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Objective: To 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.Methods: This 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).Results: The 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.Conclusions: Patients 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 Number: NCT01706198. [ABSTRACT FROM AUTHOR]

Objectives We explored children's views on research without prior consent (RWPC) and sought to identify ways of involving children in research discussions. Design Qualitative interview study. Setting Participants were recruited through a UK children's hospital and online advertising. Participants 16 children aged 7-15 years with a diagnosis of asthma (n=14) or anaphylaxis (n=2) with recent (<12 months) experience of emergency care. Results Children were keen to be included in medical research and viewed RWPC as acceptable in emergency situations if trial interventions were judged safe. Children trusted that doctors would know about their trial participation and act in their best interests. All felt that children should be informed about the research following their recovery and involved in discussions with a clinician or their parent(s) about the use of data already collected as well as continued participation in the trial (if applicable). Participants suggested methods to inform children about their trial participation including an animation. Conclusions Children supported, and were keen to be involved in, clinical trials in emergency situations. We present guidance and an animation that practitioners and parents might use to involve children in trial discussions following their recovery. [ABSTRACT FROM AUTHOR]

Introduction There are growing concerns about the increase in rates of commonly used childbirth interventions. When indicated, childbirth interventions are crucial for preventing maternal and perinatal morbidity and mortality, but their routine use in healthy women and children leads to avoidable maternal and neonatal harm. Establishing ideal rates of interventions can be challenging. This study aims to describe the range of variations in the use of commonly used childbirth interventions in high-income countries around the world, and in outcomes in nulliparous and multiparous women. Methods and analysis This multinational cross-sectional study will use data from births in 2013 with national population data or representative samples of the population of pregnant women in high-income countries. Data from women who gave birth to a single child from 37 weeks gestation onwards will be included and the results will be presented for nulliparous and multiparous women separately. Anonymised individual level data will be analysed. Primary outcomes are rates of commonly used childbirth interventions, including induction and/or augmentation of labour, intrapartum antibiotics, epidural and pharmacological pain relief, episiotomy in vaginal births, instrument-assisted birth (vacuum or forceps), caesarean section and use of oxytocin postpartum. Secondary outcomes are maternal and perinatal mortality, Apgar score below 7 at 5 min, postpartum haemorrhage and obstetric anal sphincter injury. Univariable and multivariable logistic regression analyses will be conducted to investigate variations among countries, adjusted for maternal age, body mass index, gestational weight gain, ethnic background, socioeconomic status and infant birth weight. The overall mean rates will be considered as a reference category, weighted for the size of the study population per country. Ethics and dissemination The Medical Ethics Review Committee of VU University Medical Center Amsterdam confirmed that an official approval of this study was not required. Results will be disseminated at national and international conferences and published in peer-reviewed journals. [ABSTRACT FROM AUTHOR]

In the article, the author discusses issues regarding research without consent also called 'deffered consent' in case of pediatric critical care trials. Topics discussed include Exception from Informed Consent (EFIC) by the U.S. Food and Drug Administration (FDA) for the same, conditions for conducting deferred consent research such as urgent requirement of treatment and approval from ethics committee, and points to tell to child's parent such as reason and purpose of the research.

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. [ABSTRACT FROM AUTHOR]

Objective: To inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process. Design: Qualitative interview and focus group study. Setting: 8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care. Participants: 17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE. Results: Most parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information. Conclusions: Our study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making. [ABSTRACT FROM AUTHOR]

Background: Combination therapy with an inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) is recommended for patients with asthma symptomatic on ICS alone. However, there is ongoing debate regarding the risk-benefit ratio of using LABA in asthma. Objective: To evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe asthma exacerbations in patients with uncontrolled asthma. Methods: This randomised double-blind comparative study of variable duration (≥24-78 weeks) was designed to finish after 330 events (each patient's first ontreatment severe asthma exacerbation). 2019 patients with asthma aged ≥12 years with ≥1 recorded exacerbation within 1 year were randomised and received FF/VI 100/25 μg or FF 100 μg, administered once daily in the evening. The primary endpoint was time to first severe exacerbation; secondary endpoints were rate of severe asthma exacerbations per patient per year and change in trough evening forced expiratory volume in 1 s (FEV1) from baseline. Results: Compared with FF, FF/VI delayed the time to first severe exacerbation (HR 0.795, 95% CI 0.642 to 0.985) and reduced the annualised rate of severe exacerbations (rate reduction 25%, 95% CI 5% to 40%). Significantly greater improvements in trough FEV1 (p<0.001) were observed with FF/VI than with FF at weeks 12, 36, 52 and at endpoint. Both treatments were well tolerated with similar rates of treatmentrelated adverse events and on-treatment serious adverse events. Conclusions: Once-daily FF/VI reduced the risk of severe asthma exacerbations and improved lung function compared with FF alone, with good tolerability and safety profile in adolescents and adults with asthma currently receiving ICS. [ABSTRACT FROM AUTHOR]

Objectives: To test whether older drug users (aged 40 and over) could be recruited to an exercise referral (ER) scheme, to evaluate the feasibility and acceptability and measure the impact of participation on health. Design: Observational pilot. Setting: Liverpool, UK. Participants: (1) 12 men and 5 women recruited to ER. (2) 7 specialist gym instructors. Outcome measures: Logistic feasibility and acceptability of ER and associated research, rate of recruitment, level of participation over 8 weeks and changes in health. Results: 22 gym inductions were arranged (recruitment time: 5 weeks), 17 inductions were completed and 14 participants began exercising. Attendance at the gym fluctuated with people missing weeks then re-engaging; in week 8, seven participants were in contact with the project and five of these attended the gym. Illness and caring responsibilities affected participation. Participants and gym instructors found the intervention and associated research processes acceptable. In general, participants enjoyed exercising and felt fitter, but would have welcomed more support and the offer of a wider range of activities. Non-significant reductions in blood pressure and heart rate and improvements in metabolic equivalents (METs; a measure of fitness) and general well-being were observed for eight participants who completed baseline and follow-up assessments. The number of weeks of gym attendance was significantly associated with a positive change in METs. Conclusions: It is feasible to recruit older drug users into a gym-based ER scheme, but multiple health and social challenges affect their ability to participate regularly. The observed changes in health measures, particularly the association between improvements in METs and attendance, suggest further investigation of ER for older drug users is worthwhile. Measures to improve the intervention and its evaluation include: better screening, refined inclusion/exclusion criteria, broader monitoring of physical activity levels, closer tailored support, more flexible exercise options and the use of incentives. [ABSTRACT FROM AUTHOR]

The NHS in England is an organisation undergoing substantial change. The passage of the Health and Social Care Act 2012, consolidates and builds on previous health policies and introduces further 'market-style' reforms of the NHS. One of the main aspects of these reforms is to encourage private and third sector providers to deliver NHS services. The rationale for this is to foster a more competitive market in healthcare to encourage greater efficiency and innovation. This changing healthcare environment in the English NHS sharpens the need for attention to be paid to the ethical operation of healthcare organisations. All healthcare organisations need to consider the ethical aspects of their operation, whether state or privately run. However, the changes in the type of organisations used to provide healthcare (such as commercial companies) can create new relationships and ethical tensions. This paper will chart the development of organisational ethics as a concern in applied ethics and how it arose in the USA largely owing to changes in the organisation of healthcare financing and provision. It will be argued that an analogous transition is happening in the NHS in England. The paper will conclude with suggestions for the development of organisational ethics programmes to address some of the possible ethical issues raised by this new healthcare environment that incorporates both private and public sector providers. [ABSTRACT FROM AUTHOR]

In 1997, a court in Cyprus jailed Pavlos Georgiou for fifteen months for knowingly infecting a British woman, Janet Pink, with HIV-1 through unprotected sexual intercourse. Pink met Georgiou in January 1994 whilst on holiday. She discovered that she had contracted the virus from him in October 1994 but continued the relationship until July 1996 when she developed AIDS. She returned to the UK for treatment and reported Georgiou to the Cypriot authorities.(n1) There have been a number of legal cases involving deliberate transmission of HIV, but most have involved forced exposure to infected bodily fluids for example, rape or biting, and have been dealt with using the existing legislation for rape or assault. While it is often difficult to prove responsibility for transmission in cases of forced exposure to HIV, it is even more contentious in cases like those of Janet Pink where an individual has consented to sex but claims that he/she was not forewarned of his/her partner's HIV-positive status. At present there is no specific criminal offence of having unprotected sexual intercourse without disclosing one's HIV-positive status but a prosecution could possibly be brought under any one of a number of existing offences.(n2) Perhaps a change of policy needs to be considered. The Home Office has issued a consultation document which outlines a proposal that will allow the criminalisation of intentional transmission of diseases, like HIV, that are likely to cause serious harm. This revised legislation would cover all other potentially fatal diseases (including salmonella and legionnaire's disease, for instance) but seems primarily to be targeted at HIV transmission. Should transmission of HIV through consensual sex, without the HIV-positive status of the individual being disclosed, be an offence? This question, and that of whether there is a moral obligation to disclose a positive HIV status prior to having a sexual relationship is the subject of this paper. (Journal ... [ABSTRACT FROM AUTHOR]

Competing Interests: Competing interests: None declared.

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

In their paper Horton et al argue 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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: None declared.