5
Implementation: Quality, Cost, and Risk Management

Administration is difficult; agitation is easy.

C. Rufus Rorem, 1946

Although those who plan and manage education programs and information systems can encourage the application of practice guidelines, more central to this effort will be those who design and administer programs to assure quality of care, manage health care costs, and protect practitioners and institutions from malpractice liability. The ways in which these programs can support and be supported by guidelines is, so far, poorly charted, although journal articles, conferences, and similar information sources are beginning to focus on the more practical challenges of incorporating guidelines into programs for quality, cost, and risk management. This chapter explores some of those challenges and presents the rationales for investing resources to overcome or manage them.

Perhaps the most appealing rationale for the development and use of clinical practice guidelines is that they can help improve the quality of health care; certainly, it is the most positive and optimistic reason to invest time, resources, and energy in guidelines development. The first section of this chapter thus focuses on programs to assess, assure, and improve the quality of care and on the potential role that guidelines might have in this area. The committee does not, however, take any formal stance on the several approaches to quality assurance, improvement, and management now being promulgated by various groups; neither its charge nor its deliberations were this expansive.

Despite the near universal appeal of the quality-of-care rationale, cost containment appears to be the most urgent and contentious motive behind calls for guidelines development and use. Were it not for this motive, the



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Guidelines for Clinical Practice: From Development to Use 5 Implementation: Quality, Cost, and Risk Management Administration is difficult; agitation is easy. C. Rufus Rorem, 1946 Although those who plan and manage education programs and information systems can encourage the application of practice guidelines, more central to this effort will be those who design and administer programs to assure quality of care, manage health care costs, and protect practitioners and institutions from malpractice liability. The ways in which these programs can support and be supported by guidelines is, so far, poorly charted, although journal articles, conferences, and similar information sources are beginning to focus on the more practical challenges of incorporating guidelines into programs for quality, cost, and risk management. This chapter explores some of those challenges and presents the rationales for investing resources to overcome or manage them. Perhaps the most appealing rationale for the development and use of clinical practice guidelines is that they can help improve the quality of health care; certainly, it is the most positive and optimistic reason to invest time, resources, and energy in guidelines development. The first section of this chapter thus focuses on programs to assess, assure, and improve the quality of care and on the potential role that guidelines might have in this area. The committee does not, however, take any formal stance on the several approaches to quality assurance, improvement, and management now being promulgated by various groups; neither its charge nor its deliberations were this expansive. Despite the near universal appeal of the quality-of-care rationale, cost containment appears to be the most urgent and contentious motive behind calls for guidelines development and use. Were it not for this motive, the

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Guidelines for Clinical Practice: From Development to Use recent flood of interest in and support for practice guidelines would probably have been a more modest stream. The second section of this chapter examines how cost management programs may employ guidelines, and the next chapter describes the committee's vigorous debate about what developers of guidelines should do to better support these programs. Relatively few existing guidelines appear to have been prompted primarily by liability concerns. Nevertheless, the broadly perceived medical malpractice "crisis" has inevitably made the role of guidelines an issue in risk management programs and tort law. The last section of this chapter takes up this topic. QUALITY ASSURANCE AND IMPROVEMENT Basic Concepts and Propositions The IOM has defined quality of care as "the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge" (IOM, 1990i, p. 21). To the extent that guidelines are based on scientific knowledge, estimate expected health outcomes, and delineate current professional judgment, they clearly have a role to play in assessing and assuring the quality of care. Efforts to ensure high-quality care must prevent or, alternatively, detect and overcome three main problems: (1) overuse of unnecessary care and of inappropriate care, (2) underuse of necessary care, and (3) poor performance (in both the technical and interpersonal senses). Most experts now agree that a comprehensive approach to quality of care must address all three problems, perhaps to different degrees depending on the setting or nature of the care and various local or institutional factors. Good practice guidelines have the potential to contribute in each area. First, guidelines and review criteria that explicitly and clearly describe appropriate care for particular clinical problems provide a solid base for detecting patterns of overuse or underuse. Second, detailed guidelines may improve the technical provision of care. Certainly, some aspects of technique have to do with physical capacity, skill built on experience and repetition, attention to detail, and similar factors. Good performance, however, depends on a solid understanding of what constitutes appropriate care (e.g., choice of antibiotic) or correct performance of a technical task (e.g., sterile technique). Finally, when guidelines include good estimates of outcomes (risks, benefits, harms), they can contribute to better communication and shared decision making on the part of patients and practitioners. These interpersonal processes lie at the heart of the humanistic "art of care" vision of quality.

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Guidelines for Clinical Practice: From Development to Use Traditional programs of quality assurance (QA) (see Donaldson and Lohr, 1990) derive from a conceptual framework advanced more than a quarter-century ago by Donabedian (1966). This conceptualization (further explicated in Donabedian, 1980, 1982, 1985) emphasizes (1) the structure of care—that is, characteristics of practitioners, institutions, and the health care system including regulatory mechanisms; (2) the process of care, meaning at least patient care activities and, in some formulations, the housekeeping, administrative, and other activities that may affect quality of care; and (3) the outcomes of care, including patient health status and functioning, well-being, and satisfaction. Clinical practice guidelines, medical review criteria, and standards of quality relate more directly to the processes of care than to outcomes because they describe what constitutes appropriate management of specific clinical problems. Performance measures describe the data needed to evaluate whether actual behavior conforms to guidelines, criteria, and standards. Utilization and quality review programs may employ all these instruments to identify and deter unnecessary and inappropriate services. As more and more guidelines explicitly estimate expected benefits and harms of care (that is, possible outcomes), they may more directly contribute to the specification of sophisticated criteria that relate good quality of care to expected (good) patient outcomes. The use and development of review criteria are discussed further in a later section. At a systems level of quality assurance strategies, the potential role of guidelines in certification and re-certification programs and examinations should be noted. For example, as mentioned in Chapter 4, the American Board of Family Practice has for many years administered a re-certification process that involves review of office records against a predetermined list of performance criteria (Langsley, 1991). In Canada, the College of Family Physicians and McMaster University have been involved in an extensive effort to develop and apply chart audits, tests of basic clinical skills, and other methods. These criteria and assessments do not appear to be based explicitly on published practice guidelines, but such guidelines could certainly be factored into the certification and re-certification processes. As specialty boards continue their work on methods to judge qualifications accurately, attention to practice guidelines as one base for performance evaluation is an obvious step. Continuous Quality Improvement The case studies in Chapter 3 reflect the extent to which the use of guidelines to improve quality of care is a subtext in a managerial and policy debate over the relative contributions of traditional QA strategies and newer quality management approaches. These approaches are variously called

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Guidelines for Clinical Practice: From Development to Use total quality management (TQM) or continuous quality improvement (CQI). This discussion, which employs the latter term and abbreviation, relies on a composite model of CQI based on principles described in recent literature1 and on observations drawn from the health care press, committee site visits, and other discussions. (The IOM committee that studied issues of quality assurance in Medicare [IOM, 1990i] compared traditional QA and CQI models in more depth.) The growing interest in CQI is reflected in statements by the Joint Commission on Accreditation of Health care Organizations that it intends to shift from a QA to a CQI perspective and develop new principles and standards of hospital accreditation to reflect this shift (O'Leary, 1991). In describing the Joint Commission approach, O'Leary (1991) says, "We tend to use CQI . . . because to us the term means a way of life in an organization. Total quality management . . . might imply that there is a single management style that is necessary for all of this change to happen" (p. 74). A recent American Hospital Association survey states that more than 40 percent of reporting hospitals say they are engaged in continuous quality improvement (Utilization Review Newsletter, 1991b). The Maryland Hospital Association's ambitious quality indicator project is cast in a continuous quality framework (Maryland Hospital Association, 1990). In addition, the Robert Wood Johnson Foundation supports a program for "Improving the Quality of Hospital Care"; a quarterly newsletter for that program, entitled Quality Exchange, is produced at the Johns Hopkins University.2 CQI models are generally described in terms of a set of reinforcing principles for implementing change. They aim to make nonpunitive tactics for quality assurance more usable and, it is hoped, more effective than they have been under traditional approaches. Each of these principles has impli- 1   See Deming, 1986; Walton, 1986; Garvin, 1988; Batalden and Buchanan, 1989; Berwick, 1989; Berwick et al., 1990; Gottlieb et al., 1990; Nash, 1990a,b; Jennison, 1991; Williamson, 1991. 2   Interest in CQI is not confined to the hospital community. For example, the American Medical Record Association (AMRA; now the American Health Information Management Association) has recently compiled a useful bibliography of QA and CQI sources (AMRA, 1991) and distributed The Memory Jogger, a pocket-sized guide to basic CQI tools and methods (Brassard, 1988). The CQI movement has also spawned at least two newsletters. One is QI/TQM, which describes itself as the health care executive's guide to quality improvement through total quality management (Ql/TQM, 1991). Quality Connection is a quarterly produced by the National Demonstration Project (NDP) on Quality Improvement in Health Care; NDP also sponsors a Quality Management Network and an electronic "Quality Information Support System." In this same vein, the Health care Forum, which offers educational programs for health care leaders, has launched the Quality Improvement Network project; its aim is to use quarterly meetings to link hospitals and hospital systems to permit them to share QI models and ideas (QRC, 1991).

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Guidelines for Clinical Practice: From Development to Use cations for the way practice guidelines may be incorporated into the fabric of health care organizations.3 The principles emphasize the following: close relationships between so-called customers and suppliers, that is, the partners in any given health care transaction; errors being more often the result of defects in systems (e.g., those for reporting test results or scheduling operating rooms) than the consequence of individual deficiencies ("bad apples");4 planning, control, assessment, and improvement activities grounded in statistical and scientific precepts and techniques; reliance on internal (self-) monitoring—as opposed to external (regulatory) inspection—with mistakes viewed as "treasures" that should be used for learning and for resolving problems rather than as an occasion for punishment; standardization of processes (decreasing their variability) to reduce the opportunity for error and to link specific care processes to health outcomes; feedback to practitioners of statistical information on how their practices may differ from those of their peers or depart from evidence-based standards for practice; visible commitment to quality by the top leadership of the organization and involvement by all parts of the organization in processes of quality improvement; and a striving for continuous improvement in contrast to simply achieving preset goals. Within this framework, sound practice guidelines and medical review criteria have several possible uses. First, to the extent that guidelines become more sensitive to patient preferences and participation in decision making, they should improve patients' informed consent, their participation in decision making and, ultimately, their satisfaction with both the processes and outcomes of care. Guidelines could also help identify important patient outcomes to incorporate in patient satisfaction surveys and other instruments designed to improve or assess "customer-supplier" relationships. Second, 3   CQI has tended to assume an organizational context, that is, a hospital or large group practice. Its application to individual and small group practice has been little explored, although many of its principles, if not its techniques, appear relevant and worth considering in these settings (Stocker. 1989). 4   Jennison (1991) notes that it is also important to study why competent physicians make errors. For example, she cites one hospital that identified "inadequate hypothesis generation" (consideration of possible diagnoses) as a major source of error in managing patients with congestive heart failure: for patients with pneumonia, "mismanagement of therapy" was the major problem (p. 453).

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Guidelines for Clinical Practice: From Development to Use guidelines and review criteria could play a role in identifying possible quality problems arising from underuse, overuse, or incompetent provision of care. They may be particularly useful in instances in which short-term health outcomes (those that are most readily employed) may not be good indicators of long-term results. Third, to the extent that guidelines identify how compelling is the evidence for certain clinical practices, they will help in determining priorities for improving or standardizing specific patterns of clinical care and in sorting out competing claims for funding for biomedical and outcomes or effectiveness research. Fourth, participation by clinicians in the review, critique, and improvement of practice guidelines can help bring the science of medicine more forcefully into the equivalent ''cycles" emphasized by CQI. Just as guidelines have the potential to contribute to continuous quality improvement, the application of CQI principles and processes can support the effective implementation of practice guidelines. Schoenbaum notes (1990, p. 102) that between the step in an algorithm (guideline) directing a colonoscopy and the actual procedure lie "dozens or hundreds of steps," such as locating, notifying, scheduling, and preparing patients. At all of these points things can and sometimes do go awry in ways that may undermine the successful application of guidelines for appropriate care. A number of CQI techniques are designed to uncover such process flaws and to structure activities to correct them. Moreover, because CQI generally tends to have a "quantitative" emphasis and to be detail oriented, it may encourage those who design practice guidelines and medical review criteria to be more explicit, specific, and comprehensive with respect to the clinical content of guidelines and to better anticipate and confront the practical problems that may face prospective users of guidelines. In addition, the CQI stress on cycles of planning, testing, evaluating, and revising of procedures—the "Plan/Test/Check/Act" cycle—can encourage the processes of guideline assessment and improvement called for in this report and elsewhere. Although practice guidelines have a potential role in CQI, some aspects of CQI models or strategies may deflect attention from guidelines. To date, CQI efforts have tended to focus more on nonclinical than on clinical issues. Quality problems arising from poor clinical performance and decision making thus have not been highlighted (Causey, 1991). In discussing a series of quality management projects, Berwick and colleagues (1990, p. 24) reported that few of the project teams tackled clinical processes; rather, they focused on problems similar to those found in other industries, problems that were on the "comfortable fringes" of clinical processes. Typical of the problems to which these and other projects gave attention were the length of time needed to get X-rays posted to the medical record department, the late arrival of patient meals, and delays in patient discharge or admission. Williamson (1991) cites a study of TQM prepared for the feder-

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Guidelines for Clinical Practice: From Development to Use al Office of Management and Budget that reports that "nearly 40 of 44 examples [almost 90 percent] of improvement achieved focused specifically on administration process variables as opposed to outcomes, especially health outcomes" (p. 55). How much this near-total emphasis on administrative rather than clinical processes will change as CQI becomes more institutionalized is unknown. Also unclear is how much the focus should change given the unknown magnitude of clinical versus nonclinical quality programs and the relative susceptibility of each to improvement. The focus on nonclinical issues is, in any case, understandable. CQI is still relatively new, users are looking for easier rather than harder targets of opportunity, and nonclinical problems are likely to be easier to solve from both technical and behavioral perspectives. Nonetheless, even when clinical outcomes are at issue, practice guidelines and outcome measures do not appear to be widely perceived or explicitly applied as benchmarks for informing or assessing performance. For example, in a recent article examining CQI concepts and applications for physician care, the only reference to practice guidelines occurred in a discussion on the need for chart review and other monitoring activities to supplement CQI (Kritchevsky and Simmons, 1991). Among the hospitals visited during this study, several were using or trying to develop clinical protocols or pathways that specified the sequence and timing of various interventions for different clinical problems; the object was to standardize practice and reduce errors. (Appendix A presents a pathway for coronary artery bypass surgery.) Most pathways in these hospitals and elsewhere appear to be built on implicit clinical judgments and local statistical data rather than on systematically developed practice guidelines (Coombs, 1991). This reflects the highly operational environment of pathway development and the relatively immediate opportunities for incremental action, monitoring, and adjustment. The focus of most pathways appears to be when and how to undertake a particular intervention (such as cardiac monitoring or respiratory therapy), not whether the intervention is appropriate. Similarly, in confidential materials reviewed by the committee, several organizations structured their feedback to physicians almost entirely in statistical terms, in part because they feared that substantive guidelines might antagonize physicians, at least initially. An individual physician might be informed how often he or she performed a particular procedure compared with patterns of care for the same procedure by peers—without an explicit accompanying statement of the appropriate indications for the procedure. Notwithstanding that the principle of variation reduction may be generally sound, specific reductions in practice variation and moves toward consistency are not inevitably shifts toward more appropriate care. Quantita-

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Guidelines for Clinical Practice: From Development to Use tive analyses of variation ideally should consider explicit practice guidelines as one reference point, given that soundly developed guidelines represent the best current understanding of which health interventions will produce desired results (Coombs, 1991). This understanding, in turn, can be evaluated and revised based on a systems study of the link between practice choices and short- and long-term changes in health outcomes. To some degree, reliance on statistical feedback may reflect the lack of credible, relevant, and specific guidelines for problems targeted by a quality improvement effort. However, other explanations are also likely to apply. One anonymous reviewer of this report observed that many advocates of CQI see practice guidelines as "outdated." This view may reflect an identification of guidelines with the procedures for external review that have been widely criticized by CQI proponents, both on grounds of general principle and on grounds of poor administration. In stressing internal strategies for improvement and rejecting outside review, advocates of CQI may disregard the legitimate interest of other parties in external oversight and systems-level monitoring through retrospective, concurrent, and prospective review programs. In this context, it is important to recall the observation in the IOM report (1990i) on quality of care in the Medicare program that the superiority of specific CQI techniques, although plausible, has not been demonstrated. Further, and consistent with the sense of the committee, Williamson (1991) reports that "many [CQI] advocates whom I have queried acknowledge that they have had difficulties adopting industrial [quality improvement] methods to clinical outcomes" (p. 55). As a practical matter, people are still trying to grasp what CQI means, how to use it, and how to assess its impact.5 As one hospital manager said, "We are only at mile two on a never ending journey" (Causey, 1991, p. 3). The stress on guidelines is even more recent than the promotion of CQI and postdates the initiation of CQI projects in many institutions. As credible and relevant practice guidelines become more available and more widely known, they should be perceived as more relevant to those attempting to implement quality improvement models in health care settings. Medical Review Criteria Although CQI programs may emphasize professionalism and internal quality improvement rather than regulation and external inspection, both 5   One result is a thriving business for consultants as health care institutions call on them for assistance in understanding and using the CQI model. One observer pungently reflected on the quality of this business: "Some consultants are real gems; some are semi-precious; and some are rocks" (Curt Lindberg, quoted in Burda, 1991a, p. 27).

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Guidelines for Clinical Practice: From Development to Use approaches are needed for a public program such as Medicare and for private health plans that are accountable to employers and others for their performance. How well a continuous improvement mentality can dovetail with outside monitoring, periodic audits, and externally developed review criteria is an important—and unanswered—question. The characteristics of specific medical review criteria and the processes for developing and applying them can make coexistence either easier or more difficult. General Issues in the Use of Medical Review Criteria Medical review criteria may be used for quality assessment and improvement purposes and also as part of utilization management programs that aim to reduce spending for unnecessary and inappropriate care. Some will be derived from existing practice guidelines; others may be developed de novo. Like guidelines for clinical practice, some review criteria will be more credible, sophisticated, and useful than others. Although quality and utilization review require specificity in review criteria, these criteria will not necessarily incorporate every recommendation or specification contained in a set of guidelines. For example, in the judgment of a review organization, some elements of a set of guidelines to assist clinical decision making may not provide sufficient additional information to justify the cost of using them in the review process. Review programs may add to as well as subtract from particular practice guidelines. As a case in point, review programs directed at patterns of care may employ quantitative thresholds that do not appear in guidelines to assist individual patient or practitioner decision making. Thus, such programs may specify institutional rates of infection or percentages of surgery with normal tissue removed that will trigger remedial actions or further investigation. Processes for creating review criteria from scratch or for transforming guidelines into review criteria and related tools have been little documented and appear to vary considerably. Many review criteria are not based on clinical practice guidelines at all but originate in "global" judgments about the "proper" frequency of certain tests or the acceptable interval between office visits. Such judgments may involve some kind of systematic process of expert judgment, or they may involve only an organization's medical director or consultant. Organizations that consider their review criteria proprietary may reveal little of the processes they use to create them. The lack of external scrutiny of review criteria is a major criticism of many public and private utilization management programs (IOM, 1989a). Practitioners complain that they cannot find out in advance what are the criteria for review decisions; this particular criticism has been leveled frequently at the actions of Medicare carriers and fiscal intermediaries (but not

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Guidelines for Clinical Practice: From Development to Use at Medicare peer review organizations, or PROs). Clinicians also complain that criteria differ from organization to organization and sometimes conflict, even when they are said to be based on the same starting point.6 Nonpublic criteria also preclude the kinds of education efforts described in the preceding chapter. Review organizations, in turn, express concern about physicians who may try to "game the system" if they know the review criteria in advance. Selected Illustrative Activities Related to Medical Review Criteria Public Sector Medicare peer review organizations have for the past few years been expected to carry out a variety of utilization review activities, chiefly preprocedure and preadmission review as well as some retrospective review (IOM, 1990i, see especially vol. 2). The PROs, which are regulated and directed in great detail in many respects, have been explicitly granted considerable freedom either to use national criteria or to develop their own criteria for these tasks, based on local patterns of practice. PROs have submitted their criteria to the Health Care Financing Administration (HCFA) for approval, but variability among PROs and between PRO criteria and national guidelines has nevertheless been considerable (Project Hope, 1987; IOM, 1990i). PRO review criteria have also been criticized for lack of precision and specificity and poor documentation. A recent study of PRO preprocedure review criteria found considerable variability in criteria for carotid endarterectomy and cataract removal but less for cardiac pacemaker implants (Kellie and Kelly, 1991). In an effort to move toward greater consistency (and efficiency), the American Medical Peer Review Association in early 1991 drafted a two-volume set of review criteria for some 3,000 surgical procedures.7 Further, HCFA-funded pilot projects to develop methods and criteria for evaluating office-based care are being undertaken with a level of conscientiousness that reflects the sensitiv- 6   Criteria for reviewing the appropriateness of hospital admissions and continued hospital stays are often based on the AEP or Appropriateness Evaluation Protocol (Gertman and Restuccia, 1981) or the ISD-A criteria set (Intensity of services, Severity of illness, Discharge and Appropriateness screens; InterQual, 1987). These systems ostensibly provide the same or similar guidance about appropriateness of inpatient care, but depending on the interpretations of information made by those who apply the criteria, they may yield quite different findings. 7   The use of this document in actual PRO activities may prove moot if PROs do not continue to conduct preprocedure reviews. The so-called Fourth Scope of Work issued by HCFA for the PRO program eliminated all preprocedure review (as of October 1991). The PRO community objected greatly to this change in their usual required activities, believing that preprocedure review had been a successful aspect of their work. PROs are permitted to propose to continue such activities as part of special review objectives.

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Guidelines for Clinical Practice: From Development to Use ity of the quality assurance community to charges of poorly developed or "black box" criteria (Darby, 1991a). Consistent with its charge to arrange for the development of medical review criteria as well as practice guidelines, AHCPR in August 1991 issued a request for proposals (RFP) with three major aims: (1) to derive review criteria from AHCPR guidelines on benign prostatic hypertrophy (BPH), urinary incontinence, and postoperative pain management; (2) to apply these criteria to samples of hospital or nursing home records that have already been reviewed by the PROs to determine how using these criteria will affect current PRO processes to identify quality and utilization problems; and (3) to evaluate practitioner education programs related to the parent BPH guideline document and its associated review criteria. The work will begin in late 1991 under the direction of the American Medical Review Research Center with the assistance of four PROs (Alabama, Massachusetts, Michigan, and Pennsylvania) and a large group of consultants; it is scheduled to be completed by September 1993. It is expected that the three (original) guideline panels will evaluate the review criteria developed in this project. At the time this report was being prepared, a similar "non-PRO" RFP was expected as well. In addition to these efforts, the agency will create a new expert panel to develop criteria for evaluating medical review criteria. The panel will consist of representatives of Medicare PROs, health maintenance organizations, private insurers, and others in the private sector, as well as HCFA staff. Private Sector Value Health Sciences (VHS), a for-profit utilization management company, creates its preprocedure and other prior-authorization review criteria in a formal manner. Originally it based its Medical Review System (MRS) criteria on appropriateness indications developed by a team of researchers at the RAND Corporation and the University of California at Los Angeles. VHS incorporated those very complex indications through a specific set of steps and supporting tools into detailed computer algorithms. The RAND work is in the public domain; the VHS work is not. Other companies are developing somewhat similar strategies linked to the RAND methodology (Winslow, 1990). The VHS MRS technology has the following components: (1) selection of procedures according to several criteria including risks to patients, financial impact of the procedure, and extent of agreement about appropriateness within the medical community; (2) review of the medical literature with respect to circumstances in which the procedure has been shown to be effective or ineffective; (3) development of a "framework" of clinical criteria of appropriateness for major procedures, using a "catalogue" of indications (detailed descriptions of specific classes of patients who are potential candidates for the procedure); (4) review and refinement of the framework

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Guidelines for Clinical Practice: From Development to Use Risk Management Risk management programs attempt to evaluate and decrease liability risks related to clinical care, housekeeping functions, management decisions, and other sources. Liability claims may arise from adverse events experienced by patients, visitors, staff, and others—even by prospective patients turned away from care. Across health care institutions, risk management programs and quality assurance programs are generally distinct organizational functions with varying degrees of interaction (Donaldson and Lohr, 1990). The wider availability and application of clinical practice guidelines should provide a stimulus for closer coordination. For risk management programs, clinical practice guidelines offer several potential benefits, as shown in Figure 5-1. First, the wider application of good guidelines should improve clinical performance and thereby reduce HYPOTHESIS AND HOPE: Good Practice Guidelines, When Widely Disseminated and Integrated into Good Quality Assurance and Improvement Programs, Will Help (1) IMPROVE MEDICAL PRACTICE AND QUALITY OF CARE (a) BETTER TECHNICAL CARE (less iatrogenesis, negligence) ↓ medical costs, ↓legal costs (b) LESS OVERUSE (INCLUDING DEFENSIVE MEDICINE) ↓ medical costs, ↓exposure to iatrogenesis (c) LESS UNDERUSE ↑medical costs (short-term at least), ? legal costs* (d) BETTER ART OF CARE, PATIENT SATISFACTION ↓ legal costs, ? medical costs (net) (2) STRENGTHEN ACCURATE EVALUATION OF CARE BY PEERS, PATIENTS, AND OTHERS (a) MORE NEGLIGENT CARE IDENTIFIED (b) LESS NONNEGLIGENT CARE MISLABELED (3) IMPROVE QUALITY OF LITIGATION AND COMPENSATION FOR NEGLIGENCE a) EARLIER RESOLUTION OF WORTHY CASES ↓ legal costs, ? medical costs (b) REDUCED PURSUIT OF UNWORTHY CASES ↓ legal costs, ↓ medical costs (c) FAIRER LIABILITY DETERMINATIONS ? legal costs, ? medical costs * Question marks indicate that the net impact (increase or decrease) cannot be readily predicted. FIGURE 5-1 Guidelines and Malpractice Incidence and Costs.

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Guidelines for Clinical Practice: From Development to Use the number of adverse events. These outcomes have been one objective of guidelines for anesthesiology and emergency room care. An important corollary aim has been to have malpractice insurers recognize adherence to such guidelines as an indicator of lower risk and a basis for lower premiums (Eichorn et al., 1986; Holzer, 1990). Second, practitioners and health care institutions should find well-developed, condition-specific or treatment-specific guidelines useful in communicating to patients the risks and benefits of treatment alternatives, thus helping patients to make informed choices among alternative courses of care. From a risk management perspective, among the objectives of such communication should be the reduction of litigation inspired by poor communication and of disappointment resulting from unrealistic patient expectations of perfect or guaranteed outcomes. Third, guidelines that define appropriate care for specific clinical conditions can help in determining whether identified adverse events are the result of poor care rather than the unfortunate consequence of medical uncertainty. An adverse drug reaction following first-time administration of a drug to a patient with no ascertainable contraindications would fall in the latter category; a second use of the drug followed by another adverse reaction would, absent qualifying circumstances, likely be judged negligent (Brennan, 1991b). Sound guidelines should provide a strong basis for distinguishing negligent from nonnegligent care, which, in turn, should help deter unjustified malpractice claims, resolve justified claims earlier, and improve decisions for cases that go to trial. Fourth, if practitioners have confidence in particular clinical practice guidelines and expect that documented conformance with these guidelines will do much to protect them against unwarranted claims (and findings) of malpractice, the anxieties that give rise to defensive medicine should diminish and the willingness to apply guidelines should increase. Given that defensive medicine occurs when practitioners provide or order services that are unnecessary except as potential malpractice protection, a reduction in defensive medicine should both improve quality of care and help contain health care costs.17 17   The extent and consequences of defensive medicine have been the subject of much debate and are difficult to document empirically. A 1990 congressional report on medical malpractice cited two estimates of the costs of defensive medicine (U.S. House of Representatives, Committee on Ways and Means, 1990). First, it cited the American Medical Association's estimate that defensive medicine accounted for $11.7 billion (about 75 percent) of the total $15.4 billion cost for the medical liability system in 1985. Second, it reported HCFA's estimate that defensive medicine cost the Medicare program $2.5 billion in 1987. Such cost estimates are notoriously slippery (Mills and Lindgren, 1991) because they are based on physician self-reports, they ignore certain costs, and they do not reflect offsetting savings from avoided adverse events. A full discussion of the economics of malpractice must also acknowledge evidence that much negligence is never identified or compensated (Harvard Medical Practice Study, 1990; Brennan et al., 1991; Localio et al., 1991).

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Guidelines for Clinical Practice: From Development to Use Medical Malpractice The second, third, and fourth points above bring clinical practice guidelines directly into debates about medical liability, standards of care, and malpractice reform. Most proposals for malpractice reform concentrate on such issues as limits on punitive damages and use of alternative dispute resolution mechanisms; many, if not most, make no mention of practice guidelines (GAO, 1987; Macchiaroli, 1990; U.S. House of Representatives, Committee on Ways and Means, 1990; Miller, 1991). Nonetheless, the increasing interest in guidelines has prompted several analyses of their potential for improving decision making in cases of alleged malpractice. Although opinions about this potential are mixed, the precept that "good medicine is good law" is widely accepted (Miller, 1991, p. 1). The legal theory of liability provides a deterrent to wrong behavior as well as a form of redress for such behavior when it occurs. To influence behavior, the liability strategy relies on economic penalties and fear. In this context, the role for guidelines is not to motivate but rather to assist decision making—prospectively in the case of clinicians and retrospectively in the case of those evaluating claims of malpractice. The potential impact of guidelines on the incidence and resolution of cases of medical negligence depends on many factors that have already been discussed and questioned here. These factors include the soundness of guidelines (e.g., their validity, reliability, precision), the degree to which practitioners accept and effectively employ them, and the extent to which guidelines exist for particular types of care—in this case, care that is likely to incur negligence and give rise to legal claims of negligence. On this last point, one recent article estimated that existing guidelines could provide relevant evidence for 20 percent of the medical injuries identified in a major study of adverse medical events and related litigation (Garnick et al., 1991). Since the availability of practice guidelines is growing, this percentage should also grow somewhat—even if malpractice concerns are not the key factor motivating the development of most guidelines. In addition, for guidelines to influence legal decision making, courts have to accept guidelines as important evidence of the standard of care. Some argue that the potential of guidelines to reduce defensive medicine, improve decisions in liability cases, and discourage unwarranted claims cannot be adequately realized unless courts accord clinical practice guidelines more weight than they currently do in determining the standard of care to be applied in assessing claims of malpractice (Hall, 1989; Brennan, 1991b; McCormick, 1991). This committee agrees generally with that proposition. The rest of this section presents definitions and describes options for granting guidelines more weight in malpractice decision making. The next section presents the committee's assessment.

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Guidelines for Clinical Practice: From Development to Use Malpractice Defined Medical malpractice is conventionally described as a deviation from the accepted medical standard of care that causes injury to a patient for whom a clinician has a duty of care (Kinney and Wilder, 1989; AMA, 1990b; U.S. House of Representatives, Committee on Ways and Means, 1990; Miller, 1991). The definition of the accepted standard of care may be supplied by case law (i.e., judicial precedent) or by state statute or regulation (Brennan, 1991b; Miller, 1991). In case law, the accepted medical standard of care traditionally has been described as that degree of care exercised by physicians of good standing in the same or in a similar locality as the defendant physician—in essence, medical custom. More recently, case and statutory law have moved away from geographically delimited standards of care (in legal terms, the ''strict locality rule" and the "similar locality rule") to national standards of care, particularly for specialists (Bovbjerg, 1989; Hall, 1989; Kinney and Wilder, 1989).18 Geographical factors, however, may still be considered—for example, if they affect the availability of medical facilities and resources.19 In addition, traditional case law allows for some divergence from common practice when that divergence is backed by a "respectable minority" of professionals. What a "respectable minority" is and will be in the future is far from clear (Hall, 1991; Miller, 1991). For example, if guidelines conflict, how will courts determine whether the respective sponsors are respectable? For other areas of tort law, the standard of care for evaluating someone's conduct is quite different from that applied in medical malpractice cases (Kinney and Wilder, 1989). It is usually defined as what a reasonable person would have done under similar circumstances. Industry customs may be cited to help juries and courts assess what is reasonable, but evidence of customary practice carries far less weight than it has in medical malpractice.20 18   Traditionally, the "strict locality" rule has referred to customary practice of physicians in the same geographic area as the defendant. The "similar locality" rule has been less delimiting; for example, it allows practice in rural areas generally to be cited as the basis of comparison for the practices of a particular rural physician. 19   At this time, the consideration of available resources is fairly limited and does not extend to any broad balancing of patient needs against any social interest in limiting resources for services of uncertain or limited benefit (Hirshfield, 1990a,b). Whether this will and should change and how practice guidelines will figure in any change are issues in the general discussion of the role guidelines should have in determining medical liability (Hall. 1989; Morreim, 1989). 20   As Kinney and Wilder point out (1989, pp. 439-440). the rationale for not automatically deferring to custom was described by Justice Oliver Wendell Holmes: "What usually is done may be evidence of what ought to be done ... [However] what ought to be done is fixed by a standard of reasonable prudence, whether it is usually complied with or not."

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Guidelines for Clinical Practice: From Development to Use The legal standard of medical care is, for the most part, established by expert physician testimony based on the expert's judgment. Because both plaintiffs and defendants usually present their own experts, this practice is informally described in legal circles as a "duel of experts" or "swearing contest." Subject to some limitations, experts may also cite published standards or textbooks (in legal jargon, "learned treatises"). Some states have given the courts explicit discretion to admit such standards without accompanying expert testimony, apparently to make it easier for plaintiffs to use their sources without running afoul of prohibitions against ''hearsay" evidence (Kinney and Wilder, 1989; Brennan, 1991b). It is in the guise of learned treatises that clinical practice guidelines can be cited as evidence. In theory, in medical malpractice, judges and juries evaluate only the persuasiveness of the expert's testimony; they are not supposed to evaluate directly the reasonableness of conduct.21 Hall physician (1991), however, argues that conflicting expert testimony and the lack of definitive scientific standards in most cases give juries ample opportunity to apply their own judgments about what is reasonable. The hope is that the development and adoption of soundly based practice guidelines will permit a better fit between theory and fact. According Guidelines Greater Weight in Determining the Standard of Care Although the definition of standard of care in medical liability law has been changing—moving away from local toward national standards and permitting published standards to be cited as evidence—change based on case law tends to be neither quick nor predictable. Some statutory or administrative mechanism may well be needed to give guidelines based on sound, documented scientific evidence and analytic processes greater weight in litigation than they now have. In particular, such a mechanism may be needed to provide immunity from malpractice liability for performance in accord with practice guidelines. Immunity means that a conforming clinician, if sued, would not be held liable absent some other basis of liability. Assuming the existence of good guidelines that can be used in everyday medical practice and as a basis for evaluating performance, what else may be necessary to accord guidelines greater weight in determining the legal standards of care? Table 5-2 lists some options and considerations for 21   In one exception, Helling v. Carey (83 Wash. 2d 514, 519 P.2d [1974]), the Washington State supreme court held that a jury could find a defendant liable for not testing a 27-year-old woman for glaucoma—even though experts for both plaintiff and defendant stated that it was not customary to start routine testing until age 40. This case has not, to date, been taken as a precedent for similar decisions by other courts.

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Guidelines for Clinical Practice: From Development to Use action. They relate to (1) how guidelines might be granted special recognition, (2) what authoritative status guidelines might have, (3) what parties could use the guidelines in the prosecution or defense of a malpractice suit, and (4) what weight might be granted guidelines. Proposals for legislation that would confer malpractice protection on clinicians who practice in conformance with guidelines have a precedent dating back to the 1972 law (Public Law 92-703) that created professional standards review organizations (PSROs); the relevant provision continues to apply to the successor peer review organizations (Gosfield, 1975). That provision declares that if a doctor has exercised due care, he or she cannot be held liable for actions that conform to norms developed by PSROs. It appears, however, that this "immunity" provision has never been used as a defense against a malpractice claim (Gosfield, 1989). Perhaps the due care TABLE 5-2 Options For Recognition of Guidelines in Medical Malpractice Law SOURCE OF RECOGNITION 1. Legislation a. Federal b. State 2. Rules of evidence developed within or by the judiciary and promulgated through administrative rulemaking a. Federal b. State 3. Judicial precedent (case law) AUTHORITATIVE STATUS 1. Guidelines developed by a specific entity are authoritative. 2. Guidelines developed according to specified criteria are authoritative. 3. Judges have case-by-case discretion to determine whether a guideline is authoritative. 4. Juries can decide as a matter of fact whether a guideline is authoritative. RIGHT TO USE 1. Only the defendant(s) can cite and use guidelines as a "shield" to claim immunity from liability for care delivered in accordance with guidelines. 2. Only the plaintiff(s) can cite and use guidelines as a "sword" to claim malpractice for defendant failure to deliver care in accordance with guidelines. 3. Both defendant(s) and plaintiff(s) can cite guidelines. WEIGHT 1. A guideline provides per se or conclusive definition of an applicable standard of care. 2. A guideline raises a rebuttable presumption; proof to counter this presumption can be offered. 3. A guideline can be considered as some evidence of an applicable standard.   SOURCE: This table was suggested by Arnold J. Rosoff in a discussion of legal implications of practice guidelines.

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Guidelines for Clinical Practice: From Development to Use reference raises the specter of continued argument about whether the standard of care was met, thus making the immunity promise appear dubious. More important may be the general low representation of Medicare patients among litigants and the lack of knowledge among attorneys of this provision of the Social Security Act and its amendments. More explicit and more controversial than the PRO immunity provision is the approach taken by the state of Maine. The state legislature has initiated a 5-year demonstration project to produce "standards of practice designed to avoid malpractice claims and increase the defensibility of the malpractice claims that are pursued" (Edwards, 1991, p. 3).22 Unlike the federal legislation that created AHCPR, the Maine statute does not explicitly require that the guidelines that are developed be based on the best available scientific data. The process was designed by the Maine Medical Association and is defined by statute. The state's Bureau of Insurance and Board of Registration in Medicine oversee the project, which started with three medical specialty advisory committees composed of physicians and public members serving 3-year terms. The advisory committees have, as directed by statute, focused on anesthesia, obstetrics and gynecology, and emergency medicine; radiologists recently asked to be included, and legislation to that effect is pending. Smith (1990), in explaining the legislature's action, states that the first two clinical areas were selected because of the "well-established standards that have already been promulgated nationally" (p. 2). Once guidelines and protocols are developed, the Board of Registration will adopt them as rules under the state's Administrative Procedure Act. If 50 percent of the physicians in the state agree to practice according to the guidelines, then physicians can cite the guidelines in their defense in malpractice cases. Plaintiffs cannot use the guidelines unless they are first cited by the defense or unless the provisions they cite are identical to those in some other independently developed set of guidelines. At this point, it seems that most of the Maine guidelines will incorporate guidelines already issued by other organizations; one exception may be provisions regarding preoperative tests for patients facing relatively uncomplicated surgery (G. Smith, Maine Medical Association, personal communication, June 10, 1991). Questions have been raised about the constitutionality of the "defendant use only" aspect of the Maine project. Indeed, one malpractice insurer, nervous over the questions raised about the law, has backed away from the effort. Nonetheless, the legislature does not appear inclined to change this aspect of the law, which was a significant element in the careful, lengthy 22   Voters in California may soon vote on a proposal similar to the Maine model (McCormick, 1991).

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Guidelines for Clinical Practice: From Development to Use process of negotiation among involved parties that led to the demonstration project (State Representative C. Rydell, Maine House of Delegates, personal communication, August 5, 1991). In 1986, the legislature of Massachusetts took a different approach. It created a risk management unit in the state's medical licensing and discipline agency and required physicians to participate in a quality assurance program as a condition of licensure. Guidelines feature prominently in the quality assurance program, and the statute includes certain requirements for their content and for the development process. Physicians who participate in the program are entitled to reductions in malpractice insurance premiums from the state's liability insurers. Two specialties, anesthesiology and emergency medicine, have developed guidelines that initially qualified participating physicians for a 20 percent discount in liability premiums (McGinn, 1988). Whether the experience of Massachusetts can be generalized to other types of guidelines is not clear. For example, the anesthesiology guidelines have several characteristics that are not common to most guidelines. Specifically, they were developed as a direct response to problems recognized as sources of liability; they are precise, particularly in their key recommendations for the use of pulse oximeters; and professional support for them was virtually unanimous. (It should be noted, however, that these guidelines do not cite or analyze any scientific evidence of effectiveness.) Statutes that would allow judicial and jury discretion in determining the admissibility of guidelines or that provide for their consideration as merely some evidence of the applicable standard of care accord little more stature to guidelines than is granted under existing case law. Hall (1991), however, suggests that statutes specifically allow judges to consider, without the jury present, the stature of guidelines offered by defendants. Thus, without being bound by the technical rules of evidence, judges could determine the weight to give guidelines and could, in the case of "authoritative and indisputably applicable" guidelines, direct a verdict for the defense (p. 135). Authority would be assessed according to "the respectability of the issuing organization and its process of promulgation, [separate] from the inherent appropriateness of the standard itself" (p. 140). At the federal level, several legislative proposals link guidelines to medical liability reform (McCormick, 1991). The most far-reaching would enmesh guidelines in the competition strategy for health care reform (described earlier), using contract law and federal tax policy as leverage (Havighurst, 1990a, 1991a; Blumstein, 1991). This approach would encourage consumers to choose among health plans that could offer different standards of care. Health plans could incorporate (or cite) particular practice guidelines in their contracts, or the contracts could provide for the application of guidelines developed according to specific procedural and substantive crite-

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Guidelines for Clinical Practice: From Development to Use ria.23 How courts would reconcile this approach with the mostly unitary standard of care that has been developing through medical liability case law is far from clear (Blumstein, 1991; Schulman, 1991). This uncertainty has prompted a proposal that would essentially require, first, that health plans and their participants use an arbitration procedure for dealing with malpractice and, second, that the arbitration process apply the standard of care defined in the health plan contract (Havighurst and Metzloff, 1991). Directions for Risk Management and Liability Standards Once again, the committee stresses the desirable attributes of guidelines that were identified in Chapter 1. Regardless of specific statutory developments, guidelines that are based on scientific evidence and judgment and that are clear, specific, and developed by a reputable organization and process should carry greater weight in malpractice decision making than vague, nonspecific, and undocumented guidelines; they should certainly be accorded more weight than isolated expert testimony (Miller, 1991; Hirshfield, 1990b). To the extent that guidelines document the strength of the evidence, the importance of the risks and benefits, and how compelling is the case for a particular intervention, they should help courts distinguish required care from optional or unindicated care. The committee vigorously debated whether to recommend that federal or state legislation grant immunity to practitioners acting in conformance with practice guidelines. Although some members argued quite forcefully that such a recommendation was warranted now, the committee on balance concluded that it would be premature. 23   Havighurst (1991b, pp. 25-26) has proposed the following contract language for HMOs concerned about malpractice liability: "The Plan warrants that each of its physicians possesses at least the skill and knowledge of a reasonably competent medical practitioner in his or her specialty and undertakes to you that its physicians will exercise that skill and knowledge in a reasonable and prudent manner in your case. In so doing, a Plan physician may sometimes depart from practices customary among other physicians. Such departures shall not be deemed to breach the foregoing undertaking, however, unless they are expressly found to have been unreasonable and imprudent; evidence to support such a finding shall include the testimony of experts knowledgeable about practices customary among physicians in other organized health plans in which physicians are not compensated on a fee-for-service basis. In instances where the Plan has consulted with the Members' Advisory Panel concerning a particular practice or method of diagnosis or treatment and obtained the Panel's approval of a particular clinical policy, adherence by the Plan's physicians to the policy shall not be deemed unreasonable and imprudent unless such approval was obtained by misrepresentation or unless changes in medical knowledge between the time such approval was obtained and the time you were treated indicated that continued adherence to such policy was unreasonable and imprudent. You agree that the undertaking in this paragraph fully defines the duties of the Plan and its physicians to you."

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Guidelines for Clinical Practice: From Development to Use Legislation that provides for immunity, the committee believes, ought to specify either operational criteria for the organizations developing guidelines or particular criteria for the guidelines themselves. Criticism of the variability and weaknesses of guidelines developed by PROs made the committee reluctant to accept organizational imprimatur alone as a sufficient basis for a grant of immunity. More broadly, existing publicly and privately developed guidelines and related organizational processes for developing guidelines vary widely in quality; some are clearly inferior. As discussed in Chapter 8 (and Appendix B), an entity to assess the soundness of guidelines might provide the foundation on which legislation could rest. Such a body could help users of guidelines, including attorneys and courts, to evaluate the merits of different guidelines, and hence the merits of lawsuits that employ guidelines as evidence. Although the committee understands that allowing only the defense to cite authoritative guidelines in court might reassure physicians and speed acceptance of guidelines, such a restriction is unfair and probably constitutionally suspect (McCormick, 1991). Equally important from the committee's perspective, such restrictiveness is inconsistent with the basic concept of science-based guidelines for appropriate care. Both the evidence and any further credibility offered by a sound process of guideline development should be available to defendants and plaintiffs alike. The lack of a legislative imprimatur does not mean that guidelines cannot and will not be increasingly used to define the standard of care (Hall, 1991). For example, judges are in a position to consider the reputability of organizations that develop guidelines. As the development and assessment of guidelines become more firmly grounded and more recognized in practice, judges and juries should eventually give them greater weight than isolated expert witnesses, less firmly grounded testimony, or older medical treatises. The committee urges AHCPR to continue to support scientifically meritorious research on medical liability that could simultaneously examine topics related to guideline development. One question the agency might consider is whether clinical practice guidelines for services of unclear or very marginal benefit could be phrased and explained in ways that would reduce the likelihood of defensive medicine. For example, are judges or juries (or, for that matter, patients, lawyers, or practitioners) likely to make different decisions depending on whether guidelines (a) explicitly state that, given the scientific evidence, a practitioner can prudently forego a specific service under specific circumstances, (b) explicitly state that a practitioner may want to provide the service although evidence does not support a specific recommendation, or (c) are silent on the issue? Chapter 6 suggests how guideline developers might construct recommendations that would be

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Guidelines for Clinical Practice: From Development to Use more useful to those who must make decisions in the face of weak or nonexistent evidence. The committee noted one serious potential problem that medical liability law raises for the CQI model of quality assurance. Current liability procedures and standards could jeopardize implementation of the CQI vision of mistakes as "treasures" to be uncovered, analyzed, and used for learning. In an ideal world, if such mistakes resulted in harm to patients or others, institutions and practitioners would admit liability and compensate the injured party. This practice operates now to some degree, but the financial, reputational, and other potential harms of this aspect of the CQI strategy must be recognized as a powerful disincentive to such behavior. SUMMARY Guidelines do not implement themselves. Patients and practitioners make the key clinical choices that determine whether care will or will not be consistent with guidelines. Good guidelines aim to strengthen the scientific basis and consistency of these choices and ensure that patients and practitioners are well informed about the risks and benefits of alternative courses of care. For such guidelines to be more widely and successfully applied, however, patients and practitioners need an extremely broad range of supportive conditions and organizations. The last two chapters have examined several critical areas of support: educational activities, information and decision assistance systems, quality assurance and improvement programs, cost control strategies, and risk management. In considering these supportive programs, this chapter and the next underscore a theme of this report: successful implementation of guidelines begins with the process of developing guidelines. The more developers of guidelines can anticipate what will make guidelines practical and credible, the more likely it will be that guidelines will be used in the kinds of activities described here. At several points, the discussion has suggested that cost control, quality assurance, equity, and other strategies may conflict and pose problems for organizations and policy makers seeking coherent programs. The next chapter considers interrelated questions of cost-effectiveness, minimum standards of care, and requirements for informed patient consent.