OBJECTIVES: Cognitive and sensory difficulties frequently jeopardize informed consent of frail elderly patients This study is the first to test whether preliminary research experience could enhance geriatric patients' capacity to consent. DESIGN/SETTING: A step-wise consent procedure was introduced in a study on fluid balance in geriatric patients. Eligible patients providing verbal consent participated in a try-out of a week, during which bioelectrical impedance and weight measurements were performed daily. Afterwards, written informed consent was requested. Comprehension, risk and inconvenience scores (ranges: (...) 0-10) were obtained before and after the try-out by asking ten questions about the study's essentials and by asking for a risk and inconvenience assessment on a ten-points rating scale. SUBJECTS AND RESULTS: Seventy of the 78 eligible subjects started the try-out and 53 (68%) provided written consent. The comprehension score increased from 5.0 (+/- 2.3) to 7.0 (+/- 1.9) following the try-out (P < 0.001). The number of subjects capable of weighing risks and inconveniences increased from 32 to 48 (P < 0.001). CONCLUSIONS: Research experience improved the capacity to consent, still enabling an acceptable participation rate. Therefore, experienced consent seems a promising tool to optimize informed consent in frail elderly subjects. (shrink)

Overzicht van de rationalistische traditie in de filosofie van de kunst sinds Kant door een hoogleraar aan de Leuvense universiteit.

Background: Debates over legalisation of physician-assisted suicide or euthanasia often warn of a “slippery slope”, predicting abuse of people in vulnerable groups. To assess this concern, the authors examined data from Oregon and the Netherlands, the two principal jurisdictions in which physician-assisted dying is legal and data have been collected over a substantial period.Methods: The data from Oregon comprised all annual and cumulative Department of Human Services reports 1998–2006 and three independent studies; the data from the Netherlands comprised all four (...) government-commissioned nationwide studies of end-of-life decision making and specialised studies. Evidence of any disproportionate impact on 10 groups of potentially vulnerable patients was sought.Results: Rates of assisted dying in Oregon and in the Netherlands showed no evidence of heightened risk for the elderly, women, the uninsured , people with low educational status, the poor, the physically disabled or chronically ill, minors, people with psychiatric illnesses including depression, or racial or ethnic minorities, compared with background populations. The only group with a heightened risk was people with AIDS. While extralegal cases were not the focus of this study, none have been uncovered in Oregon; among extralegal cases in the Netherlands, there was no evidence of higher rates in vulnerable groups.Conclusions: Where assisted dying is already legal, there is no current evidence for the claim that legalised PAS or euthanasia will have disproportionate impact on patients in vulnerable groups. Those who received physician-assisted dying in the jurisdictions studied appeared to enjoy comparative social, economic, educational, professional and other privileges. (shrink)

PurposeThe relation between fear of childbirth and gestational age is inconclusive, and self-reported need for help regarding this fear has never been investigated. This study aimed to determine the prevalence and course of FoC according to gestational age, to identify risk factors for the development of FoC, the influence of this fear on preferred mode of delivery, and self-reported need for help.MethodsNulliparous pregnant women of all gestational ages completed an online survey. The study consisted of a cross-sectional and a longitudinal (...) analysis. Women who completed the survey in the first or second trimester were approached again in their third trimester. The Wijma Delivery Expectancy Questionnaire Version A was used with a cut-off score ≥ 85 to define presence of fear of childbirth. Questionnaires indexing social support, anxiety, symptoms of depression, preferred mode of delivery, and self-reported need for help were included.ResultsIn total, 364 women were enrolled at T0, and 118 out of 184 eligible women were included in the longitudinal analysis. Point prevalence of FoC at T0 was 18.4% with no significant difference between trimesters. In the longitudinal sample, the prevalence of FoC decreased from 18.6% to 11.0%, p = 0.004. Although mean scores for FoC decreased significantly, p < 0.001, scores increased in 41 women. The presence of FoC was associated with elevated anxiety, less family support, prenatal care of the obstetrician by choice, preference for a cesarean section, and for pain relief. Women with FoC were more likely to actively seek for help compared to women without FoC.ConclusionWhile FoC is common in each trimester, prevalence decreases over the course of pregnancy. Women with FoC are often actively seeking for help, suggesting that this fear should be addressed better, and help should be offered accordingly. (shrink)

The editors welcome letters from readers, although we cannot guarantee that all will be published. To ensure timeliness, correspondents must respond to an article within seven weeks and not exceed two double‐spaced pages. Letters become the property of the editors and may be edited and shortened at our discretion.

This monograph-length contribution to the Common Knowledge symposium “Peace by Other Means” reviews and assesses the state of ethnographic and political scholarship concerning how nonstate, tribal societies deal with peacemaking and peacekeeping. A central argument is that the condition among nonstate societies was and is neither one of permanent war nor one of permanent peace but one of permanent peacelessness. Nonstate societies recognize the danger of warfare and take measures to reduce its likelihood, or at least try to mitigate its (...) destructiveness. This article treats the politics, strategies, and practices of peacemaking in tribal societies throughout the world, as well as the full spectrum of attempts at war mitigation. (shrink)

Worries about safety of approved drugs have pushed post registration research to become the fastest growing drug research phase. Until recently, phase IV studies were mainly conducted for marketing purposes and run much like a phase III trial—at institutions with experienced investigators and a list of inclusion and exclusion criteria. Innovative phase IV studies involve ordinary physicians in research naïve communities. This brings ethical issues familiar to medical research into clinical practice. As a consequence, individual physicians are challenged to protect (...) scientific integrity and to secure the ethical conduct of research. Several ethical issues need to be addressed in the process of developing a scientifically sound and ethically high principled practice of phase IV research.PHASE IVEssential to phase IV research is the focus on how drugs work in the real world. The research goal may be to explore a specific pharmacological effect, to establish the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. They may also be designed to establish a new clinical indication for a drug.1 Subjects may or may not be randomised, and the studies typically involve large numbers of patient-subjects and physicians.Doubts concerning the scientific rigor and clinical value have put postmarketing research in a poor light. However, high quality phase IV research is badly needed to further pharmaceutical science. First, because it can provide reliable data on the effectiveness, safety and optimal use of a drug in treated populations.2 3 In pre-registration clinical trials , a pharmaceutical product is studied under unrealistic circumstances. Under-representation of women and elderly are common and the concomitant use of medicines is usually extremely restrictive in these trials.4 Second, phase IV can provide much needed data for evidence-based …. (shrink)

In debates about genetic testing of children, as well as about disclosing unsolicited findings (UFs) of pediatric exome sequencing, respect for future autonomy should be regarded as a prima facie consideration for not taking steps that would entail denying the future adult the opportunity to decide for herself about what to know about her own genome. While the argument can be overridden when other, morally more weighty considerations are at stake, whether this is the case can only be determined in (...) concrete cases. Importantly, when children grow into adolescents, respect for future autonomy will have to give way to respecting their emerging autonomy. When pediatric exome sequencing is done for complex conditions not involving developmental delay, respect for the child’s future or emerging autonomy should be a primary consideration for those charged with deciding on behalf of the child. Building on what Emanuel and Emanuel have termed the ‘deliberative model’ of shared decision making, we argue that if parents fail to give these considerations their due, professionals should actively invite them to do so. Taking a directive stance may be needed in order to make sure that the future or emerging autonomy of the child are duly considered in the decision-making process, but also to help the parents and themselves to shape their respective roles as responsible care-givers. (shrink)

This article reports on a survey of the moral problems that Dutch nurses experience during their everyday practice. A questionnaire was developed, based on published literature, panel discussions, in-depth interviews and participation observations. The instrument was tested in a pilot study and proved to be useful. A total of 2122 questionnaires were sent to 91 institutions in seven different health care settings. The results showed that nurses were not experiencing important societal issues such as abortion and euthanasia as morally the (...) most problematic, but rather situations such as verbally aggressive behaviour of colleagues towards patients, keeping silent about errors, and medical treatment given against the wishes of patients. Moral problems occurred especially when nurses experienced feelings of powerlessness with regard to the well-being of patients. Moreover, these moral problems proved to be related to institutional organization, leadership, and collaboration with colleagues and other disciplines. Nurses appeared to have a limited awareness of the moral dimensions of their practice. (shrink)

Background: Although genetic research into Alzheimer disease (AD) is increasing, the ethical aspects of this kind of research and the differences between ethical issues related to genetic and non-genetic research into AD have not yet received much attention. Objectives: (1) To identify and compare the five ethical issues considered most important by surveyed expert panellists in non-genetic and genetic AD research and (2) to compare our empirical findings with ethical issues in genetic research in general as described in the literature. (...) Method: A modified Delphi study in two rounds Results: Genetic and non-genetic research into AD generated an approximately equal number of topics with a considerable overlap. Different priorities in the ethics of both types of research were found. Genetic research raised new topics such as “confidentiality of genetic information” and “implications of research for relatives” which changes the impact and application of existing ethical topics such as “informed consent” and is judged to have more impact on both individuals and society. A difference with the results of more theoretical approaches on ethical aspects related to AD research was also found. Conclusions: Different priorities are given to ethical issues in genetic and non-genetic research. These arise partly because genetic research causes unique and new questions, mostly related to the position of family members and the status of and access to genetic information. Differences found between the results of our empirical study and the more theoretical literature, suggest an additional value for empirical research in medical ethics. (shrink)

In this introduction to the first installment of the Common Knowledge symposium “Peace by Other Means,” the journal's editor questions the assumptions that underwrite standard approaches in the social sciences to the issue of how non-state, tribal societies have dealt with matters of war and peace. He in particular examines and finds wanting the approach that Jared Diamond takes in The World until Yesterday: What Can We Learn from Traditional Societies?. Whereas Diamond's theme is that modern states can learn much (...) about many things from traditional hunter-gatherer societies, with respect to peacemaking and peace-keeping he finds traditional societies distinctly inferior, and the arguments by which he reaches this conclusion are tautological and also beg the question. This prefatory essay explains that “Peace by Other Means” will analyze and detail non-Western and premodern European means of keeping peace that modern theorists of conflict resolution are reluctant to credit or incompetent to assess. (shrink)

About one third of patients with epilepsy have seizures refractory to the medical treatment. Electrical stimulation mapping is the gold standard for the identification of “eloquent” areas prior to resection of epileptogenic tissue. However, it is time-consuming and may cause undesired side effects. Broadband gamma activity recorded with extraoperative electrocorticography during cognitive tasks may be an alternative to ESM but until now has not proven of definitive clinical value. Considering their role in cognition, the alpha and beta bands could further (...) improve the identification of eloquent cortex. We compared gamma, alpha and beta activity, and their combinations for the identification of eloquent cortical areas defined by ESM. Ten patients with intractable focal epilepsy participated in a delayed-match-to-sample task, where syllable sounds were compared to visually presented letters. We used a generalized linear model approach to find the optimal weighting of each band for predicting ESM-defined categories and estimated the diagnostic ability by calculating the area under the receiver operating characteristic curve. Gamma activity increased more in eloquent than in non-eloquent areas, whereas alpha and beta power decreased more in eloquent areas. Diagnostic ability of each band was close to 0.7 for all bands but depended on multiple factors including the time period of the cognitive task, the location of the electrodes and the patient’s degree of attention to the stimulus. We show that diagnostic ability can be increased by 3–5% by combining gamma and alpha and by 7.5–11% when gamma and beta were combined. We then show how ECoG power modulation from cognitive testing can be used to map the probability of eloquence in individual patients and how this probability map can be used in clinical settings to optimize ESM planning. We conclude that the combination of gamma and beta power modulation during cognitive testing can contribute to the identification of eloquent areas prior to ESM in patients with refractory focal epilepsy. (shrink)

In the Netherlands, the legalization of assisted suicide for persons with a death wish without severe illness, often referred to as persons with “completed life” or “tiredness of life,” is intensel...

Instruction in peer assessment of complex task performance may cause high cognitive load, impairing learning. A stepwise instructional strategy aimed at reducing cognitive load was investigated by comparing it with a combined instructional strategy in an experiment with 128 secondary school students (mean age 14.0?years; 45.2% male) with the between-subjects factor instruction (stepwise, combined). In the stepwise condition, study tasks in Phase 1 were domain-specific and study tasks in Phase 2 had both domain-specific and peer assessment components. In the combined (...) condition, these two components were present in all tasks in both phases. Final performance (i.e. speed and accuracy in domain-specific skills and peer assessment skills) showed no significant differences, but performance improved more from Phase 1 to Phase 2 in the stepwise condition than in the combined condition. The results suggest that, with complex study tasks, it might be beneficial to teach domain-specific skills before peer assessment skills. (shrink)