Evidence map›Paper›PMID 42245816›Full record

ArticleResearch square2026

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

Denise Kent, Michelle Villegas-Downs, Mary Pasquinelli, Adriana Arcia, Lauren Greene, Sarah Darski, Elizabeth Sugar, Ravi Kalhan, Subidsa Srikantha, Hugh Musick and 2 more

Abstract readPreprint
In one paragraph

Article in Research square, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Denise KentUniversity of Illinois at Chicago.
Michelle Villegas-DownsUniversity of Illinois at Chicago.
Mary PasquinelliUniversity of Illinois at Chicago.
Adriana ArciaUniversity of San Diego.
Lauren GreeneUniversity of Illinois at Chicago.
Sarah DarskiUniversity of Illinois at Chicago.
Elizabeth SugarJohns Hopkins University.
Ravi KalhanNorthwestern University.
Subidsa SrikanthaUniversity of Illinois at Chicago.
Hugh MusickUniversity of Illinois at Chicago.
Jerry KrishnanUniversity of Illinois at Chicago.
Lynn GeraldUniversity of Illinois at Chicago.

Funding

The American Lung Association (ALA) Lung Health CohortU01HL146408 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI CARNETHON, MERCEDES RENEE, KALHAN, RAVI · 2019 to 2024
$25.2M
NHLBI NIH HHS U01 HL146408
6 · The paper itself

Abstract

Introduction: 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. Methods: 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. Results: 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. Conclusions: 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.

Indexed as

Consolidated Framework for Implementation ResearchHealth communicationImplementation scienceImplementation strategiesIncidental findingsIndividual research results (IRRs)Mixed-methodsMultisite researchParticipant engagementReturn of results

Identifiers

PMID42245816
PMCPMC13232467

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.