Tuberculosis; Pulmonary, Confirmed, Unspecified Means Clinical Trial
Official title:
Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
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).
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.
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