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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