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Setting Priorities for Health Technology Assessment: A Model Process Summary The Institute of Medicine (IOM) Committee on Priorities for Assessment and Reassessment of Health Care Technologies was charged to propose a process for setting priorities for technology assessment in the Office of Health Technology Assessment (OHTA) of the Agency for Health Care Policy and Research (AHCPR) and in other assessment organizations. (AHCPR is part of the U.S. Public Health Service.) In responding to this charge, the committee organized its work and this report at three levels of specification: general principles, a proposed process, and information about how to implement the process in OHTA and other organizations that conduct health technology assessment. This summary reviews the main points of the report: the rationale for the process developed by the committee, the committee's 11 recommendations, seven steps needed to implement the proposed process, anticipated resources and periodicity of the process, and implementation issues that require consideration. Further, it examines how the proposed priority-setting process might be used or adapted by other organizations and for purposes other than technology assessment. RATIONALE Clinicians, payers, and policymakers turn to technology assessment to help provide better information for clinical decision making, to guide coverage decisions, and to set national health policy. Technology assessment can play a valuable role in the entire process of improvement of health and health care. For example, an assessment may show that the data needed for
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Setting Priorities for Health Technology Assessment: A Model Process a complete evaluation of a technology are not available. This finding may serve as an impetus to initiate research to supply the missing information. Similarly, an assessment may lead to changes in practice norms when it yields a conclusion that differs from common clinical behavior. Yet efficient use of resources for technology assessment requires a systematic priority-setting process. In the legislation establishing AHCPR, the IOM was asked to develop a process and criteria for setting priorities for health care technology assessment and reassessment to assist OHTA in its expanded role within that agency. The establishment of AHCPR itself can be seen as recognition of the need to look systematically at the value of health care services in improving health. This kind of assessment uses measures of effectiveness as a means of better understanding the appropriate use of new and established technologies; the expansion of the role of OHTA to develop a comprehensive process to guide this work is consistent with that goal. Such a process should also be of value to other organizations that, notwithstanding their different goals, must develop priorities for the use of limited assessment resources. METHODS OF PRIORITY SETTING The committee described several examples of priority setting from a number of different organizations or groups: (1) the Health Care Financing Administration; (2) a research-intensive pharmaceutical company; (3) the Clinical Efficacy and Assessment Program of the American College of Physicians and the Diagnostic and Therapeutic Technology Assessment Program of the American Medical Association; (4) the priority-setting process used by the IOM's Council on Health Care Technology in its 1990 pilot study; (5) the Food and Drug Administration; two examples of quantitative models of priority setting—(6) David Eddy's Technology Assessment Priority-Setting System and (7) the Phelps and Parente model; and (8) the process developed under the Oregon Basic Health Services Act to set priorities for Medicaid spending. The committee drew on these examples to derive a set of principles for developing a process for OHTA to use in setting priorities. Although individual assessment organizations may have various goals in assessment, the public as a whole has an interest in the effects and use of medical technologies. Public agencies need a comprehensive, proactive process of public input to ensure that the technology assessment provides the greatest gain to the health of the public. In addition, priority setting must be accountable to the public. It cannot be private, implicit, or internal to the organization, and it must include a process that is open, fair, and credible to discriminate among the array of possible technologies that it might assess or reassess.
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Setting Priorities for Health Technology Assessment: A Model Process There are a number of benefits to be derived from the use of analytic models—they structure thinking, use what data are available, open the process to review and accountability, and are amenable to examination and adjustment of both the results and the methodology. Such models move the technology assessment process closer to a realization of its potential for strengthening the scientific basis for decision making. The use of analytic models, however, is more complex and requires more resources (at least initially) and expertise than an implicit process that simply reacts to requests for technology assessment. The committee concluded that any analytic model must include a process to review its product, and a way to include issues of equity, as well as unusual ethical and legal dimensions presented by health care technologies. Nevertheless, priority rankings established by means of an analytic model should be understood as inputs to a final decision process, not the final product of the process itself. GUIDING PRINCIPLES The committee formulated several general principles to direct its development of a priority-setting process. The first such principle is that any priority-setting process for technology assessment must be consistent with the mission of the organization that uses it. For a public agency, the values of the public that the agency serves need to be incorporated into the priority-setting process. Such a process for OHTA will have to assemble information about the potential of a technology to improve health outcomes, to reduce inappropriate expenditures, to redress inequity among those receiving health care, and to inform special social issues. Second, the priority-setting process must consider the information needs of users. The process designed for OHTA should, in general, focus on technology assessment for specific clinical conditions and on alternative approaches to management of those conditions. Third, the priority-setting process must be efficient so that scarce resources for technology assessment are not needlessly consumed in the process of setting assessment priorities. OHTA should seek broad input at the outset, but it should also have some relatively simple mechanism to identify the important topics. The process should also take advantage of available data or, where data are lacking, of subjective judgments, rather than require the collection of new data. Finally, the priority-setting process must be sensitive to its political context; it must be—and must appear to be—objective, open, and fair; it must invite input from a variety of interested parties; and it must present the logic of the process clearly and carefully to others.
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Setting Priorities for Health Technology Assessment: A Model Process THE PROCESS PROPOSED BY THE IOM COMMITTEE Steps in the Process The committee presents below the description of a process that can be understood as logically deriving from consideration of the issues noted in the above principles. Figure S.1 shows seven elements: (1) selecting and weighting criteria for establishing priorities: (2) eliciting broad input for candidate conditions and technologies; (3) winnowing the number of topics; (4) gathering the data needed to assign a score for each priority-setting Figure S.1 Overview of the IOM priority-setting process.
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Setting Priorities for Health Technology Assessment: A Model Process criterion for each topic; (5) assigning criterion scores for each topic, using objective data for some criteria and a rating scale anchored by low- and high-priority topics for subjective criteria; (6) calculating priority scores for each condition or technology and ranking the topics in order of priority; and (7) requesting review by the AHCPR National Advisory Council. Seven Criteria The committee recommended and defined seven priority-setting criteria and explained how to assign scores for each of them. Three of the criteria are objective—prevalence, cost, and clinical practice variations; they are scored using quantitative data to the extent possible. Four of the criteria are subjective—burden of illness, and the likelihood that the results of the assessment will affect patient outcomes, costs, and ethical, legal, and social issues; these criteria are scored according to ratings on a scale from 1 to 5. Reassessment Certain aspects of priority setting apply only to reassessment of previously assessed technologies: these include recognizing events that trigger reassessment (e.g., changes in the nature of the condition, in knowledge, or in clinical practice); the need to track information related to previous assessments; and the obligation to update a previous assessment as a fiduciary responsibility and to preserve the credibility of the assessing organization. Because the committee believes that OHTA has a special obligation to consider previously assessed topics as candidates for reassessment, it also believes that the agency should maintain a process for monitoring the published literature on previously assessed topics and should place candidates for reassessment on the same competitive footing in the priority-setting process as candidates for first-time assessment. The Priority-Setting Cycle The committee envisions priority setting as occurring in a cycle. The panel (see below) sets criterion weights approximately every 5 years. The priority-setting cycle itself repeats at least once every 3 years and leads to a rank-ordered list of conditions and technologies. The priority-setting cycle begins and ends with involvement of persons and institutions outside the federal government. At the beginning, OHTA asks a broad range of persons and institutions to nominate conditions and technologies that they wish to have assessed. OHTA staff collect the data required to set objective crite-
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Setting Priorities for Health Technology Assessment: A Model Process rion scores and convene panels to assign criterion scores to each condition or technology. Human Resources Required to Implement the Process A broadly representative panel would set criterion weights, reduce the list of nominations of conditions or technologies, and assign criterion scores to each of these topics. Subpanels might be required to divide the workload; the subpanels would need to be separately constituted to assign subjective or objective criterion scores. The subpanel(s) assigning subjective criterion scores would be composed of individuals with the same range of perspectives as the full panel. The subpanel(s) assigning objective criterion scores would require experts in epidemiology and health statistics to review the data collected by OHTA staff and to develop estimates when necessary. Publicly Available Products The committee envisions two products of the priority-setting process that would be publicly available: a list of the priority-ranked technologies and the data base used to construct the list. Both would contribute to a priority-setting document published by OHTA. Each highly ranked technology should also be accompanied by a discussion of the features that contributed to its ranking, the data sources used, the level of confidence the panels assigned to the data, and any strongly held minority views. Topics for Which There is Insufficient Evidence to Conduct an Assessment Based on Review of the Literature OHTA should adopt methods that will enable it to conduct preliminary assessments even when there is not yet adequate evidence on which to base a strong clinical policy recommendation. For topics that are of high priority for assessment but for which there is insufficient evidence, the committee particularly recommends using decision analysis as a way to identify which missing evidence is most important for decision making. These results can then be used as input to the development of an agenda for empirical research sponsored by AHCPR. This concept of linking priority setting, assessment of the evidence, and a research agenda is very important to the future of technology assessment and of evidence-based medical practice. RECOMMENDATIONS The committee's recommendations are listed in Table S.1 and are described briefly below.
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Setting Priorities for Health Technology Assessment: A Model Process Table S.1 Recommendations RECOMMENDATION 1 OHTA should adopt a systematic process to assist decision making about which medical conditions and technologies it should assess or reassess. The process should involve a broad spectrum of interested parties and should be open to public view, resistant to control by special interests, and clearly understandable. RECOMMENDATION 2 OHTA technology assessment, whenever feasible, should focus on a clinical problem (e.g., diagnosis of coronary artery disease) rather than on a technology per se (e.g., exercise thallium radionuclide scan). Similarly, priority setting should address clinical conditions. RECOMMENDATION 3 OHTA technology assessments should compare the alternative technologies for managing a clinical condition. Similarly, the priority-setting process should include alternative technologies for managing a clinical condition. RECOMMENDATION 4 OHTA should identify criteria that best characterize a topic's importance as a candidate for assessment. The committee recommends the following objective criteria: • prevalence of the specific condition; • unit cost of the technologies commonly used to manage the condition (or the unit cost of a technology and its alternatives); and • variation in the rate of use of a technology for managing the condition (or variations in the rates of use of the technology and its alternatives). The committee also recommends the following subjective criteria: • burden of illness imposed by the clinical condition; • potential of the results of the assessment to change health outcomes; • potential of the results of the assessment to change costs; and • potential of the results of the assessment to inform ethical, legal, or social issues. RECOMMENDATION 5 OHTA should use an explicit process to determine a candidate topic's priority ranking. In the ranking process, the criteria that are important in deciding whether to do an assessment determine a topic's priority rank. RECOMMENDATION 6 The committee recommends a specific quantitative method to calculate a priority score for each candidate topic using the following formula: where W is the criterion weight, S is the criterion score, and In is the natural logarithm of the criterion scores. A panel of people from a broad spectrum of interests should set the criterion weights.
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Setting Priorities for Health Technology Assessment: A Model Process RECOMMENDATION 7 OHTA should actively solicit nominations of topics to be considered for assessment. The solicitation should include payers, health professionals and their representative organizations, manufacturers of medical products, business, labor, government agencies, and consumers of health care. RECOMMENDATION 8 OHTA should develop a structured procedure for reducing the number of nominations. RECOMMENDATION 9 OHTA should consider all previously assessed topics as candidates for reassessment. RECOMMENDATION 10 OHTA should maintain a data base on each topic that has been previously assessed and should catalog information pertaining to the topic. RECOMMENDATION 11 OHTA should set priorities among topics for reassessment at the same time and on the same footing that it sets priorities for first-time assessment. That is, the committee recommends that OHTA create one rank-ordered list that contains both topics for reassessment and topics for first-time assessment. Recommendation 1 OHTA should adopt a systematic process to assist decision making about which medical conditions and technologies it should assess or reassess. The process should involve a broad spectrum of interested parties and should be open to public view, resistant to control by special interests, and clearly understandable. The process proposed by the committee would be conducted in two phases—the setting of weights for criteria, which is performed approximately every 5 years, and the rest of the priority-setting process, which is performed approximately every 3 years. Recommendation 2 OHTA technology assessment, whenever feasible, should focus on a clinical problem (e.g., diagnosis of coronary artery disease) rather than on a technology per se (e.g., exercise thallium radionuclide scan). Similarly, priority setting should address clinical conditions. Although concern about a new test or treatment often leads to calls for its assessment, whenever possible, a technology should be evaluated within the
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Setting Priorities for Health Technology Assessment: A Model Process context of the clinical condition for which it is being used. There are two reasons for proposing this orientation. First, technology assessment should be comparative, implying that it should answer a useful clinical question: Which technology should a practitioner use and under what clinical circumstances? Second, a technology can only be evaluated in the context of what it does, which is to help solve a clinical problem. Recommendation 3 OHTA technology assessments should compare the alternative technologies for managing a clinical condition. Similarly, the priority-setting process should include alternative technologies for managing a clinical condition. The data required to determine the assessment priority of a clinical condition depend on which technologies are relevant to its management. (For example, the expected cost of managing a condition depends on the costs of the individual technologies that might be used.) Many parties need information about alternative technologies for managing a condition. For instance, clinicians and patients must choose among alternatives tests and treatments. Third parties, too, are concerned about the marginal effects of a technology—the additional benefits and risks represented by one technology in comparison with another. This recommendation holds true even when a new technology is the first to be applied to a clinical problem: when there are no obvious comparative technologies, watchful waiting without therapeutic intervention is always a valid, and important, alternative. The comparison of technologies should take place on a ''level playing field''; that is, the same methods and similar circumstances should be applied to all of the technologies. Recommendation 4 OHTA should identify criteria that best characterize a topic's importance as a candidate for assessment. The committee recommends the following objective criteria: prevalence of the specific condition; unit cost of the technologies commonly used to manage the condition (or the unit cost of a technology and its alternatives); and variation in the rate of use of a technology for managing the condition (or variations in the rates of use of the technology and its alternatives). Ordinarily, the data required to characterize a candidate topic may be found in the published literature or elsewhere in the public record. Preva-
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Setting Priorities for Health Technology Assessment: A Model Process lence is the number of people with the condition per 1,000 persons in the general population. Unit cost is the total direct and induced cost of conventional management for a person with the clinical condition. Variation in rates of use across different settings of care is measured by the coefficient of variation. A high coefficient of variation frequently implies a low level of consensus about clinical management. The committee also recommends the following subjective criteria: burden of illness imposed by the clinical condition; potential of the results of the assessment to change health outcomes; potential of the results of the assessment to change costs; and potential of the results of the assessment to inform ethical, legal, or social issues. Although objective data may exist with which to characterize a candidate topic, integration of these data often requires a subjective estimate. Burden of illness, which is estimated at the level of the patient rather than of society, is the difference between the quality-adjusted life expectancy (QALE) of a patient who has the condition and who receives conventional treatment and the QALE of a person of the same age who does not have the condition. The potential of the results of the assessment to change health outcomes is the expected effect of the result of the assessment on health outcomes for patients with the illness. It includes consideration of the findings of the assessment and of the likelihood of policy and administrative changes, clinical practice changes, and patient acceptance. The potential of the results of an assessment to change costs is the expected effect of the results of an assessment on the costs of illness for patients with the illness. It includes direct costs to the patient and induced costs. The committee anticipates that most conditions will be adequately ranked based on the first six criteria listed above. The seventh criterion—the potential of the results of the assessment to inform ethical, legal, or social issues—gives the priority-setting panelists the opportunity to take a broad social perspective and to ask whether there is anything that has not been captured in the first six criteria that would alter the priority listing of a particular topic. Recommendation 5 OHTA should use an explicit process to determine a candidate topic's priority ranking. In the ranking process, the criteria that are important in deciding whether to do an assessment determine a topic's priority rank.
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Setting Priorities for Health Technology Assessment: A Model Process The committee recommends the use of a process that can be examined, challenged, and adjusted on the basis of tests of its reliability and validity. Use of a quantitative model as part of this process allows assumptions to be explicitly stated and individually assessed; it also permits the use of data, whenever they are available. Recommendation 6 The committee recommends a specific quantitative method to calculate a priority score for each candidate topic using the following formula: where W is the criterion weight, S is the criterion score, and In is the natural logarithm of the criterion scores. A panel of people from a broad spectrum of interests should set the criterion weights. In the process proposed by the committee, a broadly based panel would be created to lead the necessary activities. Its first task would be to establish the criterion weights through one of several possible procedures that are detailed in the full report. Once established, these criterion weights remain constant for the entire priority-setting process (i.e., across all candidate topics). A topic's priority score determines its priority rank. According to the committee's method, each candidate topic receives a criterion score for each of the seven criteria (for example, S1 might be prevalence expressed as a number per 1,000 persons in the general population). In addition, each criterion has a criterion weight that reflects its importance in determining priorities for technology assessment. (W1, for example, might be a weight of 2 for prevalence, relative to a burden-of-illness criterion weight of 3.) Each candidate topic has its own combination of criterion scores (Sn) for the seven attributes. The panel noted above (or a subset of its members) reviews data prepared for each topic by OHTA staff and assigns the critelion scores. Objective criterion scores are determined by a subpanel with expertise in clinical epidemiology and statistics. Subjective criterion scores are determined by a broadly representative panel (or subpanel) with expertise in health care. Recommendation 7 OHTA should actively solicit nominations of topics to be considered for assessment. The solicitation should include payers, health profes-
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Setting Priorities for Health Technology Assessment: A Model Process sionals and their representative organizations, manufacturers of medical products, business, labor, government agencies, and consumers of health care. The committee judged that a widespread solicitation of topics is crucial to the success of the priority-setting effort. In particular, the solicitation should be broad enough to ensure that important technologies are not omitted inadvertently from consideration and that all important constituencies are included in the process. Recommendation 8 OHTA should develop a structured procedure for reducing the number of nominations. The initial number of nominations will almost certainly far exceed staff capacity to collect the data required to assign criterion scores to each topic. Therefore, the committee proposes that a formal procedure be adopted to reduce that initial list to a manageable size—a technique it calls "winnowing." The full report describes three possible methods of winnowing and proposes one for OHTA. Recommendation 9 OHTA should consider all previously assessed topics as candidates for reassessment. OHTA has a special obligation as an influential public agency to revisit any previously assessed topics whose recommendations may be based on outdated or now erroneous information. A change in the nature of the condition, expanded professional knowledge, a shift in clinical practice, or publication of a new, conflicting assessment might trigger consideration of a condition and technology for reassessment. Recommendation 10 OHTA should maintain a data base on each topic that has been previously assessed and should catalog information pertaining to the topic. A catalog will make it easier for OHTA to know when to consider topics for reassessment and when newly published information is relevant to a topic that has been previously assessed. Information should include descriptions of data, populations, and methods used in the earlier assessment, the impact and controversy generated, and a topic-specific estimated date or interval for considering reassessment.
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Setting Priorities for Health Technology Assessment: A Model Process Recommendation 11 OHTA should set priorities among topics for reassessment at the same time and on the same footing that it sets priorities for first-time assessment. That is, the committee recommends that OHTA create one rank-ordered list that contains both topics for reassessment and topics for first-time assessment. The process of determining the need for reassessment can be accommodated within a priority-setting process for first-time assessments with the addition of several specific components: (1) a system for tracking previous assessments and events that prompt recognition that a major factor (e.g., a clinical condition or practice, information) has changed relative to the old assessment; (2) evaluation of literature that suggests that reassessment might be needed; (3) a decision by the priority-setting panel that a technology or clinical practice has changed sufficiently to warrant reassessment; and (4) a sensitivity analysis that suggests that the conclusion of an initial assessment might change when a reassessment is conducted. ADOPTION OF THE IOM'S PRIORITY-SETTING PROCESS BY OTHER ORGANIZATIONS Many organizations evaluate health technology, although the major categories of such organizations are third-party payers, such as the Health Care Financing Administration (HCFA) and the Blue Cross and Blue Shield Association (BCBSA), and associations that represent physicians, such as the American College of Physicians. The committee developed this proposal for a priority-setting process with the expectation that the process would apply and be useful to these and similar organizations, as well as to OHTA. That expectation is based on the following: Although these organizations are part of the private sector, they also constitute a major public resource, both individually and collectively. The more they structure their technology assessment activities, including priority setting, as a public service, the greater the good they will do for their own private purposes and for their mission of public service. By focusing on clinical conditions rather than on individual technologies, their assessments are more likely to compare relevant alternative patient care strategies. The argument that priorities for assessment should be determined by several attributes is quite generalizable. An organization that uses only one dimension (e.g., cost, burden of illness) is oversimplifying a very complex matter. The trade-off between cost and effectiveness is one of the most
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Setting Priorities for Health Technology Assessment: A Model Process important questions that physicians and patients must understand and resolve daily in the office or hospital. Because the committee's process accommodates the choice of any priority-setting criteria, an organization may choose criteria that serve its own interests. The committee argues, however, that public trust, which sustains any large organization of payers or professionals, requires criteria that are responsive to the public interest, as exemplified by the committee's seven criteria. If one accepts the argument that any organization performing health technology assessment, or the officers of that organization who are responsible for the technology assessment, are accountable to the public, at least in very general terms, it would seem to follow that any process of establishing priority rankings should be open, explicit, and understandable. The process of soliciting nominations is one element of an ideal process that could be designed to satisfy the needs of a specific organization without compromising the public interest. The committee believes that any program of technology assessment must encompass a commitment to reassess topics that have been previously assessed. This commitment must be supported by a program to monitor previously assessed topics for new information that might prompt a reassessment. The rationale for this recommendation is public accountability, but it applies to private interests as well. For example, an organization of physicians should not have a potentially obsolete policy on the public record. Neither should a payer continue to provide or to withhold coverage on the basis of information that may have been superseded by newly published data. Technology Assessment and Clinical Practice Guidelines The committee's priority-setting process may also be useful in setting priorities for developing practice guidelines. Clinical practice guidelines, according to another IOM committee's definition, are "systematically developed statements to assist the practitioner and patient in decisions concerning appropriate health care for specific clinical circumstances." Clinical practice guidelines are one vehicle for disseminating the results of technology assessment, and technology assessment is one method of producing information for a practice guideline. In particular, clinical practice guidelines may use the synthesis of available evidence and projection of outcomes that are a part of technology assessment as a foundation for statements that are clinically useful in individual patient care. Good practice guidelines go one step further, however, to rely on expert consensus to develop practical advice for clinicians in situations not directly addressed by clinical research.
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Setting Priorities for Health Technology Assessment: A Model Process What further distinguishes practice guidelines from technology assessment is the requirement that guidelines very carefully and explicitly describe the thinking that links the evidence (that is, the product of the technology assessment), or the lack of evidence, with the advice. Nonetheless, because technology assessment is so closely related to the development of practice guidelines, the priority-setting process proposed in this report appears to be largely, if not completely, applicable to guidelines development as well. POTENTIAL PROBLEMS WITH THE PRIORITY-SETTING PROCESS The report discusses several potential problems with the proposed priority-setting process. For example, will a numerical priority score lead to unrealistic inferences about the precision of the ranks? Does codifying an idealized process lead to inflexibility? Will there be a bias toward choosing topics that are quantifiable? The committee believes that most of these apparent difficulties are the result of misperceptions stemming from the use of a quantitative model to calculate a priority score for an assessment candidate. The great advantages of the model process are that it is explicit, that it contains a representation of the values of society, and that it defines the information-gathering tasks involved in priority setting. CONCLUDING REMARKS Although this committee has recommended a specific step-by-step methodology as a priority-setting process, it believes that the four principles noted earlier in this summary are far more important than the specifics of its model. In the case of OHTA, satisfying the first principle will require determining which assessments are most likely to result in improvement in the health of the public, reduction of inappropriate health care expenditures, reduction of inequities in access to effective health care services or of maldistribution across equally needy populations, and the informing of other ethical, legal, and social issues. OHTA and other organizations may wish to modify some of the components of the process as proposed. Experience with using this method or others will provide a sound basis for change, and organizations should constantly reexamine their methods for setting priorities. When making any changes, these groups should consider carefully whether modifying a given element might adversely affect the performance of the entire process. In proposing a strategy for an optimal priority-setting process, the committee realizes that funding for technology assessment is already constrained and that its proposed priority-setting system will require some additional
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Setting Priorities for Health Technology Assessment: A Model Process resources. Given the potential value of priority setting, however, the funding for this effort appears to be justified. The committee views its report as a strategic effort to look ahead to reasonable goals for AHCPR and OHTA and to create a process that will be credible, sound, and defensible. During the process of compiling data for the quantitative model, OHTA will create a valuable data base and a ranking of priorities; both will be important resources for other organizations as well as for OHTA itself. Indeed, such a program could lead not only to wise use of public and private resources for technology assessment but also to an increase in public support for the entire technology assessment process.
Representative terms from entire chapter: