Cohort study on association between catastrophic costs and unfavorable tuberculosis treatment outcomes among TB-HIV and TB-diabetes comorbid patients in India.

BACKGROUND: India grapples with an alarming burden of tuberculosis (TB), reporting 2.6 million incident cases in 2023, necessitating intensified efforts toward TB elimination. The prevalence of catastrophic costs, defined as expenses exceeding 20% of annual household income, varies widely. Our objective was to determine the association between catastrophic costs from TB-HIV and TB-diabetes care and unfavorable TB treatment outcomes. METHODS: We conducted a cohort study in Bhavnagar, India, from July 2019 to January 2021, involving 234 TB-HIV and 304 TB-diabetes patients. Catastrophic costs were assessed using the World Health Organization's tool. Unfavorable TB treatment outcomes included positive results from sputum smear, nucleic acid amplification, or culture tests at treatment completion, death during treatment, or treatment cessation for a month (for drug-sensitive TB) or two months (for drug-resistant TB). Firth regression was employed to address quasi-separation issues and identify predictors. RESULTS: Among TB-HIV patients, 12% faced catastrophic costs, with 20% experiencing unfavorable TB outcomes. In this group, significant predictors included weight (OR: 0.93, 95% CI: 0.89-0.98), family type (OR: 2.5, 95% CI: 1.2-5.5), and initial hospitalization (OR: 2.6, 95% CI: 1.1-6.3). For TB-diabetes patients, 5% faced catastrophic costs, and 14% had unfavorable outcomes, with significant predictors being below the poverty line (BPL) (OR: 2.9, 95% CI: 1.5-5.9) and initial hospitalization (OR: 3.4, 95% CI: 1.1-11.1). Catastrophic cost incidence was higher in TB-HIV (12% vs. 4% in TB only) and TB-diabetes (5% vs. 4% in TB only) patients. However, catastrophic costs did not show a direct association with unfavorable outcomes in either group. CONCLUSIONS: Our study found no direct association between catastrophic costs and unfavorable TB outcomes among TB-HIV/TB-diabetes patients. Instead, factors such as weight, family type, BPL status, and initial hospitalization were significant predictors. These findings underscore the importance of socio-economic conditions and initial hospitalization, advocate for enhanced support mechanisms including nutritional and financial aid, especially for BPL families.

Determinants of catastrophic costs among households affected by multi-drug resistant tuberculosis in Ho Chi Minh City, Viet Nam: a prospective cohort study.

BACKGROUND: Globally, most people with multidrug-resistant tuberculosis (MDR-TB) and their households experience catastrophic costs of illness, diagnosis, and care. However, the factors associated with experiencing catastrophic costs are poorly understood. This study aimed to identify risk factors associated with catastrophic costs incurrence among MDR-TB-affected households in Ho Chi Minh City (HCMC), Viet Nam. METHODS: Between October 2020 and April 2022, data were collected using a locally-adapted, longitudinal WHO TB Patient Cost Survey in ten districts of HCMC. Ninety-four people with MDR-TB being treated with a nine-month TB regimen were surveyed at three time points: after two weeks of treatment initiation, completion of the intensive phase and the end of the treatment (approximately five and 10 months post-treatment initiation respectively). The catastrophic costs threshold was defined as total TB-related costs exceeding 20% of annual pre-TB household income. Logistic regression was used to identify variables associated with experiencing catastrophic costs. A sensitivity analysis examined the prevalence of catastrophic costs using alternative thresholds and cost estimation approaches. RESULTS: Most participants (81/93 [87%]) experienced catastrophic costs despite the majority 86/93 (93%) receiving economic support through existing social protection schemes. Among participant households experiencing and not experiencing catastrophic costs, median household income was similar before MDR-TB treatment. However, by the end of MDR-TB treatment, median household income was lower (258 [IQR: 0-516] USD vs. 656 [IQR: 462-989] USD; p = 0.003), and median income loss was higher (2838 [IQR: 1548-5418] USD vs. 301 [IQR: 0-824] USD; p < 0.001) amongst the participant households who experienced catastrophic costs. Being the household's primary income earner before MDR-TB treatment (aOR = 11.2 [95% CI: 1.6-80.5]), having a lower educational level (aOR = 22.3 [95% CI: 1.5-344.1]) and becoming unemployed at the beginning of MDR-TB treatment (aOR = 35.6 [95% CI: 2.7-470.3]) were associated with experiencing catastrophic costs. CONCLUSION: Despite good social protection coverage, most people with MDR-TB in HCMC experienced catastrophic costs. Incurrence of catastrophic costs was independently associated with being the household's primary income earner or being unemployed. Revision and expansion of strategies to mitigate TB-related catastrophic costs, in particular avoiding unemployment and income loss, are urgently required.

Socio-protective effects of active case finding on catastrophic costs from tuberculosis in Ho Chi Minh City, Viet Nam: a longitudinal patient cost survey.

BACKGROUND: Many tuberculosis (TB) patients incur catastrophic costs. Active case finding (ACF) may have socio-protective properties that could contribute to the WHO End TB Strategy target of zero TB-affected families suffering catastrophic costs, but available evidence remains limited. This study measured catastrophic cost incurrence and socioeconomic impact of an episode of TB and compared those socioeconomic burdens in patients detected by ACF versus passive case finding (PCF). METHODS: This cross-sectional study fielded a longitudinal adaptation of the WHO TB patient cost survey alongside an ACF intervention from March 2018 to March 2019. The study was conducted in six intervention (ACF) districts and six comparison (PCF) districts of Ho Chi Minh City, Viet Nam. Fifty-two TB patients detected through ACF and 46 TB patients in the PCF cohort were surveyed within two weeks of treatment initiation, at the end of the intensive phase of treatment, and after treatment concluded. The survey measured income, direct and indirect costs, and socioeconomic impact based on which we calculated catastrophic cost as the primary outcome. Local currency was converted into US$ using the average exchange rates reported by OANDA for the study period (VND1 = US$0.0000436, 2018-2019). We fitted logistic regressions for comparisons between the ACF and PCF cohorts as the primary exposures and used generalized estimating equations to adjust for autocorrelation. RESULTS: ACF patients were poorer than PCF patients (multidimensional poverty ratio: 16 % vs. 7 %; p = 0.033), but incurred lower median pre-treatment costs (US$18 vs. US$80; p < 0.001) and lower median total costs (US$279 vs. US$894; p < 0.001). Fewer ACF patients incurred catastrophic costs (15 % vs. 30 %) and had lower odds of catastrophic cost (aOR = 0.17; 95 % CI: [0.05, 0.67]; p = 0.011), especially during the intensive phase (OR = 0.32; 95 % CI: [0.12, 0.90]; p = 0.030). ACF patient experienced less social exclusion (OR = 0.41; 95 % CI: [0.18, 0.91]; p = 0.030), but more often resorted to financial coping mechanisms (OR = 5.12; 95 % CI: [1.73, 15.14]; p = 0.003). CONCLUSIONS: ACF can be effective in reaching vulnerable populations and mitigating the socioeconomic burden of TB, and can contribute to achieving the WHO End TB Strategy goals. Nevertheless, as TB remains a catastrophic life event, social protection efforts must extend beyond ACF.

Households experiencing catastrophic costs due to tuberculosis in Uganda: magnitude and cost drivers.

BACKGROUND: Tuberculosis (TB) patients in Uganda incur large costs related to the illness, and while seeking and receiving health care. Such costs create access and adherence barriers which affect health outcomes and increase transmission of disease. The study ascertained the proportion of Ugandan TB affected households incurring catastrophic costs and the main cost drivers. METHODS: A cross-sectional survey with retrospective data collection and projections was conducted in 2017. A total of 1178 drug resistant (DR) TB (44) and drug sensitive (DS) TB patients (1134), 2 weeks into intensive or continuation phase of treatment were consecutively enrolled across 67 randomly selected TB treatment facilities. RESULTS: Of the 1178 respondents, 62.7% were male, 44.7% were aged 15-34 years and 55.5% were HIV positive. For each TB episode, patients on average incurred costs of USD 396 for a DS-TB episode and USD 3722 for a Multi drug resistant tuberculosis (MDR TB) episode. Up to 48.5% of households borrowed, used savings or sold assets to defray these costs. More than half (53.1%) of TB affected households experienced TB-related costs above 20% of their annual household expenditure, with the main cost drivers being non-medical expenditure such as travel, nutritional supplements and food. CONCLUSION: Despite free health care in public health facilities, over half of Ugandan TB affected households experience catastrophic costs. Roll out of social protection interventions like TB assistance programs, insurance schemes, and enforcement of legislation related to social protection through multi-sectoral action plans with central NTP involvement would palliate these costs.

Patient costs of hypertension care in public health care facilities in Kenya.

BACKGROUND: Hypertension in low- and middle-income countries, including Kenya, is of economic importance due to its increasing prevalence and its potential to present an economic burden to households. In this study, we examined the patient costs associated with obtaining care for hypertension in public health care facilities in Kenya. METHODS: We conducted a cross-sectional study among adult respondents above 18 years of age, with at least 6 months of treatment in two counties. A total of 212 patients seeking hypertension care at five public facilities were interviewed, and information on care seeking and the associated costs was obtained. We computed both annual direct and indirect costs borne by these patients. RESULTS: Overall, the mean annual direct cost to patients was US$ 304.8 (95% CI, 235.7-374.0). Medicines (mean annual cost, US$ 168.9; 95% CI, 132.5-205.4), transport (mean annual cost, US$ 126.7; 95% CI, 77.6-175.9), and user charges (mean annual cost, US$ 57.7; 95% CI, 43.7-71.6) were the highest direct cost categories. Overall mean annual indirect cost was US$ 171.7 (95% CI, 152.8-190.5). The incidence of catastrophic health care costs was 43.3% (95% CI, 36.8-50.2) and increased to 59.0% (95% CI, 52.2-65.4) when transport costs were included. CONCLUSIONS: Hypertensive patients incur substantial direct and indirect costs. High rates of catastrophic costs illustrate the urgency of improving financial risk protection for these patients and strengthening primary care to ensure affordability of hypertension care.

How affordable is TB care? Findings from a nationwide TB patient cost survey in Ghana.

OBJECTIVES: Tuberculosis (TB) is known as a disease of the poor. Despite TB diagnosis and care usually being offered for free, TB patients can still face substantial costs, especially in the context of multi-drug resistance (MDR). The End TB Strategy calls for zero TB-affected families incurring 'catastrophic' costs due to TB by 2025. This paper examines, by MDR status, the level and composition of costs incurred by TB-affected households during care seeking and treatment; assesses the affordability of TB care using catastrophic and impoverishment measures; and describes coping strategies used by TB-affected households to pay for TB care. METHODS: A nationally representative survey of TB patients at public health facilities across Ghana. RESULTS: We enrolled 691 patients (66 MDR). The median expenditure for non-MDR TB was US$429.6 during treatment, vs. US$659.0 for MDR patients (P-value = 0.001). Catastrophic costs affected 64.1% of patients. MDR patients were pushed significantly further over the threshold for catastrophic payments than DS patients. Payments for TB care led to a significant increase in the proportion of households in the study sample that live below the poverty line at the time of survey compared to pre-TB diagnosis. Over half of patients undertook coping strategies. CONCLUSION: TB patients in Ghana incur substantial costs, despite free diagnosis and treatment. High rates of catastrophic costs and coping strategies in both non-MDR and MDR patients show that new policies are urgently needed to ensure TB care is actually affordable for TB patients.

Adaptation of the Tool to Estimate Patient Costs Questionnaire into Indonesian Context for Tuberculosis-affected Households.

BACKGROUND: Indonesia is the second-highest country for tuberculosis (TB) incidence worldwide. Hence, it urgently requires improvements and innovations beyond the strategies that are currently being implemented throughout the country. One fundamental step in monitoring its progress is by preparing a validated tool to measure total patient costs and catastrophic total costs. The World Health Organization (WHO) recommends using a version of the generic questionnaire that has been adapted to the local cultural context in order to interpret findings correctly. This study is aimed to adapt the Tool to Estimate Patient Costs questionnaire into the Indonesian context, which measures total costs and catastrophic total costs for tuberculosis-affected households. METHODS: the tool was adapted using best-practice guidelines. On the basis of a pre-test performed in a previous study (referred to as Phase 1 Study), we refined the adaptation process by comparing it with the generic tool introduced by the WHO. We also held an expert committee review and performed pre-testing by interviewing 30 TB patients. After pre-testing, the tool was provided with complete explanation sheets for finalization. RESULTS: seventy-two major changes were made during the adaptation process including changing the answer choices to match the Indonesian context, refining the flow of questions, deleting questions, changing some words and restoring original questions that had been changed in Phase 1 Study. Participants indicated that most questions were clear and easy to understand. To address recall difficulties by the participants, we made some adaptations to obtain data that might be missing, such as tracking data to medical records, developing a proxy of costs and guiding interviewers to ask for a specific value when participants were uncertain about the estimated market value of property they had sold. CONCLUSION: the adapted Tool to Estimate Patient Costs in Bahasa Indonesia is comprehensive and ready for use in future studies on TB-related catastrophic costs and is suitable for monitoring progress to achieve the target of the End TB Strategy.

Catastrophic "costs": A hindrance to eliminate tuberculosis.

Globally, one quarter of the population is infected with TB; and only a small proportion of those infected will become sick. Tuberculosis along with poverty disproportionately affects the households causing a financial burden and catastrophic costs (if the total costs incurred by a household's exceeds 20% of its annual income), which could be direct or indirect and procuring detrimental effects on the effective strategic plans. Out of all diseases, India accounts for 18% of the catastrophic health expenditure including tuberculosis. Therefore, an utmost need for a national cost survey either separately or combined with other health surveys should be held for the comprehension of the baseline burden of Tuberculosis in the affected households, to identify the predictors of catastrophic costs, and simultaneously, intensive research and appropriate innovations are needed to assess the effectiveness of the measures undertaken for the reduction of the proportionate patients who overlook catastrophic costs.

Roadblocks and resilience: A qualitative study of the impact of pediatric tuberculosis on Tanzanian households and solutions from caregivers.

Distinct from quantifying the economic sequelae of tuberculosis (TB) in adults, data are scarce regarding lived experiences of youth and their caregivers seeking and sustaining TB treatment in low income communities. Children ages 4-17 diagnosed with TB and their caregivers were recruited from rural and semi-urban northern Tanzania. Using a grounded theory approach, a qualitative interview guide was developed, informed by exploratory research. Twenty-four interviews were conducted in Kiswahili, audio-recorded and analyzed for emerging and consistent themes. Dominant themes found were socioemotional impacts of TB on households, including adverse effects on work productivity, and facilitators and obstacles to TB care, including general financial hardship and transportation challenges. The median percentage of household monthly income spent to attend a TB clinic visit was 34% (minimum: 1%, maximum: 220%). The most common solutions identified by caregivers to mitigate adverse impacts were transportation assistance and nutrition supplementation. To end TB, healthcare systems must acknowledge the total financial burden shouldered by low wealth families seeking pediatric TB care, provide consultations and medications locally, and increase access to TB-specific communal funds to mitigate burdens such as inadequate nutrition.Trial registration: planned sub-study of the registered prospective study, NCT05283967.Trial registration: ClinicalTrials.gov identifier: NCT05283967.

The Association Between Household Financial Burden and Patient Mobility and Their Impact on Loss to Follow-Up Among Multidrug-Resistant Tuberculosis Patients in Guizhou, China.

Purpose: We aimed to assess the household financial burden due to multidrug-resistant tuberculosis (MDR-TB) treatment and its predictors, examine its association with patient mobility, and test their impact on patient loss to follow-up (LTFU). Methods: A cross-sectional study combining follow-up data collection was conducted at the largest designated MDR-TB hospital in Guizhou. Data were collected from medical records and questionnaires. Household financial burden was measured by the incidence of 2 indicators: catastrophic total costs (CTC) and catastrophic health expenditure (CHE). Mobility was classified as mover or non-mover after the patient's address was verified twice. A multivariate logistic regression model was used to identify associations between variables. Model I and Model II were separated by CHE and CTC. Results: Out of 180 households, the incidence of CHE and CTC was 51.7% and 80.6%, respectively. Families with low income and patients who were primary income earners were significantly associated with catastrophic costs. 42.8% of patients were movers. Patients from households with CHE (ORadj=2.2, 95% CI: 1.1-4.1) or with CTC (ORadj=2.6, 95% CI: 1.1-6.3) were more likely to move. Finding a job against financial difficulty (58.4%) was the top reason for movers. 20.0% of patients experienced LTFU. Patients from households with catastrophic payments (CHE: ORadj=4.1, 95% CI 1.6-10.5 in Model I; CTC: ORadj=4.8, 95% CI 1.0-22.9 in Model II), patients who were movers (ORadj=6.1, 95% CI 2.5-14.8 in Model I; ORadj=7.4, 95% CI 3.0-18.7 in Model II) and primary income earners (ORadj=2.5, 95% CI: 1.0-5.9 in Model I; ORadj=2.7, 95% CI 1.1-6.6 in Model II) had an increased risk of LTFU. Conclusion: There is a significant association between household financial burden due to MDR-TB treatment and patient mobility in Guizhou. They impact patients' treatment adherence and cause LTFU. Being a primary breadwinner increases the risk for catastrophic household payments and LTFU.

The impact of social protection interventions on treatment and socioeconomic outcomes of people with tuberculosis and their households: Protocol for a systematic review and meta-analysis.

Background: Tuberculosis (TB) is a leading cause of death due to infectious disease worldwide. People with TB and their households often suffer social and economic losses due to the cost of tuberculosis care. The World Health Organization 2015 End TB strategy called for socioeconomic support through social protection interventions. Social protection has the potential to enable people with TB and their households to break the cycle of TB and poverty, thereby improving both treatment and socioeconomic outcomes. This study aims to evaluate whether people with TB who are recipients of social protection interventions have better treatment and socioeconomic outcomes than those who are not recipients of social protection interventions. Methods: We will systematically review literature published in English between 2012 and 2021 from PubMed, Embase, and Web of Science, and grey literature from Google Scholar and selected, relevant databases. We will include studies that describe a social protection intervention (as defined by the World Bank) and report on TB treatment outcomes and/or socioeconomic outcomes. We will only include studies pertaining to populations in low-and-middle-income countries and/or countries with high TB burden. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Study quality will be assessed using the Cochrane Risk of Bias for randomized controlled trials and the Newcastle Ottawa Scale for non-randomised controlled studies. If sufficient quantitative data are available, we will perform a meta-analysis of aggregated outcomes. Lastly, we will use the Grading Recommendations Assessment, Development, and Evaluation to describe the overall quality of evidence. Ethics and dissemination: Ethical approval is not required for this systematic review, as all data extraction and analysis will be conducted on published documents. We will disseminate this protocol through conference presentations. The systematic review has been registered prospectively in the PROSPERO database (registration number CRD42022382181).

Out-of-pocket expenditure and catastrophic costs due to COVID-19 in Indonesia: A rapid online survey.

Background: The Corona Virus Disease 2019 (COVID-19) pandemic has created a substantial socioeconomic impact, particularly in developing countries such as Indonesia. Purposes/objectives: This study aimed to describe the COVID-19-related out-of-pocket spending of Indonesian citizens and the proportion of whom experienced catastrophic health spending during the COVID-19 pandemic using the patient's perspective. Methodology: We conducted a rapid cross-sectional online survey across provinces in Indonesia to capture participants' experiences due to COVID-19. Data were collected between September 23rd to October 7th of 2021 including demographics, income, and expenditures. Descriptive statistics were used to analyze the respondents' characteristics. Patients's perspective of total cost was estimated from out-of-pocket of COVID-19 direct costs and compared them to total expenditure. If the proportion of COVID-19 total costs exceeded 40% of the total expenditure, the respondents were deemed to have faced catastrophic costs. Results: A total of 1,859 respondents answered the questionnaire. The average monthly income and expenditure of respondents were 800 USD, and 667 USD respectively. The monthly expenditure was categorized into food expenditure (367 USD) and non-food expenditure (320 USD). The average of COVID-19-related monthly expenditure was 226 USD, including diagnostic expenditure (36 USD), preventive expenditure (58 USD), medical expenditure (37 USD for COVID-19 treatment; and 57 USD for post-COVID-19 medical expenses), and non-medical expenditure (30 USD). Analysis showed that 18.6% of all respondents experienced catastrophic costs while 38.6% of the respondents who had COVID-19 treatment experienced catastrophic costs. Conclusion: The high proportion of catastrophic costs among respondents suggests the need for COVID-19 social protection, especially for COVID-19 diagnostic and prevention costs. The survey findings have led the government to increase the benefit coverage other than medical costs at the hospitals.

Assessment of Household Catastrophic Total Cost of Tuberculosis and Its Determinants in Cairo: Prospective Cohort Study.

BACKGROUND: One goal of the End tuberculosis (TB) Strategy is to see no TB-affected households experiencing catastrophic costs. Therefore, it is crucial for TB-elimination programs to identify catastrophic costs and their main drivers in order to establish appropriate health and social measures. This study aimed to measure the percent of catastrophic costs experienced by Egyptian TB patients and to identify its determinants. METHODS: We conducted a prospective cohort study with 151 Egyptian TB patients recruited from two chest dispensaries from the Cairo governate from May 2019 to May 2020. We used a validated World Health Organization TB patient-cost tool to collect data on patients' demographic information, household income, and direct and indirect expense of seeking TB treatment. We considered catastrophic TB costs to be total costs exceeding 20% of the household's annual income. RESULTS: Of the patients, 33% experienced catastrophic costs. The highest proportion of the total came in the pretreatment stage. Being the main breadwinner, experiencing job loss, selling property, and the occurrence of early coronavirus disease 2019 lockdown were independent determinants of the incidence of catastrophic costs. Borrowing money and selling property were the most-often reported coping strategies adopted. CONCLUSION: Despite the availability of free TB care under the Egyptian National TB Program, nearly a third of the TB patients incurred catastrophic costs. Job loss and being the main breadwinner were among the significant predictors of catastrophic costs. Social protection mechanisms, including cash assistance and insurance coverage, are necessary to achieve the goal of the End TB Strategy.

Interventions aiming to eliminate catastrophic costs due to tuberculosis: a protocol for a systematic review and meta-analysis.

Background : People with tuberculosis disease and their household members may suffer direct out-of-pocket expenses and indirect costs of lost income. These tuberculosis-related costs can worsen poverty, make tuberculosis treatment completion unaffordable, impair quality of life and increase the risk of death. Costs due to tuberculosis are usually defined as catastrophic if they exceed 20% of the pre-disease annual household income. The World Health Organisation strategy to "End TB" and the United Nations Sustainable Development Goals include the target that no households should face catastrophic costs due to tuberculosis. However, there is limited evidence and policy concerning how this global priority of eliminating catastrophic costs due to tuberculosis should be achieved. This systematic review and meta-analysis aims to address this knowledge gap. Methods : Publications assessing interventions that aimed to eliminate catastrophic costs will be identified by searching three electronic databases (PubMed, Scopus and Web of Science) together with reference lists from pertinent publications. We will screen eligible studies, extract data, and assess the risk of bias with the quality assessment tool from the National Heart, Lung, and Blood Institute. Discrepancies will be resolved by discussion between the reviewers. If we find sufficient comparable studies quantifying strategies to eliminate catastrophic costs then a meta-analysis will be performed. This systematic review and meta-analysis is registered with the PROSPERO database (CRD42022292410). Conclusion : This systematic review and meta-analysis aims to rigorously assess the evidence for strategies to eliminate catastrophic costs due to tuberculosis.

Protocol for the Addressing the Social Determinants and Consequences of Tuberculosis in Nepal (ASCOT) pilot trial.

BACKGROUND: The World Health Organization's End TB (tuberculosis) Strategy advocates social and economic support for TB-affected households but evidence from low-income settings is scarce. We will evaluate the feasibility and acceptability of a locally-appropriate socioeconomic support intervention for TB-affected households in Nepal. METHODS: We will conduct a pilot randomised-controlled trial with mixed-methods process evaluation in four TB-endemic, impoverished districts of Nepal: Pyuthan, Chitwan, Mahottari, and Morang. We will recruit 128 people with TB notified to the Nepal National TB Program (NTP) and 40 multisectoral stakeholders including NTP staff, civil-society members, policy-makers, and ASCOT (Addressing the Social Determinants and Consequences of Tuberculosis) team members. People with TB will be randomised 1:1:1:1 to four study arms (n=32 each): control; social support; economic support; and combined social and economic (socioeconomic) support. Social support will be TB education and peer-led mutual-support TB Clubs providing TB education and stigma-reduction counselling. Economic support will be monthly unconditional cash transfers during TB treatment with expectations (not conditions) of meeting NTP goals. At 0, 2, and 6 months following TB treatment initiation, participants will be asked to complete a survey detailing the social determinants and consequences of TB and their feedback on ASCOT. Complementary process evaluation will use focus group discussions (FGD), key informant interviews (KII), and a workshop with multi-sectoral stakeholders to consider the challenges to ASCOT's implementation and scale-up. A sample of ~100 people with TB is recommended to estimate TB-related costs. Information power is estimated to be reached with approximately 25 FGD and 15 KII participants. CONCLUSIONS: The ASCOT pilot trial will both generate robust evidence on a locally-appropriate, socioeconomic support intervention for TB-affected households in Nepal and inform a large-scale future ASCOT trial, which will evaluate the intervention's impact on catastrophic costs mitigation and TB outcomes. The trial is registered with the ISRCTN ( ISRCTN17025974).

How to reduce household costs for people with tuberculosis: a longitudinal costing survey in Nepal.

The aim of this study was to compare costs and socio-economic impact of tuberculosis (TB) for patients diagnosed through active (ACF) and passive case finding (PCF) in Nepal. A longitudinal costing survey was conducted in four districts of Nepal from April 2018 to October 2019. Costs were collected using the WHO TB Patient Costs Survey at three time points: intensive phase of treatment, continuation phase of treatment and at treatment completion. Direct and indirect costs and socio-economic impact (poverty headcount, employment status and coping strategies) were evaluated throughout the treatment. Prevalence of catastrophic costs was estimated using the WHO threshold. Logistic regression and generalized estimating equation were used to evaluate risk of incurring high costs, catastrophic costs and socio-economic impact of TB over time. A total of 111 ACF and 110 PCF patients were included. ACF patients were more likely to have no education (75% vs 57%, P = 0.006) and informal employment (42% vs 24%, P = 0.005) Compared with the PCF group, ACF patients incurred lower costs during the pretreatment period (mean total cost: US$55 vs US$87, P < 0.001) and during the pretreatment plus treatment periods (mean total direct costs: US$72 vs US$101, P < 0.001). Socio-economic impact was severe for both groups throughout the whole treatment, with 32% of households incurring catastrophic costs. Catastrophic costs were associated with 'no education' status [odds ratio = 2.53(95% confidence interval = 1.16-5.50)]. There is a severe and sustained socio-economic impact of TB on affected households in Nepal. The community-based ACF approach mitigated costs and reached the most vulnerable patients. Alongside ACF, social protection policies must be extended to achieve the zero catastrophic costs milestone of the End TB strategy.

Costs incurred by patients with oral potentially malignant disorders: is there a public health need for financial protection in India?

OBJECTIVES: Financial protection mechanisms are in place to overcome the costs of a few diseases in India. Our objective was to estimate the costs incurred due to Oral Potentially Malignant Disorders (OPMD) and to determine predictors of such costs. RESULTS: We found that the median (Interquartile range IQR) total costs of OPMD was Indian Rupees (INR) 500 (350-750), direct medical costs was INR 0 (0-50), direct non-medical costs was INR 150 (40-200) and indirect costs was INR 350 (250-500). The travel cost to attend the health facilities [INR 100 (40-150)] and the patient's loss of wages [INR 200 (150-400)] mainly accounted for the direct non-medical and indirect costs respectively. The median expenditure on smokeless and smoking forms of tobacco was INR 6000 (5400-7200) and INR 2400 (1800-3600) respectively. On multiple linear regression analysis, rural residence, belonging to below poverty line family, being a sole earner in the family, number of months since diagnosis and first visit at a private provider were found to be the significant predictors of total costs of OPMD. Financial protection mechanisms are needed for covering the direct non-medical and indirect costs. Early management of OPMD might mitigate the costs of OPMD.

Patient-incurred costs in a differentiated service delivery club intervention compared to standard clinical care in Northwest Tanzania.

INTRODUCTION: Placing all clients with a positive diagnosis for HIV on antiretroviral therapy (ART) has cost implications both for patients and health systems, which could, in turn, affect feasibility, sustainability and uptake of new services. Patient-incurred costs are recognized barriers to healthcare access. Differentiated service delivery (DSD) models in general and community-based care in particular, could reduce these costs. We aimed to assess patient-incurred costs of a community-based DSD intervention (clubs) compared to clinic-based care in the Shinyanga region, Tanzania. METHODS: Cross-sectional survey among stable ART patients (n = 390, clinic-based; n = 251, club-based). For each group, we collected socio-demographic, income and expenditure data between May and August 2019. We estimated direct and indirect patient-incurred costs. Direct costs included out-of-pocket expenditures. Indirect costs included income loss due to time spent during transport, accessing services and off work during illness. Cost drivers were assessed in multivariate regression models. RESULTS: Overall, costs were significantly higher among clinic participants. Costs (USD) per year for clinic versus club were as follows: 11.7 versus 4.17 (p < 0.001) for direct costs, 20.9 versus 8.23 (p < 0.001) for indirect costs and 32.2 versus 12.4 (p < 0.001) for total costs. Time spent accessing care and time spent in illness (hours/year) were 38.3 versus 13.8 (p < 0.001) and 16.0 versus 6.69 (p < 0.001) respectively. The main cost drivers included transportation (clinic vs. club: 67.7% vs. 44.1%) for direct costs and income loss due to time spent accessing care (clinic vs. club: 60.4% vs. 56.7%) for indirect costs. Factors associated with higher total costs among patients attending clinic services were higher education level (coefficient [95% confidence interval]) 20.9 [5.47 to 36.3]) and formal employment (44.2 [20.0 to 68.5). Differences in mean total costs remained significantly higher with formal employment, rural residence, in addition to more frequent visits among clinic participants. The percentage of households classified as having had catastrophic expenditures in the last year was low but significantly higher among clinic participants (10.8% vs. 5.18%, p = 0.014). CONCLUSIONS: Costs incurred by patients accessing DSD in the community are significantly lower compared to those accessing standard clinic-based care. DSD models could improve access, especially in resource-limited settings.

Does tuberculosis screening improve individual outcomes? A systematic review.

BACKGROUND: To determine if tuberculosis (TB) screening improves patient outcomes, we conducted two systematic reviews to investigate the effect of TB screening on diagnosis, treatment outcomes, deaths (clinical review assessing 23 outcome indicators); and patient costs (economic review). METHODS: Pubmed, EMBASE, Scopus and the Cochrane Library were searched between 1/1/1980-13/4/2020 (clinical review) and 1/1/2010-14/8/2020 (economic review). As studies were heterogeneous, data synthesis was narrative. FINDINGS: Clinical review: of 27,270 articles, 18 (n=3 trials) were eligible. Nine involved general populations. Compared to passive case finding (PCF), studies showed lower smear grade (n=2/3) and time to diagnosis (n=2/3); higher pre-treatment losses to follow-up (screened 23% and 29% vs PCF 15% and 14%; n=2/2); and similar treatment success (range 68-81%; n=4) and case fatality (range 3-11%; n=5) in the screened group. Nine reported on risk groups. Compared to PCF, studies showed lower smear positivity among those culture-confirmed (n=3/4) and time to diagnosis (n=2/2); and similar (range 80-90%; n=2/2) treatment success in the screened group. Case fatality was lower in n=2/3 observational studies; both reported on established screening programmes. A neonatal trial and post-hoc analysis of a household contacts trial found screening was associated with lower all-cause mortality. Economic review: From 2841 articles, six observational studies were eligible. Total costs (n=6) and catastrophic cost prevalence (n=4; range screened 9-45% vs PCF 12-61%) was lower among those screened. INTERPRETATION: We found very limited patient outcome data. Collecting and reporting this data must be prioritised to inform policy and practice. FUNDING: WHO and EDCTP.

There's no such thing as a free TB diagnosis: Catastrophic TB costs in Urban Uganda.

Identifying and reducing TB-related costs is necessary for achieving the End TB Strategy's goal that no family is burdened with catastrophic costs. This study explores costs during the pre-diagnosis period and assesses the potential for using coping costs as a proxy indicator for catastrophic costs when comprehensive surveys are not feasible. Detailed interviews about TB-related costs and productivity losses were conducted with 196 pulmonary TB patients in Kampala, Uganda. The threshold for catastrophic costs was defined as 20% of household income. Multivariable regression analyses were used to assess the influence of patient characteristics on economic burden, and the positive predictive value (PPV) of coping costs was estimated. Over 40% of patients experienced catastrophic costs, with average (median) pre-diagnosis costs making up 30.6% (14.1%) of household income. Low-income status (AOR = 2.91, 95% CI = 1.29, 6.72), hospitalisation (AOR = 8.66, 95% CI = 2.60; 39.54), and coping costs (AOR = 3.84, 95% CI = 1.81; 8.40) were significantly associated with the experience of catastrophic costs. The PPV of coping costs as an indicator for catastrophic costs was estimated to be 73% (95% CI = 58%, 84%). TB patients endure a substantial economic burden during the pre-diagnosis period, and identifying households that experience coping costs may be a useful proxy measure for identifying catastrophic costs.