Steven Joffe Lands $1 Million PCORI Grant
Penn Medicine bioethicist and LDI Senior Fellow Steven Joffe has received a $1 million grant from the Patient-Centered Outcomes Research Institute (PCORI) to fund a three year study of the governance structures of 16 Learning Health Systems across the country.
Joffe, MD, MPH, is Emanuel and Robert Hart Associate Professor and Vice Chair of Medical Ethics and Health Policy at Penn's Perelman School of Medicine, Director of the Penn Fellowship in Advanced Biomedical Ethics, and Associate Professor of Pediatrics at PSOM and the Children’s Hospital of Philadelphia.
Important new feature
"Learning Health Systems are potentially a very important new feature of the US healthcare landscape," Joffe said. "They have the potential to improve care, both for patients in general and for patients specifically taken care of within the systems. I believe patients, policymakers and clinicians should understand, contribute to and promote them."
The Learning Health System (LHS) concept emerged in National Academy of Sciences white papers a decade ago when barely 10% of U.S. hospital systems had fully integrated electronic records systems. It imagined how those systems could be used as the hub of a new approach that made health services research an integral part of a hospital's daily clinical and IT activities.
Clinical practice and scientific investigation
The idea was that all the electronically recorded patient data and claims records of a hospital would become part of an ongoing "feedback loop in which scientific evidence informed clinical practice while data gathering from clinical practice informed scientific investigation."
One of the assumptions underpinning the Affordable Care Act's push for widespread adoption of electronic health records was that such collections of daily patient data would support new scientific analysis of the effectiveness, safety and costs of routine hospital care. Another was that the process would inevitably enhance an institution's focus on daily patient experiences.
"LHSs need to be highly patient-centered," Joffe said, "which means giving patients & families a very strong voice in their governance and mission. Our grant is half about governance, and half about patient engagement in the governance process and the extent to which LHSs give patients a genuine & influential voice. We're really looking forward to learning more about both halves."
He pointed out that there is currently no master list of LHSs across the country but that over 90 institutions are members of the American Association of Medical Colleges’s Research on Care Community (ROCC). Membership in the ROCC means that these institutions either are already functioning as LHSs or have set themselves on the pathway to becoming LHSs.
"I suspect the LHS notion will spread steadily as models and best practices become established and institutions demonstrate the value of the concept," Joffe said. "At the same time, because it’s more challenging, I think LHSs that build genuine clinical experiments into their operations -- which I see as the ideal -- will spread more slowly than those that focus mainly on enhancing the use of observational data."
Some medical professionals view the emergence of LHSs as a welcome complement to the traditional -- but now very costly -- clinical trials process that most often occurs in isolation and excludes many sorts of patients, thus producing results that can't easily be generalized to real-world clinical conditions.
Internal hospital politics
Still in its infancy, the LHS concept is widely recognized to raise a number of logistical, ethical, regulatory and public engagement policy issues. Its implementation can also impact the delicately balanced internal politics of a hospital. The National Academy has noted that "one persistent obstacle... is the friction that may arise between researchers, healthcare providers, and health systems. Many health systems are primarily configured to support the efficient provision of patient care, but less accommodating to the presence of research activities within the same space."
Joffe's research will focus on the governance structures that LHSs deploy for their learning activities, because there are currently no guidelines that define the most appropriate governance models for such hybrid clinical practice/research environments.
"Developing appropriate systems of governance for learning activities, that simultaneously achieve the goals of protecting and respecting patient-participants and enhancing the knowledge gains, and doing so in a transparent, patient-centered and patient-engaged way, will be the greatest challenge," said Joffe.