation
  • Karen Jackler, Center for Biologics Evaluation and Research
  • Douglas Kelly, US Food and Drug Administration
  • Michelle Tarver, US Food and Drug Administration

Project Kickoff Announcement

Read more on our blog.


Phase One Sponsors: