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Background: Research in emergencies is needed to understand the prevalence of mental health and psychosocial problems and strengthen the evidence base for interventions. All research - including operational needs assessments, programme monitoring and evaluation, and formal academic research - must be conducted ethically. While there is broad consensus on fundamental principles codified in research ethics guidelines, these do not address the ethical specificities of conducting mental health and psychosocial support (MHPSS) research with adults in emergencies. To address this gap, this paper presents a review of multidisciplinary literature to identify specific ethical principles applicable to MHPSS research in emergencies.Discussion: Fifty-nine sources meeting the literature review inclusion criteria were analysed following a thematic synthesis approach. There was consensus on the relevance of universal ethical research principles to MHPSS research in emergencies, including norms of participant informed consent and protection; ensuring benefit arises from research participation; researcher neutrality, accountability, and safety; and the duty to ensure research is well designed and accounts for contextual factors in emergency settings. We go onto discuss unresolved issues by highlighting six current debates relating to the application of ethics in emergency settings: (1) what constitutes fair benefits?; (2) how should informed consent be operationalised?; (3) is there a role for decision making capacity assessments?; (4) how do risk management approaches impact upon the construction of ethical research?; (5) how can ethical reflection best be achieved?, and (6) are ethical review boards sufficiently representative and equipped to judge the ethical and scientific merit of emergency MHPSS research? Underlying these debates is a systemic tension between procedural ethics and ethics in practice. In summary, underpinning the literature is a desire to ensure the protection of participants exposed to emergencies and in need of evidence-based MHPSS. However, there is a lack of agreement on how to contextualise guidelines and procedures to effectively maximise the perspectives of researchers, participants and ethical review boards. This is a tension that the field must address to strengthen ethical MHPSS research in emergencies. [ABSTRACT FROM AUTHOR]

Background: In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting. Methods: As part of a wider study investigating consent methods in paediatric emergency care trials (called CONNECT), a 20 item online questionnaire was sent by email inviting practitioners (doctors and nurses) who were involved in talking with families about children’s and young people’s (aged 0–16 years) participation in UK EC trials. To ensure those with and without experience of deferred consent were included, practitioners were sampled using a combination of purposive and snowball sampling methods. Simple descriptive statistics were used to analyse the quantitative data, whilst the constant comparative method was used to analyse qualitative data. Elements of a symbiotic empirical ethics approach was used to integrate empirical evidence and bioethical literature to explore the data and draw practice orientated conclusions. Results: Views on deferred consent differed depending upon whether or not practitioners were experienced in this consent method. Practitioners who had no experience of deferred consent reported negative perceptions of this consent method; these practitioners were concerned about the impact that deferred consent would have upon the parent-practitioner relationship. In contrast, practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. Experienced practitioners also described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting. Conclusions: The views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future paediatric EC trials; the design and ethical review of such trials should not solely be informed by the beliefs of those without experience of using deferred consent. Further research involving parents and children is required to inform practitioner training and normative guidance on the use and appropriateness of deferred consent in emergency settings. [ABSTRACT FROM AUTHOR]

Background: Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients. Methods: Patients with moderate asthma (age ⩾ 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of ⩾ 12% and ⩾ 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for ⩾ 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 μg OD, FF or FP 100 μg BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 μg OD and FF 100 μg BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed. Results: The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 μg OD to be non-inferior (pre-defined limit -110 ml) to FF 100 μg BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p ⩽ 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 μg OD, 0.75; 100 μg BD, 0.84; p ⩽ 0.02). Conclusions: FF 200 μg OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose. [ABSTRACT FROM AUTHOR]

A correction to the article "Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates" that was published in the previous issue is presented.

Background: This paper critically reviews published tools and indicators currently used to measure maternity care performance within Europe, focusing particularly on whether and how current approaches enable systematic appraisal of processes of minimal (or non-) intervention in support of physiological or "normal birth". The work formed part of COST Actions IS0907: "Childbirth Cultures, Concerns, and Consequences: Creating a dynamic EU framework for optimal maternity care" (2011-2014) and IS1405: Building Intrapartum Research Through Health - an interdisciplinary whole system approach to understanding and contextualising physiological labour and birth (BIRTH) (2014-). The Actions included the sharing of country experiences with the aim of promoting salutogenic approaches to maternity care., Methods: A structured literature search was conducted of material published between 2005 and 2013, incorporating research databases, published documents in english in peer-reviewed international journals and indicator databases which measured aspects of health care at a national and pan-national level. Given its emergence from two COST Actions the work, inevitably, focused on Europe, but findings may be relevant to other countries and regions., Results: A total of 388 indicators were identified, as well as seven tools specifically designed for capturing aspects of maternity care. Intrapartum care was the most frequently measured feature, through the application of process and outcome indicators. Postnatal and neonatal care of mother and baby were the least appraised areas. An over-riding focus on the quantification of technical intervention and adverse or undesirable outcomes was identified. Vaginal birth (no instruments) was occasionally cited as an indicator; besides this measurement few of the 388 indicators were found to be assessing non-intervention or "good" or positive outcomes more generally., Conclusions: The tools and indicators identified largely enable measurement of technical interventions and undesirable health (or pathological medical) outcomes. A physiological birth generally necessitates few, or no, interventions, yet most of the indicators presently applied fail to capture (a) this phenomenon, and (b) the relationship between different forms and processes of care, mode of birth and good or positive outcomes. A need was identified for indicators which capture non-intervention, reflecting the reality that most births are low-risk, requiring few, if any, technical medical procedures.