Formulation protocol of guidelines for diagnosis and treatment of diabetic kidney disease with integrated traditional Chinese and Western medicine

doi:10.3877/cma.j.issn.2095-3216.2024.06.001

Abstract

Abstract:

To further enhance the clinical diagnosis and treatment level of diabetic kidney disease（DKD）， standardize the clinical application of Western and traditional Chinese medicines for DKD， and promote the development of precise diagnosis and treatment of DKD by integrated traditional Chinese and Western medicine， the Chinese Association of Integrative Medicine， the China Association of Chinese Medicine， the Chinese Medical Association， and the Chinese PLA General Hospital have taken the lead in initiating the formulation of guidelines for diagnosis and treatment of DKD with integrated traditional Chinese and Western medicine. This article elaborated on the formation process of the guideline development committee， the definition of clinical questions， data collection and selection strategies， the retrieval and screening process for evidence， the establishment of recommendations， external review of the guidelines，publication strategies， and promotion and implementation measures. The aim of this article was to provide a clear framework and technical support for the development of the guidelines， enhance the transparency of the guidelines development process， and offer references and insights for the formulation of other diagnostic and treatment guidelines in the field of integrated traditional Chinese and Western medicine.

Key words: Diabetic kidney disease, Diagnosis and treatment, Guideline, Formulation, Protocol

Xuefeng Zhou, Zheyi Dong, Zhe Feng, Guangyan Cai, Xiangmei Chen. Formulation protocol of guidelines for diagnosis and treatment of diabetic kidney disease with integrated traditional Chinese and Western medicine[J]. Chinese Journal of Kidney Disease Investigation(Electronic Edition), 2024, 13(06): 301-305.

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工作小组	专家组成	职能
指南负责人	2～3位（由首席临床医学专家和首席指南方法学专家组成）	首席临床专家是指南的总负责人，具有决策权，对指南的内容负责，对临床体系的适用性负责；首席指南方法学专家协助临床专家，并对指南方法学负责，进行顶层设计以及证据质量控制；建立指南制订小组，规避利益冲突
执笔人	7～10位（由资深临床专家、指南方法学专家组成）	制订指南计划书；确定指南适用范围、主题、范围；提出临床问题，确定相应的推荐意见；指导、监督证据检索、评价和形成证据总结表；审核、修订指南全文，处理外审意见；批准指南发布
主审人	7～9位	对最终草案的临床诊疗指南进行全面审查，以确保其内容的科学准确性、表述的清晰度以及决策的客观公正性。针对指南中潜在的重大风险或问题，以及具体的推荐意见，提供详细的反馈和建设性的建议，以促进指南的质量和实用性
讨论专家	100位左右（由本学科领域临床专家组成）	审核修订指南全文，提出指南制订过程中存在的问题以及可能解决的方案和建议
证据评价组	4～10位	实施全面的文献检索，并进行严格的方法学评估以确保证据的质量和可靠性。据此构建临床证据等级体系。编制详尽的证据总结表以明确展示关键结果。依据证据质量和推荐强度，制定推荐意见，为临床决策提供指导

工作小组	专家组成	职能
指南负责人	2～3位（由首席临床医学专家和首席指南方法学专家组成）	首席临床专家是指南的总负责人，具有决策权，对指南的内容负责，对临床体系的适用性负责；首席指南方法学专家协助临床专家，并对指南方法学负责，进行顶层设计以及证据质量控制；建立指南制订小组，规避利益冲突
执笔人	7～10位（由资深临床专家、指南方法学专家组成）	制订指南计划书；确定指南适用范围、主题、范围；提出临床问题，确定相应的推荐意见；指导、监督证据检索、评价和形成证据总结表；审核、修订指南全文，处理外审意见；批准指南发布
主审人	7～9位	对最终草案的临床诊疗指南进行全面审查，以确保其内容的科学准确性、表述的清晰度以及决策的客观公正性。针对指南中潜在的重大风险或问题，以及具体的推荐意见，提供详细的反馈和建设性的建议，以促进指南的质量和实用性
讨论专家	100位左右（由本学科领域临床专家组成）	审核修订指南全文，提出指南制订过程中存在的问题以及可能解决的方案和建议
证据评价组	4～10位	实施全面的文献检索，并进行严格的方法学评估以确保证据的质量和可靠性。据此构建临床证据等级体系。编制详尽的证据总结表以明确展示关键结果。依据证据质量和推荐强度，制定推荐意见，为临床决策提供指导

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