The Inclusion of Ethnic Minority Patients and the Role of Language in Telehealth Trials for Type 2 Diabetes: A Systematic Review

Abstract

BackgroundType 2 diabetes is a serious, pervasive metabolic condition that disproportionately affects ethnic minority patients. Telehealth interventions can facilitate type 2 diabetes monitoring and prevent secondary complications. However, trials designed to test the effectiveness of telehealth interventions may underrecruit or exclude ethnic minority patients, with language a potential barrier to recruitment. The underrepresentation of minorities in trials limits the external validity of the findings for this key patient demographic.ObjectiveThis systematic review examines (1) the research reporting practices and prevalence of ethnic minority patients included in telehealth randomized controlled trials (RCTs) targeting type 2 diabetes and the trial characteristics associated with recruiting a high proportion of minority patients, and (2) the proportion of included RCTs that report using English language proficiency as a patient screening criterion and how and why they do so.MethodsTelehealth RCTs published in refereed journals targeting type 2 diabetes as a primary condition for adults in Western majority English-speaking countries were included. Ethnically targeted RCTs were excluded from the main review, but were included in a post hoc subgroup analysis. Abstract and full-text screening, risk of bias assessment, and data extraction were independently conducted by two reviewers.ResultsOf 3358 records identified in the search, 79 articles comprising 58 RCTs were included. Nearly two-thirds of the RCTs (38/58) reported on the ethnic composition of participants, with a median proportion of 23.5% patients (range 0%-97.7%). Fourteen studies (24%) that included at least 30% minority patients were all US-based, predominantly recruited from urban areas, and described the target population as underserved, financially deprived, or uninsured. Eight of these 14 studies (57%) offered intervention materials in a language other than English or employed bilingual staff. Half of all identified RCTs (29/58) included language proficiency as a participant-screening criterion. Language proficiency was operationalized using nonstandardized measures (eg, having sufficient “verbal fluency”), with only three studies providing reasons for excluding patients on language grounds.ConclusionsThere was considerable variability across studies in the inclusion of ethnic minority patients in RCTs, with higher participation rates in countries with legislation to mandate their inclusion (eg, United States) than in those without such legislation (eg, United Kingdom). Less than 25% of the RCTs recruited a sizeable proportion of ethnic minorities, which raises concerns about external validity. The lack of objective measures or common procedures for assessing language proficiency across trials implies that language-related eligibility decisions are often based on trial recruiters’ impressionistic judgments, which could be subject to bias. The variability and inconsistent reporting on ethnicity and other socioeconomic factors in descriptions of resea...

Developing the INCLUDE Ethnicity Framework– a tool to help trialists design trials that better reflect the communities they serve

“…Ethnic minority groups are often under-represented in trials despite being 1 in 8 of the UK population and frequently having most to gain clinically 2,3 . In a review of 12 trials for patients with type 2 diabetes, the mean percentage of South Asian recruits in eight of them was 5.5% despite South Asians representing 11.2% of the UK type 2 diabetes population 3 .…”

Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study

“…Recent meta-analyses showed that telehealth interventions result in a modest but significant improvement in reductions in glucose levels when compared to usual care [14,15]. In addition, two 2016 systematic reviews, one based on 111 randomized controlled trials (RCTs) and another on 55 RCTs, found that home telemonitoring significantly improves glucose management; however, less than 25% of RCTs were conducted with ethnically diverse patients, thereby diminishing the external validity of the findings [16][17][18] Polisena et al 's [19] meta-analysis of 26 studies revealed a positive effect on glucose management, noting that more research of higher methodological quality is required, recommending the inclusion of patients from diverse backgrounds to increase external validity and assess technology adaptation to optimize use among different populations [19]. Other meta-analyses on underserved populations, which conclude that home telemonitoring improves glucose management, note that studies should utilize community-based participatory research (CBPR) approaches involving patients and caregivers to develop personalized interventions to enhance persistence in usage and treatment adherence [20][21][22].…”

Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus

“…The standard dietary education and advice provided by mainstream health care services may not adequately address the daily challenges faced by minority patients as their cultural, social, and dietary norms and socioeconomic realities differ from that of the majority population. IT tools can provide new opportunities to make DM-related dietary education and counseling more relevant and individually tailored for patients [7,8]; however, few existing examples/initiatives have included sizeable proportions of ethnic minority patients [7,15]. There is a need to expand the evidence base for new digital health technologies that can address these needs [16] among the highest-risk, most vulnerable patient populations.…”