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

The morbidity and mortality of gastric cancer are very high in China. Helicobacter pylori (Hp) infection plays an important role in gastric mucosa inflammation, atrophy and intestinal metaplasia. A large number of epidemiological researches have shown a positive correlation between Hp infection and morbidity of gastric cancer. The current infection rate of Hp in China is nearly 50%. Eradication of Hp may reduce the risk of gastric cancer and bring a better cost-effectiveness. However, screening and eradication of Hp had not been taken seriously in China. This article analyzed the effectiveness and affecting factors of screening and eradication of Hp for gastric cancer prevention from the health economics perspective view.

Objective: To evaluate Chinese clinical practice guideline/consensus for digestive diseases published in the past five years in order to recommend the high-quality guidelines and help with the promotion and implementation of them. Methods: From January 2013 to June 2018, the officially published Chinese practice guideline/consensus for digestive diseases were selected. The inclusion and exclusion criteria of the guideline/consensus was evaluated by "Evaluation Criteria for Chinese Clinical Practice Guidelines 2017(AGREE-China 2017)" . The guideline/consensus were independently scored by three evaluators and then calculated the average value. Descriptive analysis methods were used to analyze the Chinese clinical practice guideline/consensus for digestive diseases. Those with the total score more than 40.0 points were included in the recommended list. Results: A total of 119 officially published clinical practice guideline/consensus of digestive diseases were retrieved, and 74 clinical practice guideline/consensus for digestive diseases were included in the evaluation. Among them, 18 (24.3%, 18/74) scored over 60.0 points, 31 (41.9%, 31/74) scored between 40.0 and 59.9 points. Finally 48 guideline or consesus were selected for the recommended list 19 cases of esophagus and gastrointestinal diseases, 18 cases of liver diseases, five cases of biliary and pancreafic diseases, and six cases of digestive endoscopy. The three guideline/consensus with the high scores (> 80.0 points) were The Fifth Chinese National Consensus Report on the Maragement of Helicobacter pylori Infection, Consensus on the Diagnosis and Treatmeat of Cholestatic Liver Disease (2015) and Guidelines for the Prevention and Treatment of Chroaic Hepatitis B (2015 Update). The higher the score of the guideline/consensus, the more scientific and rigorous the method, and the clearer the evaluation of evidence grade and the description of the formation of recommendations. Compared with international standards of guideline/consensus development, there are still some problems in Chinese guidelines or consensus such as no explanation of retrieval strategy, no basis of evidence classification and no description of the formation process from evidence to recommendation. Conclusions The quality of Chinese clinical practice guideline/consensus for digestive diseases has been improved year by year. However the scientific aspects need to be further improved. AGREE-China which demonstrates good validity, realiability and practicability is easy and clear to use.

OBJECTIVETo evaluate the cost-effectiveness of preventive treatment on diabetes, using metformin or acarbose among patients with impaired glucose tolerance.

METHODSUsing data from diabetes prevention program (DPP) and STOP-NIDDM study, we evaluated the cost of preventing one new onset of diabetes in Shanghai, and to compare its cost with the current treatment cost.

RESULTSIf metformin was used for preventive treatment as in DPP study, a total cost of 69 122.95RMB was needed for preventing one new onset of diabetes in three years period. If acarbose was used for preventive treatment as in STOP-NIDDM, then 154 116.05RMB was the cost to prevent one diabetes in 3.3 years of treatment. However, if the generic metformin was used, the total cost was only 21 666.63RMB for the 3-years treatment. Data showed that the average cost for treating diabetes per year was 9143.70RMB in Shanghai.

CONCLUSIONThe total cost of diabetes prevention was formidable, although generic metformin showed the trend of cost-effective. The cost of drugs took the biggest part of the total cost. To choose the cheap but effective drug for treatment might save a large part of the cost. Further clinical research concerning the prevention of complications might provide us with more information on the cost-effectiveness of preventive treatment on diabetes.

Acarbose ; therapeutic use ; Attitude to Health ; Cost-Benefit Analysis ; Diabetes Mellitus, Type 2 ; economics ; prevention & control ; Follow-Up Studies ; Glucose Intolerance ; drug therapy ; economics ; Glucose Tolerance Test ; Humans ; Hypoglycemic Agents ; economics ; therapeutic use ; Metformin ; therapeutic use ; Preventive Health Services ; economics ; Risk Reduction Behavior ; Surveys and Questionnaires

In order to standardize the application of imaging techniques in the clinical diagnosis and treatment of patients with Takayasu arteritis in China,the protocol for development of the guidelines for the imaging diagnosis and treatment of Takayasu arteritis was written by Zhongshan Hospital of Fudan University,the Rheumatology Committee of Chinese Medical Association,China Primary Health Care Foundation,and the Evidence-Based Medicine Center of Fudan University.The guideline working group will standardize the development of guidelines based on the existing imaging literature evidence of Takayasu arteritis and with reference to the WHO Guideline Development Manual.This protocol mainly introduced the significance of guideline formulation,the formation of working group,the selection of clinical problems,evidence retrieval and evaluation,the formation and publication of guidelines and other processes.

Objective: To compare the clinicopathological characteristics and the prognosis of gastric adenocarcinoma patients with and without neuroendocrine differentiation (NED) after radical gastrectomy plus D2 lymph node dissection. Methods: A retrospective cohort study was performed. The inclusion criteria were as follows: (1) patients who underwent radical resection of gastric cancer plus D2 lymph node dissection and were confirmed as gastric adenocarcinoma by postoperative pathology and received immunohistochemical examination of neuroendocrine markers Syn and/or CgA; (2) patients aged 20 to 75 years with normal organ function; (3) patients who did not receive neoadjuvant chemotherapy or radiotherapy before operation; (4) patients with postoperative pathological stage I to III according to the 8th edition of tumor staging system of American Joint Committee on Cancer (AJCC); and (5) patients who completed adjuvant chemotherapy according to the postoperative pathological stage. Those who had other malignant tumors in the past 5 years and who could not be followed up according to the required rules were excluded. According to the above criteria, the clinicopathological characteristics of gastric cancer patients who underwent radical resection plus D2 lymph node dissection in Zhongshan Hospital of Fudan University from January 2010 to June 2017 were collected and compared. All patients were followed up till June 2020. The disease-free survival (DFS) and overall survival (OS) between the patients with and without NED were compared, and the effect of NED on the prognosis was corrected by Cox proportional hazards model. The propensity score matching method was used for sensitivity analysis. Results: A total of 539 patients were enrolled in this study, including 35 with NED and 504 without NED. Compared with the patients without NED, the patients with NED were older [(65.0±7.5) years vs. (54.5±11.3) years, t=-7.681, P<0.001], had higher proportion of undergoing proximal gastrectomy [22.9% (8/35) vs. 7.6% (36/504), χ(2)=10.335, P=0.006], higher proportion of intestinal-type based on Lauren classification [77.1% (27/35) vs. 42.5% (214/504), χ(2)=14.553, P<0.001], and higher proportion of pathologic stage III [65.7% (23/35) vs. 27.6% (139/504), χ(2)=25.653, P<0.001]. The 3-year DFS of patients with NED and those without NED was 48.9% (95% CI: 33.8%-70.8%) and 37.4% (95% CI: 32.9%-42.5%) respectively, and no significant difference was found (P=0.44). The 3-year OS was 56.1% (95% CI: 39.9%-79.1%) and 64.3% (95% CI: 59.3%-69.7%) respectively, and no significant difference was found as well (P=0.32). Univariate and multivariate analyses showed that NED was not an independent risk factor for DFS and OS (all P>0.05). Sensitivity analysis showed that there was no significant difference in DFS and OS between the two groups after propensity score matching. Conclusion: Compared with patients without NED, patients with NED were older at onset, had a higher proportion of proximal gastrectomy, intestinal-type, and later diagnostic stage, but the survival prognosis had no significant difference with that of patients without NED.
Adult ; Aged ; Gastrectomy ; Humans ; Lymph Node Excision ; Middle Aged ; Neoplasm Staging ; Prognosis ; Retrospective Studies ; Stomach Neoplasms/surgery* ; Young Adult

Objective: To predict the efficacy of endoscopic tissue adhesives in the treatment of gastric varices in patients with liver cirrhosis by Nomogram model. Methods: From August 2014 to September 2017, 158 patients with liver cirrhosis caused esophagogastric variceal bleeding and received endoscopic tissue adhesives treatment at Zhongshan Hospital, Fudan University were collected. All patients were followed for 12 months. The primary outcome was rebleeding. The factors of rebleeding after endoscopic treatment of esophagogastric varices were analyzed. Nomogram prognostic model was developed and compared with Child-Pugh grading, computed tomography angiography (CTA) and hepatic venous pressure gradient (HVPG) in prognostic accuracy in rebleeding after endoscopic treatment in liver cirrhosis caused esophagogastric varices. Univariate and multivaricate Cox regression analysis, Kaplan-Meier curve and log-rank test were performed for statistical analysis. Results: During the follow-up, rebleading occurred in 18 cases (11.4%), 37 cases (23.4%) and 49 cases (31.0%) at 2, 6, and 12 months after endoscopic treatment. The results of univariate Cox regression analysis showed the risk factors of rebleeding after endoscopic treatment of gastric varices included gender, alcoholic liver cirrhosis, diabetes mellitus, Child-Pugh grade (Grade A vs. B or C), extraluminal vessels on CTA (presence vs. absence) HVPG (<16 mmHg vs. ≥16 mmHg, 1 mmHg = 0.133 kPa), extensive portal embolism, esophageal varices, type 2 gastric varices, injection points of tissue adhesive (≤3 points vs. > 3 points), injection volume of tissue adhesive (≤ 3 mL vs. > 3 mL) (hazard ratio (HR)=0.575, 2.018, 1.562, 3.433, 2.945, 1.859, 2.743, 0.324, 1.840, 1.477, and 1.716; 95% confidence interval (CI) 0.305 to 1.084, 0.902 to 4.514, 1.753 to 6.724, 1.663 to 5.217, 1.012 to 3.415, 0.852 to 8.830, 0.079 to 1.335, 1.012 to 3.317, 0.839 to 2.602, and 0.935 to 3.152; all P<0.2). The results of multivariate Cox regression analysis indicated that Child-Pugh grade, extraluminal vessels by CTA, and HVPG (HR = 2.095, 95% CI 1.099 to 3.995, P = 0.025) were all independent risk factors of rebleeding after endoscopic treatment of gastric varices (HR=2.665, 2.886, and 2.095; 95% CI 1.339 to 5.300, 1.580 to 5.271, and 1.099 to 3.995; all P<0.05). Kaplan-Meier curves showed that Child-Pugh grade (Grade A vs. B or C), extraluminal vessels on CTA (presence or absent) and HVPG (<16 mmHg vs. ≥16 mmHg) could effectively predict cumulative non-rebleeding rate in one year after endoscopic treatment of gastric varices, and the differences were statistically significant (all P<0.05). Receiver operataring characteristic curve analysis demonstrated that the predictive value of the model combined with Child-Pugh grade, extraluminal vessels on CTA and HVPG was higher than that of Child-Pugh grade and HVPG (AUC=0.746, 0.673 and 0.585; 95% CI 0.662 to 0.829, 0.583 to 0.762, and 0.486 to 0.683; P<0.01, P=0.001 and P=0.089, respectively). Patients were divided into low, medium, and high-risk groups according to the 25th and 75th percentiles of the Nomogram score. The results showed that Nomogram model could effectively distinguish high-risk groups of rebleeding after endoscopic treatment of gastric varices, and the difference was statistically significant (P <0.01). Conclusions Extraluminal vessels on CTA, HVPG and Child-Pugh grade are independent prognostic evaluation indexes of rebleeding after endoscopic treatment of gastric varices. The predictive accuracy of Nomogram model based on these three prognostic factors may be better than Child-Pugh grade and HVPG.

BACKGROUND: This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability. METHODS: This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability. RESULTS: STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min. CONCLUSION The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
Reproducibility of Results ; Surveys and Questionnaires ; Practice Guidelines as Topic ; Humans

Transparency Ecosystem for Research and Journals in Medicine (TERM) working group summarized the essential recommendations that should be considered to review and publish a high-quality guideline. These recommendations from editors and reviewers included 10 components of essential requirements: systematic review of existing relevant guidelines, guideline registration, guideline protocol, stakeholders, conflicts of interest, clinical questions, systematic reviews, recommendation consensus, guideline reporting and external review. TERM working group abbreviates them as PAGE (essential requirements for Publishing clinical prActice GuidelinEs), and recommends guideline authors, editors, and peer reviewers to use them for high-quality guidelines.
Humans ; Practice Guidelines as Topic