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Scott L. Parker, Stephen K. Mendenhall, David N. Shau, Owoicho Adogwa, William N. Anderson, Clinton J. Devin and Matthew J. McGirt

Object

Spine surgery outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect, but the extent of improvement in the numerical scores of these questionnaires lacks a direct clinical meaning. Because of this, the concept of a minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of same-level recurrent stenosis following index lumbar fusion, which commonly requires revision decompression and fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for this pathology.

Methods

In 53 consecutive patients undergoing revision surgery for same-level recurrent lumbar stenosis–associated back and leg pain, PRO measures of back and leg pain were assessed preoperatively and 2 years postoperatively, using the visual analog scale for back pain (VAS-BP) and leg pain (VAS-LP), Oswestry Disability Index (ODI), Physical and Mental Component Summary categories of the 12-Item Short Form Health Survey (SF-12 PCS and MCS) for quality of life, Zung Depression Scale (ZDS), and EuroQol-5D health survey (EQ-5D). Four established anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for 2 separate anchors (health transition index of the SF-36 and the satisfaction index).

Results

All patients were available for 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs assessed. The 4 MCID calculation methods generated a range of MCID values for each of the PROs (VAS-BP 2.2–6.0, VAS-LP 3.9–7.5, ODI 8.2–19.9, SF-12 PCS 2.5–12.1, SF-12 MCS 7.0–15.9, ZDS 3.0–18.6, and EQ-5D 0.29–0.52). Each patient answered synchronously for the 2 anchors, suggesting both of these anchors are equally appropriate and valid for this patient population.

Conclusions

The same-level recurrent stenosis surgery-specific MCID is highly variable based on calculation technique. The “minimum detectable change” approach is the most appropriate method for calculation of MCIDs in this population because it was the only method to reliably provide a threshold above the 95% confidence interval of the unimproved cohort (greater than the measurement error). Based on this method, the MCID thresholds following neural decompression and fusion for symptomatic same-level recurrent stenosis are 2.2 points for VAS-BP, 5.0 points for VAS-LP, 8.2 points for ODI, 2.5 points for SF-12 PCS, 10.1 points for SF-12 MCS, 4.9 points for ZDS, and 0.39 QALYs for EQ-5D.

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Owoicho Adogwa, Scott L. Parker, David N. Shau, Stephen K. Mendenhall, Clinton J. Devin, Joseph S. Cheng and Matthew J. McGirt

Object

Over the past decade, there has been a dramatic increase in the number of spinal fusions performed in the US and a corresponding increase in the incidence of adjacent-segment disease (ASD). Surgical management of symptomatic ASD consists of decompression of neural elements and extension of fusion. It has been shown to have favorable long-term outcomes, but the cost-effectiveness remains unclear. In this study, the authors set out to assess the cost-effectiveness of revision surgery in the treatment of ASD over a 2-year period.

Methods

Fifty patients undergoing neural decompression and extension of fusion construct for ASD-associated back and leg pain were included in the study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed.

Results

The mean (± SD) interval between prior fusion and revision surgery for ASD was 3.07 ± 2.02 years. A mean cumulative 2-year gain of 0.76 QALYs was observed after revision surgery. The mean total 2-year cost of extension of fusion constructs was $47,846 ± $32,712 (surgery cost: $24,063 ± $300; outpatient resource utilization cost: $4175 ± $3368; indirect cost: $19,607 ± $32,187). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $62,955.

Conclusions

In the authors' practice, revision decompression and extension of fusion provided a significant gain in health state utility for patients with symptomatic ASD, with a 2-year cost per QALY gained of $62,995. When indicated, revision surgery for ASD is a valuable treatment option for patients experiencing back and leg pain secondary to ASD. The findings provide a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

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Owoicho Adogwa, Scott L. Parker, David N. Shau, Stephen K. Mendenhall, Oran Aaronson, Joseph S. Cheng, Clinton J. Devin and Matthew J. McGirt

Object

Despite advances in technology and understanding in spinal physiology, reoperation for symptomatic same-level recurrent stenosis continues to occur. Although revision lumbar surgery is effective, attention has turned to the question of the utility and value of revision decompression and fusion procedures. To date, an analysis of cost and heath state gain associated with revision lumbar surgery for recurrent same-level lumbar stenosis has yet to be described. The authors set out to assess the 2-year comprehensive cost of revision surgery and determine its value in the treatment of same-level recurrent stenosis.

Methods

Forty-two patients undergoing revision decompression and instrumented fusion for same-level recurrent stenosis–associated leg and back pain were included in this study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed.

Results

The mean (± SD) interval between prior and revision surgery was 4.16 ± 4.64 years. Bone morphogenetic protein was used in 7 cases of revision arthrodesis (16.7%). A mean cumulative 2-year gain of 0.84 QALY was observed after revision surgery. The mean total 2-year cost of revision fusion was $49,431 ± $7583 (surgery cost $21,060 ± $4459; outpatient resource utilization cost $9748 ± $5292; indirect cost $18,623 ± $9098). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $58,846.

Conclusions

In the authors' practice, revision decompression and fusion provided a significant gain in health state utility for patients with symptomatic same-level recurrent stenosis, with a 2-year cost per QALY gained of $58,846. When indicated, revision surgery for same-level recurrent stenosis is a valuable treatment option for patients experiencing back and leg pain secondary to this disease. The authors' findings provide a value measure of surgery that can be compared with the results of future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

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Scott L. Parker, Stephen K. Mendenhall, David Shau, Owoicho Adogwa, Joseph S. Cheng, William N. Anderson, Clinton J. Devin and Matthew J. McGirt

Object

Spinal surgical outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lack a direct clinical meaning. As a result, the concept of minimum clinical important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of adjacent-segment degeneration following index lumbar fusion, which commonly requires revision laminectomy and extension of fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for adjacent-segment disease (ASD).

Methods

In 50 consecutive patients undergoing revision surgery for ASD-associated back and leg pain, PRO measures of back and leg pain on a visual analog scale (BP-VAS and LP-VAS, respectively), Oswestry Disability Index (ODI), 12-Item Short Form Health Survey Physical and Mental Component Summaries (SF-12 PCS and MCS, respectively), and EuroQol-5D health survey (EQ-5D) were assessed preoperatively and 2 years postoperatively. The following 4 well-established anchor-based MCID calculation methods were used to calculate MCID: average change; minimum detectable change (MDC); change difference; and receiver operating characteristic curve (ROC) analysis for the following 2 separate anchors: health transition item (HTI) of the SF-36 and satisfaction index.

Results

All patients were available for 2-year PRO assessment. Two years after surgery, a statistically significant improvement was observed for all PROs (mean changes: BP-VAS score [4.80 ± 3.25], LP-VAS score [3.28 ± 3.25], ODI [10.24 ± 13.49], SF-12 PCS [8.69 ± 12.55] and MCS [8.49 ± 11.45] scores, and EQ-5D [0.38 ± 0.45]; all p < 0.001). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS score, 2.3–6.5; LP-VAS score, 1.7–4.3; ODI, 6.8–16.9; SF-12 PCS, 6.1–12.6; SF-12 MCS, 2.4–10.8; and EQ-5D, 0.27–0.54). The area under the ROC curve was consistently greater for the HTI anchor than the satisfaction anchor, suggesting this as a more accurate anchor for MCID.

Conclusions

Adjacent-segment disease revision surgery–specific MCID is highly variable based on calculation technique. The MDC approach with HTI anchor appears to be most appropriate for calculation of MCID after revision lumbar fusion for ASD because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was not significantly affected by choice of anchor. Based on this method, MCID following ASD revision lumbar surgery is 3.8 points for BP-VAS score, 2.4 points for LP-VAS score, 6.8 points for ODI, 8.8 points for SF-12 PCS, 9.3 points for SF-12 MCS, and 0.35 quality-adjusted life-years for EQ-5D.

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Owoicho Adogwa, Scott L. Parker, David Shau, Stephen K. Mendelhall, Joseph Cheng, Oran Aaronson, Clinton J. Devin and Matthew J. McGirt

Object

The number of low-back fusion procedures for the treatment of spine disorders has increased steadily over the past 10 years. Lumbar pseudarthrosis is a potential complication of lumbar arthrodesis and can be associated with significant pain and disability. The aim of this study was to assess, using validated patient-reported outcomes measures, the long-term effectiveness of revision arthrodesis in the treatment of symptomatic pseudarthrosis.

Methods

This is a retrospective study of 47 patients who underwent revision lumbar arthrodesis for pseudarthrosis-associated back pain. Baseline 2-year outcomes were assessed using the following: visual analog scale (VAS) for back pain, Oswestry Disability Index (ODI), Zung Self-Rating Depression Scale, time to narcotic independence, time to return to work, EuroQol health-state utility, and physical and mental quality of life (Short Form [SF]–12 Physical and Mental Component Summary scores).

Results

The mean duration of time between prior fusion and development of symptomatic pseudarthrosis was 2.69 years. Bone morphogenetic protein was used in 4 cases (8.5%) of revision arthrodesis. A significant improvement in VAS back pain (7.31 ± 0.81 vs 5.06 ± 2.64, p = 0.001), ODI (29.74 ± 5.35 vs 25.42 ± 6.0, p = 0.001), and physical health SF-12 (23.83 ± 6.89 vs 27.85 ± 8.90, p = 0.001) scores was observed when comparing baseline and 2-year post–revision arthrodesis scores, respectively, with a mean cumulative 2-year gain of 0.35 quality-adjusted life years. The median time to narcotics independence was 12.16 (interquartile range 1.5–24.0) months and the median time to return to work was 4 months (interquartile range 3–5 months). By 2 years after revision surgery, no patients had experienced pseudarthrosis. The SF-12 Mental Component Summary (44.72 ± 7.90 vs 43.46 ± 7.51, p = 0.43) and Zung Self-Rating Depression Scale scores (39.36 ± 7.48 vs 41.39 ± 10.72, p = 0.37) were not significantly improved by 2 years.

Conclusions

The authors' study suggests that revision lumbar arthrodesis for symptomatic pseudarthrosis provides improvement in low-back pain, disability, and quality of life. Revision lumbar arthrodesis should be considered a viable treatment option for patients with pseudarthrosis-related back pain. Mental health symptoms from pseudarthrosis-associated back pain may be more refractory to revision surgery.

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Owoicho Adogwa, Scott L. Parker, Brandon J. Davis, Oran Aaronson, Clinton Devin, Joseph S. Cheng and Matthew J. McGirt

Object

Transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis-associated back and leg pain is associated with improvement in pain, disability, and quality of life. However, given the rising health care costs associated with spinal fusion procedures and varying results of recent cost-utility studies, the cost-effectiveness of TLIF remains unclear. The authors set out to assess the comprehensive costs of TLIF at their institution and to determine its cost-effectiveness in the treatment of degenerative spondylolisthesis.

Methods

Forty-five patients undergoing TLIF for Grade I degenerative spondylolisthesis–associated back and leg pain after 6–12 months of conservative therapy were included. The authors assessed the 2-year back pain visual analog scale (VAS) score, leg pain VAS score, Oswestry Disability Index, and total back-related medical resource utilization, missed work, and health-state values (quality-adjusted life years [QALYs], calculated from EQ-5D with US valuation). Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after TLIF was assessed.

Results

Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in back pain VAS score, leg pain VAS score, and Oswestry Disability Index was observed 2 years after TLIF, with a mean 2-year gain of 0.86 QALYs. The mean ± SD total 2-year cost of TLIF was $36,836 ± $11,800 (surgery cost, $21,311 ± $2800; outpatient resource utilization cost, $3940 ± $2720; indirect cost, $11,584 ± $11,363). Transforaminal lumbar interbody fusion was associated with a mean 2-year cost per QALY gained of $42,854.

Conclusions

Transforaminal lumbar interbody fusion improved pain, disability, and quality of life in patients with degenerative spondylolisthesis–associated back and leg pain. The total cost per QALY gained for TLIF was $42,854 when evaluated 2 years after surgery with Medicare fees, suggesting that TLIF is a cost-effective treatment of lumbar spondylolisthesis.

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Scott L. Parker, Owoicho Adogwa, Alexandra R. Paul, William N. Anderson, Oran Aaronson, Joseph S. Cheng and Matthew J. McGirt

Object

Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice.

Methods

In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index).

Results

All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1–5.3; LP-VAS, 2.1–4.7; ODI, 11–22.9; and EQ-5D, 0.15–0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor.

Conclusions

The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.