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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 domainsTrial outcomes
Reach• Number/proportion completing Xpert testing
EffectivenessProcess 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
• 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
• 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