Date: April 12, 2016
Author: Bray Patrick-Lake, MFS, Director of Patient Engagement, Duke Clinical and Translational Science Award (CTSA)
Ms. Patrick-Lake supports efforts to actively engage research participant partners in Duke University’s research programs. She is also part of the PCORnet Coordinating Center where she develops and supports patient engagement efforts. Read more about Bray Patrick-Lake.
PCORnet, the National Patient-Centered Clinical Research Network, has “patient-centered” prominently in its name and aims to become a role model of patient-driven research. For PCORnet to be true to its name and ambitious goal, however, will take far more than a compelling title and technical expertise. It will take a shift in the culture of research — from a traditional investigator-driven model where patients rarely have a role other than as study subjects to one where research interests and activities originate in the needs of the communities and people that health research is designed to serve in the first place.
PCORnet and the Patient-Centered Outcomes Research Institute (PCORI), which funded PCORnet’s creation and development, certainly have moved the needle on including the patient voice in the design, conduct, governance, and dissemination of research. However, many challenges remain. So if we are to optimize research and drive the rapid-cycle learning and uptake of new findings that we involved in PCORnet so desire in research and health care, PCORnet must push even harder to advance a model where building trust and sharing power with the people all health professionals serve is built into the very fabric of our work.
Scores of people — patients, researchers, and many other stakeholders — committed to such a paradigm shift gathered in Washington, DC, on March 28 and 29 to work on advancing that agenda through the Building Trustworthiness in PCORnet meeting. Here are some key takeaways from that event.
A Reframing: Trustworthiness Comes Before Trust
“Why am I in such demand as a research subject when no one wants me as a patient?” Query from a young minority patient.
The keynote speaker, Dr. Ruha Benjamin of Princeton University, talked about how to cultivate trustworthiness in the current landscape of medical research from her perspective as an expert in the study of science, medicine, race-ethnicity and gender. She said that distrust is more the rule than the exception—and yet, distrust is actually a rational response toward biomedicine in a socially stratified society. To achieve trust, we must first be trustworthy. Trustworthiness is the “substrate upon which all other medical and ethical considerations depend,” she noted. The way to cultivate trustworthiness is to embrace cultural humility, which is a courageous and honest process of self-reflection and self-critique where we examine patterns of unintentional bias and discrimination rather than mastering a checklist of cultural traits about groups. It is a lifelong journey that we take with patients, communities, colleagues, and research subjects. It means developing a healthy and ongoing relationship with uncertainty.
Dr. Benjamin further explained that ultimately, being trustworthy will take having a deep and abiding respect—even love—for those whose trust we seek to earn. For true community engagement, we must build trustworthiness before the research even begins. Trustworthiness values two-way communication and holds to the highest standards of transparency. It allows community collaborators to question and contradict the larger agenda—and then lets that disagreement guide the process forward.
What Can We Learn from our Failures?
“Is the intent of trust to empower people, or get them to do what we want?” Stephen Thomas, MD, University of Maryland School of Public Health
In this session, we heard from Jane Kaye, who presented a case example of the demise in public trust in the United Kingdom with the development of care.data, a national program of data collection. We also heard from Rosalina James who provided stories of mistrust from the Native American community and from David Lacks who told the story of his grandmother, Henrietta Lacks, who unknowingly made a significant scientific contribution to the world.
Three real-life examples of spectacular failures highlight how trust was eroded when researchers made assumptions about the legitimacy of their study, or bypassed patients completely. The scenarios illustrate how power can be misused in the pursuit of research questions. They also show how far-reaching such breaches extend, where for some individuals and groups, mistrust of medical research has a long and painful history.
We have to remember that we are the holders of our own trustworthiness. To be trustworthy is to share the power and recognize that it is the community who defines the meaningful research questions. Participants want to feel ownership and be valued and equal. To be trustworthy is to prioritize tangible benefits to participants and to include all stakeholders in the development and dissemination of results.
Academic-Community Partnerships: Building Trust
“It’s about solidarity, not charity.” Ashley Wennerstrom, Co-Principal Investigator, Community Partnered Participatory Research Network
Dr. Bowen Chung, Co-Principal Investigator of the Community Partnered Participatory Research Network, compared academic and community partnerships with marriage. Similar to a marriage, partnerships require commitment, time, and effort to develop. Not everyone gets all they want, but when the partnership works and the community is engaged, then it can result in better science and lead to better health for the community.
So what does it take to engage a community? In contrast to the traditional model of community involvement, real engagement is done “with” and not “for” the community. This is a model built on a sustainable capacity to address issues, fostering trust and ownership over time, sharing agendas, being accountable, and understanding that everyone will contribute and all ideas and contributions be equally valued. Real partnerships begin before the project starts, where the community provides input to shape the project at every critical milestone, from design discussions to dissemination of results.
Ashley Wennerstrom gave attendees a strong take-home message that academic-community research is about solidarity, not charity. We do not go into communities to save them; we collaborate with the community to perform research because it is the right thing to do and is exactly what is needed to battle current horrific health disparities.
Policy Approaches Re-imagined
Do we have “cultural” rights to our data?
Rather than finding ways to share information, researchers and institutions have a tendency to hide behind the regulations—consent forms, the institutional review board approval process, institutional policies, and perverse financial incentives that seem immutable. The Health Insurance Portability and Accountability Act (HIPAA) ensures that we own our data and can request it in a form and format we want, and that it be sent to third parties whom we designate.
When we ask for our data, healthcare systems and researchers often do not accommodate our requests. In some cases, financial barriers, such as high per-page charges for medical records or administration fees are introduced, or health systems and providers actively block health information by producing PDFs rather than digital data files that can be used to create longitudinal health records or shared for research. In addition, there are stories about patients being asked to pay astounding charges to obtain their data.
We are essentially in a place now where we have legal rights to our digital data, but not cultural rights. Cultural change around data access and flow can come about by a combination of enforcement and exercising our rights and specifying what we want done with our data. It is up to all of us to make that legal right into a cultural right by speaking up, educating, and challenging health systems, providers, and researchers. We can share our stories through initiatives like Get My Health Data to shine a light on, and ultimately obliterate data access and sharing practices that are not transparent and trustworthy.
Recommendations for Building a Trustworthy PCORnet
It is time to move from “why don’t they trust us” to “how are we trustworthy?”
There is great potential for PCORnet: we have the opportunity to create a research community that is rooted in trust of “We” rather than “Us vs. Them,” where the assumption is that everyone contributes, information is shared, and all partners are valuable.
One goal of this two-day meeting was to deeply and honestly explore issues together and hear contrary points of view. At the culmination of the meeting, four breakout groups were convened to develop key recommendations for PCORnet leadership. Ideas from attendees centered on making PCORnet more transparent, outward facing and resourceful for everyone.
Attendees suggested developing a PCORnet directory so the public can learn about governance, committee and project charters, and the percentage of community representation. This directory could be housed on the public website and also be a place where the public learns about trial terminology, best practices, and research ethics, as well as ways to connect participants with investigators, networks, and an IRB hotline. The website could be more interactive and teach interested parties—inside and outside the researcher and clinician communities—about successful methods of meaningful engagement, partnership, and ownership. A detailed communications action plan, on which the public can comment, would be helpful for a transformative PCORnet—a unique entity in the clinical trials enterprise.
Dr. Adrian Hernandez, Principal Investigator of the Coordinating Center, stated that PCORnet is getting ready to “open the front door.” The Front Door will be an opportunity for investigators to submit requests to collaborate with PCORnet on research that matters or to request collaboration with one or more of PCORnet partner networks.
The spirit of this meeting embodies what we want PCORnet to be and it will be of utmost importance that we continually convey and incorporate the essence of this meeting as we set forth to building a trustworthy PCORnet. Resources from this Building Trustworthiness workshop will be collected and shared via the website, newsletters, blogs, member networks, and news outlets. There are plans in July 2016 to launch a PCORnet Collaborative Commons, a public-facing website where stakeholders as well as others working broadly in the field of healthcare and clinical research could share document templates and best practices. Please stay tuned to a new and exciting interface with PCORnet and keep the #BuildingTrust conversation alive.
The information presented in this blog does not necessarily represent the views of PCORI or its Board of Governors.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information about PCORI can be found here.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information about PCORnet can be found here.