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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