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Summary The goal of Be Institute of Medicine's Council on Health Care Tech- nology is to promote the development and application of technology assessment in heath and medicine. Its efforts are guided by the premise ~ the purpose of technology assessment is to improve patient weB- be~ng and Be quality of care, consistent with the effective use of health care msources. Among the activities cited in the congressional charge that provided for its formation, We council is to "identify needs in the assessment of heady care technology" (P.~. 98-551, as amended). Early In its deliberations, Be council decided to expand its charge to identify priority clinical conditions as wed as medical technologies and practices. The process for setting assessment priorities demonstrated in this pilot study and Be Initial set of 20 priority assessment areas selected are in response to this expanded charge. The council and its prionty-setting group opted for a two-stage strategy to address its charge to set priorities for health care technology assess- ment. The pnority-setting group recognized bow Be need for a national process for the assessment of medical practice and the lack of widely accepted pnonty-set~ng methodologies and adequate primary data to address this need. The group decided to undertake a pilot effort Cat would set a framework for national pnonty-setting, outline national pnor- iW-sefflng cntena, and use a consensus process to identify a preliminary list of priority clinical conditions and medical technologies. A second, foBow-up effort to furler support and descnbe Be pnondes would build on Be experience of the pilot effort and on available data and resources for furler methodologic development This report is the record of the Fist, pilot effort. The pnonty-setting approach demonstrated here relies upon explicit criteria that are applicable at We national level and reflect Be diverse needs of patients, clinicians, researchers, payers, heady facility manager, and policymakers. The members of Be pnonty-sening group and Be organizations Cat provided infoImadon about the pnondes are broadly representative of beach care sectors having different types of assessment needs. The list of priorities identified in this pilot study represents assessment areas Rat are of national importance fimm Be broad, mul~pro- gram, multiorganization, and multisector perspective considered. These

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2 NATIONAL ASS=SM&VTPRlORmES priority areas may be tailor, however, to reflect the needs and pnor~ty- setting criteria of different health care sectors. The council used both a clinical condition approach and a technology approach for setting national assessment pnor~ties. In evaluating medical technologies and practices, the clinical context in which they are used and the needs and characteristics of He patient populations of interest should be taken into account. Accordingly, we favor the clinical condition approach to evaluating medical practice. The council recognizes, how- ever, that priorities may arise as well in terms of particular technologies, and that a national process for setting priorities must also accommodate the needs of those onented to a technology approach. ASSESSING MEDICAL PRACTICE An increasing interest in what constitutes appropriate and cost-effec- tive medical practice is leading to more assessment of the drugs, devices, medical and surgical procedures, and other technologies used in patient care. Such evaluations use a variety of approachesólaboratory or bench testing, clinical trials, experimental and quasiexperimental epidemiologic mesons, consensus methods, and others. Even so, many medical tech- nolog~es and practices have not been subjected to rigorous assessment. Although much of the evaluation activity conducted to date has been canned out in expenmental or other more-or-less contmBed conditions, new attention is being given to '6 whet works" in genes medical practice, that is, to assessing We effectiveness of medical care delivered in eve~y- day practice to improve the health outcome of patients. Research into effectiveness and patient outcomes has been prompted, in part, by rising expenditures for health care, now at about 11 percent of the yearly gross national product. These concerns are heightened by findings about medical practice pattems, such as Lose indicating wide geographic variations in practice Cat apparently are not associated wad underlying differences in need or major differences in health outcomes. "E:ffec~veness" and "patient outcomes" research are contributing to the knowledge needed to guide appropn ate medical care. There is greater emphasis on using and increasing He quality of data included in patient records, ~ird-party payment claims, and other sources. Advances in as- sessing heath and functional status also contribute to the evaluation of medical practice. The growing interest in the evaluation of medical practice is high- lighted by several recently initiated government programs. The Patient

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SUMMARY 3 Outcome Assessment Research Program of the National Center for Health Services Research and He Effectiveness Initiative of the Health Care Financing AS stration were incorporated into the Medical Treatment Effectiveness Program of the Department of Health and Human Services. Legislation enacted In November 1989 established a new Agency for Health Care Policy and Research"to enhance He quality, appropnate- ness, and effectiveness of health care services." These federal research programs, as wed as He varied and numerous efforts in the private sector, pose a need for choices about which assess- ments to undertake. Limited resources for evaluation need to be allocated to realize the greatest impact. Different assessment programs set priorities using their own implicit or explicit cnteria, and conduct evaluations according to Heir missions, perspectives, and constituencies. In order to take the best advantage of the overall national assessment capacity, the council seeks to encourage these programs to conduct assessments that would yield the most benefit from a national perspective. A NATIONAL APPROACH The council recommends that a national process for setting assessment . ∑ . prlontles encompass: explicit and welB-accepted criteria for pnor~ty-seuing mat are applicable at the national level, a conceptual framework that accommodates bow clinical condi- tions and medical technologies as assessment pnonties, and ∑ an accountable process for pnority-sefflng Hat involves a broad range of assessment interests. The national pnonty-setting approach described here is distinct from previous approaches In two ways. First, this approach attempts to incor- porate the assessment needs of multiple organizations concerned why He production, delivery, and payment of a range of medical services and products for a variety of padent populations. Second, He conceptual framework used here is intended to integrate the perspectives of Nose whose priorities arise in teens of coca conditions and those whose priorities arise in terms of particular technologies. In developing pnonties, the council consulted organizations represent- ing major types of assessment activity. Among He 14 organizations Hat provided background information for the prion~-setting group are two physicians' organizations, a hospital association, a federal payer for heath

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4 NAT70NAL ASSESSME=PRlORITIES care, two private sector payers, two health care product makers, two federal agencies that conduct and support research, two federal policy advisory agencies, an independent health product evaluator, and an aca- demic-based policy institute (see Appendix C). The members of the prionty-sefflng group were also broadly representative of sectors of health care, both in and out of government, having different types of assessment needs. Finally, He pnonty-seuing group was also informed by quantitative models under development by individual investigators. Of particular use to Be group were Me econometric mode] developed by Charles Phelps of the University of Rochester and We interactive expert systems approach developed by David Eddy of Duke University. PRIORITY-SETTING CRITERIA The council determined that it is appropn ate to select priorities based upon the potential for a wet/-conducted assessment of a clinical condition or technology to improve medical practice. The pnma~y and secondary criteria used here provide explicit standards for comparing candidate as- sessment areas in teens of the relative impact that may result from an in- vestment in evaluating each area. The primary pnonty-setting criteria account for important elements that must be considered in aB evaluations and Cat may be readily quand- fiable Hugh different measures. They include He potential for an assessment to: ∑ improve individual patient outcome, ∑ affect a large patient population, ∑ reduce unit or aggregate cost, and ∑ reduce unexplained variations in medical practice. The secondary criteria account for over factors Hat should be taken into account in pnonty-setting decisions, but that may be more difficult to quantify because of their more genera or subjective nature. They include the potential for an assessment to: address social and ethical implications, advance medical knowledge, affect policy decisions, enhance He national capacity for assessment, and be readily conducted.

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SUMMARY s The 20 assessment priorities selected In this pilot sway satisfy all or most of the pnmary criteria and one or more of the secondary critena. TWENTY ASSESSMENT PRIORITIES Using a two-round modified Delphi approach, He pnonty-setting group chose 20 national assessment priorities from a list of 496 candidate topics (see Appendix A). The priority assessment areas listed below include 14 clinical conditions and 6 technologies: Clinical Conditions: Breast cancer Cataracts Chronic obstructive pulmonary disease Coronary artery disease Gallbladder disease Gastrointestinal bleeding Human unmunodeficiency vines infection loins disease & injury Low back pain Osteoporosis Pregnancy Prostatism Psychiatric disorders Substance abuse Technologies: Diagnostic imaging technologies Diagnostic laboratory testing Ery~poietin Lrnplantable devices Intensive care units Organ transplantation & replacement In identifying these priorities He group considered altemative medical technologies that may be used for each of the priority clinical conditions and He multiple cI~n~cal indications for the priority technologies. This list of priorities represents, however, a preliminary set of general assessment areas that need to be delineated further. USING THE PRIORITIES Although individual assessment programs continue to set Heir own priorities based on their respective needs and resources, a national agenda is intended to can attention to the evaluadon of areas of national ~mpor- tance that reflect broader needs and interests and Hat may not be ad- dressed otherwise.

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6 NA77ONAL ASSESSMENT PRIOR1~17ES The priorities may be used: ∑ to assist federal research programs, private foundations, and over major funding sources in supporting assessments of national importance, ∑ to encourage progrmns to undertake evaluations in areas of national need, consistent with their respective program missions and capabilities, and ∑ to provide the basis for a national-level broker~ng or cleannghouse function that would assist in coordinating the funding of assessments by appropriately qualified prog~ns. Although existing data and me~odologic approaches may suffice to meet certain assessment needs, addressing many priorities win reveal a lack of data, the inadequacy of existing means of investigation, balkers to the use of existing data, or an inadequate expertise for conducting needed studies. Caning attention to such shortcomings may influence the aBoca- tion of funds to develop resources for overcoming these problems. ACCOMMODATING CLINICAL CONDITIONS AND TECHNOLOGIES A continuing process for setting national assessment priorities must accommodate the different manners and contexts in which questions about evaluating medical practice anse. It must consider how technolo- gies may be used to manage clinical conditions for different types of patients. Questions about particular medical drugs, devices, or proce- dures must be answered in the context of the coccal conditions for which they are appropn ate and in comparison win other clinical management altemadves. The combined coca condidon/technology framework for pr~ondes presented in this report takes into account which altemative medical technologies and practices, or combinations of these, may be used for the management of particular clinical conditions. Medical technologies may be used for different types of interventions, such as prevention, screening, diagnosis' and treatment. The use of no technology may be the most appropriate altemative in certain situations. On the one hand, concerns may arise about the best or most appropn ate approach for preventing or treating clinical conditions such as myocardial infarction or hip fracture. This calls for a comparative assessment of the set of alternative technologies or practices Hat may be applied to the

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SUMMARY clinical condition affecting the patient. These are instances in which assessment priorities arise in the form of particular clinical conditions. On Me other hand, the introduction of a promising new technology such as a genetically engineered clot-lysing agent, or concerns about technologies already in genes practice, may raise questions about the safety, effectiveness, cost, and appropriateness of these specific technolo- g~es. A technology such as magnetic resonance imaging may be used for multiple clinical conditions and may compare differently with altema- tives depending upon the clinical condition at hand. These are instances in which assessment priorities may arise In He form of particular tech- nologies or practices. Whether an assessment is prompted by questions about a particular technology that has one or more applications or by questions about the best way to manage a clinical condition for which alternative technologies may be applicable, these questions must be considered in a shared frame- work. This pilot effort therefore integrates the clinical condition approach and technology approach to set national assessment priorities. This com- bined approach accounts for priorities that arise in the form of clinical conditions, as well as priorities that arise in the form of particular prac- tices or technologies. NEXT STEPS In this pilot study the council outlines national pnor~ty-setting criteria, provides a framework for selecting evaluation topics, and uses a consen- sus process to identify an initial set of 20 priority clinical condition and medical technology areas that merit assessment at a national level. A follow-up effort will be needed to update and further develop the descnp- tion of the priority areas and to provide more specific guidance conce~n- ing the steps needed to address these pnonties. The specific questions about these general assessment areas need to be fonnulated, the data bases and methodologies necessary to conduct these studies need to be identi- fied or developed, the necessary manpower and financial resources need to be allocated, and the findings of these evaluations need to be widely disseminated to the health care community. Consistent win one of the roles of the Institute of Medicine, the council seeks to convene assessment organizations to encourage them to undertake high-pnonty assessments and engage them In this process.

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