Appendix I Introduction Background Objective, Scope, and The U.S. Congress, in an effort to enhance the quality, appropriateness, and effectiveness of health care services and access to such services, passed legislation in December 1989 establishing the Agency for Health Care Policy and Research (AHCPR). The new agency, a successor to the National Center for Health Services Research, is charged with many of the same functions as its predecessor. Its role differs, however, in one major respect. Specifically, the legislation (P.L. 101-239) requires that the administrator of AHCPR "arrange for the development and periodic review and updating of clinically relevant guidelines." It further requires that guidelines for no less than three clinical treatments or conditions be completed under the AHCPR's direction by no later than January 1, 1991. Although the congressional call for guidelines at first seems a radical departure from traditional policy, it is very much in line with a series of recent developments. Both the Institute of Medicine (of the National Academy of Sciences) and the American Medical Association (AMA) Support the development of guidelines.1 In fact, some medical practice guidelines already exist. A variety of groups, such as hospitals, pharmacists, and insurance companies already have developed guidelines in an effort to reduce unnecessary or inappropriate care, malpractice premiums and awards, as well as costs. Historically, intensive efforts at guideline development in the United This report is one product in a larger effort mounted in response to a request from Senators Mitchell, Glenn, Pryor, and Heinz, in their respective roles as Majority Leader; Chairman, Committee on Governmental Affairs; and Chairman and Ranking Minority Member of the Special Committee on Aging. They asked us to examine the steps that need to be 1Both organizations have issued reports on guidelines. The AMA issued Attributes to Guide the Development of Practice Parameters in January 1990. The Institute issued Clinical Practice Guidelines: Directions for a New Program late in 1990. The terminology used to refer to guidelines differs in the two reports, and for purposes of clarity, we will use the term "guidelines" throughout this report. Introduction taken to make effective practice guidelines a reality. The objective of this first study is to examine how guidelines have been developed in the past, so as to use that experience to inform future guideline development. Specifically, we describe the methods employed by medical specialty societies in their development efforts and the lessons learned from those experiences. Toward that end, we report both the unique approaches and the commonalities among specialty societies in guideline development. After we reviewed the literature on medical practice guidelines, we met with staff from the American Medical Association and Council of Medical Specialty Societies (CMSS) for an overview of the current status of practice guideline development. They indicated that medical specialty societies have been the primary developers of guidelines and identified 35 societies that have worked on them. We sent a letter describing our study to each of those societies. The letter presented the following working definition of a guideline: "guidance by whatever name-that aids practicing physicians and others in the medical community (and consumers, if included) in day-to-day decisions by describing the degree of appropriateness and the relative effectiveness of alternate approaches to detecting, diagnosing, and/or managing selected health conditions." We asked if their guidelines met our definition and whether representatives of the societies would be willing to share their experiences with us. Twenty-seven societies responded that they had or were developing such guidelines, and they agreed to participate in our study. (Appendix IV lists the organizations that provided information to us.) During our initial interviews, we found that there was such diversity of motivations, approaches, and views about guidelines among societies that any attempt to characterize the universe of experiences through contact with only a sample of societies would be inappropriate. Therefore, we decided to conduct interviews with designated representatives of all societies that expressed a willingness to meet with us. In most cases, we met with one or two representatives; in one case, eight persons attended for the society. In two instances, one representative described the activities of two societies. In addition to conducting formal interviews with society and medical association representatives, we reviewed testimony presented in 1989 by federal officials, medical organization leaders, and physician experts Introduction during hearings on proposed health care legislation. Finally, we identified and analyzed the salient characteristics of guideline examples provided to us by 20 societies that have completed guidelines. To help ensure that our interviews contributed to an accurate and useful study, we first sent outlines of topics to be discussed so that participants had the opportunity to prepare thoughtful and complete responses. We assured them that we would not attribute information in our report to specific organizations or individuals. Finally, upon completion of the interviews, we sent copies of interview write-ups to each individual or set of individuals with whom we met, asking them to review and annotate them if they wished to correct or add information. Twenty-four organizations took the opportunity to confirm the information in our write-ups by returning them to us with a representative's signature. In some cases, additional or updated information was added or changes were made. Because our time and resources were limited, we did not obtain information from other sectors with an interest in practice guidelines—sectors such as payers and quality assurance or utilization review groups. It was beyond the scope of our work to evaluate either the ways in which guidelines have been developed or the results of those efforts because of the length of time over which guidelines have been developed, the extreme variability of the development process, and the lack of evaluative data from development efforts. Our study is thus limited to describing guideline efforts that have already been undertaken, reporting medical societies' views of the lessons they have learned, and distilling this information for use in the present federal initiative to develop clinical practice guidelines. Appendix II Experiences With Guideline Development Introduction Kinds of Products No two medical specialty societies with whom we spoke have produced similar guidelines for similar reasons in a similar fashion. This appendix shows the broad range of these societies' experiences. Included are descriptions of the variety of guidelines we saw, why societies developed guidelines, who was involved, and how guidelines were developed and disseminated. The appendix concludes with information on medical specialty societies' plans for updating guidelines and the magnitude of effort involved in producing guidelines. Guideline types vary greatly, from a 3-page quality assurance tool to a book with recommendations for whether, when, and how to treat a host of medical conditions. There is no consistent correlation between the size of a society or the length of its experience with guideline development and the characteristics of its products. Some comparatively small societies, less experienced with guidelines, produced comprehensive and innovative products. Societies designed guidelines with different audiences, and sometimes no specific audience, in mind. Some society representatives said the potential audience influenced the form and substance of their products. One society, for example, produced a set of different products on one topic to make the guideline readily useful to several types of users. Another expected to switch from diagnosis-based to procedure-based guidelines to make them useful to health care reviewers, but felt that some of the guidelines' utility to physicians thereby would be sacrificed.1 'Guidelines for care of breast cancer are diagnosis-based; mammography guidelines are procedurebased. Of the 24 products we reviewed, 7 were diagnosis-based, 15 were procedure-based, and 2 were both. Experiences With Guideline Development Most of the guidelines we reviewed had recommendations that specific action be taken in a given clinical situation. Several guidelines, however, indicated what could, might, or should not be done in response to a clinical problem. And some even concluded that there was insufficient evidence to offer any prescription for action. The variation in how definitive the recommendations were was reflected Other terms used to distinguish between levels of recommendations were "standard, guideline, and practice option," where "standard" means that the consequences of an intervention are sufficiently well known to permit meaningful decisions, and there is virtual unanimity about the desirability of the intervention and about the proper use of the intervention; "guideline" means that outcomes are well enough understood to permit meaningful decisions about proper uses of an intervention, and an appreciable, but nonunanimous, majority of physicians and informed patients share preferences regarding the intervention; and "practice option" is used when either outcomes are not known, or a significant proportion of physicians or patients feel the intervention is not worth the benefit, or the preferences of informed patients are not known or are evenly divided. Reasons for Guidelines Medical specialty societies formulate guidelines for a variety of reasons. The two primary ones we were told during the course of our interviews |