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Table 2 Endpoints and data collection

From: Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial

Study endpointDescriptionData source
Primary endpoints
 Case notification rates (cases notified per 10,000 population per year)Numerator: number of cases notified by the selected districtsCase notification data from CENAT
Denominator: total population in the ODPopulation statistics (Ministry of Planning/Department of Statistics/CENAT)
 Additionality (additional number of cases reported compared to historical baseline)Number of cases notified by the selected districtsCase notification data from CENAT
Historical data (cases notified in the preceding 3 years)Historical case notification data from CENAT
 Cumulative yield (cases diagnosed per 1000 screened)Numerator: number of cases reported by each armProgram data
In the control arm, data to be collected from the health centers monthly
Denominator: total number of individuals screenedProgram data
Provincial health department laboratory data to determine the number of people screened at health centers in the control arm
Secondary endpoints
 Treatment outcomesTB treatment outcomes of all new patients 6 months after treatment initiationHealth centers
 Number needed to screenNumerator: total number of individuals screenedProgram data
Provincial health department laboratory data to determine the number of people screened at health centers in the control arm
Denominator: number of cases reported by each armProgram data
Control arm: data to be collected from the health centers monthly
 Cost per TB case diagnosed/notifiedDirect and indirect medical costs while seeking care for TB
Staff and intervention costs
Diagnostics and medication costs
Health-care-seeking costs: data to be collected in the baseline and follow-up survey
Intervention costs: data to be collected from KHANA, CENAT, and CATA
DALYs: data to be extracted from WHO global burden of disease studies and other existing literature
 Incremental cost-effectiveness ratio per DALY averted
  1. CATA Cambodia Anti-Tuberculosis Association, CENAT National Center for Tuberculosis and Leprosy Control, DALY disability-adjusted life year, OD operational district, TB tuberculosis, WHO World Health Organization