Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent.Design: 11 stroke patients (...) who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

In this paper we argue that knowledge in health care is a multidimensional dynamic construct, in contrast to the prevailing idea of knowledge being an objective state. Polanyi demonstrated that knowledge is personal, that knowledge is discovered, and that knowledge has explicit and tacit dimensions. Complex adaptive systems science views knowledge simultaneously as a thing and a flow, constructed as well as in constant flux. The Cynefin framework is one model to help our understanding of knowledge as a personal construct (...) achieved through sense making. Specific knowledge aspects temporarily reside in either one of four domains – the known, knowable, complex or chaotic, but new knowledge can only be created by challenging the known by moving it in and looping it through the other domains. Medical knowledge is simultaneously explicit and implicit with certain aspects already well known and easily transferable, and others that are not yet fully known and must still be learned. At the same time certain knowledge aspects are predominantly concerned with content, whereas others deal with context. Though in clinical care we may operate predominately in one knowledge domain, we also will operate some of the time in the others. Medical knowledge is inherently uncertain, and we require a context-driven flexible approach to knowledge discovery and application, in clinical practice as well as in health service planning. (shrink)

We are never illness or disease, but, rather, always their sum in the world of day-to-day experience. Disease and illness are not closed systems, but mutually constitutive and continuously interacting worlds. In the patient’s case it is always experience as well. Pain, sickness and death help make that particular experienced identity unavoidable, and at some level ultimately inaccessible to medicine’s changing understanding of disease and tools for managing it. Health—rather than cost containment, specific conditions, or technologies—should be the central focus (...) for health care and health-care reform. A compelling reason to focus on health comes from the observation that the prevalence of disease over the .. (shrink)

Background Metaphors are central to the human understanding of complex issues; through the immediate associations they evoke and frame problems and suggest solutions. Our suggestion of Music in the Park as a metaphor for health systems reform brings to the forefront the environmentally diverse but bounded spaces of health services that offer a variety of attractors within their confines, while pushing into the background organizational and economic concerns.Reflections Parks, like health services, are embedded in their local landscape, serving their communities, (...) but most importantly parks are public spaces, publically funded, ideally offering universal access and equity and to be shared by all who want to go there.Music, like health, is tangible, technical and scientific, yet ultimately experiential and based on meaning. While it encompasses a wide range of styles and approaches, music making requires as its most important skill active listening which brings with it to be ‘in the moment’, to take personal risks and to draw energy and inspiration from the participants. Hence ‘audiences’ are equally active participants because music only has meaning if it internally resonates with the listener and only can exist in what is a co-constructed experience.Conclusions Music in the Park is a metaphor for primary health care systems based on shared values of experts and unique local communities. Health professionals are players in this arena, who develop and practise the full range of their skills in response to individual and community needs and preferences. Their leadership works through inspiration and empowerment, making patients ‘co-producers’ of their own health and ‘co-shapers’ of their health services. (shrink)

In “Potential Subjects’ Responses to an Ethics Questionnaire in a Phase I Study of Deep-Brain Stimulation in Early Parkinson’s Disease,” Finder, Bliton, Gill, Davis, Konrad, and Charles undertake informed consent research on what they describe as a Phase I trial of deep brain stimulation (DBS) for Parkinson’s disease. We argue that the authors should have more carefully characterized the nature of the DBS study at the start of their clinical study.

BACKGROUND AND RATIONALE: Evidence based medicine is the present backbone of rational and objective, modern medical problem solving and is a meeting ground for quantitative and qualitative researchers alike as it culminates into applying the fruits of clinical research to the individual patient. A systematic enquiry into the evolving paradigms in EBM is a need of the hour. AIMS AND METHODS: A qualitative enquiry examining the impact of different methodologies in EBM and their role in generating meaning interpretable at individual (...) levels. RESULTS: Present day outcome based research deals less with patients as individuals than as populations. Evidence based medicine struggles to apply the fruits of population based research to individuals who are often not as predictable as linear quantitative research would like them to be. The present EBM literature neglects a lot of events it doesn't believe to be statistically significant and perhaps here is an area that needs to be improved on - it assumes that because associations are demonstrated between interventions and outcomes in RCTs/meta-analysis, these associations are linear and causal in the real world. While they may be demonstrated repeatedly in highly controlled environments, in the real 'uncontrolled' world of clinical practice with real people, their validity breaks down. CONCLUSIONS: One needs to make the EBM standard model patient-individual (a projection of collective patient event data) resemble the real human individual patient so that optimal EBM individual data that matches our query can be easily and quickly spotted from the dense jungle of information that has grown over the years. This hints at rethinking our entire research methodology and modifying it to suit the needs of the individual patient. (shrink)

Volume 20, Issue 7, July 2020, Page 196-198.

Clinical ethicists encounter the most emotionally eviscerating medical cases possible. They struggle to facilitate resolutions founded on good reasoning embedded in compassionate care. This book fills the considerable gap between current texts and the continuing educational needs of those actually facing complex ethics consultations in hospital settings. 28 richly detailed cases explore the ethical reasoning, professional issues, and the emotional aspects of these impossibly difficult consultations. The cases are grouped together by theme to aid teaching, discussion and professional growth. The (...) cases inform any reader who has a keen interest in the choices made in real-life medical dilemmas as well as the emotional cost to those who work to improve the situations. On a more advanced level, this book should be read by ethics committee members who participate in ethics consultations, individual ethics consultants, clinicians who seek education about complex clinical ethics cases, and bioethics students. (shrink)

Traditionally, heated philosophical debates regarding the status of categories have turned on questions of "nominal" vs "real" existence, where the role and significance of rhetoric and politics is obscured. Feminists in the late 20th century acknowledge a variety of elements involved in the construction of categories such as "human," "nature," rhetoric and logic. I argue for a position which undercuts the traditional debates between nominalism and realism, and using "wo men" as a case study, demonstrate the intricacies of the relationship (...) of logic and rhetoric in category construction. (shrink)

This dissertation is comprised of three parts. The first part is an intellectual historical thesis, regarding the place of Jean Piaget in philosophic thought. In Chapter One I outline the differences between my thesis and Piaget's position on the development of spatial concepts. My second chapter places his theory within the context of congruent accounts from the philosophy of nature, neurophysiology, and philosophy of psychology. Chapter Three situates him in relation to a selection of philosophers in the history of western (...) philosophy, through a metapsychology. ;In Part II I provide a dynamic account of the order of conceptual development, and clarification of the concepts of topological space, projective space, and euclidean or metric space.$\sp1$ In three chapters I outline a systematic analysis of the genetic development of the concepts based on an analysis and critique of Piaget's observations. The emergence of each concept is shown to be a result of the experience of some incongruity between the concept immediately preceding, and experience. The order I outline differs in some specifics from that suggested by Piaget's broad outline, and I explain the differences as they occur. ;The third part of this dissertation is the most tentative. Chapter Nine discusses the kind of testing I will employ when I test the logical order of concepts. There are four kinds of modes which I use to test each concept. This is followed by Chapter Ten, which tests the dynamic development of concepts of space. In this I attempt to confirm those changes in the development of the concepts, as well as Piaget's overall framework, through the use of Piaget's pre-logical modes as well as others I have extracted from the dynamic development of concepts. ftn $\sp1$ I note here that Piaget means, by euclidean geometry, metric geometry. The distinction between geometry with a euclidean and a non-euclidean metric is not crucial for the purpose of this thesis. (shrink)

PURPOSE: To evaluate the effects of social support on comprehension and recall of consent form information in a study of Parkinson disease patients and their caregivers.DESIGN and METHODS: Comparison of comprehension and recall outcomes among participants who read and signed the consent form accompanied by a family member/friend versus those of participants who read and signed the consent form unaccompanied. Comprehension and recall of consent form information were measured at one week and one month respectively, using Part A of the (...) Quality of Informed Consent Questionnaire .RESULTS: The mean age of the sample of 143 participants was 71 years . Analysis of covariance was used to compare QuIC scores between the intervention group and control group . In the 1-week model, no statistically significant intervention effect was found . However, the intervention status by patient status interaction was statistically significant . In the 1-month model, no statistically significant intervention effect was found . Again, however, the intervention status by patient status interaction was statistically significant . At both time periods, intervention group patients scored higher on the QuIC than did intervention group caregivers, and control group patients scored lower on the QuIC than did control group caregivers.IMPLICATIONS: Social support played a significant role in enhancing comprehension and recall of consent form information among patients. (shrink)

Leeds Teaching Hospitals NHS Trust v Mr & Mrs A & othersThe decision of Dame Butler-Sloss in the case of Leeds Teaching Hospitals NHS Trust v Mr & Mrs A & Others1 has already achieved notoriety. The disturbing facts have received widespread media coverage and fuelled further legal and political debate surrounding the “reproductive revolution”.2 This short paper assesses the context and potential implications of the recent decision and, in particular, the nature and meaning of parenthood and the family.THE CASETwo (...) couples, referred to Mr and Mrs A and Mr and Mrs B, were attending the assisted conception unit at Leeds General Infirmary to receive infertility treatment. Both couples understood that they were participating in a technique called intracytoplasmic sperm injection , a technique which would use the eggs of the wife and the sperm of the husband in each case. Mrs A had consented to her eggs being mixed with her husband’s sperm to create an embryo which would then be implanted in her, hopefully resulting in pregnancy. Mr A had consented to his wife’s treatment. Mr and Mrs B gave their consent to similar IVF procedures, although Mr B had expressly refused to consent to his sperm being used in treating others.Following a mix up at the unit, which Butler-Sloss referred to as “a ‘mistake’ … despite its inadequacy as a description of what occurred”, Mr B’s sperm was injected into Mrs A’s eggs. She became pregnant and later gave birth to healthy twins. The mistake became apparent only on Mrs A’s delivery of twins of mixed race; Mr and Mrs A are both white, Mr and Mrs B both black. DNA testing subsequently established that Mr B was the biological father of the children. He has had no subsequent contact with them and …. (shrink)

Background: Thrombolytic drugs to treat an acute ischaemic stroke reduce the risk of death or major disability. The treatment is, however, also associated with an increased risk of potentially fatal intracranial bleeding. This confronts the patient with the dilemma of whether or not to take a risk of a serious side effect in order to increase the likelihood of a favourable outcome. Objective: To explore acute stroke patients’ perception of risk and willingness to accept risks associated with thrombolytic drug treatment. (...) Design: Eleven patients who had been informed about thrombolytic drug treatment and had been through the process of deciding whether or not to participate in a thrombolytic drug trial went through repeated qualitative, semistructured interviews. Results: Many patients showed a limited perception of the risks connected with thrombolytic drug treatment. Some perceived the risk as not relevant to them and were reluctant to accept that treatment could cause harm. Others seemed to be aware that treatment would mean exposure to risk. The patients’ willingness to take a risk also varied substantially. Several statements revealed ambiguity and confusion about being involved in a decision about treatment. The patients’ reasoning about risk was put into the context of their health-related experiences and life histories. Several patients wanted the doctor to be responsible for the decisions. Conclusion: Acute stroke patients’ difficulties in perceiving and processing information about risk may reduce their ability to be involved in clinical decisions where risks are involved. (shrink)

Objective To study how doctors care for their patients, both medically and as fellow humans, through observing their conduct in patient–doctor encounters. Design Qualitative study in which 101 videotaped consultations were observed and analysed using a Grounded Theory approach, generating explanatory categories through a hermeneutical analysis of the taped consultations. Setting A 500-bed general teaching hospital in Norway. Participants 71 doctors working in clinical non-psychiatric departments and their patients. Results The doctors were concerned about their patients' health and how their (...) medical knowledge could be of service. This medical focus often over-rode other important aspects of the consultations, especially existential elements. The doctors actively directed the focus away from their patients' existential concerns onto medical facts and rarely addressed the personal aspects of a patient's condition, treating them in a biomechanical manner. At the same time, however, the doctors attended to their patients with courteousness, displaying a polite and friendly attitude and emphasising the relationship between them. Conclusions The study suggests that the main failing of patient–doctor encounters is not a lack of courteous manners, but the moral offence patients experience when existential concerns are ignored. Improving doctors' social and communication skills cannot resolve this moral problem, which appears to be intrinsically bound to modern medical practice. Acknowledging this moral offence would, however, be the first step towards minimising the effects thereof. (shrink)

When Did I Begin? investigates the theoretical, moral, and biological issues surrounding the debate over the beginning of human life. With the continuing controversy over the use of in vitro fertilization techniques and experimentation with human embryos, these issues have been forced into the arena of public debate. Following a detailed analysis of the history of the question, Reverend Ford argues that a human individual could not begin before definitive individuation occurs with the appearance of the primitive streak about two (...) weeks after fertilization. This, he argues, is when it becomes finally known whether one or more human individuals are to form from a single egg. Thus, he questions the idea that the fertilized egg itself could be regarded as the beginning of the development of the human individual. The author also differs sharply, however, from those who would delay the beginning of the human person until the brain is formed, or until birth or the onset of conscious states. (shrink)

Irrelevant emotional stimuli often capture attention, disrupting ongoing cognitive processes. In two experiments, we examined whether availability of rewards can prevent...

The chapters in this book have evolved from talks originally presented at The First International Workshop on Human and Machine Cognition.

Category-specific impairments of object recognition and naming are among the most intriguing disorders in neuropsychology, affecting the retrieval of knowledge about either living or nonliving things. They can give us insight into the nature of our representations of objects: Have we evolved different neural systems for recognizing different categories of object? What kinds of knowledge are important for recognizing particular objects? How does visual similarity within a category influence object recognition and representation? What is the nature of our semantic knowledge (...) about different objects? We review the evidence on category-specific impairments, arguing that deficits even for one class of object cannot be accounted for in terms of a single information processing disorder across all patients; problems arise at contrasting loci in different patients. The same apparent pattern of impairment can be produced by damage to different loci. According to a new processing framework for object recognition and naming, the hierarchical interactive theory, we have a hierarchy of highly interactive stored representations. HIT explains the variety of patients in terms of lesions at different levels of processing and different forms of stored knowledge used both for particular tasks and for particular categories of object. Key Words: category-specific deficits; functional imaging; hierarchical models; interactive activation models; neuropsychology; object recognition; perceptual and functional knowledge. (shrink)

Objective: To determine the views of people with multiple sclerosis (MS) and professionals in relation to confidentiality, consent and access to data within a proposed MS register in the UK. Design: Qualitative study using focus groups (10) and interviews (13). Setting: England and Northern Ireland. Participants: 68 people with MS, neurologists, MS nurses, health services management professionals, researchers, representatives from pharmaceutical companies and social care professionals. Results: People with MS expressed open and altruistic views towards the use of their personal (...) information to facilitate service provision and research, placing trust in responsible guardianship and legitimate use of their information. Participant’s proposed that people with MS should be able to select their individual level of involvement in a register using levels of consent. It was agreed that access to the register should be governed by a guardianship committee composed of a range of stakeholders. People with MS did not wish their details to be used by marketing agencies and did not consider this a legitimate use of their data. Whilst participants were positive of the role a register could play in promoting research, participants felt that access to data by pharmaceutical industries should be administered by the guardianship committee. People with MS are concerned should their employers be able to access their personal information. Professionals were more cautious than people with MS in their approach to the use of patient personal data within a register. Conclusions: Whilst all stakeholders were positive of the benefits of an MS register, development of such a resource must incorporate robust data security and guardianship measures in order to ensure that, whilst opportunities are maximised, risks to the privacy of individuals and legal challenges to professionals are avoided. (shrink)