Should research samples reflect the diversity of the population?

Recent research governance documents say that the body of research evidence must reflect population diversity. The response to this needs to be more sophisticated than simply ensuring minorities are present in samples. For quantitative research looking primarily at treatment effects of drugs and devices four suggestions are made. First, identify where the representation of minorities in samples matters - for example, where ethnicity may cause different treatment effects. Second, where the representation of a particular group matters then subgroup analysis of the results will usually be necessary. Third, ensuring representation and subgroup analysis will have costs; deciding on whether such representation is worthwhile will involve cost benefit analysis. Fourth, the representation of minorities should not be seen as mainly a locality issue. For qualitative research it is argued that the representation of diversity is often important. Given the small samples of many qualitative projects, however, the best way to ensure representation occurs is to allow a proliferation of such research, not to stipulate such representation in samples

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process

Objectives: To assess whether continuous consent, a process whereby information is given to research participants at different stages in a trial, plus clinician training in that process was effective when used by clinicians gaining consent to the TOBY trial. The TOBY trial is a randomised controlled trial investigating the use of whole body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for TOBY is difficult; as such, it is a good test of the effectiveness of continuous consent. Methods: Semi-structured interviews were conducted with 30 sets of parents who gave consent to TOBY and with 10 clinicians who sought it using the continuous consent process. Analysis focused on the validity of parental consent based upon the consent components of competence, information, understanding and voluntariness. Results: 19/27 (70%) couples had no significant problems with consent validity at the point of signature. Problems lay mainly with the parents’ competence and understanding. Mothers particularly had competence problems in the early stages of consent. The understanding problems were primarily to do with side effects. Problems in both areas (competence and understanding) reduced markedly, particularly for mothers, in the post signature phase when further discussion took place. Randomisation was generally understood but unpopular. Clinicians did not always give information in stages during the short period of time available before parents gave consent. However, most clinicians were able to give follow up information. Discussion: The consent validity compares favourably with similar trials examined in a comparable study (the Euricon study). Conclusion: Researchers should consider adopting elements of the continuous consent process and clinician training in RCTs, particularly where they have concerns about the quality of consent they are likely to obtain using a conventional process.</p

Delivering effective NHS services to our multiethnic population: collection and application of ethnic monitoring within primary care

Government health policy has emphasised the importance of understanding and tackling ethnic disparities in health and healthcare for at least four decades. Yorkshire & the Humber includes areas with large, well-established minority ethnic populations. In addition, most cities in the region, including those that have in the past been dominated by the White British majority, are now experiencing rapid migration. Persistent patterns of health disadvantage among established minority ethnic communities are now compounded by the differing health needs of new migrant populations. NHS organisations in Yorkshire & the Humber have begun to respond more systematically to the needs of minority ethnic groups. However, there is still progress to be made on establishing basic requirements for effective commissioning, including effective ethnic monitoring systems that provide high quality intelligence to commissioners, service managers and health professionals. While there are examples of innovation and good practice, there is significant variation across the region and a lack of sharing and learning between organisations. Here we report on a workshop that was convened by the Strategic Health Authority in June 2009 as a first step towards addressing this recognised area of need. The Workshop Chair was John Chuter, Chair of NHS Bradford & Airedale. The aims of the workshop were to: • Highlight the policy context and imperatives for ethnic monitoring. • Raise awareness of the current position with regard to ethnic monitoring and use of data in Yorkshire & the Humber. • Share emerging good practice. • Identify ways to move forward to improved ethnic monitoring across the region

Reducing Health Inequalities Implementation Theme. Briefing paper 1: Why health inequalities matter

This first briefing paper is an account of why health inequality matters and why health inequalities deserve consideration across all areas of CLAHRC (SY) activity. We begin by briefly reviewing the policy landscape and the prominence of 'inequality' as a growing focus of concern over the past 30 years. We then set out the type of philosophical and political considerations that may underpin the view that health inequality is a problem. Next we identify the main axes of inequality with which we suggest CLAHRC (SY) should concern itself. In the next section of the paper we set out the extent of health inequality in South Yorkshire, as far as available data allow. Finally, we show the relevance of health inequality across the CLAHRC (SY) themes and raise for discussion the implications for CLAHRC (SY) activity

How should public health professionals engage with lay epidemiology?

"Lay epidemiology" is a term used to describe the processes through which health risks are understood and interpreted by laypeople. It is seen as a barrier to public health when the public disbelieves or fails to act on public health messages. Two elements to lay epidemiology are proposed: (a) empirical beliefs about the nature of illness and (b) values about the place of health and risks to health in a good life. Both elements have to be dealt with by effective public health schemes or programmes, which would attempt to change the public's empirical beliefs and values. This is of concern, particularly in a context in which the lay voice is increasingly respected. Empirically, the scientific voice of standard epidemiology should be deferred to by the lay voice, provided a clear distinction exists between the measurement of risk, which is empirical, and its weighting, which is based on values. Turning to engagement with values, health is viewed to be an important value and is discussed and reflected on by most people. Public health professionals are therefore entitled and advised to participate in that process. This view is defended against some potential criticisms