High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context
Summary: Background: Tuberculosis (TB) mortality remains persistently high, despite global TB control efforts. The aim of this study was to assess if a quality improvement (QI) intervention reduced deaths in TB patients accessing primary healthcare (PHC) services. Methods: In this pre specified sec...
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Elsevier
2025-04-01
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| author | Kogieleum Naidoo Nonhlanhla Yende Zuma Mikaila Moodley Felix Made Rubeshan Perumal Santhanalakshmi Gengiah Jacqueline Ngozo Nesri Padayatchi Andrew Nunn Salim Abdool Karim |
| author_facet | Kogieleum Naidoo Nonhlanhla Yende Zuma Mikaila Moodley Felix Made Rubeshan Perumal Santhanalakshmi Gengiah Jacqueline Ngozo Nesri Padayatchi Andrew Nunn Salim Abdool Karim |
| author_sort | Kogieleum Naidoo |
| collection | DOAJ |
| description | Summary: Background: Tuberculosis (TB) mortality remains persistently high, despite global TB control efforts. The aim of this study was to assess if a quality improvement (QI) intervention reduced deaths in TB patients accessing primary healthcare (PHC) services. Methods: In this pre specified secondary analysis of a cluster-randomized controlled study conducted in 2016–2018 in South Africa (Clinicaltrials.gov, NCT02654613), we compared 18-month case-fatality rates among newly diagnosed TB patients irrespective of HIV status randomized to clinics receiving the QI intervention and standard of care (SOC) [(eight clusters and 20 clinics per arm)]. Statistical inferences used a t-test from a two-stage approach recommended for cluster-randomized trials with fewer than 15 clusters per arm. Findings: Among the 5817 newly diagnosed TB patients enrolled (intervention = 3473; control = 2344), 562 died by 18-months [case-fatality rate (CFR) = 9·7%]. Ninety percent of the deaths (506/562) occurred within six months of TB treatment initiation. Quality improvement intervention arm clinics compared to control arm clinics did not demonstrate a significant difference in TB CFR. Case-fatality rates were 9·5% [95% Confidence Interval (CI): 6·9–12·9] and 11·3% (95% CI: 8·7–14·7) [adjusted rate ratio (aRR), 0·9 (95% CI: 0·6–1·2)] in the intervention and control arms, respectively. In people living with HIV/AIDS (PLWHA) CFR in the intervention and control arms: were 10·8% (95% CI: 7·8–14·7) and 14·4% (95% CI: 9·3–22·4) in those on antiretroviral therapy (ART) and 18·6 (95% CI: 9·1–38·0) and 33·0 (95% CI: 16·2–67·3), in those with no ART data respectively. In the intervention and control arms CFR in HIV-TB coinfected patients was 6·5 (95% CI: 3·6–11·6) and 11·5 (95% CI: 6·5–20·0) in those on ART with viral loads <200 copies/ml and 22·4 (95% CI: 16·7–30·2) and 19·7 (95% CI: 11·3–34·5) in those with no viral load data as they commenced ART within 12 months before initiating TB treatment, respectively. Interpretation: The quality improvement intervention did not significantly reduce mortality. We observed that TB CFR was higher among PLWHA not on ART and HIV-TB coinfected patients. Funding: Research reported in this publication was supported by South African Medical Research Council (SAMRC), and UK Government’s Newton Fund through United Kingdom Medical Research Council (UKMRC). |
| format | Article |
| id | doaj-art-555ef4c2f1ee457c871d1a6f1c5e4666 |
| institution | DOAJ |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
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| series | EClinicalMedicine |
| spelling | doaj-art-555ef4c2f1ee457c871d1a6f1c5e46662025-08-20T02:59:46ZengElsevierEClinicalMedicine2589-53702025-04-018210315110.1016/j.eclinm.2025.103151High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in contextKogieleum Naidoo0Nonhlanhla Yende Zuma1Mikaila Moodley2Felix Made3Rubeshan Perumal4Santhanalakshmi Gengiah5Jacqueline Ngozo6Nesri Padayatchi7Andrew Nunn8Salim Abdool Karim9Centre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South Africa; Corresponding author. Centre for the AIDS Programme of Research in South Africa (CAPRISA), CAPRISA-MRC TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Private Bag X7, Congella, Durban, 4013, South Africa.Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; Biostatistics Research Unit, South African Medical Research Council, Durban, South AfricaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South AfricaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South AfricaCentre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South AfricaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South AfricaDepartment of Health, KwaZulu- Natal Provincial HIV, AIDS, TB, and STI Directorate, South AfricaCentre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South AfricaMedical Research Council Clinical Trials Unit at University College London, London, UKCentre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South Africa; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USASummary: Background: Tuberculosis (TB) mortality remains persistently high, despite global TB control efforts. The aim of this study was to assess if a quality improvement (QI) intervention reduced deaths in TB patients accessing primary healthcare (PHC) services. Methods: In this pre specified secondary analysis of a cluster-randomized controlled study conducted in 2016–2018 in South Africa (Clinicaltrials.gov, NCT02654613), we compared 18-month case-fatality rates among newly diagnosed TB patients irrespective of HIV status randomized to clinics receiving the QI intervention and standard of care (SOC) [(eight clusters and 20 clinics per arm)]. Statistical inferences used a t-test from a two-stage approach recommended for cluster-randomized trials with fewer than 15 clusters per arm. Findings: Among the 5817 newly diagnosed TB patients enrolled (intervention = 3473; control = 2344), 562 died by 18-months [case-fatality rate (CFR) = 9·7%]. Ninety percent of the deaths (506/562) occurred within six months of TB treatment initiation. Quality improvement intervention arm clinics compared to control arm clinics did not demonstrate a significant difference in TB CFR. Case-fatality rates were 9·5% [95% Confidence Interval (CI): 6·9–12·9] and 11·3% (95% CI: 8·7–14·7) [adjusted rate ratio (aRR), 0·9 (95% CI: 0·6–1·2)] in the intervention and control arms, respectively. In people living with HIV/AIDS (PLWHA) CFR in the intervention and control arms: were 10·8% (95% CI: 7·8–14·7) and 14·4% (95% CI: 9·3–22·4) in those on antiretroviral therapy (ART) and 18·6 (95% CI: 9·1–38·0) and 33·0 (95% CI: 16·2–67·3), in those with no ART data respectively. In the intervention and control arms CFR in HIV-TB coinfected patients was 6·5 (95% CI: 3·6–11·6) and 11·5 (95% CI: 6·5–20·0) in those on ART with viral loads <200 copies/ml and 22·4 (95% CI: 16·7–30·2) and 19·7 (95% CI: 11·3–34·5) in those with no viral load data as they commenced ART within 12 months before initiating TB treatment, respectively. Interpretation: The quality improvement intervention did not significantly reduce mortality. We observed that TB CFR was higher among PLWHA not on ART and HIV-TB coinfected patients. Funding: Research reported in this publication was supported by South African Medical Research Council (SAMRC), and UK Government’s Newton Fund through United Kingdom Medical Research Council (UKMRC).http://www.sciencedirect.com/science/article/pii/S2589537025000835Quality improvementTB case fatality rateMortalityHIV-TB coinfected mortalityPrimary healthcare |
| spellingShingle | Kogieleum Naidoo Nonhlanhla Yende Zuma Mikaila Moodley Felix Made Rubeshan Perumal Santhanalakshmi Gengiah Jacqueline Ngozo Nesri Padayatchi Andrew Nunn Salim Abdool Karim High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context EClinicalMedicine Quality improvement TB case fatality rate Mortality HIV-TB coinfected mortality Primary healthcare |
| title | High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context |
| title_full | High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context |
| title_fullStr | High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context |
| title_full_unstemmed | High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context |
| title_short | High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trialResearch in context |
| title_sort | high mortality among patients with tuberculosis accessing primary care facilities secondary analysis from an open label cluster randomised trialresearch in context |
| topic | Quality improvement TB case fatality rate Mortality HIV-TB coinfected mortality Primary healthcare |
| url | http://www.sciencedirect.com/science/article/pii/S2589537025000835 |
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