In June 2012, PCORI’s Board of Governors announced the new institute’s first funding initiative: $30 million for 50 Pilot Projects focused on research methods, including those for engaging patients and other stakeholders in health research. The work was intended to help establish a foundation for patient-centered comparative effectiveness research aimed at giving patients, caregivers, clinicians, and other stakeholders the information and tools they need every day.

These projects, most of which began in the fall of 2012, are now well under way; we expect the first of their findings to be available late this year. We have been working with these projects as part of our scientific program that focuses on filling methodological gaps in patient-centered-outcomes research (PCOR). From these pilots, we are gleaning insights about their experiences and deriving lessons that are sure to inform and enhance our future work and the field more broadly.

In early March, we convened the first gathering of our Pilot Project awardees, as well as many of the patients and other stakeholders who are partners in these studies. Participants included representatives from all 50 projects, as well as members of our Board of Governors, Methodology Committee, and staff. Also in attendance were AcademyHealth staff, who have been collecting, synthesizing, and reporting information on the projects’ experiences and facilitating cross-project learning and collaboration.

A Common Vision

During this two-day meeting, researchers, patients, and other stakeholders shared insights and challenges from the first year of their projects and both their concerns and excitement about the work yet to come. They also took advantage of the opportunity to meet in person and continue working on “extra credit” collaborative projects that have taken shape in the past several months.

“I got a lot of great points from other researchers about how to get around obstacles,” said community partner Jim Quill. “For me personally, it’s been an education. It puts everything in perspective.” Quill, from Bluffton, SC, is the general manager for a health-management company, serves as treasurer of the Alpha 1 Foundation, and is a community partner with A Community Partnership Approach for Advancing Burden Measurement in Rare Genetic Conditions.

Researcher Clifton Bingham, MD, added: “What I really sense from this meeting and from the people here is a common vision of patient-centered research. We understand how this can make a difference in people’s lives and how it can be the future of medicine.” Bingham, from Johns Hopkins University, is the Principal Investigator on the project Integrating Patient-Centered Outcomes in Arthritis Clinical Care.

Enthusiasm, Progress, and Challenges

Several themes emerged from the plenary sessions and discussion groups. The first was strong enthusiasm for having diverse partners engaged in various aspects of the research projects—giving input on the original question, study design, research execution, and data analysis. Researchers commented on the capacity of such input to reframe and enhance outreach strategies and also facilitate planning for dissemination efforts.

Participants also discussed a related challenge: engaging patients and other community stakeholders requires extra time and resources relative to “usual” research procedures. Many noted that future PCOR studies will need an infrastructure that enables them, for example, to cultivate and maintain relationships, support the involvement of multiple stakeholders, and navigate potential institutional barriers.

Several participants noted that their projects have enabled them to start building this infrastructure, often fundamentally altering the research culture at their respective host institutions. In some cases, organizations have dedicated resources and developed policies and operations, such as remuneration strategies and training curricula, that facilitate more meaningful input of patients and other community stakeholders.

This progress toward patient-informed research is not without challenges. Many projects reflected on the tension between standardizing around common norms or “best practices” versus allowing for local creativity and flexibility. For example, in the project Boot Camp Translation for Patient Centered Outcomes, community groups in different parts of Colorado followed a standardized approach to designing initiatives but came up with strikingly different messages and products to encourage blood pressure control for their respective communities.

Looking Toward the Future

As they progress and learn, the PCORI Pilot Projects investigators and their partners are looking forward to sharing their findings with both scientific and lay communities. A panel of communications experts provided meeting participants with suggestions for sharing their stories and insights with a range of audiences, including those community members for whom the research is most relevant.

Several cross-project collaborative groups are also planning to publish or otherwise disseminate findings. Their topics include:

• Applied lessons from the design and use of patient-reported outcomes
• Opportunities and challenges in designing, disseminating, and implementing healthcare decision-support tools
• Approaches to navigating the Institutional Review Board process—particularly in cases where patients serve as both research partners and subjects.

Overall, the attendees expressed concern about ensuring respect for PCOR as a scientific approach and retaining support mechanisms for this type of research.

We’re excited about the contributions these projects are making both in developing methods for conducting PCOR and moving the healthcare system toward major change. We look forward to continuing to see and hear results as the projects analyze and disseminate their results.

Gerson is a Senior Program Officer in PCORI’s CER Methods and Infrastructure Program
Rein is a Senior Director for Evidence Generation and Translation at AcademyHealth