Research and Service Programs in the PHS: Challenges in Organization (1991)

The committee did not find it useful to categorize grants by funding mechanisms because the number of grants in some funding categories is too large to be manageable (e.g., R01s), the use of other funding mechanisms is inconsistent across time (e.g., R18s), some funding mechanisms are not used uniformly (e.g., P60s), and other funding mechanisms are interchangeable in the eyes of some funding institutes (e.g., R01s, P50s, P01s). Similarly, it was not useful to categorize grants strictly by the terms used by the institutes because most have in-house classifications that are not intended to be used by others. Nor was it helpful to categorize grants by the thesaurus developed by the Division of Research Grants (DRG), which changes from year to year based not on scientific principles but on the level of use of terms. Thus, it was necessary to develop a classification that could be used across time, across agencies, and across disciplines.

The most common language used to describe research and research-related activities includes basic research, clinical research, applied research, development, and technology transfer. These categories represent a continuum of activities, the boundaries between which are not well defined. (In addition, there is considerable question as to whether there truly is a meaningful research-services continuum.) The utility of such a simple nomenclature is limited by the different and often conflicting definitions used for these terms. The distinctions between these standard typologies do not necessarily reflect the research process, and the mystique surrounding the use of the term basic research, in particular, limits its utility. ¹ Because there is no standardized terminology within DHHS for describing research and service programs, the committee developed its own nomenclature for research, research-related, and service programs after a review of the pertinent literature.

In 1979, the then Department of Health, Education, and Welfare (HEW) proposed a classification system that was intended to describe the substance of research programs and to be a universal mechanism by which HEW would assign resources and plan allocations. ² The so-called SATT system was composed of four parts: science base, applications, transfer, and training. Most PHS components experienced difficulty classifying their activities within the SATT system, however, and it was not formally adopted by HEW.

A recently published alternative nomenclature for health research emphasizes the content of functional areas rather than providing a dictionary of descriptive terms. This framework has three levels of criteria:

1. the focus of research (health state or health intervention);

2. the level of research (molecule-cell, tissue-organ, individual, and community-population for health states and technique, practice, program, and policy for health interventions); and

3. its purpose (development, description, explanation, and evaluation).

The framework's authors describe it as follows:

a straightforward, comprehensive classification scheme that demonstrates the continuity of health-related research across the whole range of disciplines now engaged and is capable of including any that might become involved in the future. It directs attention to the content of areas rather than to the development of a lexicon of standard terms to replace discipline specific jargon . . . [It does] attempt, nonetheless, to fit the more commonly used terms into the framework. ³

The nomenclature used in this study was based to a large extent on the two systems described above. Several criteria were used in the development of this system. First, the system had to include research, research-related, and service activities. By definition, the research classification schemes described above did not include health service development and delivery systems; the services classifications were therefore developed based on background information, but still stressing functional areas. Second, the activities within each category should make scientific and programmatic sense. Although standard terms such as basic, applied, and development are not used, activities generally described by such terms fall within the classification scheme. A third criteria was that activities within each category could

not be identified only by the funding mechanism used by the funding institute or agency, as these have shifted over time. Lastly, the nomenclature should facilitate communication rather than hinder it.

The five main components of the nomenclature are (1) health status research, (2) health interventions research, (3) systems development, (4) services, and (5) information dissemination. Specific categories within this nomenclature are descriptive of functional activities that, it was thought, best represent and communicate the breadth of research, research-related, and service activities undertaken by the PHS:

1. Health status research provides new knowledge regarding health, disease, biological, and behavioral processes. Health status research is distinguished from health interventions research in that health status research does not study ways to change or influence health status.

   1. Nonhuman research includes both in vivo and in vitro research, ranging from molecules to cells to organs to organisms.

   2. Human research includes behavioral, biobehavioral, or biomedical research in individual humans (frequently referred to as clinical research) or research on populations, such as epidemiological or demographic studies.

2. Health interventions research provides new knowledge concerning the modulation of health status (i.e., those research endeavors addressing not just disease but attempts to intervene in disease). This topic is quite broad:

   1. Product development includes research applicable to the development of a new product or procedure that will then be tested to intervene in health and disease. This would include animal or human in vivo or in vitro research or even nonbiological research, such as medicinal chemistry research on pharmaceuticals or engineering research applicable to new devices.

   2. Program assessment includes research that tests the efficacy or effectiveness of an intervention in diseased humans (frequently referred to as clinical research or clinical trials) or in animal models of human disease. The intervention can address prevention, diagnosis, or treatment of disease with any number of strategies (e.g., behavioral, pharmacological, surgical, mechanical, or any combination of the above).

   3. Health services research includes research examining the relationships among health care consumers, providers, services, and facilities in order to increase effectiveness and efficiency, improve clinical care and outcomes, and evaluate health care policies. It

includes research into the access, utilization, organization, costs, financing, and outcomes of service delivery systems.

4. Research demonstrations include those demonstration projects that are hypothesis-driven and include control groups, and whose purpose is the generation of new knowledge.

3. Systems development refers to activities intended to provide incentives for the development of service systems.

   1. Services demonstrations includes demonstration projects that gather information about populations or services about which there is little information, as well as demonstration projects intended to illustrate that a given service system works in real-world settings. These demonstrations are not hypothesis driven and do not have a strong research component, although evaluation is frequently included in the design.

   2. Technical assistance (including technology introduction) includes activities aimed at helping state and local governments or service providers develop and implement prevention or treatment service delivery systems.

4. Services includes activities that directly or indirectly provide services.

   1. Direct services includes activities in which direct treatment of patients occurs, such as those of the Veterans Administration hospitals, other military hospitals, and the Indian Health Service.

   2. Indirect services includes funding to state or local groups to provide care; this can include categorical or formula grants as well as block grants to states. PHS block grant programs provide money to states for preventive health care programs (via CDC) and for health care programs relevant to select populations: substance abusers, the mentally ill, and women and their children (via ADAMHA and HRSA). An important federal contribution to patient care (reimbursement for health care services by Medicare and Medicaid through the Health Care Financing Administration) was not assessed directly in the study because HCFA is outside of the PHS.

5. Information dissemination includes activities that transmit information about research results or services to any population, such as professional, patient, or public education programs. (Training of research and service personnel is an important means of disseminating information, but neither the case studies nor the report included training programs in analyses.) Information dissemination programs differ greatly, depending upon the knowledge base from which information is drawn and the population for whom the information is intended. Information dissemination includes but is not limited to

conferences, publications, workshops, pamphlets, hotlines, and clearinghouses.

1. H. W. Lane, R. G. Beddows, and P. R. Lawrence, Managing Large Research and Development Programs (Albany: State University of New York Press, 1981).

2. Department of Health Education and Welfare, “ Appendix B SATT-A New Viewpoint On Health Research,” Health Research Activities of the Department of Health, Education, and Welfare Current Efforts and Proposed Initiatives. A Report of the HEW Steering Committee for the Development of a Health Research Strategy (Rockville, Md.: DHEW, 1979).

3. R. N. Battista, A. P. Contandriopoulos, F. Champagne, J. I. Williams, R. Pineault and P. Boyle, “An Integrative Framework for Health-Related Research” (Journal of Clinical Epidemiology 42, 1989: 1155-1160).