Informing Scalable Implementation Strategies for Returning Individual Research Results: A Mixed-Methods Study Across...

Despite growing national guidance supporting the return of individual research results (IRRs) to participants, scalable, theory-informed implementation strategies to support consistent and effective return across multi-site studies remain underdeveloped. This study aimed to identify multilevel determinants of IRR return and to use those determinants to inform the inform the specification of implementation strategies for multisite research settings.

A mixed-methods study, guided by the Consolidated Framework for Implementation Research (CFIR), was conducted within the American Lung Association's NIH-funded Lung Health Cohort (LHC) study, a 26-site multisite research network. A structured CFIR-informed survey and qualitative thematic analysis were used to examine IRR return practices. Survey and focus group questions were mapped to CFIR domains. Descriptive statistics summarized quantitative findings, and inductive thematic analysis was applied to open-ended survey responses and focus group data. Emergent themes were mapped to CFIR domains and synthesized to inform implementation strategy development.

Fifty-one research team members representing all twenty-six sites participated in a structured survey. Multilevel determinants influencing IRR return were identified across all CFIR domains. Two focus groups (n = 26) were held with research coordinators and study investigators to understand key challenges including complexity of communicating findings of uncertain clinical significance (Innovation), variability in participant access to care and health literacy (Outer Setting), heterogeneity in workflows and role delineation (Inner Setting), differences in team confidence and preparedness (Characteristics of Individuals), and lack of standardized communication tools and monitoring systems (Implementation Process). These determinants were used to specify a set of theory-informed implementation strategies, including standardized communication templates, role-specific scripts, clinical escalation pathways, participant navigation supports, and workflow tracking systems.

This study moves beyond descriptive assessment to inform the development of scalable, theory-informed implementation strategies for returning IRRs in multisite research. By linking empirically identified determinants to actionable strategies, these findings provide a foundation for future intervention development and evaluation aimed at improving consistency, efficiency, and participant-centered communication of research results.