Too often the questions of basic biomedical research have been mistaken to represent the critical scope of all medical research, and traditional laboratory methods have been seen as necessary and sufficient methods for understanding human health and illness. As a result, approximately 90% of National Institutes of Health (NIH) funding is spent on research within the traditional biomedical sciences (anatomy, biochemistry, genetics, microbiology, molecular biology, physiology, and so forth). The smaller amount of federal funding available for clinical research has been spent primarily on specific disease entities, such as cancer and heart disease. These funding decisions have resulted in the neglect of a large proportion of the problems and issues that confront primary care physicians and their patients.
Clinical research
Perhaps not surprisingly in an era of academic medical centers’ increasing dependence on clinical revenues, the amount of clinical research and the number of clinical investigators have decreased. It has been difficult to track the magnitude of this trend, however, because a concise definition of clinical research is lacking. To address this concern, a national consensus-building conference, the Clinical Research Summit, was held in November 1998, and a working definition was adopted.1 Clinical research was defined as “a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health.” Attendees further agreed that “clinical research embraces a continuum of studies involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories: (1) disease mechanisms; (2) bidirectional integrative research; (3) clinical knowledge, detection, diagnosis, and natural history of disease; (4) therapeutic interventions including clinical trials of drugs, biologics devices, and instruments; (5) prevention (primary and secondary) and health promotion; (6) behavioral research; (7) health services research, including outcomes and cost effectiveness; (8) epidemiology; and (9) community-based and managed care trials.”
Primary care research
In the broader context of clinical research, primary care research remains a fledgling enterprise with many institutions and funding agencies still having difficulty understanding what it includes and what its potential value might be despite a considerable body of supportive literature. The need for primary care research,2-4 the research traditions of relevance to primary care and the scope of its methods,5 and efforts to elevate primary care research to a national priority6-8 have been documented. However, only 0.4% of NIH funding (up from 0.3% in 1984) and only 4% of the funding from the Agency for Health Care Policy and Research (down from 4.4% in 1984) goes to departments of family medicine.9 Both private (eg, the American Academy of Family Physicians) and public (eg, the Agency for Health Care Policy and Research) organizations have formulated working descriptions of primary care research. Nonetheless, primary care researchers still lack a coherent definition with which most can agree. We believe it is particularly important to address this problem now, during a time of concern about and advocacy for clinical research. The definition and examples provided here should be useful for those who are trying to explain the importance of this work to academic administrators and funding agencies.
Primary care has most recently been defined as “the provision of integrated, accessible, health-care services by clinicians that are accountable for addressing a large majority of personal health-care needs, developing a sustained partnership with patients, and practicing within the context of family and community.”6 This definition was debated andwas based on a comprehensive literature review and multidisciplinary input. It has been widely adopted since its publication and offers a sensible, if not perfect, definition to guide research in primary care. One of its most important aspects is the concept that primary care is a function that does not necessarily belong to a particular discipline but is dependent on knowledge from many sources. On the basis of this definition, primary care research can be as defined as research directed toward the better understanding and practice of the primary care function.
Categories of research
Primary care research has traditionally included studies that fall into the following overlapping categories.
Theoretical and Methodologic Research. This category includes the development and testing of theoretical models, operational definitions, and measurement tools relevant to the primary care function. Included in this category are such things as: classification systems designed to capture the phenomena of primary care; ways to measure concepts, such as integrated, accessible, and accountable care; methods for distinguishing the separate and combined effects of primary care on individuals, family units, or the community; and ways to observe and measure important relationships (eg, the physician-patient relationship) and their impact on outcomes. Other investigations involve generating and testing alternative conceptualizations of the tasks and methods of primary care (eg, goal-directed care, family-centered care) and efforts to expand the methods available to primary care researchers (eg, mixed methods research, complexity theories).