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Introduction In 1988 the Health Care Financing A~ninistration (HCFA) of the U.S. Department of Health and Human Services proposed an Effectiveness Initiative to bring He resources of Medicare to bear on the question of what works in the practice of medicine. During this time, HCFA consulted widely with many individuals and organizations in medicine, heal care financing, and health services and policy research for guidance on this new program initiative. In August 1988 HCFA requested the Institute of Medicine, National Academy of Sciences, to recommend clinical conditions that should receive priority attention initially. This emphasis on the clinical condition reflected a decision to focus on this unit of analysis rather than specific procedures or technologies. To accomplish this task, He Institute appointed a committee according to National Academy of Sciences procedures (following a collaborative consultation between the Institute and HCFA) and convened a one-day workshop on October 27, 1988, preceded by an opening session on He evening of October 26. The committee, chaired by Kenneth I. Shine, M.D., Dean of the UCLA School of Medicine, included He physicians named in the accompanying roster. This report conveys He committee's findings and recommendations pursuant to workshop deliberations.! For a copy of appendix materials describing the process of the project in more detail, which are available at cost, contact the Divsion of Health Care Services at the Institute of Medicine, National Academy of Sciences, 2101 Constitution Avenue, N.W., Washington, DC 20418. 1

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2 COMMITTEE CHARGE The committee was charged with two responsibilities: 1. to recommend to the HCFA Administrator a small number of clinical conditions (three to five) to receive priority in the early stages of the Effectiveness Initiative and 2. after nominating clinical conditions, to identify specific dimensions of the management of those conditions that might receive attention. PURPOSES AND ELEMENTS OF THE EFFECTIVENESS INITIATIVE The purposes of the Effectiveness Initiative for any given clinical condi- tion can be summarized as follows: 1. to assess the overall merit of competing interventions and 2. to provide information Hat will help clinicians in the management of their patients; assist and improve the peer review process (e.g., of the Medicare Peer Review Organizations [PROs]~; and aid policymakers in allocating Medicare resources. We understand the sequence of steps for the Effectiveness Initiative to be four: 1. monitoring of time trends in the use of services by the Medicare population; 2. analysis of geographic (population-based) variations in the use of services and in outcomes of care; 3. assessment of interventions through four steps: monitoring (as above), variations analysis (as above), clinical demonstrations and obser- vational studies, and randomized clinical trials; and 4. feedback and education. According to the committee's understanding, HCFA will do several things in making its data bases available for the analysis of effectiveness. First, it will use and improve its own data bases as much as possible. Second, when indicated, it will go beyond these administrative data sets to acquire data through clinical demonstration projects and dials. Specially collected information might include data from medical charts (abstracted by He Medicare PROs as part of the Uniform Clinical Data Set effort) and

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3 data obtained directly from patients or over respondents (as part of patient follow-up activities or surveys). Third, HCFA will collect and improve data through both intramural and extramural projects. Finally, the agency will devote a portion of its resources to making data, whether administrative or clinical, available to He research community through public-use tapes and over means, including the proposed national data resource center. The committee strongly supports this approach. We wish to underscore the view that initial assessments of any clinical problem area cannot provide satisfactory effectiveness data in the absence of prospective assessments, even though these can and will be guided by retrospective review of data. We also want to emphasize our particular concern that interpretations of data concerning prevention, management, and rehabilitation are critically dependent on adequate risk-adjusted information, properly matched popu- lations, comparison of alternative approaches, and valid endpoints other than mortality; that is, we believe that both the potential utility and the limitations of the HCFA data sets must be clearly understood and acknow- ledged. One committee member drew the following analogy between the Effec- tiveness Initiative and high-altitude observation of He earth. The process begins win a satellite view of the HCFA data to identify the main features of the scene that deserve closer attention. This step is followed by U-2 surveillance a somewhat closer look at selected areas of He terrain that might, for instance, involve chart reviews by Medicare PROB. The ultimate result is a focus for detailed, low-level reconnaissance based on carefully designed clinical demonstration programs and trials. It was in this context that He committee was pleased to undertake its deliberations and to make its recommendations about the clinical conditions that would provide, initially, He opportunity for satellite observation.