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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.

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Kaisorn L. Chaichana, Debraj Mukherjee, Owoicho Adogwa, Joseph S. Cheng and Matthew J. McGirt

Object

Lumbar discectomy is the most common surgical procedure performed in the US for patients experiencing back and leg pain from herniated lumbar discs. However, not all patients will benefit from lumbar discectomy. Patients with certain psychological predispositions may be especially vulnerable to poor clinical outcomes.

The goal of this study was therefore to determine the role that preoperative depression and somatic anxiety have on long-term back and leg pain, disability, and quality of life (QOL) for patients undergoing single-level lumbar discectomy.

Methods

In 67 adults undergoing discectomy for a single-level herniated lumbar disc, the authors determined quantitative measurements of leg and back pain (visual analog scale [VAS]), quality of life (36-Item Short Form Health Survey [SF-36]), and disease-specific disability (Oswestry Disability Index) preoperatively and at 6 weeks, 3, 6, and 12 months after surgery. The degree of preoperative depression and somatization was assessed using the Zung Self-Rating Depression Scale and a modified somatic perception questionnaire (MSPQ). Multivariate regression analyses were performed to assess associations between Zung Scale and MSPQ scores with achievement of a minimum clinical important difference (MCID) in each outcome measure by 12 months postoperatively.

Results

All patients completed 12 months of follow-up. Overall, a significant improvement in VAS leg pain, VAS back pain, Oswestry Disability Index, and SF-36 Physical Component Summary scores was observed by 6 weeks after surgery. Improvements in all outcomes were maintained throughout the 12-month follow-up period. Increasing preoperative depression (measured using the Zung Scale) was associated with a decreased likelihood of achieving an MCID in disability (p = 0.006) and QOL (p = 0.04) but was not associated with VAS leg pain (p = 0.96) or back pain (p = 0.85) by 12 months. Increasing preoperative somatic anxiety (measured using the MSPQ) was associated with decreased likelihood of achieving an MCID in disability (p = 0.002) and QOL (p = 0.03) but was not associated with leg pain (p = 0.64) or back pain (p = 0.77) by 12 months.

Conclusions

The Zung Scale and MSPQ are valuable tools for stratifying risk in patients who may not experience clinically relevant improvement in disability and QOL after discectomy. Efforts to address these confounding and underlying contributors of depression and heightened somatic anxiety may improve overall outcomes after lumbar discectomy.