Surgical vs nonoperative treatment for lumbar disk herniation - The Spine Patient Outcomes Research Trial (SPORT) observational cohort
Surgical vs nonoperative treatment for lumbar disk herniation - The Spine Patient Outcomes Research Trial (SPORT) observational cohort
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DOI：
10.1001/jama.296.20.2451
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发表时间：
2006-11-22
影响因子：
120.7
通讯作者：
Deyo, Richard A.
中科院分区：
文献类型：
--
作者：
Weinstein, James N.;Lurie, Jon D.;Deyo, Richard A.
背景对于腰椎间盘突出症患者，脊柱患者结局研究试验（SPORT）随机试验意向治疗分析显示，与常规治疗相比，椎间盘切除术的优势较小，但无统计学显著性差异。然而，大量的病人谁之间的交叉分配组排除任何结论的比较有效的手术治疗与常规护理。目的比较椎间盘切除术和常规护理的治疗效果。设计，设置，和患者前瞻性观察队列的外科候选人与成像-在2000年3月至2010年3月期间，在美国11个州的13家脊柱诊所接受治疗的确诊腰椎间盘突出症患者符合SPORT资格标准，但拒绝随机分组。2003.标准开放性椎间盘切除术与常规非手术治疗的干预：主要结果指标：医疗结果研究简表健康调查（SF-36）身体疼痛和身体功能量表和改良的奥斯韦斯特里残疾指数较基线的变化（美国矫形外科医师学会/MODEMS版本）。结果在纳入观察队列的743名患者中，528例患者接受手术治疗，191例接受常规非手术治疗。在3个月时，选择手术的患者在身体疼痛的主要结局指标方面有更大的改善（平均变化：手术，40.9 vs非手术治疗，26.0;治疗效果，14.8; 95%置信区间，10.8-18.9），身体功能（平均变化：手术，40.7 vs非手术治疗，25.3;治疗效果，15.4; 95% CI，11.6-19.2）和奥斯韦斯特里功能障碍指数（平均变化：手术，-36.1 vs非手术治疗，-20.9;治疗效果，-15.2; 95% CI，-18.5。-11.8）。这些差异在2岁时有所缩小：身体疼痛（平均变化：手术，42.6 vs非手术治疗，32.4;治疗效果，10.2; 95% CI，5.9-14.5），身体功能（平均变化：手术，43.9 vs非手术治疗31.9;治疗效果，12.0; 95% CI; 7.9-16.1）和奥斯韦斯特里残疾指数（平均变化：手术组-37.6 vs非手术组-24.2;治疗效果，-13.4; 95%CI，-17.0 to -9.7）。结论腰椎间盘突出症所致持续性坐骨神经痛患者在手术组和常规治疗组均得到改善。那些选择手术干预的患者比选择非手术治疗的患者有更大的改善。然而，自我报告结果的非随机比较可能存在混杂因素，必须谨慎解释。clinicaltrials.gov
Context For patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care.Objective To compare the treatment effects of diskectomy and usual care.Design, Setting, and Patients Prospective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003.Interventions Standard open diskectomy vs usual nonoperative care.Main Outcome Measures Changes from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version).Results Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery -37.6 vs nonoperative care -24.2; treatment effect, -13.4; 95% CI, -17.0 to -9.7).Conclusions Patients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously.Trial Registration clinicaltrials.gov Identifier: NCT00000410.