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国际腰椎研究学会奖得主:两种形式的腰椎环形融合术的成本效益:一项前瞻性随机对照试验

ISSLS prize winner: cost-effectiveness of two forms of circumferential lumbar fusion: a prospective randomized controlled trial.

作者信息

Freeman Brian J C, Steele Nicholas A, Sach Tracey H, Hegarty James, Soegaard Rikke

机构信息

Centre for Spinal Studies and Surgery, Nottingham University Hospitals NHS, Trust, Queen's Medical Centre Campus, Nottingham, UK.

出版信息

Spine (Phila Pa 1976). 2007 Dec 1;32(25):2891-7. doi: 10.1097/BRS.0b013e31815b75e2.

DOI:10.1097/BRS.0b013e31815b75e2
PMID:18246014
Abstract

STUDY DESIGN

Economic evaluation alongside a prospective, randomized controlled trial from a secondary care National Health Service (NHS) perspective.

OBJECTIVE

To determine the cost-effectiveness of titanium cages (TC) compared with femoral ring allografts (FRA) in circumferential lumbar spinal fusion.

SUMMARY OF BACKGROUND DATA

A randomized controlled trial has shown the use of TC to be clinically inferior to the established practice of using FRA in circumferential lumbar fusion. Health economic evaluation is urgently needed to justify the continued use of TC, given that this treatment is less effective and, all things being equal, is assumed more costly than FRA.

METHODS

Eighty-three patients were randomly allocated to receive either the TC or FRA as part of a circumferential lumbar fusion between 1998 and 2002. NHS costs related to the surgery and revision surgery needed during the trial period were monitored and adjusted to the base year (2005-2006 Pounds Sterling). The Short Form-6D (SF-6D) was administered before surgery and at 6, 12 and 24 months in order to elicit patient utility and subsequently Quality-Adjusted Life Years (QALYs) for the trial period. Return to paid employment was also monitored. Bootstrapped mean differences in discounted costs and benefits were generated in order to explore cost-effectiveness.

RESULTS

A significant cost difference of pound 1950 (95% CI, pound 849 to pound 3145) in favor of FRA was found. Mean QALYs per patient over the 24-month trial period were 0.0522 (SD, 0.0326) in the TC group and 0.1914 (SD, 0.0398) in the FRA group, producing a significant difference of -0.1392 (95% CI, -0.2349 to -0.0436). With regard to employment, incremental productivity costs were estimated at pound 185,171 in favor of FRA.

CONCLUSION

From an NHS perspective, the trial data show that TC is not cost-effective in circumferential lumbar fusion. The use of FRA was both cheaper and generated greater QALY gains. In addition, FRA patients reported a greater return to work rate.

摘要

研究设计

从英国国家医疗服务体系(NHS)二级医疗保健的角度,开展一项前瞻性随机对照试验并进行经济学评估。

目的

确定在腰椎环形融合术中,钛笼(TC)与股骨环同种异体移植物(FRA)相比的成本效益。

背景数据总结

一项随机对照试验表明,在腰椎环形融合术中,使用TC在临床上不如使用FRA的既定做法。鉴于这种治疗效果较差,且在其他条件相同的情况下,预计比FRA成本更高,因此迫切需要进行卫生经济学评估,以证明继续使用TC的合理性。

方法

1998年至2002年期间,83例患者被随机分配接受TC或FRA作为腰椎环形融合术的一部分。监测试验期间与手术及翻修手术相关的NHS成本,并将其调整至基年(2005 - 2006英镑)。术前以及术后6个月、12个月和24个月时进行简短健康调查问卷简表6D(SF - 6D)评估,以获取患者效用值,进而得出试验期间的质量调整生命年(QALY)。还监测了恢复带薪工作的情况。通过自抽样法得出贴现成本和效益的平均差异,以探讨成本效益。

结果

发现FRA组成本显著低1950英镑(95%可信区间,849英镑至3145英镑)。在24个月的试验期内,TC组每位患者的平均QALY为0.0522(标准差,0.0326),FRA组为0.1914(标准差,0.0398),差异显著为 - 0.1392(95%可信区间, - 0.2349至 - 0.0436)。在就业方面,有利于FRA的增量生产力成本估计为185,171英镑。

结论

从NHS的角度来看,试验数据表明,在腰椎环形融合术中,TC不具有成本效益。使用FRA既更便宜,又能带来更大的QALY增益。此外,FRA组患者的工作恢复率更高。

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