Abstract
BackgroundConcerns have been raised about low participation rates of people from minority ethnic groups in clinical trials. However, the evidence is unclear as many studies do not report the ethnicity of participants and there is insufficient information about the reasons for ineligibility by ethnic group. Where there are data, there remains the key question as to whether ethnic minorities more likely to be ineligible (e.g. due to language) or decline to participate. We have addressed these questions in relation to the Birmingham Rehabilitation Uptake Maximisation (BRUM) study, a randomized controlled trial (RCT) comparing a home-based with a hospital-based cardiac rehabilitation programme in a multi-ethnic population in the UK.MethodsAnalysis of the ethnicity, age and sex of presenting and recruited subjects for a trial of cardiac rehabilitation in the West-Midlands, UK.Participants: 1997 patients presenting post-myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery.Data collected: exclusion rates, reasons for exclusion and reasons for declining to participate in the trial by ethnic group.ResultsSignificantly more patients of South Asian ethnicity were excluded (52% of 'South Asian' v 36% 'White European' and 36% 'Other', p < 0.001). This difference in eligibility was primarily due to exclusion on the basis of language (i.e. the inability to speak English or Punjabi). Of those eligible, similar proportions were recruited from the different ethnic groups (white, South Asian and other). There was a marked difference in eligibility between people of Indian, Pakistani or Bangladeshi origin.ConclusionOnce eligible for this trial, people from different ethnic groups were recruited in similar proportions. The reason for ineligibility in the BRUM study was the inability to support the range of minority languages.
Highlights
Concerns have been raised about low participation rates of people from minority ethnic groups in clinical trials
BMC Medical Research Methodology 2005, 5:18 http://www.biomedcentral.com/1471-2288/5/18. Once eligible for this trial, people from different ethnic groups were recruited in similar proportions
The reason for ineligibility in the Birmingham Rehabilitation Uptake Maximisation (BRUM) study was the inability to support the range of minority languages
Summary
Concerns have been raised about low participation rates of people from minority ethnic groups in clinical trials. Proportional representation of research participants by race is a requirement of The National Institutes of Health in the USA [1] No such requirement exists in the UK, but concern has been expressed about the low representation of patients from ethnic minority groups in clinical trials [2,3]. Much research on ethnicity has focused on testing hypotheses about differences in outcome by race or ethnicity whilst the issue that participants of trials should represent the population that will be receiving an intervention has been relatively neglected. This is essential for the generalisability of the results [8,9], and to achieve this, trial participants need to mirror the demographic profile of the disease group being studied. Whether participants in trials of chronic disease management reflect the population who are affected by such disease is an issue of growing importance in the UK as the black and minority ethnic population ages
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