全椎间盘置换与多学科康复治疗慢性下腰痛患者的成本效果分析：一项挪威多中心 RCT 研究。
Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT.
机构信息
*Neuroclinic, Center of Spinal Disorder and †Department of Orthopaedic Surgery, Clinic of Orthopaedics and Rheumatology, St. Olavs Hospital, Trondheim University Hospital, Norway ‡Department of Neuroscience, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway §Orthopaedic Department, Clinic for Surgery and Neurology, Oslo University Hospital and University of Oslo, Oslo, Norway ¶FORMI, Clinic for Surgery and Neurology, Oslo University Hospital, Oslo, Norway ‖Regional Centre for Child and Youth Mental Health and Child Welfare-Central Norway, Norwegian University of Science and Technology, Trondheim, Norway **Aleris Hospital, Oslo, Norway ††SINTEF Technology and Society, Trondheim, Norway ‡‡Department of Clinical Medicine, Neuromuscular Diseases and Research Group, University of Tromsø, Tromsø, Norway §§Quantify Research, Stockholm, Sweden ¶¶Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden; and ‖‖Ryhov Hospital, Jönköping, Sweden.
出版信息
Spine (Phila Pa 1976). 2014 Jan 1;39(1):23-32. doi: 10.1097/BRS.0000000000000065.
STUDY DESIGN
Randomized clinical trial with 2-year follow-up.
OBJECTIVE
To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP).
SUMMARY OF BACKGROUND DATA
The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR.
METHODS
Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio.
RESULTS
The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18-0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: -4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D.
CONCLUSION
In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR.
LEVEL OF EVIDENCE
研究设计
为期 2 年的随机临床试验。
目的
评估全椎间盘置换术（TDR）与多学科康复（MDR）治疗慢性下腰痛（CLBP）患者的成本效益。
背景数据摘要
现有 CLBP 研究报告了融合手术与椎间盘置换和融合与康复的成本效益。本研究评估了 TDR 与 MDR 的成本效益。
方法
2004 年 4 月至 2007 年 5 月，173 例慢性腰痛（>1 年）患者被随机分为 TDR 组（n=86）或 MDR 组（n=87）。在治疗后 6 周以及 3、6、12 和 24 个月时评估治疗效果（欧洲五维健康量表[EQ-5D]和简短健康调查量表 6 维度[SF-6D]）和相关直接和间接成本。估计 2 年后获得的质量调整生命年（QALY）增益。成本效益表示为增量成本效益比。
结果
使用 EQ-5D 获得的平均 QALY（标准差）在 TDR 组为 1.29（0.53），在 MDR 组为 0.95（0.52），差异显著（0.34；95%置信区间 0.18-0.50）。TDR 组每位患者的平均总成本为 87622 瑞典克朗（58351 欧元），MDR 组为 74116 瑞典克朗（58237 欧元），差异无统计学意义（95%置信区间：-4041 至 31755）。使用 EQ-5D 时，TDR 手术的增量成本效益比为 39748 瑞典克朗（TDR 具有成本效益），而使用 SF-6D 时为 128328 瑞典克朗（TDR 无成本效益）。脱落率为 20%（TDR 组 15%，MDR 组 24%）。5 名 MDR 组患者转为 TDR 组，而 9 名随机接受 TDR 治疗的患者拒绝手术。使用方案治疗分析而非意向治疗分析表明，使用 EQ-5D 评估 QALY 获益和愿意支付 74600 瑞典克朗（500000 瑞典克朗/QALY）时，TDR 无成本效益。当使用 SF-6D 时，TDR 无成本效益；因此，我们的结果应谨慎解释。需要更长的随访时间来准确评估 TDR 的成本效益。
证据水平
2。
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