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

Should desperate volunteers be included in randomised controlled trials?

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. Some claim this practice is unethical for at least three reasons. The first is that the notion of equipoise, which is often used as a justification for running a RCT, is subjective and value-based. Desperate volunteers are clearly not in equipoise and it is their values that should take precedence. The second is that clinicians who enter patients onto trials are disavowing their therapeutic obligation to deliver the best treatment to patients; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. This leads to the third reason: desperate volunteers do not give a proper consent; they are, in effect, coerced. We begin our reply by advocating a notion of equipoise based on, first, expert knowledge and, second, widely shared values. Where such collective, expert equipoise exists there is a prima facie case for a RCT. Next we argue that trial entry does not involve clinicians’ disavowing their therapeutic obligation; individualised care based on whims and fancies is not in patients’ best interest. Finally, we argue that where equipoise exists it is acceptable to limit access to experimental agents. In the cases desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire. </p

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

Can a nudge keep you warm? Using nudges to reduce excess winter deaths: insight from the Keeping Warm in Later Life Project (KWILLT)

Nudges are interventions that aim to change people's behaviour through changing the environment in which they choose rather than appealing to their reasoning. Nudges have been proposed as of possible use in relation to health-related behaviour. However, nudges have been criticized as ethically dubious because they bypass peoples reasoning and (anyway) are of little help in relation to affecting ill-health that results from social determinants, such as poverty. Reducing the rate of excess winter deaths (EWDs) is a public health priority; however, EWD seems clearly to be socially determined such that nudges arguably have little role. This article defends two claims: (i) nudges could have a place in tackling even the heavily socially determined problem of EWD. We draw on evidence from an empirical study, the Keeping Warm in Later Life Project (KWILLT), to argue that in some cases the risk of cold is within the person’s control to some extent such that environmental modifications to influence behaviour such as nudges are possible. (ii) Some uses of behavioural insights in the form of nudges are acceptable, including some in the area of EWD. We suggest a question-based framework by which to judge the ethical acceptability of nudges

Professional boundaries: research report

In 2008 the General Social Care Council (GSCC) published Raising standards: Social work conduct in England 2003-2008. This constituted the GSCC’s first report covering the work undertaken to uphold standards and protect people who use social care services. The GSCC’s analysis revealed that a considerable proportion of conduct cases, some 40%, involved allegations of 'inappropriate relations'. In the light of this finding, and the release by the Council for Healthcare Regulatory Excellence (CHRE) of sexual boundaries guidance for healthcare workers at the beginning of this year (Halter et al, 2009), the GSCC committed itself to exploring the possibility of producing professional boundaries guidance for social workers. To begin this exploration, the GSCC commissioned a study in early 2009.This is the report of that study. There were two main purposes. First, to establish what professional boundaries1 guidance currently exists for social workers, or for sections of the workforce that includes social workers in the United Kingdom, and the content of any such guidance. Secondly, to identify and discuss a number of other examples of professional boundaries guidance to act as points of reference for the GSCC’s project. The aim was to identify and discuss examples relevant to the GSCC’s project