Journal of neurosurgery
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Journal of neurosurgery · Jan 2022
ReviewUS FDA best practices for initiating early feasibility studies for neurological devices in the United States.
This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.
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Journal of neurosurgery · Dec 2021
ReviewEnhanced Recovery After Surgery strategies for elective craniotomy: a systematic review.
Enhanced Recovery After Surgery (ERAS) has led to a paradigm shift in perioperative care through multimodal interventions. Still, ERAS remains a relatively new concept in neurosurgery, and there is no summary of evidence on ERAS applications in cranial neurosurgery. ⋯ A wide range of evidence-based interventions are available to improve recovery after elective craniotomy, although there are few published ERAS protocols. Patient-centered optimization of neurosurgical care spanning the pre-, intra-, and postoperative periods is feasible and has already provided positive results in terms of improved outcomes such as postoperative pain, patient satisfaction, reduced length of stay, and cost reduction with an excellent safety profile. Although fast-track recovery protocols and ERAS studies are gaining momentum for elective craniotomy, prospective trials are needed to provide stronger evidence.
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Journal of neurosurgery · Sep 2021
ReviewResection of vestibular schwannomas after stereotactic radiosurgery: a systematic review.
Multiple short series have evaluated the efficacy of salvage microsurgery (MS) after stereotactic radiosurgery (SRS) for treatment of vestibular schwannomas (VSs); however, there is a lack of a large volume of patient data available for interpretation and clinical adaptation. The goal of this study was to provide a comprehensive review of tumor characteristics, management, and surgical outcomes of salvage of MS after SRS for VS. ⋯ This study showed that the leading cause of MS after SRS was tumor growth at an average of 39.4 months after radiation. There were no significant differences in outcomes of facial nerve preservation, postoperative HB grade, or complication rate based on surgical approach. Patients who underwent STR showed statistically significant better HB outcomes compared with GTR. MS after SRS was considered by most authors to be more difficult than primary MS. These data support the notion that the surgical goals of salvage surgery are debulking of tumor mass, decreasing compression of the brainstem, and not necessarily pursuing GTR.
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Journal of neurosurgery · Aug 2021
ReviewSurgery versus radiosurgery for facial nerve schwannoma: a systematic review and meta-analysis of facial nerve function, postoperative complications, and progression.
Intracranial facial nerve schwannomas (FNS) requiring treatment are frequently recommended for surgery or stereotactic radiosurgery (SRS). The objective of this study was to compare facial nerve function outcomes between these two interventions for FNS via a systematic review and meta-analysis. ⋯ Unfavorable facial nerve function outcomes are associated with surgical treatment of intracranial FNS, whereas stable facial nerve function outcomes are associated with SRS. Therefore, SRS should be recommended to patients with FNS who require treatment, and surgery should be reserved for patients with another indication, such as decompression of the brainstem. Further study is required to definitively optimize and validate management strategies for these rare skull base tumors.
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Journal of neurosurgery · Aug 2021
ReviewAssessment of burnout prevention and wellness programs for US-based neurosurgical faculty and residents: a systematic review of the literature.
Neurosurgeon burnout is a serious and prevalent issue that has been shown to impact professionalism, physician health, and patient outcomes. Interventions targeting physician burnout primarily focus on improving physician wellness. Many academic neurosurgery programs have established wellness curricula to combat burnout and improve wellness. No official recommendations exist for establishing a wellness program that effectively targets sources of burnout. The aim of this review was to examine measures of burnout and report objective results of wellness interventions for neurosurgical faculty and residents. ⋯ Burnout among neurosurgical faculty and residents is prevalent and permeates the daily lives of neurosurgeons, negatively affecting patient outcomes, career satisfaction, and quality of life. Many neurosurgery programs have instituted wellness programs to combat burnout, but few have published evidence of improvement after implementation. While studies have shown that residents and faculty recognize the importance of wellness and look favorably on such initiatives, very few studies have reported objective outcomes.