Definition of Implanted Neurological Device Abandonment: A Systematic Review and Consensus Statement.

Autor:	Okun MS; Department of Neurology, Norman Fixel Institute for Neurological Diseases, Gainesville, Florida.; Department of Neurosurgery, Norman Fixel Institute for Neurological Diseases, Gainesville, Florida., Marjenin T; Musculoskeletal Clinical Regulatory Advisers, Washington, District of Columbia., Ekanayake J; Department of Neurosurgery, National Guard Hospital, Riyadh, Saudia Arabia.; Department of Electronic Engineering, Imperial College London, United Kingdom.; Quetz Ltd, Chelmsford, England., Gilbert F; University of Tasmania, Tasmania, Australia., Doherty SP; Department of Medical Physics and Biomedical Engineering, University College London, London, England.; Amber Therapeutics Limited, London, England., Pilkington J; The Royal Society, London, England., French J; Neurotech Network, St Petersburg, Florida., Kubu C; Center for Neuro-Restoration, Cleveland Clinic, Cleveland, Ohio., Lázaro-Muñoz G; Center for Bioethics, Massachusetts General Hospital, Harvard Medical School, Boston.; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston., Denison T; Amber Therapeutics Limited, London, England.; Medical Research Council Brain Network Dynamics Unit, Departments of Engineering Sciences and Clinical Neurosciences, University of Oxford, Oxford, England., Giordano J; Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia.; Department of Biochemistry, Georgetown University Medical Center, Washington, District of Columbia.; Neuroethics Studies Program, Georgetown University Medical Center, Washington, District of Columbia.; Defense Medical Ethics Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland.; Department of Psychiatry, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2024 Apr 01; Vol. 7 (4), pp. e248654. Date of Electronic Publication: 2024 Apr 01.
DOI:	10.1001/jamanetworkopen.2024.8654
Abstrakt:	Importance: Establishing a formal definition for neurological device abandonment has the potential to reduce or to prevent the occurrence of this abandonment. Objective: To perform a systematic review of the literature and develop an expert consensus definition for neurological device abandonment. Evidence Review: After a Royal Society Summit on Neural Interfaces (September 13-14, 2023), a systematic English language review using PubMed was undertaken to investigate extant definitions of neurological device abandonment. Articles were reviewed for relevance to neurological device abandonment in the setting of deep brain, vagal nerve, and spinal cord stimulation. This review was followed by the convening of an expert consensus group of physicians, scientists, ethicists, and stakeholders. The group summarized findings, added subject matter experience, and applied relevant ethics concepts to propose a current operational definition of neurological device abandonment. Data collection, study, and consensus development were done between September 13, 2023, and February 1, 2024. Findings: The PubMed search revealed 734 total articles, and after review, 7 articles were found to address neurological device abandonment. The expert consensus group addressed findings as germane to neurological device abandonment and added personal experience and additional relevant peer-reviewed articles, addressed stakeholders' respective responsibilities, and operationally defined abandonment in the context of implantable neurotechnological devices. The group further addressed whether clinical trial failure or shelving of devices would constitute or be associated with abandonment as defined. Referential to these domains and dimensions, the group proposed a standardized definition for abandonment of active implantable neurotechnological devices. Conclusions and Relevance: This study's consensus statement suggests that the definition for neurological device abandonment should entail failure to provide fundamental aspects of patient consent; fulfill reasonable responsibility for medical, technical, or financial support prior to the end of the device's labeled lifetime; and address any or all immediate needs that may result in safety concerns or device ineffectiveness and that the definition of abandonment associated with the failure of a research trial should be contingent on specific circumstances.
Databáze:	MEDLINE
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