Show Me the Numbers: The Role Electronic Data Can Play in Advancing Patient-Centered Outcomes Research

We talk a lot about the value of data in making the most appropriate and effective health and health care decisions. But we’d be hard-pressed not to acknowledge the severe limitations in the systems we have for gathering, assessing and using those data, especially data from clinical care settings, to best serve patients and those who care for them.

So, spurred by our Methodology Committee and our Board of Governors' Program Development Committee, we organized an expert workshop at Stanford University in early July to ask what we can do to convene, support and advance current efforts to build a national data infrastructure for conducting and disseminating patient-centered outcomes research. Although focused on electronic data, this was a model for what we plan as a robust series of events to inform our work by bringing key stakeholders together to share ideas and concerns on a variety of topics.

Nearly 100 people attended our workshop, including members of our Board of Governors and Methodology Committee, along with representatives from the patient and caregiver communities, health-system based research networks, patient-driven online research networks, the informatics and health services research communities, and the venture capital and industry sectors.

We started by outlining an “ideal data network. Such an enterprise would be very large, involve complete longitudinal data capture and involve patients and clinicians in its development and governance. Such a database would have the ability to capture patient-reported information, involve healthcare systems in dissemination of findings, and be able to randomize data when needed for research purposes.

We heard about six “models” that might serve as jumping-off points for our ideal approach, including system-based models, practice-based research network models, and models built on social networks within a patient community. It was clear that although no single current model approaches the ideal, various models have essential features that need to be incorporated into next-generation approaches.

We spent a substantial portion of the meeting addressing a number of challenges, including how to run such networks, the need to incorporate patient-reported outcomes into their design and operations, issues related to data architecture and exchange, system interoperability and analytic methods, and the potential that online patient communities and networks have as an alternative hub for these networks.

We heard from patients, caregivers and others about the critical importance of having patients deeply involved in network governance, about the need to implement sound, consistent data standards to support the merging and exchange of data across networks, and about the critical issue of providing value early on to the patients, clinicians and systems who provide the data –to ensure the network’s sustainability.

One critical insight that attendees shared broadly: recognition that a successful infrastructure will require that patients have a greater role in creating, governing and using the infrastructure. Toward the end of the meeting, the vision of a “network of networks” emerged, with data contributions not just from health systems and their electronic health records but also from patients through online networks that both provide information and the ability to connect and communicate with others.  These networks promise new possibilities for collecting patient-reported outcomes, for facilitating consent to participate in research, and even for participation in trials.

There seemed to be a near-uniform feeling that the meeting was successful, “different,” constructive and informative, and that we’d broken some new ground.  We had a sense that, for those in the room and many others who joined us via a live interactive webcast, there was a recognition that we’re taking the research enterprise in new directions and bringing it closer to the patient and caregiver communities.

Next steps include convening PCORI staff and leadership to determine how we can continue to advance the vision outlined in Palo Alto and fully and meaningfully engage patients and caregivers as we do so. We hope all of our stakeholders will join us in this effort.