The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis

Proportion of children treated for TB among those with presumptive TB, including children with microbiologically confirmed TB.

Proportion of children from high-risk groups treated for TB (age <2 years, CLHIV, children with SAM) i) among all children from high-risk groups attending care, ii) among children from high-risk groups with presumptive TB.

Proportion of children with TB that are microbiologically confirmed (i.e. smear or Xpert or LAM positive), ratio of <5 to 5-14 years among children with TB, ratio of pulmonary TB to extrapulmonary TB (EPTB).

Time from presumptive TB identification to final TB treatment decision and access to TB diagnostic assessment defined as the proportion of children with presumptive TB having completed assessment with the TDAs and CDSS, including in high-risk groups.

Concordance of the TDA result and the final TB treatment decision using the proportion of children wrongly initiated or not initiated on TB treatment defined as: i) children not started on TB treatment despite positive score; ii) children initiated on TB treatment despite negative score. Reasons for both decisions will be collected.

Proportion of missed TB cases (false negative) and over-diagnosed TB cases (unlikely TB with a positive score, i.e. false positive).

Concordance of the severity evaluation and decision for short TB treatment regimen using the proportion of i) children with 4-month TB treatment regimen used despite severe disease as assessed by the clinical/CXR evaluation; ii) children with 6-month TB treatment regimen despite non-severe disease as assessed by the clinical/CXR evaluation.

Proportion of false positive and false negative TB severity assessments at low level of health care: i) children with non-severe disease according to clinical criteria despite severe disease as evaluated by expert CXR read; ii) children with clinically assessed severe disease despite non-severe disease as evaluated by expert CXR read.

Proportion of children with presumptive TB and with non-severe TB disease initiated on shorter TB treatment.

TB treatment outcomes as defined per WHO (treatment success, cured, treatment completion, loss to follow-up, death, treatment failure) overall and stratified by severity and regimen duration.

Number of deaths averted assessed through modelling.

Number of adults with TB, including microbiologically confirmed TB, and proportion of all TB diagnosed that is child TB.

Proportion of healthcare providers' preferences in delivering childhood TB screening, diagnosis, and treatment decision-making, comparing the comprehensive TDA-based approach vs. the Standard of Care (SOC) approach, as assessed by TB diagnosis questionnaire, a self-administered questionnaire, completed every 3months in both arms, by all healthcare providers involved in child care.

Proportion of healthcare providers' preferences/ alignment with values and perceived potential to impact on lived experience) of the comprehensive TDA-based approach, including associated digital tools, to users (healthcare providers) as part of their work duties in childhood TB care, assessed by questionnaires.

Proportion of beneficiaries' (children and their caregivers receiving a diagnosis of TB) local social value of the comprehensive TDA-based approach, including associated digital tools, as assessed by interviews and group discussions

Number of health systems and socioeconomic factors influencing preferences and local social value of the comprehensive TDA-based approach, including associated digital tools, for users and beneficiaries, as assessed by questionnaires, interviews and group discussions

Feasibility of implementing and delivering the comprehensive TDA-based approach, including associated digital tools: health systems, logistical, managerial, challenges faced during implementation, and solutions found as assessed by the TB diagnosis questionnaire.

Fidelity to intervention delivery and to implementation strategies: adherence to intervention procedures and implementation guide/manuals, adaptations, quality of implementation and intervention delivery.Assessed based on project process data (for example number and regularity of support supervision visits achieved compared to what was planned); fidelity of intervention delivery will based on the TB diagnosis questionnaire (number of health care worker reporting using TDAs to diagnose TB in children).

Number of contextual factors influencing intervention delivery and implementation (at Individual, facility, health systems and community-level): barriers and facilitators as assessed by questionnaires, interviews and group discussions.

Number of facilities reporting using TDAs for childhood TB diagnosis 6 months post intervention period as assessed by sustainability questionaries.

Total TB care costs from the health system perspective.

Unit cost per TB care activity (e.g. clinical assessment, CXR).

Total TB care costs of overdiagnosis (false positive)

Total costs incurred by parents/caregivers for receiving child TB care

Number of children treated for TB.

Number of adults treated for TB.

Number of deaths.

Measure of healthy life lost, either through premature death or living with disability due to illness; Disability-Adjusted Life Years (DALYs)

Incremental number of children treated for TB.

Incremental cost per Death averted.

Incremental cost per DALY averted.

Cost of scaling up the comprehensive TDA-based approach nationally.

Cumulative number of children and adults treated for TB, lives saved, and DALYs averted during a 5-year scale-up.

Roles, practices and processes among implementers and decision-makers of the comprehensive TDA-based approach, including associated digital tools, at district-level.

Mechanism of translation of the research results and evidence on the comprehensive TDA-based approach, including associated digital tools, into public policies and practices: experience and perceptions of key stakeholders at regional, national and district-level.