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Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.

ABSTRACT: BACKGROUND:Deep brain stimulation (DBS) as investigational intervention for symptomatic relief from Alzheimer disease (AD) has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical. METHOD:We performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the analysis of research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients. RESULTS:The results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely. CONCLUSION:Based on our empirical analysis, we argue that clinical research on interventions of risk class III (Food and Drug Administration and European Medicines Agency) should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period.

SUBMITTER: Bittlinger M

PROVIDER: S-EPMC5994654 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.

Bittlinger Merlin M Müller Sabine S

BMC medical ethics 20180611 1

<h4>Background</h4>Deep brain stimulation (DBS) as investigational intervention for symptomatic relief from Alzheimer disease (AD) has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical.<h4>Method</h4>We performed a systemat ...[more]

PMID: 29886845

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Project description:Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to maneuver between the Skylla of hyper accelerated translation without rigorously conducted RCTs and the Charybdis of the missed opportunity of valuable knowledge.

Project description:In this article, we explore a specific controversy about animal experimentation and animal models in the recent history of deep brain stimulation (DBS), and we question its ramifications. DBS development intertwines clinical practice with fundamental research and stands at the crossroads of multiple legacies. We take up the various issues and controversies embedded in this rarely addressed dispute, from a standpoint that combines socio-anthropological and legal aspects. Our starting point is a debate on the role of animal experimentation in the development of DBS between Jarrod Bailey, a researcher promoting the abolition of animal experimentation, and Alim Louis Benabid, Marwan Hariz, and Mahlon DeLong, three key figures in the area of DBS and neuroscience. By clarifying the positions of the different protagonists and retracing the issues raised in these discussions, our objective is to show how this specific debate has extended from its initial space and how it provides an object of study with heuristic scope. We first present this partially polemic discussion about the history of DBS, and its link with a more general debate on the validity and use of animal models and the need for animal experiments. Then, we raise the issue of the relations and interactions between experiments on animals and on humans in the logics of biomedical innovation. The third step is to situate the discussion within the wider framework of opposition towards animal experimentation and the promotion of animal' rights. Finally, combining these interweaved issues, possible implications emerge regarding the future of DBS. We show that behind these several controversies lie the question of translational research and the model of medicine upheld by DBS. We describe how the technology contributes to blurring the lines between research (fundamental, preclinical and clinical research) and care, as well as between humans and animals as substrates and objects of knowledge. The dynamics of DBS future development might then become a point of convergence for neuroscientists and animal rights defenders' interests.

Project description:BackgroundEthical conflict is a problem with negative consequences, which can compromise the quality and ethical standards of the nursing profession and it is a source of stress for health care practitioners', especially for nurses.ObjectivesThe main aim of this study was to analyze Spanish critical care nurses' level of exposure to ethical conflict and its association with sociodemographic, occupational, and COVID-19-related variables. Research Design, Participants, and Research context: This was a quantitative cross-sectional descriptive study conducted among 117 nurses working in critical care units. Data collection tools were sociodemographic, occupational, and COVID-19-related questionnaires and previously validated Spanish version of Ethical Conflict in Nursing Questionnaire-Critical Care Version.Ethical considerationsWe obtained permission from the Ethics Committee and participants' informed consent.FindingsData indicates a moderate level of exposure to ethical conflicts. The most frequent ethical conflicts were related to situations about "treatment and clinical procedures." The most intensity of ethical conflicts was related to situations about "treatment and clinical procedures" and "dynamics of the service and working environment." No statistical significance was identified between the socio-demographic variables and level of exposure to ethical conflicts. However, for critical care nurses working in ICU, nurses with perceived worked stress had a higher level of exposure to ethical conflicts. Likewise, critical care nurses whose family/friends were infected with COVID-19 had a higher level of exposure.ConclusionsCritical care nurses experience a moderate level of exposure to ethical conflicts which is consistent with the results of previous studies. A deeper understanding of ethical conflicts in conflictive situations allows recognition of the situations that occur in everyday clinical practice, identification of the ethical conflicts, and facilitation of the nurses working in the challenging clinical situation.

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Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.

Publications

Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.

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