Guide to Development of Practice Guidelines

Abstract

A commonly accepted definition of a clinical practice guideline is “a systematically developed statement to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” [1]. Guidelines are written to improve the quality of care, to improve the appropriateness of care, to improve cost-effectiveness, and to serve as educational tools [2, 3]. The goal is not to create standards of care; however, other organizations may choose to adopt these guidelines or components thereof for such purposes. Practice guidelines, however, are never a substitute for clinical judgment. Clinical discretion is of the utmost importance in the application of a guideline to individual patients, because no guideline can ever be specific enough to be applied in all situations. To fulfill the objectives of guidelines adequately, standards must be established for the quality of guidelines so that their scientific validity and clarity of communication may be ensured (table 1) [4]. The challenge to guideline writers, therefore, is to adhere to these standards in the guideline development process while also making the document user-friendly. Recommended timeline for steps in the guideline development process. Because the majority of the guidelines of the Infectious Diseases Society of America (IDSA) will be published in the journal Clinical Infectious Diseases, it is essential that the turnaround time from concept to final draft be as short as possible, preferably <12 months. The IDSA Practice Guidelines Committee recommends that guideline developers carefully consider and incorporate the following standards. Choosing guideline topics. Guideline topics should be chosen for the impact that they will have on the practice of medicine. Topics should come from an area of interest that has a high volume of cases, high cost, issues related to risk management, or significant variation in practice. There should be sufficient evidence available for review to justify the development of a guideline. The scope of the guideline topic should be narrow enough to be thoroughly explored with the time and resources available. In most cases, the IDSA Practice Guidelines Committee will suggest the topic to the committee, but members can certainly suggest topics in areas that they believe warrant such a document. Specifying the purpose. The purpose for which the guideline is being written should be clearly specified. It should be clear to the target audience why this is an important topic and why it has been chosen for review at this time. What is the impact that the guideline is expected to have on the practice of medicine? Clarification of controversy, proper uses of newer technologic or diagnostic tools, and appropriate use of pharmaceuticals are examples of appropriate reasons for guideline development. Unambiguous terminology should be used. Choosing the panel participants. Participants in the guideline development process should represent a range of experts that is sufficiently broad enough to adequately explore the topic. Ideally, 6–10 members should be chosen by the guideline leader. The IDSA Practice Guidelines Committee can be a useful resource in helping to find panel members. When appropriate, it is desirable to include members of related disciplines. Guideline developers are strongly encouraged to include members of relevant professional societies and to work toward consensus in their recommendations. This process can only serve to enhance the validity and credibility of the guideline. Inclusion of members of other specialty societies, however, should include a discussion of who will fund their participation. Specifying the target population. The targeted patient population should be clearly specified. Consider age, sex, clinical condition, or other factors that might affect the recommendations and then define these limitations. Give special consideration to (1) the inclusion of special populations, such as pediatric patients, pregnant women, or immunocompromised individuals, and (2) how—or whether—the guideline recommendations are altered by these circumstances. If the recommendations are significantly different for specific populations, it may be best to propose that a separate guideline be developed to encompass these groups. Specifying the target audience. Specify clearly who the target audience is at the beginning of the guideline. Is the guideline primarily intended for primary care physicians, specialty physicians, or another audience? Exploring the diagnostic and therapeutic options. Specify clearly the principal diagnostic or therapeutic options that are available and how they will be explored in the guideline. The reasons why these options were chosen and why other options might not be considered should also be specified. Specifying the desired outcome. Specify the desired outcome of the guideline. If the target audience adopts the guideline, what health, economic, or other outcomes might be e