Table 2 Four levels of evidence for evaluations and examples in scaling-out an evidence-based intervention (EBI)
From: “Scaling-out” evidence-based interventions to new populations or new health care delivery systems
Level Of evidence | Implementation fidelity (Implementation strategy delivered as intended) | Intervention fidelity (Clinical or health intervention delivered as intended) | Reach and exposure | Adoption | Sustainment | Effect on health outcome | Potential use |
|---|---|---|---|---|---|---|---|
0: minimal or no new empirical evidence | Not measured | Training certification of facilitator and/or clinician prior to new implementation | Numbers of individuals exposed | Attendance of organizational representatives at trainings | Not measured | Not measured | Demonstration program that explicitly follows an intervention manual |
1. Proxy empirical evidence | Leadership and staff self-efficacy to support EBI | Facilitator and/or clinician ; self-assessment of fidelity | Attendance for behavioral intervention; filled prescriptions | Formal acknowledgment by organizations of adoption | Completion of yearly reports by implementing agencies | Assessment of intermediate and/or proximal health outcome | Inexpensive large-scale implementation evaluation |
2. Direct empirical evidence | Measurement of milestone attainment; speed, quality, and quantity of implementation | Independent assessment of fidelity | Ratings of quality of behavioral homework, medication adherence | Quality of staff training | Sustained number of staff and number of subjects exposed to intervention with fidelity | Change in primary health outcome from baseline | Formal implementation evaluation to establish evidence base through mediational mechanisms |
3. Full randomized hybrid trial | Evaluate intervention vs comparison on primary outcome | Type II hybrid trial to directly establish full evidence base |