2022 Science of Patient Engagement Symposium: From Research to Action: Health Equity for All
- Event Date: Oct. 19 - 20, 2022
- Event Time: 9:00 a.m. - 5:00 p.m.
- Event Location:
Day 1: October 19, 2022, 2:00 p.m. – 6:30 p.m. ET (In person)
Day 2: October 20, 2022, 10:00 a.m. – 4:30 p.m. ET (Virtual)
The National Health Council’s (NHC) Science of Patient Engagement Symposium was held in person and virtually October 19-20, 2022. This year’s Symposium brought together more than 160 leaders from patient advocacy and non-profit groups, the medical product industry, professional associations, academia, government, and others to discuss how to conduct research that helps to advance health equity and improve diagnosis, treatments, and outcomes for all. Several common themes emerged:
- Inequities related to unmet needs and engagement were greatly exacerbated during the COVID-19 pandemic, and this has renewed a collective emphasis on the role of social determinants of health (SDOH).
- There needs to be a focus on true community-based participatory research; there is a big difference between community outreach and community engagement. This means that patients are partners, not just subjects; and that community, patient, and caregiver involvement is already present.
- Engagement is not a unidirectional experience. There is still a level of trust that must be built. If the community is part of the planning and patients are at the table from the beginning, they can be validators, endorsers, and co-leaders. Consider factors that are barriers to their participation and accept that “not one shoe fits all.”
- Underrepresentation in clinical trials is a social justice and public health problem that requires a multifaceted approach. This includes policy efforts to improve trial diversity and to improve transparency. Trial participation should reflect the realities of the burden of disease, use cultural humility, and listen to patients’ voices.
- Evidence-based policy is only as good as the data, and the data is only as good as: the source; the infrastructure; the interoperability; the freedom from bias/equity; and the ability to access it and use it. The best policy solutions are informed by real-world experiences and complex problems often require whole-of-government, whole-of-society approaches.
Following is a summary of each session.
DAY 1 SESSIONS
- Randall Rutta, MA, Chief Executive Officer, National Health Council
- Omar Escontrías, DrPH, MPH, Vice President of Research, Education & Programs, National Health Council
- Eric Racine, PharmD, MBA, Vice President & Head, Public Affairs & Patient Advocacy, Sanofi
The 2022 Symposium started with Mr. Rutta welcoming attendees, recognizing the event planners, and thanking event sponsors. Dr. Escontrías noted that eliminating disparities in the health care system is a key focus of the NHC’s work, and that the work being done by the Symposium’s participants will help achieve better health and outcomes for all. Meeting co-chair Eric Racine introduced the keynote speaker.
KEYNOTE REMARKS: Advancing Health Equity – Translating Stories into Research, Policy and Practice
- Darrell M. Gray, II, MD, MPH, Chief Health Equity Officer, Elevance Health, Inc.
Dr. Gray began his remarks by telling the story of Mr. Willie, a husband, a father, a retired Navy officer, and one of the first black photographers for the Social Security Administration. One morning Mr. Willie developed a debilitating headache as he drove to work. His coworkers called an ambulance, but by the time he reached the hospital, he was comatose; he died five days later. Mr. Willie was Dr. Gray’s grandfather.
Dr. Gray noted that stories of health inequity, like Mr. Willie’s, have been family and community legacies for too long. These stories threaten to be our children’s and grandchildren’s stories, and these inequities are getting worse. He pointed out that inequity is not just about ethnicity and race, but also about geography; statistics confirm that there are stark differences based on where someone lives. He believes we can collectively translate stories to research, policy, and practice in advancing health equity. One way to do that is by focusing on true community-based participatory research; there is a big difference between community outreach and community engagement.
He shared the example of a study on the role of social support in cardiovascular clinical trial participation by black men that looked at how changing things like diet and exercise can affect the contributing factors to cardiovascular disease. An important element of the study was that it employed researchers who looked like the participants. The results saw positive impact across all of the American Heart Association’s Life’s Simple 7 metrics.
He concluded his remarks by saying it is our inter-connectedness that is most important, and how we must cultivate a culture of belonging in all that we do and hold ourselves accountable – so that stories CAN have impact and can translate research into action.
MEANINGFUL PATIENT ENGAGEMENT: GENDER EQUITY AND THE CROSSROADS OF INFECTIOUS DISEASE
Moderator: Cynthia Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- Irene O. Aninye, PhD, Chief Science Officer, Society for Women’s Health Research (SWHR)
- Shanina Knighton, PhD, RN, CIC, Executive Director for Research Practice and Innovation, Association for Professionals in Infection Control and Epidemiology (APIC)
- Gail Graham, Patient Consultant, University of Maryland PATIENTS Program
- Marissa Robinson, DrPH, MPH, RPCV, Management Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services (HHS)
All of the panelists agreed that the COVID-19 pandemic has impacted issues uniquely facing women in the infectious disease space. Two key examples are: 1) Women tend to be the Chief Medical Officers in their households and in charge of taking care of their families’ health, often at the expense of their own health, and 2) women make up a large majority of the U.S. health care workforce (close to 80%), and many of these women have no insurance, and lack funds for proper hygiene products. Some of the work the speakers are doing in their respective roles and organizations to address these, and other challenges include:
- Creating projects around community participatory research;
- Studying patient hand hygiene;
- Focusing research specifically on how COVID-19 affects pregnant/lactating women; and
- Seeking ways to close the research, policy, and health care loop to better address women’s health needs overall.
When asked to share advice and insights on how to better incorporate gender equity into all aspects of the health care research ecosystem, the panelists offered the following:
- Invite women in when brainstorming a program affecting women
- Employ persons of lived experience among your staff
- The definition of “Community” changes; we all need to meet people where they are.
- Find out who the gatekeepers are within the community you want to reach. While you have science behind you, there is still a level of trustworthiness you need to build. If community members are at table from beginning, they can be validators/endorsers.
DAY 2 SESSIONS
KEYNOTE REMARKS: From Research to Action – Health Equity for All
- Kristin Carman, PhD, MA, Director of Public and Patient Engagement, PCORI
Dr. Carman began her remarks by providing an overview of the Patient-Centered Outcomes Research Institute (PCORI) and its approach to engagement. PCORI helps people make informed health care decisions and improves health care delivery and outcomes by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the health care community.
PCORI’s engagement rubric is designed to influence research to be patient centered, relevant, and useful; to establish trust and a sense of legitimacy in research findings; and to encourage successful uptake and use of research results. Its national priorities for health and research include funding research that:
- Fills patient- and stakeholder-prioritized evidence gaps and is representative of diverse patient populations and settings;
- Aims achievement of health equity and eliminate health/health care disparities;
- Builds the evidence base for emerging interventions by leveraging the full range of data resources and partnerships;
- Examines the diverse burdens and clinical and economic impacts important to patients and other stakeholders;
- Focuses on health promotion and illness prevention by addressing health drivers that occur where people live, work, learn, and play; and
- Integrates implementation science that advances approaches for communicating evidence so the public can access, understand, and act on research findings.
Dr. Carman then shared what PCORI has learned. Patient engagement is feasible in all phases of comparative effective research and patient-centered outcomes research and with a variety of stakeholders. It can influence the design and conduct of research studies. It can impact research in meaningful ways including acceptability, feasibility, quality, and relevance. Partner involvement should be dynamic, non-linear, and iterative, taking different forms over the course of the study. PCORI’s approach to engagement influences the culture of health care research.
PATIENT SCIENCE AND THE SOCIAL DETERMINANTS OF HEALTH POLICY
Moderator: Cynthia Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- Carrie D. Wolinetz, PhD, Deputy Director for Health and Life Science White House Office of Science and Technology Policy
Dr. Wolinetz began the session by describing the structure and mission of the White House Office of Science and Technology Policy (OSTP). She noted equity has been a focus of the Biden Administration from Day One, when President Biden launched the Health Equity Task Force and signed Executive Order 13985, that dictated “It is the policy of my Administration that the Federal Government should pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality. Affirmatively advancing equity, civil rights, racial justice, and equal opportunity is the responsibility of the whole of our Government.”
A key mission of OSTP is to figure out how to operationalize advancement and support of health equity across government. Operationalizing health equity requires better understanding of the systemic relationships between our society and our health, especially the social determinates of health (SDOH), which OSTP is at the forefront.
She emphasized the need to create opportunities, and design interventions that are maximally effective. Research is always better when participants are partners. Complex problems often require whole-of-government, whole-of-society approaches, and it is incumbent upon those involved to actively figure out who is missing from the conversation and how to include them.
MENTAL HEALTH AND PATIENT SCIENCE: HOW COVID-19 REFRAMED OUR RESEARCH, OUTREACH AND CLINICAL-COMMUNITY LINKAGES
Moderator: Jill Yersak, PhD, Medical Science Liaison, Biogen
- Regina James, MD, Chief, Division of Diversity and Health Equity, American Pychiatric Association
Dr. James first described the mental health and patient engagement landscape before COVID -19 arrived, noting that it was already poor. Optimal patient engagement is hindered by significant unmet mental health needs, particularly in the marginalized and disenfranchised communities who disproportionally experience them – and that despite decades of effort to improve access, demand continues to outstrip provider capacity for face-to-face services.
She noted that while the first 10 years of the Affordable Care Act helped improve access to mental health care, many are still uninsured and even those with health insurance often don’t have mental health services covered or have expensive co-pays or deductibles. Access is limited, wait times are long, the process to reach a mental health care provider can be overwhelming, there is a nationwide shortage of behavioral health providers, and also stigma around mental health. The COVID-19 pandemic exacerbated mental health symptoms and unmet mental health needs across the board.
The post-COVID-19 environment has prompted the American Psychiatric Association (APA) to develop a bridge to enhance awareness, education, and access for marginalized communities. Dr. James observed that because patient engagement involves ensuring that health care providers are respectful of and responsive to patient needs, giving attention to social factors that impact mental health becomes critical. As such, the APA is taking action in several key areas. It has introduced new curriculum into its Leadership Equity and Diversity (LEAD) Institute that includes:
- Social determinants of mental health;
- Structural and institutional racism in mental health;
- Applying a racial equity lens;
- Cultural competence; and
- Mentorship and networking.
It is also leveraging technologies (e.g., telehealth) that facilitate effective and convenient care. It is educating providers to administer culturally and linguistically sensitive care, educating communities about their mental health, and empowering them to actively engage patients. It is encouraging patients to weigh in on their medical options. And advocating for legislation that increases the number of health care providers that reflect the populations they serve and improves access to mental health care for all.
GLOBAL HEALTH EQUITY AND PATIENT ENGAGEMENT: Engaging Patients to Drive Diversity, Health Equity, and Inclusion
Moderator: Julie Fiol, MSW, BSN, RN, MSCN, Associate Vice President, Health Care Access, National MS Society
- Nicholas Brooke, Executive Director, The Synergist, and Executive Director, PFMD
Mr. Brooke set the stage by explaining the purpose of Patient Focused Medicines Development (PFMD). It’s aim is to improve global health by co-designing the future of health care for patients WITH patients. Its mission is to bring together initiatives and best practices that integrate the voice of the patient thereby speeding up the creation and implementation of an effective, globally standardized framework – that involves patients as partners – as well as the necessary tools, services, and support to allow the adoption of the framework by various stakeholders.
He noted that universal health coverage is a key priority for many European Union (EU) health policymakers; yet a formal entitlement to coverage does not always result in real access, as individuals face barriers in accessing health services. And despite overall improvements in health and well-being in the EU over the past 15 years, these successes have been distributed unequally and strong inequities persist. He also pointed out that there is a lack of data and indicators to fully understand coverage and access. To address some of these challenges, PFMD developed the Patient Engagement Management Suite, an online resource that includes:
- The Seven Patient Engagement Quality Criteria to respect in all interactions with patients: 1) shared purpose; 2) respect and accessibility; 3) representativeness of stakeholders; 4) roles and responsibilities; 5) capacity and capability for engagement; 6) transparency in communication and documentation, and 7) continuity and sustainability.
- A how-to guide for patient engagement in the early discovery/preclinical phases and also in clinical trial protocol design. The guide also helps generate diversity from the outset as a means for achieving equity as an outcome.
- The Clinical Trial Distribution Network (CTDN) to address the equity and inclusion gaps in clinical trials and is a co-designed standard structure and distribution network that collects information on protocols from multiple sources; aggregates, and generates standardized trial protocols; and distributes the aggregates and enriched, protocols to matching services, clinicians, and patient advocacy organizations.
In closing, Mr. Brooke emphasized that meaningful patient engagement data needs patient engagement throughout for co-creation and contextualization and that multi-stakeholder collaboration is essential to address health diversity and equity issues.
DISMANTLING HEALTH DISPARITIES BY BUILDING TRUST AND PATIENT CENTRICITY IN LIFE SCIENCE
Moderator: Omar A. Escontrías, DrPH, MPH, Vice President of Research, Education & Programs, National Health Council
- Jennifer Miller, PhD, Associate Professor, Yale University School of Medicine
There is widespread consensus on the need to improve clinical trial diversity. This is a social justice and public health problem because underrepresentation challenges the ability to apply findings equally while also exacerbating disparity. The barriers to and facilitators of representation are widely documented, and yet the disparities persist. Policy efforts to improve diversity span decades but have had limited impact. This is why Dr. Miller and her colleagues created the Good Pharma Scorecard (GPS), because what gets measured gets done.
As Dr. Miller described, the GPS, is an index that ranks life science companies on their bioethics, social responsibility, equity, and patient-centricity performance. Its research is contracted with Stanford University and Yale School of Medicine and is disseminated in partnership with Scientific American to an audience of more that eight million. Its bioethics, social responsibility and patient centricity measures include:
- Patient engagement;
- Transparency and data sharing;
- Trial design and conduct;
- Marketing integrity;
- Product access; and
- Diversity and fair inclusion.
Dr. Miller noted that the GPS has already had measurable impact. Half of low scoring large pharmaceutical firms improve their practices within thirty days of receiving a low GPS score, and industry median scores rise year after year on the GPS measures.
LESSONS LEARNED FROM THE 2020 CLINICAL TRIALS TREATMENT ACT: INCREASING ACCESS TO CLINICAL TRIALS IN MEDICAID AND DIVERSE PATIENTS
Moderator: Eric Gascho, Senior Vice President of Policy and Government Affairs, National Health Council
- Ricki Fairley, Chief Executive Officer, TOUCH, The Black Breast Cancer Alliance
- Ruben Mesa, MD, FACP, Executive Director, Mays Cancer Center at UT Health San Antonio MD Anderson, Mays Family Foundation Distinguished University Presidential Chair, Professor of Medicine
- Alycia Shilton-Lloyd, PhD, VP Medical Affairs, Imago BioSciences, Inc.
- Alexis Reisin Miller, Executive Director, Global Regulatory Policy (US Led), Merck
Mr. Gascho opened the session by asking the panelists to offer examples of how they and their organizations are addressing diversity.
- Fairly noted that black women represent only a 3% participation rate in breast cancer clinical trials. Currently, doctors aren’t encouraging black women to participate, and her organization is working to change that by educating patients to be their own advocates and ask their doctors about how to participate in trials.
- Mesa shared that his organization has a minority accrual treatment plan for every study that works with Black churches for multiple myeloma, as Blacks suffer from the disease in higher percentages than other groups.
- Miller noted that Merck is taking steps to embed diversity within the company (e.g., integrated dashboards; dedicated diversity program leads; multifaceted approach), and they have three core guiding principals: 1) go where the patients are; 2) communicate effectively; and 3) learn from everyone you can, find out what’s already out there, but don’t lose accountability.
The panelists were then asked their perspectives on how best to create inclusive trials:
- Shilton-Lloyd said it must start with the patient’s perspective first. Think about how this will fit into patients’ lives, and don’t answer that on your own. Partner and listen.
- Fairley added that you have to commit to be intentional about diversity and admit you’re not doing it right. Use cultural humility; think, for example, about how your materials are going to make the patient feel. Take advantage of patients’ voices; think about people who are unsupported, who don’t know what they don’t know.
- Miller noted that Merck is working to upscale and train to make clinical research accessible. She also said we need to make Human Resource (HR) professionals and clinical trial recruiters look like the people we want to recruit.
When asked to share their thoughts on what the 2020 Clinical Trials Treatment Act has accomplished so far, all the panelists agreed it has been impactful, but only a partial fix. It has helped reduce one of the barriers (Medicaid coverage) in 41 states, but it has made everyone aware of the decision-making process and what is being asked of clinical research firms in terms of finding participants. Sites need to be aware that this has changed, and they can go to additional places to recruit. As is the case now, Medicaid health insurers often cover clinical trial medications but don’t cover standard-of-care medications. Dr. Mesa noted in Arizona for example, a significant number of large academic centers try to exclude Medicaid patients in the payer mix because they are underwater financially. And if we can’t get insurance to cover and authorize a standard-of-care drug it causes problems in the protocol if the protocol says to dose the patient with the standard-of-care drug every third day. Some therapies are very costly, and it can make it difficult for patients to participate if these drugs aren’t covered.
The session concluded with the panelists offering their thoughts on caregivers’ advice. The agreed everyone must be mindful of how important caregivers’ roles are in patient access and treatment. Organizations benefit from relationships with patient advocacy groups who have brought in the caregiver voice and get positive feedback from engaging patients and caregivers early and often. Ms. Fairley aptly summed up, when the patient is sick everyone is sick; it’s a family affair and everyone is involved.
- Omar Escontrías, DrPH, MPH, Vice President of Research, Education & Programs, National Health Council
In his brief closing remarks, Dr. Escontrías thanked all the moderators, panelists and attendees once again and emphasized that the National Health Council (NHC) is where all can come for support, conversation, and idea sharing. He also encouraged everyone to continue to share and collaborate with the NHC so that organizations can amplify all of the important work, research, and insights they are doing to improve patient engagement and advance health equity for all.
The next Science of Patient Engagement Symposium will be held in May 2023.