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PART I Intro flu c t i on

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1 Genesis of the Effectiveness Initiative and lOM's Role Kim A. Heithoff, Kathieen N. Lohr, and Richard A. Rettig In 1988, the Health Care Financing Administration (HCFA) of the U.S. Department of Health and Human Services (DHHS) proposed a research program called the Effectiveness Initiative to bring the resources of Medi- care to bear on the question of what works in the practice of medicine. This initiative, in HCFA's view, was intended to help it fulfill its responsibilities for ensuring the quality of care of some 30 million Medicare beneficiaries. The initial objectives of the Effectiveness Initiative were (a) to assess the merits of alternative health care interventions; (b) to provide information that would help clinicians in the management of their patients; (c) to assist and improve the Medicare program's quality assurance efforts; and (d) to aid policymakers in allocating Medicare resources. The subsequent evolu- tion of the DHHS effectiveness and outcomes research programs has made it clear that improving patient outcomes is a unifying, primary objective and that identifying additional issues for further research is also important. HCFA originally identified the following activities as elements of the Effectiveness Initiative: (a) monitoring time trends in the use of services by the Medicare population; (b) analyzing geographic (population-based) variations in the use of services and in outcomes of care; (c) assessing interventions by clinical demonstrations, observational studies, and randomized controlled trials (RCTs) in addition to monitoring and analyses of variations; and (d) feeding information back to clinicians. THE BROADER CONTEXT The Effectiveness Initiative did not occur in a vacuum. Within HCFA, it represented another step in the evolution of its responsibilities in quality assurance. Its other responsibilities include the Peer Review Organizations 3

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4 EFFECTIVENESS AND OUTCOMES IN HEALTH CARE (PROs), which followed the Professional Standards Review Organizations (PSROs), and the periodic release of hospital mortality data, a highly con- troversial step that has provided a powerful stimulus for clarifying the use- fulness of mortality data as a measure of quality. In a different vein, HCFA has acted, through its Bureau of Data Management and Strategy, to facilitate the research community's access to its major data bases. In general terms, then, the Effectiveness Initiative both extended these earlier efforts and brought them into a more coherent framework. Elsewhere in DHHS an Outcomes Research Program had been authorized by Congress in 1987 and was being administered by the National Center for Health Services Research (NCHSR). This program, inspired largely by the work of John E. Wennberg and associates in small-area variations in utiliza- tion and outcomes of medical interventions, invited research proposals in late 1988 and announced the first four awards in September 1989, a few weeks before the conference held by the Institute of Medicine (IOM). The program intends to make a number of additional awards on a regular cycle. Conceptually, outcomes and effectiveness research are very similar; dif- ferences lie in legislative, administrative, and funding histories. Consequently, when the DHHS, through Secretary Louis Sullivan, announced in mid-1989 that the department was including the HCFA Effectiveness Initiative in a comprehensive outcomes and effectiveness research program, the announcement was greeted with approval by many in the health services research commu- nity. Another strong general influence in the evolution of DHHS efforts has been the emphasis on appropriateness of care. The issue here deals with whether effective medical interventions-effective, that is, in the context of normal practice situations-are being used appropriately or inappropriately, given the indications for use and the characteristics of the particular patient. Robert Brook and his colleagues have been strongly associated with this research emphasis and have published several important papers in the past few years. Appropriateness research, then, constitutes one more converging stream of influence in the broader developments leading to the DHHS effort in effectiveness and outcomes research. Ideas in good currency influence Congress, as well as the executive branch. Various legislative proposals in 1988 and 1989, therefore, culminated in the Omnibus Budget Reconciliation Act of 1989 and a reorganization of part of the Public Health Service (PHS). The NCHSR was disestablished, and the Agency for Health Care Policy and Research was authorized in its place. The new agency absorbed from the prior organization the functions of health services research (including outcomes research) and technology assessment, especially the PHS advisory function to Medicare. In addition, a new function was added, namely, responsibility for devel- oping medical practice guidelines. This responsibility represents congres

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INTRODUCTION signal thinking that such guidelines represent the practical application of outcomes and effectiveness research to the practice of medicine. This set of developments evolution of the HCFA responsibility in qual- ity assurance, emergence of outcomes research and its incorporation into federal research programs, articulation of the general concern for appropri- ateness and of specific research approaches in this area, and creation of a new federal agency with responsibility for the development of practice guidelines provides the nutrient bath in which the IOM contribution has grown. THE INSTITUTE OF MEDICINE'S CONTRIBUTION In planning the Effectiveness Initiative, HCFA consulted widely in 1987 and 1988 with representatives of medicine, health financing, and health services and policy research. It also coordinated its efforts closely with other agencies of DHHS. In August 1988, William L. Roper' then Adminis- trator of HCFA, asked Samuel O. Thier, president of the Institute of Medi- cine, to convene a group of clinicians to advise the agency on the Effeci~ve- ness Initiative. HCFA specifically asked the IOM for advice concerning what clinical conditions ought to receive priority in the initial period of the new program. Clinical conditions, rather than specific procedures or tech- nologies, were chosen as the unit of analysis because they permitted exami- nation of the full range of patient care opportunities, including prevention and follow-up care. THE IOM CLINICAL WORKSHOP The IOM hosted a meeting of clinicians for the above purpose in October 1988. This "clinical workshop committee,' recommended that five condi- tions receive highest priority: angina (stable and unstable); acute myocar- dial infarction; carcinoma of the breast; congestive heart failure; and hip fracture. These conditions were selected because of their high prevalence, the substantial burden''they impose on elderly persons, appreciable varia- tions in use of services and in outcomes, high costs, and the existence of alternative ways of managing patient care that reflect professional and clinical disagreement or uncertainty. The committee also recommended a second tier of clinical conditions for later attention: cataracts, depressive disorders, prostatic hypertrophy, and transient ischemic attacks with or without occlu- sion.~ The report of this study was published as Effectiveness Initiative: Setting Priori- ties for Clinical Conditions in April 1989; it is available from the National Academy Press (Report No. IOM-89-04~.

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6 EFFECTIVENESS AND OUTCOMES IN HEALTH CARE THE CONDITION-SPECIFIC WORKSHOPS After the clinical workshop, HCFA asked the IOM to organize three additional workshops, one on each of the three clinical conditions of highest priority to the agency namely breast cancer, acute myocardial infarction, and hip fracture. These condition-specific workshops were held in March, May, and July 1989, respectively. Each had three objectives: (a) to identify key research questions in more detail than had occulted at the October workshop; (b) to identify critical patient care topics deserving further inves- tigation; and (c) to propose appropriate research strategies and methods.2 The IOM appointed a core committee to oversee the entire series of workshops. This core group included: Kenneth I. Shine (chair), Maureen M. Henderson, Emmett B. Keeler, Barbara J. McNeil, David G. Murray, Alan R. Nelson, J. Sanford Schwartz, G. Richard Smith, and Harold C. Sox. (Drs. Shine, Murray, Nelson, Smith, and Sox had also been on the clinical workshop committee.) For each meeting, IOM augmented the core group with additional experts in the condition under consideration. The names of all participants can be found in the committee rosters in the front of this monograph. EFFECTIVENESS AND OUTCOMES CONFERENCE The September 1989 IOM conference, "Effectiveness and Outcomes in Health Care," concluded this series of activities. It had four main objec- tives: to explore the social, clinical, and legislative environment for research on the topic of "what works in the practice of medicine"; to review the conclusions and recommendations of the IOM workshops on breast cancer, acute myocardial infarction, and hip fracture; to highlight four important methodological issues In effectiveness studies, specifically, use of adminisaai~ve data bases, collection of primary data, development and use of outcome measures, and applications in clinical practice; and to examine the question of where we go from here. PROCEEDINGS This book represents the proceedings of that conference and is divided into five parts. The first is an introduction consisting of the foregoing description of how the Effectiveness Initiative and IOM's role in it evolved 2The reports of the three research workshops have been or are being published as a series: Breast Cancer; Hip Fracture; Acute Myocardial Infarction, with the subtitle Setting Priorities for Electiveness Research. All are available from the National Academy Press.

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INTRODUCTION 7 and the summary statement of the TOM core committee. Although most of the issues in the summary are addressed in the individual workshop reports, the committee believed it would be helpful to draw them together in a single statement. That statement was distributed in advance to particpants in the September conference to stimulate discussion and is published here as Chapter 2. The second, third, fourth, and fifth parts comprise the conference pro- ceedings papers. Each section focuses on one of the four main objectives of the conference described above.