ObjectiveTo construct an outcome set for clinical evaluation of traditional Chinese medicine （TCM） for chronic pulmonary heart disease， and to provide consensus outcomes for the evaluation of the clinical effectiveness of TCM for chronic pulmonary heart disease. MethodsWe searched randomised controlled trials of TCM for chronic pulmonary heart disease on China National Knowledge Infrastructure （CNKI）， Wanfang Data Knowledge Service Platform （WF）， VIP Chinese Science Journals Database （VIP）， Chinese Biomedical Literature Service Database （SinoMed）， PubMed， Cochrane Library， and Embase. We also searched Chinese Clinical Trial Registry Platform and the U.S. Clinical Trial Registry database to obtain the outcome indicators reported in the clinical research protocols of TCM for chronic pulmonary heart disease. The outcome indicators were also collected through semi-structured interviews of clinicians and patients. Then integrated the outcome indicators collected by the above methods to construct the indicator pool. Through two rounds of Delphi surveys and a consensus conference， the core outcome set for clinical evaluation of TCM for chronic pulmonary heart disease was determined. ResultsAfter screening， there were 1313 literature meeting the criteria， and 595 outcome indicators were extracted， then combined with the outcomes from semi-structured interviews which clinicians and patients concerned， finally an indicator item pool containing 369 outcome indicators were formed. After the initial screening of indicators in the pool by the steering committee， 58 indicators were established into the initial list of indicator entries. In the first round of Delphi survey， the expert coordination coefficient for the results was 0.401， and the Cronbach coefficient was 0.989. A total of 35 indicators that did not meet the criteria ［＜70% of the participants rated the outcome as 7~9 （critical） and the mean of the expert ratings ＜7］ were deleted， and 23 were retained， with 7 new indicators added that were open to supplementation by the experts， resulting in a total of 30 indicators that were included in the second round of Delphi survey. In the second round of Delphi survey， the expert coordination coefficient was 0.303， and the Cronbach coefficient was 0.974， with a total of 7 indicators that did not meet the criteria being deleted， and 21 indicators being retained for the consensus conference. After the consensus meeting， the core outcome set for clinical evaluation of chronic pulmonary heart disease in two major categories， acute exacerbation stage and stable stage， was finally determined， in which there were four indicators in acute exacerbation stage： N-terminal B-type natriuretic peptide precursor （NT-proBNP）， blood qi analysis， all-cause mortality rate， and complication rate； and there were eight indicators in the stable stage： pulmonary function index， six-minute walk test distance， New York cardiac function classification， all-cause mortality rate， re-hospitalisation rate， Chronic Obstructive Pulmonary Disease Assessment Test （CAT） score， Short Form 36 Health Survey （SF-36）， and TCM syndrome score. ConclusionThe core outcome sets of TCM clinical evaluation in the acute exacerbation stage and stable stage are constructed， which is helpful to improve the practicability， comparability and transparency of TCM clinical research results in pulmonary heart disease.

Objective: Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. Methods: RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated. Results: A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized. Conclusion Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.

Objective This study aims to summarize and evaluate clinical evidence of randomized controlled trial(RCT)of Chinese patent medicine published in 2021 and providing reasonable suggestions.Methods The collection literatures of Evidence Database System of TCM(EVDS)was main source,and CNKI,Wan Fang Data,VIP,SinoMed,Cochrane Library,PubMed,and EMbase databases were supplement.Obtaining the RCT of Chinese patent medicine published in 2021,and to analyze and evaluate their characteristics and methodological quality.Results 2215 RCTs of Chinese patent medicine(2206 in Chinese/9 in English)were included,which involving 237,379 patients,26 types of diseases,and 750 types of proprietary Chinese medicines(619 types of oral Chinese patent medicine,91 types of Chinese injections,and 40 types of topical Chinese patent medicine).The circulatory system diseases,respiratory system diseases and neurological diseases was highlight research area.The most number of diseases were ischemic Stroke,coronary heart disease,and angina pectoris.The sample size between 30 and 8,000 cases,and the case sources were mainly single-center.Methodologically,the implementation of allocation concealment and blinding remained unappreciated.Conclusion The number of RCTs publication increased in 2021 compared with 2020,more studies pay attention to neurological disease research,and quality control and standardized management during study design and implementation still need to be improved.

Morita therapy has been bom for more than 100 years.Inpatient Morita therapy is highly oper-able and easy to master.It can improve many refractory neuroses through four-stage treatment.But more neuroses are treated in outpatient clinics,and Morita therapy cannot be used in hospitalized patients.Therefore,the formula-tion of expert opinions on outpatient operations is particularly important.This paper is based on domestic and for-eign references,and after many discussions by domestic Morita therapy experts,and then drew up the first version of the expert opinions on operation of outpatient Morita therapy.Meanwhile the operation rule of Morita therapy in three stages of outpatient treatment was formulated:in the etiological analysis stage,under the theoretical guidance of Morita therapy,analyze the pathogenic factors,to improve treatment compliance and reduce resistance;during the operating stage,guide patients to engage in constructive and meaningful actions,realizing the achievement of letting nature take its course principle;in the cultivating character and enriching life stage,pay attention to positive infor-mation,expanding the scope and content of actions,improving the ability to adapt to complex life,and preventing recurrence caused by insufficient abilities.It will lay a foundation for the promotion of Morita therapy in domestic outpatient clinics,so that more patients with neurosis and other psychological diseases could receive characteristic Morita therapy treatment in outpatient clinics.

Objective:To discuss how to construct the medical insurance access for medical service items based on Health Tech-nology Assessment(HTA)applicable to China.Methods:This study consolidated the current medical insurance access in some prov-inces and cities from China and identified deficiencies through the expert interview.We summarized the experience and indicators contained in the HTA report in UK and Singapore by using literature analysis.Results:In most regions of China,the management of medical services price is gradually moving from exclusion items based on certain conditions to access approach,lacking of tools for assessment.In UK and Singapore,the medical insurance access mechanism mainly consists of subject selection,scoping,HTA imple-mentation and decision-making,in the HTA report,with the data including clinical evidence,cost evidence and budget impact on health system,etc.Conclusion:Building an evidence-based health policy decision-making framework through multi-criteria deci-sion analysis and the construction of medical insurance access mechanism based on HTA can be achieved by developing national guidelines,multi-scenario HTA systems,and enhancing the supervision on the process of HTA.

Objective:To provide suggestions for exploring the ICER threshold's calculation method and reasonable estimation in China.Methods:It summarizes the consensus and analyze the disputes on thresholds in China based on theoretical and empirical research by literature review,compares the thresholds derived from willingness to pay versus opportunity cost methods.Results:Theoretical researches on threshold of China mainly focus on method for calculation,health output index,and health equity,etc.The controversy persists over the threshold's characteristics.The health care demand-side perspective willingness-to-pay method was the most widely used in the empirical studies,but the results of the thresholds measured by this method varied widely;the thresholds measured by the health care supply-side perspective opportunity cost method were lower than the thresholds obtained from the demand-side perspective.Conclusion:It is still essential to discuss the threshold's characteristics and establish the methods framework complementing both demand and supply side for Chinese health insurance,and to standardize and normalize the measurement methods,as well as to set up multi-level thresholds according to the preferences of the population,the severity of the disease,and so on,in order to take into account both economy and equity.

Objective:To discuss how to construct the medical insurance access for medical service items based on Health Tech-nology Assessment(HTA)applicable to China.Methods:This study consolidated the current medical insurance access in some prov-inces and cities from China and identified deficiencies through the expert interview.We summarized the experience and indicators contained in the HTA report in UK and Singapore by using literature analysis.Results:In most regions of China,the management of medical services price is gradually moving from exclusion items based on certain conditions to access approach,lacking of tools for assessment.In UK and Singapore,the medical insurance access mechanism mainly consists of subject selection,scoping,HTA imple-mentation and decision-making,in the HTA report,with the data including clinical evidence,cost evidence and budget impact on health system,etc.Conclusion:Building an evidence-based health policy decision-making framework through multi-criteria deci-sion analysis and the construction of medical insurance access mechanism based on HTA can be achieved by developing national guidelines,multi-scenario HTA systems,and enhancing the supervision on the process of HTA.

Objective:To provide suggestions for exploring the ICER threshold's calculation method and reasonable estimation in China.Methods:It summarizes the consensus and analyze the disputes on thresholds in China based on theoretical and empirical research by literature review,compares the thresholds derived from willingness to pay versus opportunity cost methods.Results:Theoretical researches on threshold of China mainly focus on method for calculation,health output index,and health equity,etc.The controversy persists over the threshold's characteristics.The health care demand-side perspective willingness-to-pay method was the most widely used in the empirical studies,but the results of the thresholds measured by this method varied widely;the thresholds measured by the health care supply-side perspective opportunity cost method were lower than the thresholds obtained from the demand-side perspective.Conclusion:It is still essential to discuss the threshold's characteristics and establish the methods framework complementing both demand and supply side for Chinese health insurance,and to standardize and normalize the measurement methods,as well as to set up multi-level thresholds according to the preferences of the population,the severity of the disease,and so on,in order to take into account both economy and equity.

Objective:To discuss how to construct the medical insurance access for medical service items based on Health Tech-nology Assessment(HTA)applicable to China.Methods:This study consolidated the current medical insurance access in some prov-inces and cities from China and identified deficiencies through the expert interview.We summarized the experience and indicators contained in the HTA report in UK and Singapore by using literature analysis.Results:In most regions of China,the management of medical services price is gradually moving from exclusion items based on certain conditions to access approach,lacking of tools for assessment.In UK and Singapore,the medical insurance access mechanism mainly consists of subject selection,scoping,HTA imple-mentation and decision-making,in the HTA report,with the data including clinical evidence,cost evidence and budget impact on health system,etc.Conclusion:Building an evidence-based health policy decision-making framework through multi-criteria deci-sion analysis and the construction of medical insurance access mechanism based on HTA can be achieved by developing national guidelines,multi-scenario HTA systems,and enhancing the supervision on the process of HTA.

Objective:To provide suggestions for exploring the ICER threshold's calculation method and reasonable estimation in China.Methods:It summarizes the consensus and analyze the disputes on thresholds in China based on theoretical and empirical research by literature review,compares the thresholds derived from willingness to pay versus opportunity cost methods.Results:Theoretical researches on threshold of China mainly focus on method for calculation,health output index,and health equity,etc.The controversy persists over the threshold's characteristics.The health care demand-side perspective willingness-to-pay method was the most widely used in the empirical studies,but the results of the thresholds measured by this method varied widely;the thresholds measured by the health care supply-side perspective opportunity cost method were lower than the thresholds obtained from the demand-side perspective.Conclusion:It is still essential to discuss the threshold's characteristics and establish the methods framework complementing both demand and supply side for Chinese health insurance,and to standardize and normalize the measurement methods,as well as to set up multi-level thresholds according to the preferences of the population,the severity of the disease,and so on,in order to take into account both economy and equity.