Translational Medical Research ; standards

Comparative effectiveness research (CER) now is a very popular concept in the field of international heath care reformation. Although its contents are not essentially changed, it advocates a new medical idea, a policy orientation at the national medical system level. The European countries and America hope CER could initiate the construction of a new historical milestone. Although there are already some guidelines for the design and report of CER by authorized international organizations, its assessment standards have not been involved. Therefore, good research for comparative effectiveness (GRACE) was signed by International Society Pharmacoepidemiology. A series of standard rules were formulated on how to assess the observational studies. In this article by analyzing the GRACE, we hope to provide the referential standards for enforcing observational studies by introducing CER in the clinical studies of Chinese medicine.
Comparative Effectiveness Research ; Research Design ; standards

Biomedical Research ; standards ; Clinical Trials as Topic ; standards ; Diagnosis, Differential ; Humans ; Medicine, Chinese Traditional ; Research Design ; standards

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 ; Editorial Policies ; Humans ; Periodicals as Topic/standards* ; Publishing/standards* ; Reference Standards ; Research Design

Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Documentation ; standards ; Research Design ; standards

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 ; standards ; Biomedical Research ; standards ; Evidence-Based Medicine ; standards ; Humans ; Medicine, Chinese Traditional ; Moxibustion ; standards

With the development of the methodology of clinical trials and the appearance of medical big data, the real-world study (RWS) presents its unique advantages, plays a role in clinical practice and research, and its importance is more and more recognized by scholars in recent years. In surgical research field, due to the specificity of surgical diseases and operational procedures, confounding factors and risk of bias are greatly higher than those of traditional medications. Therefore, using unique advantages of the RWS to solve the actual clinical problem in surgical field is the main goal of performing surgical RWS. This article will systematically elucidate how to perform the surgical RWS and the special matters of concern in carrying out surgical RWS.
Clinical Studies as Topic ; methods ; standards ; General Surgery ; standards ; Humans ; Research Design ; standards ; Surgical Procedures, Operative ; standards

An international brainstorming session on standardizing pattern identification (PI) was held at the Korea Institute of Oriental Medicine on October 1, 2013 in Daejeon, South Korea. This brainstorming session was convened to gather insights from international traditional East Asian medicine specialists regarding PI standardization. With eight presentations and discussion sessions, the meeting allowed participants to discuss research methods and diagnostic systems used in traditional medicine for PI. One speaker presented a talk titled "The diagnostic criteria for blood stasis syndrome: implications for standardization of PI". Four speakers presented on future strategies and objective measurement tools that could be used in PI research. Later, participants shared information and methodology for accurate diagnosis and PI. They also discussed the necessity for standardizing PI and methods for international collaborations in pattern research.
Internationality ; Medicine, Chinese Traditional ; standards ; Reference Standards ; Research

OBJECTIVE: To develop a scientific and effective evaluation index system for equalization of basic public health services. METHODS: Through 2 rounds of expert evaluation, based on the relative importance of expert scoring on each index, index was screened according to the scores of mean and coefficient of variation and the weight were determined. RESULTS: The two rounds of consulting experts response rates were more than 90%, and the average authority coefficients were 0.779 and 0.781. The coordination coefficients were 0.229 and 0.349. The evaluation index system of basic public health services was composed of 3 first level, 17 second level and 47 third level indicators after 2 rounds of consultation. CONCLUSION The evaluation index system of basic public health services is reasonable, and it can be used to evaluate the equalization of basic public health services.
Health Services ; standards ; Health Services Research ; Public Health ; standards

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 ; Humans ; Medicine, Chinese Traditional ; standards