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

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

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
Biostatistics ; Clinical Trials as Topic ; statistics & numerical data ; Data Collection ; standards ; Quality Control ; Research Design ; standards

Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.
Clinical Trials as Topic ; Cost-Benefit Analysis ; Economics, Pharmaceutical ; Guidelines as Topic ; Humans ; Pharmaceutical Preparations ; economics ; Product Surveillance, Postmarketing ; economics ; Statistics as Topic

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.
Abdominal Pain/*chemically induced ; Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group/statistics & numerical data ; Benzofurans/*adverse effects ; Clinical Trials, Phase III as Topic ; Constipation/*drug therapy/ethnology ; Diarrhea/*chemically induced ; Double-Blind Method ; Female ; Headache/*chemically induced ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Regression Analysis

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.
Abdominal Pain/*chemically induced ; Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group/statistics & numerical data ; Benzofurans/*adverse effects ; Clinical Trials, Phase III as Topic ; Constipation/*drug therapy/ethnology ; Diarrhea/*chemically induced ; Double-Blind Method ; Female ; Headache/*chemically induced ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Regression Analysis

To reduce the incidence of surgical site infection (SSI), perioperative antimicrobial prophylaxis has long been advocated for joint replacement and open reduction with internal fixation of long bones. Increasing health care costs have focused hospital interest on more cost-effective procedures. Although current literature indicates that single-dose antibiotic prophylaxis is comparable to a 3-dose regimen, there are no reports from lowincome countries. The primary aim of this study was to compare the infection rate following open reduction and internal fixation of long-bone fractures in groups with a single dose and 3 doses of prophylactic antibiotic. The secondary aim was to compare the costeffectiveness of both antibiotic regimens. This is a prospective randomized clinical trial (RCT) to compare the incidence of surgical site infection between the patients allocated randomly into two groups with different antibiotic prophylactic regimens: single dose or 3 doses 8 hourly of 1g ceftriaxone administered intravenously. 200 consecutive patients who underwent open reduction and internal fixation (ORIF) for closed long-bone fractures were enrolled in this study. The rate of postoperative SSI was 4.1% in the single-dose group and 2.2% in the 3-dose group; the overall SSI rate was 3.2%. The primary endpoint of this study, which is the incidence of SSI, showed no significant difference between the single-dose and 3-dose prophylactic antibiotic groups. Furthermore, there was no difference between groups regarding the length of hospital stay. Our randomized clinical trial affirmed that single-dose antibiotic prophylaxis in orthopaedic clean operations is not only a cost-saving practice but also is effective for SSI prevention, and should be incorporated in the development of clinical practice guidelines in tropical hospitals.
Clinical Trials as Topic- statistics & ; numerical data,

The papers regarding moxibustion published in science citation index (SCI) journals for the recent 5 years were searched to explore the international tendency of moxibustion researches, which provided references for moxibustion to have a better internationalization. With methods of internet search and database search, a total of 116 papers regarding moxibustion were included. These papers were published in 40 kinds of journals, mostly in Britain and the United States. The journal with the highest impact factor was Stroke, which had 5729 points. The number and impact factor of these journals were inferior to those of acupuncture journal. Compared among these journals, the depth and width of moxibustion research were increasing year by year. The category of diseases related with moxibustion is mainly digestive system diseases, motor system diseases and urinary-genital system diseases. The type of papers was characterized with clinical observation and mechanism research. Researches related with moxibustion included moxibustion dose and safety. It was believed that the international recognition of moxibustion effectiveness, standardization of moxibustion manipulation, standardization research, etc. were needed to be solved in the further.
Bibliometrics ; Clinical Trials as Topic ; Humans ; Journal Impact Factor ; Moxibustion ; Publications ; statistics & numerical data

OBJECTIVEBased on real world research the circumstances of the clinical use of usual drugs combined with salvianolate injection are surveyed.

METHODDescriptive statistics on the use of salvianolate injection in 18 general hospitals in China.

RESULTIn 1 605 patients with coronary heart disease (CHD), salvianolate injection was most frequently (51%) combined with clopidogrel and isosorbide dinitrate. In addition this combination showed a higher clinical effectiveness as compared with other drug combinations.

CONCLUSIONIn the real world, salvianolate injection combined with usual treatment was found to be more effective than other treatment combinations. In addition practice conformed to the clinical treatment of coronary heart disease (CHD) guidelines for drug use. However, liver and kidney function, routine blood tests and the blood's coagulation function require ongoing monitoring.

Aged ; Aged, 80 and over ; Coronary Disease ; drug therapy ; mortality ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Hospital Information Systems ; statistics & numerical data ; Humans ; Isosorbide Dinitrate ; therapeutic use ; Male ; Middle Aged ; Plant Extracts ; administration & dosage ; Pragmatic Clinical Trials as Topic ; Propensity Score ; Ticlopidine ; analogs & derivatives ; therapeutic use ; Treatment Outcome