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 ; ethics ; Humans ; Microbiota ; 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

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

Humans ; Quality Control ; Randomized Controlled Trials as Topic ; standards ; Research ; standards ; Research Design

The concept of evidence in evidence based medicine (EBM) and the current main grading systems of evidence in the world were introduced systematically in this paper. And the methodological issues and challenges related to the efficacy evaluation of traditional medicine were analyzed. Targeting the characteristics and current status of clinical research in TCM, a proposal for evidence grading was suggested and recommended to provide the referential basis developing the clinical practical guidance of TCM.
Evidence-Based Medicine ; methods ; standards ; Humans ; Medicine, Chinese Traditional ; methods ; standards ; Research Design ; standards

The difficulty in the participant recruitment is the common question in acupuncture clinical trial study. The existing recruitment of clinical trial is most applicable for the clinical trial of medicines. Because the intervention of acupuncture clinical trial is different from that of medicines, characterized as the specialties in "theory, principle, acupoints, technique", it is very necessary to develop the strategy on the participant recruitment in acupuncture clinical trial. The free community medical consultation is one of the important means of recruitment. In the paper, by taking the participant recruitment of acupuncture clinical trial on chronic stable angina pectoris as the example, the discussion is given on the strategy on the recruitment of free community medical consultation in the aspects of feasible investigation of recruitment approach, recruitment plan, participant screening, etc. The revisiting after the free community medical consultation is the important approach to the improvement of successful recruitment. This strategy on the recruitment of free community medical consultation is highly practical and improves the successful rate and compliance of the participant recruitment. Hence, this strategy deserves to be promoted.
Acupuncture Therapy ; Clinical Trials as Topic ; standards ; Humans ; Personnel Selection ; standards ; Research Design ; standards

PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December 2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81, P < 0.001), score rate of items increased except adverse events (P < 0.001). The special rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.
Clinical Trials as Topic ; standards ; Equipment and Supplies ; standards ; Humans ; Research Design ; standards