Simon Scott D, Koyama Tatsuki, Zacharia Brad E, Schirmer Clemens M, Cheng Joseph S
Department of Neurosurgery, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA.
Center for Quantitative Sciences, Vanderbilt University, Nashville, Tennessee, USA.
World Neurosurg. 2015 Apr;83(4):431-7. doi: 10.1016/j.wneu.2015.01.011. Epub 2015 Feb 3.
To evaluate the effect of important trials on the practice of neurosurgery.
We hypothesized that evidence from trials addressing the management of intracranial aneurysms (International Subarachnoid Aneurysm Trial [ISAT]) and nontraumatic intracerebral hemorrhages (Surgical Trial in Intracerebral Hemorrhage [STICH]) and vertebral augmentation for osteoporotic vertebral body fractures had a significant impact on the frequency of the corresponding neurosurgical procedures. A Medicare administrative database was queried for corresponding Common Procedural Terminology codes and units billed per calendar year. The effects of ISAT and STICH were evaluated using a generalized linear model. The effect of the vertebral augmentation study was evaluated using a t test.
After publication of ISAT in 2002, the rate of increase in proportion of cerebral aneurysms that were treated with embolization (Common Procedural Terminology code 61624) per year increased from 3.9% to 5.5% (P = 0.01). After publication of STICH in 2005, the number of craniotomies performed for intracerebral hematoma decreased from 2341 in 2002 to 1646 in 2011 (P = 0.03). After 2 publications in 2009, performance of vertebral augmentation decreased from a high of 99,961 in 2009 per year to 77,108 in 2013 (P = 0.002).
Randomized clinical trials remain the gold standard in the medical community to demonstrate efficacy, but their true impact relies on rapid and extensive assimilation into everyday medical practice. However, the described methodology establishes a temporal relationship only and does not prove causation. Nonetheless, trends in procedural volume suggest that the results of these select randomized clinical trials had a significant effect on neurosurgical practice affecting Medicare patients within an interval of a few years.
评估重要试验对神经外科手术实践的影响。
我们假设，关于颅内动脉瘤治疗（国际蛛网膜下腔动脉瘤试验[ISAT]）、非创伤性脑出血（脑出血手术试验[STICH]）以及骨质疏松性椎体骨折椎体强化的试验证据，对相应神经外科手术的频率有显著影响。查询医疗保险行政数据库以获取相应的通用程序术语代码和每年计费的单位数量。使用广义线性模型评估ISAT和STICH的影响。使用t检验评估椎体强化研究的影响。
2002年ISAT发表后，每年接受栓塞治疗的脑动脉瘤比例（通用程序术语代码61624）的增长率从3.9%升至5.5%（P = 0.01）。2005年STICH发表后，因脑内血肿进行的开颅手术数量从2002年的2341例降至2011年的1646例（P = 0.03）。2009年两项研究发表后，椎体强化手术的实施量从2009年每年的99,961例的高位降至2013年的77,108例（P = 0.002）。
随机临床试验仍是医学界证明疗效的金标准，但其真正影响依赖于迅速广泛地融入日常医疗实践。然而，所描述的方法仅建立了时间关系，并未证明因果关系。尽管如此，手术量趋势表明，这些精选随机临床试验的结果在几年时间内对影响医疗保险患者的神经外科手术实践产生了重大影响。
