Evidence map›Paper›PMID 41004496›Full record

ArticlePloS one2025

Study team perspectives on a multisite randomized clinical trial with underserved rural populations: A mixed methods feasibility analysis.

Kristina L Foster, Sarah Sanders, Christi A Madden, Lacy Malloch, Amy Swango-Wilson, Barbara Jandasek, Maryam Y Garza, Jaime Baldner, Erin Dawley, Timothy VanWagoner and 2 more

Abstract read
In one paragraph

Article in PloS one, 2025. 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.

Kristina L FosterDepartment of Pediatrics, University of Kansas Medical Center, Kansas City, Kansas, United States of America.ORCID 0000-0002-4503-6694
Sarah SandersDepartment of Pediatrics, University of New Mexico, Albuquerque, New Mexico, United States of America.
Christi A MaddenTranslational Research Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America.
Lacy MallochDepartment of Pediatrics, University of Mississippi Medical Center, Jackson, Mississippi, United States of America.
Amy Swango-WilsonDepartment of Research Services, Alaska Native Tribal Health Consortium, Anchorage, Alaska, United States of America.
Barbara JandasekDepartment of Psychiatry and Human Behavior and the Department of Pediatrics, Warren Alpert Medical School of Brown University, Bradley Hasbro Children's Research Center, Brown University Health, Both in Providence, Rhode Island, United States of America.ORCID 0000-0001-9217-9287
Maryam Y GarzaDepartment of Population Health Science Center, University of Texas Health Sciences at San Antonio, San Antonio, Texas, United States of America.ORCID 0000-0002-2652-5935
Jaime BaldnerDepartment of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States of America.
Erin DawleyDepartment of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Timothy VanWagonerDepartment of Pediatrics, University of Oklahoma Health College of Medicine, Oklahoma City, Oklahoma, United States of America.
Jerome Philip SaulDepartment of Pediatrics, West Virginia School of Medicine, Morgantown, West Virginia, United States of America.
Ann M DavisDepartment of Pediatrics, University of Kansas Medical Center, Kansas City, Kansas, United States of America.

Funding

MS-ISPCTN (Cycle 3)UG1OD024942 · OD · UNIVERSITY OF MISSISSIPPI MED CTR · PI Joseph Marc Majure · 2016 to 2026
$4.7M
Sunflower Pediatric Clinical Trials (SPeCTr 3.0)UG1OD024943 · OD · UNIVERSITY OF KANSAS MEDICAL CENTER · PI Ann M Davis, BRIDGETTE L. JONES · 2016 to 2026
$4.7M
Rhode Island Child Clinical Trials CollaborativeUG1OD024951 · OD · RHODE ISLAND HOSPITAL · PI THOMAS H CHUN, PHYLLIS A. DENNERY · 2016 to 2026
$4.7M
Trials and ReseArch Network FOR even More- South Carolina (TRANSFORM-3)UG1OD024956 · OD · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · PI ANDREW M ATZ, Lisa Knight · 2016 to 2026
$4.3M
The Oklahoma Pediatric Clinical Trials NetworkUG1OD024950 · OD · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Amanda L Bogie, Jeanie Beatrice Tryggestad · 2016 to 2026
$4.1M
NIH HHS UG1 OD024942NIH HHS UG1 OD024943NIH HHS UG1 OD024950NIH HHS UG1 OD024951NIH HHS UG1 OD024956
6 · The paper itself

Abstract

Although the literature on clinical trial methodology is quite robust, the voices of study staff as key influencers of this process are lacking, particularly for rural and underserved pediatric clinical trials. Using qualitative and quantitative (i.e., survey) methodology, the purpose of the current study was to gather information from study investigators and staff who served on one of the initial multi-state trials in the IDeA States Pediatric Clinical Trials Network (ISPCTN) regarding barriers and facilitators of conducting this rural clinical trial. Quantitative analysis indicated most study investigators and staff who responded (55%) were neutral about the various recruitment methods. Qualitative analyses identified 6 relevant themes: 1) Participant families felt overwhelmed with study procedures, 2) Incentives are important and should be given in a timely fashion to child as well as adult participants, 3) A personal connection is key to engagement and retention, 4) Specific recruitment materials and methods are preferred including family friendly consent forms and advertisements that clearly explain study procedures and clear expectations, 5) There was enthusiasm for the intervention and ideas for consideration in implementing future interventions of this type, and 6) Staff expressed enthusiasm for working in rural areas with rural participants and appreciated the unique aspects of working with this population. This paper provides valuable insight into the operational feasibility of a large, multi-site behavioral intervention trial and outlines lessons learned from study personnel with actionable tips for improving recruitment, retention, and other study procedures. These staff are open to various recruitment methods, and are enthusiastic about working with underserved, rural families. They report that they believe families can be overwhelmed by study procedures, and that a personal connection with families can facilitate study conduct.

Indexed as

Medically Underserved AreaRandomized Controlled Trials as TopicRural PopulationAdultChildFeasibility StudiesFemaleHumansMalePatient SelectionResearch Personnel

Identifiers

PMID41004496
PMCPMC12468765

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.