Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative review & case studies.

ABSTRACT: Hybrid effectiveness-implementation studies allow researchers to combine study of a clinical intervention's effectiveness with study of its implementation with the aim of accelerating the translation of evidence into practice. However, there currently exists limited guidance on how to design and manage such hybrid studies. This is particularly true for studies that include a comparison/control arm that, by design, receives less implementation support than the intervention arm. Lack of such guidance can present a challenge for researchers both in setting up but also in effectively managing participating sites in such trials. This paper uses a narrative review of the literature (Phase 1 of the research) and comparative case study of three studies (Phase 2 of the research) to identify common

SUBMITTER: Jurczuk M 

PROVIDER: S-EPMC10012616 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature