Tuberculosis
Conditions
Interventions
None listed
Sponsors
NHO Tokyo National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Single-center data: Patients aged 18 years or older who visited our hospital between April 1, 2014, and March 31, 2026, with a first-time definitive diagnosis of ICD-10 codes A15-A19, and a history of same-day prescription of 3 or more groups among first-line anti-tuberculosis drugs (INH, RFP/RBT, PZA, EMB/SM). 2) JMDC and DeSC databases: Patients aged 18 years or older with a first-time definitive diagnosis of ICD-10 codes A15-A19, and a history of same-day prescription of 3 or more groups among first-line anti-tuberculosis drugs.
Exclusion criteria
Exclusion criteria: 1) Patients for whom anti-tuberculosis drugs were used for purposes other than active tuberculosis treatment (e.g., non-tuberculous mycobacterial infection, latent tuberculosis infection, prophylactic use). 2) Patients for whom the purpose of anti-tuberculosis drug administration is indeterminate. 3) Patients whose minimum necessary medical records are missing, making it extremely difficult to evaluate the implementation of low-dose incremental reintroduction or desensitization therapy (for single-center data). 4) Patients who refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive predictive value (PPV) of the pre-fixed SQL extraction algorithm identifying low-dose incremental reintroduction and desensitization therapy based on a history of administration below a specific threshold. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory evaluation of sensitivity, specificity, and negative predictive value (NPV) of the SQL extraction algorithm in our validation study. Inter-reviewer agreement (kappa coefficient). Frequency of off-target cases (cases not intended for active tuberculosis treatment). Real-world practices of the therapy in a single center and large-scale medical information databases (JMDC, DeSC) (target drugs, starting dose, increment interval and duration, days to reach maintenance dose, frequency of implementation and prescription patterns, maintenance dose achievement rate, transition rate to alternative drugs, and adverse event recurrence rate). Treatment completion rate or treatment continuation status in our hospital. Exploratory investigation of patient background and drug factors associated with the success or failure of low-dose incremental reintroduction and desensitization therapy. | — |
Countries
Japan
Contacts
Public ContactTakafumi Kato
NHO Tokyo National Hospital Center for Pulmonary Diseases, Clinical Research Center
Outcome results
None listed