Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
研究概览
详细说明
This research is a retrospective, multicenter, case-control study. The purpose of this study is to collect and assess health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).
According to inclusion criteria and exclusion criteria, a total of 400 participants with bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated medical institutions will be conducted in depth, covering the eastern region (7), the central region (8) and the western region (5), each hospital will enroll 20 eligible patients on the basis of convenience.
The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined if The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. By offline or online interview, we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway, including: hospital name, the date of each visit, laboratory tests and radiology evaluation results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of previous consultations and trace their classification through the official website of the Health and Medical Commission. Determine whether these hospital are designated institution based on the CDC's publicity. Consult the laboratory facilities by phone.
The primary objective is to gain the median time of pulmonary tuberculosis diagnosis confirmed and the correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis.
The secondary objective is to gain the bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Anhui
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Hefei、Anhui、中国
- Anhui Province Hospital
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Guangdong
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Shenzhen、Guangdong、中国
- The Third People's Hospital of Shenzhen
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Guangxi
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Beihai、Guangxi、中国
- Beihai Tuberculosis Hospital
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Guizhou
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Guiyang、Guizhou、中国
- Guiyang Public Health Clinical Center
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Hei Longjiang
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Daqing、Hei Longjiang、中国
- The 2th Hospital of Daqing
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Henan
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Zhengzhou、Henan、中国
- Henan Province Infectious Diseases Hospital
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Hubei
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Wuhan、Hubei、中国
- Wuhan Medical Treatment Center
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Hunan
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Huaihua、Hunan、中国
- The First People's Hospital of Huaihua
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Jiangsu
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Taicang、Jiangsu、中国
- The First People's Hospital of Taicang
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Xuzhou、Jiangsu、中国
- Xuzhou Infectious Diseases Hospital Huimei Liu
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Jiangxi
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Nanchang、Jiangxi、中国
- Jiangxi Province Chest Hospital
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Jilin
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Changchun、Jilin、中国
- Changchun Infectious Diseases Hospital
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Shandong
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Jinan、Shandong、中国
- Shandong Province Chest hospital
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Shanghai
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Shanghai、Shanghai、中国
- Shanghai Public Health Clinical Center
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Shanghai、Shanghai、中国
- 905th Hospital of PLA Navy
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Shanxi
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Xian、Shanxi、中国
- Xian Chest Hospital
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Sichuan
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Luzhou、Sichuan、中国
- Southwest Medical University Affiliated Hospital
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Yunnan
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Qiubei、Yunnan、中国
- Qiubei People's Hospital
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Zhejiang
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Hangzhou、Zhejiang、中国
- Hangzhou Red Cross Hospital
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Wenzhou、Zhejiang、中国
- Wenzhou Central Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Bacteriological positive: including positive AFB smear/ culture / molecular test;
- Agree to accept this survey;
Exclusion Criteria:
- HIV antibody positive and AIDS patients;
- Combined with extrapulmonary TB;
- Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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delayed diagnosis
The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days.
Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.
|
undelayed diagnosis
The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days.
Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The median time of pulmonary tuberculosis diagnosis confirmed
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
|
Time from the date of patients' symptoms onset to the date of pulmonary tuberculosis diagnosis confirmed
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immediately after asking the medical history and collecting the result of TB diagnosis
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The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
|
We collect the classification and the quality of the first-visit-institution of diagnosis confirmed patients by asking the past medical histories.
According to the evidence of duration from symptoms onset to pulmonary TB diagnosis confirmed, use logistic correlation to find the relation between the classification of the first-visit-institution and the diagnosis delay.
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immediately after asking the medical history and collecting the result of TB diagnosis
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
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According to the patients' health-seeking pathways, calculate the test coverage rates including anti fast bacteria smear, tuberculosis culture, and GeneXpert in different clinical institutions.
The test coverage rates is acquired by recording the laboratory test reports in medical systems or paper version from patients.
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immediately after asking the medical history and collecting the result of TB diagnosis
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The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
|
We collect the fluoroquinolones use evidence of each patients in different clinical institutions by asking the past medical histories and reviewing paper reports from patients as well as medical system.
Then use logistic correlation to find the relation between the fluoroquinolones use history and the diagnosis delay of the pulmonary tuberculosis.
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immediately after asking the medical history and collecting the result of TB diagnosis
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The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
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Calculating the distribution of patients' sociodemographic characteristics and correlation between results above and pulmonary tuberculosis diagnosis delay.
Patients' sociodemographic characteristics includes: age, sex, marriage status, nation, occupation, education status, annual family income per capita, underlying disease such as diabetes, habits of smoking and habits of drinking alcohol.
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immediately after asking the medical history and collecting the result of TB diagnosis
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The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
|
According to the past medical history of each pulmonary tuberculosis diagnosis confirmed patients, we collect their onset symptoms and calculate the rate respectively.
Then use logistic correlation to find the relation between the onset symptoms and the diagnosis delay of the pulmonary tuberculosis.
|
immediately after asking the medical history and collecting the result of TB diagnosis
|
合作者和调查者
调查人员
- 首席研究员:Wenhong Zhang, PHD、Huashan Hospita
出版物和有用的链接
一般刊物
- Liu R, Li J, Tan Y, Shang Y, Li Y, Su B, Shu W, Pang Y, Gao M, Ma L. Multicenter evaluation of the acid-fast bacillus smear, mycobacterial culture, Xpert MTB/RIF assay, and adenosine deaminase for the diagnosis of tuberculous peritonitis in China. Int J Infect Dis. 2020 Jan;90:119-124. doi: 10.1016/j.ijid.2019.10.036. Epub 2019 Nov 4.
- Martinez L, Xu L, Chen C, Sekandi JN, Zhu Y, Zhang C, Whalen CC, Zhu L. Delays and Pathways to Final Tuberculosis Diagnosis in Patients from a Referral Hospital in Urban China. Am J Trop Med Hyg. 2017 May;96(5):1060-1065. doi: 10.4269/ajtmh.16-0358. Epub 2017 Feb 13.
- Hogan CA, Puri L, Gore G, Pai M. Impact of fluoroquinolone treatment on delay of tuberculosis diagnosis: A systematic review and meta-analysis. J Clin Tuberc Other Mycobact Dis. 2016 Dec 13;6:1-7. doi: 10.1016/j.jctube.2016.12.001. eCollection 2017 Jan.
- Storla DG, Yimer S, Bjune GA. A systematic review of delay in the diagnosis and treatment of tuberculosis. BMC Public Health. 2008 Jan 14;8:15. doi: 10.1186/1471-2458-8-15.
- Hanson CL, Osberg M, Brown J, Durham G, Chin DP. Conducting Patient-Pathway Analysis to Inform Programming of Tuberculosis Services: Methods. J Infect Dis. 2017 Nov 6;216(suppl_7):S679-S685. doi: 10.1093/infdis/jix387.
- Hanson C, Osberg M, Brown J, Durham G, Chin DP. Finding the Missing Patients With Tuberculosis: Lessons Learned From Patient-Pathway Analyses in 5 Countries. J Infect Dis. 2017 Nov 6;216(suppl_7):S686-S695. doi: 10.1093/infdis/jix388.
- Farhat MR, Jacobson KR, Franke MF, Kaur D, Murray M, Mitnick CD. Fluoroquinolone Resistance Mutation Detection Is Equivalent to Culture-Based Drug Sensitivity Testing for Predicting Multidrug-Resistant Tuberculosis Treatment Outcome: A Retrospective Cohort Study. Clin Infect Dis. 2017 Oct 15;65(8):1364-1370. doi: 10.1093/cid/cix556.
- Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH, O'Brien RJ, Pai M, Richeldi L, Salfinger M, Shinnick TM, Sterling TR, Warshauer DM, Woods GL. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. 2017 Jan 15;64(2):111-115. doi: 10.1093/cid/ciw778.
- GBD Tuberculosis Collaborators. Global, regional, and national burden of tuberculosis, 1990-2016: results from the Global Burden of Diseases, Injuries, and Risk Factors 2016 Study. Lancet Infect Dis. 2018 Dec;18(12):1329-1349. doi: 10.1016/S1473-3099(18)30625-X.
- Mijiti P, Yuehua L, Feng X, Milligan PJ, Merle C, Gang W, Nianqiang L, Upur H. Prevalence of pulmonary tuberculosis in western China in 2010-11: a population-based, cross-sectional survey. Lancet Glob Health. 2016 Jul;4(7):e485-94. doi: 10.1016/S2214-109X(16)30074-2. Epub 2016 Jun 6.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KY-2019TB-20
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
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