Treatment outcomes and associated factors among patients with drug-sensitive tuberculosis on daily fixed-dose combination drugs: A cohort study from Ahmedabad, India

Abstract

A BSTRACT Background and Aim: The National Tuberculosis Elimination Program (NTEP) has been progressive in addressing the issues related to tuberculosis (TB) control in the country, with constant programmatic changes based on evidence available from operational research. Our objectives were 1. to assess the sociodemographic and clinical characteristics, and the treatment outcomes of patients on fixed-dose combination (FDC) daily regimen and 2. to assess the factors associated with unsuccessful treatment outcomes among patients with DS-TB. Materials and Methods: A retrospective cohort study was conducted based on record review. The study population included all patients with drug-sensitive TB, registered and initiated on treatment under NTEP “new category” from January to June 2018 and under “previously treated category” from January to March 2018. Quantitative data downloaded from Nikshay in Excel format was imported. Results: A total of 8301 patients with DS-TB registered under NTEP. Mean (standard deviation [SD]) age of DS-TB patients was 35.3 + 16.9 years, and 63.2% were in the age group of 15–44 years. Also, 60.1% were male, 2.5% were human immunodeficiency virus (HIV) positive, 65.3% were pulmonary TB cases, and 70.4% obtained treatment from public providers. Proportion of “successful” and “unsuccessful” outcomes was 87.9% and 12.1%, respectively, in the new treatment category and 78.3% and 21.7%, respectively, in the previously treated category. Among the patients classified under new category, the unsuccessful treatment outcome remained significantly high after adjustments with known confounders among patients aged 45–54 years (adjusted relative risks [aRR] 1.59, 95% confidence interval [CI] 1.31–1.93) and 55–64 years (aRR 1.67, 95% CI 1.36–2.05) compared to patients aged <15 years. Conclusion: Unsuccessful treatment outcome was significantly high among patients aged 45–54 years. Various adherence mechanisms implemented can be evaluated for further upscaling and improving the program effectiveness.

Barriers to engagement in the care cascade for tuberculosis disease in India: A systematic review of quantitative studies

“…Across 51 studies reporting adjusted analyses including people with drug-susceptible TB, male sex and older age were associated with unfavorable treatment outcomes in 15 [ 41 , 66 – 79 ] and 15 [ 68 , 69 , 72 , 75 – 86 ] studies, respectively (Fig I in the S6 Appendix and Table D in the S4 Appendix ). Sex and age had nonsignificant associations in 21 [ 67 , 68 , 72 , 77 , 80 , 82 , 84 – 98 ] and 18 [ 41 , 68 , 71 , 72 , 76 – 78 , 83 , 87 , 89 , 91 – 94 , 98 – 101 ] studies, respectively. While being married was associated with unfavorable treatment outcomes when compared to having never been married in 2 studies [ 41 , 73 ], people who were married had better outcomes when compared to those who were separated or divorced in 1 study [ 100 ].…”

“…Across 51 studies reporting adjusted analyses including people with drug-susceptible TB, indicators of diagnostic delay or advanced TB—including illness >2 months in 1 study [ 102 ], advanced radiographic (e.g., cavitary) disease in 2 studies [ 102 , 103 ], and smear–positive or microbiologically diagnosed TB (versus smear–negative, extrapulmonary, or clinically diagnosed TB) in 11 studies [ 68 , 70 , 71 , 73 , 76 , 81 , 85 , 87 , 89 , 97 , 104 ]—were associated with unfavorable treatment outcomes (Fig J in the S6 Appendix and Table D in the S4 Appendix ). People with more severe symptoms at treatment initiation were less likely to experience loss to follow-up in 2 studies [ 91 , 105 ], but more likely to experience composite unfavorable TB treatment outcomes in 1 study [ 99 ].…”

“…People with HIV, or unknown HIV status, had higher unfavorable outcomes in 10 studies [ 69 , 71 – 73 , 76 , 77 , 79 , 82 , 110 ] (Fig K in the S6 Appendix and Table D in the S4 Appendix ); HIV status had nonsignificant associations in 7 studies [ 68 , 73 , 77 , 79 , 87 , 93 , 106 ]. In 5 studies, pretreatment undernutrition—assessed by weight, body mass index (BMI), or stunting [ 72 , 77 , 82 , 84 , 96 ]—or non-improvement in nutritional status with treatment [ 77 ] were associated with unfavorable outcomes.…”

“… All studies used multivariable regression and reported adjusted effect estimates [ 41 , 73 , 76 , 78 , 83 , 87 – 89 , 91 , 93 , 104 , 105 , 109 , 110 , 123 , 125 ]. Estimates greater than 1 represent increased risk of unfavorable outcomes; estimates less than 1 represent decreased risk of unfavorable outcomes.…”

“…Receiving care in the public (versus the private) sector was associated with unfavorable outcomes in 2 studies [ 76 , 83 ]; however, for people with previously treated TB, prior private sector treatment was associated with unfavorable outcomes [ 78 ]. With the exception of 1 study [ 104 ], DOT by a public sector provider (usually requiring people to visit clinics for observation) was associated with unfavorable outcomes in 3 studies when compared to alternative monitoring approaches, including medication self-administration [ 41 ], DOT by Anganwadi (community health) workers [ 78 ], and 99DOTS (cellphone-based monitoring) [ 76 ]. Lack of community health worker support [ 73 ] or non-participation in TB support groups [ 126 ] was associated with unfavorable outcomes in 2 studies.…”