Experiences With Guideline Development The Effort Required to Society representatives reported that shaping and launching guideline Produce Guidelines development programs was time consuming. While some societies produced guidelines in as little as 3 months and one effort took 5 years, more typically development took 1 to 3 years.3 Of those societies that provided estimates, costs ranged from $5,000 to $130,000 per guideline or set of guidelines, excluding volunteer time. For $100,000, one society produced a guideline package that included quality assurance, risk management, and reimbursement applications with its physician guidelines. Some societies budget for guidelines; one has set aside $500,000 over an unspecified time, with $180,000 earmarked for the first year. Other societies budget yearly amounts. Some smaller societies are devoting larger amounts of money to guideline development than are larger societies. For example, one society spending approximately $75,000 per year has 4,500 members; the one that has committed $500,000 ($180,000 for the first year) has 5,000 members; one society forecasting $218,000 for guideline development in 1990 has 15,000 members; and one committing $100,000 a year has approximately 66,000 members. Several society representatives spoke of the value of the time physicians 3Several society representatives speculated that future efforts will require less time since they now have criteria and methodologies. Appendix III Suggestions Provided and Issues Raised by Introduction The experience of medical specialty societies with guideline development renders their views especially important to those about to embark on the process themselves. Presented below are the comments of society representatives about desirable characteristics of guidelines, factors they believe helpful to guideline development, and their thoughts on achieving compliance with and measuring the impact of guidelines. The appendix concludes by listing some questions and concerns expressed by society representatives about guideline development. Varied Characteristics of Guidelines Guideline Recommendations In appendix II, we described components of existing guidelines. Medical association and specialty society representatives correspondingly offered a variety of views and suggestions—sometimes conflicting— about what they considered to be characteristics of good guidelines (for example, how recommendations should be framed and how guidelines should be designed to avoid legal pitfalls). Spokespersons also provided suggestions about disclosing the bases, methodologies, and targets of guidelines. As noted earlier, medical specialty societies approached guideline recommendations in different ways. Whereas some were quite definitive, others developed guidelines for areas of uncertainty or conflict regarding appropriate practice. Suggestions by society representatives for framing recommendations ranged from advice that they be quite prescriptive (that is, do this, do not do that) to advice that they be explicitly neutral when necessary or that they state that there is legitimate disagreement over the best course of action. Legal Considerations In the view of some societies, guidelines should be developed to minimize possible adverse legal consequences. Some suggest using disclaimers to emphasize that the societies neither endorse particular interventions nor present the guidelines as the only acceptable approaches. One society's lawyers cautioned guideline developers to avoid using such words as "always," "never," and "standards." Another society believes it unnecessary to attach disclaimers, noting that topics should be chosen and guidelines formed with sufficient scientific rigor that the society can stand behind its products without qualification. Suggestions Provided and Issues Raised by Public Disclosure Perceived Factors for Who Should Be Involved? Society representatives advised that guidelines be flexible enough to avoid unreasonable restraints of trade. They stated that overly restrictive guidelines could present resource or technology requirements that might unjustly preclude some physicians from practicing. Medical societies differed greatly in the extent to which they disclosed how guidelines were formed and who developed them. Proponents of disclosure suggested that information be provided on the intended users of the guidelines; the methodology used to develop them, including the evidence used to reach conclusions (e.g., literature, efficacy and outcomes information, consensus); areas of variation, ambiguity, and controversy, including issues about which there was a lack of unanimity; ⚫ areas where additional research is needed because of gaps in knowledge; and resources needed to implement the guidelines. Medical specialty society spokespersons shared many suggestions they believe would be helpful to the guideline development and dissemination process. For example, they offered suggestions on who should be involved, how to increase the efficiency and effectiveness of the process, and how to address and reduce the magnitude of effort required. Society representatives emphasized the need for vigorous guideline development committee leaders who are skilled at facilitating group processes. They recommended engaging recognized, respected panel members from various parts of the country-members who are enthusiastic and dedicated to completing the job of guideline development. They emphasized the value of including persons who represent both sides of an issue, but also cautioned that persons involved with development be neither rigid nor overly ideologic. One spokesperson also stated the importance of demonstrating the independence of the committee developing the guidelines. This avoids creating the appearance that the committee is driven by the federal government or proponents of special interest groups. Suggestions Provided and Issues Raised by How to Increase General Suggestions Some persons recommended including on committees representatives, as As society representatives described their experiences with guideline development and dissemination, they spoke of pitfalls they experienced, or those they identified and avoided, and described lessons they had learned. Without recounting their stories or how they reached their conclusions, we list their suggestions for what can be done to promote strong development and dissemination processes. General suggestions were to Ensure that guidelines are credible and useful. Offer guidelines, rather than seeming to impose them. Avoid politicizing guideline development. Allow for technology dissemination and attainment of competence before developing guidelines for a new technology. Link education and review tools to avoid replication of work by separate development groups. Suggestions about the scope and methodology for guidelines were to Specify, at the start of the process, the scope of all guidelines the society ultimately intends to undertake. (For example, the society will develop guidelines for 20 conditions, which account for 95 percent of all treatment costs for that specialty.) Make the scope of current work manageable. Define what should be done during the process and the methodology that will be followed; allow for evolution of the methodology if needed. Let society members know what is being done and how; involve the members. • Focus on quality of care, "letting the chips fall where they may" in regard to cost. (Depending on what practice they are describing, guidelines may have positive, negative, or neutral effects on costs.) Suggestions Provided and Issues Raised by Incorporate ideas from other societies' development efforts. Hold face-to-face committee meetings. Recognize differences with other specialties and groups. Avoid duplicating the efforts of related societies. Use a small number of people to write the initial draft of the product. • Have a thorough review process, incorporating review comments. • Document the criteria and methodology. Keep everything "above board": allow everyone to "shoot at❞ the guidelines; publish guidelines in a scientific journal, allowing everyone to dispute guidelines through letters to the editor. Avoid disseminating guidelines through vehicles that may be discarded, such as newsletters. Avoid sending guidelines through bulk mail; this type of mail is not forwarded. Set expiration dates for products, at which time they are to be reevaluated for relevance. How to Manage the Making Guidelines Guideline developers offered suggestions and issued several caveats about managing the resources required to produce guidelines. They stated the importance of having the commitment of the organization, along with funds needed for guideline development. They pointed to the need to develop realistic estimates of the time, effort, and money that will be required. They emphasized that societies should explain at the start the extent of commitment and time that will be required of the volunteers who will work on guideline development. Some suggested that face-to-face meeting costs be reduced through such technologies as conference calls, mail, and word processing. Another suggestion was that guideline development meetings be combined with other society meetings. Finally, one representative suggested that societies develop fund-raising programs to support guideline development. For guidelines to have an impact, either physicians must be receptive to them or mechanisms must be developed to achieve compliance. Presented below are the medical society representatives' views on the related issues of receptivity and compliance. It is important to note that societies see themselves as educational arms of the medical profession, with no direct role in promoting compliance. |