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Table 1 Outcome variable definitions

From: Tuberculosis clinical presentation and treatment outcomes in pregnancy: a prospective cohort study

Outcome Composite Outcome Definition (DS- definition / DR- definition) Source DS-, DR-, or Both
Cured Successful A pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment who was smear- or culture-negative in the last month of treatment and on at least one previous occasion. / Treatment completed as recommended by the national policy without evidence of failure AND three or more consecutive cultures taken at least 30 days apart are negative after the intensive phase. WHO [12] Both
Treatment Completed Successful A TB patient who completed treatment without evidence of failure BUT with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative, either because tests were not done or because results are unavailable. / Treatment completed as recommended by the national policy without evidence of failure BUT no record that three or more consecutive cultures taken at least 30 days apart are negative after the intensive phase. WHO [12] Both
Treatment completed early Successful If the patient received more than 5 months of treatment (but less than 6 months) AND the outcome recorded by the treating physician was “completed dose” or “cured.” Local physicians DS-
Died Unsuccessful A TB patient who dies for any reason before starting treatment or during the course of treatment. WHO [12] Both
Treatment failed Unsuccessful A TB patient whose sputum smear or culture is positive at month 5 or later during treatment. / Treatment terminated or need for permanent regimen change of at least two anti-TB drugs because of: lack of conversion by the end of the intensive phase; bacteriological reversion in the continuation phase after conversion to negative; evidence of additional acquired resistance to fluoroquinolones; adverse drug reactions. WHO [12] Both
Clinical default Unsuccessful If the patient did not receive at least 18 months of treatment AND the outcome recorded by the treating physician was “cure.” Local physicians DR-
Lost to follow up Lost to follow up A TB patient who did not start treatment or whose treatment was interrupted for 2 consecutive months or more. WHO12 Both
Not evaluated Not evaluated A TB patient for whom no treatment outcome is assigned. This includes patients “transferred out” to another treatment unit as well as patients for whom the treatment outcome is unknown to the reporting unit. WHO12 Both
Still on active treatment Still on active treatment If no outcome was provided because the patient was still on active treatment. Local physicians Both