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Clinical research in intensive care units (ICUs) is essential for improving treatments for critically ill patients. However, invitations to participate in clinical research in this situation pose numerous challenges. Studies are frequently initiated within a narrow time window when patients are often unconscious and unable to consent. Consultations or consent discussions must therefore be held with consultees or representatives, usually the patient’s relatives. Conversations about research participation in this setting may be difficult, as relatives are often overwhelmed and may feel uneasy about making decisions on behalf of their relatives. In some circumstances, legislation allows doctors to act as consultees or representatives to enrol patients in research. However, there is little good quality evidence on UK stakeholders’ perspectives to inform how recruitment is carried out in ICU studies. The Perspectives Study collected evidence on the views of over 1400 stakeholders, including patients, relatives and healthcare practitioners, many of whom had first-hand experience of ICU treatment and research. This evidence was used to inform good practice guidance on recruitment of critically ill patients to research. Established social science methods and empirical ethics were employed to reflect the interests of stakeholders and justify recommendations. This guidance aims to bridge the gap between the legal frameworks and the realities of ICU studies and to ensure that research recruitment processes reflect the views of patients and families. Researchers and an expert Advisory Group brought different perspectives to interpreting the evidence to develop the guidance. In this article we present guidance for future ICU studies.

ObjectiveTo compare the effects of switching from a pressurised metered dose inhaler (pMDI)-based to a dry powder inhaler (DPI)-based maintenance therapy versus continued usual care on greenhouse gas emissions (carbon dioxide equivalents, CO2e) and asthma control.MethodsThis post-hoc analysis was based on a subset of 2236 (53%) patients from the Salford Lung Study in Asthma who at baseline were using a pMDI-based controller therapy. During the study patients were randomised to fluticasone furoate/vilanterol (FF/VI) via the ELLIPTA DPI (switched from pMDI to DPI) (n=1081) or continued their usual care treatment (n=1155), and were managed in conditions close to everyday clinical practice. Annual CO2e (kg) was calculated for the total number of maintenance and rescue inhalers prescribed. Asthma control was assessed by the proportion of ACT responders (composite of ACT total score ≥20 and/or increase from baseline ≥3).ResultsThe groups were well matched for demographic characteristics and baseline Asthma Control Test (ACT) total score (mean age: 49 years; mean ACT score: usual care, 16.6; FF/VI, 16.5). Annual CO2e kg per patient (maintenance plus rescue therapy) was significantly lower with FF/VI DPI treatment (‘switch’ group) than usual care (least squares geometric mean 108 kg (95% CI 102 to 114) vs 240 kg (95% CI 229 to 252), p<0.001). Asthma control was consistently superior over the 12 months in the FF/VI DPI group compared with usual care.ConclusionsPatients switching from a pMDI-based to a DPI-based maintenance therapy more than halved their inhaler carbon footprint without loss of asthma control. The remaining inhaler carbon footprint could be reduced through switches from pMDI to DPI rescue medications or alternative lower-carbon footprint rescue inhalers if available. Asthma control improved in both groups, with greater control demonstrated in those initiated on FF/VI DPI.Trial registration numberNCT01706198.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

In their paper Horton et alargue that it is acceptable to contact an anonymous egg-donor to facilitate diagnostic genetic testing for the donor conceived child, despite the donor, ‘indicating on a historical consent form that she did not wish to take part in future research, and that she did not wish to be informed if she was found to be a carrier of a “harmful inherited condition”’. There are a number of claims embedded in Horton et al’s position that it is acceptable to contact the donor and request that she at least think about participating in genetic testing. In this response. I will go through their main claims and argue that the area of genomic medicine does not justify exceptions to general consent conditions as the authors suppose and conclude that the donor should not be contacted. I will then go on to suggest a policy change that would address Horton et al’s concerns but would not involve over-riding any previously expressed wishes.

Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice.

Measuring of antenatal care utilisation is important from a public health perspective. The Content and Timing of care in Pregnancy tool (CTP) focuses on the care process and includes aspects on quality of care. The aim of the study is to gain insight in the applicability of the CTP tool across Europe. National guidelines for routine antenatal care were examined, analysing the degree to which the four items in the CTP tool were included in these guidelines. From the 30 countries, 22 had a national guideline for routine antenatal care. The CTP tool is applicable in over 60% of the European countries with a national guideline. The CTP tool can be used to measure antenatal care delivery in Europe. The tool is useful to evaluate the care process, focusing on rates of interventions as the closest approximation to the delivery of health care, with a focus on content of visits rather than simply the number of visits. Together with indicators measuring structure and outcome of health care, conclusions about the quality of care can be made.

This article presents a case study on the organization of maternity health care in Switzerland. Switzerland has a costly health care system with high intervention rates within an obstetric-led maternity care model. Evidence has shown that midwifery care is associated with lower cost, higher satisfaction rates among women, and less intervention. However, in this model, midwives are both marginalized and underused.The article focuses on the distribution of power and knowledge between midwives, women, and the medical profession. The varying power structures that shape the maternity care system in Switzerland are examined, using a case study approach that draws on Foucault’s concepts of the gaze, surveillance, disciplinary power, and the docile body. This article critically analyzes the model of maternity care received by women in Switzerland and how it negatively impacts on both women’s personal and midwives’ professional autonomy while simultaneously driving up costs.A better understanding of the underlying power structures operating within the maternity care system may facilitate the implementation of more midwifery-led care currently being endorsed by the Swiss Midwifery Association and some government agencies. This could result in reduced cost and lower intervention rates with reduced associated morbidity.

An integrated analysis was performed using safety data from 18 randomized, parallel-group studies from the fluticasone furoate/vilanterol (FF/VI) GSK asthma clinical study program. Efficacy data from four pivotal studies were also analyzed. Data were integrated from 18 Phase IIb and Phase III clinical studies. Key treatment arms were FF/VI 200/25 µg, FF/VI 100/25 µg, FF 200 µg, FF 100 µg, VI [with inhaled corticosteroids (ICSs)] 25 µg, and placebo. Safety endpoints included adverse events (AEs), AEs of special interest, 24-h urinary cortisol, vital signs, electrocardiograms, and asthma composite endpoints (defined as asthma-related hospitalizations, intubations, or death). Key efficacy endpoints included lung function assessments and symptomatic measures. In total, 7229 patients were randomized to one of six key treatment groups. The most frequently experienced AEs across key treatment groups were headache, nasopharyngitis, and upper respiratory tract infection. A greater incidence of local steroid effects was reported with FF-containing treatment groups versus placebo. No statistically significant difference was observed in asthma composite endpoint (asthma-related hospitalizations, intubations, or death) analysis of all FF/VI doses versus all ICS doses. A statistically significant difference in trough forced expiratory volume in one second (FEV1), 0–24 h weighted mean FEV1, and rescue-free and symptom-free 24 h periods was reported between FF/VI and FF treatment groups in all studies except one (NCT01165138). There was no evidence of an increased safety risk associated with FF/VI versus FF, VI, or placebo. FF/VI improved lung function and symptomatic endpoints versus FF alone. These data support the positive benefit:risk ratio of FF/VI versus FF alone and of having two approved FF/VI strengths to ensure appropriate treatment for patients with different asthma severity. GSK.

This document is designed to give guidance on assessing researchers in bioethics/medical ethics. It is intended to assist members of selection, confirmation and promotion committees, who are required to assess those conducting bioethics research when they are not from a similar disciplinary background. It does not attempt to give guidance on the quality of bioethics research, as this is a matter for peer assessment. Rather it aims to give an indication of the type, scope and amount of research that is the expected in this field. It does not cover the assessment of other activities such as teaching, policy work, clinical ethics consultation and so on, but these will be mentioned for additional context. Although it mentions the UK’s Research Excellence Framework (REF), it is not intended to be a detailed analysis of the place of bioethics in the REF.

This paper will critically examine the use of evidence in creating policy in the area of reproductive technologies. The use of evidence in health care and policy is not a new phenomenon. However, codified strategies for evidence appraisal in health care technology assessments and attempts to create evidence based policy initiatives suggest that the way evidence is used in practice and policy has changed. This paper will examine this trend by considering what is counted as ‘good’ evidence, difficulties in translating evidence into policy and practice and how evidence interacts with principles. To illustrate these points the removal of gamete donor anonymity in the UK in 2005 and the debates that preceded this change in the law will be examined. It will be argued that evidence will only ever take us so far and attention should also be paid to the underlying principles that guide policy. The paper will conclude with suggestions for how underlying principles can be more rigorously used in policy formation.

The British government is currently considering whether to review the law on information provision for donor offspring. This paper therefore provides an overview of the current international legal situation relating to donor anonymity and a review of the key arguments and evidence on both sides of the debate. While the British government is considering all aspects of information giving, both identifying and non-identifying donor information, this paper will focus on the most contentious issue: the provision of information that would identify the donor. The current legal situation in the UK and internationally is examined, drawing attention to a possible international trend towards more information giving. The evolution of the present British system is outlined and it is asked whether some of the concerns and values that gave rise to the practice of anonymous donation are still relevant today. Looking at the concept of a child's right to know their biological identity it examines the possible basis of such a right and its potential conflict with the perceived interests of the child's parents. Finally, some of the practical obstacles to non-anonymous donation are evaluated. The paper concludes that a review of the British law is both timely and desirable.

The purpose of this paper is to consider the role that values play in priority setting through the use of EBP. It is important to be clear about the role of values at all levels of the decision making process. At one level, society as a whole has to make decisions about the kind of health provision that it wants. As is generally accepted, these priority setting questions cannot be answered by medical science alone but involve important judgements of value. However, as I hope to show values come into priority setting questions at another level, one not often explicitly recognised in much of the literature: that of the very definition of the effectiveness of treatments. This has important consequences for patient care. If we do not recognise that the effectiveness of a treatment involve subjective elements — a patient's own assessment of the value of the treatment — then this could lead to the belief that we can purchase one treatment that is the most effective for all patients. This might result in a detrimental reduction in the range of options that a patient is given with some patients not receiving the treatment that is most effective for them.

Fluticasone furoate (FF) is an inhaled corticosteroid (ICS) with 24-hour activity in development as a once-daily treatment for the long-term management of asthma.