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Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial.比较腰椎手术稳定术与慢性下腰痛患者强化康复计划的随机对照试验:医学研究委员会脊柱稳定试验
BMJ. 2005 May 28;330(7502):1233. doi: 10.1136/bmj.38441.620417.8F. Epub 2005 May 23.
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National Institute for Clinical Excellence and its value judgments.国家临床优化研究所及其价值判断。
BMJ. 2004 Jul 24;329(7459):224-7. doi: 10.1136/bmj.329.7459.224.
3
Cost-effectiveness of lumbar fusion and nonsurgical treatment for chronic low back pain in the Swedish Lumbar Spine Study: a multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group.瑞典腰椎研究中腰椎融合术与非手术治疗慢性下腰痛的成本效益:瑞典腰椎研究小组的一项多中心、随机、对照试验
Spine (Phila Pa 1976). 2004 Feb 15;29(4):421-34; discussion Z3. doi: 10.1097/01.brs.0000102681.61791.12.
4
Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.腰椎内固定融合术与认知干预及运动疗法对慢性下腰痛伴椎间盘退变患者的随机临床试验
Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A.
5
Multicentre aneurysm screening study (MASS): cost effectiveness analysis of screening for abdominal aortic aneurysms based on four year results from randomised controlled trial.多中心动脉瘤筛查研究(MASS):基于随机对照试验四年结果的腹主动脉瘤筛查成本效益分析
BMJ. 2002 Nov 16;325(7373):1135. doi: 10.1136/bmj.325.7373.1135.
6
Relative cost-effectiveness of extensive and light multidisciplinary treatment programs versus treatment as usual for patients with chronic low back pain on long-term sick leave: randomized controlled study.长期病假的慢性腰痛患者接受广泛和轻度多学科治疗方案与常规治疗的相对成本效益:随机对照研究
Spine (Phila Pa 1976). 2002 May 1;27(9):901-9; discussion 909-10. doi: 10.1097/00007632-200205010-00002.
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2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.2001年沃尔沃临床研究奖获得者:腰椎融合术与非手术治疗慢性下腰痛的比较:瑞典腰椎研究组的一项多中心随机对照试验。
Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.
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The Oswestry Disability Index.奥斯威斯利功能障碍指数
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Surgery versus conservative management in adult isthmic spondylolisthesis--a prospective randomized study: part 1.成人峡部裂性腰椎滑脱症手术与保守治疗的前瞻性随机研究:第1部分
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10
Cost-effectiveness of fusion with and without instrumentation for patients with degenerative spondylolisthesis and spinal stenosis.退行性腰椎滑脱症和腰椎管狭窄症患者融合术加与不加内固定的成本效益分析
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脊柱手术稳定术与强化康复方案治疗慢性下腰痛患者的比较:基于随机对照试验的成本效用分析

Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial.

作者信息

Rivero-Arias Oliver, Campbell Helen, Gray Alastair, Fairbank Jeremy, Frost Helen, Wilson-MacDonald James

机构信息

Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford OX3 7LF.

出版信息

BMJ. 2005 May 28;330(7502):1239. doi: 10.1136/bmj.38441.429618.8F. Epub 2005 May 23.

DOI:10.1136/bmj.38441.429618.8F
PMID:15911536
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC558091/
Abstract

OBJECTIVE

To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain.

DESIGN

Economic evaluation alongside a pragmatic randomised controlled trial.

SETTING

Secondary care.

PARTICIPANTS

349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002.

MAIN OUTCOME MEASURES

Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY.

RESULTS

At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be 7830 pounds sterling (SD 5202 pounds sterling) in the surgery group and 4526 pounds sterling (SD 4155 pounds sterling) in the intensive rehabilitation arm, a significant difference of 3304 pounds sterling (95% confidence interval 2317 pounds sterling to 4291 pounds sterling). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (-0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be 48,588 pounds sterling per QALY gained (- 279,883 pounds sterling to 372,406 pounds sterling).

CONCLUSION

Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change-for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.

摘要

目的

从医疗服务提供者和患者的角度,确定与慢性下腰痛患者的强化康复计划相比,脊柱手术固定是否具有成本效益。

设计

经济评估与一项实用的随机对照试验同步进行。

地点

二级医疗保健机构。

参与者

1996年6月至2002年2月期间,来自英国各地15个中心的349名患者被随机分配至手术组(n = 176)或强化康复计划组(n = 173)。

主要观察指标

随机分组后24个月内,与背痛相关的成本以及国民保健制度(NHS)和患者产生的费用。恢复带薪工作情况和总工作时长。在多个时间点使用欧洲五维度健康量表(EuroQol EQ - 5D)问卷评估患者效用,并用于计算质量调整生命年(QALY)。成本效益以每获得一个QALY的增量成本表示。

结果

两年时,随机分配至康复组的38名患者接受了康复和手术治疗,而手术组仅有7名患者接受了两种治疗。手术组患者的平均总成本估计为7830英镑(标准差5202英镑),强化康复组为4526英镑(标准差4155英镑),显著差异为3304英镑(95%置信区间2317英镑至4291英镑)。试验期间手术组的平均QALY为1.004(标准差0.405),强化康复组为0.936(标准差0.431),差异不显著,为0.068(-0.020至0.156)。每获得一个QALY的增量成本效益比估计为48588英镑(-279883英镑至372406英镑)。

结论

两年随访数据表明,脊柱手术固定可能并非有效利用稀缺医疗资源的成本效益方式。然而,敏感性分析表明,这种情况可能会改变,例如,如果需要后续手术的康复患者比例持续增加。