TY - JOUR
T1 - Cost-effectiveness of Operative versus Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis an Intent-to-treat Analysis at 5-year Follow-up
AU - Carreon, Leah Y.
AU - Glassman, Steven D.
AU - Lurie, Jon
AU - Shaffrey, Christopher I.
AU - Kelly, Michael P.
AU - Baldus, Christine R.
AU - Bratcher, Kelly R.
AU - Crawford, Charles H.
AU - Yanik, Elizabeth L.
AU - Bridwell, Keith H.
N1 - Funding Information:
This is a secondary analysis of prospective data collected from subjects enrolled in nine centers in North America. The primary study evaluated Op and NonOp treatments in patients with ASLS and included randomized and observational arms. It is widely accepted that patients with ASD represent a heterogeneous population in terms of symptoms, functional limitations, and radiographic characteristics. To mitigate this heterogeneity, the present study included only patients between 40and 80 years’ old with lumbar scoliosis with coronal Cobb ≥30°, and either an ODI score of ≥20, or an Scoliosis Research Society 22R (SRS-22R) Pain, Function, or Appearance score <4.0, and no previous fusion surgery. Exclusion criteria were the presence of medical comorbidities that precluded surgery, high-grade (≥3) spondylolisthesis, previous thoracic or lumbar fusion, previous multilevel (≥3) thoracolumbar decompression, severe osteoporosis (femoral neck t score ≥–3.0), neuromuscular scoliosis and presence of congenital lumbar spine anomalies. Subjects were enrolled from 2010 to 2014. Funding was provided by the NIH through an RO1 grant: A Multi-Center Prospective Study of Quality of Life in Adult Scoliosis (R01AR055176-01A2). Institutional review board approval was obtained at each participating center before subject enrollment. Institutional review board approval was also obtained for this secondary analysis.
Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Study Design.Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms.Objective.The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS.Summary of Background Data.The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates.Methods.Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D.Results.There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain.Conclusion.In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years.Level of Evidence: 2.
AB - Study Design.Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms.Objective.The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS.Summary of Background Data.The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates.Methods.Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D.Results.There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain.Conclusion.In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years.Level of Evidence: 2.
KW - adult lumbar scoliosis
KW - cost-effectiveness
KW - decision analysis
KW - nonoperative treatments
KW - spine surgery
UR - http://www.scopus.com/inward/record.url?scp=85073184390&partnerID=8YFLogxK
U2 - 10.1097/BRS.0000000000003118
DO - 10.1097/BRS.0000000000003118
M3 - Article
C2 - 31205182
AN - SCOPUS:85073184390
SN - 0362-2436
VL - 44
SP - 1499
EP - 1506
JO - Spine
JF - Spine
IS - 21
ER -