Trends in High-Impact Neurosurgical Randomized Controlled Trials Published in General Medical Journals: A Systematic Review.

Abstract

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.