Goud Rick, Hasman Arie, Strijbis Anne-Margreet, Peek Niels
Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Int J Med Inform. 2009 Aug;78(8):513-20. doi: 10.1016/j.ijmedinf.2009.02.010. Epub 2009 Apr 17.
Clinical practice guidelines often contain ambiguities, inconsistencies, and logical errors that hamper implementation of these guidelines in practice. As guideline formalization is useful to verify the logical structure, consistency, and completeness of guidelines, several authors have argued that the formalization of guidelines concurrent with their development may improve their quality. However, experiences with such a parallel guideline development and formalization approach have not yet been reported. The goal of this study was to develop such a strategy and evaluate its application in practice.
Existing methodologies for guideline development and guideline formalization were analyzed and used as a basis to develop a strategy in which guideline formalization is performed concurrently with guideline development. The developed strategy was applied in the development of a clinical practice guideline for cardiac rehabilitation.
A parallel guideline development and formalization strategy was developed that intertwines the processes of guideline development and guideline formalization. Central assets are early involvement of guideline formalization specialists and formalization tools, cooperation between guideline authors and guideline formalization specialists in the development of clinical algorithms, access to domain knowledge when formalization identifies inconsistencies or omissions, and formal verification of the guideline model prior to guideline dissemination. This strategy was applied in the development of a guideline for cardiac rehabilitation and helped to identify several vague and inconsistent recommendations and impracticabilities in the narrative guidelines that could be resolved before publication. In addition, the strategy ensured consistency between the narrative and formalized guideline.
Based on our experience, formalizing a guideline concurrent with its development is feasible in practice and we recommend applying such a strategy as it can be beneficial to the quality of and consistency between the guideline's narrative and formalized version.
临床实践指南常常存在模糊性、不一致性和逻辑错误,这阻碍了这些指南在实际中的实施。由于指南形式化有助于验证指南的逻辑结构、一致性和完整性,一些作者认为在指南制定过程中同时进行形式化可能会提高其质量。然而,尚未有关于这种并行的指南制定和形式化方法的经验报道。本研究的目的是开发这样一种策略并评估其在实际中的应用。
分析了现有的指南制定和指南形式化方法,并以此为基础开发一种在指南制定的同时进行指南形式化的策略。所开发的策略应用于心脏康复临床实践指南的制定。
开发了一种并行的指南制定和形式化策略,该策略将指南制定过程与指南形式化过程交织在一起。核心要素包括指南形式化专家和形式化工具的早期参与、指南作者与指南形式化专家在临床算法开发中的合作、在形式化发现不一致或遗漏时获取领域知识,以及在指南发布前对指南模型进行形式验证。该策略应用于心脏康复指南的制定,有助于识别叙述性指南中一些模糊、不一致的建议以及不实用性,这些问题在发布前得以解决。此外,该策略确保了叙述性指南与形式化指南之间的一致性。
基于我们的经验,在指南制定过程中同时进行形式化在实际中是可行的,我们建议应用这样的策略,因为它有助于提高指南叙述性版本和形式化版本的质量及一致性。