Using a composite maternal-infant outcome measure in tuberculosis prevention studies among pregnant women

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dc.contributor.authorMontepiedra, Graceen_ZA
dc.contributor.authorKim, Soyeonen_ZA
dc.contributor.authorWeinberg, Adrianaen_ZA
dc.contributor.authorTheron, Gerharden_ZA
dc.contributor.authorSterling, Timothy R.en_ZA
dc.contributor.authorLaCourse, Sylvia M.en_ZA
dc.contributor.authorBradford, Sarahen_ZA
dc.contributor.authorChakhtoura, Nahidaen_ZA
dc.contributor.authorJean-Philippe, Patricken_ZA
dc.contributor.authorEvans, Scotten_ZA
dc.contributor.authorGupta, Amitaen_ZA
dc.date.accessioned2022-06-07T10:47:59Zen_ZA
dc.date.available2022-06-07T10:47:59Zen_ZA
dc.date.issued2021-08-02en_ZA
dc.descriptionCITATION: Montepiedra, G. et al. 2021. Using a Composite Maternal-Infant Outcome Measure in Tuberculosis-Prevention Studies Among Pregnant Women. Clinical infectious diseases, 73(3):587–e593. doi:10.1093/cid/ciaa1674en_ZA
dc.descriptionThe original publication is available at https://academic.oup.com/cid/en_ZA
dc.description.abstractBackground: Tuberculosis (TB-)-preventive therapy (TPT) among pregnant women reduces risk of TB in mothers and infants, but timing of initiation should consider potential adverse effects. We propose an analytical approach to evaluate the risk-benefit of interventions. Methods: A novel outcome measure that prioritizes maternal and infant events was developed with a 2-stage Delphi survey, where a panel of stakeholders assigned scores from 0 (best) to 100 (worst) based on perceived desirability. Using data from TB APPRISE, a trial among pregnant women living with human immunodeficiency virus (WLWH) that randomized the timing of initiation of isoniazid, antepartum versus postpartum, was evaluated. Results: The composite outcome scoring/ranking system categorized mother-infant paired outcomes into 8 groups assigned identical median scores by stakeholders. Maternal/infant TB and nonsevere adverse pregnancy outcomes were assigned similar scores. Mean (SD) composite outcome scores were 43.7 (33.0) and 41.2 (33.7) in the antepartum and postpartum TPT initiation arms, respectively. However, a modifying effect of baseline antiretroviral regimen was detected (P = .049). When women received nevirapine, composite scores were higher (worse outcomes) in the antepartum versus postpartum arms (adjusted difference, 14.3; 95% confidence interval [CI], 2.4-26.2; P = .02), whereas when women received efavirenz there was no difference by timing of TPT (adjusted difference, .62; 95% CI, -3.2-6.2; P = .53). Conclusions: For TPT, when used by otherwise healthy persons, preventing adverse events is paramount from the perspective of stakeholders. Among pregnant WLWH in high-TB-burden regions, it is important to consider the antepartum antiretroviral regimen taken when deciding when to initiate TPT. Clinical Trials Registration. NCT01494038 (IMPAACT P1078).en_ZA
dc.description.urihttps://academic.oup.com/cid/article/73/3/e587/5955952?login=trueen_ZA
dc.description.versionPublishers versionen_ZA
dc.format.extent7 pagesen_ZA
dc.identifier.citationMontepiedra, G. et al. 2021. Using a Composite Maternal-Infant Outcome Measure in Tuberculosis-Prevention Studies Among Pregnant Women. Clinical infectious diseases, 73(3):587–e593. doi:10.1093/cid/ciaa1674en_ZA
dc.identifier.issn1537-6591 (online)en_ZA
dc.identifier.issn1058-4838 (print)en_ZA
dc.identifier.otherdoi:10.1093/cid/ciaa1674en_ZA
dc.identifier.urihttp://hdl.handle.net/10019.1/125333en_ZA
dc.language.isoen_ZAen_ZA
dc.publisherOxford University Pressen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectTuberculosis -- Risk factorsen_ZA
dc.subjectPregnant womenen_ZA
dc.subjectHIV-positive womenen_ZA
dc.subjectHIV infections -- Transmissionen_ZA
dc.subjectPrenatal care -- Effect of managed care onen_ZA
dc.titleUsing a composite maternal-infant outcome measure in tuberculosis prevention studies among pregnant womenen_ZA
dc.typeArticleen_ZA
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