Exact(8)
The primary outcome measure recommended by the EMA is an investigator-determined clinical outcome (cure, failure, or indeterminate responses) measured at 7 to 14 days after the end of therapy.
Considering that the average time required for disease outcome (cure or fatality) is five years for complicated cases [17], we identified this structure by collecting the CTs that presented at least one new case of pulmonary TB in each of the five consecutive years.
While such studies may provide little information on the duration of disease they do provide data on ultimate outcome (cure versus death) as CF = M/I although one cannot be certain that all incident cases are notified nor that all deaths occur among patients ever notified.
Of the 313 (72%) patients who completed treatment, 228 (73%) had a good outcome (cure or treatment completion).
Six standard and mutually exclusive categories were used to define treatment outcome: cure, treatment completed, death, default, failure, and transfer out (14 ) (Table 1).
Since 43% of subjects with TB were excluded due to missing information of HIV status, we analyzed the treatment outcome (cure, default, death from TB, death from other causes and MDR TB) for HIV status.
Similar(52)
Among PTCs, most had received only 1 previous category I treatment course; 55.7% had a successful outcome (cured or treatment completed) in their last treatment, and 28.6% failed treatment.
For TB outcomes, the site of TB treatment, date of TB treatment initiation, date of TB treatment completion, date of assigned treatment outcome, and treatment outcome (cured, treatment completed, treatment defaulted, treatment failure, death) will be collected from study site TB registers as well as from the Department of Health's TB outcomes database.
We abstracted data on patient demographics, TB diagnosis (pulmonary versus extrapulmonary), treatment category (new versus re-treatment), treatment outcome (cured, completed, died, defaulted, or transferred out), HIV status, and receipt of CTX and/or initiation of ART for patients with TB/HIV.
Fever (≥37.5°C or ≥1.5°C above usual body temperature), diagnosis at onset and outcomes (cure at home, hospitalisation and death).
Tuberculosis treatment outcomes (cure, treatment completed, treatment failure) were evaluated by using definitions from WHO and the European Region of the International Union Against Tuberculosis and Lung Disease IUATLDD) [ 13].
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