Methodological recommendations for assessing the impact of adaptations on outcomes in implementation research

Abstract

Background

A major gap in implementation research is guidance for designing studies to assess the impact of adaptations to interventions and implementation strategies. Many researchers regard experimental designs as the gold standard. However, the possible study designs for assessing the impact of adaptation on implementation, service and person-level outcomes is broad in scope, including descriptive and correlational research and variations of randomized controlled trials. This article provides a set of key methodological recommendations for assessing the impact of adaptations to interventions and implementation strategies on implementation outcomes.

Recommendations

We offer four key recommendations for investigating the impact of adaptations on implementation outcomes. First, we recommend defining the construct of adaptations and identifying the type and timing of adaptations. Second, we recommend that study teams identify the expected proximal and distal outcomes of adaptations. Third, we recommend that study teams consider all possible study design options and select the design that is best suited to answer the research question(s), and is feasible given practical and technical constraints, and acceptable to research partners and participants. Fourth, we recommend that study teams consider the type of adaptation and outcome data available, the goals of the adaptation study, and the complexity of the study design when selecting analytic approaches. We provide materials and examples related to the four key recommendations to help study teams plan and conduct adaptation studies.

Conclusions

This article provides methodological recommendations for assessing the impact of adaptations to interventions and implementation strategies on implementation, service, and person-level outcomes that are grounded in the practical realities of implementation research. Increasing the number of studies examining how, which, and under what conditions adaptations are associated with mechanisms and outcomes will advance research on adaptation.