磁共振引导聚焦超声神经外科治疗难治性强迫症:一项卫生技术评估。
Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Treatment-Refractory Obsessive-Compulsive Disorder: A Health Technology Assessment.
出版信息
Ont Health Technol Assess Ser. 2025 May 6;25(1):1-123. eCollection 2025.
BACKGROUND
Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values.
METHODS
We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist.
RESULTS
We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quality of life.
CONCLUSIONS
MRgFUS neurosurgery may be an effective and generally safe treatment option for severe, treatment-refractory OCD, but the evidence is very uncertain. The cost-effectiveness of MRgFUS neurosurgery could not be determined given the lack of comparative clinical evidence. Publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would result in an additional cost of $1.9 million over 5 years. Patients and care partners emphasized the negative impact of OCD in their lives and highlighted the importance of having access to MRgFUS neurosurgery as a treatment option for treatment-refractory OCD.
背景
强迫症(OCD)是一种使人衰弱的神经精神疾病,其特征为令人痛苦、损害功能且耗时的强迫观念和强迫行为,在严重病例中尤为如此。高达40%的强迫症患者患有难治性强迫症,对多种治疗试验和联合治疗反应不佳。神经外科手术是重度难治性强迫症患者的一种重要治疗选择,但通常具有侵入性。磁共振引导聚焦超声(MRgFUS)是一种用于实施神经外科手术的非侵入性技术。我们对重度难治性强迫症患者的MRgFUS神经外科手术进行了卫生技术评估,其中包括对有效性、安全性、公共资助MRgFUS神经外科手术的预算影响以及患者偏好和价值观的评估。
方法
我们对2013年以来发表的临床证据进行了系统的文献检索。我们使用乔安娜·布里格斯研究所的病例系列关键评估清单评估每项纳入研究的偏倚风险,并根据推荐分级评估、制定和评价(GRADE)工作组标准评估证据体的质量。我们对经济证据进行了系统的文献检索。我们估计了安大略省为患有难治性强迫症的人公共资助MRgFUS神经外科手术的5年预算影响。由于缺乏比较临床证据,我们未进行初步经济评估。为了解MRgFUS神经外科手术的价值,我们与接受该手术的难治性强迫症患者以及候补名单上的患者进行了交谈。
结果
我们在临床证据综述中纳入了2项研究。在这些小型病例系列中,MRgFUS神经外科手术使许多但并非所有患者的强迫症症状、生活质量和患者功能得到改善,以及治疗反应改善(GRADE:极低)。在少数情况下,由于颅骨因素,手术无法成功进行(GRADE:极低)。还发现MRgFUS神经外科手术具有良好的安全性(GRADE:极低)。未报告再次治疗的病例(GRADE:极低)。没有研究将MRgFUS神经外科手术与其他神经外科手术进行比较。由于缺乏比较临床证据,无法确定MRgFUS神经外科手术的成本效益。我们的预算影响分析发现,安大略省为患有难治性强迫症的人公共资助MRgFUS神经外科手术在5年内将额外花费190万美元。患者报告了强迫症对其日常活动、工作和学习、社交生活以及家庭关系和心理健康的负面影响。接受MRgFUS神经外科手术的6名参与者评论了该手术对其强迫症症状、心理健康和生活质量的积极影响。
结论
MRgFUS神经外科手术可能是重度难治性强迫症的一种有效且总体安全的治疗选择,但证据非常不确定。鉴于缺乏比较临床证据,无法确定MRgFUS神经外科手术的成本效益。安大略省为患有难治性强迫症的人公共资助MRgFUS神经外科手术在5年内将导致额外成本190万美元。患者和护理伙伴强调了强迫症对他们生活的负面影响,并强调了获得MRgFUS神经外科手术作为难治性强迫症治疗选择的重要性。
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