Rosenbaum Benjamin P, Kshettry Varun R, Kelly Michael L, Mroz Thomas E, Weil Robert J
*Department of Neurosurgery, Neurological Institute, Cleveland Clinic, Cleveland, OH †Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, Portland, OR ‡Center for Spine Health §Department of Orthopaedic Surgery ∥Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, OH.
Clin Spine Surg. 2017 Apr;30(3):E276-E282. doi: 10.1097/BSD.0000000000000207.
Retrospective analysis of the Nationwide Inpatient Sample, 2005-2011.
To identify trends in procedural volume and rates in the time period surrounding publication of randomized controlled trials (RCTs) that examined the utility of vertebroplasty and kyphoplasty.
Vertebroplasty and kyphoplasty are frequently performed for vertebral compression fractures. Several RCTs have been published with conflicting outcomes regarding pain and quality of life compared with nonsurgical management and sham procedures. Four RCTs with discordant results were published in 2009.
The Nationwide Inpatient Sample provided longitudinal, retrospective data on United States' inpatients between 2005 and 2011. Inclusion was determined by a principal or secondary International Classification of Diseases, Ninth Revision, Clinical Modification code of 81.65 (percutaneous vertebroplasty) or 81.66 (percutaneous vertebral augmentation; "kyphoplasty"). No diagnoses were excluded. Years were stratified as "pre" (2005-2008) and "post" (2010-2011) in relation to the 4 RCTs published in 2009. Patient, hospital, and admission characteristics were compared using Pearson χ test.
The estimated annual inpatient procedures performed decreased from 54,833 to 39,832 in the pre and post periods, respectively. The procedural rate for fractures decreased from 20.1% to 14.7% (P<0.0001). Patient and hospital demographics did not change considerably between the time periods. In the post period, weekend admissions increased (34.2% vs. 12.4%, P<0.0001), elective admissions decreased (21.4% vs. 40.0%, P<0.0001), routine discharge decreased (33.0% vs. 52.1%, P<0.0001), and encounters with ≥3 Elixhauser comorbidities increased (54.5% vs. 39.1%, P<0.0001).
The absolute rate of inpatient vertebroplasty and kyphoplasty procedures for fractures decreased 5% in the period (2010-2011) following the publication of 4 RCTs in 2009. The proportion of elective admissions and routine discharges decreased, possibly indicating a population with greater disease severity. Although our analysis cannot demonstrate a cause-and-effect relationship, the decreased inpatient volume and procedural rates surrounding the publication of sentinel negative RCTs is clearly observed.
对2005 - 2011年全国住院患者样本进行回顾性分析。
确定在关于椎体成形术和后凸成形术效用的随机对照试验(RCT)发表前后时间段内手术量和手术率的趋势。
椎体成形术和后凸成形术常用于治疗椎体压缩性骨折。与非手术治疗和假手术相比,已有多项RCT发表,其在疼痛和生活质量方面的结果相互矛盾。2009年发表了四项结果不一致的RCT。
全国住院患者样本提供了2005年至2011年美国住院患者的纵向回顾性数据。纳入标准由国际疾病分类第九版临床修订本的主要或次要编码81.65(经皮椎体成形术)或81.66(经皮椎体强化术;“后凸成形术”)确定。不排除任何诊断。根据2009年发表的四项RCT,年份分为“术前”(2005 - 2008年)和“术后”(2010 - 2011年)。使用Pearson χ检验比较患者、医院和入院特征。
估计每年进行的住院手术量在术前和术后分别从54,833例降至39,832例。骨折的手术率从20.1%降至14.7%(P<0.0001)。不同时间段患者和医院的人口统计学特征变化不大。在术后阶段,周末入院率增加(34.2%对12.4%,P<0.0001),择期入院率下降(21.4%对40.0%,P<0.0001),常规出院率下降(33.0%对52.1%,P<0.0001),且患有≥3种埃利克斯豪泽合并症的病例增加(54.5%对39.1%,P<0.0001)。
2009年四项RCT发表后的时期(2010 - 2011年),用于骨折的住院椎体成形术和后凸成形术的绝对手术率下降了5%。择期入院和常规出院的比例下降,这可能表明患者群体的疾病严重程度更高。虽然我们的分析无法证明因果关系,但在具有标志性意义的阴性RCT发表前后住院手术量和手术率下降的情况清晰可见。