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

Objective: To evaluate the diagnostic accuracy of line probe assays for drug- resistant tuberculosis (TB) in China. Methods: Chinese databases (CNKI, Wanfang, SinoMed, VIP Information) and English databases (PubMed, Embase, Cochrane Library) were used to retrieve the literatures regarding the accuracy of line probe assays in the diagnosis of drug-resistant tuberculosis in China between January 1, 2000 and September 1, 2017. Quality Assessment of Diagnostic Accuracy Studies-2 was used to evaluate the quality of the included studies. Sensitivity and specificity in different studies (using drug sensitivity test or gene sequencing as gold standard) were combined by Meta-analysis using bivariate or univariate model. In addition, subgroup analysis (GenoType MTBDRplus, GenoType MTBDRsl and Reverse dot blot hybridization) and sensitivity analysis were also carried out. Results: A total of 24 literatures involving 82 studies were included in the final analysis. The sensitivity and specificity of line probe assays for rifampicin resistant TB were 0.91(0.88-0.94) and 0.98 (0.97-0.99), respectively. The sensitivity and specificity of line probe assays for isoniazid resistant TB were 0.80 (0.77-0.83) and 0.98 (0.96-0.99), respectively. The sensitivity and specificity of line probe assays for multidrug-resistant TB were 0.81 (0.76-0.85) and 0.99 (0.99-1.00), respectively. The sensitivity and specificity of line probe assays for quinolone resistant TB were 0.92(0.88-0.95) and 0.94 (0.91-0.97), respectively. The sensitivity and specificity of line probe assays for second-line injectable drug resistant TB (including kanamycin, Capreomycin, amikacin) were 0.79(0.58-0.91) and 0.98 (0.90-1.00), respectively. The sensitivity and specificity of line probe assays for extensively drug-resistant TB were 0.46 (0.19-0.75) and 1.00 (0.98-1.00), respectively. Subgroup analysis showed that the overall diagnostic accuracy of GenoType MTBDRplus and GenoType MTBDRsl was higher than that of Reverse dot blot hybridization. According to the results of sensitivity analysis, the results of this study were robust. Conclusion: The diagnostic accuracy of line probe assays for drug-resistant TB is high.
Antitubercular Agents/therapeutic use* ; Biological Assay/methods* ; China ; Humans ; Isoniazid/pharmacology* ; Microbial Sensitivity Tests/methods* ; Mycobacterium tuberculosis/isolation & purification* ; Rifampin/pharmacology* ; Sensitivity and Specificity ; Tuberculosis, Multidrug-Resistant/drug therapy*

To evaluate the intervention effects of randomized controlled trials (RCT) involved in theoretical efficacy and actual clinical outcome (effectiveness). Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) is a tool to help researchers make decisions in study design which is consistent with the intended purpose of their trial which can be used in the design of RCT to balance the internal validity and external validity. The role of PRECIS has been gradually recognized in the practice of designing clinical trials. To ensure that the design choices are concordant with the intention and the facilitation of use set by patients, clinicians and policy makers, a new PRECIS-2 tool has been developed by mangy international team experts under modification and upgrading the existing PRECIS. The PRECIS-2 tool mainly focuses on trial design choices which determining the applicability of a trial. PRECIS-2 has nine domains, with each of them intends to help the researchers consider the consequences of that design decision in terms of the applicability of the results under particular setting. The purpose of this paper is to introduce the development, basic principle, characteristics and application of PRECIS-2 for the designers and decision makers when working on clinical trials.
Communication ; Decision Making ; Humans ; Randomized Controlled Trials as Topic/methods* ; Research Design/standards*

This paper introduces the tools related to Quality In Prognosis Studies (QUIPS) to assess the risk of bias in studies of prognostic factors and the relevant points of assessment and to illustrate the application of QUIPS in published prognostic research. The QUIPS tool identified 6 important areas to consider when evaluating validity and bias in studies of prognostic factors including participation, attrition, measurement on prognostic factors, outcomes, confounding factors, statistical analysis and reporting. It also provided a new method for evaluation on bias in the areas of prognostic research.
Bias ; Humans ; Prognosis ; Quality Improvement ; Research Design

This paper introduced the Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2), including the development and comparison with the original QUADAS, and illustrated the application of QUADAS-2 in a published paper related to the study on diagnostic accuracy which was included in systematic review and Meta-analysis. QUADAS-2 presented considerable improvement over the original tool. Confused items that included in QUADAS had disappeared and the quality assessment of the original study replaced by the rating of risk on bias and applicability. This was implemented through the description on the four main domains with minimal overlapping and answering the signal questions in each domain. The risk of bias and applicability with 'high','low' or 'unclear' was in line with the risk of bias assessment of intervention studies in Cochrane, so to replace the total score of quality assessment in QUADAS. Meanwhile, QUADAS-2 was also applicable to assess the diagnostic accuracy studies in which follow-up without prognosis was involved in golden standard. It was useful to assess the overall methodological quality of the study despite more time consuming than the original QUADAS. However, QUADAS-2 needs to be modified to apply in comparative studies on diagnostic accuracy and we hope the users would follow the updates and give their feedbacks on line.
Bias ; Diagnostic Tests, Routine/standards* ; Humans ; Quality Assurance, Health Care ; Research Report ; Risk

In this last paper of the series about risk of bias assessment, we introduce the application of risk of bias assessment results. Risk of bias assessment is one of the key steps in the assessment of quality of evidence. The risk of bias assessment results could be the "diagnosis" of individual studies, which helps decision making related to the inclusion and exclusion of individual studies, as well as the data analysis in the systematic review process. This paper focuses on how to incorporate risk of bias assessment results in the GRADE assessment for quality of evidence, including the principles and the tips for the application.
Bias ; Outcome Assessment, Health Care ; Risk Assessment

Objective: To analyze the spatial distribution and identify the high risk areas of pulmonary tuberculosis at the township level in Beijing during 2005-2015. Methods: Data on pulmonary tuberculosis cases was collected from the tuberculosis information management system. Global autocorrelation analysis, local indicators of spatial association and Kulldorff's Scan Statistics were applied to map the spatial distribution and detect the space-time clusters of the pulmonary tuberculosis cases during 2005-2015. Results: Spatial analysis on the incidence of pulmonary tuberculosis at the township level demonstrated that the spatial autocorrelation was positive during the study period. The values of Moran's I ranged from 0.224 3 to 0.291 8 with all the P values less than 0.05. Hotspots were primarily distributed in 8 towns/streets as follows: Junzhuang, Wangping, Yongding and Tanzhesi in Mentougou district, Yancun in Fangshan district, Wangzuo town in Fengtai district, Tianqiao street in Xicheng district and Tianzhu town in Shunyi district. Spatiotemporal clusters across the entire study period were identified by using Kulldorff's spatiotemporal scan statistic. The primary cluster was located in Chaoyang and Shunyi districts, including 17 towns/streets, as follows: Cuigezhuang, Maizidian, Dongfeng, Taiyanggong, Zuojiazhuang, Hepingjie, Xiaoguan, Xiangheyuan, Dongba, Jiangtai, Wangjing, Jinzhan, Jiuxianqiao, Laiguangying, Sunhe towns/streets in Chaoyang district, Houshayu and Tianzhu town in Shunyi district, during January to December 2005. Conclusion: Incidence rates of pulmonary tuberculosis displayed spatial and temporal clusterings at the township level in Beijing during 2005-2015, with high risk areas relatively concentrated in the central and southern parts of Beijing.
Beijing ; China ; Cluster Analysis ; Humans ; Incidence ; Spatial Analysis ; Spatio-Temporal Analysis ; Tuberculosis ; Tuberculosis, Pulmonary/ethnology*

This paper introduced the Revised Cochrane Risk of Bias Tool RoB2.0 for cluster-randomized control trials (CRCT) and compared RoB2.0 of CRCT with individually randomized, parallel group trials, and illustrated the application of RoB2.0 for CRCT in a published CRCT. Special signal questions were designed for CRCT according to its specialty that different from individually randomized, parallel group trials in RoB2.0 and also providing information on risk of bias about CRCT in systematic reviews for the synthesis of evidence.
Bias ; Humans ; Randomized Controlled Trials as Topic ; Risk ; Risk Assessment/methods*

This paper introduces the Risk of Bias in Systematic Review (ROBIS), including: 1) the development of ROBIS, 2) three phases of ROBIS tool judging the overall risk of bias that related to systematic reviews, and 3) illustration on the application of ROBIS in a published systematic review. ROBIS is the first rigorously developed tool which is specifically designed to assess the risk of bias in systematic reviews. ROBIS will help improve the process of risk assessment on bias which appeared in overviews and guidelines.
Humans ; Bias ; Risk Assessment/methods* ; Systematic Reviews as Topic

Objective: To investigate the utilization of antibiotics in emergency departments (EDs) of class Ⅲ general hospitals in China. Methods: Data from a national monitoring network for rational use of drugs was used. The data included prescriptions of EDs from 114 class Ⅲ general hospitals in 30 provinces (autonomous regions, municipalities) of China. A total of 10 260 595 prescriptions from October 1, 2014 to December 31, 2016 were extracted. The Anatomical Therapeutic Chemical Classification/Defined Daily Dose (DDD) system was used for the classification of antibiotics and calculation of antibiotic use intensity. An auto-regression model was used to analyze the trend over time and seasonal variation of antibiotic use in EDs. Results: The rate of antibiotic prescriptions was 27.82% in EDs, among the antibiotics prescribed, 25.58% were for the combination therapy with 2 or more antibiotic agents, and injectable antibiotic prescriptions accounted for 60.59%. Besides, the number of DDDs per 100 patient visits was 81.84. Broad-spectrum agents were the most commonly used antibiotics, among which the second and third generation cephalosporins, quinolones and macrolides accounted for 23.83%, 21.68%, 19.17% and 7.89% of all prescribed antibiotics, respectively. The use of antibiotics, including prescription frequency and use intensity, in EDs had a slight but significant increase tendency (P<0.05), and the seasonal variation of antibiotic use in EDs was obvious, characterized by the highest frequency and intensity of antibiotic use in winter, the differences were significant (P<0.05). Conclusion: The antibiotic prescription rate in EDs of classⅢ general hospitals in China was controlled at a low level, but the proportions of broad-spectrum antibiotics and injectable antibiotics were high, and a significant increase trend in antibiotic use in EDs was found.
Anti-Bacterial Agents/therapeutic use* ; China ; Drug Prescriptions ; Drug Utilization ; Emergency Service, Hospital ; Hospitals ; Hospitals, General ; Humans