Recruitment of ethnic minority patients to a cardiac rehabilitation trial: The Birmingham Rehabilitation Uptake Maximisation (BRUM) study [ISRCTN72884263]
© Jolly et al; licensee BioMed Central Ltd. 2005
Received: 21 January 2005
Accepted: 17 May 2005
Published: 17 May 2005
Concerns 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.
Analysis 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.
Significantly 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.
Once 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.
Proportional representation of research participants by race is a requirement of The National Institutes of Health in the USA . However, 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]. There are some examples of good practice with a representative proportion of trial participants from minority ethnic groups recruited from areas of the UK with a diverse ethnic population [4, 5]. In addition, there is some evidence that once patients have met the inclusion criteria for a clinical trial, then equal recruitment of patients from different ethnic groups can be achieved [6–8].
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.
There are some unanswered questions with respect to the low representation of patients from minority ethnic groups in clinical trials. Firstly, compared to the majority white population, are patients from ethnic minority groups less likely to meet the eligibility criteria for a trial (e.g. because of language)? Secondly, are patients from ethnic minority groups more likely to refuse to participate in randomized trials ? Birmingham is an excellent place to explore this issue – some 30% of the population are from black and minority ethnic groups . We have the opportunity to address 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 .
The BRUM study recruited 525 (26.3%) participants from the 1997 patients who presented following a myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery to one of four West Midland hospitals from February 2002–January 2004 . The hospitals are located in an area of the UK with a high proportion of people of South Asian origin. The BRUM study sought to include patients who spoke either English or Punjabi (which is the most frequently spoken minority language locally), but was unable to include patients with other minority languages because of the lack of validated outcome measures in these languages.
Basic demographic data including self-defined ethnic group was sought on all presenting patients. Ethnic status was recorded using the same categories as the 2001 UK Census . Data on ethnicity was obtained for 1933 (96.8%) of the patients presenting following a heart attack, PTCA or CABG, following which the ethnic categories were then combined into three broad groups: White, South Asian (Pakistani, Indian and Bangladeshi) and Other (Caribbean, African, Chinese). No-one described themselves as being of mixed ethnicity. Data on individual social class was not collected on all presenting patients, so postcodes were used to assign the Index of Multiple Deprivation 2004 (IMD) . Details about the eligibility of patients, reasons for exclusion from the trial, and reason for declining to participate were collected. Data were entered into a Microsoft Windows ACCESS database (Microsoft Inc, USA) and analysed using SPSS version 12 (SPSS Inc, Chicago USA). Chi-squared tests were used to compare proportions across ethnic groups. For normally distributed data the one-way ANOVA was used to compare means, and the Kruskal-Wallis test to compare means for non-parametric data. Logistic regression was used to determine relative risks of eligibility and recruitment adjusted for sex, age, deprivation index and initial diagnosis.
Recruitment to and exclusion from the BRUM trial, by ethnic group
All presenting, n
MI n (%)
PTCA n (%)
CABG n (%)
Mean (SD) age
Males n (%)
Mean (SD) Index of Multiple Deprivation (IMD) 
Excluded n (%)
Reason for exclusion (more than 1 may apply) n (%)
bHigh cardiac risk
In other trial
Out of area
Excluded for language only n (%)
Eligible n (% of all presenting)
Males (% of presenting males)
Female (% presenting females)
Mean (SD) IMD of eligible patients
Refused (% of eligible)
Reason for refusal: n (%)
Did not want rehabilitation
Did not want to take part in research
Preference for hospital programme
No reason given
Total recruited (% of eligible)
(% of all)
Males (% of eligible males)
Female (% of eligible females)
Mean (SD) IMD of recruited patients
Eligibility and recruitment BRUM by ethnicity, adjusted for age, sex, deprivation and initial diagnosis
Adjusted RRa of eligibility
Adjusted RR of recruitment
0.81 to 2.84
0.60 to 2.02
0.33 to 0.55
0.44 to 0.78
0.70 to 2.35
0.54 to 2.00
0.16 to 4.19
0.23 to 4.21
In each ethnic group (white, South Asian and other) women were less likely to be eligible for the study than men (table 1). This was statistically significant for the white and South Asian groups. Overall the women presenting with ischaemic heart disease were significantly older than the men (mean age 69.2 versus 63.6 years for men, p = 0.002) and were more likely to be excluded because of co-morbidity (16.8% v 8.6% of men, p < 0.001). Women of white and South Asian ethnicity were significantly less likely than the men of these ethnic groups to be recruited once eligible (p < 0.01) (table 1). There was no difference given in the reasons for declining to participate in the study by men and women.
Exclusions by ethnic group within the South Asian population presenting with a cardiovascular event
n = 136
n = 238
n = 20
Mean (SD) age, years
Males n, (%)
Mean (SD) IMD score
Reason for exclusion (more than one may apply) n (%)
bHigh cardiac risk
Excluded for language only:
All n (%)
Aged <65 years
4 (8.2) p = 0.2
44 (43.6) p = 0.002
7 (87.5) p = 0.2
3 (7.5) p = 0.4
27 (50) p = 0.003
5 (100) p = 0.04
Total recruited n
(% of eligible)
(% of all presenting)
RR of ineligibility (95%CI)*
0.89 (0.6, 1.3)
4.0 (2.9, 5.5)
4.4 (1.6, 11.8)
This report has detailed the process of recruitment to a randomized controlled trial for patients from different ethnic groups from presentation with a cardiac event, through the eligibility criteria and consent process.
We have demonstrated that the point of inequality in recruitment between ethnic groups in this study occurred because of an inability to support the range of minority languages. This was despite additional measures employed to recruit Punjabi speaking patients, including a Punjabi speaking research nurse, translated (and recorded) patient information and the translation and validation of the Hospital Anxiety and Depression Scale into Punjabi. It is possible that those excluded on the grounds of language would have refused to participate in the trial, but we have no evidence to support or refute this possibility. Of those excluded as a result of language, 74% described themselves as of Pakistani origin and thus would have been catered for by the provision of Urdu and Mirapuri (an oral only language used by people of rural Pakistani origin). The socio-economic status of the presenting patients this is clearly a potential confounding factor, with people from minority ethnic groups who do not speak English being more likely to be of lower socio-economic status . Presenting patients from minority ethnic groups had significantly higher deprivation indices than the white ethnic group, using the IMD as a measure of socio-economic status, in this study. Whilst the level of deprivation was a significant factor in the multiple regression analysis, ethnicity was still a significant factor in the likelihood of eligibility and recruitment to the trial when deprivation was included in the regression model.
We found no significant differences in the proportions of people from the three main ethnic groups who gave the reason for their refusing to participate as 'not wishing to take part in research.' This result differs from the evidence from the USA, which suggests that people from minority ethnic groups are less likely to agree to participate in clinical research because of a lack of trust . The UK does not have the past history of the Tuskegee Syphilis study which appears to be the cause of this mistrust of research in black and minority ethnic groups in the US [17, 18]. It is true that in this study a higher proportion of the minority ethnic groups who declined to participate in the trial gave no reason for their decision, so it is possible that there were differences in the reasons for not-participating that we failed to identify.
In addition, our findings provide further support for the limited evidence base that patients from ethnic minority groups can be recruited in a similar proportion to the majority population, once they have fulfilled the trial's eligibility criteria [7, 8]. Other studies have tried to retrospectively estimate the proportion of patients from different ethnic groups, who would have been potential trial participants . However, we believe that this is the first published report that has detailed the whole recruitment process of cardiac patients presenting with the index conditions, reasons for ineligibility and rates and reasons for refusal to participate. In the BRUM trial, the eligible patients of South Asian ethnicity were no more likely to decline to participate on the grounds of not wishing to take part in a research study than other ethnic groups.
This research raises the issue of feasibility versus inclusivity. In this study, even with considerable effort, time and resources to try to recruit a representative population to the trial, we were unable to meet the wide language requirements. This must be considered in the context that this was a trial of a behavioural intervention with a psychological questionnaire as a main outcome measure. In other trials, with only objective clinical measurements as endpoints, it might be possible to exclude less patients due to language restrictions. In a geographical area of ethnic diversity, a number of languages would need to be supported to achieve equivalent recruitment rates for different ethnic groups, which has considerable cost and methodological implications. The importance of achieving a sample that is ethnically representative will depend on the research question and the context.
The BRUM study is funded by the NHS HTA Programme. The views and opinions expressed in this paper do not necessarily reflect those of the Department of Health.
The BRUM Steering Committee consists of Jolly K (Principal investigator), Lip GYH, Sandercock J, Greenfield SM, Raftery JP, Mant JW, Taylor RS, Lee KW, Lane D, Stevens AJ.
- National Institutes of Health Revitalisation Act of 1993.Google Scholar
- Mason S, Hussain-Gambles M, Leese B, Atkin K, Brown J: Representation of South Asian people in randomized clinical trials: analysis of trials' data. BMJ. 2003, 326: 1244-1245. 10.1136/bmj.326.7401.1244.View ArticlePubMedPubMed CentralGoogle Scholar
- Heiat A, Gross CP, Krumholz HM: Representation of the elderly, women and minorities in heart failure clinical trials. Arch Intern Med. 2002, 162: 1682-1688. 10.1001/archinte.162.15.1682.View ArticlePubMedGoogle Scholar
- Cooper H, Lester H, Wilson S, Freemantle N, Riley H: Representation of south Asian people in clinical trials: ethnic origin need not be a barrier to participation. BMJ. 2003, 327: 394-395. 10.1136/bmj.327.7411.394-c.View ArticlePubMedPubMed CentralGoogle Scholar
- Moudgil H, Marshall T, Honeybone D: Asthma education and quality of life in the community: a randomized controlled study to evaluate the impact on white European and Indian subcontinent ethnic groups from socioeconomically deprived areas in Birmingham UK. Thorax. 2000, 55: 177-183. 10.1136/thorax.55.3.177.View ArticlePubMedPubMed CentralGoogle Scholar
- Corbie-Smith G, Viscoli CM, Kernan WN, Brass LM, Sarrel P, Horwitz RI: Influence of race, clinical, and other socio-demographic features on trial participation. J Clin Epidemiol. 2003, 56: 304-309. 10.1016/S0895-4356(03)00046-5.View ArticlePubMedGoogle Scholar
- Welsh JL, Adam P, Fontaine P, Gjerdingen D: Recruiting for a randomized controlled trial from an ethnically diverse population: lessons from the maternal Infection and Pretrem Labor Study. J Fam Pract. 2002, 51: 760-PubMedGoogle Scholar
- Newman LA, Hurd T, Leitch M, Kuerer HM, Diehl K, Lucci A, Giuliano A, Hunt KK, Putnam W, Wells SA: A report on accrual rates for elderly and minority-ethnicity cancer patients to clinical trials of the American College of Surgeons Oncology Group. J Am Coll Surg. 2004, 199: 644-651. 10.1016/j.jamcollsurg.2004.05.282.View ArticlePubMedGoogle Scholar
- Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C: Threats to applicability of randomized trials: exclusion and selective participation. J Health Serv Res Policy. 1999, 4: 112-121.PubMedGoogle Scholar
- Rathore SS, Krumholz HM: Race, ethnic group, and clinical research. BMJ. 2003, 327: 763-764. 10.1136/bmj.327.7418.763.View ArticlePubMedPubMed CentralGoogle Scholar
- Cotterill S, Editor: Key Health Data for the West Midlands. 2003, [http://www.pcpoh.bham.ac.uk/publichealth/publications/key_health_data/index.html]
- Jolly K, Lip GYH, Sandercock J, Greenfield SM, Raftery JP, Mant JW, Taylor RS, Lee KW, Lane D, Stevens AJ: Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM): a randomized controlled trial [ISRCTN72884263]. BMC Cardiovascular Disorders. 2003, 3: 10-10.1186/1471-2261-3-10.View ArticlePubMedPubMed CentralGoogle Scholar
- UK 2001 Census form. [http://www.statistics.gov.uk/census2001/pdfs/H1.pdf]
- Office of the Deputy Prime Minister: Indices of Deprivation. 2004, [http://www.odpm.gov.uk/stellent/groups/odpm_urbanpolicy/documents/page/odpm_urbanpol_028470.hcsp]Google Scholar
- Birmingham City Council: Community languages in Birmingham. Birmingham City Council. 1993Google Scholar
- Roberson NL: Clinical trial participation. Viewpoints from racial/ethnic groups. Cancer. 1994, 74 (9 Suppl): 2687-2691.View ArticlePubMedGoogle Scholar
- Gamble V: A legacy of distrust: African Americans and medical research. Am J Prev Med. 1993, 9 (6 Supplement): 35-8.PubMedGoogle Scholar
- Thomas SB, Quinn SC: The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV education and AIDS risk education programs in the black community. Am J Public Health. 1991, 81 (11): 1498-1505.View ArticlePubMedPubMed CentralGoogle Scholar
- Oddone EZ, Olsen MK, Linquist JH, Orr M, Horner R, Reda D, Lavori P, Johnson G, Collins J, Feussner JR: Enrollment in clinical trials according to patients race: experience from the VA Cooperative Studies Program (1975–2000). Controlled Clinical Trials. 2004, 25: 378-387. 10.1016/j.cct.2004.05.001.View ArticlePubMedGoogle Scholar
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2288/5/18/prepub
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