Computational Neurosciences Outcomes Center, Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands.
Computational Neurosciences Outcomes Center, Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands.
World Neurosurg. 2019 Sep;129:e158-e170. doi: 10.1016/j.wneu.2019.05.083. Epub 2019 May 17.
The neurosurgery literature lacks a comprehensive report of neurosurgical randomized controlled trials (RCTs) published in general medical journals. RCTs published in these journals have high visibility and impact on decision-making by general medical practitioners and health care policymakers.
A systematic review of neurosurgical RCTs in the New England Journal of Medicine, The Lancet, Journal of the American Medical Association, The BMJ, and Annals of Internal Medicine was completed.
There were 78 neurosurgical RCTs published in the selected high-impact journals from 2000 to 2017. The most common study topics were neurovascular (n = 39, 50%) and spine (n = 24, 30.8%). Of these RCTs, 44 (56.4%) compared operative with nonoperative management. For studies published before 2017, the mean number of citations was 899. Approximately half of the studies showed superiority of operative management over nonoperative management in the intent to treat primary outcome of interest (n = 24, 54.5%). However, stratified by subsubspecialty, 7 (87.5%) of the functional RCTs, 9 (50%) of the neurovascular RCTs, 1 (50%) of the trauma RCTs, and 7 (43.8%) of the spinal RCTs demonstrated superiority of operative management over nonoperative management. Additionally, there were large subspecialty differences in study characteristics, such as rate of double blinding, proportion of patient enrollment from patients screened, and proportion of crossover from nonsurgical to surgical arm.
Neurosurgical RCTs in general medical journals have large subspecialty differences in characteristics such as crossovers from nonsurgical to surgical treatment arms and the proportion of studies demonstrating benefit of operative intervention over nonoperative management.
神经外科学文献缺乏对普通医学期刊发表的神经外科随机对照试验(RCT)的全面报道。这些期刊发表的 RCT 具有很高的知名度和影响力,对普通内科医生和医疗保健政策制定者的决策有影响。
对《新英格兰医学杂志》《柳叶刀》《美国医学会杂志》《英国医学杂志》和《内科学年鉴》发表的神经外科 RCT 进行了系统评价。
2000 年至 2017 年,在选定的高影响力期刊上发表了 78 项神经外科 RCT。最常见的研究主题是神经血管(n=39,50%)和脊柱(n=24,30.8%)。这些 RCT 中,44 项(56.4%)比较了手术与非手术治疗。对于 2017 年以前发表的研究,平均引用次数为 899 次。大约一半的研究(n=24,54.5%)显示手术治疗在主要研究终点上优于非手术治疗。然而,按亚专科分层,7 项(87.5%)功能 RCT、9 项(50%)神经血管 RCT、1 项(50%)创伤 RCT 和 7 项(43.8%)脊柱 RCT 显示手术治疗优于非手术治疗。此外,研究特征(如从非手术治疗到手术治疗组的交叉率、从筛选患者中招募患者的比例以及从非手术组到手术组的交叉比例)存在较大的亚专科差异。
普通医学期刊上的神经外科 RCT 在特征上存在较大的亚专科差异,例如从非手术治疗到手术治疗组的交叉以及显示手术干预优于非手术治疗的研究比例。