‘No Time to be Lost!’: Ethical Considerations on Consent for Inclusion in Emergency Pharmacological Research in Severe Traumatic Brain Injury in the European Union

Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on concept that in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials

Developing and testing a nurse-led intervention to support bereavement in relatives in the intensive care (BRIC study): a protocol of a pre-post intervention study

BACKGROUND: When a patient is approaching death in the intensive care unit (ICU), patients' relatives must make a rapid transition from focusing on their beloved one's recovery to preparation for their unavoidable death. Bereaved relatives may develop complicated grief as a consequence of this burdensome situation; however, little is known about appropriate options in quality care supporting bereaved relatives and the prevalence and predictors of complicated grief in bereaved relatives of deceased ICU patients in the Net

Clinical research without consent in adults in the emergency setting: a review of patient and public views

<p>Abstract</p> <p>Background</p> <p>In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected.</p> <p>Methods</p> <p>Seven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded.</p> <p>Results</p> <p>Considering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did <it>not </it>agree generally with RWC, though paradoxically, a higher percentage would <it>personally </it>take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol.</p> <p>Conclusion</p> <p>There are too few data to evaluate whether the rules and regulations permitting RWC protects – or is acceptable to – the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.</p

Early mobilisation in mechanically ventilated patients:A systematic integrative review of definitions and activities

From PubMed via Jisc Publications RouterHistory: received 2018-10-23, accepted 2018-12-11Publication status: epublishMechanically ventilated patients often develop muscle weakness post-intensive care admission. Current evidence suggests that early mobilisation of these patients can be an effective intervention in improving their outcomes. However, what constitutes early mobilisation in mechanically ventilated patients (EM-MV) remains unclear. We aimed to systematically explore the definitions and activity types of EM-MV in the literature. Whittemore and Knafl's framework guided this review. CINAHL, MEDLINE, EMBASE, PsycINFO, ASSIA, and Cochrane Library were searched to capture studies from 2000 to 2018, combined with hand search of grey literature and reference lists of included studies. The Critical Appraisal Skills Programme tools were used to assess the methodological quality of included studies. Data extraction and quality assessment of studies were performed independently by each reviewer before coming together in sub-groups for discussion and agreement. An inductive and data-driven thematic analysis was undertaken on verbatim extracts of EM-MV definitions and activities in included studies. Seventy-six studies were included from which four major themes were inferred: (1) , (2) , (3) and (4) . The first theme indicates that EM-MV is either not fully defined in studies or when a definition is provided this is not standardised across studies. The remaining themes reflect the diversity of EM-MV activities which depends on patients' characteristics and ICU settings; the negotiated decision-making process between patients and staff; and their interdependent relationship during the implementation. This review highlights the absence of an agreed definition and on what constitutes early mobilisation in mechanically ventilated patients. To advance research and practice an agreed and shared definition is a pre-requisite

Searching for meaning : a grounded theory of family resilience in adult ICU

Aim: To explore families’ experiences of their interactions in an Australian adult intensive care unit (ICU) to develop a grounded theory that can be used by critical care nurses to improve patient- and family-centred care (PFCC). Background: Families in ICU play an important role in the patient's recovery and outcomes. However, families are at risk of significant psychological morbidity due to their experiences in ICU. Although many ICU patients can make their own decisions, a large proportion are unconscious or chemically sedated and unable to contribute to decisions about their care, leaving the decision-making role to the family. Therefore, the families’ psychosocial and emotional well-being must be supported by implementing evidence-based interventions that align with a PFCC approach. This study describes the findings of a grounded theory of family resilience in ICU, of which the core category is Regaining control. The focus of this paper is on the major category: Searching for meaning. Methods: We adopted a constructivist grounded theory method. Twenty-five adult family members (n = 25) of 21 patients admitted unexpectedly to an ICU in metropolitan Australia were recruited. In-depth interviews were used to collect the data, and the analytical processes of constructivist grounded theory underpinned the development of a core category and related subcategories. Results: When adult family members experience the unexpected admission of a relative to ICU, they move towards a state of being beyond emotional adversity and regaining control when facilitated to search for meaning in their situation. When families were able to make sense of their situation and find a purpose by contributing to their relative's recovery, it encouraged them to cope and be resilient. Conclusions: Our findings can be used to promote PFCC in ICU, which considers a collaborative approach to meet the patient's needs while providing emotional and psychosocial support to their families

Identifying improvement opportunities for patient- and family-centered care in the ICU: Using qualitative methods to understand family perspectives

Purpose: The purposes of the study were to provide richer context for families' quantitative assessments of the quality of ICU care, and to describe further quality areas of importance for family members. Materials and methods: Free-text comments from 1077 family members of 920 patients focusing on family evaluation of ICU quality of care were analyzed using content analysis. Twenty-one Danish and Dutch ICUs participated from October 2014 to June 2015. Results: Four themes emerged as important to families: information, clinician skills, ICU environment, and discharge from the ICU. Families highlighted the importance of receiving information that was accessible, understandable and honest. They indicated that quality care was ensured by having clinicians who were both technically and interpersonally competent. The ICU environment and the circumstances of the transfer out of the ICU were described as contributing to quality of care. The comments identified room for improvement within all themes. Conclusions: The study highlights the importance of including both technical and emotional care for patients and families and the consequent need to focus on clinicians' mastery of interpersonal skills. (C) 2018 Elsevier Inc. All rights reserved