Lars Gunnar Johnsen1, Christian Hellum, Kjersti Storheim, Øystein P Nygaard, Jens Ivar Brox, Ivar Rossvoll, Magne Rø, Hege Andresen, Stian Lydersen, Oliver Grundnes, Marit Pedersen, Gunnar Leivseth, Gylfi Olafsson, Fredrik Borgström, Peter Fritzell. 1. *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.
Abstract
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: 2.
RCT Entities:
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: 2.
Authors: Aileen R Neilson; Hanne Bruhn; Christine M Bond; Alison M Elliott; Blair H Smith; Philip C Hannaford; Richard Holland; Amanda J Lee; Margaret Watson; David Wright; Paul McNamee Journal: BMJ Open Date: 2015-04-01 Impact factor: 2.692
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