1.Requirements and Technical Aspects of Real world Data Governance in China's Medical Standards and Specifications
Xinmiao GUAN ; Yanzi ZHU ; Hao LIU ; Minjing LUO ; Changhao LIANG ; Feng CAO ; Zhihan LIU ; Jianguo ZHOU ; Dong ZHANG ; Yutong FEI
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1008-1017
Objective To investigate the governance requirements for real world data(RWD)in China's medical standards and specifications,summarize key technical aspects of data governance,and provide refer-ences for RWD governance-related research.Methods Computerized searches were conducted in CNKI,Wan-fang Data,VIP,and SinoMed,as well as the official websites of 29 national medical societies and the National Standard Information Public Service Platform,covering all records from inception to December 12,2023.A data extraction form was developed,and the included standards and specifications were categorized according to the first six RWD governance processes outlined in the Guidelines for Real World Data Used to Generate Real-World Evidence(Trial)issued by the National Medical Products Administration:data security,data extraction,data cleaning,data transformation,data transmission and storage,and quality control.Relevant content on data governance was systematically summarized and comparatively analyzed.Results A total of 32 standards and specifications were included,comprising 15 foundational medical data standards and 17 data gov-ernance technical specifications.Among these,6 addressed data security,6 covered data extraction,5 focused on data cleaning,5 involved data transformation,6 pertained to data transmission and storage,and 4 discussed quality control.Foundational medical data standards included data description elements,terminology,and format standards,broadly covering essential data elements and meeting basic standardization needs.Data gov-ernance technical specifications primarily provided general guidelines for medical data governance,emphasizing requirements and recommendations.While requirements for data security and extraction were relatively well-de-fined,technical guidance on data transformation and quality control remained limited,and implementation pathways for data cleaning,transmission,and storage were insufficiently detailed.Conclusions As real-world evidence plays an increasingly critical role in healthcare decision-making,China's medical standards and speci-fications have established a preliminary governance framework for RWD.However,technical details and practi-cal implementation of RWD governance still require further refinement.
2.Requirements and Technical Aspects of Real world Data Governance in China's Medical Standards and Specifications
Xinmiao GUAN ; Yanzi ZHU ; Hao LIU ; Minjing LUO ; Changhao LIANG ; Feng CAO ; Zhihan LIU ; Jianguo ZHOU ; Dong ZHANG ; Yutong FEI
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1008-1017
Objective To investigate the governance requirements for real world data(RWD)in China's medical standards and specifications,summarize key technical aspects of data governance,and provide refer-ences for RWD governance-related research.Methods Computerized searches were conducted in CNKI,Wan-fang Data,VIP,and SinoMed,as well as the official websites of 29 national medical societies and the National Standard Information Public Service Platform,covering all records from inception to December 12,2023.A data extraction form was developed,and the included standards and specifications were categorized according to the first six RWD governance processes outlined in the Guidelines for Real World Data Used to Generate Real-World Evidence(Trial)issued by the National Medical Products Administration:data security,data extraction,data cleaning,data transformation,data transmission and storage,and quality control.Relevant content on data governance was systematically summarized and comparatively analyzed.Results A total of 32 standards and specifications were included,comprising 15 foundational medical data standards and 17 data gov-ernance technical specifications.Among these,6 addressed data security,6 covered data extraction,5 focused on data cleaning,5 involved data transformation,6 pertained to data transmission and storage,and 4 discussed quality control.Foundational medical data standards included data description elements,terminology,and format standards,broadly covering essential data elements and meeting basic standardization needs.Data gov-ernance technical specifications primarily provided general guidelines for medical data governance,emphasizing requirements and recommendations.While requirements for data security and extraction were relatively well-de-fined,technical guidance on data transformation and quality control remained limited,and implementation pathways for data cleaning,transmission,and storage were insufficiently detailed.Conclusions As real-world evidence plays an increasingly critical role in healthcare decision-making,China's medical standards and speci-fications have established a preliminary governance framework for RWD.However,technical details and practi-cal implementation of RWD governance still require further refinement.
3.Moxibustion for the Treatment of Knee Osteoarthritis:An Overview of Systematic Reviews
Zhiyi WANG ; Yutong FEI ; Shumeng REN ; Leqi LYU ; Hanwei LUN ; Minjing LUO ; Yicheng GAO ; Ruyu XIA
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(3):56-63
Objective To evaluate the effectiveness and safety of moxibustion for knee osteoarthritis and the methodological quality of systematic reviews(SRs).Methods SRs of moxibustion for knee osteoarthritis were retrieved from CNKI,VIP,Wanfang Data,SinoMed,PubMed,Cochrane Library,Embase and Web of Science was conducted from the establishment of the databases to February 10,2022.AMSTAR 2 was used to assess the methodological quality of SRs.The randomized controlled trials(RCTs)included in these SRs were screened and summarized according to inclusion standard.RevMan 5.4 software was used for Meta-analysis,and GRADE approach was used to assess the certainty of evidence.Results A total of 15 SRs were included.The evaluation results of the AMSTAR 2 showed that the methodological quality was very low for 14 SRs,and low for other 1 SR.A total of 36 RCTs were included.Meta-analysis results showed that compared with the non-steroidal anti-inflammatory drugs(NSAIDs),the moxibustion group had better effects on improvement of WOMAC scores[mean difference(MD)=-5.95;95%confidence interval(CI):-9.25 to-2.65;low quality],relieving pain[MD=-1.26;95%CI:-2.19 to-0.32;very low quality],and improving effective rate[risk ratio(RR)=1.16;95%CI:1.11 to 1.22;low quality].In the moxibustion group,some patients experienced blisters,and most healed in 3 days.Conclusion Moxibustion has advantages in pain reduction and improving effective rate compared with routine Western therapy for knee osteoarthritis.However,well-designed high-quality RCTs are needed for further verification.
4.The Difficulties and Methodological Suggestions for the Recommendation Formation of Clinical Practice Guidelines of Traditional Chinese Medicine
Yicheng GAO ; Rui CAO ; Zhihan LIU ; Yuting FENG ; Qianyun CHAI ; Minjing LUO ; Ruyu XIA ; Yutong FEI
Journal of Traditional Chinese Medicine 2024;65(3):251-255
Currently, there are many difficulties in formulating recommendations of traditional Chinese medicine (TCM) clinical practice guidelines. This paper analyzed and summarized the unique or prominent difficult issues in the formulation of recommendations faced by TCM guidelines, such as experts' professional background and experience bringing about the preferance from the academic emotion, inconsistency between different academic schools making it difficult to reach consensus, lack of guiding principles of the decision weight of different dimensions for recommendations. Therefore, methodological suggestions have been put forward, including organizing parallel TCM and western medicine consensus group, improving the method of combining TCM and western medicine paradigm, attaching great importance to the evidence-based governance of academic schools, and promoting the research on different dimensions for recommendation formulation, which may provide a methodological reference for the guideline development.
5.Study on the effect of neutrophil and interleukin-8 on exercise-induced asthma.
Lixian ZHENG ; Minjing LI ; Zhiyang LUO
Chinese Journal of Practical Internal Medicine 2006;0(18):-
Objective To explore the relationship of neutrophil and interleukin-8(IL-8)with exercise-induced asthma(EIA).Methods From May 15,2001 to Dec 19.2005 the levels of peripheral neutrophil superoxide anion and IL-8 in the blood and the induced sputum from patients with EIA,non EIA and normal control subjects were measured respectively before and after exercises,meanwhile a comparison was made among them.Results Before exercise:the level of neutrophil superoxide anion was slightly higher in EIA group and non EIA group than that in control group;however,the differences were insignificant;the IL-8 and MDA levels in blood and induced sputum were higher in EIA group and non EIA group than those in control group,but there was no significant difference between EIA group and non EIA group;however,they were significantly different between EIA group and control group,non EIA group and control group respectively( P 0.05).Conclusion Oxyradical produced by neutrophil and IL-8 has significant effect on the production of EIA.

Result Analysis
Print
Save
E-mail