Participation of Patients With Limited English Proficiency in Gynecologic Oncology Clinical Trials

Abstract

Background: Significant disparities exist in recruitment of minorities to clinical trials, with much of the prior literature focused on race/ethnicity only. Limited English proficiency (LEP) is a known barrier in healthcare that may also drive disparities in trial enrollment. We sought to determine participation rates in gynecologic oncology trials among patients with LEP and to explore barriers to their participation. Methods: In a retrospective cohort study, electronic health record data from >2,700 patients treated over 2 years at one academic gynecologic oncology practice were abstracted and the primary exposure of having LEP was identified. The primary outcome was enrollment in a clinical trial. Demographic, financial, clinical, and healthcare access–related covariates were also abstracted and considered as potential confounders in a multivariable logistic regression model. Age, race, ethnicity, and insurance status were further examined for evidence of effect modification. In addition, a survey was administered to all gynecologic oncology research staff and gynecologic oncology providers (n=25) to assess barriers to research participation among patients with LEP. Results: Clinical trial enrollment was 7.5% among fluent English speakers and 2.2% among patients with LEP (risk ratio, 0.29; 95% CI, 0.11–0.78; P=.007), and remained significantly lower in patients with LEP after adjusting for the identified confounders of Hispanic ethnicity and insurance payer (odds ratio, 0.34; 95% CI, 0.12–0.97; P=.043). There was a trend toward race and LEP interaction: Asian patients were equally likely to participate in research regardless of language fluency, whereas White and Black patients with LEP were less likely to participate than non-LEP patients in both groups (P=.07). Providers reported that the most significant barriers to enrollment of patients with LEP in research were unavailability of translated consent forms and increased time needed to enroll patients. Conclusions: Patients with LEP were 3.4 times less likely to participate in gynecologic oncology trials than fluent English speakers. De-aggregation of race, ethnicity, and language proficiency yielded important information about enrollment disparities. These findings offer avenues for future interventions to correct disparities.

Lost in Translation: Participation in Cancer Clinical Trials for Patients With Limited English Proficiency

“…In a retrospective cohort study based on reviews of electronic health record data from 2,793 patients with gynecologic cancers, the authors found a 71% reduction in likelihood of trial participation for those with LEP (2.2% participation) compared with fluent English speakers (7.5%). 6 This finding was robust to covariate adjustment for known confounders of ethnicity and insurance, and the observed trends were consistent across levels of demographic, socioeconomic, and other key variables, further supporting the idea that LEP is independently related to trial participation. Importantly, to underscore the causal relationship, the authors also surveyed gynecologic research staff and providers, who indicated that the main reasons for limited participation of patients with LEP were unavailability of translated consent forms and increased time needed to enroll patients.…”

“…4 Indeed, in a recent study, when patients were offered the opportunity to participate in a trial that was available and for which they were clinically eligible, they agreed to do so at astounding rates; .50% of patients of all racial and ethnic backgrounds indicated they wished to enroll. 5 With this as background, the findings from Jorge et al, 6 reported elsewhere in this issue, represent an important contribution to the literature. The authors investigated the role of limited English proficiency (LEP) as a reason for nonparticipation in clinical trials.…”

“…A limitation in English proficiency is a modifiable factor that can be easily and readily alleviated as a reason for nonparticipation. Jorge et al 6 See page 27 for related article.…”

“…Notably, nearly all of the trials included in the dataset (97%) were sponsored by pharmaceutical companies, which predominantly conduct trials in large academic centers and are able to commit substantial resources toward patient enrollment. The results reported by Jorge et al 6 suggest that one strategy whereby pharmaceutical company-sponsored trials may yield improved representation would be to ensure that sufficient support is provided to aide patients with LEP with all patient-facing questionnaires, including consent forms, and to provide translation services as needed.…”

Access Denied: Disparities in Thyroid Cancer Clinical Trials

“…Cancer patients with limited English proficiency (LEP) encounter similar challenges to accessing and participating in cancer clinical trials [ 66 ]. In a retrospective cohort study of patients with gynecologic cancers, Jorge et al [ 67 ] found that even after adjusting for ethnicity and insurance status, patients with LEP had 66% lower odds of participating in clinical trials than fluent English speakers. In addition, a survey of gynecologic research staff and providers identified the most significant barriers to research participation for patients with LEP to be the lack of translated consent forms and increased time needed to enroll patients with LEP [ 67 ].…”