In a burgeoning era of "big health data," patients, patient advocates, clinicians, and other "end users" of health research results will have unprecedented opportunities to help shape the direction of such research, say several papers in the July issue of Health Affairs, a theme issue about big data.
By giving greater say over study design and implementation to patients who choose to share their clinical data and other health information, new Patient-Powered Research Networks (PPRNs) have the potential to more systematically address questions of genuine importance to patients, according to one of those papers, authored by senior staff at the Patient-Centered Outcomes Research Institute (PCORI).
PCORI has funded the development of 18 PPRNs as part of PCORnet, the National Patient-Centered Clinical Research Network. PCORnet seeks to harness the power of large amounts of health data, including from electronic health records and information reported by patients themselves, to enable researchers draw from real-world clinical settings and conduct studies more quickly and cost-effectively. Patients will help set the rules under which such studies will be conducted. Several papers in the theme issue discuss PCORnet, its partner networks, and their goals.
"For patients, their families, and caregivers, the era of big data provides new opportunities to generate and contribute data about themselves and to actively collaborate with researchers in prioritizing and answering clinical research questions," writes lead author Rachael Fleurence, PhD, Director of PCORI's CER Methods and Infrastructure Program. She and colleagues describe the unique patient-centered attributes of the PCORnet approach as well as the challenges to realizing its potential.
Another paper illustrates how patient-centered approaches to big health data are being put into practice through ImproveCareNow, a PPRN focused on pediatric inflammatory bowel disease, and PEDSnet, which aims to become a national clinical data network covering the full spectrum of pediatric disorders. PEDSnet is one of the 11 Clinical Data Research Networks (CDRNs) that also are part of PCORnet and are designed to engage health systems in the initiative.
The new systems of care made possible by PEDSnet and ImproveCareNow will enable innovative types of research using big data resources, the results of which could lead to continual improvements in care delivery. Engaging all stakeholders in the process will increase the likelihood that the most important research questions will be asked and answered, write co-authors Christopher Forrest, MD, PEDSnet Principal Investigator and Professor of Pediatrics at the Children's Hospital of Philadelphia and University of Pennsylvania, and Peter Margolis, MD, PhD, ImproveCareNow Principal Investigator and Professor of Pediatrics Director of Research at the James M. Anderson Center for Health System Excellence at Cincinnati Children's Hospital Medical Center.
Patient-reported outcomes (PROs), data directly shared by patients about their experiences, offer a rich resource to improve research and care, according to another paper in the issue. Lead author Amy Abernethy, MD, PhD, Director of the Center for Learning Health Care, Duke Clinical Research Institute, Duke University, and leader of the PCORnet Patient-Reported Outcomes Task Force, and colleagues describe the critical role of PROs for improving health research and care as well as ways that PCORnet and other initiatives are seeking to tap this resource and the challenges they must overcome.
A fourth paper describes PCORnet and three other national initiatives to use big health data for research as the promising first stage in the development of the foundation for a healthcare system that can truly apply lessons learned to improve continuously care and outcomes. The paper was written by Leslie Curtis, PhD, and Jeffrey Brown, PhD, co-leaders of the PCORnet Task Force on Data Standards, Security, and Network Infrastructure; and Richard Platt, MD, MS, Professor and Chair of the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute, and Co-Director of the PCORnet Coordinating Center.
In addition, another paper notes there many challenges to achieving the full potential of using patient data in research, including the need to ensure the privacy and security of sensitive information as well as to ensure data used in research are valid, reliable, and standardized. Nonetheless, the effort is essential, writes Harlan Krumholz, MD, a member of PCORI's Board of Governors and Professor of Medicine and Epidemiology and Public Health, Yale University School of Medicine.
"Until medicine develops a robust clinical research community that embraces these contemporary opportunities and fully realizes the promise of big data, the large gap between the available evidence, what is needed, and what could be generated will persist," he writes.
Link to "Using Big Data To Transform Care" articles.