A Systematic Review of Live Animal Use as a Simulation Modality ("Live Tissue Training") in the Emergency Management of Trauma.

INTRODUCTION: Live anaesthetized animals are used as simulation models to teach techniques in the emergency management of trauma. We aimed to explore how "live tissue training" (LTT) is designed, delivered and evaluated in order to better understand and characterize aspects of educational merit. METHODS: A systematic review was performed using PRISMA guidance. A combined approach, involving a 3-stage modified narrative synthesis process and reflexive thematic analysis was used to identify key concepts across the published literature. FINDINGS: Qualitative synthesis of 48 selected articles suggests that LTT is mainly used to teach military and civilian physicians and military medical technicians. The procedures trained vary with the learner population, from simple pre-hospital trauma tasks to advanced operative surgical skills. Many courses use a combination of didactic and practical training, with an animal model used to train practical application of knowledge and procedural skills. Descriptions of the learning interventions are limited, and explicit use of educational theory or pedagogic frameworks were absent within the literature. Four themes were identified regarding aspects of LTT that are valued by learners: "recreating the experience," relating to fidelity and realism; "tick tock" "dynamics of hemorrhage", encompassing the impact of bleeding and urgent pressure to act; "emotional impact" of conducting the training, and "self-efficacy: I believe I can do it." CONCLUSION: Thematic analysis of published literature suggests that there may be educational benefit in the use of live tissue models due to time criticality and bleeding, which creates a real-life event. LTT also invokes an emotional response, and learners experience an increase in self-efficacy from participation. We consider that these aspects and associated pedagogy should be addressed when researching and developing alternative simulation modalities, in order to intelligently replace, reduce and refine the use of animals in training practitioners in the emergency management of trauma.

Ethical dilemmas and ethical competence in the daily work of research nurses.

In spite of the growing interest in nursing ethics, few studies have focused on ethical dilemmas experienced by nurses working with clinical studies as 'research nurses'. The aim of the present study was to describe and explore ethical dilemmas that Swedish research nurses experience in their day-to-day work. In a qualitative study a purposeful sample of six research nurses from five wards of differing disciplines in four Swedish hospitals was interviewed. The analysis displayed several examples of ethical dilemmas, primarily tensions between the nurses' obligations to the study and to the patients involved. A guiding moral principle for the nurses was patient-centeredness, where the interest of research must not override the interest of the patient. In situations where tensions between research and patient interests occurred, and doctors and nurses disagreed upon the judgement, the nurses sometimes chose to follow the doctors' advice, and thus acted against their own moral judgment. Such situations seemed to create feelings of moral distress among the nurses. They described their profession as being 'invisible' and as lacking opportunities for ethical competence building. The conclusion is that research nurses frequently experience severe and difficult ethical dilemmas in their daily work. They need to be acknowledged as a particular profession in the health care organisation and encouraged to develop their specific ethical competence.

Split views among parents regarding children's right to decide about participation in research: a questionnaire survey.

Based on extensive questionnaire data, this paper focuses on parents' views about children's right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings.

Self-assessed understanding as a tool for evaluating consent: reflections on a longitudinal study.

Based on extensive clinical questionnaire data, this paper explores the relation between research subjects' self-assessed understanding and actual knowledge of a large-scale predictive screening study, and its implications for the proper handling of information and consent routines in longitudinal studies. The initial data show that low self-assessed understanding among participants was correlated with limited knowledge, concern over participation and collected samples, less satisfaction with information, and feeling passive or negative towards the study. Among those reporting high understanding, a non-negligible number displayed a lack of knowledge regarding central aspects of the study. Regarding high assessed understanding, the multivariate analysis identified the main predictor variables to be knowledge, having a positive attitude towards participation and the study itself, being satisfied with information, having a stable psychosocial background and feeling calm regarding the handling of samples. These findings indicate that to evaluate participants' understanding through self-assessment may not be reliable method. Self-assessed understanding may rather be a good indicator of general attitudes than a tool for analysing content. The data also show that actual understanding varies considerably among participants, suggesting that more effort needs to be put into adjusting the information to the needs of different subgroups. It is argued that when doing this, researchers in longitudinal studies must be careful not to exhaust participants with excessive information that they do not want and that may cause them to drop out. The ethical relevance of obtaining repeated consents in longitudinal research is discussed.

Should physicians fake diagnoses to help their patients?

Are fake diagnoses and false or misleading certificates permissible means of helping patients? This question is examined in relation to four examples from Swedish health care: the sterilisation case, the asylum case, the virginity case, and the adoption case. We argue that both consequentialist and deontological ethical theories, to be reasonable, need to balance values, principles, and interests such as wellbeing, truthfulness, autonomy, personal integrity, trust in the medical profession, and abidance by national legislation. We conclude that it can be justifiable for physicians to fake diagnoses and write false or misleading certificates in order to help patients when not doing so has dire consequences. However, physicians must also consider the long-term effects of making exceptions to honest, non-deceitful behaviour based on the best empirical evidence available. Otherwise valuable social practices might erode and public confidence in physicians be threatened.

Views on data use, confidentiality and consent in a predictive screening involving children.

Data from the 5-6 year control questionnaire of the ABIS study, a Swedish prospective screening of children for Type 1 diabetes, indicates a genuine trust in the researchers--very few participating families expressed concern about their participation. Nevertheless, a majority do not want their research data to be used beyond the agreement of the original consent. They want to be asked for renewed consent in such cases. A vast majority also want potential high-risk information about their child to be communicated to them. Most participating families want this regardless of whether any preventive treatment is available. Although potential benefits for their child is a motivation for participation for a majority of the respondents, they also claim to be motivated by altruistic reasons. These results are compared to results from two similar studies in the UK.

Against the principle that the individual shall have priority over science.

This paper highlights a feature common to many ethical guidelines--namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed.

How to handle informed consent in longitudinal studies when participants have a limited understanding of the study.

Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of knowledge they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected.

Keep people informed or leave them alone? A suggested tool for identifying research participants who rightly want only limited information.

People taking part in research vary in the extent to which they understand information concerning their participation. Since they may choose to limit the time and effort spent on such information, lack of understanding is not necessarily an ethical problem. Researchers who notice a lack of understanding are in the quandary of not knowing whether this is due to flaws in the information process or to participants' deliberate choices. We argue that the two explanations call for different responses.A tool for identifying those research participants who want limited information is presented. This consists of a restricted number of questions about trust in and appraisal of research, priority of time and privacy, and perception of a duty to participate. It is argued that an important group of participants who purposely lack understanding of the study can be identified with this tool. Some limitations to this approach are also discussed.