M Elske van den Akker-van Marle1, Wouter A Moojen2, Mark P Arts3, Carmen L A M Vleggeert-Lankamp4, Wilco C Peul2. 1. Department of Medical Decision Making, Leiden University Medical Center, PO Box 9600, 2300RC Leiden, The Netherlands. Electronic address: m.e.van_den_akker-van_marle@lumc.nl. 2. 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. 3. Department of Neurosurgery, Medical Center Haaglanden, PO Box 432, 2501 CK, The Hague, The Netherlands. 4. Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300RC Leiden, The Netherlands.
Abstract
BACKGROUND CONTEXT: 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. PURPOSE: 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. PATIENT SAMPLE: 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 underwentspinal bony decompression. OUTCOME MEASURES: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Dutch Trial Register Number: NTR1307.
RCT Entities:
BACKGROUND CONTEXT: 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. PURPOSE: 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. PATIENT SAMPLE: 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: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Dutch Trial Register Number: NTR1307.
Authors: Johnathan H Sherman; Nader S Dahdaleh; Panayiotis Pelargos; Sandi Lam; Winward Choy; Isaac Yang; Zachary A Smith Journal: Surg Neurol Int Date: 2015-06-17
Authors: Joseph L Laratta; Hemant Reddy; Joseph M Lombardi; Jamal N Shillingford; Comron Saifi; Charla R Fischer; Ronald A Lehman; Lawrence G Lenke Journal: Global Spine J Date: 2017-09-14