Clinical guidelines are advocated as a means to improve quality of care, reduce variations in practice, and increase cost-effectiveness of care. However, acceptance of guidelines and their actual impact on practice have been limited. Two apparently self-contradictory attributes, imprecise recommendations and well-specified recommendations (inapplicable in a local practice or to specific groups of patient), have been found as important causes of poor compliance with guidelines. We hypothesize that a solution to this problem is to design guidelines in a manner that focuses on objectives rather than institution-specific or context-specific practices, which can then be adapted to the latter in local settings. We propose to develop a formal methodology for authoring setting-independent clinical guidelines and for adapting them to specific clinical environments and patient populations. Professional societies, and regional, national, or international organizations can utilize this methodology to create setting- independent guidelines. Health care settings such as hospitals, clinics, and practice groups can adapt these guidelines to their contexts by adapting recommendations and decision criteria contained in the guideline to those local settings appropriately. At each decision point, different management options can be specified along with rationale and considerations for use in different subgroups of patients. Guidelines will be specified in a hierarchical manner, i.e., guidelines will be decomposed recursively into subguidelines that may be further divided into other subguidelines. Higher level subguidelines will specify conditions and actions in an """"""""intentional"""""""" manner, in terms of objectives (like """"""""reduce systolic blood pressure"""""""") rather than """"""""extensionally,"""""""" in terms of particular approaches to achieving the objective (e.g., """"""""give beta-blocker""""""""). The model will contain a specification for constraints that can be applied to subguidelines of setting-independent guidelines. These constraints limit allowed modifications to a guideline during adaptation in order to preserve the integrity of the setting-independent guideline. We will conduct a formative study to understand issues pertaining to authoring guidelines using this approach. Setting-independent guidelines will be created for problems in primary care practice. These guidelines will then be adapted to a particular primary care clinical setting. The potential impact of this approach on adherence to guidelines in that practice will also be evaluated. We will compare the acceptance of recommendations contained in guidelines that have been adapted to acceptance of recommendations contained in guidelines that have not been adapted.
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