Are there ways to both empower patients and make clinical research better, faster and cheaper? Harlan Krumholz, M.D., thinks so. The director of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital in Connecticut, argues that putting the patients in control of their data and making it easier for them to participate in research has the potential to disrupt traditional models of research, which can take years to complete and cost lots of money.
Last week Krumholz, co-director of the Robert Wood Johnson Foundation Clinical Scholars Program, gave an inspiring talk as part of a “Grand Rounds” series of online presentations to a shared forum of the NIH Health Care System Research Collaboratory and PCORnet, the National Patient-Centered Clinical Research Network.
Krumholz believes that the significance of the Precision Medicine Initiative’s commitment to allowing patients to participate by sharing their data is underappreciated. Much of the attention about the rollout of the initiative, now branded as “All of Us,” was on the precision aspect, he said. “Another revolutionary piece is often overlooked,” he said. “One key to PMI was the development of tools that enable patients to acquire their data from multiple providers. This doesn’t necessarily get you up cheering in the aisles, but it is an incredible statement. In a section of the report, it says we really should build the PMI in a way that data goes to the people and then to the PMI. Coming out of NIH, from the president’s signature program, to say we are going to be doing research in this way is nothing short of revolutionary. The endorsement from NIH is remarkable.”
PMI is creating the ability for consumer-mediated exchange, he said. “It could be a means by which we can leverage a partnership with people and potentially decrease the cost of data acquisition and improve the accuracy and scope of data being collected.”
Krumholz spoke about some of the limitations of the current model of research. In research studies, the screening, enrollment, retention and follow-up all take a lot of resources and oversight. They require a structure be set up for the research project that is taken down again once the research project is over. Even for great centers like the Duke Clinical Research Institute, this can feel like a Sisyphean task, requiring resources and creativity to answer that one question, but with the resources not reusable.
Another issue is time. “Facing a high-stakes clinical condition, every day matters,” he said. He pointed to a study of the safety of NSAIDs for people with arthritis. The study began in 2006 and the results were not published until 2016. “Far too often, timeliness is not something we are excelling at,” he said. “How do we improve that and break through these constraints?” he asked. We need to be disruptive, he added, not to replace what we are doing, but to complement and strengthen our strategies.
Krumholz is convinced that patient engagement is the path. Mobile and internet technologies can put people in position to participate with more and more agency over their data — not just to donate data like they would blood, but be participants and determine where their data could go and generate questions about the data.
He mentioned that there were earlier efforts to create personal health records by companies such as Google, Microsoft and Dossia. Krumholz called these efforts noble but ultimately failures because they were more like scrapbooks with no way to move the data. They didn’t focus enough on the use case of what patients would do with the data once they had it. But now that EHRs are so widely adopted, it is getting easier for patients to get and share their data. (Krumholz is co-founder of a startup mobile app called Hugo that collects and consolidates health information including medical records and data generated from surveys or wearable devices. He said Hugo is testing the assumptions that you can connect with patient portals on behalf of people, harmonize the data, and create a means to share it.)
Krumholz is a member of the board of governors of PCORI, the Patient-Centered Outcomes Research Institute. Its projects are uncovering the wisdom of people in larger communities to help generate research questions. Researchers can put people in the position have their data used, and to generate data. “They just want to be sure it is a partnership.
The promise of this approach is to give people the power of their own data so that researchers can go to work for them and for others. The important thing is for data to flow to people and then from people to science, and then from science back to people, he said. It becomes bidirectional.
One impediment, he noted, is a health system mindset or business model that sees patient data as a proprietary asset. He said he has heard healthcare executives say that ready access to medical records makes it easy for patients to leave the health system. 38. Rather than creating affinity by offering an excellent experience, they want to do it by making it hard to move. Data are being sold in ways that bypass patient. Krumholz proposes tilting that balance of power. There needs to be stringent privacy and security, and no data moves without your permission, he said. The consumer is in control. “We need to create a culture where this is done in a way that minimizes dependence on data holders.”
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