MDIC’s 2020 Patient Engagement Forum
MDIC held its Virtual Patient Engagement Forum on November 18, 2020.
The Forum provided opportunities to virtually engage with patients, patient groups, medical device industry, investigators, healthcare providers, payers and regulators to learn and share challenges and best practices for communicating uncertainty, benefit and risk of medical devices to patients. Two Interactive Activities allowed attendees to discuss the current challenges in communications these difficult topics and then brainstorm possible solutions based on learnings throughout the forum.
During the forum, attendees heard directly from experts on practices for communicating benefit, risk and uncertainty, and mediums to communicate such as shared-decision making and device labeling to understand how engaging patients can help tailor effective messaging. Attendees had the opportunity to hear directly from patients on their perspectives and first-hand experience with these types of communications.
Session recordings are available below.
Patient Engagement Forum Introductions
Hear from MDIC’s President and CEO, Pamela Goldberg, about MDIC and the Science of Patient Input (SPI) Initiative and the role of the organization in the development of Patient Preferences. We also hear from the Jeff Shuren on the FDA-CDRH perspectives on patient preferences. David Walton, a patient representative, then walks us through his first-hand experience in regard to communicating benefits, risks, and uncertainties with medical devices. Lastly, Scott Goates, the Chair of the SPI Communications Working Group presents the forum objectives and sets expectations for the rest of the forum.
- Pamela Goldberg, MBA | President and CEO, Medical Device Innovation Consortium (MDIC)
- Jeff Shuren, MD, JD | Director of the Center for Devices and Radiological Health (CDRH), FDA
- David Walton | Patient and Patient Advocate, CEO of T1D Exchange
- Scott Goates, PhD | SPI Communications Working Group Chair, Senior Advisor, HEOR, Abbott Laboratories
Patient Panel #1: Challenges in Communicating Uncertainty and Benefit/Risk
During this panel session, learn about patient challenges in communications from patient experts and hear specific patient stories and examples of communications challenges. Patient advocacy group representatives provide a summary of specific challenges experienced by their patient communities.
- Jijo James, MD (Moderator) | Chief Medical Officer, Johnson & Johnson Medical Devices
- Anna Legassie | Patient Advocate, Joint replacement patient
- Jay MacIntosh | Patient Advocate, Spinal cord stimulator patient
- Julie Eller | Arthritis Foundation Representative
- Mariann Farrell | American Chronic Pain Association Representative
Key Findings from MDIC Report & Understanding Medical Device Information
Key Findings from MDIC report: Best Practices for Communicating Benefit, Risk and Uncertainty: Forum attendees learned about the key findings of challenges and best practices of patient communication with a focused introduction of key topics to be used during interactive activities.
Speaker: Wendy Selig | Founder & CEO, WSCollaborative LLC
Understanding Medical Device Information: Cognition vs. MetaCognition: Forum attendees where presented some of the key issues identified in the science of communicating medical information followed by an opportunity to ask questions of leading expert in field of communication and comprehension.
Speaker: Ruth Day, PhD | Director, Medical Cognition Lab, Duke University
Interactive Activity #1: Challenges in Communicating Uncertainty and Benefit/Risk
Medtronic’s Innovation Lab facilitate a highly interactive brainstorming session to help identify the different ways in which communication can be challenging. Participants provide perspectives and learn from first-hand experiences with communicating difficult topics about medical devices. Results from this activity have helped shape output for this MDIC initiative, as the learnings from this session will be documented in a companion report.
Keynote on Shared Decision Making
During this Keynote Session, attendees heard from Dr. J. Matthew Brennan on Shared Decision Making and about one approach to effectively communicate medical information to patients. This keynote was followed by Barry Liden who provided information on a case study that serves as an example of how patient preferences can be incorporated into Shared Decision Making.
- J. Matthew Brennan, MD, MPH | Associate Professor of Medicine, Duke University School of Medicine
- Barry Liden, JD | Vice President Patient Engagement, Edwards Lifesciences
Patient Panel 2: Best Practices in Communicating Uncertainty, Benefit or Risk
During this panel session, Best Practices in communicating uncertainty, benefit or risk and relationship to patient preferences, forum attendees learned about success stories in communications from patient experts. Attendees also heard specific patient stories and examples of communications success and summaries from patient advocacy group representatives successful communication practices experienced by their patient communities.
- Sue Peschin, MHS (Moderator) | President & CEO, Alliance for Aging Research
- Marianne Sherman | Patient Advocate, Pacemaker patient
- Pat Gray | Patient Advocate, Insulin pump patient
- Paul Madden, M.Ed. | American Diabetes Association Representative
- Mellanie True Hills, CSP | StopAfib.org Representative
Interactive Activity #2: Learn by Doing: Best Practices in Communication
Medtronic’s Innovation Lab facilitated a communication development exercise among participants. Participants pilot tested the principles and techniques identified in the MDIC Report for communicating about benefit, risk, and uncertainty for medical devices. This will help shape output for this MDIC initiative, as the learnings this session will be documented in a companion report.
Patient Engagement Forum Closing Sessions: Reflection Panel and FDA Next Steps
Reflections on the Lessons Learned and Additional Observations: Attendees heard from key stakeholders who summarized key findings from the event and provided additional observations from the day. The panel discussed challenges and best practices in communicating benefit, risk, and uncertainty and how to increase interpretability.
- Barry Liden, JD (Moderator) | Vice President Patient Engagement, Edwards Lifesciences
- Brett Hauber | Senior Economist and Vice President of Health Preference Assessment, RTI
- Jodi Duckhorn | Acting Deputy Director for the Office of Communication and Education, CDRH, FDA
- Heidi Dohse | Patient Advocate and Professional Heart Patient, Founder & CEO, Tour de Heart
FDA Next Steps: Dr. Michelle Tarver and Alicia Witters from CDRH identify key areas of opportunity for FDA and the medical device community to incorporate some of the lessons learned from the Patient Engagement Forum.
- Michelle Tarver, MD, PhD |Director of Patient Science and Engagement, CDRH, FDA
- Alicia Witters | Director, Division of Communication, CDRH, FDA