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patient reported outcomes (PRO) to assess treatment effect. Commonly used health-related quality-of-life questionnaires include pain scales for back and leg pain (Visual Analog Scale), 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. Hense, the concept of minimum clinical important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment

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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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Tobias A. Mattei and Daniel R. Fassett

minimum detectable change using the 36-Item Short Form Health Survey (SF-36) health transition index anchor appears to be the most appropriate tool for calculating MCID in such patients. Based on this method the MCID scores following TLIF were 2.1 points for back pain VAS, 2.8 points for leg pain VAS, 14.9 points for the Oswestry Disability Index, and 0.46 quality-adjusted life years for the EuroQol-5D health survey. After reading both papers, one crucial question in relation to the paper comparing fusion and laminoplasty for treatment of cervical stenotic

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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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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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Matthew R. Sanborn, Jayesh P. Thawani, Robert G. Whitmore, Michael Shmulevich, Benjamin Hardy, Conrad Benedetto, Neil R. Malhotra, Paul Marcotte, William C. Welch, Stephen Dante and Sherman C. Stein

Object

There is considerable variation in the use of adjunctive technologies to confirm pedicle screw placement. Although there is literature to support the use of both neurophysiological monitoring and isocentric fluoroscopy to confirm pedicle screw positioning, there are no studies examining the cost-effectiveness of these technologies. This study compares the cost-effectiveness and efficacy of isocentric O-arm fluoroscopy, neurophysiological monitoring, and postoperative CT scanning after multilevel instrumented fusion for degenerative lumbar disease.

Methods

Retrospective data were collected from 4 spine surgeons who used 3 different strategies for monitoring of pedicle screw placement in multilevel lumbar degenerative disease. A decision analysis model was developed to analyze costs and outcomes of the 3 different monitoring strategies. A total of 448 surgeries performed between 2005 and 2010 were included, with 4 cases requiring repeat operation for malpositioned screws. A sample of 64 of these patients was chosen for structured interviews in which the EuroQol-5D questionnaire was used. Expected costs and quality-adjusted life years were calculated based on the incidence of repeat operation and its negative effect on quality of life and costs.

Results

The decision analysis model demonstrated that the O-arm monitoring strategy is significantly (p < 0.001) less costly than the strategy of postoperative CT scanning following intraoperative uniplanar fluoroscopy, which in turn is significantly (p < 0.001) less costly than neurophysiological monitoring. The differences in effectiveness of the different monitoring strategies are not significant (p = 0.92).

Conclusions

Use of the O-arm for confirming pedicle screw placement is the least costly and therefore most cost-effective strategy of the 3 techniques analyzed.

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Jared D. Ament and Kee D. Kim

Excellence (NICE) publicly announced their threshold definition for cost-effective treatments to range between $40,000–$60,000 US dollars per QALY. 8 , 17 Indeed, regulatory and insurance bodies have repeatedly recognized the inherent limitations in using dollars/QALY as a proxy for value in medicine, and therapeutics costing beyond these guidelines are frequently funded. Preference-based QOL instruments, such as the SF-36, SF-12, EQ-5D (EuroQol-5D health survey) often used in Europe, and the HUI (Health Utilities Index) are increasingly common in the medical literature

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Basheal M. Agrawal, Nathaniel P. Brooks and Daniel K. Resnick

probably change from the SF-36 to the 5-item EuroQol-5D health survey. We will remove the questions on symptomatology, because these are better obtained during the clinic encounter, and their value is better expressed in the ODI. Additionally, we will condense portions of the medical history. Regarding the efficiency of the study, a point of concern is the number of eligible patients who were missed by the clinic schedulers. For the registry to be successful, identifying potential participants is critical. We are working with clinic managers to identify the reasons for

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Owoicho Adogwa, Ricardo K. Carr, Katherine Kudyba, Isaac Karikari, Carlos A. Bagley, Ziya L. Gokaslan, Nicholas Theodore and Joseph S. Cheng

Object

Same-level recurrent lumbar stenosis, pseudarthrosis, and adjacent-segment disease (ASD) are potential complications that can occur after index lumbar spine surgery, leading to significant discomfort and radicular pain. While numerous studies have demonstrated excellent results following index lumbar spine surgery in elderly patients (age > 65 years), the effectiveness of revision lumbar surgery in this cohort remains unclear. The aim of this study was to assess the long-term effectiveness of revision lumbar decompression and fusion in the treatment of symptomatic pseudarthrosis, ASD, and same-level recurrent stenosis, using validated patient-reported outcomes.

Methods

After a review of the institutional database, 69 patients who had undergone revision neural decompression and instrumented fusion for ASD (28 patients), pseudarthrosis (17 patients), or same-level recurrent stenosis (24 patients) were included in this study. Baseline and 2-year scores on the visual analog scale for leg pain (VAS-LP), VAS for back pain (VAS-BP), Oswestry Disability Index (ODI), and Zung Self-Rating Depression Scale (SDS) as well as the time to narcotic independence, time to return to baseline activity level, health state utility (EQ-5D, the EuroQol-5D health survey), and physical and mental component summary scores of the 12-Item Short-Form Health Survey (SF-12 PCS and MCS) were assessed.

Results

Compared with the preoperative status, VAS-BP was significantly improved 2 years after surgery for ASD (mean ± standard deviation 9 ± 2 vs 4.01 ± 2.56, p = 0.001), pseudarthrosis (7.41 ± 1 vs 5.52 ± 3.08, p = 0.02), and same-level recurrent stenosis (7 ± 2.00 vs 5.00 ± 2.34, p = 0.003). The 2-year ODI was also significantly improved after surgery for ASD (29 ± 9 vs 23.10 ± 10.18, p = 0.001), pseudarthrosis (28.47 ± 5.85 vs 24.41 ± 7.75, p = 0.001), and same-level recurrent stenosis (30.83 ± 5.28 vs 26.29 ± 4.10, p = 0.003). The Zung SDS score and SF-12 MCS did not change appreciably after surgery in any of the cohorts, with an overall mean 2-year change of 1.01 ± 5.32 (p = 0.46) and 2.02 ± 9.25 (p = 0.22), respectively.

Conclusions

Data in this study suggest that revision lumbar decompression and extension of fusion for symptomatic pseudarthrosis, ASD, and same-level recurrent stenosis provides improvement in low-back pain, disability, and quality of life and should be considered a viable treatment option for elderly patients with persistent or recurrent back and radicular pain. Mental health symptoms may be more refractory to revision surgery.

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Owoicho Adogwa, Ryan Owens, Isaac Karikari, Vijay Agarwal, Oren N. Gottfried, Carlos A. Bagley, Robert E. Isaacs and Joseph S. Cheng

treatment arm, the numerator is the total cost over the entire cycle of care, and the denominator is a measurement of the health state gained from the societal perspective (preference-based utility, as measured by the EQ-5D, that is, the EuroQol 5D health survey), resulting in a cost/outcome ratio. General health state (EQ-5D) is the ideal measure of benefit since it allows comparison across all disease states (as a measure of general quality of life), and it incorporates societal “preference” via a population's valuation of the health state. Hence, it provides a measure