Sauvaget Anne, Poulet Emmanuel, Mantovani Antonio, Bulteau Samuel, Damier Philippe, Moutaud Baptiste, Paternoster Mariano, de Bartolomeis Andrea, DʼUrso Giordano
CHU de Nantes, CIC0004, Nantes & Université de Nantes, UFR Médecine, Nantes.
CNRS, Cermes3, Research Center on Sciences, Health, Mental Health and Society, Paris, France.
J ECT. 2018 Dec;34(4):211-219. doi: 10.1097/YCT.0000000000000513.
The proven effectiveness of neuromodulation and stimulation techniques for the management of psychiatric disorders has brought strongly needed innovation in psychiatry, given the high prevalence and high costs of treatment resistance. Although evidence-based guidelines in neuromodulation have been implemented to improve the clinical efficacy, safety, and research procedures, practical suggestions on how to design a psychiatric neuromodulation unit (PNU) are not available in the scientific literature. In this contribution, we have combined the results of a literature search with the suggestions of clinical psychiatrists, managers, and bioethicists who have had firsthand experience in building a PNU. Eleven key issues concerning the implementation and management of a PNU were identified: general context, team composition, environment, basic technical equipment, clinical versus research activities, target clinical population, education and training, interdisciplinarity, ethical aspects, regulatory and reimbursement issues, fund-raising, and partnership development. Moreover, a business plan comprising pragmatic solutions and recommendations for designing an efficient PNU was laid out.
鉴于治疗抵抗的高发生率和高成本，神经调节和刺激技术在精神疾病管理方面已证实的有效性为精神病学带来了迫切需要的创新。尽管已经实施了基于证据的神经调节指南以提高临床疗效、安全性和研究程序，但科学文献中尚无关于如何设计精神病神经调节单元（PNU）的实用建议。在本论文中，我们将文献检索结果与临床精神科医生、管理人员和生物伦理学家的建议相结合，这些人员在建立PNU方面拥有第一手经验。确定了与PNU实施和管理相关的11个关键问题：总体背景、团队组成、环境、基本技术设备、临床与研究活动、目标临床人群、教育与培训、跨学科性、伦理方面、监管与报销问题、筹资以及伙伴关系发展。此外，还制定了一份商业计划，其中包含设计高效PNU的务实解决方案和建议。
