Background Genuine uncertainty on superiority of one intervention over the other is called equipoise. Physician-investigators in randomized controlled trials need equipoise at least in studies with more than minimal risks. Ideally, this equipoise is also present in patient-participants. In pediatrics, data on equipoise are lacking. We hypothesize that 1) lack of equipoise at enrolment among parents may reduce recruitment; 2) lack of equipoise during participation may reduce retention in patients assigned to a less favoured treatment-strategy. Methods We compared preferences of (...) parents/patients at enrolment, documented by a questionnaire, with preferences developed during follow-up by an interview-study to investigate equipoise of child-participants and parents in the BeSt-for-Kids-study. This trial in new-onset Juvenile Idiopathic Arthritis-patients consists of three strategies. One strategy comprises initial treatment with a biological disease-modifying-antirheumatic-drug, currently not standard-of-care. Semi-structured interviews were conducted with 23 parents and 7 patients, median 11 months after enrolment. Results Initially most parents and children were not in equipoise. Parents/patients who refused participation, regularly declined due to specific preferences. Many participating families preferred the biological-first-strategy. They participated to have a chance for this initial treatment, and would even consider stopping trial-participation when not randomized for it. Their conviction of superiority of the biological-first strategy was based on knowledge from internet and close relations. According to four parents, the physician-investigator preferred the biological-first-strategy, but the majority stated that she had no preferred strategy. In phase 2, preferences tended to change to the treatment actually received. Conclusions Lack of equipoise during enrolment did not reduce study recruitment, mainly due to the fact that preferred treatment was only available within the study. Still, when developing a trial it is important to evaluate whether the physicians’ research question is in line with preferences of the patient-group. By exploring so-called ‘informed patient-group’-equipoise, successful recruitment may be enhanced and bias avoided. In our study, lack of equipoise during trial-participation did not reduce retention in those assigned to a less favoured option. We observed a change for preference towards treatment actually received, possibly explained by comparable outcomes in all three arms. (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 lieu of an abstract, here is a brief excerpt of the content:Kinship:The Relationship Between Johnstone's Ideas about Philosophical Argument and the Pragma-Dialectical Theory of ArgumentationFrans H. van Eemeren and Peter Houtlosser1. Johnstone on the Nature of Philosophical ArgumentAs he himself declared in Validity and Rhetoric in Philosophical Argument (1978, 1), the late philosopher Henry W. Johnstone Jr. devoted a long period of his professional life to clarifying the nature of philosophical argument. His well-known view was that philosophical arguments are (...) sui generis, i.e., not to be judged by the standards of argumentation in science or everyday discourse. Philosophical arguments are not ad rem, but are based on premises that are expressed or implied commitments of a party in dialogue. This is why philosophical argumentation is, according to Johnstone, always ad hominem. In philosophical argumentation, every ad rem argument begs the question.Usually, ad hominem argumentation is dismissed as invalid. Johnstone, however, maintains that making use of argumentum ad hominem is the only way to establish a philosophical conclusion. In an argumentum ad hominem, inferences are drawn from propositions stated or implied by the other party and critical questions are raised about the conclusions that were drawn, so that it can be used to refute a philosophical position by showing that this position is inconsistent. As Walton (2001) rightly observes, this type of ad hominem argumentation boils down to arguing from commitments of the other party, i.e., ex concessis.The use of ad hominem argumentation as the criticism of a position in terms of its own presuppositions is, in Johnstone's view, the only valid argument in philosophy, if any philosophical argument is indeed valid. All philosophical polemic is in this perspective in fact addressed ad hominem. This applies not only to philosophical argumentation that concerns self-referential refutation but also to other ad hominem types of philosophical argumentation, including the tu quoque argument (1978, 11–12).According to Johnstone, there is no objective criterion for determining the validity of ad hominem argumentation. Validity must, says Johnstone in the [End Page 51] epilogue of his collected essays on philosophical argument, be viewed as "a regulative ideal" (135). Much earlier, Johnstone had already come to the conclusion that "the valid argument is the one that maintains philosophical discussion" (38). It is this self-perpetuating feature that is the distinctive rationality of philosophy. By forcing the interlocutor to elaborate his philosophical position rather than just repeat it, the gap between the interlocutors is bridged.In order to distinguish between constructive persuasive argumentation and mere repetition or other forms of paralyzing the discourse, the line must be drawn between responsible and irresponsible persuasion. This is a problem for Johnstone. Where the Ancients solved the problem by insisting that the persuader be virtuous, Johnstone proposed to base the distinction between responsible and irresponsible persuasion on the attitude of the philosopher and his interest in maintaining the philosophical enterprise. The philosopher is a critic who criticizes con amore. His intention to do so, however, is revealed "only in the way he goes about his work" (84).A more down to earth criterion for responsible persuasion that Johnstone proposed is that the discourse should not tend to degenerate. Logic, as the discipline concerned with reason, serves to prevent the discussion from degenerating, but it can do so only if the parties concerned have jointly committed themselves to certain logical principles. If in philosophical argument a defendant is under no obligation to acknowledge an inconsistency when the other party points out an inconsistency in his position, then the other party's criticism cannot count as valid. According to Johnstone, however, it will depend on the parties' presuppositions whether or not they consider two statements as being inconsistent. In other words, what is inconsistent for the one party may not be inconsistent for the other party.Few obligations are imposed on everyone; most obligations arise from commitments made by specific individuals or groups of individuals. As Johnstone says, "Even the cogent philosophical argument is not, of course, absolutely cogent; it is cogent only relatively to interlocutors who maintain the premises on which it depends" (27). Once we abandon the search for objective conditions under which philosophical arguments can be valid, according... (shrink)