Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
- Conditions
- Tuberculosis; Pulmonary, Confirmed, Unspecified Means
- Registration Number
- NCT04434976
- Lead Sponsor
- Huashan Hospital
- Brief Summary
The purpose of the study is to collect health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Bacteriological positive: including positive AFB smear/ culture / molecular test;
- Agree to accept this survey;
- 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;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The median time of pulmonary tuberculosis diagnosis confirmed 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
The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis 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.
- Secondary Outcome Measures
Name Time Method The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients. 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.
The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis 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.
The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay. immediately after asking the medical history and collecting the result of TB diagnosis 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.
Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert. immediately after asking the medical history and collecting the result of TB diagnosis 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.
Trial Locations
- Locations (20)
The 2th Hospital of Daqing
🇨🇳Daqing, Hei Longjiang, China
Wuhan Medical Treatment Center
🇨🇳Wuhan, Hubei, China
Jiangxi Province Chest Hospital
🇨🇳Nanchang, Jiangxi, China
Xian Chest Hospital
🇨🇳Xian, Shanxi, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China
Southwest Medical University Affiliated Hospital
🇨🇳Luzhou, Sichuan, China
Anhui Province Hospital
🇨🇳Hefei, Anhui, China
Henan Province Infectious Diseases Hospital
🇨🇳Zhengzhou, Henan, China
The Third People's Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Guiyang Public Health Clinical Center
🇨🇳Guiyang, Guizhou, China
Xuzhou Infectious Diseases Hospital Huimei Liu
🇨🇳Xuzhou, Jiangsu, China
Beihai Tuberculosis Hospital
🇨🇳Beihai, Guangxi, China
The First People's Hospital of Huaihua
🇨🇳Huaihua, Hunan, China
The First People's Hospital of Taicang
🇨🇳Taicang, Jiangsu, China
Changchun Infectious Diseases Hospital
🇨🇳Changchun, Jilin, China
Shandong Province Chest hospital
🇨🇳Jinan, Shandong, China
905th Hospital of PLA Navy
🇨🇳Shanghai, Shanghai, China
Qiubei People's Hospital
🇨🇳Qiubei, Yunnan, China
Hangzhou Red Cross Hospital
🇨🇳Hangzhou, Zhejiang, China
Wenzhou Central Hospital
🇨🇳Wenzhou, Zhejiang, China