Sue Sheridan

Director of Patient Engagement, Patient-Centered Outcomes Research Institute (PCORI )

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What is the source of your personal inspiration in improving patient engagement in your work?
My family experience in healthcare. I was kind of knee deep in it as a wife and a mom. (Sheridan became involved in research and improving outcomes after her husband, Pat, died in 2002 due to synovial cell sarcoma. Their son, Cal, has a rare neurological condition known as kernicterus, which is brain damage from newborn jaundice. Sheridan’s husband participated in 2 clinical trials, provided bio specimens with research institutions.) Cal’s clinical data was used in several studies and my entire family and some extended family participated in some genetic research. In my son’s case, a group of mothers formed an advocacy organization around new-born jaundice and partnered with researchers and brought in policy makers, payers, accreditors and professional societies. We grouped together and worked directly with researchers to develop a research agenda, create a registry and recruit other mothers to donate data. We participated in some of the planning, conduct and dissemination of the study results to prevent future cases of kernicterus. I got to see how infusing the patient’s “lived experience” and perspective in the research process ended up changing the standard of care and improved outcomes. Patients are the beneficiaries of outcome research. That’s the passion that comes behind engaging patients.

If you could name the major challenges of why the patient voice is often not heard in drug development, what would they be?

It’s about changing the culture, the mind-set and creating a framework and common language in patient engagement in research. And there is currently scarce evidence that patient engagement in research makes a difference. Historically patients have not played a significant role in determining the research questions or the outcomes that really matter to patients. I think it has been assumed that this is only researcher’s territory and that it is too complex. But given the patient centeredness and patient engagement movement coupled with the Internet Connectedness of the patient community, patients are calling for a bigger role in assuring that the research that is conducted is ethical, safe, urgent and meaningful to them. Patients are experts in their disease and some are becoming experts themselves in the scientific world; we all know that. However, the ‘how’ has been missing, not the will. It’s the ‘how’; merging two different worlds… and then we will have to create the evidence that it makes a difference.  At PCORI we have developed a framework for engaging patients throughout the entire research process; that framework has been missing and now we have one. We get calls all the time from patients and patient organizations asking ‘how do we get involved as a research partner?’ The ‘how’ has been missing. Patients and researchers are helping us to build this Engagement rubric almost like a Wikipedia. It’s a framework for innovation and a sort of crowdsourcing of engagement activities by the patient and researcher community in our funded portfolio. We plan to evolve this framework continually based on examples from the field in the future.”

In a few words, what is your working definition of patient-centricity?
There are two areas of focus regarding patient centricity in research: patient centeredness and patient engagement, both funding criteria at PCORI. Patient centeredness in research is defined as research that is based on outcomes that are important to patients. Patient engagement in research is the active participation of patients throughout the entire research process – the planning, the conduct and the dissemination. Patient engagement is the means to the patient centeredness. These are two elements of our five funding criteria; no other funder has those criteria. We also believe that patient-centered research is grounded in principles of partnership, co-learning, reciprocal relationships, trust, honesty and transparency.

Can you share a successful example of an actual study that has changed based on direct patient involvement (may be in design or execution)?
There are many examples of patient engagement that are redirecting perspective in PCORI’s patient-powered research networks (PPRNs), for instance patient recruiting via social media patient groups crafting their own privacy and data-sharing agreements. A really simple but important initiative is where a patient group has rewritten a consent form in collaboration with a patient group in the UK to make it understandable and patient friendly, and now recruiting via Facebook in both countries. There are also examples of patient groups suggesting the use of cell phone technology to report patient reported outcomes and for research interventions; there are many examples of patients changing or being the source of the research questions, such as a research question that was identified by an adolescent with diabetes. We’re seeing some interesting shifts: for instance, in one research program patients shortened a survey tool developed by a research team; it originally included 22 items and took 45 minutes to complete but with patient intervention the tool now has 15 items and takes 20-25 minutes.

Based on your experience, what is the ideal role and responsibility patient advocates should have in clinical research?
They have a variety of roles; they need to be a decision maker and they need to have a significant voice in what’s happening in the planning and conduct of the trial. Matter of fact, there are examples of patients being the “inviters” to research and have recruited their research team. Patients and researchers are sharing that building relationships up front will create greater trust. Many patient groups have voiced that they are often only approached post research to help disseminate research findings, but patients are now calling for greater involvement throughout the process not just after research is complete. Patient advocates really have a role reshaping the research to reflect what’s really important to these groups.

In terms of getting closer to a process of patient-centered drug development, what will be key priorities for the next 2 years?
We’re all on a parallel track. The priority over the next couple of years is developing the framework that identifies where patients can be plugged into the process in a meaningful way, to ensure that patients are not token. We also need to ensure that this extends to a diverse patient population, including those from under-served communities, and those from different ethnic and racial backgrounds.
And, maybe most importantly, we need to measure and evaluate how patients are making a difference in research. PCORI has created the WE-ENACT tool to evaluate the engagement in our projects.

Arguably, the ‘patient-friendliest’ clinical trial is the one least disruptive to a patient’s life. Will there be a role for clinical trial sites in an era of “direct-topatient” efforts?
This is a principle in the Engagement rubric. We do want the research and the research setting itself to be patient friendly; for instance, with the community of those with physical disabilities, research should be located next to appropriate transport facilities, be accessible or use technology to reduce travel requirements. For a trial involving Latinas, it should all be translated into Spanish. I think patients will be more demanding about trials being disruptive to enhance recruitment.

Susan Sheridan
, M.B.A., M.I.M., is the Director of Patient Engagement at the Patient-Centered Outcomes Research Institute (PCORI). She is responsible for creating networks and engaging patients across the nation to provide broad-based input on the development and execution of PCORI’s research. Sheridan became involved in patient safety after her family experienced two serious medical system failures.
Her husband, Pat, died in 2002 after his diagnosis of spinal cancer failed to be communicated. Their son, Cal, suffered brain damage called kernicterus five days after his birth in 1995 when his neonatal jaundice was untreated.
Sheridan is Co-Founder and a Past President of Parents of Infants and Children with
Kernicterus, which works in partnership with private and public health agencies to eradicate kernicterus. In 2003, she co-founded Consumers Advancing Patient Safety (CAPS), a non-profit organization that seeks a safe, compassionate, and just healthcare system through proactive partnership between consumers and providers of care.

Nassim Azzi, MS, MBA
Project Director
201 2234 4804

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