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Chapter 1 INTRODUCTION AND SUMMARY OF RECOMMENDATIONS A need for more knowledge about health services in the United States is becoming increasingly apparent to health care professionals, government officials, and the public. Management of the highly diverse and inter- dependent personnel, facilities, and technologies that constitute modern health care institutions requires information similar to that employed in other complex business enterprises. In addition, the growing involvement of government in the financing, planning, and regulation of health care has heightened the demand of government officials for know- ledge to guide the formulation and implementation of policy and the desire of the public for more information about their health care and the political choices that affect it. In response to these needs, govern- ments, philanthropic foundations, and private organizations are invest- ing in research on virtually all aspects of the nation's health services. Research on health services began in the United States in the 1920s, prompted by the efforts of philanthropic foundations to improve the living conditions of the poor. Over the following three decades, this research developed in various settings, but remained primarily under the auspices of foundations and other private organizations. It was only a sporadic and relatively small scale activity within the federal government until the mid-19SOs, when the first major authorities for support of health services research were enacted. These increased in numbers and scope during the Lyndon Johnson admin- istration of the 1960s, when new social legislation vastly extended federal responsibilities for financing health services. By the mid-1960s, health services research had become a distinct field of inquiry, supported largely by grants and contracts from federal agencies administering the government's health care programs. Recog- nizing that attainment of national health care objectives and efficient management of the federal government's disparate research activities required a coordinated effort, President Johnson in 1967 ordered the creation of the National Center for Health Services Research and Development within the Department of Health, Education, and Welfare. 1

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2 The National Center* was given a broad mandate to conduct and support health services research. Unlike other federal agencies involved in research on health care, the Center had no direct relationship to operating programs. Rather, its mandate was broadly conceived to en- compass research and experimentation on fundamental problems of health care. Additionally, the Center was to expand the nation's research capability by sponsoring training in health services research. Although there have been large investments in health services research in recent years, many government officials, health care professionals, and health services researchers have expressed confusion as to what the field encompasses and skepticism about its relevance to the needs of decision makers.[l] Moreover, the growth of research in health services throughout the federal government has occasioned concern about the necessity for continuing the National Center for Health Services Research, and possibly wasteful duplication and fragmentation of research efforts.~2] In view of these concerns, the Office of Science and Technology Policy of the Office of the President of the United States in September 1977 commissioned the Institute of Medicine to undertake an assessment of the field of health services research for the purpose of proposing recommendations that would clarify the focuses and boundaries of the field and improve its contributions to decisions affecting health care. This report presents the findings and conclusions of that assessment. Issues Addressed in the Study The doubts of those who sponsor health services products center on whether their investment has intended returns and, if not, what might be situation. If answers to these questions are Lion, several preliminary problems require ~ needs to develop an operational definition of health services research and enumerate over some period the resources devoted to its activities. Likewise, the intended and unintended benefits of research must be defined and assessed in a context of the resources used to produce them. Finally, if these comparisons are judged not favorable, one must identify and alter the circumstances that are to blame. research and use its resulted in the done to improve the to ~ more than specula- attention. First. one *Since its inception, the agency has experienced three name changes from the original National Center for Health Services Research and Development to the Bureau of Health Services Research, the Bureau of Health Services Research and Evaluation, and the current National Center for Health Services Research. In this report, the current name or the abbreviated "the National Center" or "the Center" is used.

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3 Although the study committee attempted to follow this path of logic, its efforts were only partially successful. The paucity of reliable data within the federal government and elsewhere about health services research, coupled with the inherent difficulty of measuring the effects of research on decision making, preclude the application of precise cost-benefit reasoning and analysis to this field. Nevertheless, it is evident that on several issues, such as health maintenance organizations, hospital bed supply, and increases in health care expenditures, research findings have influenced both the level and focuses of debate. Health services research within the federal government can produce findings that frequently have political implications. Therefore, recent debate as to where within the federal structure primary responsibility for health services research should rest raised complex questions about trade-offs between the preservation of free and open inquiry and the needs of government officials for ready information upon which to base program- matic and policy decisions. In view of the government's several extensive reorganizations of health services research activities since 1968, the most recent of which occurred within the past year, the committee had little evidence upon which to base recommendations about further struc- tural changes. On the basis of its charge from the Office of Science and Technology Policy and its reviews of literature and testimony of interested and knowledgeable persons, the committee concentrated on the following issues: 1. What is health services research? How does it differ from other related types of inquiry? 2. What is the nature of the field of health services research? What are its priorities, and how are they established? Who contributes to the field, and who uses its products? 3. How is health services research organized within the federal government? What are the research priorities and needs of federal agencies? How are their studies done internally, and what mechanisms are used to support re- search done in universities and other settings outside government? How are the research programs of various agencies coordinated? What mechanisms are employed to promote and evaluate the quality of research? 4. What is the role of the National Center for Health Services Research? How is the agency organized? What are its priorities and programs, and how do they differ from those of other federal agencies?

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4 Boundaries of the Study Although the questions above and the issues they imply are of major importance to the federal government, their answers will not con- stitute an assessment of the totality of health services research. Much of this activity lies beyond the purview of the committee--in state and local governments, private organizations, and philanthropic foundations. A broader study would examine the relative contributions of the federal government's health services research activities to the overall effects of all such efforts. The committee's direct information about the utility of health services research is limited to the federal government. It did not systematically assess the effects of research findings on state and local officials or the general public, although these are important audiences. The committee did not set out to evaluate particular agencies or to assess research on particular problems. In keeping with its charge to examine generic issues in health services research, the committee attempted to take a broad perspective. Occasionally, however, the information obtained led logically to committee judgments involving issues related to effectiveness. Its emphasis on some agencies, particularly the National Center for Health Services Research, reflects the committee's recognition of their primary importance in the federal government's health services research structure. Finally, the committee did not attempt to weigh the contributions of health services research in all issues of health care delivery or to set forth research agendas for them. Although the committee recognizes the pressing need for research in a variety of areas, some of which are noted throughout this document, detailed comment on each is pre- cluded by their number and complexity. Methods Information in this report was gathered from literature reviews, hearings, reviews of documents, interviews, and deliberations of the committee. In January 1978, the committee held a two-day session of hearings which invited persons presented views on health services research On the first day, in open session, 19 persons representing pro- fessional, public, and research organizations spoke and responded questions from the committee. These persons had been selected from 35 who submitted written testimony in response to the committee's mailed solicitation to approximately 175 organizations or institutions. On the following day, a closed session was held at which 12 officials representing congressional committees and offices and executive agencies spoke and responded to questions.

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5 Much of the information reported here was gathered in interviews with government officials and others. At least two Institute of Medicine staff members were present at more than two-thirds of the interviews. Except where the interview was aimed at acquiring only specific factual information, conversations with respondents were structured by interview guides. Although these guides were altered to fit particular circum- stances, they typically addressed agencies' requirements for and uses of information and the means by which they are satisfied. For those agencies which conducted or supported health services research, the questioning extended to the methods by which research priorities are established, mechanisms for assuring the quality of research, and relationships with other agencies engaged in health services research, especially the National Center for Health Services Research and the Health Care Financing Administration. Information assembled by staff was summarized in memoranda that were distributed to committee members. These and related matters were discussed at four meetings of the committee. They constitute the basis for the committee recommendations, which are summarized below. Findings and Recommendations The committee found that several departments and agencies of the federal government sponsor health services research, principally as an adjunct to their programmatic missions. Because agencies' man- dated responsibilities for personal health services are defined in various ways, each has needs for information that emphasize parti- cular population groups, health problems, or government functions. In many instances, agencies' needs and interests necessarily overlap, causing apparent similarities in the types and focuses of their health services research agendas and projects. However, more problematic in the committee's view are the fragmentation and gaps in knowledge that result from the widespread involvement of federal agencies in health services research that is closely identified with their operating needs. Analysis of the history and current situation of the National Center for Health Services Research (NCHSR) revealed that the Center has several unique and worthwhile roles in health services research within the federal government. The committee found, however, that financial and other constraints prevent it from realizing its full potential. In view of its findings of the widespread involvement in health services research by agencies throughout the federal government, of the absence of systematic and effective mechanisms for coordinating activi- ties of departments and agencies, and of the consequent problems of fragmentation and omissions in health services research, the committee recommends that

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6 administrative procedures be established within . . the federal government to coordinate the setting of departmental and agency health services re- search priorities, agendas, and projects. These procedures should apply to all departments engaged in health services research, and should emphasize the identification of areas of common interest among departments and agencies and, in such instances, facilitate interdepartmental and interagency exchange of information and collaboration. The committee further believes that efforts to coordinate health services research priorities, agendas, and projects should not hamper agencies' abilities to carry out their mandated missions and should encourage experimentation with diverse perspectives and approaches to problems. Therefore, the committee recommends that attempts to coordinate health services research _ within the federal government should not centralize responsibility for the conduct or sponsorship of research required for the attainment of specific and identifiable program or agency objectives. This recommendation has two implications. First, the committee would not endorse a research plan (either government-wide or DHEW-wide) that would limit the scope or content of agencies' research agendas if they can be demonstrated to be reasonably related to agencies' mandated missions. Second, the committee would not be in favor of a reorganization of health services research that would remove responsibilities for the conduct or sponsorship of programmatic research from operating agencies. In view of its findings of important matters missing from the research priorities of individual agencies within the Department of Health, Education, and Welfare, created by the close identification of agencies' health services research priorities with their program missions, the committee recommends that agencies be designated to assume responsibilities for studies that will fill the gaps in knowledge. These agencies should periodically review their own research agendas and those of other agencies with common or logically related interest identify research needs that are not being met, and propose projects that would meet these needs. These findings and plans should be s ,

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7 submitted to departmental officials who, in turn, should designate agencies to implement them. Having found that substantial portions of federal spending for health services research are disbursed for extramural studies, the majority through contracts, and that most of these disbursements are made without the benefit of systematic and open peer review, the committee recommends that all Executive departments and agencies sponsoring extramural studies in health services research establish peer review by nongovernment personnel of all projects involving appreciable expenditures. These procedures should (1) subject requests for proposals to review before they are advertised, (2) facilitate competition for funds among qualified researchers, and (3) review results of projects for their scientific and technical merit. Finding that federal agencies are increasingly relying upon intramural research and research funded by contracts, and being concerned over the long-term consequences of these funding strategies for the types of research that will be done and for the quality of health services research, the committee recommends that the federal government adopt a policy regarding health services research to assure that a significant portion of all monies invested in this-area go to support investigator-initiated extramural research. Intramural research should not be viewed as a substitute for extramural research, nor contracted research as a substitute for grant-supported, investigator-initiated research. Rather, a strategy of funding should be developed that identifies the strengths and problems associated with each and achieves a balance among them. From its review of the history of the National Center for Health Services Research, the Center's current priorities and functions, and potential for effecting greater coordination of the health services research activities of the Public Health Service, the committee recommends that the National Center for Health Services Research be maintained as a general-purpose health services research agency within the federal government.

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8 Further, the committee recommends that the Center's functions should be to sponsor health services research and research in related disciplines through a program of extra- mural, investigator-initiated grants and contracts, o to conduct intramural research, to sponsor through a program of extramural grants and contracts training in health services research and related disciplines, to monitor the development of knowledge relevant to health services research, and disseminate this knowledge, to assist other federal agencies in developing health services research priorities and programs and in designing and executing evaluations of federal programs, and to facilitate the development of the health services research capabilities of non-federal organizations and agencies. The committee believes that one of the National Center's principal missions should be to conduct and sponsor synthesizing research aimed at filling gaps in research and knowledge. Therefore, the Center's purview must not be limited to particular types of questions. Indeed, the Center should be encouraged to pursue research on issues that are related to the principal focuses of operating agencies and should be accorded the opportunity to be designated as the lead agency in coordinating and developing important areas of health services research. Accordingly, the committee recommends that the purview of the NCHSR should not be constrained by specific federal policies or programs and should encompass research_on dental, mental, and nursing services. Although the recommendations regarding the Center's functions are similar to those established for the agency at its outset, the commit- tee is mindful of the fact that they cannot be performed adequately under current circumstances. In retrospect, the committee believes that initial expectations about the Genter's objectives were unrealis- tically optimistic, especially in light of the meager resources devoted

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9 to them. Declining budgets and limitations on the Center's ability to recruit personnel needed to address each of its missions have placed the agency under doubly difficult constraints. If these constraints are not relaxed, the Center will be forced to continue to suspend important functions entirely or to pursue them with less vigor than they warrant. Therefore, the committee recommends that DREW review the budgetary and personnel require- ments for each of the functions identified in the committee's recommendations and provide the NCHSR with the resources required to perform them. The committee did not consider in detail issues relating to health ser- vices research training because of the existence within the Academy of the Commission on Human Resources panel on health services research, which was created specifically for that purpose. The committee re- viewed the Commission's reports and endorses its recommendation that a program for health services research training be established under the National Research Award Act of 1974 (P.L. 93-348) and recommends that the National Center for Health Services Research be permitted to re-institute its support of health services research training, based on a careful review of the most appropriate mix of disciplines and levels of training deserving of support. The National Center is required by legislation to make grants to health services research centers. This program accounts for approxi- mately 15 percent of the Center's total research budget. In view of the limited funds available to support investigator-initiated health services research, the committee recommends that legislation authorizing the National Center for Health Services Research be amended to strike the requirement that the Center support centers for health services research. ~ _ The National Center should be petted to support center grants if a consensus is reached that the program complements the Center's overall mission and the evolution of the field as a whole. Awards of center grants should be based on review by peers of the scientific and technical

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10 merits of proposed studies, their coherence as a set, qualifications of principal investigators and staff, and other features that are relevant to the applicants' abilities to complete the proposed work, rather than the existence of a legislative mandate. The committee recognizes that the National Center requires a strong intramural research effort to attract and keep qualified researchers. Such persons are needed to assist other federal agencies in their health services research activities, to develop the Centers' priorities, to monitor health services research studies and literature, to identi- fy, summarize, and critique methods and findings, and to conduct studies that are best done within the government structure. However, the committee believes that because of current government- wide restrictions on hiring, the Center has been unable to attract the full complement of experienced staff required to conduct an effective intramural research program. The legislative requirement that at least a one-quarter of the Center's budget be devoted to intramural research means that extremely limited resources are channeled to intramural efforts that might be spent more wisely on investigator- initiated extramural research. In view of the stringent fiscal and personnel constraints faced by the National Center for Health Services Research, the committee recommends that the legislation mandating the intramural research program of the National Center for Health Services Research be amended to strike the language re- quiring the Center to allocate not less than twenty-five percent of its budget to intramural research. Over the past decade, the National Center has occupied three different locations within the federal government. It has been situated in the Office of the Assistant Secretary for Health for less than one year. In light of Congressional debate about the appropriate organizational locus for the Center which occurred during the course of this study, the committee reviewed several options. These include leaving the Center in its present position, relocating it in the National Institutes of Health, re-creating it as a free-standing agency with- in the Public Health Service, or re-creating it as a free-standing agency within the Office of the Secretary of the Department of Health, Education, and Welfare. The associated strengths and weaknesses of each option were carefully analyzed. Many of the arguments are essentially variations on themes surrounding a central dilemma: the need to infuse the Center with the requisite organizational, political, and intellectual authority to achieve the desired coordina- tion of research priorities and high standards of quality; combined

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11 with the need to avoid the politicization of decision-making that potentially adheres to levels of bureaucracy sufficiently high to achieve the desired degree of coordination. After carefully considering these and other issues, the committee con eluded that there are no compelling grounds for recommending specific organizational changes. As the Center has experienced frequent and significant disruptions from previous reorganizations, the committee believes that further changes of location would create additional difficulties. The committee notes that the Center's present location within GASH provides the possibility for enhanced organizational and political visibility and authority. This may, however, lead to inappropriate politicization of its research priorities, agendas, and roles. As the Center has been in CASH for only a limited period, it is too early to determine whether its current location is, overall a desirable one. Therefore, the committee recommends that the National Center for Health Services . Research remain in its present location in the Office of the Assistant Secretary for Health - and that the effects of these arrangements on the various functions and priorities of the Center be evaluated after a suitable interval, say five years, to determine whether further reorganiza- , Lion is warranted.

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12 REFERENCES 1 2 David H. Banta and Patricia Bauman, "Health Services Research and Health Policy," Journal of Community Health 2 (Winter 1976) 121-32; Charles E. Lewis, "Health Services Research and Innova- tions in Health Care Delivery: Does Research Make a Difference?" New England Journal of Medicine 297 (25 August 1977~: 423-27; Beverlee A. Myers, "Health Services Research and Health Policy: . . Interactions, Medical Care 11 (July-August 1973~: 352-58; Sherman R. Williams and Jere A. Wysong, "Health Services Research and Health Policy Formulation: An Empirical Analysis and a Structural Solution," Journal of Health Politics, Policy and Law 2 (Fall 1977~: U.S. Congress, Senate, Committee on Appropriations, Departments of Labor, and Health, Education, and Welfare and Related Agencies Appropriations Bill, 1978, Report No. 95-283, 95th Cong., 1st sees., 1977, p. 81 .