Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 20
- 主要终点
- The median time of pulmonary tuberculosis diagnosis confirmed
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bacteriological positive: including positive AFB smear/ culture / molecular test;
- •Agree to accept this survey;
排除标准
- •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;
结局指标
主要结局
The median time of pulmonary tuberculosis diagnosis confirmed
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases
Huashan Hospital