The GPG 7.0 marks the start of a new journey where this guide will be reviewed every year to better reflect the changing practices of the business continuity and resilience industry as they happen. The new edition maintains a collaborative approach to business continuity, ensuring that organizations and individuals understand how to work with related management disciplines to successfully implement business continuity and resilience solutions.
The new GPG consists of six Professional Practices, split into two management practices and four technical practices, which provide a structure to be used in the development of a Business Continuity Management System.
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Developing practice guidelines that enlighten practitioners and patients is an exceptionally challenging task. It requires diverse skills ranging from the analysis of scientific evidence to the management of group decisionmaking to the presentation of complex information in useful forms. Although the need for these skills has not always been recognized in the past, the recent focus on guidelines is bringing not only a greater awareness of what is required for their development but also a higher level of expertise to the field. The Office of the Forum for Quality and Effectiveness in Health Care should make every effort to reinforce this trend as it works with contractors, expert panels, and others to develop and disseminate practice guidelines.
This chapter describes eight attributes that the committee believes are essential if a set of guidelines are to serve their intended purposes of assisting practitioners and patients, providing a better foundation for the evaluation of services and practitioners, and improving health outcomes. These attributes are ideal characteristics to which real guidelines are unlikely to conform fully either now or in the future. However, in the committee's judgment, guidelines can approach these ideals to a greater extent than has generally been achieved to date.
The next four sections review the context, working assumptions, principles, and sources that guided the committee in developing its list of attributes, followed by a discussion of the attributes themselves. This chapter, however, is not intended either as an exhaustive description of how guidelines should be developed or as an endorsement of one specific method.1 The discussion in this chapter focuses on attributes of guidelines rather than attributes of medical review criteria, standards of quality, and performance measures. The recent IOM report on quality assurance in the Medicare program (1990d) discusses some attributes that good medical review criteria should have, for example, specificity and sensitivity.
One further introductory point: the committee has urged AHCPR and its Forum to focus their efforts on guidelines for clinical conditions rather than specific treatments or procedures. This focus will undoubtedly make their task more difficult: a consideration of conditions generally involves a broader look at alternatives, evidence, practice settings, and outcomes. The result, however, should be guidelines that are both more broadly and more specifically useful to clinicians and patients. The discussion of attributes in this chapter reflects this emphasis on conditions rather than procedures.
OBRA 89 specifies that "the Director [of the Forum] shall establish standards and criteria to be utilized by the recipients of contracts" for "developing and periodically reviewing and updating" guidelines, standards, performance measures, and review criteria. Confusion is likely if "criteria and standards" are used to label both the bases for prospectively assessing practice guidelines and the bases for assessing clinician practice. Consequently, to reduce possible terminological confusion, this report refers to ''attributes of guidelines" rather than to "standards and criteria" for "guidelines, standards, performance measures, and review criteria." Synonyms include properties and characteristics. 2
The Forum must be able to employ the list of attributes set forth in this chapter in at least two ways. First, it will need to communicate its expectations in advance to the contractors or expert panels that may develop guidelines for the agency. Second, the Forum and potential users of the guidelines must be able to assess the soundness of a given set of guidelines after they are developed. The IOM expects in a second project to prepare a practical assessment instrument that the Forum can use to systematically review guidelines developed by its panels or by other groups (Appendix C).
During the committee's deliberations, a question was raised about whether the Forum has formal authority under OBRA 89 either to reject or approve the guidelines developed by its contractors or expert panels. This report does not speak to that legal point. Nevertheless, regardless of the Forum's statutory authority in this regard, it is reasonable that the agency should examine the soundness of guidelines developed under its auspices. This examination may (1) improve the way the agency works with contractors or panels in the future, (2) contribute to more informed consideration of dissemination options and evaluation strategies, (3) allow more sophisticated consultations with HCFA and other government agencies about their use of the guidelines, and (4) provide feedback about the feasibility of the assessments proposed here.
In this report, assessment means the prospective or initial judgment of the soundness and feasibility of a set of guidelines. In contrast, the empirical evaluation of the cost, quality, and other effects of guidelines occurs after they are published and implemented.
Further, a set of guidelines includes a series of statements or recommendations about appropriate practice and the accompanying descriptions of evidence, methodology, and rationale. A guideline in the singular refers to a discrete statement or recommendation (for example, annual breast physical examination for women aged 40 to 49 with no family or personal history of breast cancer). Each of the appropriateness reports published by the RAND Corporation clearly exemplifies a set of guidelines (Park et al., 1986). Likewise, using this terminology, the report of the U.S. Preventive Services Task Force (1989) contains 60 sets of guidelines and not 60 guidelines.
Second, the committee assumes that the Forum will (in line with OBRA 89 provisions) convene expert panels to assess either existing guidelines or guidelines for which the Forum has contracted. These panels will need to make both objective and subjective assessments guided by instructions from the Forum. This report is a step toward the preparation of an assessment instrument that the expert panels can use in their reviews and deliberations (Appendix C). The AMA has recently taken a similar step by developing a preliminary worksheet to evaluate what it terms practice parameters (AMA, 1990b).
Third, the committee sees the initial assessment of guidelines as part of an evolutionary process of guidelines development, assessment, use, evaluation, and revision. This evolutionary process will involve the government, professional organizations, health service researchers, consumers, and others. As a result, the committee fully expects the set of attributes presented here to be tested, reassessed, and revised, if necessary.
Practicality requires that attributes be definable in operational as well as conceptual terms; that is, it should be possible to devise an instrument that instructs assessors of a set of guidelines on how they can determine whether the guidelines conform to the attributes. Not only is this necessary if the Forum is to judge the soundness of the guidelines that emerge from its expert panels; it is fundamental that the Forum instruct developers of guidelines on the desired properties of guidelines and on the documentation needed as a basis for assessment. As mentioned earlier, the development of a formal instrument for assessing guidelines is an important next step for this committee.
More generally, the number of attributes must be sensible and practical. An appropriate balance must be reached between enough attributes to allow adequate assessment of the guidelines but not so many that the assessment exercise becomes infeasible, confusing, or excessive, given limited resources. It is likely that an instrument for assessing guidelines will need to weight the eight attributes in some manner, specifying which of them are more significant in determining whether a given set of guidelines are sound. Given its time and resource constraints, this committee did not systematically rank the different attributes by relative importance, although the discussion below does distinguish some of the more important ones.
A final point: this report differentiates between the priorities for selecting particular targets for guidelines and the desirable attributes of guidelines. The attributes listed in this chapter do not incorporate the OBRA 89 provisions requiring that priorities for the development of guidelines reflect the needs and priorities of the Medicare program and include clinical treatments or conditions accounting for a significant portion of Medicare expenditures.
The legislation also calls on the Secretary of Health and Human Services to consider the extent to which guidelines can be expected "(i) to improve methods of prevention, diagnosis, treatment, and clinical management for the benefit of a significant number of individuals; (ii) to reduce clinically significant variations among physicians in the particular services and procedures utilized in making diagnoses and providing treatment; and (iii) to reduce clinically significant variations in the outcomes of health care services and procedures." In arriving at its eight recommended properties of guidelines, the committee did not incorporate these factors. Priority setting is a crucial but separate task and one that IOM has undertaken as part of other studies (IOM, 1990a,b,c,e). 2351a5e196