Analysis | Valuation | Outcomes |
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Societal costs | Patient costs: the sum of all out-of-pocket costs incurred by patients in accessing treatment and treatment support, plus the cost of time spent in accessing treatment. The proportion of patients who incur catastrophic costs is estimated by the number of patients who incur costs that exceed 10% of their self-reported income, as a percentage of all TB patients Provider costs: the sum of costs incurred by the health service in providing care. An ingredient costing approach is used to identify the costs of purchasing and implementing the technology, plus the human resource costs to provide treatment support. Overhead costs incurred by the health facility are allocated down to the intervention using an allocation factor based on facility workload data. Societal costs refer to the sum of patient-incurred and provider costs Poverty case: a participant will be counted as a poverty case if the direct costs incurred (e.g. out-of-pocket costs of transport to clinics and purchasing healthcare) reduce their self-reported income to below the national poverty line in Ethiopia | Patient cost per patient Provider cost per patient Societal cost per patient Proportion of patients who incurred catastrophic costs Poverty case |
Disability-adjusted life years | Disability-adjusted life years (DALYs) is an outcome measure that is the sum of years of life lost due to premature mortality (life expectancy in country minus age at death) and the years of life lived with the disease where the number of years lived with the disease is adjusted by a utility weight. Mortality/deaths as recorded in the treatment register and/or during the 12-month follow-up will be used to estimate years of life lost. Years of life lived with a disability (YLD) will be the time from diagnosis to successful treatment estimated from the trial outcomes | Years of life lost (YLL) Years of life lived with a disability (YLD) Disability-adjusted life years (DALYs) |
Cost-effectiveness | Cost-effectiveness is estimated as the difference in the per-patient costs incurred in the intervention compared to the standard of care arm of the study, divided by the difference in DALYs between the two study arms. If the cost per DALY averted value (incremental cost-effectiveness ratio) for the intervention is below the cost-effectiveness decision threshold, the intervention will be considered cost-effective | Cost per unfavourable outcome averted Cost per DALY averted |
Equity impact analysis | The distribution of costs and outcomes by household socio-economic position (SEP) will be assessed by estimating the illness—and cost-concentration indices by study arm. The illness concentration index is defined as twice the area between the concentration curve and the line of equality on a graph of the cumulative percentage of people in the same ranked by economic status against the cumulative percentage of ill health | Distribution of costs and outcomes by household SEP Illness concentration index (ICI) for each study arm Cost concentration index (CCI) for each study arm |