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1.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(10): 1186-1190, 2019 Oct 10.
Artigo em Chinês | MEDLINE | ID: mdl-31658514

RESUMO

Pharmacoepidemiology refers to the use of epidemiological research methods in studying the application and use of drugs in large populations to evaluate the safety and efficacy of medical products. Therefore, standardized pharmacoepidemiology research is the basis of the above work. Based on systematic reviews of national and international pharmacoepidemiological methodological standards and guidelines, and in combination with Chinese medical and health practice and experts' opinions, the Professional Committee of Pharmacoepidemiology of Chinese Pharmaceutical Association developed the group standard, guide on methodological standards in pharmacoepidemiology (T/CPHARMA 002-2019), to better guide the work of pharmacoepidemiology. The guideline was designed to provide advice and reference for pharmacoepidemiology research by government, regulatory agencies, research institutions, and pharmaceutical manufacturers in China.


Assuntos
Farmacoepidemiologia/métodos , Farmacoepidemiologia/normas , Projetos de Pesquisa/normas , China , Guias como Assunto , Revisão Sistemática como Assunto
2.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(10): 1324-1328, 2019 Oct 10.
Artigo em Chinês | MEDLINE | ID: mdl-31658538

RESUMO

Medical claims database is an important source of data for studying the characteristics, and burden of diseases, to provide a basis for the development of policy on management. The database is usually used to identify patients through International Classification of Diseases and free text-building algorithms, thus it is crucial to validate whether the algorithm is correctly identifing the targeted population. This paper introduces both traditional and emerging validation methods including machine learning, natural language processing and database linkage etc.. We also have tried to present a suitable validation method for the current situation in China, so as to promote the application of big data in medical areas and to provide reference for epidemiology studies, based on medical claims database in this country.


Assuntos
Algoritmos , Bases de Dados Factuais , Classificação Internacional de Doenças , Aprendizado de Máquina , China , Humanos
3.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(7): 664-667, 2019 Jul 06.
Artigo em Chinês | MEDLINE | ID: mdl-31288335

RESUMO

Post-marketing surveillance of vaccine safety is an important measure to detect adverse events following immunization and therefore reduce the harms to public health. The conventional method for safety surveillance is a passive way through spontaneous reporting, which suffer from under-reporting and incomplete. While active surveillance, a newly proposed surveillance method in developed countries, is capable to make up the deficiencies of passive surveillance. The surveillance system of vaccine safety in China is currently using passive surveillance, and facing many problems and challenges. This arouses a need to promote development of an active surveillance system for vaccine safety in China, learning from the experience world-wide. This commentary aims to throw out suggestions for establishing the active surveillance system, according to the specific situation in China and based on a scoping review of literature.


Assuntos
Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , China , Humanos , Literatura de Revisão como Assunto
4.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(7): 724-730, 2019 Jul 06.
Artigo em Chinês | MEDLINE | ID: mdl-31288345

RESUMO

Objective: To identify post-marketing active surveillance systems for vaccine safety around the world and understand their features and mechanisms, in order to provide guidance for vaccine administration activities in China. Methods: Following the steps of scoping review, literature about active surveillance system for vaccine safety and published by 30 June 2018 were identified by searching electronic databases, including PubMed, Scopus, and Cochrane Library. Grey literature were also sought by exploring relevant websites. Identified literature were screened according to eligibility criteria, and informative data from included literature were then charted. Framework Synthesis and Thematic Analysis were performed to integrate the charted data. Results: 97 pieces of literature were included for review, and 11 active surveillance systems for vaccine safety were identified, mostly located in developed countries. These systems were constructed by 3 types of organizations: administration departments, academic or research institutions, and health care providers. Their data sources included immunization registries, electronic medical records, claims data, case reports of adverse events following immunization electronic questionnaires, and epidemiologic study data. According to their operation procedures, these systems were grouped into 4 modes of active surveillance: Data Linkage, Investigator Network, Automatic Follow-up System, Studies Consortium. Conclusion: Practice of active surveillance for vaccine safety greatly varies across countries, with different conditions and advantages. It is suggested that developing countries should choose suitable mode of active surveillance considering their local situations.


Assuntos
Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , China , Países em Desenvolvimento , Humanos
5.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(7): 832-838, 2019 Jul 10.
Artigo em Chinês | MEDLINE | ID: mdl-31357807

RESUMO

Comprehensive interventions have been widely used in health system, public health, education and communities and have become increasingly focus of systematic reviews. There have been many reporting guidelines about systematic reviews, but they do not take the features of comprehensive interventions in medical area into consideration. As a result, PRISMA-CI has been developed as an extension of PRISMA, which adds or modifies the essential items of PRISMA. This paper introduces the items of PRISMA-CI and explains the items with an example to help authors, publishers, and readers understand PRISMA-CI and use it in systematic reviews on comprehensive interventions. As it become more and more popular with comprehensive interventions, PRISMA-CI will provide important structure and guidance for its systematic review and Meta-analysis.


Assuntos
Lista de Checagem , Editoração/normas , Projetos de Pesquisa , Revisão Sistemática como Assunto , Humanos
6.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(6): 702-706, 2019 Jun 10.
Artigo em Chinês | MEDLINE | ID: mdl-31238623

RESUMO

A large amount of data has been accumulated in Chinese medical area. Problems as how to use big data to carry out randomized controlled trials have also been increasingly noteworthy. Through learning the successful experiences in conducting randomized controlled trials on big data from abroad, this article introduces the knowledge regarding sources of data, identification of research subjects and outcomes, interventions, methods of randomization and the implementation of informed consent, etc., all related to big data, hoping to shed light on studies of this kind, for the years to come in China.


Assuntos
Big Data , Ensaios Clínicos Controlados Aleatórios como Assunto , China , Humanos , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa
7.
Beijing Da Xue Xue Bao Yi Xue Ban ; 51(3): 548-555, 2019 Jun 18.
Artigo em Chinês | MEDLINE | ID: mdl-31209430

RESUMO

OBJECTIVE: To systematically review and assess the quality of guidelines on colorectal cancer screening worldwide to provide guidance for the development of high-quality colorectal cancer screening guidelines in mainland China. METHODS: CNKI, WanFang Data, VIP, SinoMed, PubMed, Embase, and Web of Science were systematically searched to identify guidelines on colorectal cancer screening from inception to Jun. 20th, 2018, and so were some websites and major search engines about the development of the guidelines from the existing literature (search date: Aug. 3rd, 2018). Two experienced reviewers independently examined these abstracts and then extracted information, and the Appraisal of Guidelines for Research and Evaluation II (AGREE II) were used to evaluate the methodological quality of these guidelines by four well trained reviewers. RESULTS: In this study, 46 guidelines published from 1994 to 2018 were finally included in our analysis from 10 countries and 5 regions, among which 5 were from mainland China. The quality of these guidelines was relatively high in domain 1 (scope and purpose) and domain 4 (clarity of presentation), and medium in domain 2 (stakeholder involvement). While in the other three domains (domain 3: rigour of development; domain 5: applicability; domain 6: editorial independence), the results were quite different among these guidelines. The quality of evidence-based guidelines (defined by the criteria based on World Health Organization guideline development handbook) was generally higher than that of the common guidelines. Existing guidelines from mainland China were not evidence-based guidelines, which were of low quality. CONCLUSION: The colorectal cancer screening guidelines all over the world are generally large in number, low in quality, different in statements, and so are the guidelines in China. There are no evidence-based guidelines in mainland China, which cannot provide effective guidance for colorectal cancer screening, so we need to pay more attention to the establishment of guidelines with high quality and high credibility for colorectal cancer screening as well as for cancer screening based on the national condition, in order to provide reasonable guidance for practice in public health and improve the health conditions in our society.


Assuntos
Neoplasias Colorretais , Detecção Precoce de Câncer , China , Neoplasias Colorretais/diagnóstico , Humanos
8.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(1): 106-111, 2019 Jan 10.
Artigo em Chinês | MEDLINE | ID: mdl-30669741

RESUMO

This paper summarizes the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions revised by the Agency for Healthcare Research and Quality (AHRQ) and introduces how to use Revman software make risk of bias graph or risk of bias summary. AHRQ tool can be used to evaluate following study designs: RCTs, cohort study, case-control study (including nested case-control), case series study and cross-sectional study. The tool evaluates the risk of bias of individual studies from selection bias, performance bias, attrition bias, detection bias and reporting bias. Each of the bias domains contains different items, and each item is available for the assessment of one or more study designs. It is worth noting that the appropriate items should be selected for evaluation different study designs instead of using all items to directly assess the risk of bias. AHRQ tool can be used to evaluate risk of bias individual studies when systematic reviews of health care interventions is including different study designs. Moreover, the tool items are relatively easy to understand and the assessment process is not complicated. AHRQ recommends the use of high, medium and low risk classification methods to assess the overall risk of bias of individual studies. However, AHRQ gives no recommendations on how to determine the overall bias grade. It is expected that future research will give corresponding recommendations.


Assuntos
Viés , Medicina Baseada em Evidências/métodos , Pesquisa sobre Serviços de Saúde , Revisão Sistemática como Assunto , Medicina Baseada em Evidências/normas
9.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(12): 1648-1654, 2018 Dec 10.
Artigo em Chinês | MEDLINE | ID: mdl-30572394

RESUMO

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.


Assuntos
Viés , Medição de Risco
10.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(11): 1491-1495, 2018 Nov 10.
Artigo em Chinês | MEDLINE | ID: mdl-30462960

RESUMO

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.


Assuntos
Antituberculosos/farmacologia , Bioensaio/métodos , Testes de Sensibilidade Microbiana/métodos , Mycobacterium tuberculosis/efeitos dos fármacos , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Antituberculosos/uso terapêutico , China , Humanos , Isoniazida/farmacologia , Mycobacterium tuberculosis/isolamento & purificação , Rifampina/farmacologia , Sensibilidade e Especificidade
11.
Zhonghua Yi Xue Za Zhi ; 98(40): 3274-3278, 2018 Oct 30.
Artigo em Chinês | MEDLINE | ID: mdl-30392295

RESUMO

Objective: To investigate and analyze the distribution of 121 diseases of China's First List of Rare Diseases based on hospitalized patients of tertiary hospitals and to explore the current situation of rare diseases in China. Methods: Based on previous data of study from Beijing Society of Rare Diseases, a comparison between China's First List of Rare Diseases and the survey list from the pre-study was performed. Descriptive analysis was carried out on the current situation of rare diseases on hospitalizations in 96 tertiary hospitals from year of 2014 to 2015. Results: Nineteen out of 121 diseases on China's First List of Rare Diseases were not included in the rare diseases survey list of Beijing Society of Rare Diseases. The total number of other 102 rare disease cases was 54 468, accounting for 0.35% of the inpatients during the same period. The top ten most and least cases with rare disease were demonstrated in this study. The number of the top ten most cases was 37 977, accounting for 0.25% of the inpatients during the same period. The number of the top ten least cases was 24, accounting for 0.000 16% of the inpatients during the same period. The top most five types of rare diseases counted on the provinces and municipalities were Beijing, Hunan, Shanghai, Shandong and Guangdong. The top five most cases of rare diseases counted on the provinces and municipalities were Beijing, Shanghai, Guangdong, Shandong and Hubei. The age distribution showed that the cases with rare diseases aged 25-64 years accounted for 45.8%, and the cases in children aged 0-14 accounted for 28.6%. The top ten readmission rate ranged from 28.42% to 64.88%. Conclusions: This study preliminarily investigates the number, type, province and municipality distribution, age distribution, and readmission rate of 121 rare diseases from China's First List of Rare Diseases in the hospitalized patients of tertiary hospitals, which provides important data for registration study, medical and drug policy making and other relevant work on rare diseases in China in the future.


Assuntos
Doenças Raras , Adolescente , Adulto , Criança , Pré-Escolar , China , Coleta de Dados , Hospitalização , Humanos , Lactente , Recém-Nascido , Pessoa de Meia-Idade
12.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(8): 1125-1129, 2018 Aug 10.
Artigo em Chinês | MEDLINE | ID: mdl-30180441

RESUMO

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.


Assuntos
Viés , Literatura de Revisão como Assunto , Medição de Risco/métodos , Humanos
13.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(7): 959-965, 2018 Jul 10.
Artigo em Chinês | MEDLINE | ID: mdl-30060312

RESUMO

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.


Assuntos
Antibacterianos/uso terapêutico , Uso de Medicamentos , Serviço Hospitalar de Emergência , China , Prescrições de Medicamentos , Hospitais , Hospitais Gerais , Humanos
14.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(7): 1003-1008, 2018 Jul 10.
Artigo em Chinês | MEDLINE | ID: mdl-30060320

RESUMO

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.


Assuntos
Viés , Prognóstico , Melhoria de Qualidade , Projetos de Pesquisa , Humanos
16.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(6): 816-820, 2018 Jun 10.
Artigo em Chinês | MEDLINE | ID: mdl-29936753

RESUMO

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.


Assuntos
Análise Espaço-Temporal , Tuberculose Pulmonar/epidemiologia , Pequim , China , Análise por Conglomerados , Humanos , Incidência , Análise Espacial , Tuberculose , Tuberculose Pulmonar/etnologia
17.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(3): 374-381, 2018 Mar 10.
Artigo em Chinês | MEDLINE | ID: mdl-29609257

RESUMO

This paper summaries the Risk Of Bias In Non-randomized Studies-of Interventions (ROBINS-I), a tool for evaluating risk of bias about Non-randomized Studies-of Interventions (NRSI), and introduces the application of ROBINS-I in a published NRSI. According to the characteristics of NRSI, evaluation field and signaling question were designed in ROBINS-I to provide essential information about risk of bias for NRSI included in systematic reviews. ROBINS-I is the tool in assessment of risk of bias in observational studies and quasi-randomised studies. Although the tool has been used in practice to some extent, but it still needs further improvement. Attention should be paid to its update and progress.


Assuntos
Viés , Ensaios Clínicos Controlados como Assunto , Medição de Risco/métodos , Animais , Humanos , Reprodutibilidade dos Testes , Viés de Seleção
18.
Beijing Da Xue Xue Bao Yi Xue Ban ; 50(2): 381-385, 2018 Apr 18.
Artigo em Chinês | MEDLINE | ID: mdl-29643545

RESUMO

Cohort study is one of the important epidemiological methods which plays an irreplaceable status and role in etiological study. Using cohort study design, we can accurately and continuously collect genetic and environmental information, and identify and validate omics biomarkers to provide evidences for precision public health and medicine. However, results from a new cohort would not be available for at least ten years, as five years would be needed for funding, planning and enrolment, and another five for following up even the earliest analyses of the most common diseases; results for most cancers would take longer, with an unaffordable budget for many research investigators or institutions. That brings an alternative strategy of using existing cohort studies by sharing data between each other. Data sharing of cohort studies would be beneficial in many ways. Data sharing of cohort studies has the potential to make large samples unattainable in a single study, increase statistical power, enable more accurate and detailed subgroup analysis, increase the generalizability of results. It would also facilitate exchange of experiences and learning from each other, avoid for duplicated research and effectively promote the second use of existing data (i.e. using old data to discover new results). The data sharing would save staff recruitment, follow-up, laboratory analysis of the cost, with a high cost-benefit returns and economies of scale. Data sharing enables cross-validation and repeated verification across different data. Many international research funding agencies or leading research groups have also reached consensus on the principles and goals for promoting the sharing of medical research data. Due to rapid development of cohort studies in the past decades, China already has the basis for data sharing of cohort studies. Unfortunately, most of the existing cohort studies are self-contained, independent, lack of visibility, with insufficient co-operation and data sharing between each other. The academic value of the existing data collected in these cohort studies have not been fully exploited and utilized so far. Therefore, the China Cohort Consortium is trying to establish a multi-level three-dimensional cooperation and data sharing strategy. We hope that it will encourage researchers from public health, clinical and other related fields to work more closely through providing data management, data integration, data interaction, tools development, data repositories and other functions.


Assuntos
Estudos de Coortes , Disseminação de Informação , China , Neoplasias
19.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(4): 524-531, 2018 Apr 10.
Artigo em Chinês | MEDLINE | ID: mdl-29699051

RESUMO

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.


Assuntos
Viés , Testes Diagnósticos de Rotina/normas , Garantia da Qualidade dos Cuidados de Saúde , Humanos , Relatório de Pesquisa , Risco
20.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(2): 222-226, 2018 Feb 10.
Artigo em Chinês | MEDLINE | ID: mdl-29495210

RESUMO

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.


Assuntos
Tomada de Decisões , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa/normas , Comunicação , Humanos
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