“Comparative Effectiveness Research” is, in many ways, a new term for research that has gone on for decades under different labels. Here at the Harvard School of Public Health, innovations in biostatistics, clinical epidemiology, and decision science, have led to important research findings about “what works best”, with important public health implications. Many of the ideas developed at the School are now considered part of CER. Over the years, a number of other rubrics have emerged that also include many of these same methods and concepts, and that overlap considerably with CER including evidence-based medicine, program evaluation, health technology assessment and cost-effectiveness analysis. Catalyzed by the creation of the Patient-Centered Outcomes Research Institute (PCORI) established by Congress through the 2010 Patient Protection and Affordable Care Act, the term patient-centered outcomes research is now also often used.
In 2009, panels of both the Federal Coordinating Council on Comparative Effectiveness Research (FCC) and the Institute of Medicine (IOM) have proposed definitions of Comparative Effectiveness Research that have been widely cited. In addition, the federal government has established criteria for CER funding under the ARRA, which is the largest single source of funding specifically earmarked for CER. At the Harvard School of Public Health (HSPH), we take a broad view of CER that encompasses not only health care interventions but also community and other public health interventions. Moreover, we intend CER research to inform the question of which health interventions offer the most health value in a society with competing priorities.
Considering the HSPH CER Initiative’s vision and scope, we extend the domain of CER, emphasizing the public health perspective:
Comparative Effectiveness Research (CER) is research that identifies what clinical and public health interventions work best for improving health. Interventions include not only the elements of direct clinical care such as diagnosis and treatment protocols, but also innovations in health care delivery, organization and financing, as well as public health interventions in the community, including those intended to modify health awareness, lifestyle, diet, or environmental exposures. In a CER study, interventions should, at a minimum, be compared on the basis of some health-related outcome measure. Study methods may include randomized trials with at least two active (non-placebo) intervention arms, database studies, observational studies, model-based studies, and decision analysis. Research projects that develop methods or infrastructure for CER would also be classifiable as CER.