The Future of Cardiovascular Clinical Research
Authors: Robert M. Califf, Iain Sanderson, Marie Lynn Miranda
Journal: JAMA (2012)

SUBSTANTIAL AGE-ADJUSTED REDUCTIONS IN CARDIOvascular mortality and morbidity over the past few decades are being challenged by increases in physical inactivity, diabetes mellitus, and obesity, creating a large and aging population with long-term cardiovascular disease (CVD). However, the US national investments in discovery and translational science continue to produce major advances, both in understanding these conditions at the cellular level and in development of therapeutic and diagnostic tools that can improve health outcomes. Innovative research and clinical opportunities may arise from the ability to combine clinical and geospatial data at the regional scale in large, integrated health care delivery systems. The concept of a “learning health system” can be advanced if this capacity is coupled with the ability to perform practical clinical trials and comparative effectiveness research, using the results to further improve health and health care. Such integrated systems promise a common approach to issues that previously seemed irreconcilable: personalized medicine vs population health, traditional medicine vs public health. The CVD epidemic is particularly amenable to this approach because of its magnitude, the advanced understanding of its biological and social basis, and the availability of effective treatments. Reductions in cardiovascular morbidity and mortality, however, will depend on enhanced individual and community engagement with the research enterprise. The advent of electronic health records (EHRs) in the 1970s created expectations, but the challenges of human interfaces in these early systems, coupled with a lack of terminology standards and limited computational power for large data sets, restricted electronic data capture to specialized applications: simply collecting data in one place was a major task. After 3 decades of technological progress, population clinical data sets for research are more widely available, and the major challenges are (1) organizing data into information, (2) analyzing information to distill actionable knowledge, and (3) presenting knowledge in ways that can inform personal or policy decisions. Debate continues about how current EHR user interfaces help or hinder patient outcomes. However, the overall efficiency of medicine and the rational basis for decision making will be enhanced as the practical issues of integrating data, information, and knowledge into clinical care and public health practice are solved. Two projects provide examples of the potential of this approach. These efforts integrate clinical and geospatially mapped data with the purpose of improving individual and population health in geographically defined regions, accelerating the rate at which reliable evidence can be generated to support rational decision making. This work is predicated on informatics-driven approaches to the disciplined collection of structured data as part of routine clinical practice and to aggregating those data in novel ways that enable multiple uses. The first project is based in Durham County, North Carolina, and uses geospatial methods to connect clinical data from Duke Medicine, the Durham County Health Department, and Lincoln Community Health Center (Durham’s Federally Qualified Health Center) with data on housing, neighborhoods, social stressors, environmental exposures, and culture. This allows researchers and clinicians to understand patients both from their medical records and from the social and environmental contexts in which they live, work, and play. This project also has engaged the Durham community in a direct conversation about how the composite influences of human biology and social and environmental influences shape individual and population health, as well as how this knowledge can and should be used to develop tailored, community-based interventions that improve individual and population health. The second project builds on this approach but focuses particularly on adults living with type 2 diabetes mellitus and extends the work to other counties in North Carolina, Mississippi, and West Virginia.