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.

Chinese version of NCCN Clinical Practice Guidelines in Oncology officially authorized by NCCN

The publishing conference of the Chinese version of National Comprehensive Cancer Network （NCCN） Clinical Practice Guidelines in Oncology （hereinafter referred to as NCCN Guidelines） and the inaugural peer reviewer meeting of NCCN Clinical Practice Guidelines in Oncology： Digestive System Cancers （hereinafter referred to as NCCN Guidelines on Digestive System Cancers） were held in People＇s Medical Publishing House in January 28^th, 2016 （Figure 1）.

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.

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.

Appraising the quality of clinical practice guidelines in Chinese patent medicine

Background:Chinese patent medicine(CPM)is a type of traditional Chinese medicine(TCM)that utilizes Chi-nese medicinal materials as its raw ingredients.Following the principles of TCM theory,it undergoes specific processing techniques to create various dosage forms for the prevention and treatment of diseases.The current CPM guidelines,both domestically and internationally,are constrained by limitations in methodological quality and reporting,which do not adequately address the requirements of the majority of clinicians and patients.Objective:To evaluate the methodological rigor and reporting quality of clinical practice guidelines(CPGs)in CPM,with aim to assess their current quality and to provide recommendations for improving guideline develop-ment.Methods:The study utilized the Appraisal of Guidelines for Research and Evaluation II(AGREE II)tool and the Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine(RIGHT for TCM)checklist to evaluate the methodological rigor and reporting quality of CPM guidelines.After the training session,the four investigators were divided into two groups to evaluate the guidelines of patent Chinese medicine included in this study based on the aforementioned criteria.In case of any discrepancies,a secondary analysis was conducted by all four researchers under the guidance of two clinical experts,ensuring an impartial evaluation outcome.Average score or average reporting rate were calculated for each domain.Results:A total of 32 CPM guidelines that met the inclusion criteria were analyzed.The AGREE II yielded an average score of 67.2%.The domain scores were as follows:scope and purpose(93.3%),stakeholder involve-ment(50.1%),rigor of development(76.8%),clarity of presentation(79.4%),applicability(40.1%),and editorial independence(63.6%).The average reporting rate of the RIGHT for TCM checklist was 70.0%,with the report-ing rates for the seven domains as follows:basic information(94.2%),background(87.9%),evidence(97.5%),recommendation(57.5%),review and quality assurance(11.4%),funding and declaration and management of interests(26.6%),and other information(68.8%).Conclusions:The methodological and reporting quality of CPGs for CPM have been deemed acceptable since 2020.However,there is still room for improvement,particularly in enhancing the reporting quality to provide clinicians and patients with more effective and comprehensive guidance.Additionally,it may be beneficial to develop a comprehensive reporting checklist specifically tailored for CPM guideline development.

儿童腺样体肥大中医临床实践指南

检索儿童腺样体肥大相关文献,形成专家问卷,依据中华中医药学会团体标准编写规则,通过3轮德尔菲法专家问卷调查及专家论证会进行意见整理及总结分析,在此基础上完成同行征求意见、质量评价及适用性评价,最终形成《儿童腺样体肥大中医临床实践指南》。此次制定明确指南适用范围、规范性引用文件、术语和定义、诊断、辨证、治疗、预防和调护,以期为儿童腺样体肥大中医临床实践、诊疗规范等提供重要参考。

中医适宜技术治疗脑卒中后偏瘫的循证临床实践指南

脑卒中是成年人死亡和残疾的主要原因之一。中医适宜技术在脑卒中后偏瘫的康复治疗中广泛应用,然而尚缺乏系统的、高质量的循证指南来指导这些实践。本指南根据《世界卫生组织指南制订手册》和《中西医结合诊疗指南制订手册》制定,遵循卫生保健实践指南的报告要求,并参照推荐分级的评估、制定与评价系统对证据质量及推荐强度进行分级。本指南组建了包括5个小组在内的跨学科工作团队,通过问卷、面对面专家会议和问题解构方法来选择指南中需要回答的关键临床问题。从25个关键问题中筛选出10个进行研究。基于系统评价的结果,考虑到证据的优缺点、干预成本、证据质量、患者偏好及价值观、多学科专家的反馈和共识,本指南提出了20条关于中医适宜技术在脑卒中后偏瘫康复治疗中应用的推荐意见。本指南主要面向中国各级医院和康复机构的医务工作者,专注于中医适宜技术在脑卒中后偏瘫康复治疗中的临床应用。

Appraisal of the Quality and Contents of Clinical Practice Guidelines for Hypertension Management in Chinese Medicine: A Systematic Review

Objective： To evaluate the quality and consistency of recommendations in the clinical practice guidelines（CPGs） for hypertension in Chinese medicine（CM）. Methods： CM CPGs were identified from 5 electronic databases and hand searches through related handbooks published from January 1990 to December 2013. Three reviewers independently appraised the CPGs based on the Appraisal of Guidelines for Research and Evaluation（AGREE Ⅱ） instrument, and compared the CPGs＇ recommendations on CM syndrome pattern classification and treatment. Results： Five CM CPGs for hypertension were included. The quality score of the evidence-based（EB） guideline was higher than those of the consensus-based with no explicit consideration of evidence-based（CB-EB） and the consensus-based（CB） guidelines. Three out of five patterns in the CPGs were recommended by the EB guideline. Tianma Gouteng Formula（天麻钩藤复方） in the EB guideline was recommended mostly for hypertension patients with pattern of ascendant hyperactivity of Gan（Liver）-yang and pattern of yin deficiency with yang hyperactivity in the CPGs. Acupuncture and massage were recommended for Grade Ⅰ and Grade Ⅱ hypertension with severe symptoms weakening the quality of life in the EB guideline. For Grade Ⅰ and Grade Ⅱ hypertension, CM could be used alone, while for Grade Ⅲ hypertension, they should be used in combination with Western medicines. Conclusion： The quality of EB guideline was higher than those of CB and CB-EB CPGs in CM for hypertension and CM should be prescribed alone or combined with Western medicines based on the grade of hypertension.

Clinical Practice Guideline of Chinese Medicine for Chronic Gastritis

Chronic gastritis （CG） is an inflammatory condition of the gastric mucosa, induced by various causes. A commonly-seen disease in clinical practice, it is found in about 80%-90% of patients undergoing gastroscopic examination. The prevalence rate in the general population remains unclear. It is generally considered that its incidence rate accords with Helicobacter. pylori infection rate and the prevalence of CG is 30%-80% in China. Possible etiological factors include H. pylori infection, smoking, drinking alcohol, food allergies, duodenal juice reflux, drug-induced injuries, heredity, immunity, and radiation.^[1-8].

Clinical Practice Guideline of Integrative Chinese and Western Medicine for Acute Myocardial Infarction

With increasing morbidity and mortality,acute myocardial infarction(AMI)has become one of the major causes of human death,leading to heavy burdens to individuals,families and society.Previous researches have found that though large amount of resources and great effort were devoted,no significant improvements were achieved in reducing the in-hospital mortality of AMI patients.Meanwhile,extensive studies about Chinese medicine(CM)have found that CM has special advantages in treating AMI patients.However,there is no standardized and unified clinical practice guideline(CPG)of CM for AMI.Therefore,a CPG with strict standard and generally acknowledgement is urgent to be established.This guideline was developed following the methodological process established by the World Health Organization Handbook for Guideline Development.Extensive search on clinical evidences including systematic review(SR),randomized controlled trial(RCT),observational study and case reports was launched,covering evidence of CM for AMI on several aspects,such as diagnosis,CM patterns,CM interventions on AMI and complications,cardiac rehabilitation and clinical pathway management.Besides,the application of Grading of Recommendations Assessment,Development and Evaluation(GRADE)approach enabled the evaluation of evidence and formulation of grade of recommendation(GOR)and level of evidence(LOE).With the help of GOR and LOE,this CPG recommends the integrative CM and WM treatment method in AMI patients and provides useful information on medical decision for clinical physicians.

Clinical Practice Guidelines and Experts’Consensuses for Treatment of Coronavirus Disease 2019(COVID-19)Patients with Chinese Herbal Medicine:A Systematic Review

Objective:To systematically review the clinical practice guidelines for the treatment of coronavirus disease 2019(COVID-19)patients with Chinese herbal medicine(CHM),summarize their recommendations and evaluate their qualities.Methods:Electronic databases,websites of governments,academic associations or organizations for eligible guidelines were searched up to April 2020.Information were extracted to summarize recommendations for the use of Chinese herbal formulae and Chinese patent medicine(CPM)for COVID-19 patients.The methodological quality and reporting quality of the included guidelines were independently evaluated,using the Appraisal of Guidelines for REsearch and Evaluation(AGREE)Ⅱtool and Reporting Items for Practice Guidelines in healthcare(RIGHT)statement,respectively.Results:Totally 45 guidelines were identififi ed:42(93%)suggested specific CM formulae for treating COVID-19 patients;and 35(78%)assigned patients diagnosed with COVID-19 to 4 stages(early,development,critical and recovery).The recommended formulae and CPMs for each stage with diverse syndrome types have been summarized.Most of the included guidelines were of low methodological quality,with only one achieving moderate quality of AGREEⅡ.The frequency with which the 35 items in the Reporting Items for Practice Guidelines in Healthcare(RIGHT)checklist were reported averaged 36.5%across the 45 guidelines.Conclusions:This systematic review has summarized current recommendations for treating COVID-19 patients with CHM and shows that the general quality of present guidelines is quite low.The development of future guidelines should include increased awareness of the features of good quality guidelines.

Evidence-Based Chinese Medicine Clinical Practice Guideline for Stomach Pain in Hong Kong

Stomach pain in Chinese medicine（CM） is a very common disorder in clinical practice and it has been listed as one of the pilot three conditions in Hong Kong to develop evidence-based CM clinical practice guidelines（CM CPGs）. The aim of this stomach Pain CPG is to summarize the treatment methods of stomach pain with CM and evaluate reasonably, then to guide local licensed CM practitioners and provide beneficial reference for social medical decision makers and patients. In this manuscript, we defined stomach pain in CM and the category of chronic gastritis in Western medicine. The clinical manifestation, CM pattern classification, and CM intervention including herbal medicine treatment based on pattern differentiation, symptomatic treatment, acupuncture treatment, regulation and nursing were illustrated.

脑卒中中西医结合康复临床循证实践指南

脑卒中是导致死亡和长期残疾的首要原因,属于重大公共卫生问题[1]。研究[2-3]显示,全球因脑卒中导致的伤残调整生命年增加了32.4%,而脑卒中后幸存人群中不同程度后遗症的发生率高达70%~80%。因此,脑卒中后康复对于降低残疾发生率和改善功能障碍尤为重要。但由于全球康复服务发展水平的不均衡,世界许多地方医院、社区的康复设施以及服务能力有限,无法充分满足患者的健康需求,特别是在中低收入国家(LMICs)[4]。

中西医结合临床实践指南的可实施性评价

目的应用可实施性评价工具,系统评价中西医结合临床实践指南(下文简称“指南”)的质量,为提高我国中西医结合指南的可实施性提供参考依据。方法检索PubMed、Web of Science、Embase、中国生物医学文献数据库、中国知网和万方数据库,补充检索中华医学会、中医药管理局、梅斯医学、中华中医药学会、当当网、医脉通、中国中西医结合学会和世界中医药联合会官网,以获取中西医结合指南,检索时间范围为建库至2022年12月31日。由4名评价员采用指南可实施性评价工具对纳入指南进行评价。结果共纳入61部中西医结合指南。其中,可实施性非常强的指南9部(14.75%),一般40部(65.57%),较差12部(19.67%)。5个评价领域中,“可及性”和“可执行性”领域的质量较高,“沟通性”“易识别性”和“应用性”领域相对较低。相较于2006—2016年发布的指南,2017—2022年发布的指南在“易识别性”和“应用性”领域均有提高。结论现有中西医结合指南的可实施性一般,有待进一步提高;今后应注重医教研一体化,加大对指南的宣传力度,加强继续医学教育和培训,以更简洁的形式呈现指南推荐意见,促进临床医生对指南的应用,提升中西医结合指南的可实施性。

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。

中西医结合耳鼻咽喉科学临床实践专家共识与指南的现状和展望

循证医学的发展促进了临床实践指南与专家共识制定的规范化,中西医并举是我国医疗体系特色,中西医结合的规范化是国家大力推进的工作。本文对中西医结合耳鼻咽喉科学相关临床实践专家共识和指南的进展与问题进行回顾与分析,供同行参考与讨论。共同促进中西医结合耳鼻咽喉科学领域共识和指南的制定,为相关临床工作提供更多规范和依据,促进学科规范化发展。

Development of Clinical Practice Guidelines in 11 Common Diseases with Chinese Medicine Interventions in China

Objective： To analyze the clinical practice guideline （CPG） development on 11 common diseases with Chinese medicine （CM） interventions in China. Methods： The CPGs of 11 common diseases which could be treated effectively with CM had been published between 1980 and 2010 in China. The 11 diseases include coronary heart disease （angina pectoris）, hypertension, chronic gastritis, rheumatoid arthritis, cerebral infarction, migraine, diabetes, primary osteoporosis, insomnia, common cold, and IgA nephropathy. The issuing organization, date of publication, development methods, and citation rate of the CPGs were analyzed. According to the development method, each guideline was categorized as consensus-based （CB）, evidence-based （EB）, or consensus based with no explicit consideration of evidence-based （CB-EB）. Results： Thirty-three CPGs on the 11 common diseases were found： 20 guidelines were classified as CB, 13 as CB-EB and none as EB. Fifteen CPGs were issued by the China Association of Chinese Medicine, 8 by professional working groups, and 4 by the State Administration of Traditional Chinese Medicine. Six guidelines were published between 1980 and 1990, 9 between 1991 and 2000, and 18 between 2001 and 2010. Fifty-eight percent of these guidelines have not been amended timely. Only 54.5% （18/33） of the 33 guidelines were cited by other researchers and 45.5% （15/33） percent had never been cited. Conclusions： Most CPGs developed for 11 common diseases with CM approaches in China are consensus, and their citation rates are relatively low. The results suggest that more EB CPG or CPG strictly based on expert consensus could be developed, and great efforts should be made for future CM CPG application.

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.

International Clinical Practice Guideline of Chinese Medicine: Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a major chronic disease that seriously endangers public health. Some remarkable results have shown that Chinese medicine has an obvious clinical effect in preventing and treating COPD. To further promote the normative use of Chinese medicine to better guide the clinical diagnosis and treatment of COPD,the World Federation of Chinese Medicine Societies developed a panel to establish the guidelines by systematically evaluating, based on the revision and transformation of Guidelines for Chinese Medicine Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease released by the China Association of Chinese Medicine in 2019(Standard No:T/CACM 1319-2019), the latest clinical research evidence at home and abroad, formatting the International Clinical Practice Guideline of Chinese Medicine—Chronic Obstructive Pulmonary Disease, and publishing in both Chinese and English. The guidelines consist of 12 parts:preface, introduction, scope, normative references, terms and definitions, disease diagnosis and staging, severity assessment,etiology and pathogenesis, syndrome differentiation and treatment, other treatment, prevention and care, and appendix. They also standardize the contents of traditional Chinese medicine (TCM) etiology and pathogenesis, syndrome differentiation and treatment, and prevention and care of COPD. These guidelines are applicable to clinical respiratory physicians of TCM and integrated traditional Chinese and western medicine.The release of these guidelines will help improve the effect and level of Chinese medicine for COPD.