Center of Ethics and Humanities in the Life Sciences and Department of Translational Science and Molecular Medicine, Michigan State University, East Lansing, Michigan, USA.
Parkinson's Disease and Movement Disorders Institute, Weill Cornell Medicine and NY Presbyterian Hospital Center, New York, New York, USA.
World Neurosurg. 2019 Aug;128:e16-e20. doi: 10.1016/j.wneu.2019.03.051. Epub 2019 Mar 14.
In November 2015, the U.S. Food and Drug Administration (FDA) approved the use of deep brain stimulation (DBS) therapy in people with Parkinson's disease (PD) "of at least four years duration and with a recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication." Although the full implications of this more recent approval are yet to be determined, to date, there are no strict criteria defining appropriate earlier use of DBS. As such, confusion remains regarding the actual meaning of early DBS initiation. To better inform responsive policy, we sought the perspectives of movement disorder neurologists and neurosurgeons regarding the earlier use of DBS. Insights from these clinicians are key to developing appropriate clinical guidelines and determining how early is too early. The objective of this study is to explore attitudes among clinicians toward the earlier use of DBS for PD.
Twelve Michigan-based clinicians were interviewed both about DBS referral/use processes and their perspectives regarding the earlier use of DBS in PD. We used a structured interview with closed- and open-ended questions. All interviews were transcribed verbatim and analyzed using a mixed-method approach.
We found that most clinicians considered earlier use not solely to be time dependent but instead determined by patient symptoms. Only 16.8% were aware of the FDA's recent indication of early use of DBS, with 25% of our respondents being unsure as to whether it should be seen as an early treatment modality. On average, neurologists suggested DBS as the next treatment option, after medications have been exhausted, typically 6 years after diagnosis.
There remain wide variations in terms of clinicians' parameters for referrals and timing of DBS. Larger studies are needed to support or refute our findings.
2015 年 11 月,美国食品和药物管理局(FDA)批准将深部脑刺激(DBS)疗法用于帕金森病(PD)患者,“病程至少 4 年,近期出现运动并发症,或病程较长且药物治疗效果不佳的运动并发症”。尽管这一最新批准的全部影响尚待确定,但迄今为止,尚无严格标准来定义 DBS 的适当早期使用。因此,对于早期 DBS 启动的实际含义仍存在混淆。为了更好地为相关政策提供信息,我们征询了运动障碍神经科医生和神经外科医生对 PD 中早期使用 DBS 的看法。这些临床医生的观点是制定适当的临床指南和确定何时过早的关键。本研究的目的是探讨临床医生对 PD 中早期使用 DBS 的态度。
对 12 名密歇根州的临床医生进行了访谈,内容涉及 DBS 转诊/使用流程以及他们对 PD 中早期使用 DBS 的看法。我们采用了一种带有封闭和开放式问题的结构化访谈。所有访谈都进行了逐字转录,并采用混合方法进行分析。
我们发现,大多数临床医生认为早期使用不仅取决于时间,还取决于患者的症状。只有 16.8%的人了解 FDA 最近关于早期使用 DBS 的指示,我们的 25%的受访者不确定它是否应被视为早期治疗方法。平均而言,神经科医生建议在药物治疗用尽后,通常在诊断后 6 年,将 DBS 作为下一个治疗选择。
在转诊和 DBS 时机方面,临床医生的参数仍存在很大差异。需要进行更大规模的研究来支持或反驳我们的发现。