Clinical equipoise in idiopathic normal pressure hydrocephalus: A survey of physicians on the need for randomized controlled trials assessing the efficacy of cerebrospinal fluid diversion

Clinical equipoise in idiopathic normal pressure hydrocephalus: A survey of physicians on the need for randomized controlled trials assessing the efficacy of cerebrospinal fluid diversion
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DOI:
10.1016/j.jns.2013.06.024
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发表时间:
2013-10-15
影响因子:
4.4
通讯作者:
Cusimano, Michael D.
Cusimano, Michael D.
中科院分区:
医学3区
文献类型:
--
作者:
McGirr, Alexander;Mohammed, Safraz;Cusimano, Michael D.

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背景:特发性正常压力脑积水(iNPH)是一种可通过脑脊液(CSF)分流逆转的综合征。这是越来越多地认识到,相应的CSF分流率正在增加,尽管缺乏I级证据的疗效,不可忽视的并发症率和一个不明确的自然history.Methods:共349神经外科医生,神经科医生,老年病学家和神经精神科医生评价了CSF分流的感知疗效,CSF分流的持续时间的影响,和风险效益比的CSF分流在iNPH。然后,这些医生对iNPH患者CSF分流的随机对照试验(RCT)的需求进行了评级。参与者详细介绍了他们所需的选择标准和支持性测试的随机对照试验,他们的首选control group.Results:医生认为,有不确定的疗效CSF分流在iNPH,以及预期的持续时间,这种好处和风险效益比的患者。最大程度的不确定性与手术的长期受益有关。因此,超过75%的患者希望通过RCF来确定iNPH患者CSF分流的疗效。只有2.7%的参与者认为iNPH患者CSF分流的RCT是不道德的。没有分流和可调压阀在“关闭”设置的患者是首选的对照groups.Conclusion:在iNPH的CSF分流的RCT是从文献中缺席。大多数(>75%)参与iNPH诊断和治疗的医生认为需要进行RCT来确定iNPH中CSF分流的疗效、疗效持续时间和风险-获益比。(C)2013爱思唯尔有限公司版权所有。
Background: Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome that may be reversible by diversion of cerebrospinal fluid (CSF). It is increasingly recognized, and accordingly rates of CSF diversion are increasing despite the absence of level I evidence of efficacy, non-neglible rate of complications and an unclear natural history.Methods: A total of 349 neurosurgeons, neurologists, geriatricians and neuropsychiatrists rated the perceived efficacy of CSF diversion, the duration of effect of CSF diversion, and the risk-benefit ratio of CSF diversion in iNPH. These physicians then rated the need for a randomized controlled trial (RCT) of CSF diversion in iNPH. Participants detailed their desired selection criteria and supportive testing for a RCT, and their preferred control group.Results: Physicians believe that there is uncertain efficacy of CSF diversion in iNPH, as well as the expected duration of this benefit and the risk-benefit ratio for patients. The greatest degree of uncertainty related to the long-term benefit of surgery. Accordingly, over 75% desire a RCf to determine the efficacy of CSF diversion in iNPH. Only 2.7% of participants believe a RCT of CSF diversion in iNPH is unethical. Patients without a shunt and a programmable valve in the 'off' setting were the preferred control groups.Conclusion: A RCT of CSF diversion in iNPH is absent from the literature. The majority (>75%) of physicians involved in the diagnosis and treatment of iNPH believe a RCT is required to determine the efficacy, duration of efficacy and risk-benefit ratio of CSF diversion in iNPH. (C) 2013 Elsevier B.V. All rights reserved.