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We examined treatment outcomes of adults diagnosed with pulmonary TB who initiated TB treatment between January 1, 2009 and December 31, 2014 at National Hospital Organization Ibarakihigashi National Hospital in Ibaraki Prefecture, Japan. This hospital provides both inpatient and outpatient-based care of patients with TB. We excluded patients who were lost to follow-up, were under the age of 18 years, or were diagnosed with multidrug-resistant TB (MDR-TB; resistant to at least isoniazid and rifampin). Medical records were reviewed and the following data were abstracted: age at TB diagnosis, birth sex, race/ethnicity, country of birth (Japan vs outside Japan), comorbidities (diabetes, end-stage renal disease, human immunodeficiency virus [HIV], other immunosuppression), microbiological results, cavitation on chest radiograph, site of TB disease, information on TB treatment including interruptions, treatment outcome, and, if applicable, cause of death (death related to TB vs unrelated to TB). ‘Death related to TB’ includes death related to TB disease and/or TB treatment. Since approximately 50% of our cohort included patients aged over 75 years, it was often difficult to differentiate whether symptoms or laboratory abnormalities were due to adverse events related to TB treatment or other causes.

During the first 2 months of treatment, blood chemistry, complete blood count, and sputum for acid-fast bacilli smear and culture were obtained at least every 2 weeks, and a chest radiograph was obtained at least once a month.

We used the definition set forth by the Report of Verified Case of Tuberculosis of the US Centers for Disease Control and Prevention [13] to differentiate ‘death related to TB’ versus ‘death unrelated to TB’. Significant adverse events for this study were ascertained by searching for interruptions in one or more drugs during TB treatment. For those who had adverse events, the following determinations were made: the onset of the adverse event, the impact of the adverse event (refer to the international WHO definitions of adverse drug reactions [14]: ‘modest’—medications permanently discontinued and/or adverse effect requiring additional medication; or ‘severe’—requiring hospitalization from outpatient-based care, or death), type of the adverse event (hypersensitivity, liver injury, gastrointestinal intolerance, musculoskeletal, or other), medications responsible for the adverse event, and level of certainty that the medication was responsible (‘confirmed’ based on drug challenges, or ‘high level of certainty’ based on resolution of the adverse event after medication changes while other causes were unlikely). Where there was polytherapy, the responsible drug was determined based on the pattern of adverse events (e.g., liver injury; hepatocellular injury vs cholestatic pattern) or based on re-challenge of drugs. ‘Multiple adverse events’ was defined as two or more adverse events resulting in treatment interruption at different times during treatment. The assessment documented by the primary physician managing the patient was used; if it was not clearly documented, the study investigators (IH, HH, TS) made a decision.

Patients were categorized into the following age groups: 18–44, 45–64, 65–74, 75–83, and ≥ 84 years. The median age among the older patients over 75 years was 84 years. Patients whose initial regimen consisted of isoniazid, rifampin, PZA and ethambutol were considered to have been started on the standard TB regimen (‘HRZE’). The physicians who primarily managed the patients decided whether to include PZA in the initial regimen. ‘Time to sputum culture conversion’ was calculated using the date when a specimen was collected for the first consistently negative sputum culture results minus the date TB treatment started. ‘Time to treatment completion’ was calculated only for those who successfully completed treatment and was grouped into < 26 weeks, 26 to < 39 weeks, 39 to < 52 weeks, and 52 weeks or more. Treatment completion was verified by the TB clinician who cared for the patient. For those who died during TB treatment, ‘time to death’ was calculated using the date of death minus the date TB treatment was started.

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