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在SPORT研究中随机分组的腰椎间盘突出症患者与来自NSQIP的6846例椎间盘切除术患者的比较:人口统计学、围手术期变量和并发症相关性良好。

Comparison of the lumbar disc herniation patients randomized in SPORT to 6,846 discectomy patients from NSQIP: demographics, perioperative variables, and complications correlate well.

作者信息

Golinvaux Nicholas S, Bohl Daniel D, Basques Bryce A, Yacob Alem, Grauer Jonathan N

机构信息

Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, 800 Howard Ave., New Haven, CT 06510, USA.

Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, 800 Howard Ave., New Haven, CT 06510, USA.

出版信息

Spine J. 2015 Apr 1;15(4):685-91. doi: 10.1016/j.spinee.2014.12.008. Epub 2014 Dec 11.

DOI:10.1016/j.spinee.2014.12.008
PMID:25499208
Abstract

BACKGROUND CONTEXT

The Spine Patient Outcomes Research Trial (SPORT) is a highly referenced clinical trial that randomized patients with lumbar pathology to receive surgery or continued conservative treatment.

PURPOSE

The purpose of this study was to compare the SPORT lumbar disc herniation cohort and an analogous cohort from the National Surgical Quality Improvement Program (NSQIP) database.

STUDY DESIGN/SETTING: This is a retrospective cohort study comparing a national database population to a randomized clinical trial.

PATIENT SAMPLE

Elective lumbar discectomies from NSQIP between 2010 and 2012 were used.

OUTCOME MEASURES

Demographics were compared between the randomized SPORT cohorts (surgical and nonoperative) and NSQIP. Perioperative factors and complications were then compared between SPORT discectomy patients and NSQIP.

METHODS

Using current procedural terminology and International Classification of Diseases, ninth revision codes, all elective lumbar discectomies from NSQIP between 2010 and 2012 were identified. Where possible based on the published data and variables available in each cohort, the two populations were compared.

RESULTS

A total of 6,846 NSQIP discectomy patients were compared with the randomized SPORT surgical and nonoperative cohorts. Demographic comparisons showed that NSQIP patients were older (average age 48.2±14.5 years [mean±standard deviation] vs. 41.7±11.8 and 43.0±11.3 years, respectively [p<.001]) and had higher body mass index (29.6±6.2 kg/m(2) vs. 27.8±5.6 and 28.2±5.4 kg/m(2), respectively [p<.001]). No statistical differences existed for gender or race. Smoking status was not different between the SPORT nonoperative group and NSQIP but was higher in NSQIP compared with SPORT surgical patients (p=.020 by 7%). Comparisons of perioperative factors and complications between the SPORT surgical cohort and NSQIP showed no statistical difference in average operative time, length of stay, deep wound infections, wound dehiscence, total wound complications, or blood transfusions. Spine Patient Outcomes Research Trial superficial wound infection rates were higher than NSQIP (p=.029 by 1.4%). As expected, SPORT 1-year reoperation rates were higher than NSQIP 30-day rates (7% vs. 2%, p<.001).

CONCLUSIONS

Spine Patient Outcomes Research Trial lumbar disc herniation results are similar to those from a large national patient sample. Even statistically significant differences would be considered clinically similar. These findings support the generalizability of the SPORT lumbar disc herniation results.

摘要

背景信息

脊柱患者预后研究试验(SPORT)是一项被广泛引用的临床试验,该试验将患有腰椎疾病的患者随机分组,分别接受手术治疗或继续进行保守治疗。

目的

本研究的目的是比较SPORT腰椎间盘突出症队列与国家外科质量改进计划(NSQIP)数据库中的类似队列。

研究设计/设置:这是一项回顾性队列研究,将一个国家数据库中的人群与一项随机临床试验进行比较。

患者样本

使用了NSQIP在2010年至2012年间的择期腰椎间盘切除术患者。

结局指标

比较了随机分组的SPORT队列(手术组和非手术组)与NSQIP之间的人口统计学数据。然后比较了SPORT椎间盘切除术患者与NSQIP之间的围手术期因素和并发症。

方法

使用当前手术术语和国际疾病分类第九版编码,确定了NSQIP在2010年至2012年间的所有择期腰椎间盘切除术。根据每个队列中已发表的数据和可用变量,尽可能对这两个人群进行比较。

结果

共将6846例NSQIP椎间盘切除术患者与随机分组的SPORT手术组和非手术组队列进行了比较。人口统计学比较显示,NSQIP患者年龄更大(平均年龄48.2±14.5岁[均值±标准差],而SPORT手术组和非手术组分别为41.7±11.8岁和43.0±11.3岁[p<0.001]),体重指数更高(分别为29.6±6.2kg/m²、27.8±5.6kg/m²和28.2±5.4kg/m²[p<0.001])。性别和种族方面无统计学差异。SPORT非手术组与NSQIP的吸烟状况无差异,但NSQIP中吸烟患者的比例高于SPORT手术患者(高7%,p=0.020)。SPORT手术队列与NSQIP之间围手术期因素和并发症的比较显示,平均手术时间、住院时间、深部伤口感染、伤口裂开、总伤口并发症或输血方面无统计学差异。SPORT浅表伤口感染率高于NSQIP(高1.4%,p=0.029)。正如预期的那样,SPORT的1年再次手术率高于NSQIP的30天再次手术率(7%对2%,p<0.001)。

结论

SPORT腰椎间盘突出症的结果与一个大型国家患者样本的结果相似。即使是具有统计学意义的差异在临床上也可视为相似。这些发现支持了SPORT腰椎间盘突出症结果的可推广性。

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