Table 1.
Treatment Outcomes [19, 20] | |
---|---|
Favorable treatment outcomes | |
Cured | Treatment completed as recommended by the national policy without evidence of failure, AND ≥3 consecutive cultures taken at least 30 days apart are negative after the intensive phase. |
Treatment completed | Treatment completed as recommended by the national policy without evidence of failure, BUT no record that ≥3 consecutive cultures taken at least 30 days apart are negative after the intensive phase. |
Treatment success | The sum of cured and treatment completed. |
Unfavorable treatment outcomes | |
Treatment failed | Treatment terminated or need for permanent regimen change of at least 2 antituberculosis drugs because of a lack of culture conversion by the end of the intensive phase; bacteriological culture reversion in the continuation phase after conversion to negative; evidence of additional acquired resistance to fluoroquinolones or second-line injectable drugs; ADRs. |
Died | A patient who dies for any reason during treatment. |
Lost to follow-up | A patient whose treatment was interrupted for ≥2 consecutive months. |
Treatment unsuccessful | The sum of failed, died, lost to follow-up, and not evaluated. |
Pregnancy outcomes | |
Favorable pregnancy outcomes—all the below features are required to classify a pregnancy outcome as favorable | |
Full term | Babies born ≥37 weeks of pregnancy. |
Normal birth weight | Birth weight of ≥2500 grams according to the World Health Organization (WHO) [21]. |
Alive | A baby born alive who lives for >28 days. |
Unfavorable pregnancy outcomes—any of the following classify a pregnancy as having an unfavourable outcome | |
Preterm birth | Babies born <37 weeks of pregnancy. |
Miscarriage | Spontaneous loss of a pregnancy before the fetus has reached viability at 24 weeks. This includes all pregnancy losses from the time of conception until 23 completed weeks of gestation [22]. |
Stillbirth | In South Africa, the legal definition of stillbirth is an infant born dead after “6 months of intrauterine life” (ie, 28 weeks since the start of the last period or 26 weeks since conception). If the gestational age is not known, a weight of 1000 g is used to legally define a stillbirth. Infants that are born dead before this time are legally regarded as miscarriages. |
Termination of pregnancy | Termination of pregnancy is when a woman decides to end her pregnancy before the full term by medical means. The woman must be <13 weeks pregnant to end the pregnancy without giving reasons. If she is between 13 and 20 weeks pregnant, the pregnancy may be terminated only under specific conditions. If she is >20 weeks pregnant, it will be done only if her life or the fetus’ life is in danger, or there are likely to be serious birth defects [23]. |
Low birth weight | A birth weight of <2500 g (up to and including 2499 g), as per the World Health Organization (WHO) [21]. |
Infant outcomes | |
Development | Child development refers to how a child becomes able to do more complex things as they get older. Developmental milestones are a set of functional skills or age-specific tasks that most children can do at a certain age range [24]. These skills include gross and fine motor, language, cognitive, and social skills. |
Lost to follow-up | It was not possible to verify the status of the child at 12 months. |
Favorable infant outcomes—both of the following are required to state that an infant has a favorable outcome | |
Thrive normally | If a child gains weight following the normal trajectory according to the growth chart, the child is said to be thriving normally. |
Normal development | A child is described as having normal development if they achieve the developmental milestones timeously. |
Unfavorable infant outcomes—any of the following classify the child as having an unfavorable outcome | |
Failure to thrive | The infant fails to maintain an established pattern of growth [25]. |
Delayed development | The child reaches developmental milestones later than the average child. |
TB diagnosis | Diagnosed with TB or RR-TB before 12 months of age. |
Neonatal death | Death of a live born infant in the first 28 days of life. An early neonatal death is a death that occurs in the first week of life [26]. |
Infant death | Infant dies before 12 months. |
Abbreviations: ADR, adverse drug reactions; RR-TB, rifampicin-resistant TB; TB, tuberculosis.