Failure to directly and appropriately assess language proficiency when recruiting patients to randomised controlled trials (RCTs) for diabetes treatments may be leading to black and ethnic minority (BAME) patients being underrepresented or excluded, new research has found.
BAME patients are more susceptible to and have a higher incidence of type 2 diabetes compared to the wider population. However, the underrepresentation of BAME patients in type 2 diabetes RCTs makes it difficult to generalise the findings of these trials, and to determine whether the treatment is beneficial for this patient group.
Dr Talia Isaacs, the Principal Investigator of the study from the University of Bristol’s Graduate School of Education, said: “Randomised controlled trials test the effectiveness of new medical treatments. Ideally, the group of patients participating in a trial should reflect the wider population who will be using the treatment."
The study, which also included researchers from Bristol’s School of Social and Community Medicine and School for Policy Studies, was the first systematic review to address the role of language in recruiting ethnic minority patients to RCTs targeting type two diabetes. It focussed on telehealth interventions, which involve remote healthcare delivery using phone, internet, or other technology, and can involve increased communication demands. The researchers found that, when making decisions about patient eligibility for RCT participation, language proficiency was only mentioned in half of the 58 RCTs studied.
Dr Daniel Hunt, Assistant Professor in Discourse Analysis from The University of Nottingham, and a co-author of the study, said: “There were no common procedures across RCTs to assess if patients had the necessary language ability to take part in the RCTs. For example, some listed different combinations of language skills as being considered (speaking, listening, reading, and writing) whereas others referred to patients’ native speaker status.”
Dr Isaacs continued: “None specified how the stated language criterion was measured. This suggests that decisions about whether or not patients have adequate language skills to participate in RCTs could be based on trial recruiters’ subjective decisions, which may be biased.”
Nearly two-thirds of the RCTs included in the review provided information about the ethnic composition of the sample of patients recruited. However, less than a third of the studies that reported on this recruited a sizeable proportion of ethnic minorities (defined as over 30% of the total number of participants). Although research from all Western countries where English is an official language was included in the review, all high-recruiting studies were US-based and involved a wide range of different telehealth technologies. The majority offered their intervention or trial materials in another language as well as English.
Unlike the UK and other countries included in the review (eg. Canada, Australia), the USA legislates on the inclusion of BAME patients in medical research. Although America has a larger proportion of BAME individuals compared to the other countries, the greater inclusion of BAME patients in RCTs is likely to be, at least in part, a reflection of this policy.
Dr Isaacs said: “As a result of our findings, we recommend clearer guidelines for reporting on recruited patients’ sociodemographic characteristics, including language background and ethnicity. A practical language assessment tool should be developed in future research to minimise the possibility of patients being unfairly excluded from RCTs based on trial recruiters' arbitrary judgments.”
This study, which was part of a Marie Curie grant, was carried out by an interdisciplinary research team at the Universities of Bristol and Nottingham. It was supported by the Medical Research Council (MRC) ConDuCT-II Hub at the University of Bristol’s School of Social and Community Medicine, which conducts leading methodological research on RCTs, including ways of optimising recruitment to trials.