High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an...

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.

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.

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.

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.

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).