Study: BAME patients underrepresented or excluded in clinical trials for diabetes treatments

Study: BAME patients underrepresented or excluded in clinical trials for diabetes treatments

Study: BAME patients underrepresented or excluded in clinical trials for diabetes treatments

NOTTINGHAM, 04-Oct-2016 — /EuropaWire/ — Failure to assess people’s language skills when recruiting patients to clinical trials for diabetes treatments may be leading to black, Asian and ethnic minority (BAME) patients being underrepresented or excluded, says a new study.

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 Randomised Controlled Trials (RCTs) makes it difficult to generalise the findings of these trials, and to determine whether the treatment is beneficial for this patient group – according to a new study from the universities of Bristol and Nottingham.

Testing the effectiveness of new treatments

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 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.

Language skills

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 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.

Recommendations

Unlike the UK and other countries included in the review (e.g., 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.

The full study is published online at the Journal of Medical Internet research.

— Ends —

Our academics can now be interviewed for broadcast via our Media Hub, which offers a Globelynx fixed camera and ISDN line facilities at University Park campus. For further information please contact a member of the Communications team on +44 (0)115 951 5798, email mediahub@nottingham.ac.uk or see the Globelynx website for how to register for this service.

For up to the minute media alerts, follow us on Twitter

Notes to editors: The University of Nottingham has 43,000 students and is ‘the nearest Britain has to a truly global university, with a “distinct” approach to internationalisation, which rests on those full-scale campuses in China and Malaysia, as well as a large presence in its home city.’ (Times Good University Guide 2016). It is also one of the most popular universities in the UK among graduate employers and the winner of ‘Outstanding Support for Early Career Researchers’ at the Times Higher Education Awards 2015. More than  97% of research at The University of Nottingham is recognised internationally and it is 8th in the UK by research power according to the Research Excellence Framework 2014. It has been voted the world’s greenest campus for four years running, according to Greenmetrics Ranking of World Universities.

Impact: The Nottingham Campaign, its biggest-ever fundraising campaign, is delivering the University’s vision to change lives, tackle global issues and shape the future. More news…

Story credits

More information is available from Dr Daniel Hunt on +44 (0)115 748 6364 or daniel.hunt@nottingham.ac.uk

Charlotte Anscombe – Media Relations & Campaign Manager

Email: charlotte.anscombe@nottingham.ac.uk
Phone:+44 (0)115 74 84 417
Location: University Park

SOURCE: The University of Nottingham

Follow EuropaWire on Google News
EDITOR'S PICK:

Comments are closed.