Author ORCID Identifier

https://orcid.org/0009-0007-9393-680X

Document Type

Dissertation

Date of Award

2026

Degree Name

Doctor of Philosophy (PhD)

Department

Health Science

First Advisor

Susan Puumala

Abstract

In the United States, the Food and Drug Administration sets expectations on the collection and reporting of race and ethnicity data. Ethnic data for Mexican Americans is often reported as “Hispanic or Latino.” Mexican Americans make up a significant percentage of “Hispanic or Latinos,” however, they remain significantly underrepresented in clinical trials. Grounded in Expectation-Disconfirmation Theory (EDT) and Social Cognitive Theory (SCT), this mixed-methods study investigates the relationship between satisfaction and perception of Mexican Americans who have participated in an ophthalmology clinical trial. This research aimed to understand the relationships among satisfaction with the clinical trial process, patient-reported outcomes, and the diversity of clinical trial participants. A scoping review was conducted to identify patient-reported outcomes and satisfaction with clinical trials among Hispanic or Latino participants. A quantitative study, using surveys (N=23) assessed the relationship between demographic factors, study characteristics, health-related quality of life, acculturation, and satisfaction with the clinical trial. A qualitative study, which consisted of semi-structured qualitative interviews with research coordinators (N=7), explored the institutional, cultural, and relational dynamics affecting patient engagement. The scoping review identified a critical data gap, revealing that studies rarely address patient experience or satisfaction with the clinical trial. The quantitative analysis identified that communication quality was a strong predictor of participant satisfaction in clinical trials. The qualitative findings from the coordinators’ interviews highlight the importance of culturally tailored clinical trials, visually heavy instructional tools, and linguistic alignment, which are pivotal for navigating systemic barriers, creating trust, and fostering a sense of participant value. This dissertation finds that Mexican Americans are heavily driven by relational communication and by trust in health care providers. To improve minority enrollment and retention, clinical trial sponsors must aim to design culturally adapted studies.

Subject Categories

Medicine and Health Sciences

Keywords

Clinical Trial, Health Equity, Ophthalmology

Number of Pages

156

Publisher

University of South Dakota

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