Experiences With Guideline Development were to improve quality of care or, most commonly, to defend against a variety of forces outside their specialties. Representatives of several societies emphasized that while their organizations have many reasons for guideline development at this time, their primary motive is to improve quality of care. They see guidelines as educational tools for physicians and patients-tools that can help reduce uncertainty and clarify controversial and unproven areas of medicine. Among their views on the ways in which guidelines can lead to improvements in care were the following: Guidelines can help physicians monitor their own profession by Guidelines can help to elevate the quality of care provided by all Guidelines can help reduce waste and abuse, while they promote both One medical organization official pointed out what he sees as a dichotomy: the types of guidelines that would help elevate the quality of care by all physicians would not necessarily meet the needs of thirdparty payers, who seek lines of demarcation for payment or denial of medical charges. One society has attempted to treat that issue by creating several products for one medical condition: quality assurance, risk management, and reimbursement applications as well as physician guidelines. The most commonly stated reason specialty societies are currently developing guidelines is to help defend against forces outside their specialties. Among the views expressed by society representatives are the following: Physicians want to help determine, and reduce the variability in, review and payment criteria so as to defend against unmerited payment denial. They are concerned that groups such as the federal government, insurance companies, payment review organizations, utilization and quality assurance reviewers, and health maintenance organizations may impose inappropriate guidelines. Experiences With Guideline Development Physicians want to counter or preempt guidelines, developed by other specialty societies, that they believe are inappropriate or that negatively affect their society's members. Physicians want to reduce the need to practice defensive medicine, deter inappropriate litigation, and reduce malpractice awards and insurance premiums. Guideline Developers Committees Usually Societies are more similar to each other with regard to who develops guidelines and reviews them before publication than they are in other aspects of producing guidelines. Most involve academicians and clinicians from within their societies; some include others outside their membership. Guidelines generally have been created by committees. Although the size of committees has varied from 2 to 20 members, the majority have included from 6 to 10 members. In five societies, individuals drafted guidelines, which were then reviewed by committees and others. Committees were usually composed of a mix of academicians and clinicians who were members of the originating society. Some societies included physicians in other medical societies that also deal with a condition or employ a procedure. (For example, in one case, each of three sister societies had a representative on the others' guideline committees.) Nonphysician medical personnel, such as nurses, and nonmedical personnel, such as writer-editors, methodologists, and group facilitators also served on some committees. One society worked with an insurer, and four have issued guidelines jointly with other societies or are planning to do so. Most Had Several Most societies had multiple reviews of draft guidelines by such bodies as other guideline development groups, guideline oversight committees, boards of directors, and executive boards. In two cases, the entire society membership received drafts for comment. Persons outside the originating society were more commonly asked to review rather than help develop guidelines. Several societies sent drafts to executive boards of other societies that had an interest in the topics. In one instance, however, the society saw less need to go outside its membership, since specialized knowledge could be drawn from among its many members who are certified in more than one specialty. Experiences With Guideline Development Processes for Some medical specialty societies benefited from the past experience and guidance of others; however, most laboriously evolved their own processes for guideline development. Society representatives said that AMA and CMSS meetings on guidelines were helpful, and nine societies have either engaged a well-known guidelines consultant or adapted features of his outcomes-based methodology to their processes. Initial practice guideline efforts, however, were usually lengthy, as methodologies evolved. Literature Review and Multiple Steps in the In some cases, guidelines were based solely on the literature or solely on opinion. The majority of guideline development processes, however, included literature review and consensus among development committee members (and, sometimes, outside experts) about the strength of clinical evidence for an intervention. Some guideline developers received direct input from clinicians in the field. Guideline developers typically (1) identified and prioritized guideline topics, (2) reviewed scientific literature (3) formed consensus, (4) drafted guidelines, (5) sent drafts for review and comment, (6) revised drafts, (7) obtained approval, and (8) printed and disseminated the products. Many variations to that basic approach occurred. In one instance, a committee chairman developed guideline methodology and prepared drafts. In other cases, topics were suggested by society or committee members. One society placed notices in its own and other medical publications soliciting input early in the process. Sometimes there was no literature review: guidelines were based only on consensus. In some cases, experts served on committees; in others, they advised committees. Some guidelines were based on literature review alone; some were researched and written by one person, with subsequent review by others. In other cases, whole committees brainstormed and produced drafts. Two societies engaged consultants to help committee members with group process development and group dynamics. Three societies asked persons in the field to test draft guidelines. Internal review involved from one to five layers, with final approval in almost all cases by the societies' governing boards. Societies that obtained extensive input and review, and based their guidelines on literature review as well as on expert opinion and consensus, believe their Experiences With Guideline Development Incorporating Outcomes of processes yielded guidelines with high validity and credibility that were accepted by physicians. Outcomes management has been described as the "technology of patient experience designed to help patients, payers, and providers make rational medical-care related choices based on better insight into the effect of these choices in the patient's life." Some guideline developers believe it is valuable to integrate information about the outcomes of medical care into their societies' guidelines. Several of our sources indicated, however, that there is a dearth of outcome information. In the absence of such information, some societies estimated outcomes, used results of controlled clinical trials when they were available, or relied on their own knowledge of outcomes and patient preferences. Many representatives said they see a need for their societies to incorporate outcomes information into guidelines, but find the cost of developing such information prohibitive. They suggested that other organizations, such as the federal government, conduct or fund outcomes research. Some have sought grants and are conducting joint outcome studies with other organizations. Not everyone agreed that outcomes research is necessary. One representative stated that in her society's area of specialization enough studies have already been published about which medical approaches work. Another noted that published outcome data are those achieved by the very best physicians getting the very best results and do not represent the circumstances and work of average physicians. He described his society's method of obtaining these data from community physicians, against whose outcomes other community physicians will be able to compare theirs. Finally, one society initially plans to describe estimated outcomes and will strive to develop the capacity within 3 to 5 years to use formal methods to determine outcomes. A society spokesman speculated that research may show that some choices are rational for individuals, but not for the society as a whole. 2Paul M. Ellwood, M.D., "Shattuck Lecture-Outcomes Management-A Technology of Patient Experience," New England Journal of Medicine, 318:23, p. 1,551. Experiences With Guideline Development Dissemination of Twenty of the societies we contacted had completed guidelines. In most cases, guidelines were disseminated to all society members at low cost through existing, sometimes multiple, vehicles. Eight societies published (or plan to publish) guidelines in, or attached to, their professional journals. Guidelines were also included in or with other society publications (for example, newsletters), were published in other societies' journals, or were mailed separately. Some societies publicized the information that guidelines were available on request, either free or at a cost. Some issued press releases indicating the existence of guidelines. One set of guidelines was published by a medical publisher and placed in medical bookstores. Several societies used multiple dissemination mechanisms. Nearly all societies sent guidelines to all their members. Guidelines appearing in society journals, of course, reach all subscribers, as well as others who may read them in libraries and elsewhere. In other cases, societies mailed guidelines to other societies; to the Department of Health and Human Services and the Health Care Financing Administration; to deans of medical schools; and to individuals and groups, such as payers and medical care reviewers, that had expressed interest in guidelines. The press releases may reach the general public, and representatives of one society spoke of adapting its guidelines for health care consumers. Provisions for Society and medical association representatives expressed the need to ensure that guidelines remain relevant, given the dynamic nature of medicine. Most societies have considered scheduling periodic review and updating of existing guidelines, although not all have begun yet, nor have all developed formal plans for doing so. Schedules for review and updating are diverse: seven societies plan to review guidelines yearly; another will do so every 10 years, or more frequently if it becomes apparent that changes are needed. One society has stated that each guideline will expire after 3 years and must be rewritten unless it was revised in the meantime. Others will keep alert to changes in medicine that signal a need to revise guidelines. Not all societies have determined who will review and update guidelines. In some cases, the groups that wrote the guidelines will review them; in other cases, the guideline development committees in place at the time of review will do so. |