Abstract
Testing interventions in real-world settings requires fidelity monitoring to ensure implementation integrity. However, strategies to enhance, monitor, and measure fidelity deployed in efficacy trials may not be feasible in pragmatic trials or sustainable in practice. This paper reviews published translational or pragmatic studies of dementia caregiver support interventions to understand how fidelity was previously treated in order to derive recommendations for future pragmatic-like trials. A search using SCOPUS, EMBASE, and Google Scholar identified 31 translational caregiver intervention studies of which 20 (64.5%) referenced fidelity. Of these 20, 11 (55.0%) reported fidelity measurement, whereas 9 (45.0%) only recognized its importance. Of the 11 studies, fidelity was assessed using investigator-developed scoring forms, audio/video recordings, evaluations from caregivers and interventionists, and by comparing outcomes with the original efficacy trial. Additionally, 7 (63.6%) of 11 studies reported fidelity results, representing only 22.5% of 31 studies reporting outcomes demonstrating the inconsistency in the field concerning the reporting outcomes of fidelity. We conclude that fidelity methods used in translational studies to date are not practical nor sustainable for ongoing monitoring of evidence-based programs in real-world settings and that only 2 aspects of fidelity, intervention and adherence, are considered. New approaches are needed to ensure fidelity integrity in pragmatic trials and which can be sustained thereafter.