Research Group of Experimental Neurosurgery and Neuroanatomy, Department of Neurosciences, KU Leuven, Leuven, Belgium Chair of Committee of Neurosurgery for Psychiatric Disorders of the WSSFN and Department of Neurosurgery, UZ Leuven, Leuven, Belgium Working Group 'Deep Brain Stimulation in Psychiatry: Guidance for Responsible Research and Application'. This Working Group is organised by the Europäische Akademie GmbH (Bad Neuenahr-Ahrweiler, Germany, http://www.ea-aw.de). It consists of an interdisciplinary and international team of neurosurgeons, neurologists, psychiatrists, neuropsychologists, bioethicists, philosophers and legal scholars, analysing ethical issues arising from the application of Deep Brain Stimulation for Psychiatric Disorders. Questions such as critical issues around regulatory processes and ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation have been comprehensively studied and the results have been published under common authorship. WSSFN Committee on Neurosurgery for Psychiatric Disorders.
Research Group of Experimental Neurosurgery and Neuroanatomy, Department of Neurosciences, KU Leuven, Leuven, Belgium.
J Neurol Neurosurg Psychiatry. 2014 Sep;85(9):1003-8. doi: 10.1136/jnnp-2013-306580. Epub 2014 Jan 20.
For patients with psychiatric illnesses remaining refractory to 'standard' therapies, neurosurgical procedures may be considered. Guidelines for safe and ethical conduct of such procedures have previously and independently been proposed by various local and regional expert groups.
To expand on these earlier documents, representative members of continental and international psychiatric and neurosurgical societies, joined efforts to further elaborate and adopt a pragmatic worldwide set of guidelines. These are intended to address a broad range of neuropsychiatric disorders, brain targets and neurosurgical techniques, taking into account cultural and social heterogeneities of healthcare environments.
The proposed consensus document highlights that, while stereotactic ablative procedures such as cingulotomy and capsulotomy for depression and obsessive-compulsive disorder are considered 'established' in some countries, they still lack level I evidence. Further, it is noted that deep brain stimulation in any brain target hitherto tried, and for any psychiatric or behavioural disorder, still remains at an investigational stage. Researchers are encouraged to design randomised controlled trials, based on scientific and data-driven rationales for disease and brain target selection. Experienced multidisciplinary teams are a mandatory requirement for the safe and ethical conduct of any psychiatric neurosurgery, ensuring documented refractoriness of patients, proper consent procedures that respect patient's capacity and autonomy, multifaceted preoperative as well as postoperative long-term follow-up evaluation, and reporting of effects and side effects for all patients.
This consensus document on ethical and scientific conduct of psychiatric surgery worldwide is designed to enhance patient safety.
对于那些对“标准”疗法仍无反应的精神疾病患者,可能会考虑神经外科手术。先前,各种地方和地区专家组已经提出了关于这些手术安全和伦理规范的指南。
为了扩展这些早期文件,大陆和国际精神病学和神经外科学会的代表成员共同努力,进一步详细阐述并采用一套实用的全球指南。这些指南旨在解决广泛的神经精神障碍、大脑靶点和神经外科技术问题,同时考虑到医疗保健环境的文化和社会异质性。
拟议的共识文件强调,尽管立体定向消融手术,如针对抑郁症和强迫症的扣带回切开术和壳切开术,在一些国家被认为是“既定”的,但它们仍然缺乏一级证据。此外,还指出,迄今为止在任何尝试的大脑靶点进行的深部脑刺激,以及任何精神或行为障碍,仍处于研究阶段。鼓励研究人员根据疾病和大脑靶点选择的科学和数据驱动的理由,设计随机对照试验。经验丰富的多学科团队是任何精神神经外科安全和伦理操作的强制性要求,确保患者有记录的难治性、尊重患者能力和自主权的适当同意程序、多方面的术前和术后长期随访评估,以及报告所有患者的效果和副作用。
这份关于全球精神外科伦理和科学操作的共识文件旨在提高患者的安全性。