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Background Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur. To address these potential difficulties, we undertook a qualitative evaluation of the internal pilot of a trial (Got-it) involving women who had a retained placenta (RP). We explored the experiences and views of women and staff about the information and consent pathway used within the pilot, in order to provide recommendations for use in future peripartum trials involving recruitment in emergency situations. Methods In-depth interviews were undertaken with staff ( n  = 27) and participating women ( n  = 22). Interviews were analysed thematically. The accounts of women and staff were compared to identify differences and similarities in their views about recruitment and consent procedures. Results Women and staff regarded recruitment as having been straightforward and facilitated by the use of simplified (verbal and written) summaries of trial information. Both parties, however, conveyed discordant views about whether fully informed consent had been obtained. These differences in perspectives appeared to arise from the different factors and considerations impinging on women and staff at the time of recruitment. While staff placed emphasis on promoting understanding in the emergency situation of RP by imparting information in clear and succinct ways, women highlighted the experiential realities of their pre- and post-birthing situations, and how these had led to quick decisions being made without full engagement with the potential risks of trial participation. To facilitate informed consent, women suggested that trial information should be given during the antenatal period, and, in doing so, articulated a rights-based discourse. Staff, however, voiced opposition to this approach by emphasising a duty of care to all pregnant women, and raising concerns about causing undue distress to the majority of individuals who would not subsequently develop a RP. Conclusions By drawing upon the perspectives of women and staff involved in the same trial we have shown that they may operate within different experiential and ethical paradigms. In doing so, we argue for the potential benefits of drawing upon multiple perspectives when developing information and consent pathways used in future (peripartum) trials. Trial registration ISCRTN 88609453 .

Background Research guidelines generally recognize vulnerable populations to include neonates with the aim of enhancing protections from harm. In practice, such guidance results in limiting participation in randomized clinical trials (RCTs). Yet while medical care of neonates should be based on best research evidence to ensure that safe, efficacious treatment or procedures are used, this seldom happens in contemporary practice. Discussion The compelling need to generate information on effectiveness and safety of procedures and medications that are already in use during neonatal care has led to increase in calls for pragmatic randomized clinical trials (PCTs). This raises ethical concerns as to whether exclusion of the vulnerable populations from research participations constitutes harm. First, neonates are denied access to both potentially beneficial research outputs and an opportunity to generate data on how interventions or medications perform in diverse clinical settings and inform clinical decision-making. Secondly, risks and harms in PCTs may differ from traditional RCTs, and can be reduced by modifications in study designs. The latter may involve assessment of effectiveness of comparable medication, devices or practices (whose safety data is available), randomization at the group level rather than at the individual level, avoidance of invasive and innovative study procedures, reliance on locally available data on relevant patient outcomes, and employment of procedures that tend to meet the criteria of minimal risk for human subject research. Thirdly, informed consent procedures should be modified from those of traditional RCTs, as neonates in traditional RCTs may be vulnerable to different extents in PCTs. Lastly, regulatory and oversight procedures designed for traditional RCT settings need modification, as they may not be translatable, feasible, appropriate or even ethical to apply in PCTs. Conclusion The principle of justice, commonly interpreted as preventing an inequitable burden of research, should also allow fair access to potential benefits from PCTs for neonates and other vulnerable populations. Under certain conditions, prospective randomized trials involving neonates should be ethically permissible to allow inclusion of neonates in research. This may require modification of the research design, consent procedures or regulations for research oversight.

Background. Terrorism, disease outbreaks, and other natural disasters and mass casualty events have pushed health care and public health systems to identify and refine emergency preparedness protocols for disaster response. Ethical guidance, alongside legal and medical frameworks, are increasingly common components of disaster response plans. Objectives. To systematically review the prevalence and content of ethical guidance offered for disaster response, specifically around crisis standards of care (CSCs). Search methods. We systematically indexed academic literature from PubMed, Google Scholar, and ISI Web of Science from 2012 to 2016. Selection criteria. We searched for peer-reviewed articles that substantively engaged in discussion of ethical guidance for CSCs. Data collection and analysis. Researchers screened potential articles for identification and discussion of ethical issues in CSC planning. We categorized and cataloged ethical concepts and principles. Main results. Of 580 peer-reviewed articles mentioning ethics and CSCs or disaster planning, 38 (6%) met selection criteria. The systematic review of the CSC ethics literature since 2012 showed that authors were primarily focused on the ethical justifications for CSC (n = 20) as well as a need for ethics guidelines for implementing CSCs; the ethical justifications for triage (n = 19), both as to which criteria to use and the appropriate processes by which to employ triage; and international issues (n = 17). In addition to these areas of focus, the scholarly literature included discussion of a number of other ethical issues, including duty to care (n = 11), concepts of a duty to plan (n = 8), utilitarianism (n = 5), moral distress (n = 4), professional norms (n = 3), reciprocity (n = 2), allocation criteria (n = 4), equity (n = 4), research ethics (n = 2), duty to steward resources (n = 2), social utility and social worth (n = 2), and a number of others (n = 20). Although public health preparedness efforts have paid increasing attention to CSCs in recent years, CSC plans have rarely been implemented within the United States to date, although some components are common (e.g., triage is used in US emergency departments regularly). Conversely, countries outside the United States more commonly implement CSCs within a natural disaster or humanitarian crisis response, and may offer significant insight into ethics and disaster response for US-based practitioners. Conclusions. This systematic review identifies the most oft-used and -discussed ethical concepts and principles used in disaster planning around CSCs. Although discussion of more nuanced issues (e.g., health equity) are present, the majority of items substantively engaging in ethical discussion around disaster planning do so regarding triage and why ethics is needed in disaster response generally. Public health implications. A significant evolution in disaster planning has occurred within the past decade; ethical theories and frameworks have been put to work. For ethical guidance to be useful, it must be practical and implementable. Although high-level, abstract frameworks were once prevalent in disaster planning—especially in the early days of pandemic planning—concerns about the ethically difficult concept of CSCs pervade scholarly articles. Ethical norms must be clearly stated and justified and practical guidelines ought to follow from them. Ethical frameworks should guide clinical protocols, but this requires that ethical analysis clarifies what strategies to use to honor ethical commitments and achieve ethical objectives. Such implementation issues must be considered well ahead of a disaster. As governments and health care systems plan for mass casualty events, ethical guidance that is theoretically sound and practically useful can—and should—form an important foundation from which to build practical guidance for responding to disasters with morally appropriate means.

Ethical challenges are integral to health care and are associated with moral distress among health professionals. Moral distress can turn into burnout with a range of negative effects for professionals, patients, relatives, collaborators, and the organisation. Based on action research a focus group study was conducted inclucing prehospital personnel from the emergency services in the Region of Southern Denmark. Results showed that ethical challenges arise in contexts of (1) caring for patients, (2) managing organisational demands, (3) collaborating. Ethical challenges are addressed informally among personnel in emergency vehicles, at ambulance stations, outside working hours, and ocationally involve family or friends with a background in healthcare. Prehospital physicians have the added opportunity to address ethically sensitive issues during monthly meetings. Voicing ethical challenges presupposes confidence, trust, and feeling safe in relation to colleagues, management, and the organisation. Existing forms of ethics support do not lend themselves to the present organisational setup of the studied emergency services. Targeted clinical ethics support initiatives are needed to address moral distress, prevent burnout, and build a supportive working environment. Initiatives must be developed collaboratively and tested bottom-up to identify and eliminate barriers for implementation.

BackgroundIn out-of-hospital cardiac arrest (OHCA), decisions to terminate resuscitation or transport the patient to hospital are ethically fraught. However, little is known about paramedics’ ethical concerns in these decision-making processes.ObjectiveTo develop an understanding of how paramedics experience ethical concerns in OHCA decision-making processes, and how this relates to the ethical concerns of patients’ relatives.DesignA qualitative study using semi-structured interviews with paramedics and relatives of OHCA non-survivors.SettingTwo ambulance trusts in England.ParticipantsThirty-one paramedics, identified as decision-makers in adult OHCA events in which cardiopulmonary resuscitation (CPR) had been initiated, were interviewed. Fourteen interviews with relatives of OHCA non-survivors were also conducted.AnalysisThe interviews were analysed thematically, using a coding framework and following an empirical ethics approach.ResultsFour themes were developed: preventing harm to patients, best interests, caring for the patient’s family and moral distress. Paramedics conceptualised preventing harm both as saving lives and as preventing an undignified death or a life with severe brain damage. Paramedics’ and relatives’ views of best interests were influenced by values such as patient dignity and assumptions about age and quality of life. Paramedics expressed a duty of care towards the patient’s family. Relatives conveyed the importance of clear communication and acts of care performed by the ambulance crew, underscoring the ethical commitment that paramedics had towards patients’ families. Paramedics described decision-making processes that relied on clinical guidelines, rather than personal values and beliefs; this sometimes led to moral distress.ConclusionNon-protocolised ethical considerations are important in paramedic decision-making about terminating CPR in OHCA events. While paramedics use established guidelines and processes to reach decisions that prevent patient harm, they experience moral distress when personal convictions clash with guidelines. Training around ethical reasoning and decision making may help paramedics reduce their moral distress and provide consistent and transparent decisions for patients and their families.

Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.

Patients with severe traumatic brain injury (TBI) are at high risk for airway obstruction and hypoxia at the accident scene, and routine prehospital endotracheal intubation has been widely advocated. However, the effects on outcome are unclear. We therefore aim to determine effects of prehospital intubation on mortality and hypothesize that such effects may depend on the emergency medical service providers' skill and experience in performing this intervention. PubMed, Embase and Web of Science were searched without restrictions up to July 2015. Studies comparing effects of prehospital intubation versus non-invasive airway management on mortality in non-paediatric patients with severe TBI were selected for the systematic review. Results were pooled across a subset of studies that met predefined quality criteria. Random effects meta-analysis, stratified by experience, was used to obtain pooled estimates of the effect of prehospital intubation on mortality. Meta-regression was used to formally assess differences between experience groups. Mortality was the main outcome measure, and odds ratios refer to the odds of mortality in patients undergoing prehospital intubation versus odds of mortality in patients who are not intubated in the field. The study was registered at the International Prospective Register of Systematic Reviews (PROSPERO) with number CRD42014015506. The search provided 733 studies, of which 6 studies including data from 4772 patients met inclusion and quality criteria for the meta-analysis. Prehospital intubation by providers with limited experience was associated with an approximately twofold increase in the odds of mortality (OR 2.33, 95% CI 1.61 to 3.38, p<0.001). In contrast, there was no evidence for higher mortality in patients who were intubated by providers with extended level of training (OR 0.75, 95% CI 0.52 to 1.08, p = 0.126). Meta-regression confirmed that experience is a significant predictor of mortality (p = 0.009). Effects of prehospital endotracheal intubation depend on the experience of prehospital healthcare providers. Intubation by paramedics who are not well skilled to do so markedly increases mortality, suggesting that routine prehospital intubation of TBI patients should be abandoned in emergency medical services in which providers do not have ample training, skill and experience in performing this intervention.

In the UK, the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is a widely used process, designed to facilitate shared decision-making between a clinician and a patient or, if the patient lacks capacity to participate in the conversation, a person close to the patient. A key outcome of the ReSPECT process is a set of recommendations, recorded on the patient-held ReSPECT form, that reflect the conversation. In an emergency, these recommendations are intended to inform clinical decision-making, and thereby enable the attending clinician—usually a general practitioner (GP) or paramedic—to act in the patient’s best interests. This study is the first to explore the extent to which ReSPECT recommendations realise their goal of informing best interests decision-making in community contexts. Using a modified framework analysis approach, we triangulate interviews with patients and their relatives, GPs and nurses and care home staff. Our findings show that inconsistent practices around recording patient wishes, diverging interpretations of the meaning and authority of recommendations and different situational contexts may affect the interpretation and enactment of ReSPECT recommendations. Enacting ReSPECT recommendations in an emergency can be fraught with complexity, particularly when attending clinicians need to interpret recommendations that did not anticipate the current emergency. This may lead to decision-making that compromises the patient’s best interests. We suggest that recording patients’ values and preferences in greater detail on ReSPECT forms may help overcome this challenge, in providing attending clinicians with richer contextual information through which to interpret treatment recommendations.

Background Ethical challenges constitute an inseparable part of daily decision-making processes in all areas of healthcare. Ethical challenges are associated with moral distress that can lead to burnout. Clinical ethics support has proven useful to address and manage such challenges. This paper explores how prehospital emergency personnel manage ethical challenges. The study is part of a larger action research project to develop and test an approach to clinical ethics support that is sensitive to the context of emergency medicine. Methods We explored ethical challenges and management strategies in three focus groups, with 15 participants in total, each attended by emergency medical technicians, paramedics, and prehospital anaesthesiologists. Focus groups were audio-recorded and transcribed verbatim. The approach to data analysis was systematic text condensation approach. Results We stratified the management of ethical challenges into actions before, during, and after incidents. Before incidents, participants stressed the importance of mutual understandings, shared worldviews, and a supportive approach to managing emotions. During an incident, the participants employed moral perception, moral judgments, and moral actions. After an incident, the participants described sharing ethical challenges only to a limited extent as sharing was emotionally challenging, and not actively supported by workplace culture, or organisational procedures. The participants primarily managed ethical challenges informally, often using humour to cope. Conclusion Our analysis supports and clarifies that confidence, trust, and safety in relation to colleagues, management, and the wider organisation are essential for prehospital emergency personnel to share ethical challenges and preventing moral distress turning into burnout.

Background Emergency care providers regularly deal with ethical dilemmas that must be addressed. In comparison with in-hospital nurses, emergency medical service (EMS) personnel are faced with more problems such as distance to resources including personnel, medico-technical aids, and information; the unpredictable atmosphere at the scene; arriving at the crime scene and providing emergency care for accident victims and patients at home. As a result of stressfulness, unpredictability, and often the life threatening nature of tasks that ambulance professionals have to deal with every day, ethical decision-making (EDM) has become an inevitable challenge. Methods The content analysis approach was used to conduct the present qualitative study in Iran. The participants consisted of 14 EMS personnel selected through purposive sampling, which continued until the data became saturated. Data were collected using semi-structured interviews and analyzed concurrently with their collection through the constant comparison method. Results The process of data analysis resulted in the emergence of 3 main categories “respecting client’s values”, “performing tasks within the professional manner”, “personal characteristic”, and the emergence of eight (8) sub-categories signifying participants’ experiences with regard to EDM. Conclusion According to the results, when EMS personnel are faced with ethical dilemmas, they consider the client’s values and professional dignity, and perform the assigned tasks within the framework of the regulation. The findings also suggest that pre-hospital care providers assess legal consequences before making any decision. Further studies should be conducted regarding the experiences of the subordinates and other related parties.