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Introduction Much has been expected and desired of guidelines for clinical practice, and much has been feared. A 1992 Institute of Medicine (IOM) report on practice guidelines noted that guidelines have been tied in some way positively or negatively to concerns about quality of care, patient empowerment, professional autonomy, medical liability, access to care, rationing, competition, benefit design, utilization variation, bureaucratic micromanagement of health care, and more. Recently, several legislative proposals to reform health care in the United States included a major role for practice guidelines. Although these proposals were not acted upon, guidelines are likely to remain a visible component of the restructuring of the health care system now underway. Experience has, however, tempered initial suggestions that guidelines would provide quick fixes for cost and quality problems. Naive optimism has generally been replaced by greater understanding ofthe difficulties involved in developing credible and useful guidelines, implementing them, and evaluating their effects. Fortunately, policymakers, health care organizations, and others are showing considerable persistence and energy in trying to work through these challenges. They are tackling tougher clinical problems than in the past and investing more in explicit efforts to measure whether guidelines are producing the desired outcomes and, if not, to identify why. The conceptualization of outcomes and effectiveness is becoming more sophisticated in several respects, for example, in distinguishing between short- and long-term outcomes, in considering how patients view specific outcomes, and in developing new tools for measuring different kinds of outcomes. An increasing number and range of local institutions are investing their own resources in systematic efforts to formulate or adapt guidelines that are both compatible with local objectives and environments and consistent with evidence about the outcomes of alternative 11

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12 SEWING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES preventive, diagnostic, and therapeutic interventions. The enterprise, in other words, is both evolving and expanding. Although not universally welcomed by clinicians, guidelines have gained greater legitimacy. Their acceptance reflects an increased recognition of the value of evidence-based guidelines, the refinement of methods for developing guidelines, the accumulating experience with guidelines of health care providers and others, and the changing incentives in health care delivery and financing. Since the IOM first examined practice guidelines, cost pressures have intensified. That guidelines should examine the cost implications of clinical problems and alternative courses of care is more generally accepted, but debate continues about how developers of guidelines should consider costs in formulating recommendations. In a 1992 report, another IOM committee recommended that "every set of clinical practice guidelines be accompanied by information on the cost implications of alternative preventive, diagnostic, and management strategies for the clinical situation in question." It noted that the recommendation posed a number of methodological and practical challenges and that some developers of guidelines (e.g., managed care organizations) might be better able than others to make cost-effectiveness judgments because they have better information and more consistent objectives. Others groups might be better advised to emphasize clinical judgments. The preoccupation with cost containment among providers and purchasers of care has created some concern that the incentives for undertreatment are multiplying as the incentives for overutilization of health care are being dismantled. Those with broad responsibility for the public's health most notably, federal and state governments have a clear duty to monitor potential quality-of-care problems, consider the needs of disadvantaged groups, and address such problems and needs in guidelines for clinical practice. Changes in the health care environment have implications for the federal government's role in supporting the creation and use of sound guidelines for clinical practice. That role was established in 1989 (P.L. 101-239) when Congress created the Agency for Health Care Policy and Research (AHCPR). The broad purposes of the organization were "to enhance the quality, appropriateness, and effectiveness of health care services . . . through the establishment of a broad base of scientific research and through promotion of improvements in clinical practice and in the organization, financing, and delivery of health care services." One specific way the agency was to promote these purposes was by sponsoring and encouraging the development, dissemination, and evaluation of clinical practice guidelines. In 1992, reflecting some concern about the agency's choice of topics for guidelines development, Congress directed that the agency report to it in June 1995 on "optimal methods for setting priorities for guidelines topics" (P.L. 102- 410~. The AHCPR, in turn, requested guidance from IOM on this subject, and this report presents the analyses and recommendations developed by a formally appointed IOM study committee.

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INTRODUCTION 13 Consistent with committee and staff discussions with the AHCPR's leadership, this report examines priority setting in the context of the organization's overall responsibilities, objectives, and resources. The immediate audience is the AHCPR and other government policymakers, but much of what the report says about priority setting and related issues should interest a larger audience of clinicians, administrators, and researchers. Chapter 4, in particular, moves beyond the issue of procedures and criteria for setting priorities to raise questions about the processes for developing and disseminating guidelines and the role of AHCPR. BACKGROUND The legislation that created AHCPR reflected growing public anxieties about possible inappropriate use of medical care and its cost, although the statute itself did not explicitly identify costs or cost containment as an objective for clinical practice guidelines. These concerns arose from many sources, including data showing wide variations in the use of medical services, research questioning the value of many expensive or common services, and analyses noting that the effectiveness of many services has never been established. Alarmed by escalating health care costs and limited government success with various cost containment initiatives, policymakers decided that more effort should be devoted to expanding knowledge about what works and what does not work ~ health care and at what cost. The 1989 legislation consolidated within AHCPR a health services research agenda that had already begun to focus on medical care effectiveness through three programs: (1) the Effectiveness Initiative of the Health Care Financing Administration (HCFA), (2) the Patient Outcomes Assessment Research Program of the National Center for Health Services Research (NCHSR), and (3) the Office for Health Technology Assessment (OHTA), also part of NCHSR. The new agency completely replaced NCHSR, thereby assuming responsibility for all the center's programs in health services research, not just those related to effectiveness studies.' Through its Center for Medical Effectiveness Research, AHCPR has formed a number of multi-year, multi-institutional Patient Outcome Research Teams iAs of November 1, 1994, the eight major divisions of AHCPR were Office of Planning and Resource Management, Office of Science and Data Development, Office of the Forum for Quality and Effectiveness in Health Care, Office of Health Technology Assessment, Center for Medical Effectiveness Research, Center for General Health Services Intramural Research, Center for General Health Services Extramural Research, and Center for Research Dissemination and Liaison.

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14 SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES (PORTs) to study the outcomes and costs of alternative treatments for specific clinical problems. ~ some cases, PORTs are providing knowledge that can be used by others to develop guidelines. In other areas, the PORTs themselves are developing patient care recommendations. The OHTA continues to provide HCFA with assessments and reviews of technologies being considered for coverage under the Medicare program.2 The 1989 legislation, however, broadened OHTA's focus and called for an IOM study to recommend priorities for the selection of assessment topics. After discussion between the agency and the IOM, the study was reformulated to focus on methods for setting priorities. The project report, Setting Pr~or~tiesforHealth Technology Assessment: A Model Process, was published in 1992,3 and that document has constituted an important point of reference for the current study. The model process it recommended is discussed in Chapters 2 and 3; Appendix A reproduces the summary of that report. Within AHCPR, the Office of the Forum for Quality and Effectiveness in Health Care was created to oversee guidelines development activities. The concept behind the Forum was not that it would produce "federal" guidelines but, rather, that it would "arrange for" guidelines to be developed through a cooperative public-pr~vate effort. As of October 31, 1994, the AHCPR had published 13 sets of guidelines and had 8 under development (fable 1.1~. In addition, a list of new topics under consideration was scheduled for publication in the Federal Register in late 1994. Practice guidelines constitute a relatively small part of AHCPR's responsibilities. For fiscal year 1994, $5.7 million of the agency's $154 million budget was allocated for the guideline panels and contracts managed by the Forum. This figure does not include Forum staff and overhead costs. Other parts of AHCPR also have responsibilities related to guideline dissemination and other tasks, but their fiscal impact is small. COTTA assessments were the primary basis for three of the five national Medicare coverage decisions published by HCFA between October 1992 and February 1994 (GAO, 1994~. Most coverage decisions are made by the 32 contractors that administer the Part B (physician) program. A U.S. General Accounting Office (GAO) report has suggested that HCFA "increase its assessment capabilities" by making better use of the evaluation capabilities of the contractors' medical directors and those of private insurers. 3This report, in turn, built upon an earlier pilot study on national priorities for assessing clinical conditions and medical technologies (IOM, 1991~.

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INTRODUCTION TABLE 1.1 AHCPR Guidelines as of December 1, 1994 15 Published Guidelines - Under Development Acute pain management: operative or medical procedures and trauma Urinary incontinence in adults Pressure ulcers in adults: prediction and prevention Cataract in adult: management of functional impairment Depression in primary care: Vol. 1: detection and diagnosis; Vol. 2: treatment of major depression Sickle cell disease: screening, diagnosis, management and counseling in newborns and infants Evaluation and management of early HIV infection Benign prostatic hyperplasia: diagnosis and treatment Management of cancer pain Unstable angina: diagnosis and management of Heart failure: evaluation and care of patients with left ventricular systolic dysfunction Otitis media with effusion in young children Quality determinants of mammography Acute low back problems in adults Treatment of pressure ulcers in adults Post stroke rehabilitation Cardiac rehabilitation Recognition and initial assessment of Alzbeimer's and related dementias Urinary incontinence in adults- update Smoking prevention and cessation Screening for colorectal cancer Chronic pain: headache SOURCE: AHCPR. COMMITTEE APPROACH Composition and Activities To undertake the study requested by AHCPR, the IOM appointed a 12- member committee in early 1994. Members were selected for their expertise and experience with clinical practice guidelines, health care delivery and financing, health services research, and health policy. The committee met in March and

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16 SEWING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES August 1994. AHCPR staff were invited to both meetings and made presentations on the agency's activities and concerns. In conjunction with its August meeting, the committee organized an invitational workshop to gain additional perspectives on issues in priority setting. ~ he meeting agenda and a list of participants appears in Appendix B.) Workshop participants also considered more general questions that the agency's new leadership posed about the Forum's roles and focus. As background for the workshop and the report, the committee commissioned several short papers that dealt with malpractice, local protocol development, and primary care as issues that might be considered in setting priorities for guidelines development. (These papers are included as Appendixes C, D, and E.) In developing this report, the committee drew on other IOM work in the areas of practice guidelines, health care technology, effectiveness research, quality assurance and improvement, and, as mentioned above, priority setting for technology assessment. Particularly relevant to this report are earlier analyses and advice concerning clinical conditions that should receive priority in HCFA's Effectiveness Initiative (IOM, 1989b, 1990a,b,f), quality assurance strategies for the Medicare program (IOM, 1990h), ways to improve consensus development within the National Institutes of Health program for evaluating biomedical technologies and practices (IOM, 1 990d), and methods for developing guidelines for clinical practice and for assessing guidelines to inform potential users of their strengths and limitations (IOM, 1990c, 1992a). When AHCPR requested this IOM study, it asked that priority-setting methods for guidelines be assessed in terms of organizational feasibility as well as achievement of the agency's objectives for improving the quality, effectiveness, and appropriateness of health care services. In contrast, when AHCPR asked for the earlier IOM study for technology assessment, it requested a process that would be viewed as objective, broadly based, and defensible against charges of institutional bias. The nature of the earlier request to the IOM reflected AHCPR's awareness that OHTA technology assessments had been undertaken largely in response to HCFA's requests for coverage advice and could be perceived as biased toward HCFA's economic concerns. The extent to which OHTA is actually broadening the kinds of topics it assesses is yet to be demonstrated, but, as described later in this report, the office has proposed and provisionally adopted a more open and explicit process for priority setting, as recommended by the IOM. Much of this report draws comparisons and contrasts between the two AHCPR units as a basis for considering future directions for the Forum's priority-setting processes. The committee also reviewed new or updated information on priority-setting processes used by several public and private groups with significant investments in guidelines development, technology assessment, and similar activities. These groups include both national and local organizations. Consistent with the policies

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INTRODUCTION 17 of the National Research Council, this report was reviewed by outside reviewers with expertise in the field. Definitions Because terminology is so variable, the committee needed to define several terms that are central to this report. Clinical practice guidelines are "systematically defined statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances" (IOM, 1990c, p. 38~. They provide clinical advice (and sometimes ethical, organizational, and other advice), and they may take many forms, such as algorithms, computer- based protocols, and policy documents. Some groups, such as the American Medical Association, prefer to speak of practice parameters or practice policies rather than guidelines and to focus mostly or entirely on advice for practitioners (or, more narrowly, physicians). One use of guidelines is in formulating medical review criteria, another task required of AHCPR. These are "systematically developed statements that can be used to assess the appropriateness of specific health care decisions, services, and outcomes" (IOM, 1990c, p. 44~. Because the Forum's review criteria build on its practice guidelines, priorities for the latter necessarily become priorities for the former. As broadly defined by the Office of Technology Assessment (OTA, 1978), the term medical technology covers "drugs, devices, medical and surgical procedures, and the organizational and supportive systems" employed in patient care. In this formulation, pain medications, lasers, repairs of hip fractures, intensive care units, and computer-based patient records are all medical technologies. Technology assessments present information on patient care alternatives for patients, clinicians, and others (IOM, 1992b), or, more narrowly, they provide analyses of technologies as "input to policy decisions" regarding insurance coverage or equipment purchase decisions (OTA, 1994~. The line between a guideline (which assists decisionmaking) and an assessment (which provides information) is not sharp. The different terms are useful primarily as rough indications of the focus, purpose, and style of evaluations. Practice guidelines tend to focus in the first instance on clinical conditions (e.g., benign prostatic hyperplasia), although the content of a guideline must typically present assessments of one or more technologies.4 Most 40f the guidelines already developed or planned by AHCPR, at least one (quality determinants of mammography) is directed more to a technology than to a clinical condition. Of the 30 potential topics about which the agency requested comments in 1993, three (tests of uteroplacental insufficiency in prenatal care, antibiotic therapy, and

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18 SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES technology assessments focus on technologies, but often they do so within the specific framework oftheir appropriateness for a particular clinical problem (e.g., autologous bone marrow transplants for breast cancer). In contrast to guidelines, technology assessments are more often staff documents rather than products of expert panels (OTA, 1994~. The term clinical condition has no precise definition. It is used- sometimes broadly and sometimes quite narrowly to label a health state characterized by a set of signs and symptoms indicating a departure from normal function, appearance, or feeling (derived from Stedman 's Medical Dictionary, 24th edition, 1982~. Hypertension, malignant hypertension, and hypertension in diabetics are all clinical conditions, but the latter two are more narrowly defined than the first. Clinical condition and clinical problem are sometimes treated as synonyms in this report. In the context of this report, a priori-setting method consists of several possible elements that may vary in character or even presence in actual organizations. These elements include criteria (based on program objectives) to be considered in setting priorities; techniques for judging or scoring topics on each criterion, establishing weights for each criterion, and -combining criterion scores to achieve an overall score or rank for a topic; and procedures for - identifying participants and their roles, nominating topics for initial examination, screening topics and identifying a set for more intensive examination, Collecting information about individual topics relevant to identified criteria, and making and reviewing decisions about final topics. Principles The 1992 IOM report on priorities for technology assessment proposed four principles for any priority-setting process. The process should (1) be consistent with the mission of the organization that is to use it, (2) provide results usable to that organization, (3) be feasible for the organization to implement, and (4) be efficient. This committee endorsed these principles and added another that is genetic screening and counseling during prenatal care) are wholly or partly described in terms of technologies (AHCPR, 1993~.

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INTRODUCTION 19 essentially a corollary of the first principle cited above: (5) for public agencies, in particular, the topic selection process should be open and defensible. Although not a principle per se, the committee viewed priority setting as an exercise in selecting a set of good, sound topics for guidelines development. The process should distinguish among topics of high, moderate, or low importance and then avoid the selection of unimportant topics. A moderately important topic might, however, be selected in preference to a more important topic if the development process promised to be particularly easy and inexpensive. Note that the principles cited above apply to the priority-setting process as a whole. They do not, in themselves, constitute criteria for actually selecting specific guidelines topics. Selection criteria related to the costs, prevalence, or other aspects of a clinical problem are discussed in Chapter 2. Furthermore, neither the principles nor the selection criteria discussed in this report describe desirable characteristics of processes for developing, publishing, disseminating, or evaluating guidelines. Two earlier IOM reports on clinical practice guidelines (1990c, 1992a) discussed these issues and offered recommendations. During its discussions, however, the committee sometimes found it had unintentionally shifted from a focus on desirable characteristics of a priority-setting process to desirable characteristics of a guideline development process or its product. Thus, it is important to emphasize that, unless otherwise indicated, this discussion of criteria and procedures applies to priority setting, not guidelines development. PRIORITY SETTING IN OTHER ORGANIZATIONS In addition to consulting general discussions of priority setting (Eddy, 1989; Phelps and Parente, 1990; IOM, 1992b), the committee examined priority-setting processes and criteria used by several public and private organizations in addition to the Forum and OHTA. For the most part, they represent the more well- developed programs for guidelines development and technology assessment. Some organizations, for example, the Centers for Disease Control and Prevention, have multiple units involved with guidelines, and their objectives and processes are both variable and difficult to summarize. Within organizations, priority-setting processes generally evolve from quite informal to somewhat more formal and explicit as guideline programs mature. Nonetheless, those involved in priority setting concede that more formal processes break down on occasion in favor of less explicit, more informal modes of decisionmaking. As far as the committee could determine, the organizations cited below have not formally evaluated the effectiveness oftheir priority-setting processes. The American College of Physicians has, however, surveyed members' attitudes about the value of their overall guidelines program and increased the emphasis on topics relevant to members.

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20 SEWING PRIORITIES FOR CLINICALPRACTICE GUIDELINES The organizations and processes described below are presented for illustrative purposes and are listed in alphabetical order. The committee did not assess their individual strengths and weaknesses or the degree to which the processes were actually employed in topic selection. American College of Physicians The American College of Physicians (ACP) is a private membership organization for specialists in internal medicine. It was founded in 1915 to foster excellence and professionalism in the practice of medicine. Initially developed in the late 1970s in response to queries from the Blue Cross and Blue Shield Association, the ACP's Clinical Efficacy Assessment Program (CEAP) is one of the oldest formal programs for assessing technologies and clinical practices and formulating practice guidelines (IOM, 1985, 1992b; ACP, 1993; White, 1994~. CEAP staff solicit nominations for guidelines from ACP members. In recent surveys, members assigned the highest priority to creating guidelines on the treatment of common conditions, diagnosis of common conditions, and referral to specialists. After earlier surveys indicated that members found CEAP assessments interesting but not necessarily useful in practice, those surveyed are now asked to assign priorities to topics based on the potential usefulness of a guideline to their practices. CEAP committee members assess potential topics using the following criteria: adequacy of knowledge base, relevance to internists, clinical impact, estimated aggregate costs, degree of uncertainty about appropriate practice, and likelihood that an assessment will change practice. Staff provide information on these criteria when feasible. The topics are not explicitly scored on each criterion, and the criteria are not explicitly weighted. The ACP Board of Governors makes the final selection of topics. Intermountain Health Care Intermountain Health Care (IHC) is a nonprofit, multi-institutional health care system serving Utah, Idaho, and Wyoming (see Appendix D). It includes 24 hospitals, 33 clinics, 6 home health agencies, and 10 women's centers. IHC's interest in clinical practice guidelines has evolved as part of its broader

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INTRODUCTION 21 commitment to continuous quality improvement. It develops, tests, and revises practice guidelines in the form of detailed process-of-care protocols. IHC sets priorities for protocol topics based on four factors: quality, including clinical impact (probability of improving outcomes), volume (prevalence of problem), and "problem proneness" (variability in cost, length of stay, or outcomes); financial considerations (especially capitated or fixed per-case payment for services); customer interest and community considerations; and operational feasibility, including compatibility with standards of the Joint Commission on the Accreditation of Health Care Organizations, availability of outcomes measures, and existence of a clinical "champion" (i.e., a clinician with a special interest in the subject). Each component of these factors is scored from 1 (low) to 3 (high, and the unweighted average of the component scores serves as the factor score. The average of the factor scores is in turn computed to yield an overall score for a topic. (See Appendix D for a table showing scores for 16 clinical topics.) Although any clinician can nominate a condition for consideration, many of the initial topics for protocols have been selected from the 30 to 40 conditions that account for roughly 70 percent of the institution's inpatient volume. Once a topic is selected, guidelines developed by outside organizations are assessed to determine whether they are a sound starting point for a more detailed protocol. For example, from the AHCPR guidelines on prevention of pressure ulcers, IHC developed and tested process-of-care protocols derived from the care options identified by the original guidelines. Staff have developed a methodology of clinical practice improvement that treats the care setting as a "clinical laboratory" for studies "designed to generate valid statistical inferences about the operational, day-to-day elements of the process of clinical care" (Horn and Hopkins, 1994, p. 2~. Kaiser Permanente, Northern California Region Kaiser Permanente is a nonprofit, group model, integrated health care service plan that serves 2.5 million members in Northern California. Its guidelines program is coordinated by the Permanente Medical Group's Department of Quality and Utilization, and its priority-setting process is part of the annual business plan (J. Crosson, personal communication, August 29, 1994~. Issues for guidelines development are selected on a review of six criteria:

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22 SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES Health impact. (How many people are at risk? How well do we perform in meeting the health outcomes important to our members? Is there variation in those outcomes? How significantly does the condition affect a member's or family's quality of life?) Resource utilization. (What volume and mix of resources are utilized? What is the total cost of these resources? Does variation exist?) Importance to customers. (Is the condition important to purchasers? Is the condition important to members? Is the condition important to the communities in which we operate?) Judgment of medical professionals. (Do physicians think the condition is important for improvement andlor study? Do other medical professionals think the condition is important?) Ability to influence outcomes. (What potential exists for improvement? Can potential improvements be measured? What level of resources would be needed for improvement?) Organizational issues. (What advantages or disadvantages would arise by competitively focusing on this area? Is this area already receiving adequate support elsewhere in the organization? What opportunities exist in this area to work with other organizations, including other health plans?) State of Minnesota In 1992, the Minnesota legislature adopted abroad set ofhealth care reforms ~GnnesotaCare Act of 1992) that included a program to develop, revise, and disseminate practice parameters to minimize unnecessary, unproven, or ineffective care (Gifford, 1994~. The law established a Practice Parameter Advisory Committee (PPAC) to advise the state's commissioner of health. The law also allowed practice parameters approved by the AHCPR or national health professional associations to be adopted without a formal rule-making process. State-approved practice parameters would be "an absolute defense" against an allegation that the provider did not comply with "accepted standards of practice in the community" ~IinnesotaCare Act of 1992, Article 7: Minnesota Statute section 62J:32 subd. 2 and 3~. Approved practice parameters are to be promoted and disseminated to the appropriate practitioners, but their use will not be mandated by the state. The Minnesota law established two criteria for selecting topics for large- scale outcomes studies that were included in the reform agenda. On the recommendation of the PPAC, these criteria were also adopted by the commissioner for selecting topics for practice parameter approval. The two legislative criteria are whether the clinical condition accounts for significant total costs (based on the frequency of the problem and cost per case) and is commonly

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INTRODUCTION 23 treated in hospitals (on an inpatient or outpatient basis) or freestanding outpatient surgical centers. In the process of establishing priorities for selecting guideline topics, the PPAC adopted three additional criteria: potential for cost savings (i.e., whether an effective intervention exists and significant variation in practice exists), accessibility of outcomes data, and current or near-future availability of AHCPR or other national guidelines in the condition area. The commissioner of health, on the recommendation of the PPAC, has also established that practice parameters being considered for approval will first be formally assessed against a set of explicit criteria. To assess the soundness of guidelines or parameters developed by other organizations, PPAC uses a modified version of the provisional guideline assessment instrument developed by the IOM (1992a). Office of Medical Applications and Research, National Institutes of Health Established in 1977, the consensus development program of the Office of Medical Applications and Research (OMAR) is one of the most visible technology and practice assessment efforts in the world. It has been widely studied, copied, and criticized (IOM, 1990d,g; NIH, 1993; Ferguson, 1994~. OMAR considers its assessments as part of the information base for guidelines rather than as guidelines per se. The assessments focus on the newest scientific knowledge or on areas where clinicians' application of established knowledge is limited. Most topics are suggested by individual institutes. Criteria for topic selection include the importance of the topic to public health, the existence of controversy about the scientific basis of the practice, the availability of evidence for evaluation, a gap between existing practice and a superior alternative clearly demonstrated by research, and the amenability of an issue to technical clarification. Potential topics are not formally scored on the basis of these criteria using empirical data or explicit subjective estimates, nor are they fonnally ranked. Selections are based on overall subjective assessments. In 1990, an IOM committee recommended a number of changes in various aspects of the OMAR's processes (IOM, 1990d). Among the recommendations relevant to topic selection processes and criteria were that OMAR (1) actively solicit topic suggestions throughout the health care system; (2) expand its focus to include clinical conditions, not just specific technologies; (3) extend its

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24 SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES concerns beyond safety and efficacy to clinical effectiveness and social, legal, and ethical issues; and (4) establish an advisory committee to provide guidance on topic selection and other matters. According to the program's director, the program has not been fundamentally restructured, although specific consensus conferences may have adopted the broader focus suggested in 1990. OMAR officials have discussed establishing an advisory committee, but administrative changes and new rules that abolish existing advisory committees and preclude new ones have blocked this step. U.S. Preventive Services Task Force The U.S. Preventive Services Task Force (USPSTF) is an independent panel that is appointed by the Assistant Secretary of Health of the Department of Health and Human Services (5JSPSTF, 1989; C. DiGuiseppe, personal communication, November 4, 1994~. It assesses scientific evidence on the effectiveness of preventive services. The Task Force worked from 1984 to 1989 to prepare its Guide to Clinical Preventive Services, which presented evidence- based guidelines for primary care clinicians on the appropriate content of the periodic health examination. A new Task Force was appointed in July 1990 to assess interventions not previously evaluated and to update assessments for which new evidence had become available. The first Task Force began by identifying 100 conditions that were leading causes of death and disability in the United States and were potentially preventable through clinical interventions. These conditions were ranked by the entire membership using a Delphi technique, and about half were selected for coverage in the 1989 report. In addition, another dozen topics were added after individual Task Force members volunteered to prepare the reviews. The second Task Force created an open-ended subjective list of potential topics for assessment or reassessment. These topics were rank ordered on the basis of explicit scores on the frequency of the condition (rated on a five-point scale based on how frequently the condition is seen in routine primary care); severity of the condition (rated on a five-point scale, with one point indicating a mild, self-limiting condition with temporary impact on productivity and quality of life [for example, the common cold] and five points indicating a condition that is almost uniformly fatal [for example, AIDS]~; and potential impact (rated on a five-point scale based on the degree of uncertainty about appropriate practice and the likelihood that a practice guideline would affect the use of preventive intervention and the outcome for the target condition).

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INTRODUCTION 25 Two criteria-cost and availability of research evidence that were originally to be part of the scoring scheme were eliminated because of the lack of staff resources to gather sufficient data for valid scoring. After the second Task Force ranked conditions, concerns were raised about possible bias against prenatal and pediatric conditions. The scores were then adjusted to raise the rankings of several such conditions. For conditions that were first covered in the 1989 report, a high ranking affected only the timing and intensity of review because all but two of the original conditions originally included were updated for the second edition. OVERVIEW OF REPORT Chapter 2 examines criteria for topic selection, possible changes in these criteria, and the rationale for differences in Forum and OHTA criteria. Chapter 3 reviews current AHCPR procedures for setting guidelines priorities and considers modifications to these procedures. Chapter 4 summarizes the committee's conclusions on priority setting and briefly discusses future roles for AHCPR. The background papers commissioned for the study are included as appendixes.

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