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.

Prospects for the future of clinical efficacy evaluation of traditional Chinese medicine——Emphasis on original theory and clinical practice

Traditional Chinese medicine(TCM)clinical efficacy evaluation runs through the development of TCM and has been progressing so far.With the introduction of evidence-based medicine(EBM)in recent 20 years,TCM clinical efficacy evaluation has developed rapidly,accumulated research and experience,improved the quality and standardization of research,but also gradually found deep-seated deficiencies.In 2019,the China Center for Evidence-based Traditional Chinese Medicine(CCEBTCM)was established,and TCM was included in the 11th revision of the International Statistical Classification of Diseases(ICD-11).In above opportunities for TCM clinical efficacy evaluation,it is necessary to face up to the previous deficiencies,so that the TCM clinical efficacy evaluation can truly reflect the actual clinical practice characteristics,including TCM clinical problems,TCM thinking and TCM diagnosis&treatment mode.Based on the summary and analysis of past research,development concepts are proposed in this article.On the one hand,original concepts of TCM should be confidently paid more attention to the design and implementation of TCM clinical efficacy evaluation to be close to TCM clinical practice.On the other hand,it is necessary to consolidate the foundation of TCM clinical practice before evaluating efficacy.Evaluated object built on TCM ontology knowledge should be demonstrated based on clinical practice,and unknown evaluated object combined with new methods,technologies and concepts should be maturely integrated in clinical practice firstly.

Reporting guidelines of Chinese medicine:Current situation and future development

Objective:Reporting research is as important a part of a study as its design or analysis.Reporting guidelines(RGs)provide structured advice on how to report research studies clearly and adequately.This study aimed to review the development of RGs of Chinese medicine(CM)and to provide recommen-dations for improvement.Methods:Through a systematic search of the Enhancing the QUAlity and Transparency Of health Research(EQUATOR)Network and electronic databases up to January 1,2022,we identified a total of 15 RGs of CM,and further summarized their characteristics and applications.In addition,we reviewed the development of international RGs and analyzed its impact for CM.Results:Compared with the generic RGs,the reporting standards of CM have been rapidly developed over the last 10 years,of which 57%were issued in recent 3 years(2019-2021).Currently,the system of RGs of CM has been established,especially for clinical trials,including various CM interventions and covering the guidelines from trial registration,protocol,results publication to the evidence synthesis and clinical practice guideline.However,the application of RGs of CM is suboptimal.Conclusion:It is necessary to take further measures to promote practical application,improve journals’endorsement,and establish quality monitoring procedures for RGs of CM in the future.

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.

Formulation of international standards of Chinese medicine technology:clinical practice guide of Chinese medicine for cough

OBJECTIVE:To formulate the first clinical practice guideline for the treatment of cough using Chinese medicine based on the grading of recommendations assessment,development,and evaluation(GRADE)systematic approach,including clinical evidence,evaluation of ancient literature,and expert consensus.METHODS:In the process of development,the regulation of"evidence-based,consensus-assisted,and empirical"was followed,and a comprehensive systematic approach of recommendation assessment,GRADE,evidence-based evaluation,expert consensus,and the Delphi method was used.In the process of guideline development,evidence-based evaluation of ancient literature was included for the first time,and clinical evidence was fully integrated with clinical expert consensus.RESULTS:The clinical practice guidelines for the treatment of cough with Chinese herbal medicine were developed after a comprehensive consideration of evidence-based evaluation and expert opinions.The guideline recommendations focused on recommending herbal compound decoctions and Chinese patent medicines for cough in different conditions.Based on the GRADE systematic approach,we conducted an evidence-based evaluation of the recommended Chinese patent medicines one by one;meanwhile,the expert consensus method was used to unify the recommendations of both.CONCLUSION:Based on clinical evidence,ancient literature evaluation,and expert consensus,a clinical practice guideline for Traditional Chinese Medicine(TCM)in the treatment of cough was developed,providing the first current clinical practice guideline for domestic and foreign TCM and Western medicine practitioners,especially respiratory professionals at home and abroad.

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.

International standard of Traditional Chinese Medicine Techniques: Traditional Chinese Medicine guidelines for acute primary headache(2022)

OBJECTIVE:To summarize the evidence from Traditional Chinese Medicine(TCM)practice in the treatment of acute primary headache and provide clinical practice guidance.METHODS:The guidelines were developed in accordance with the World Health Organization guideline development manual.After the establishment of steering committee,panel and the registration and protocol formulation,the evidence on TCM for acute primary headache from published guidelines,clinical evidence,and expert experience and consensus were collected.The grading of recommendations assessment,development and evaluation method was used to grade the evidence and make the recommendations.RESULTS:Based on the available evidence,the guidelines recommended three TCM herbal decoctions,six Chinese patent medicines,and two kinds of external application of Chinese herbal medicines.Diagnostic recommendations based on the expert experience and consensus were also included in the guidelines.CONCLUSION:TCM diagnosis and treatment of decoction,Chinese patent medicine and external application for treating acute primary headache were recommended.We hope these guidelines will be helpful in standardize the TCM acute treatment of primary headache.

Based on the process management of traditional Chinese medicine comprehensive intervention method on outcomes in patients with mild/moderate chronic obstructive pulmonary disease:study protocol for a practical randomized controlled trial

Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.

Clinical practice guidelines for the treatment of primary liver cancer with integrative traditional Chinese and Western medicine

Traditional Chinese medicine （TCM） is an important part of the treatment of primary liver cancer （PLC） in China; however, the current instructions for the integrative use of traditional Chinese and Western medicine for PLC are mostly based on expert opinion. There is no evidence-based guideline for clinical prac-tice in this field. Therefore, the Shanghai Association of Chinese Integrative Medicine has established a multidisciplinary working group to develop this guideline, which focuses on the most important questions about the use of TCM during PLC treatment. This guideline was developed following the method- ological process recommended by the World Health Organization Handbook for Guideline Development. Two rounds of questionnaire survey were performed to identify clinical questions; published evidence was searched; the Grading of Recommendations Assessment, Development and Evaluation approach was used to evaluate the body of evidence; and recommendations were formulated by combining the quality of evidence, patient preferences and values, and other risk factors. The guideline was written based on the Reporting Items for Practice Guidelines in Healthcare tool. This guideline contains 10 recommendations related to 8 questions, including recommendations for early treatment by TCM after surgery, TCM combined with transcatheter arterial chemoembolization for advanced PLC, TCM drugs for external use, and acupuncture and moxibustion therapy.

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.

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 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.

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.

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.

Chinese herbal medicines for prostate cancer therapy: From experimental research to clinical practice

Prostate cancer remains the second most common malignancy in men worldwide, is a global health issue,and poses a huge health burden. Precision medicine provides more treatment options for prostate cancer patients, but its popularity, drug resistance, and adverse reactions still need to be focused on. Chinese herbal medicines(CHMs) have been widely accepted as an alternative therapy for cancer, with the advantages of multiple targets, multiple pathways, and low toxicity. We searched the experimental research and clinical practice of CHMs for prostate cancer treatment published in Pub Med, Embase, and Web of Science in the last five years. We found five CHM formulas and six single CHM extracts as well as 12 CHM-derived compounds, which showed induction of apoptosis, autophagy, and cell cycle arrest, suppression of angiogenesis, proliferation, and migration of prostate cancer cells, reversal of drug resistance,and enhancement of anti-tumor immunity. The mechanisms of action include the PI3K/Akt/mTOR, AR,EGFR and Wnt/β-catenin signaling pathways, which are commonly implicated in the development of prostate cancer. We also summarized the advantages of CHMs in patients with hormone-sensitive and castration-resistant prostate cancer and provided ideas for their further experimental design and application.

Study on the Methodology of Developing Evidence-Based Clinical Practice Guidelines of Chinese Medicine

At present, evidence-based clinical practice guideline （EBCPG） is the main mode of developing clinical practice guidelines （CPGs） in the world, but in China, most of CPGs of Chinese medicine （CM） are still guidelines based on expert consensus. The objective of this study is to construct initially the methodology of developing EBCPGs of CM and to promote the development of standardization of CM. Based on the development of ＂Guideline for Diagnosis and Treatment of Common Pediatric Diseases in CM＂, the methodology of developing EBCPG of CM was explored by analyzing the pertinent literature and considering the characteristics of CM. In this study, the key problem was to put forward the suggestion and strategies. However, due to the methodology study of developing EBCPG of CM is still in the initial stage, there are still some problems which need further study.

Status Quo and Analysis of the Cardiovascular Clinical Practice Guidelines/Expert Consensuses of Chinese and Integrative Medicine:A Systematic

Objective:To describe and analyze the status quo of cardiovascular clinical practice guidelines or expert consensuses including both Chinese medicine(CM)and integrative medicine,through systematic literatures searching and quality assessment.Methods:Data bases including Chinese Biomedical Literature Database,the China National Knowledge Infrastructure,Wanfang Data,China Science and Technology Journal Database were searched for published CM or integrative cardiovascular clinical practice guidelines or expert consensuses.The website www.medlive.cn was also retrieved as supplementary.The clinical practice evaluation tool AGREEⅡwas used to assess the quality of included guidelines or consensuses.Results:A total of 31 relevant clinical practice guidelines or expert consensuses were included,covering diagnosis,treatment,Chinese patent and patient fields.Common cardiovascular diseases like coronary heart diseases,heart failure and arrhythmia were also involved.Through analysis it was found that both the quantity and quality of included guidelines have been improved year by year.A total of 4 evidence-based clinical practice guideline has been found,one of which was a guideline project plan.Except that,the remaining 27 reports were all consensusbased guidelines.The scores of each field,from highest to lowest,were clarity of presentation(58%),scope and purpose(54%),stakeholder involvement(28%),rigor of development(21%),applicability(13%)and editorial independence(8%).Conclusions:Although clinical practice guidelines in cardiovascular domain of Chinese have gained increasing concern,with both quantity and quality improved,there is still huge gap in methodology and reporting standards between CM guidelines and international ones.On the one hand,it is essential to improve and standardize the methodology of developing CM guidelines.On the other hands,the evaluation system of evidence and recommendation with CM characters should be developed urgently.

Development of rapid advice guideline and standard and continuous updating guideline:experiences and practice

We published rapid advice guidelines and updated guidelines for coronavirus disease 2019(COVID-19)management on February 6,2020,and September 4,2020,respectively.These two guidelines vary widely in their developmental background,type of evidence,grade of recommendation and so on.We shared our experience for the development of these two guidelines to help clinical practitioners better understand and implement guidelines and to help guideline developers facilitate communication and discussion for guideline development during the pandemic.