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1 Introduction and Background . . .with Humility comes not only a reverence for truth, but also a proper estimation of the difficulties encountered in our search for it. William Osler, Aequanimitas In November 1989, Congress amended the Public Health Service Act to create the Agency for Health Care Polic y and Research (AHCPR). Under the terms of Public Law 101-239 (Appendix A), this agency has been given broad responsibilities for supporting research, data development, and other activities that will "enhance the quality, appropriateness, and effectiveness of health care services...." The needs and priorities of the Medicare program are an important but not exclusive focus of the agency. Many of AHCPR's responsibilities formerly belonged to the National Center for Health Services Research, which AHCPR has now replaced, but the emphasis on outcomes and effectiveness research is considerably stronger. Other functions of the agency are new, in particular, those involv- ing a joint public-private enterprise to develop, disseminate, and evaluate guidelines for clinical practice under the sponsorship of the agency's Forum for Quality and Effectiveness in Health Care. (Appendix B provides some examples of guidelines already developed by public and private organiza- tions.) This report was prompted by AHCPR's request to the Institute of Medicine (IOM) for advice about how the agency and the Forum might approach their new and challenging responsibilities for practice guidelines. 19

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20 CLINICAL PRACT CE GUIDELINES The IOM agreed tO appoint a study committee that would work quickly tO provide technical assistance and advice on definition of terms, specification of key attributes of good guidelines, and certain aspects of planning for Implementation and evaluation. This report largely confines itself to these specific and limited tasks.: It is not a how-to-do-it manual, a methodology text, a priori~-setting exercise, or a primer on guidelines for those seek- ing an introduction to the subject. The report does, however, also aim to encourage more standardization and consistency in guidelines develop- ment, whether such development is supported directly by the Forum or is undertaken independently by medical societies and other organizations. The committee believes that the AHCPR initiative, taken as a whole, has real potential to advance the state of the art for practice guidelines, strengthen the knowledge base for health care practice, and, hence, improve the appropriateness and effectiveness of health care. One objective of this report is lo encourage realistic expectations about this potential by building a broader understanding of the difficult but important steps needed to move toward the goals for guidelines stated in P.L. 101-239 or, as it is often called, the Omnibus Budget Reconciliation Act of 1989 (OBESE 89~. CONTEXT The legislation establishing AHCPR is one consequence of accumu- lated public and private frustration about the perceived health and economic consequences of inappropriate medical care. This frustration and the per- ceptions that give rise to it stem from many sources including ceaselessly escalating health care costs, wide variations in medical practice patterns, evidence that some health care services delivered in this country are of little or no value, and claims that various kinds of financial, educational, and organizational incentives can reduce inappropriate utilization (IOM, 1989~. The combination of high levels of expenditure and doubts about the value of that spending explains policy makers' interest in improving the scope and application of knowledge about what works and what does not work in medical care- and at what price. AHCPR is supporting an extensive agenda of outcomes and effectiveness research to add to the knowledge developed through other sources such as the randomized clinical teals funded by the National Institutes of Health. In fact, the major part of the agencies 1 In addition, in May 1990, the IOM embarked on a new 18-month project funded by the John A. Hartford Foundation, Inc., and the Public Health Service to study both public and private activities to develop, use, and evaluate guidelines and to recommend a framework for better structuring of these activities where that is desirable and feasible (see Appendix C3. The report of this study is planned for release in the fall of 1991.

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INTRODUCTION AND BACKGROUND 21 work involves expanding the scope of knowledge rather than applying it. Of AHCPR's appropriation of nearly 5100 million for fiscal year 1990, it planned to obligate around $2 million for the Forum's work on practice guidelines. (Some projects funded as research on outcomes will also involve the development of guidelines.) In any case, the agency's responsibilities for such guidelines reflect congressional recognition of the practical need for ways to translate knowledge into patient and practitioner decisions that improve the value received for the nation's health care spending. More generally, the creation of a practice guidelines function within AHCPR can be seen as part of a significant cultural shift, a move away from unexamined reliance on professional judgment toward more structured support and accountability for such judgment (Physician Payment Review Commission, 1989, Roper et al., 1988~. Reflecting one element of this shift, guidelines are intended to assist practitioners and patients in making health care decisions; reflecting the second aspect, they are to serve as a foundation for instruments to evaluate practitioner and health care system performance. As the interest in practice guidelines has grown, so has scrutiny of existing guidelines and of processes for developing and using them (Brook, 1989; Eddy, 1987, 1988, 1990a-e, forthcoming (a,b); IOM, 1989, 1990; Leape, 1989, 1990; Physician Payment Review Commission, 1988a,b, 1989~. This scrutiny leads to one clear conclusion: the systematic development, implementation, and evaluation of practice guidelines, based on rigorous clinical research and soundly generated professional consensus, have been progressing but also have serious limitations in method, scope, and sub- stance. Concerns about these and other problems with practice guidelines contributed to the legislation creating AHCPR and the Forum. OVERVIEW OF PRACTICE GUIDELINES INITIATIVES Ken together, the public and private activities related to practice guidelines can be conceptualized, ideally, as having three basic stages: development, intervention, and evaluation. The second and third stages should again, ideally involve feedback loops to the first stage to prompt the revision of guidelines when omissions, technical obsolescence, or other problems are identified. Guidelines are thus dynamic, not static. They reflect the interplay of scientific and technological progress, real-world organizational pressures, and changes in social values. ~ date, most government and other initiatives emphasize the first of the three stages, the development of practice guidelines. The intervention stage involves much more diffuse and less studied efforts to disseminate guidelines to target users and to encourage these users to actually apply the guidelines in making health care decisions. Only recently has much

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22 CLINICAL PRACTICE GUIDELINES attention been paid to evaluating whether and why guidelines have any impact. PUBLIC INITL\TIVES Under OBRA 89, AHCPR has responsibilities in several areas: (1) health services research including research on effectiveness, efficiency, and quality of health care with a particular emphasis on outcomes research; (2) development, collection, and dissemination of data; (3) health care technology assessment; and (4) practice guidelines. 1b promote activities in the area of practice guidelines, Congress created a unit within AHCPR, the Office of the Forum for Quality and Effectiveness in Health Care. As described in more detail later in this chapter, the Forum must "arrange for" the development and periodic review and updating of (1) clinically relevant guidelines that may be used by physicians, educators, and health care practitioners to assist in determining how diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinicalb; and (23 standards of quality, performance measures, and medical review criteria through which health care providers and other appropriate entities may assess or review the provision of health care and assure the quality of such care. As explained by one individual intimately involved in the develop- ment of this legislation, the phrase arrange for is one key indicator of the "extent to which the legislation was structured to create a public-private enterprise with respect to guideline development. The Forum develops no guidelines; guidelines are not to be federal creations" (Peter Budetti, George Washington University, personal communication, July 13, 1989~. The committee suspects, nonetheless, that most people will continue to use the term develop to descn~e what the Forum does in this area Other agencies of the federal government have or have recently had responsibilities related to practice guidelines. These agencies include the National Institutes of Health, the U.S. Preventive Services Ask Force,2 and the Health Care Financing Administration (HCFA) and its contracting carriers, fiscal intermediaries, and peer review organizations. HCFA and its contractors have developed criteria for reviewing services provided to Medi- care beneficiaries. These criteria and their application, neither of which are examined here, have been criticized for lack of rigor and accountabil- ity (Institute of Medicine, 1990; Physician Payment Review Commission, 1988a, 1989). . . 21he G~de to Clinical Preventive Services prepared by the U.S. Preventive Senaces Task Force (1989) is a useful tart to read in conjunction with this report, although this report is not specifi- cally cross-referenced to the guide.

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INTRODUCTION AND BACKGROUND PRIVATE INITIATIVES 23 Guidelines for clinical practice, broadly defined, are not new. The processes of organized clinical education require various sorts of guidelines as do the processes of professional licensure, board certification, quality assurance, utilization review, and other aspects of health services adminis- tration. However, in recent years, the interest in practice guidelines of the medical community and others has grown exponentially. The level of interest in guidelines is not all that has changed. Ibday, there is a much greater emphasis on formal procedures and methods for arriving at a more widely scrutinized and endorsed consensus about what is appropriate clinical practice. Among the medical groups involved for some years with the develop- ment of guidelines are the American Academy of Family Physicians, the American College of Cardiology, the American College of Physicians, and the American Society of Anesthesiologists. In the research community, the RAND Corporation has pioneered the development of important tools and strategies. Newer initiatives are being undertaken or planned by the American Board of Medical Specialties, the American Medical Association, the Council of Medical Specialty Societies, and the academic medical and health services research community. Insurers, health maintenance organizations (HMOs), utilization man- agement firms, and similar organizations have not ignored the potential of practice guidelines as a basis for refusing payment for inappropriate care. For example, several years ago the Blue Cross and Blue Shield Associa- tion began its Medical Necessity Project, which supported and cooperated with researchers and some medical organizations in their efforts to identify obsolete procedures and set guidelines for the appropriate use of many diagnostic and treatment services. The Health Insurance Association of America recently established a similar function, and the Group Health Association of America has been sponsoring programs on guidelines de- velopment. Furthermore, individual members of each of these associations are involved in additional efforts to develop or adapt practice guidelines lo meet the needs of their different health plans. In addition, the activities of dozens of firms supplying utilization management services to health plan sponsors have focused attention on the quality, scope, and accessibility of the criteria they use to review care on a prospective or concurrent basis. The guidelines development efforts of private organizations are thus proceeding on many fronts. Some coordinating strategies are emerging, but important problems remain unexplained conflicts among guidelines, neglected topics, lack of follow-up, and incomplete public disclosure of the evidence, participants, and methods used to develop sets of guidelines. There is no independent entity to certify that guidelines are sound in

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24 CLINICAL PRACTICE GUIDEQNES . OFFI( ,E OF OFFIC1 . OF OFFICE OF THE OFFICE OF PIANNING & SCIENCE & FORUM FOR HEALTH RESOURCE DATA QUALITY & TECHNOLOGY MANAGEMENT DEVELOPMENT EFFECTIVENES S AS S ES SMENT IN HEAl,TH CARE OFFICE OF THE ADMINISTRATOR r ~I CENTER FOR CENTER FOR CENTER FOR MED I CAL G ENERAL G EN ERAL EFFECTIVENESS HEALTH SERVICES HEALTH SERVICES RES EARCH INTRAMURAL EXTRAMURAL RES EARCH RESEARCH CENTER FOR RESEARCH DI S. SEMINATION & LIAI SON FIGURE 1-1 Organization chart for the Agency for Health Care Policy and Research. SOURCE: Office of the Forum for Quality and Effectiveness in Health Care. method and content and no "national bureau of standards" to set standards for methods of guidelines development or their content. The legislation creating AHCPR is one response to some of these problems. SPECIFIC RESPONSIBILITIES OF AUCPR The legislative mandate for AHCPR and its Forum sets forth several specific responsibilities; it also identifies priorities and establishes certain procedural requirements. In planning to implement this mandate, the Forum has consulted with a broad allay of interested individuals and organizations. The IOM committee is itself part of this consultation process. Other efforts include presentations, meetings, and mailings to medical societies, health care organizations, and other individuals and groups. The following discussion notes the main elements of the legislative mandate and describes the agency's initial steps to fulfill its responsibilities. Figure 1-1 is an organization chart for the agency.

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INDUCTION AND BACKGROUND DEADLINES AND PRIORITIES 25 By January 1, 1991, AHCPR acting through the Forum must ar- range for the development of an initial set of guidelines, standards, perfor- mance measures, and rewew criteria for at least three clinical treatments or conditions. AHCPR is also responsible for seeing that the guidelines developed under its auspices are updated. OBRA 89 created the Advisory Council for Health Care Policy, Re- search, and Evaluation to advise the Secretary of the Department of Health and Human Services (DHHS) and the administrator of AHCPR on pri- orities and strategy. It also established the Subcouncil on Outcomes and Guidelines (of the Advisory Council) to provide advice on priorities and strategy for guidelines development and outcomes research. A key explicit objective of the guidelines legislation is to help im- prove the quality, appropriateness, and effectiveness of health care. More implicit yet widely recognized-is the hope that guidelines will help con- trol health care costs. In selecting conditions for guidelines development, the agency is to consider the extent to which guidelines for the condition can be expected to reduce variations in health care services and outcomes and to improve care for significant numbers of people. Priorities for the initial sets of guidelines to be developed by Jan- ua~y 1, 1991, are more specific and stipulate that the clinical conditions involved (1) account for significant expenditures in Medicare, (2) show significant variation in the frequency or type of treatment provided, or (3) otherwise meet the needs and priorities of the Medicare program. Target users for the guidelines, standards, review critena, and performance measures are "physicians, health care practitioners, medical educators, medical review organizations, and consumers." At this writing, the Forum is considering initial guidelines development activities in the following areas: Cataract surgery Be nign pros tatic hype rpla s ia Clinical depression Sickle-cell disease Management of incontinence Management of chronic pain Management of skin integrity and decubitus ulcers Ambulatory care for human immunodeficiency virus infection All of these areas except ambulatory care for patients with human immu- nodeficiency virus had panel chairs appointed as of July 1, 1990. These areas cover a wide varied of patients (not exclusively the elderly) and are

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26 Cl [NICAL PRACTICE GUIDELINES relevant for a variety of practitioners including physicians, nurses, nurse practitioners, and social workers. According to Forum Director Stephen King, these conditions and treatments are being considered because they are important health problems characterized by a state of clinical knowl- edge and professional judgment that warrants a guidelines development effort and for which guidelines can be expected to reduce inappropriate variation in services, improve the quality of care, and produce better health outcomes. Additional clinical conditions or treatments will be identified on an ongoing basis. The Forum expects to have several sets of guidelines under development or assessment at any given time. DEVELOPMENT PROCEDURES AND REQUIREMENTS lathe director of the Forum may contract with public and nonprofit private organizations to develop and update guidelines. The director may also convene expert panels that can either develop guidelines or review guidelines developed by contractors. (There is some disagreement about whether the legislation requires the director to use both the contracting and the panel mechanisms.) The process must include appropriate con- sultations with interested individuals and organizations, including general and specialty medical organizations and physicians in a variety of practice settings. In addition, the director of the Forum must establish the standards for methods and procedures to be followed by the contractors and expert panels. The legislation permits pilot-testing of the guidelines. One difficult task for the Forum has been deciding whether to convene expert panels to develop guidelines or to contract with outside entities. Initially, the Forum has adopted the first approach, namely, the convening of its own expert panels. As the guidelines program expands, the Forum may- some say, must use the contracting mechanism. Forum staff are discussing such arrangements with a number of organizations. In addition to arranging for the development of guidelines by expert panels or contractors, the agency may adopt guidelines developed inde- pendently of the Forum if they meet the requirements established by the legislation. As described by one person involved in the drafting of OBRA 89, "This is a critical addition to the current ad hoc system. For the first time, interested parties could turn over their products to a publicly con- stituted, disinterested body for scrutiny. After appropriate modification, the original guidelines would achieve an imprimatur of sorts from the dis- interested body" (Peter Budetti, George Washington University, personal communication, July 13, 1990~.

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INTRODUCTION AND BACKGROUND DISSEMINATION 27 The responsibilities of the Forum extend beyond the development of guidelines to their dissemination. The legislation specifies that the director of the Forum shall promote the dissemination of guidelines through organi- zations representing health care providers and health care consumers, peer review organizations, accrediting bodies, and other appropriate entities. In addition, the guidelines must be presented in formats appropriate for use by practitioners, medical educators, and medical care reviewers. Among the first steps the agency is taking to promote the dissemination of guide- lines is lo work with the National Library of Medicine for inclusion of the guidelines in the library's various information systems. USE OF GUIDELINES The legislation establishing AHCPR and the Forum states that the Secretary of Health and Human Services "shall provide for the use of the [initial sets oil guidelines. . .to improve the quality, effectiveness, and appropriateness of care" provided under the Medicare program. No further details are offered. Presumably, providing for the use of the guidelines will require that HCFA and its contracting fiscal intermediaries, carriers, and peer review organizations take steps to incorporate medical review criteria and other evaluation instruments into their programs to review care provided to Medicare beneficiaries. Discussion of these matters is at the most preliminary stages within DHHS. EVALUATION AND lIJRTHER RESEARCH The Secretary of Health and Human Services must determine the impact of the initial set of guidelines on the cost, quality, appropriateness, and effectiveness of health care and report these findings to Congress by January 1, 1993. Because an adequate evaluation within this time period is virtually impossible (see Chapter 4), the agency expects to provide Congress with a status report at the start of 1993 rather than a complete evalua- tion. More generally, the director of the Forum is to conduct and support evaluations of the impact of guidelines on clinical practice. In addition, the director is to recommend research projects to the AHCPR adminis- trator that are related to (1) evaluating outcomes of health care services and procedures, (2) developing standards and criteria for the guidelines development process (what are called "attributes" in this report), and (3) promoting the use of the guidelines, standards, performance measures, and rewew criteria developed under the Forum's auspices.

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28 CLINICAL PRACTICE GUIDEl rNES THE INSTITUTE OF MEDICINE COMMITTEE AND PROJECT ~ conduct the study requested by AHCPR, the IOM appointed a committee of experts in January 1990 (Appendix D). Members were se- lected on the basis of their expertise and familiarity with characteristics and uses of medical practice guidelines, desirable properties or attributes of guidelines, and technical methods for preparing them. The committee included practicing physicians, individuals experienced in the development of guidelines, current and potential users of guidelines, and representatives of relevant other disciplines such as nursing, law, and economics. The IOM organized and conducted two meetings of the committee, one in February and the other in April 1990. A major immediate goal of the group was to help the Forum prepare to award and administer contracts for the development of guidelines for three clinical treatments or conditions. IOM staff provided background materials for the study committee that included a survey of guidelines activity (Audet and Greenfield, 1989), a case study of the mammography screening guideline for women aged 40 to 49 (Field, 1989), a chapter on attributes of quality of care indicators from an earlier IOM report (IOM, 1990), selected journal articles, reports from the American Medical Association and other medical organizations, and two volumes of examples of guidelines and formats from various sources. The committee also received status reports from the Forum director at each meeting. The April meeting included presentations by Mark Chassin and Sheldon Greenfield on practical implementation and evaluation issues. Chapters 2, 3, and 4 describe sources of information in more detail. In addition, IOM staff prepared papers for review by the committee as a basis for recommendations and the final report Staff from the Forum attended both meetings and received copies of all draft and background materials prepared for the committee. Af- ter each meeting, IOM staff prepared meeting summaries and circulated them to committee members for their review and comment. Based on committee discussion of Stan papers and the meeting summaries, this re- port was drafted, circulated to the committee for comment, revised, and then submitted for review in accordance with IOM and National Research Council report review policies. After revisions were made based on the latter review, this document was produced, constituting the committee's final report. OVERVIEW OF THE REPORT The next chapter discusses definitions of key terms why the defi- nitions are needed, how the committee approached this task, and what the literature says about terminology. It sets forth specific definitions for

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INTRODUCTION AND BACKGROUND 29 practice guidelines, medical review criteria, and standards of quality, and a provisional definition for performance measures. Chapter 3 takes up the attributes of good guidelines. It again de- scribes how the committee approached the topic and what the literature says about desirable properties of guidelines. The themes that underlie this discussion are the importance of credibility and full disclosure of the pro- cesses, sources, methods, and participants in guidelines development. The committee has identified eight attributes of guidelines: validity, reliability/ reproducibility, clinical applicability, clinical flexibility, clanty, multidisci- plinaIy process, scheduled review, and documentation. The stringency of these attributes, especially taken together, is well recognized, and the com- mittee realizes that a balance needs to be maintained between an ideal process and a feasible one. In a second IOM project on practice guidelines (Appendix C), one task will be to take the conceptual attributes described in Chapter 3 and develop an operationally useful instrument for assessing how specific sets of guidelines conform to these attributes. In Chapter 4, the committee concentrates on implementation and evaluation. This chapter differentiates between the Implementation of a government program for guidelines (which includes hiring staff and conven- ing expert panels) and the implementation or application of guidelines after they are developed. It also differentiates between evaluating the impact of clinical practices and evaluating the impact of practice guidelines. Chapter 5 summarizes the committee's recommendations and conclu- sions. The recommendations, although sensitive to broader congressional expectations for the new agency, reflect the committee's relatively limited charge tO advise the Public Health Service on definitions and attributes of guidelines. CONCLUSIONS AND CAUTIONARY NOTES ldday, the field of guidelines development is a confusing mix of high expectations, competing organizations, conflicting philosophies, and ill- defined or incompatible objectives. It supers from imperfect and incomplete scientific knowledge as well as imperfect and uneven means of applying that knowledge. Despite the good intentions of many of the parties involved, the enterprise lacks coherent structures and credible mechanisms for evaluating, improving, and coordinating guidelines development to meet society's needs for good-quality, affordable health care. This situation will not change overnight, even though many promising acquires, including those sponsored by AHCPR, are under way. Con- sequently, expectations for quick results should be somewhat restrained. Otherwise, dashed hopes may lead tO calls for premature abandonment of

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30 Cr rNICAL PRACTICE GUIDELINES a useful strategy for improving the appropriate use of health care services and to the adoption of more draconian measures to control costs. The committee is also concerned about other unrealistic expectations or assumptions for example, the assumption that guidelines development is a relatively simple or straightforward undertaking. It is not. For many clinical conditions and services, the scientific base is [united. (This is one reason why it is important that the guidelines and knowledge development functions of AHCPR be coordinated.) Methods for analyzing evidence and developing expert opinion vary, but none of the rigorous methods can be properly applied by novices. Where considerable research has been done and good methods have been applied to analyze it, honest clinicians and analysts may come to different conclusions using the same evidence. Agreement on facts may not be accompanied by agreement on what health benefits are desirable at which economic cost with what tolerable accompanying health nsks. Such conflicts about the interpretation of evidence and the application of value judgments cannot be ignored. Indeed, the whole process of guide- lines development must be undertaken with care at every stage: selecting participants, clarifying biases, adopting procedures and methods, identifying and analyzing evidence, considering alternatives, providing for independent reviews, preparing clear recommendations, and disclosing all important in- formation about the process. This report is intended to reinforce these points. A second assumption of concern to the committee is that there is only one right way to develop guidelines. There is not. Variations in the topics, the clinical disciplines involved, the purposes, and the audiences for guidelines will justify some differences in specific development meth- ods. However, to grant some methodological diversity is not to accept all approaches as equally good. Chapter 3 pursues this point but notes that much remains to be tried and learned about the strengths and weaknesses of different guidelines development methods. One further questionable expectation, which is sometimes explicit but often unstated, is that practice guidelines will help control health care costs.3 They may not. The reasons for caution on this point are several. For instance, variation in practice does not, by itself, demonstrate that the high- use patterns are the inappropriate orles. Moreover, even if high use can be identified as inappropriate, such identification does not automatically change behavior. An array of incentives for behavioral change may be tried, but not all will succeed. Even if behavior changes, expenditures may 3See, for example, the discussions of expenditure targets, volume performance standards, and guidelines in the Physician Payment Review Commission's 1989 (Chapters 11 and 1V and 1990 (Chapter 2) reports.

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INTRODUCTION AND BACKGROUND 31 not. Some gu~delmes undoubtedly will save money by reducing the use of inappropriate services; some will increase costs by encouraging more use of underutilized services; and some will shift costs from one service, place, or payer to another. The net impact on costs cannot be predicted with confidence, even if the priorities for guidelines development focus on clinical conditions for which overuse of expensive services is suspected. One of the main areas of disagreement among committee members involved precisely how costs should be considered in the development of practice guidelines. Some committee members believed that all guidelines should incorporate judgments about cost-effectiveness whereas the majority called for the development process, at a minunum, to include projections of cost effects. In any case, if guidelines do succeed in improving the value of the nation's expenditures of medical care by allowing more informed individual and social decisionmaldng that in turn shifts expenditures from less to more appropriate forms of care, then the endeavor will be successful. As stated at the outset of this chapter, the committee believes that AHCPR has the potential tO strengthen the knowledge base for health care decisionmaking and contribute tO the development of practice guidelines. It can be an important element in the much broader array of public and private actions to improve the quality and effectiveness of health care. This report suggests some ways in which the agency-with the help of many others and a stance of constructive realism can move to meet its mandate. REFERENCES Audet, An, and Greenfield, S. A Survey of Current Activities in Practice Guideline Development. Paper prepared for an IOM Meeting on Medical Practice Guidelines: Looking Ahead, November 8, 1989, Washington, D.C. Brook, R. Practice Guidelines and Practicing Medicine. Are They Compatible? Journal of the American Medical Association 262:3027-~30, 1989. Eddy, D. Clinical Policies. Pp. 47-54 in Proceedings. Standards of Malay in Patient Care: The Importance and Risks of Standard Setting Invitational Conference, Council of Medical Specialty Societies, Washington, D.C., September 1987. Eddy, D. Methods for Designing Guidelines. Paper prepared for the Physician Payment Review Commission. Duke University, Durham, N.C, 1988. Eddy, D. Comparing Benefits and Harms: The Balance Sheet. fioumal of the American Medical Association 263:249~2505, 1990a. Eddy, D. Guidelines for Polipy Statements: The Explicit Approach. Journal of the Arnerzcan Medical Assoc~anon 263:22302240, 1990b. Eddy, D. Practice Policies Guidelines for Methods. Joumal of the American Medical Association 263:1839-1841, 1990c. Eddy, D. Practice Policies What are They? Joumal of the American Medical Association 263:877 880, 1990d. Eddy, D. Practice Policies Where Do They Come From? Journal of the American Medical Association 263:1265-1275, 1990e. Eddy, D. Designing a Practice Polio. Standards, Guidelines, and Options. Journal of the Arnencan Medical Association, forthcoming (a).

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32 CLINICAL PRACTICE GUIDELINES Eddy, D. A Manual for Assessing Health Practices and Des~gn~g Practice Policies (draft dated May 31, 1989). American College of Physicians, forthcoming (b). Field, M. Health Policy and Medical Practice Guidelines: The Case of Mammography Screening for Women Under 50. Paper prepared for an IOM Meeting on Medical Practice Guidelines: Looking A-head, November 8, 1989, Washington, D.C Institute of Medicine. Controlling Costs and Changing Portent Care? The Role of Utili~uon Alanaf~ment, B. Gray and M. Field, eds. Washington, D.C.: National Academy Press, 1989. Institute of Medicine. Medicare: A Strategy for Quality Assurance, vols. 1 and 2, K Lohr, ed. Washington, D.C.: National Academy Press, 1990. Leape, L Unnecessary Surgery. Health Services Research 24:352A07, 1989. Leape, L Practice Guidelines and Standards: An Overview. Malay Review Bulletzn 16:42~9, 1990. Physician Payment Review Commission. Annual Report lo Congress. Washington, D.C., 1988a. Physician Payment Review Commission. Improving the Quality of Care: Clinical Research and Practice Guidelines. Appendix I. Background Paper for the Conference on Practice Guidelines, Washington, D.C., October 1988b. Physician Payment Review Commission. Annual Report lo Congress. Washington, D.C, 1989. Physician Payment Review Commission. Annual Report to Congress. Washington, D.C, 1990. Roper, W., W~nkenwerder, W., Hackbarth, G., et al. Effectiveness in Health Care. An Initiative to Evaluate and Improve Medical Practice. New England Journal of Medic~ne 319:1197-1202, 1988. U.S. Preventive Services Ask Force. Guide lo Clinical Preventive Services: On Assessment of He Effectiveness of 169 Interventions. Baltimore, Md.: Williams & Wilkins, 1989.