How stakeholder engagement influenced a randomized comparative effectiveness trial testing two Diabetes Prevention Program interventions in a Marshallese Pacific Islander Community

(2019) 17:42 McElfish et al. J Transl Med https://doi.org/10.1186/s12967-019-1793-7 Journal of Translational Medicine Open Access RESEARCH How stakeholder engagement influenced a randomized comparative effectiveness trial testing two Diabetes Prevention Program interventions in a Marshallese Pacific Islander Community Pearl A. McElfish1*, Britni L. Ayers1, Holly C. Felix1, Christopher R. Long1, Zoran Bursac2, Joseph Keawe‘aimoku Kaholokula3, Sheldon Riklon1, Williamina Bing1, Anita Iban4 and Karen Hye‑cheon Kim Yeary5 Abstract Background: Marshallese face significant health disparities, with particularly high rates of type 2 diabetes. Engaging stakeholders in the research process is essential to reduce health inequities. Methods: A community- and patient-engaged research approach was used to involve community Marshallese stakeholders in a randomized comparative effectiveness trial testing two Diabetes Prevention Program interventions. Results: The article outlines the engagement process and the specific influence that stakeholders had on the research planning and implementation, discussing the areas of agreement and disagreement between community and patient stakeholders and academic investigators and documenting changes to the research protocol. Conclusion: The article provides an example of methods that can be used to design and conduct a randomized controlled trial testing with a population who has been underrepresented in research and suffered significant histori‑ cal trauma. Keywords: PCOR, CBPR, Pacific Islander, Marshallese, Diabetes Prevention Program, Type 2 diabetes, RCT Background Pacific Islanders are one of the fastest growing populations in the United States (US), with a 40% increase from 2000 to 2010 [1]. Southern and Midwestern states, such as Arkansas, Kansas, Missouri, and Oklahoma, had particularly rapid growth in Pacific Islander communities [1]. Most of the Pacific Islander population growth in these states are Micronesian populations from the Compact of Free Association (COFA) nations, including Marshallese from the Republic of the Marshall Islands (RMI). As part *Correspondence: 1 University of Arkansas for Medical Sciences, Northwest Campus, 1125 North College Ave, Fayetteville, AR 72703, USA Full list of author information is available at the end of the article of the COFA, Marshallese can freely migrate to the US [2–4]. The Marshallese began migrating to Southern and Midwestern states for work and educational opportunities [5]. Arkansas now has the largest population of Marshallese in the continental US [6–9], and rapid growth in the Marshallese population continues in Arkansas, Kansas, Missouri, and Oklahoma [9]. The US has a complex and contentious history with the Marshallese community. Between 1946 and 1958 the US military tested nuclear weapons on the RMI, which were equivalent to more than 7000 Hiroshima-sized bombs [10, 11]. While the Marshallese who lived on the bombed islands and atolls were relocated, Marshallese living on nearby atolls were not. The nuclear testing contaminated © The Author(s) 2019. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. McElfish et al. J Transl Med (2019) 17:42 food and water supplies and disrupted the Marshallese traditional way of life, which included self-reliance on fish and local fruits and vegetables. These traditional foods were replaced with commodities high in fat, refined carbohydrates, and sodium negatively affecting subsequent generations of Marshallese [12]. The US nuclear testing program exposed Marshallese to significant levels of nuclear radiation [10, 11, 13–22]. After the nuclear weapons testing, US scientists set up a study called Project 4.1 to better understand the effects of nuclear radiation on humans [10]. Marshallese who had been exposed to direct nuclear fallout were brought to Kwajalein Atoll for examination as part of Project 4.1. The research was conducted without translation of the study information into Marshallese and without informed consent [10]. The nuclear testing and subsequent research of Project 4.1 perpetuated historical trauma evidenced by Marshallese community members’ deep mistrust of research and health care providers that are past down to the next generation [10, 23, 24]. Culturally-insensitive researchers and providers only further serve to exacerbate their trauma; thus, leading to health care access issues for Marshallese. Because of the historical trauma perpetuated by the US nuclear weapons testing program and Project 4.1, many Marshallese are skeptical of health care providers and reluctant to participate in research. One way to address health disparities and historical trauma is through community- and patient-engaged research. The Patient-Centered Outcomes Research Institute (PCORI) was established to fund patient-centered outcomes research (PCOR) that evaluates research questions and meaningful outcomes to patients and caregivers [25]. PCORI posits that incorporating the patient perspective into health care research enhances usefulness and expedites the uptake of research into practice. PCOR is predicated on community-engaged research principles as it seeks to involve patients and community stakeholders in all areas of the research process. Community- and patient-engaged research has demonstrated effectiveness among underserved and disparate populations who are often underrepresented in research [26–30]. In 2012, the authors began working with the Marshallese to better understand the health disparities present in this population using a community- and patient-engaged approach to conduct qualitative and quantitative needs assessments [31–35]. Articles describing the process and results of this engagement are published elsewhere [35, 36]. Needs assessment data revealed rates of type 2 diabetes (38%), prediabetes (33%), hypertension (41%), and overweight/obesity (90%) that are substantially higher among the Marshallese than the general US population [34]. Prevention of type 2 diabetes Page 2 of 8 was prioritized as the top health concern and risk by the Marshallese community in Arkansas [37, 38]. This article describes the process of developing a randomized controlled trial (RCT) to compare the effectiveness of two Diabetes Prevention Programs using community- and patient-engaged research principles with Marshallese stakeholders’ input. Methods To address type 2 diabetes, a diverse community-academic research team was require (...truncated)