Guidelines for Clinical Practice From Development to Use (1992) / Chapter Skim
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7 EVOLUTION IN PROCEDURES AND METHODS FOR DEVELOPING PRACTICE GUIDELINES
7 EVOLUTION IN PROCEDURES AND METHODS FOR DEVELOPING PRACTICE GUIDELINES
Pages 163-195
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From page 163... ...
Involvement in implementation likewise provides lessons that are relevant to the process of developing guidelines. In examining the practical, technical, and policy questions about guidelines implementation and health care reform raised in the preceding chapters, the committee concluded that it needed to underscore the point made in Chapter 2: Planning for successful implementation begins with the development of guidelines.
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From page 164... ...
The discussion of attributes for review criteria in Chapter 5 and the discussion of cost analysis in Chapter 6 also relate to the theme of this chapter. Although the focus here is on practice guidelines, much of this chapter is also relevant to development of medical review criteria.
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From page 165... ...
When the Forum was barely into its second year, the staff organized a retreat to consider what panel participants and staff had learned from its first few guidelines panels. "Lessons learned" about these complex activities included the points below.1 First, the work of the guidelines panel chairpersons has proved vastly more demanding than had been originally envisioned.
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From page 166... ...
Among those criteria are relevant training and clinical experience, interest in quality assurance and research on the clinical condition in question, capacity to lead a health care team and to respond to consumer concerns, a broad public health view, and a commitment to and prior experience in the development of clinical practice guidelines. Building a Formal Program: The Clinical Efficacy Assessment Program The work of the American College of Physicians (ACP)
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From page 167... ...
In sum, the focus is very much on improving guidelines development and evaluation so that the products of these processes can be more readily and effectively adopted. Improving Consensus Development: The National Institutes of Health Over time, government agencies involved directly or indirectly with guideline development have like professional societies refined their procedures and methods.
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From page 168... ...
One notable effort aimed at training guidelines developers rather than developing guidelines per se has been sponsored by the John A Hartford Foundation and the Council of Medical Specialty Societies.
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From page 169... ...
The complexity of coupling organizations (not just individuals from different disciplines, has made this project quite difficult to negotiate, execute, and maintain. Two other multiorganizational efforts led by the AMA were also noted in Chapter 2: the Specialty Society Partnership, involving the AMA and 14 national medical specialty societies, and the Practice Parameters Forum, comprising national medical specialty and state medical societies.
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From page 170... ...
OMAR (for the NIH Consensus Development Conferences) and AHCPR establish independent panels for each guideline.
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From page 171... ...
The second dimension of selection physician-nonphysician is debated by most groups that engage in guideline development. It tends to dissolve into two questions: Should other clinicians and health professionals, such as nurses, therapists, health educators, and nutritionists, be involved, and if so how and how much?
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From page 172... ...
The intent is to provide greater insight into how well a guideline may work in clinical practice. For guidelines developed by a subspecialty but intended for use by all internists, network members offer broad-based feedback beyond the subspecialty.
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From page 173... ...
. The IMCARE guidelines network is informing AHCPR and other organizations of its availability to aid their guideline development or evaluation efforts.
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From page 174... ...
AREAS FOR METHODS RESEARCH AND DEVELOPMENT Several issues in particular appear to the committee to be worth further investment in methodological research and development. These issues involve the selection of topics for guideline development, processes for securing expert judgment and consensus, ways of assigning weights to the scientific evidence, outcomes measurement, techniques for determining and incorporating patient preferences, and means for identifying and evaluating inconsistencies and conflicts among guidelines on the same topic.
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From page 175... ...
Topic Selection The demands of guideline development on sponsor resources and the huge array of interesting topics make the identification of priorities and the selection of topics an inevitable and important issue. Any effort to establish a systematic process for these tasks faces certain questions of methodology.
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From page 176... ...
In its ideal form the group would be well balanced in terms of the professional disciplines and characteristics of its members (as recommended for other aspects of the guideline development process) , although this form of topic selection probably achieves the ideal only rarely, if ever.
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From page 177... ...
and related grouporiented activities (e.g., focus groups) have many uses beyond guideline development; some of these uses include technology assessment, consensus-building in areas outside health, sales and marketing, and the like.
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From page 178... ...
Evaluating Scientific Evidence The third set of methods issues involves techniques for assessing, rating, and combining scientific evidence. Guidelines developers normally must weigh the soundness and relevance of both direct and indirect evidence, evidence generated by processes of varying degrees of rigor, and studies that differ in design details and findings (Eddy, l991b)
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From page 179... ...
Patient Outcomes A fourth area of methodologic concern focuses on means of improving knowledge of patient outcomes, interest in which accelerated at about the same time but somewhat independently of the growing interest in guidelines development.5 IOM committees concerned with practice guidelines arid with related issues (quality of care, effectiveness research, disability) have been particularly strong proponents of incorporating patient outcome information into clinical practice guidelines.
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From page 180... ...
In addition to conceptual and policy challenges related to patient pref 6 In September 1991, the IOM convened a conference on advances in health status assessment that focused heavily on the use of health-related quality-of-life measures in clinical practice and clinical settings. The papers and discussions were aimed more at the practice community than at the research or policymaking community; the proceedings will be published in mid-1992 in Medical Care (Lohr, forthcoming)
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From page 181... ...
These points would highlight for physicians and other caregivers points at which options for diagnosis and management should be discussed with patients or families and their preferences for particular options elicited. An approach that focuses on how rather than when to elicit patient preferences involves the interactive videodisc technology developed at Dartmouth Medical School (Wennberg, 1990~.
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From page 182... ...
One approach to identifying and understanding inconsistencies and weaknesses in specific guidelines has been developed by Margolis, Gottlieb, and their associates (19911. This method, which they call algorithmic analysis, focuses on the completeness and consistency of clinical practice guidelines taken individually and in comparison.8 Hayward and his colleagues (1991)
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From page 183... ...
allowing options to remain where a case can be made that evidence is inconclusive, professional consensus is split, and variation is unlikely to harm quality of care. ISSUES AT THE INTERFACE OF DEVELOPMENT AND IMPLEMENTATION At least three topics are not clearly development or methodological issues in the strictest sense: local adaptation of national guidelines, translation of guidelines into medical review criteria, and formatting and dissemination activities.
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From page 184... ...
By contrast, some national guidelines are poorly drafted and give inadequate attention to their applicability to specific patient problems, identification of foreseeable exceptions, and clarity or precision. Thus, hospital medical staff who want protocols to guide treatment of patients with particular conditions may have to "fill in" when guidelines lack the specificity needed to make decisions about individual cases.
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From page 185... ...
Some departures from national guidelines are viewed as acceptable when it is thought that such variation will lead to the actual use of the most critical elements in guidelines rather than to their rejection. The committee had mixed feelings about this rationale, and this discussion should not be seen as a justification for wholesale or casual departure from welldocumented, science-based guidelines for clinical practice.
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From page 186... ...
Among such changes would be designating certain practices appropriate when national guidelines define them as inappropriate, labeling a practice optional rather than recommended or vice versa, or changing threshold values for making treatment decisions. When local institutions do adapt national guidelines, one useful step might be for them to notify the originating group and to explain the circumstances that led to their modifications.
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From page 187... ...
Where carefully developed and documented "national" guidelines exist, local adaptation processes should provide explicit rationales for changes that relate to specific, well-defined local conditions or objectives. If national guidelines are in one way or another accorded legal stature with respect to malpractice liability (or immunity from liability)
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From page 188... ...
Sponsors and developers of guidelines usually take responsibility for their initial dissemination to major target audiences, often either physicians or nurses. For example, many specialty societies, such as the ACP and the American College of Cardiology, begin their dissemination efforts by publishing individual guidelines in their journals, which all members receive.
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From page 189... ...
In addition, publications are emerging that reprint or summarize selected guidelines or otherwise report on the field; the Report on Medical Guidelines & Outcomes Research, published by Health & Sciences Communications and now nearing the end of its second year, is an example. The NLM, as described elsewhere in this report, will store, index, and otherwise make available information on practice guidelines, specifically including those from AHCPR panels.
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From page 190... ...
The AHCPR guidelines are a case in point.~° As this report was being prepared, the agency was planning to produce three versions of the guidelines aimed at the professional community: (1) the full technical guideline plus all documentation (biosketches of panel members, description of the processes followed, results of the literature review and analysis, recommendations, references, etc.~; (2)
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From page 191... ...
. Chairs of the panels and staff of the AHCPR and the Forum would be present, and representatives of relevant specialty societies and professional associations would be invited to give statements concerning at least the aim of the effort and the process followed.
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From page 192... ...
Some groups may, in fact, have sufficient concern about what influence their guidelines are having to carry out various evaluation efforts; others may simply cooperate with outside evaluation activities. This chapter briefly raises the subject, therefore, on the grounds that those in the business of developing guidelines will have concerns about, if not direct involvement in, assessing the effects of their efforts.
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From page 193... ...
As of late 1991, AEICPR's attention was solidly focused on development of guidelines and related medical review criteria; none of the guidelines due by January 1, 1991, had yet been published. Possible activities were still under discussion, and no formal research plan had been made public.
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From page 194... ...
In its 1990 report, the IOM noted that explanations of policy success or failure, in general, needed to consider the following: · the validity of the policy premises for example, the assumption of many policymakers that broader development and use of practice guidelines ...
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From page 195... ...
The next, concluding chapter of the report brings together this committee's principal conclusions and recommendations about the clinical practice guidelines enterprise. It does so in some comfort with the progress that the field has made in recent years, taking it as a good omen of the progress that can be made on the many conceptual, practical, methodological, and political challenges that still remain.
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