Evidence map›Paper›PMID 40487859›Full record

ArticleGlobal advances in integrative medicine and health

Increasing Equity Within Randomized Control Trials: A Qualitative Analysis of Focus Groups From a Multi-Site, Pragmatic Clinical Trial.

Elondra D Harr, Ruth D Rodriguez, Jose E Baez, Jessica L Barnhill, Christine R Lathren, Natalia E Morone, Isabel J Roth

Abstract read
In one paragraph

Article in Global advances in integrative medicine and health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

7 authors.

Elondra D HarrProgram on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.ORCID https://orcid.org/0000-0002-6146-6459
Ruth D RodriguezDepartment of General Internal Medicine, Boston Medical Center, Boston, MA, USA.
Jose E BaezDepartment of General Internal Medicine, Boston Medical Center, Boston, MA, USA.
Jessica L BarnhillProgram on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.ORCID https://orcid.org/0000-0003-3360-4217
Christine R LathrenProgram on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Natalia E MoroneBoston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA.ORCID https://orcid.org/0000-0002-8405-5396
Isabel J RothDivision of Health Systems, Policy, and Innovations, University of North Carolina at Chapel Hill School of Nursing, Chapel Hill, NC, USA.

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
NCCIH NIH HHS U24 AT009676
6 · The paper itself

Abstract

Background: Underrepresentation of diverse populations in clinical trials poses challenges to equity and external validity in health care research. To successfully recruit underrepresented participants in pragmatic clinical trials, researchers must understand the perspectives and needs of individuals from diverse backgrounds who participate in research. Objective: The purpose of this qualitative study was to gain an understanding of the needs and perspectives of participants of the OPTIMUM trial -- a pragmatic trial evaluating mindfulness-based stress reduction for chronic low back pain. Methods: This qualitative study employed focus groups with participants from 3 clinical sites: Boston Medical Center, the University of North Carolina at Chapel Hill, and the University of Pittsburgh. Focus group discussions centered on participants' experiences, barriers, and facilitators to engagement in the OPTIMUM trial. Data were analyzed using thematic content analysis and the rapid qualitative analysis method, Lightning Reports, for real-time feedback integration into the trial process. Results: Six focus groups were conducted with 46 participants, of whom 39.1% were first-time research participants and 56.5% identified as Black or African American. Qualitative analysis identified five key themes:1) The importance of providers in the recruitment of cLBP patients, (2) Motivators to participate and stay engaged in clinical research, (3) Participant lack of understanding of randomized control trials (RCTs) and general research processes, (4) Desire for social connection and community-building among participants, and (5) the Positive impact of regular study staff interaction. Conclusion: Equity in RCTs requires intentional strategies to address barriers to participation and engagement faced by historically underrepresented populations. Engaging health care providers in recruitment, fostering positive interactions with study staff, and creating opportunities for social connection can improve recruitment, retention, and engagement. Incorporating community-engaged research methods and real-time feedback mechanisms can further support inclusivity and equity in pragmatic clinical trials.

Indexed as

focus groupsintegrative medicinepatient participationpragmatic clinical trialsunderrepresented populations

Identifiers

PMID40487859
PMCPMC12144376

What OpenQuestion holds

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LicenceCC BY-NC
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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.