1.Scientific Positioning of Traditional Chinese Medicine.
Chinese Journal of Integrated Traditional and Western Medicine 2016;36(3):266-268
Whether traditional Chinese medicine (TCM) could be categorized as a kind of science or not has been a controversial issue over last century. Part of the confusion is caused by the indistinguishable usage of Chinese words "science" and "scientific" during discussion. According to western academic standards, TCM cannot be considered as pure or conventional science. However, in author's view, the foundation of a majority part of TCM practice is probably scientific, while many TCM theories remain unproved. In this article, medical theories and practices are classified based on scientific content into eight levels: medical science, scientific medicine, medical system, medical theory, medical opinion, medical belief, medical cultism, and medical fraud. Both Western medicine and TCM are positioned in this system accordingly. Currently, the scientific level of TCM is much lower than that of Western medicine, and more research is needed for its improvement.
Biomedical Research
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Humans
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Medicine, Chinese Traditional
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standards
4.Statistical reporting requirements for medical journals: Amplifications and explanations.
Chinese Journal of Epidemiology 2019;40(1):99-105
Our study aimed to amplify and explain the items of statistical reporting requirements proposed by medical journals, and to improve the statistical reporting quality of medical articles. Statistical reporting requirements were obtained from the reporting standards published by the International Committee of Medical Journal Editors (ICMJE), the Enhancing the QUAlity and Transparency of Health Research (EQUATOR) network, and the editorial board of Chinese Medical Journal, etc. The items involved in statistical reporting requirements were summarized as issues of study design, statistical analysis, and interpretation of results. Each item was amplified based on cases of original articles. It is noticeable that the statistical reporting requirements of English medical journals generally referring to guidance documents, including "Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals" proposed by the ICMJE, or the statements for different study types published by the EQUATOR network, where the statistical reporting of medical articles had been detailed specified. The statistical reporting requirements of Chinese medical journals, however, were usually stated by the editorial boards. Although the formats and contents of statistical analysis had been regulated, the requirements of Chinese medical journals were to some extent insufficient and should be enhanced in accordance with the international standards. In conclusion, the amplification and explanation of statistical reporting requirements were expected to help investigators understand the requirements for statistical reporting in medical researches, so as to effectively improve the quality of medical articles.
Biomedical Research
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Editorial Policies
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Humans
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Periodicals as Topic/standards*
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Publishing/standards*
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Reference Standards
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Research Design
5.Evidence-based medicine and real world study in clinical study of acupuncture and moxibustion.
Ronglin CAI ; Ling HU ; Zijian WU
Chinese Acupuncture & Moxibustion 2015;35(9):949-952
Evidence-based medicine (EBM) has been widely applied in clinical study of acupuncture and moxibustion, and the real-world study (RWS) has gradually become an important way of clinical research in the world in recent years. It is worthy of our in-depth study and discussion that how to evaluate the advantages and limitations of EBM and RWS as well as their reasonable application in clinical study of acupuncture and moxibustion. The characteristics and difference between RWS and EBM, and the situation of acupuncture clinical research methods are discussed in this paper. It is proposed that we should understand the advantages of RWS in acupuncture clinical research, fully realize the limitations of EBM and RWS, recognize the complexity and particularity of RWS, and apply EBM and RWS into acupuncture clinical research. Meanwhile acupuncture clinical manipulation standardization should be further promoted, which is benefit to develop clinical study, improve clinical efficacy and promote the popularization of acupuncture and moxibustion.
Acupuncture Therapy
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standards
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Biomedical Research
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standards
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Evidence-Based Medicine
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standards
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Humans
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Medicine, Chinese Traditional
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Moxibustion
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standards
7.The necessity and feasibility of establishing technical specifications for registry of Chinese medicine clinical study.
Peng-Fei LU ; Xing LIAO ; Yan-Ming XIE ; Zhi-Guo WANG
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(1):14-18
International clinical trials register is one of the global measures to realize transparency in clinical trials and also one of a powerful measure to improve the quality of clinical trials. Many scholars studying the quality of TCM clinical trials find that they are poor in quality and lack transparency. Furthermore, they find that TCM clinical trial registry has many problems. We must base on the successful experiences of WHO and international clinical trial registry to establish technical specifications for registry of traditional Chinese medicine clinical study of their own. Then, it can effectively improve the overall level of TCM clinical studies. We have suggested some concrete and feasible measures to establish technical specifications for registry of traditional Chinese medicine clinical study of their own based on the problems of TCM clinical trial registry.
Biomedical Research
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Humans
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Medicine, Chinese Traditional
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standards
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Registries
8.Thinking on designation of sham acupuncture in clinical research.
Li-Jia PAN ; Bo CHEN ; Xue ZHAO ; Yi GUO
Chinese Acupuncture & Moxibustion 2014;34(1):83-86
Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.
Acupuncture Therapy
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standards
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Biomedical Research
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standards
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Evidence-Based Medicine
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Humans
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Randomized Controlled Trials as Topic
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standards
9.Overview of CDISC standard and implementation in China.
Victor WU ; Wen-Jun BAO ; John WANG ; Rui-Ling PENG ; Ya-Zhong DENG ; Zi-Bao ZHANG
Acta Pharmaceutica Sinica 2015;50(11):1428-1433
CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research
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standards
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China
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Clinical Trials as Topic
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standards
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Data Collection
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standards
10.Standardization of cancer biobank in precision medicine era.
Journal of Zhejiang University. Medical sciences 2016;45(4):331-334
Tumor specimens have a great role in basic and clinical translational researches on cancer, especially in the era of precision medicine. Thus the standardization of cancer biobank is of high importance. The establishment and maintenance of cancer biobank require comprehensive quality management, so as to provide high quality service for basic and clinical researches. At present, sample-oriented collection and management, and clinical and pathological data annotation are the main focuses of biobank standardization in China.
Biological Specimen Banks
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standards
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Biomedical Research
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China
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Documentation
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standards
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Humans
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Neoplasms
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Precision Medicine
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Specimen Handling
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standards