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CC BY-NC-ND 4.0 · Appl Clin Inform 2025; 16(02): 259-266
DOI: 10.1055/a-2462-8699
Special Section on Patient-Reported Outcomes and Informatics

Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations

Andrea Cheville
1   Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, United States
,
Crystal L. Patil
2   School of Nursing, University of Michigan, Ann Arbor, Michigan, United States
,
Andrew D. Boyd
3   Department of Biomedical and Health Information Sciences, University of Illinois Chicago, Chicago, Illinois, United States
,
Leslie J. Crofford
4   Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States
,
Dana Dailey
5   Department of Physical Tehrapy and Rehabilitation Science, University of Iowa, Iowa City, Iowa, United States
6   Physical Therapy Department, St. Ambrose University, Davenport, Iowa, United States
7   Physical Therapy and Rehabilitation Department, University of Iowa, Iowa City, Iowa, United States
,
Victoria de Martelly
8   College of Nursing, University of Illinois Chicago, Chicago, Illinois, United States
,
Guilherme Del Fiol
9   Department of Biomedical Informatics, University of Utah School of Medicine, Salt Lake City, Utah, United States
,
Miriam O. Ezenwa
10   College of Nursing, University of Florida, Gainesville, Florida, United States
,
Keturah R. Faurot
11   Department of Physical Medicine and Rehabilitation, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States
,
Mitch Knisely
12   School of Nursing, Duke University, Durham, North Carolina, United States
,
Kaitlyn R. McLeod
13   Department of Medicine, University of Colorado, Denver, Colorado, United States
,
Natalia E. Morone
14   Chobanian and Avedisian School of Medicine, Boston Medical Center, Boston University, Boston, Massachusetts, United States
,
Emily O'Brien
15   Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, United States
,
Rosa M. Gonzalez-Guarda
12   School of Nursing, Duke University, Durham, North Carolina, United States
,
Kathleen A. Sluka
5   Department of Physical Tehrapy and Rehabilitation Science, University of Iowa, Iowa City, Iowa, United States
,
Karen Staman
16   Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, Utah, United States
,
Anne Thackeray
16   Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, Utah, United States
,
Christina K. Zigler
15   Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, United States
,
Judith M. Schlaeger
8   College of Nursing, University of Illinois Chicago, Chicago, Illinois, United States
› Author Affiliations Funding This work was supported within the National Institutes of Health (NIH) Pragmatic Trials Collaboratory through cooperative agreement U24AT009676 from the National Center for Complementary and Integrative Health (NCCIH), the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), the National Institute on Aging (NIA), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Nursing Research (NINR), the National Institute of Minority Health and Health Disparities (NIMHD), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the NIH Office of Behavioral and Social Sciences Research (OBSSR), and the NIH Office of Disease Prevention (ODP). This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961. Demonstration Projects within the NIH Pragmatic Trials Collaboratory were supported by the following cooperative agreements with NIH Institutes: BeatPain Utah (UG3NR019943, UH3NR019943), FM-TIPS (UG3AR076387, UH3AR076387), GRACE (UG3AT011265, UH3AT011265), NOHARM (UG3AG067593, UH3AG067593), OPTIMUM (UG3AT010621, UH3AT010621). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NCCIH, NIAID, NCI, NIA, NHLBI, NINR, NIMHD, NIAMS, OBSSR, or ODP, or the NIH or its HEAL Initiative.
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Abstract

Background The NIH Pragmatic Trials Collaboratory supports the design and conduct of 31 embedded pragmatic clinical trials, and many of these trials use patient-reported outcome measures (PROMs) to provide valuable information about the patients' health and wellness. Often these trials enroll medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnic minority groups, or rural or frontier communities.

Objectives In this series of trial case reports, we provide lessons learned about collecting PROMs in these populations. Unbiased collection of PROM data is critical to increase the generalizability of trial outcomes and to address health inequities. Use of electronic health records (EHRs) and other digital modes of PROM administration has gained traction. However, engagement with these modes is often low among populations prone to disparity due to lower digital proficiency, device access, and uptake of EHR portals and web interfaces.

Methods To maximize the completeness and representativeness of their trial outcome data, study teams tested a range of strategies to improve PROM response rates with emphasis on disparities prone and underserved patient groups. This manuscript describes the approaches, their implementation, and the targeted populations.

Conclusion Optimized PROM collection required hybrid approaches with multiple outreach modes, high-touch methods, creativity in promoting digital uptake, multimodal participant engagement, and text messaging.

Keywords

patient-reported outcome measures - patient-reported outcomes - pain - pragmatic clinical trials

Protection of Human and Animal Subjects

This paper summarizes lessons learned from ongoing trials, and human subjects were not directly involved in the project. All studies included here were performed in compliance with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects and were reviewed by Institutional Review Boards on a study-by-study basis.




Publication History

Received: 01 July 2024

Accepted: 23 September 2024

Accepted Manuscript online:
07 November 2024

Article published online:
19 March 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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