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首页> 外文期刊>British journal of neurosurgery >Community consultation in emergency neurosurgical research: Lessons from a proposed trial for patients with chronic subdural haematomas
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Community consultation in emergency neurosurgical research: Lessons from a proposed trial for patients with chronic subdural haematomas

机译：紧急神经外科研究中的社区咨询：针对慢性硬脑膜下血肿患者的拟议试验中的经验教训

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Introduction. Chronic subdural haematoma (CSDH) is one of the most common neurosurgical disorders and is especially prevalent in old age. The subdural evacuating port system (SEPS) has emerged in the last few years as a minimally invasive alternative to the standard procedure of burr-hole evacuation. NHS practice is evidence-driven and evidence from high-quality clinical studies is required prior to implementation of any changes. In the UK, the National Research Ethics Service (NRES) advises community consultation prior to starting a clinical trial, where the patient is unlikely to have capacity to consent to enrolment in the trial. To prepare for a trial comparing minimally invasive (SEPS) versus burr-hole evacuation for evacuation of a CSDH, we have designed and undertaken a pre-protocol community consultation survey to examine potential patient participation. Material(s) and methods. The study population consisted of patients, family members and carers/friends in neurosurgical clinic waiting rooms and wards at Addenbrooke's Hospital, Cambridge, who individually completed a questionnaire (n = 215). Results. Most respondents were willing to participate in the proposed randomised clinical trial (77%; 165/215). Moreover, 80% (171/215) and 74% (159/215) were willing to allow their next of kin and an independent consultant neurosurgeon to give surrogate consent, respectively. Conclusion. The results of our pre-protocol community consultation showed that not only would most respondents be willing to participate in the proposed trial, but also would be happy for either next of kin or an independent consultant neurosurgeon to give surrogate consent if they lacked capacity to consent themselves. The advantages of this type of survey are twofold: they increase patient and public involvement in the research process and allow researchers to design study protocols that are acceptable to the community.
机译：介绍。慢性硬膜下血肿（CSDH）是最常见的神经外科疾病之一，在老年尤为普遍。硬膜下疏散端口系统（SEPS）在过去几年中出现，它是毛刺疏散标准程序的一种微创替代方法。 NHS的实践是循证驱动的，在进行任何更改之前都需要来自高质量临床研究的证据。在英国，国家研究伦理服务（NRES）在开始临床试验之前建议社区咨询，因为患者不太可能有能力同意参加该试验。为了准备比较微创（SEPS）与钻孔疏散以疏散CSDH的试验，我们设计并进行了协议前社区咨询调查，以检查潜在的患者参与情况。材料和方法。研究人群包括在剑桥的阿登布鲁克医院的神经外科诊所候诊室和病房的患者，家庭成员和看护者/朋友，他们分别填写了一份问卷（n = 215）。结果。大多数受访者愿意参加拟议的随机临床试验（77％; 165/215）。此外，分别有80％（171/215）和74％（159/215）愿意允许其近亲和独立顾问神经外科医生给予替代同意。结论。我们的协议前社区协商的结果表明，大多数受访者不仅愿意参加拟议的试验，而且如果他们缺乏同意能力，那么他们将为近亲或独立顾问神经外科医生给予替代同意而感到高兴。他们自己。这种类型的调查的优点是双重的：它们增加了患者和公众对研究过程的参与，并使研究人员能够设计出社区可接受的研究方案。

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