Table 1. Possible study designs for estimating the tuberculosis burden in India.
Study design | Possible objectives | Existing data used | New data collection required | Current feasibility | Application |
|
---|---|---|---|---|---|---|
Advantages | Disadvantages | |||||
Inventory study | ||||||
Retrospective analysisa | Quantification of underreporting of diagnosed cases. Estimation of tuberculosis incidence. Demonstration of negligible underreporting | National tuberculosis surveillance database plus one or two national case-based databases – the exact number depending on objectives | None | Not feasible because multiple national case-based databases not available in India | ||
Survey of sample of all providers, selected using lot-quality assurance samplinga | Demonstration of negligible underreporting | National tuberculosis surveillance database | Provider survey of random sample of all tuberculosis providers, selected using lot-quality assurance sampling | Not appropriate because underreporting known to be substantial in India | ||
Survey of all providers in large areas suitable for capture–recapture analysisa | Quantification of underreporting of diagnosed cases. Estimation of tuberculosis incidence | National tuberculosis surveillance database plus two other case-based databases for each geographical area selected | Provider survey of all tuberculosis providers in random sample of large, self-contained geographical areas | Needs to be assessed | Generates comprehensive, direct estimate of underreporting at all levels | Assumptions regarding migration and probability of inclusion in each database. Error-prone because of reliance on probabilistic matching across multiple databases |
Survey of all providers in sampled areasa | Quantification of underreporting of diagnosed cases. Demonstration of negligible underreporting | National tuberculosis surveillance database | Provider survey of all tuberculosis providers in random sample of geographical areas | Feasible for quantifying underreporting of diagnosed cases | Of the feasible studies, relatively inexpensive because fewer data need to be collected | Proportion of cases with no health system utilization estimated from self-reported household survey data. Level of underdiagnosis estimated from other new data collection or existing data with limitations |
Survey of all providers in sampled areas with assessment of underdiagnosis | Quantification of underreporting and underdiagnosis by RNTCP and non-RNTCP providers | National tuberculosis surveillance database | Provider survey of all tuberculosis providers in random sample of geographical areas, including assessment of underdiagnosis | Feasible | Generates direct estimates of the greatest number of the parameters contributing to underreporting | Proportion of cases with no health system utilization estimated from self-reported household survey data. More expensive than assessment of only underreporting of diagnosed cases in sampled areas because of additional data collection |
National prevalence survey | Estimation of national prevalence of active tuberculosis in adults. Assessment of the proportion of tuberculosis cases which are drug-resistant | None | For nationally representative sample of adults aged ≥ 15 years: either Xpert MTB/RIF assay or X-ray screening plus two sputum samples if symptomatic or X-ray abnormal | Feasible | Generates direct estimate of national tuberculosis prevalence, with potential to assess extent of drug resistance | In comparison with other study designs, longer period of data collection and more expensive |
RNTCP: Revised National Tuberculosis Control Programme.
a Described in detail in the WHO guide for conducting inventory studies.27