Showing papers by "Brenda Leese published in 2004"

Why ethnic minority groups are under‐represented in clinical trials: a review of the literature

Abstract: Randomised controlled trials (RCTs) are considered to be the gold standard in evaluating medical interventions; however, people from ethnic minorities are frequently under-represented in such studies. The present paper addresses a previously neglected debate about the tensions which inform clinical trial participation amongst people from ethnic minorities, in particular, South Asians, the largest ethnic minority group in the UK. In a narrative review of the available literature, based mainly on US studies, the present authors aim to make sense of the issues around under-representation by providing a theoretical reconciliation. In addition, they identify a number of potential barriers to ethnic minority participation in clinical trials. In so doing, the authors recognise that the recent history of eugenic racism, and more general views on clinical trials as a form of experimentation, means that clinical trial participation among people from ethnic minorities becomes more problematic. Lack of participation and the importance of representational sampling are also considered, and the authors argue that health professionals need to be better informed about the issues. The paper concludes by offering a number of strategies for improving ethnic minority accrual rates in clinical trials, together with priorities for future research.

Involving South Asian patients in clinical trials.

Abstract: Objectives To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. Data sources A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Results Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population. Important decisions, such as participation in clinical trials, are likely to be made by those family members who are fluent in English and younger. Social class appears to be more important than ethnicity, and older South Asian people and those from working class backgrounds appear to be more mistrustful. Approachable patients (of the same gender, social class and fluent in English) tend to be 'cherry picked' to clinical trials. This practice was justified because of a lack of time and resources and inadequate support. South Asian patients might be systematically excluded from trials owing to the increased cost and time associated with their inclusion, particularly in relation to the language barrier. Under-representation might also be due to passive exclusion associated with cultural stereotypes. Other characteristics such as gender, age, educational level and social class can also affect trial inclusion. Conclusions Effective strategies for South Asian recruitment to clinical trials include: using multi-recruitment strategies; defining the demographic and social profiles of the population to be included; using focus groups to identify any potential barriers; consulting representative community members to provide assistance in the study; ensuring eligibility criteria are set as wide as possible; developing educational and recruitment approaches to attract ethnic minority health professionals; ensuring health professionals are adequately trained in culturally and ethnically orientated service provision; determining the most effective mass media to use in study promotion and recruitment; and targeting inner-city, single-handed practices likely to have high ethnic minority populations. Future research should consider: responses when invited to participate; the role of methodological and organisational barriers to recruitment; the complexities of recruitment from a health professional perspective; developing culturally sensitive research methods; the magnitude of the problem of under-recruitment; strategies to encourage inner-city, single-handed GP participation; and other factors affecting trial inclusion, such as age, gender, educational level and socio-cultural background.

The role of UK general practitioners with special clinical interests: implications for policy and service delivery.

Abstract: The development of specialist clinical interests by general practitioners (GPs) is currently receiving considerable attention in the United Kingdom. Although GPs have long been able to pursue such interests, it is only in recent years that they have taken on within primary care what were previously secondary care tasks, provided such services for patients outside their own practices, and received payment for them. The expansion of such services has been highlighted as a target in the NHS plan for England. Managerial and professional guidance is becoming available that seeks to clarify the role and nature of specialisation within general practice, to learn from the experiences of individuals who have embarked on specialist practice, and suggests procedures for future developments. Drawing on a range of sources, this paper builds on that burgeoning knowledge by setting the development of GPs with special interests in a broader policy context, highlighting the implications for the way that healthcare services are organised and delivered, and discussing their actual and potential impact of professional roles and practice.