Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese medicine and Western medicine

Integrated traditional Chinese medicine(TCM)and Western medicine(WM)is a new medical science grounded in the knowledge bases of both TCM and WM,which then forms a unique modern medical system in China.Integrated TCM and WM has a long history in China,and has made important achievements in the process of clinical diagnosis and treatment.However,the methodological defects in currently published clinical practice guidelines(CPGs)limit its development.The organic integration of TCM and WM is a deeper integration of TCM and WM.To realize the progression of"integration"to"organic integration",a targeted and standardized guideline development methodology is needed.Therefore,the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

Organic Integration of Traditional Chinese and Western Medicines—Future of Clinical Practice Guidelines of Integrated Traditional Chinese and Western Medicines

The transformation and implementation of clinical practice guidelines for integrated traditional Chinese medicine(TCM)and Western medicine(WM)is crucial to the adoption of medical science and technological findings and is an important way for TCM to be made available to the world.First,clinical practice guidelines(CPGs)of TCM and WM integration in recent years was analyzed to clarify the current situation and problems in the existing guidelines according to the following four perspectives:(1)perspective of TCM and WM integration in guidelines,(2)diagnosis Using integrated TCM and WM,(3)integration of TCM and WM treatment,(4)promoting TCM and WM integration.Secondly,the information and quality evaluation of CPGs for integrated Chinese and Western medicine in 2020–2022 were analyzed to explore the degree and methods of integration of Chinese and Western medicine guidelines.And last this study aimed to lay a foundation for the further establishment of Chinese characteristic,repeatable,and calculable clinical practice guidelines of TCM and WM integration.

Clinical practice guidelines for treating headache with Traditional Chinese Medicine: quality assessment with the appraisal of guidelines for research and evaluation Ⅱ instrument

OBJECTIVE: To critically appraise the methodological quality of clinical practice guidelines for headache produced over the last two decades, including those covering specific interventions using Traditional Chinese Medicine.METHODS: The guidelines on headache disorders were obtained by searching a number of databases, including Pub Med, EMBASE, Web of Science,Chinese Biomedical Literature Database, China National Knowledge Infrastructure Database, China Science and Technology Journal Database, and Wanfang database, three guideline-related databases [Guideline-International Network, National Guideline Clearinghouse, and Medlive], and the records of organizations that develop guidelines. The publication date was limited to the period from January 1996 to June 2015. The search terms "headache", "headache disorders", "cephalalgia", "migraine", "tension-type headache", "practice guideline", "consensus ", "statement", "regulation", and "recommendation" were used in the "Me SH" and "Free-text" fields. The guidelines were independently appraised by four researchers using the Appraisal of Guidelines for Research and Evaluation Ⅱ instrument.RESULTS: A total of 23 guidelines published between 1998 and 2014 were reviewed. The overall consistency of the four appraisers was good [interclass correlation coefficient 0.84; 95% confidence interval(CI) 0.82-0.86]. The mean(standard deviation) scores for scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence were 52.1(18.0), 39.5(17.1), 33.4(21.0), 49.8(21.9),23.8(19.3), and 24.2(23.7). Only two guidelines were recommended, 12 were recommended with modification, and nine were not recommended.CONCLUSION: Physical Traditional Chinese Medicine therapies were recommended to treat headache. The overall quality of headache guidelines was low in China, but evidence-based guidelines are gradually becoming mainstream. Guideline developers should carefully consider, in particular,three domains: rigor of development, applicability,and editorial independence.

Artificial intelligence for the development and implementation guidelines for traditional Chinese medicine and integrated traditional Chinese and western medicine

The translation and implementation of clinical practice guidelines(CPGs)for Traditional Chinese Medicine(TCM)and Integrated Traditional Chinese and Western medicine is crucial to the adoption of medical science and technology,but the low operability and slow update of integrated traditional Chinese and Western Medicine guidelines,and the lack of integration between guidelines and clinical practice,result in the guidelines not having the desired clinical effects in practice.The application of Artificial Intelligence(AI)to the field of CPGs development aims to shorten the development time,optimize and accelerate the whole process of CPG’s development.This article summarized the current research and application status of AI in development and implementation CPGs for TCM and Integrated Traditional Chinese and Western medicine and proposed the method of Combining real world data and AI technology to enrich for TCM and Integrated Traditional Chinese and Western medicine.

Assessing the Quality of the First Batch of Evidence-Based Clinical Practice Guidelines in Traditional Chinese Medicine

Objective: To assess the quality of the first batch of Chinese evidence-based clinical practice guidelines (CPGs) in Traditional Chinese Medicine (TCM) using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Methods: Evidence-based CPGs in TCM supported by the World Health Organization Western Pacific Regional Office (WHO/WPRO) and whose development was organized by the China Academy of Chinese Medical Sciences were identified and manually retrieved. CPGs were assessed using the AGREE instrument, and the data in each CPG were analyzed in terms of the six domains in the AGREE instrument: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. Results: Twenty-eight CPGs were identified, of which 26 were included in the study. The AGREE instrument rated the 26 CPGs in terms of the six domains. The assessment results showed the following average scores: for editorial independence, 84.16%; for rigor of development, 80.95%; for scope and purpose, 79.96%; for clarity and presentation, 70.88%; for stakeholder involvement, 61.28%; for applicability, the average score was only 27.09%. In summary, nine CPGs were rated as "strongly recommended", six as "recommended with provision or alternation", and 11 as "unsure". Conclusion: Most of the first batch of Chinese evidence-based CPGs in TCM had significant shortcomings in applicability. It is suggested that special attention be paid to enhancing the quality of applicability when developing evidence-based CPGs in TCM.

Improving Clinical Practice Guideline Development in Integration of Traditional Chinese Medicine and Western Medicine

Integration of traditional Chinese medicine （TCM） and Western medicine （WM）, or called as integrative medicine （IM） in China, came into being in 1950s as a new form of medicine. IM emphasizes the combination of both conventional WM and TCM alternative approaches to address all aspects of health and illness.（1） The major practice in IM includes the integration of disease diagnosis in WM and pattern classification （or syndrome differentiation） in TCM, and the integration of WM interventions and TCM interventions.

基于AGREE的中医循证临床实践指南质量评价研究

目的：采用AGREE工具评价国内第一批中医循证临床实践指南的质量。方法：采用手工检索的方法，检索2007年-2011年间，由WHO西太区资助、中国中医科学院组织编写的中医循证临床实践指南，纳入采用AGREE工具进行评价的指南。分别分析每个指南的范围与目的、参与人员、制定的严谨性、清晰性与可读性、应用性、编辑独立性，最后进行全面评估。结果：共检索到28个指南，其中26个指南符合纳入标准。研究结果表明，中医循证临床实践指南的编辑独立性质量最高，平均得分81．46％；其次为制定的严谨性，平均得分80．95％；范围与目的平均得分79．96％；清晰性与可读性平均得分70．88％；参与人员平均得分61．28％；应用性质量最低，平均得分27．09％。全面评估显示，强烈推荐使用的指南有9个，推荐（补充或改进）的指南有5个，11个指南不能确定是否推荐使用。结论：中医循证临床实践指南的应用性质量很低，在以后的指南研制中，要注重该方面质量的提高。

中药灌肠治疗溃疡性结肠炎指南共识质量评价与内容分析

目的评价中药灌肠治疗溃疡性结肠炎(ulcerative colitis,UC)临床实践指南(clinical practice guidelines,CPGs)和专家共识的质量,并对推荐的中药灌肠方案进行内容一致性分析。方法检索主要中英文数据库和医脉通、SIGN、NICE、WHO等指南网站及数据库,检索时限为建库至2023年11月1日。汇总分析中药灌肠相关推荐内容,并采用AGREE-China、RIGHT和JBI工具分别评价CPGs和专家共识的质量。结果最终纳入2部CPGs和5部专家共识。内容分析结果表明:各CPGs和专家共识中中药灌肠推荐意见存在不一致,未详细报告证据等级和推荐强度。结肠宁、锡类散和康复新液以及血竭、复方黄柏、青黛、乌梅和三七等是不同CPGs和共识中推荐频率相对较高的方剂和中药。AGREE-China 5个领域的总得分(报告率)分别为:(62.86±29.82)分、(76.07±23.29)分、(30.00±31.74)分、(85.24±17.53)分和(14.29±34.99)分。其中,4篇强推荐、2篇弱推荐和1篇不推荐。RIGHT评价结果显示:CPGs报告项目占45.71%、未报告占44.29%、部分报告(不适用)占10.00%。JBI评价结果显示:专家共识整体质量较高。结论我国中药灌肠治疗UC相关CPGs和共识整体方法学质量有待进一步加强,不同CPG和共识中药灌肠治疗UC相关推荐内容不全面且证据基础不足。期待后期国内研究者整合现有CPG和共识证据,制定全面规范的本土化中药灌肠治疗UC的循证指南,提高适用性,正确指导临床和护理合理选择灌肠中药,发挥中药灌肠疗护UC的特色优势。

中西医结合神经根型颈椎病诊断与非手术治疗指南(2023年)计划书

神经根型颈椎病(cervical spondylotic radiculopathy,CSR)是中西医结合医学的常见优势病种之一,但现有的CSR指南/共识均未提供与CSR中西医结合诊疗相关的建议。为帮助不同医学体系下的从业者更好地进行CSR中西医结合诊疗决策,亟需制订基于循证医学证据的临床实践指南。本指南计划书介绍了项目组遵照循证指南制订的原则、方法制订《中西医结合神经根型颈椎病诊断与非手术治疗指南(2023年)》的各个关键环节,旨在为科学制订本指南提供指导性和纲要性的实施方案,促进本指南规范、高效、透明化开展。

基于AGREEⅡ工具评价冠心病中西医临床实践指南的质量

目的基于AGREEⅡ工具评价国内冠心病临床实践指南的方法学及质量。方法计算机检索中国知网(CNKI)、维普(VIP)、万方(Wanfang Data)和中国生物医学文献数据库(CBM),收集国内冠心病临床实践指南,检索时间从建库至2019年10月。由4名研究者独立筛选文献、提取资料后,采用AGREEⅡ工具评价纳入指南的方法学质量。结果共纳入7部国内机构制订的指南或专家共识,包括急性心肌梗死中西医结合诊疗指南、冠心病稳定型心绞痛中医诊疗专家共识、冠心病心绞痛介入前后中医诊疗指南、动脉粥样硬化中西医结合诊疗专家共识、急性心肌梗死中西医结合诊疗专家共识、中医内科常见病诊疗指南(西医疾病部分)冠心病心绞痛、胸痹心痛中医诊疗指南。AGREEⅡ评价结果表明,多数指南在“范围和目的”“参与人员”“表达的清晰性”方面较完整,但“制订的严谨性”“应用性”“编辑的独立性”方面欠佳。急性心肌梗死中西医结合诊疗指南和急性心肌梗死中西医结合诊疗专家共识欠缺的两方面得分最高,其中“应用性”平均得分为46.3%,急性心肌梗死中西医结合诊疗专家共识得分最高,为59.4%,其次为急性心肌梗死中西医结合诊疗指南得分为52.1%;“编辑的独立性”方面,平均得分为47.3%,急性心肌梗死中西医诊疗指南得分最高,为75.0%,急性心肌梗死中西医结合诊疗专家共识得分次之,为62.5%。全面评价结果显示,强烈推荐使用的指南包括2个,推荐(补充或改进)的指南包括3个,不能确定是否推荐使用的指南包括2个。结论急性心肌梗死中西医结合诊疗指南和急性心肌梗死中西医结合诊疗专家共识在国内冠心病中西医临床实践指南的方法学质量均较高,可为临床诊疗提供指导性意见。

结直肠癌中医临床实践指南的制定及应用策略

中医临床实践指南是医疗卫生标准化的重要指导性文件,对规范临床实践及提高医疗质量起到关键作用。结直肠癌是消化道常见的恶性肿瘤,多项研究表明中医药在结直肠癌治疗全程发挥着至关重要的作用。但中医个体化辨治的特点也使结直肠癌治疗方案存在不规范、科学性低下等问题。现通过剖析结直肠癌中医临床实践指南制定的现状、意义、制定流程及应用策略为中医领域其他专业指南制定提供思路。

中医药临床实践指南制订和修订中德尔菲法应用的方法流程及建议

在临床实践指南的制订和修订过程中,共识法是确定临床问题和形成推荐意见的重要方法,其中以德尔菲法和改良德尔菲法最为常见。为此,如何科学、规范地应用德尔菲法达成共识(如专家组人员选择、流程设计等)已成为当下亟待研究的重要问题。应用德尔菲法的过程中,需借鉴国际上较为成熟的方法学建议,以使共识形成过程结构化、透明化。本文以德尔菲法在中医药临床实践指南制订和修订中的应用为切入点,阐述其基本流程和关键要素。在德尔菲法主体方面详细阐述了共识组的人数及构成、选取标准及途径、患者参与共识的方式和要点,在技术要点方面对其匿名性、达成共识的阈值、时间把控进行了阐释,进而指出德尔菲法应用的局限性及报告要点,以期促进德尔菲法在指南制订中的规范应用。

强直性脊柱炎中西医结合诊疗指南

遵循循证指南的制定方法与步骤,制定了《强直性脊柱炎中西医结合诊疗指南》。该指南针对临床医师比较关注的13个方面,共给出54条推荐意见,旨在规范强直性脊柱炎的诊疗工作,使患者得到合理、有效的诊治,从而改善其生活质量和预后。

膝骨关节炎(膝痹)中西医结合临床实践指南

膝骨关节炎(knee osteoarthritis,KOA)是当前常见的慢病之一,严重影响患者的身心健康和生存质量。中西医结合在KOA全病程管理中优势确切,基于循证医学制定的KOA中西医临床实践指南具有重要的意义,有助于规范中西医临床诊疗技术,取得更好的疗效。本指南按照临床实践指南的规范编写,从范围、术语和定义、流行病学特点、诊断、治疗、疗效评价等方面对KOA的中西医诊疗流程进行了规范。在中医辨病和辨证方面,本指南强调了地域特色对KOA发生、发展及中医证型分布的影响。在治疗方面,强调了运动训练在KOA全病程管理中的重要作用,并对运动训练的方式、方法、动作细节、强度及疗程等做出了有关推荐;同时亦强调了中医特色技术如针灸、小针刀、穴位注射等在本病非手术治疗中的应用。本指南具有较好的临床适用性、安全性及有效性。

Delphi法在循证中医临床实践指南制订中的应用

通过对循证中医临床指南制订方法学的研究,认为Delphi法是循证中医临床实践指南制订的重要方法。对Delphi法在循证中医临床实践指南制订中的地位和作用、具体应用等进行探讨,并提出将Delphi法运用于循证中医临床指南制订中需要注意的问题。

西医指南与中医药指南:在相互学习中共同提高

中西医并举是中国医疗卫生体系的特色之一,西医指南和中医药指南在指导中国医疗实践方面均具有重要意义和价值。本文将对西医指南和中医药指南的发展现状、制订区别与联系及彼此需要或值得学习的内容展开讨论,并就如何促进西医和中医药指南交流与合作,共同改进和提升指南质量提出思考与建议。

建立循证中医临床实践指南证据分级体系的构想

通过阐述证据分级体系在循证临床实践指南的重要地位,中医学和西医学临床证据特点的对比分析,评析了建立循证中医临床实践指南证据分级体系的各种设想,提出了具有本学科学术特点的中医文献证据分级标准。

专家共识法在中医临床实践指南中应用的关键技术要素研究

目的：探讨德尔菲法和共识会议法在中医临床实践指南中的应用规范。方法：检索1978年1月～2010年8月发表的采用德尔菲法、共识会议法制订的中医临床实践指南，建立指南评价数据库，提取指南的基本信息、专家基本情况、进行的轮次数、用于解决的问题进行描述性统计分析。结果：共纳入167个指南，其中德尔菲法制订12个，共识会议法制订155个。德尔菲法组的专家数为39．889±17．36，主要来源于全国，平均工龄在20年以上；轮次数为2．538±0．877；用于指南制订。共识会议法组的专家数为11．137±2．753，主要来源于省市级，平均工龄在10年以上；轮次数为3．721±0．691；用于指南制订。结论：在中医临床实践指南制订中德尔菲法和共识会议法的专家遴选有待进一步规范，建议在指南制订中综合使用这两种方法。

中医临床实践指南评价的思路和方法

指南制定的目的在于应用,没有应用,任何指南都是废纸一张。质量评价和适用性评价是保证指南作用发挥的前提。中医共识临床实践指南和中医循证临床实践指南是中医临床实践指南的主体。中医循证临床实践指南宜在指南发布前,采用AGREEⅡ进行质量评价,为指南使用者提供参考。中医共识临床实践指南应在指南推广应用中,采用《中医临床诊疗指南适用性调查问卷》评价,为指南进一步制修订提供依据。

绝经后骨质疏松症中医临床实践指南编制要点解读

为了使指南使用者了解绝经后骨质疏松症中医临床实践指南的编制过程,笔者针对编制过程中的要点问题予以解读。主要包括4项内容,分别是临床问题/结局指标的收集与遴选、证据获取、证据质量评价、推荐意见形成。其中,临床问题的收集与遴选分为3轮,第一轮是广泛收集本指南需要解决的临床问题,第二轮是对第一轮收集的临床问题进行重要性评分,第三轮是通过共识会议法,最终确定19个临床问题及结局指标。证据获取方面,首先检索中英文数据库,然后进行文献的合并与查重,文献的初筛,文献的分类、再筛选,最终纳入系统评价1篇,随机对照研究114篇。证据质量评价及推荐意见形成均按照GRADE原则完成。推荐意见形成过程中,需要注意虽然中医药文献的证据质量普遍偏低,但并不等于中药本身的疗效不佳。需要专家结合临床经验进行全面评估,形成推荐意见。本编制要点解读可使绝经后骨质疏松症中医临床实践指南的制定更加公开透明,并为今后中医临床实践指南的制定提供参考。