The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral (...) anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research. (shrink)

This article reports the findings of a study into the role of Dutch nurses in the alleviation of pain and symptoms with a life-shortening intention, conducted as part of a study into the role of nurses in medical end-of-life decisions. A questionnaire survey was carried out using a population of 1509 nurses who were employed in hospitals, home care organizations and nursing homes. The response rate was 82.0%; 78.1% (1179) were suitable for analysis. The results show that in about half (...) of the cases (55.8%) nurses were involved in the decision making by the physician and that nurses were frequently (81.5%) involved in administering the medication. The authors' conclusion is that alleviation of pain and symptoms with a life-shortening intention represents a `grey' area, in which physicians and nurses act on the basis of personal ethical norms rather than legal rules, professional guidelines or shared moral values. (shrink)

Transcranial direct current stimulation over the contralateral primary motor cortex of the target muscle has been described to enhance corticospinal excitability, as measured with transcranial magnetic stimulation. Recently, tDCS targeting the brain regions functionally connected to the contralateral primary motor cortex was reported to enhance corticospinal excitability more than conventional tDCS. We compared the effects of motor network tDCS, 2 mA conventional tDCS, and sham tDCS on corticospinal excitability in 21 healthy participants in a randomized, single-blind within-subject study design. We (...) applied tDCS for 12 min and measured corticospinal excitability with TMS before tDCS and at 0, 15, 30, 45, and 60 min after tDCS. Statistical analysis showed that neither motor network tDCS nor conventional tDCS significantly increased corticospinal excitability relative to sham stimulation. Furthermore, the results did not provide evidence for superiority of motor network tDCS over conventional tDCS. Motor network tDCS seems equally susceptible to the sources of intersubject and intrasubject variability previously observed in response to conventional tDCS. (shrink)

The paper aims at drawing the main lines of a reflection about architectonic space, starting from the comparison between two hypothesis, as much as ever different: Theodor Lipps’ spatial aesthetics and Hans van der Laan’s elemental theory. The emphasis given by both authors to the intersection between directions and way, but also to the mutual subordination between thing and space, allows to rewrite the obituary of architecture as a spatial art, according to which the Modern Style has turned the spatiality (...) into its specular visibility, into the spaciousness, into the indefinite continuity of the Bigness. (shrink)

This article reports the findings of a study into the role of Dutch nurses in the alleviation of pain and symptoms with a life-shortening intention, conducted as part of a study into the role of nurses in medical end-of-life decisions. A questionnaire survey was carried out using a population of 1509 nurses who were employed in hospitals, home care organizations and nursing homes. The response rate was 82.0%; 78.1% were suitable for analysis. The results show that in about half of (...) the cases nurses were involved in the decision making by the physician and that nurses were frequently involved in administering the medication. The authors' conclusion is that alleviation of pain and symptoms with a life-shortening intention represents a `grey' area, in which physicians and nurses act on the basis of personal ethical norms rather than legal rules, professional guidelines or shared moral values. (shrink)

Health technology assessment consists of thesystematic study of the consequences of theintroduction or continued use of the technology in aparticular context, with the explicit objective toarrive at a judgment of the value or merit of thetechnology. Ideally, it is aimed at assessing allaspects of a given technology or group oftechnologies, including non-technical, e.g.socio-ethical, aspects. However, methods for assessingsocio-ethical implications of health technology arerelatively undeveloped and few mechanisms exist totake action based on the results of such evaluations.Still, the examples of cochlear (...) inplants and other cases illustratethat HTA is not a matter of merely collecting thefacts about a technology. The facts must beplausible and relevant from a particular framework,which is not always shared by different groups. It ishere that socio-ethical aspects are encountered. Ifhealth technology assessment aims to enhance theaccountability of the decision making processregarding funding and use of health technology, it isa major challenge to assessors of health technologiesto deal adequately with existing value pluralism. Inthis respect interactive evaluation may have somethingto offer. (shrink)

Gennaro Chtjerchia, Dynamics of meaning: anaphora, presupposition, and the the of grammar. Chicago and London: The University of Chicago Press, 1995.xv+ 270 pp, £59.95, £31.95 G. Pr...

Despite the reported limited success of conventional treatments and growing evidence of the effectiveness of adult bariatric surgery, weight loss operations for (morbidly) obese children and adolescents are still considered to be controversial by health care professionals and lay people alike. This paper describes an explorative, qualitative study involving obesity specialists, morbidly obese adolescents, and parents and identifies attitudes and normative beliefs regarding pediatric bariatric surgery. Views on the etiology of obesity—whether it should be considered primarily a medical condition or (...) more a psychosocial problem—seem to affect the specialists’ normative opinions concerning the acceptability of bariatric procedures as a treatment option, the parents’ feelings regarding both being able to influence their child’s health and their child being able to control their own condition, and the adolescents’ sense of competence and motivation for treatment. Moreover, parents and adolescents who saw obesity as something that they could influence themselves were more in favor of non-surgical treatment and vice versa. Conflicting attitudes and normative views—e.g., with regard to concepts of disease, personal influence on health, motivation, and the possibility of a careful informed consent procedure—play an important role in the acceptability of bariatric surgery for childhood obesity. (shrink)