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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 endpoint

Description

Data source

Primary endpoints

 Case notification rates (cases notified per 10,000 population per year)

Numerator: number of cases notified by the selected districts

Case notification data from CENAT

Denominator: total population in the OD

Population 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 districts

Case 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 arm

Program data

In the control arm, data to be collected from the health centers monthly

Denominator: total number of individuals screened

Program data

Provincial health department laboratory data to determine the number of people screened at health centers in the control arm

Secondary endpoints

 Treatment outcomes

TB treatment outcomes of all new patients 6 months after treatment initiation

Health centers

 Number needed to screen

Numerator: total number of individuals screened

Program 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 arm

Program data

Control arm: data to be collected from the health centers monthly

 Cost per TB case diagnosed/notified

Direct 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