Pham Michelle T, Campbell Tiffany A, Dorfman Natalie, Torgerson Laura, Kostick-Quenet Kristin, Blumenthal-Barby Jennifer, Storch Eric A, Lázaro-Muñoz Gabriel
Center for Bioethics and Social Justice, College of Human Medicine, Michigan State University, East Fee Hall 965 Wilson Road Rm A-126, East Lansing, MI 48824, United States.
Center for Bioethics, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, United States.
J Obsessive Compuls Relat Disord. 2023 Oct;39. doi: 10.1016/j.jocrd.2023.100830. Epub 2023 Aug 23.
Approximately 10-20% of children with obsessive-compulsive disorder (OCD) have treatment-resistant presentations, and there is likely interest in developing interventions for this patient group, which may include deep brain stimulation (DBS). The World Society for Stereotactic and Functional Neurosurgery has argued that at least two successful randomized controlled trials should be available before DBS treatment for a psychiatric disorder is considered "established." The FDA approved DBS for adults with treatment-resistant OCD under a humanitarian device exemption (HDE) in 2009, which requires that a device be used to manage or treat a condition impacting 8,000 or fewer patients annually in the United States. DBS is currently offered to children ages 7 and older with treatment-resistant dystonia under an HDE. Ethical and empirical work are needed to evaluate whether and under what conditions it might be appropriate to offer DBS for treatment-resistant childhood OCD. To address this gap, we report qualitative data from semi-structured interviews with 25 clinicians with expertise in this area. First, we report clinician perspectives on acceptable levels of evidence to offer DBS in this patient population. Second, we describe their perspectives on institutional policies or protocols that might be needed to effectively provide care for this patient population.
约10%-20%的强迫症(OCD)儿童存在治疗抵抗表现,因此可能有开发针对该患者群体的干预措施的需求,其中可能包括脑深部电刺激(DBS)。世界立体定向和功能神经外科学会认为,在DBS治疗一种精神疾病被视为“确立”之前,至少应该有两项成功的随机对照试验。2009年,美国食品药品监督管理局(FDA)根据人道主义器械豁免(HDE)批准了DBS用于治疗抵抗性强迫症的成人患者,该豁免要求一种器械用于管理或治疗美国每年影响患者人数为8000人或更少的疾病。目前,在HDE下,DBS被用于治疗7岁及以上患有治疗抵抗性肌张力障碍的儿童。需要开展伦理和实证研究,以评估是否以及在何种情况下为治疗抵抗性儿童强迫症提供DBS治疗是合适的。为了填补这一空白,我们报告了对25名该领域专家临床医生进行半结构化访谈的定性数据。首先,我们报告临床医生对于在该患者群体中提供DBS可接受的证据水平的观点。其次,我们描述他们对于有效为该患者群体提供护理可能需要的机构政策或方案的观点。
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