OBJECTIVE: To evaluate the methodological quality and reporting quality of Meta-analysis literature published by acupuncture journals included in Chinese Science Citation Database (CSCD), and to provide references and demonstration for relevant studies. METHODS: The Meta-analysis literature published before December 2017 in , , and was retrieved by computer. AMSTAR was used for methodology quality evaluation, and PRISMA was used for reporting quality evaluation. RESULTS: A total of 69 literature was included. Among them, the co-authorship rate was 100% and the cooperation degree was 5.45. The first authors came from 32 institutions, and 29 literature (42.0%) was funded. The cited rate was 98.6%, and averagely each paper was cited 16.3 times. The mean score of methodology quality evaluation was (7.78±1.14) points, including 14 high-quality literature (20.3%), 50 moderate-quality literature (72.5%) and 5 low-quality literature (7.2%). The average score of reporting quality evaluation was (20.33±2.36) points, including 24 relatively complete literature (34.8%), 41 literature with certain defects (59.4%) and 4 literature with serious defects (5.8%). CONCLUSION The Meta-analysis reports published by acupuncture journals in CSCD have relatively high methodological quality and reporting quality, which could provide evidence for clinical decision making, but still the quality level needed to be further enhanced according to the writing standard of Meta-analysis report. At the same time, the overall level of experimental research should be constantly improved to promote the development of evidence-based research on acupuncture and promote the formation of high-quality evidence.
Acupuncture Therapy ; China ; Databases, Factual ; Humans ; Moxibustion ; Periodicals as Topic ; standards ; statistics & numerical data ; Publications

Objective: Chronic obstructive pulmonary disease, asthma, interstitial lung disease and pulmonary thromboembolism are the most common and severe respiratory diseases, which seriously jeopardizing the health of the Chinese citizens. Large-scale prospective cohort studies are needed to explore the relationships between potential risk factors and respiratory disease outcomes and to observe disease prognoses through long-term follow-ups. We aimed to develop a common data model (CDM) for cohort studies on respiratory diseases, in order to harmonize and facilitate the exchange, pooling, sharing, and storing of data from multiple sources to serve the purpose of reusing or uniforming those follow-up data appeared in the cohorts. Methods: The process of developing this CDM of respiratory diseases would follow the steps as: ①Reviewing the international standards, including the Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Acquisition Standards Harmonization (CDASH) and the Observational Medical Outcomes Partnership (OMOP) CDM; ②Summarizing four cohort studies of respiratory diseases recruited in this research and assessing the data availability; ③Developing a CDM related to respiratory diseases. Results: Data on recruited cohorts shared a few similar domains but with various schema. The cohorts also shared homogeneous data collection purposes for future follow-up studies, making the harmonization of current and future data feasible. The derived CDM would include two parts: ①thirteen common domains for all the four cohorts and derived variables from disparate questions with a common schema, ②additional domains designed upon disease-specific research needs, as well as additional variables that were disease-specific but not initially included in the common domains. Conclusion: Data harmonization appeared essential for sharing, comparing and pooled analyses, both retrospectively and prospectively. CDM was needed to convert heterogeneous data from multiple studies into one harmonized dataset. The use of a CDM in multicenter respiratory cohort studies would make the constant collection of uniformed data possible, so to guarantee the data exchange and sharing in the future.
Data Collection/standards* ; Databases, Factual/standards* ; Delivery of Health Care/organization & administration* ; Humans ; Information Dissemination ; Pulmonary Disease, Chronic Obstructive

The Western China Gastric Cancer Collaboration (WCGCC) was founded in Chongqing, China in 2011. At the early stage of the collaboration, there were only about 20 centers. While now, there are 36 centers from western area of China, including Sichuan, Chongqing, Yunnan, Shanxi, Guizhou, Gansu, Qinghai, Xinjiang, Ningxia and Tibet. During the past few years, the WCGCC organized routinely gastric cancer standardized treatment tours, training courses of mini-invasive surgical treatment of gastric cancer and the clinical research methodology for members of the collaboration. Meanwhile, the WCGCC built a multicenter database of gastric cancer since 2011 and the entering and management refer to national gastric cancer registration entering system of Japan Gastric Cancer Association. During the entering and collection of data, 190 items of data have unified definition and entering standard from Japan Gastric Cancer Guidelines. Nowadays, this database included about 11 872 gastric cancer cases, and in this paper we will introduce the initial results of these cases. Next, the collaboration will conduct some retrospective studies based on this database to analyze the clinicopathological characteristics of patients in the western area of China. Besides, the WCGCC performed a prospective study, also. The first randomized clinical trial of the collaboration aims to compare the postoperative quality of life between different reconstruction methods for total gastrectomy(WCGCC-1202, ClinicalTrials.gov Identifier: NCT02110628), which began in 2015, and now this study is in the recruitment period. In the next steps, we will improve the quality of the database, optimize the management processes. Meanwhile, we will engage in more exchanges and cooperation with the Chinese Cochrane Center, reinforce the foundation of the clinical trials research methodology. In aspect of standardized surgical treatment of gastric cancer, we will further strengthen communication with other international centers in order to improve both the treatment and research levels of gastric cancer in Western China.
Cancer Care Facilities ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Databases, Factual ; statistics & numerical data ; trends ; Education, Medical, Continuing ; Gastrectomy ; methods ; Humans ; Minimally Invasive Surgical Procedures ; education ; Organizational Objectives ; Organizations ; statistics & numerical data ; trends ; Outcome Assessment (Health Care) ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Registries ; statistics & numerical data ; Research Design ; standards ; Retrospective Studies ; Stomach Neoplasms ; epidemiology ; therapy

In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods.
Databases, Factual ; Diagnostic Tests, Routine/*standards ; Humans ; ROC Curve ; Research

The report quality of randomized controlled trials (RCTs) of moxibustion for knee osteoarthritis (KOA) in China was evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Moxibustion (STRICTOM). Computer and manual retrieval was used. Four databases of China National Knowledge Infrastructure (CNKD, China Biomedicine (CBM), VIP and WNFANG were searched in combination with manual retrieval for relevant journals to screen the literature that: met the inclusive criteria, and CONSORT and STRICTOM were used to assess the report quality. A total of 52 RCTs were included. It was found that unclear description of random methods, low use of blind methods, no allocation concealment, no sample size calculation, no intention-to-treat analysis,inadequate report of moxibustion details and no mention of practitioners background existed in the majority of the RCTs. Although the quality of RCTs of moxibustion for KOA was generally low, reducing the reliability and homogeneous comparability of the reports ,the quality of heat-sensitive moxibustion RCTs was high. It was believed that in order to improve the reliability and quality of RCTs of moxibustion, CONSORT and STRICTOM should be introduced into the RCT design of moxibustion and be strictly performed.
China ; Databases, Factual ; Humans ; Moxibustion ; methods ; standards ; Osteoarthritis, Knee ; therapy ; Randomized Controlled Trials as Topic ; standards ; Research Design

The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine, using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine, a technological innovation strategy encompassing its methodology, and the R&D direction of the subsequent core technology are also presented.
Data Mining ; Databases, Factual ; Drug Industry ; organization & administration ; standards ; Drugs, Chinese Herbal ; analysis ; pharmacology ; standards ; Humans ; Quality Control

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.
Clinical Trials as Topic ; Databases, Factual ; Documentation ; standards

Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

On the basis of real working practices in data normalization, the case reports from the monitoring system were studied, non-standard reports were summarized and the reasons were analyzed, the methods of data normalization and improving the reporting quality were discussed. The standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of new cases.
Databases, Factual ; Equipment and Supplies ; adverse effects ; standards ; Quality Control