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Table 2 Trial outcomes categorized using the RE-AIM framework

From: Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB)

RE-AIM domains

Trial outcomes

Reach

• Number/proportion completing Xpert testing

Effectiveness

Process outcomes

• Number/proportion diagnosed with and treated for TB within 14 days

• Number/proportion diagnosed with microbiologically-confirmed TB

• Time to diagnosis of microbiologically-confirmed TB

• Number/proportion diagnosed with rifampin resistance

• Number/proportion with microbiologically-confirmed TB completing treatment

Health and health economic outcomes

• Number/proportion who died within 6 months

• Number/proportion with microbiologically-confirmed TB who died within 6 months

• Number/proportion treated for TB who died within 6 months

• Incremental cost-effectiveness ratio

Adoption

• Proportion of eligible sites able and willing to initiate each component of the intervention strategy

Implementation

Fidelity

• Process metrics for each intervention strategy component

• Proportion tested by Xpert

• Number of GeneXpert device non-operation days

• Proportion of invalid, error, or indeterminate Xpert results

• Proportion treated on same-day if Xpert-positive

• Proportion of performance feedback report cards reviewed at staff meetings

• Qualitative data from health worker focus group discussions and in-depth interviews

Acceptability

• Thematic output from health worker focus group discussions

Patient and health system costs

• Incremental cost of introducing and maintaining the intervention strategy

• Incremental patient cost per diagnostic evaluation and per treatment initiated

Modification of targeted barriers

• Median scores for health worker knowledge, attitudes, subjective norms, and self-efficacy related to TB diagnostic evaluation guidelines

• Thematic output from provider in-depth interviews

• Median patient costs associated with completing TB diagnostic evaluation

• Median scores for domains of patient satisfaction questionnaire