van den Akker-van Marle M Elske, Moojen Wouter A, Arts Mark P, Vleggeert-Lankamp Carmen L A M, Peul Wilco C
Department of Medical Decision Making, Leiden University Medical Center, PO Box 9600, 2300RC Leiden, The Netherlands.
Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300RC Leiden, The Netherlands; Department of Neurosurgery, Medical Center Haaglanden, PO Box 432, 2501 CK, The Hague, The Netherlands.
Spine J. 2016 Jun;16(6):702-10. doi: 10.1016/j.spinee.2014.10.017. Epub 2014 Oct 23.
In the 1980s, a new implant was developed to treat patients with intermittent neurogenic claudication caused by lumbar spinal stenosis (LSS). This implant is now widely used.
The objective of this study is to determine whether a favorable cost-effectiveness for interspinous process devices (IPDs) compared with conventional bony decompression is attained.
STUDY DESIGN/SETTING: Cost-utility analysis was performed alongside a double-blind randomized controlled trial. Five neurosurgical centers (including one academic and four secondary level care centers) included participants for this study.
One hundred fifty-nine patients with LSS were treated with the implantation of IPD and with bony decompression. Eighty participants received an IPD, and seventy-nine participants underwent spinal bony decompression.
Outcome measures were quality-adjusted life-years (QALYs) and societal costs in the first year (estimated per quarter), estimated from patient-reported utilities (US and The Netherlands EuroQol 5D [EQ-5D] and EuroQol visual analog scale) and diaries on costs (health-care costs, patient costs, and productivity costs).
All analyses followed the intention-to-treat principle. Given the statistical uncertainty of differences between costs and QALYs, cost-effectiveness acceptability curves graph the probability that a strategy is cost effective, as a function of willingness to pay. Paradigm Spine funded this trial but did not have any part in data analysis or the design and preparation of this article.
According to the EQ-5D, the valuation of quality of life after IPD and decompression was not different. Mean utilities during all four quarters were, not significantly, less favorable after IPD according to the EQ-5D with a decrease in QALYs according to the US EQ-5D of 0.024 (95% confidence interval, -0.031 to 0.079). From a health-care perspective, the costs of IPD treatment were higher (difference €3,030 per patient, 95% confidence interval, €561-€5,498). This significant difference is mainly because of additional cost of implants of €2,350 apiece. From a societal perspective, a nonsignificant difference of €2,762 (95% confidence interval, -€1,572 to €7,095) in favor of conventional bony decompression was found.
Implantation of IPD as indirect decompressing device is highly unlikely to be cost effective compared with bony decompression for patients with intermittent neurogenic claudication caused by LSS.
Dutch Trial Register Number: NTR1307.
20世纪80年代，一种新型植入物被研发出来用于治疗由腰椎管狭窄症（LSS）引起的间歇性神经源性跛行患者。这种植入物现已被广泛使用。
本研究的目的是确定与传统的骨性减压相比，棘突间装置（IPD）是否具有良好的成本效益。
研究设计/地点：在一项双盲随机对照试验的同时进行成本效用分析。五个神经外科中心（包括一个学术中心和四个二级护理中心）纳入了本研究的参与者。
159例LSS患者接受了IPD植入和骨性减压治疗。80名参与者接受了IPD植入，79名参与者接受了脊柱骨性减压。
结果测量指标为质量调整生命年（QALY）和第一年的社会成本（按季度估算），根据患者报告的效用（美国和荷兰的欧洲五维健康量表[EQ-5D]以及欧洲五维健康量表视觉模拟量表）和成本日记（医疗保健成本、患者成本和生产力成本）进行估算。
所有分析均遵循意向性分析原则。鉴于成本和QALY之间差异的统计不确定性，成本效益可接受性曲线绘制了一种策略具有成本效益的概率，作为支付意愿的函数。Paradigm Spine资助了这项试验，但在数据分析或本文的设计与撰写过程中没有任何参与。
根据EQ-5D，IPD植入和减压后生活质量的评估没有差异。根据EQ-5D，在所有四个季度中，IPD植入后的平均效用均无显著降低，但根据美国EQ-5D，QALY下降了0.024（95%置信区间，-0.031至0.079）。从医疗保健角度来看，IPD治疗的成本更高（每位患者相差3030欧元，95%置信区间，561欧元至5498欧元）。这一显著差异主要是由于每个植入物额外增加了2350欧元的成本。从社会角度来看，发现有利于传统骨性减压的差异为2762欧元（95%置信区间，-1572欧元至7095欧元），但不显著。
对于由LSS引起的间歇性神经源性跛行患者，与骨性减压相比，植入IPD作为间接减压装置极不可能具有成本效益。
荷兰试验注册号：NTR1307。
