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Daniel Lubelski, Matthew D. Alvin, Sergiy Nesterenko, Swetha J. Sundar, Nicolas R. Thompson, Edward C. Benzel and Thomas E. Mroz

OBJECT

Studies comparing surgical treatments for cervical spondylotic myelopathy (CSM) are heterogeneous, using a variety of different quality of life (QOL) outcomes and myelopathy-specific measures. This study sought to evaluate the relationship of these measures to each other, and to better understand their use in evaluating patients with CSM.

METHODS

A retrospective study was performed in all patients with CSM who underwent either ventral or dorsal cervical spine surgery at a single tertiary-care institution between January 2008 and July 2013. Severity of myelopathy was assessed pre- and postoperatively using both the Nurick scale and the modified Japanese Orthopaedic Association (mJOA) classification of disability. Prospectively collected QOL outcomes data included Pain Disability Questionnaire (PDQ), Patient Health Questionnaire–9 (PHQ-9), and EQ-5D. Spearman rank correlations were calculated to assess the construct convergent validity for each pair of health status measures (HSMs). To assess each HSM’s ability to discriminate favorable EQ-5D index, we performed receiver operating characteristic (ROC) curve analysis and assessed the area under the curve (AUC).

RESULTS

A total of 119 patients were included. The PDQ total score had the highest correlation with EQ-5D index (Spearman’s rho = −0.82). Neither of the myelopathy scales (mJOA or Nurick) had strong correlations between themselves (0.41) or with the other QOL measures (absolute value range 0.13–0.49). In contrast, the QOL measures correlated relatively well with each other (absolute value range 0.68–0.97). For predicting favorable EQ-5D outcomes, PDQ total score had an AUC of 0.909. The AUCs were significantly greater for the QOL measures in comparison with the myelopathy measures (AUCs were 0.677 and 0.607 for mJOA and Nurick scale scores, respectively).

CONCLUSIONS

The authors found that all included measures of QOL and CSM-specific (mJOA or Nurick scale) measures were valid and responsive. The PDQ was the most predictive of positive QOL after surgery (as measured by the EQ-5D index) for patients with CSM. The substantially lower correlation between myelopathy and QOL outcomes, compared with the various QOL measures themselves, suggests that these questionnaires are measuring different aspects of the patient experience. Solely assessing the myelopathy or disease-specific signs and symptoms is likely insufficient to fully understand and appreciate clinical outcome in its totality. These questionnaire types should be used together to best evaluate patients pre- and postoperatively.

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Benjamin D. Kuhns, Daniel Lubelski, Matthew D. Alvin, Jason S. Taub, Matthew J. McGirt, Edward C. Benzel and Thomas E. Mroz

OBJECT

Infections following spine surgery negatively affect patient quality of life (QOL) and impose a significant financial burden on the health care system. Postoperative wound infections occur at higher rates following dorsal cervical procedures than ventral procedures. Quantifying the health outcomes and costs associated with infections following dorsal cervical procedures may help to guide treatment strategies to minimize the deleterious consequences of these infections. Therefore, the goals of this study were to determine the cost and QOL outcomes affecting patients who developed deep wound infections following subaxial dorsal cervical spine fusions.

METHODS

The authors identified 22 (4.0%) of 551 patients undergoing dorsal cervical fusions who developed deep wound infections requiring surgical debridement. These patients were individually matched with control patients who did not develop infections. Health outcomes were assessed using the EQ-5D, Pain Disability Questionnaire (PDQ), Patient Health Questionnaire (PHQ-9), and visual analog scale (VAS). QOL outcome measures were collected preoperatively and after 6 and 12 months. Health resource utilization was recorded from patient electronic medical records over an average follow-up of 18 months. Direct costs were estimated using Medicare national payment amounts, and indirect costs were based on patients' missed workdays and income.

RESULTS

No significant differences in preoperative QOL scores were found between the 2 cohorts. At 6 months postsurgery, the noninfection cohort had significant pre- to postoperative improvement in EQ-5D (p = 0.02), whereas the infection cohort did not (p = 0.2). The noninfection cohort also had a significantly higher 6-month postoperative EQ-5D scores than the infection cohort (p = 0.04). At 1 year postsurgery, there was no significant difference in EQ-5D scores between the groups. Health care–associated costs for the infection cohort were significantly higher ($16,970 vs $7658; p < 0.0001). Indirect costs for the infection cohort and the noninfection cohort were $6495 and $2756, respectively (p = 0.03). Adjusted for inflation, the total costs for the infection cohort were $21,778 compared with $9159 for the noninfection cohort, reflecting an average cost of $12,619 associated with developing a postoperative deep wound infection (p < 0.0001).

CONCLUSIONS

Dorsal cervical infections temporarily decrease patient QOL postoperatively, but with no long-term impact; they do, however, dramatically increase the cost of care. Knowledge of the financial burden of wound infections following dorsal cervical fusion may stimulate the development and use of improved prophylactic and therapeutic techniques to manage this serious complication.

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Daniel Lubelski, Nilgun Senol, Michael P. Silverstein, Matthew D. Alvin, Edward C. Benzel, Thomas E. Mroz and Richard Schlenk

OBJECT

The authors investigated quality of life (QOL) outcomes after primary versus revision discectomy.

METHODS

A retrospective review was performed for all patients who had undergone a primary or revision discectomy at the Cleveland Clinic Center for Spine Health from January 2008 through December 2011. Among patients in the revision cohort, they identified those who needed a second revision discectomy. Patient QOL measures were recorded before and after surgery. These measures included responses to the EQ-5D health questionnaire, Patient Health Questionnaire–9, Pain and Disability Questionnaire, and quality-adjusted life years (QALYs). Cohorts were compared by using independent-sample t-tests and Fisher exact tests for continuous and categorical variables, respectively. Multivariable logistic regression was performed to adjust for confounding.

RESULTS

A total of 196 patients were identified (116 who underwent primary discectomy and 80 who underwent revision discectomy); average follow-up time was 150 days. There were no preoperative QOL differences between groups. Postoperatively, both groups improved significantly in all QOL measures. For QALYs, the primary cohort improved by 0.25 points (p < 0.001) and the revision cohort improved by 0.18 points (p < 0.001). QALYs improved for significantly more patients in the primary than in the revision cohort (76% vs 59%, respectively; p = 0.02), and improvement exceeded the minimum clinically important difference for more patients in the primary cohort (62% vs 45%, respectively; p = 0.03). Of the 80 patients who underwent revision discectomy, yet another recurrent herniation (third herniation) occurred in 14 (17.5%). Of these, 4 patients (28.6%) chose to undergo a second revision discectomy and the other 10 (71.4%) underwent conservative management. For those who underwent a second revision discectomy, QOL worsened according to all questionnaire scores.

CONCLUSIONS

QOL, pain and disability, and psychosocial outcomes improved after primary and revision discectomy, but the improvement diminished after revision discectomy.

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Matthew D. Alvin, Jacob A. Miller, Daniel Lubelski, Benjamin P. Rosenbaum, Kalil G. Abdullah, Robert G. Whitmore, Edward C. Benzel and Thomas E. Mroz

Object

Cost-effectiveness research in spine surgery has been a prominent focus over the last decade. However, there has yet to be a standardized method developed for calculation of costs in such studies. This lack of a standardized costing methodology may lead to conflicting conclusions on the cost-effectiveness of an intervention for a specific diagnosis. The primary objective of this study was to systematically review all cost-effectiveness studies published on spine surgery and compare and contrast various costing methodologies used.

Methods

The authors performed a systematic review of the cost-effectiveness literature related to spine surgery. All cost-effectiveness analyses pertaining to spine surgery were identified using the cost-effectiveness analysis registry database of the Tufts Medical Center Institute for Clinical Research and Health Policy, and the MEDLINE database. Each article was reviewed to determine the study subject, methodology, and results. Data were collected from each study, including costs, interventions, cost calculation method, perspective of cost calculation, and definitions of direct and indirect costs if available.

Results

Thirty-seven cost-effectiveness studies on spine surgery were included in the present study. Twenty-seven (73%) of the studies involved the lumbar spine and the remaining 10 (27%) involved the cervical spine. Of the 37 studies, 13 (35%) used Medicare reimbursements, 12 (32%) used a case-costing database, 3 (8%) used cost-to-charge ratios (CCRs), 2 (5%) used a combination of Medicare reimbursements and CCRs, 3 (8%) used the United Kingdom National Health Service reimbursement system, 2 (5%) used a Dutch reimbursement system, 1 (3%) used the United Kingdom Department of Health data, and 1 (3%) used the Tricare Military Reimbursement system. Nineteen (51%) studies completed their cost analysis from the societal perspective, 11 (30%) from the hospital perspective, and 7 (19%) from the payer perspective. Of those studies with a societal perspective, 14 (38%) reported actual indirect costs.

Conclusions

Changes in cost have a direct impact on the value equation for concluding whether an intervention is cost-effective. It is essential to develop a standardized, accurate means of calculating costs. Comparability and transparency are essential, such that studies can be compared properly and policy makers can be appropriately informed when making decisions for our health care system based on the results of these studies.

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Matthew D. Alvin, Daniel Lubelski, Edward C. Benzel and Thomas E. Mroz

Cervical spondylotic myelopathy (CSM) often can be surgically treated by either ventral or dorsal decompression and fusion. However, there is a lack of high-level evidence on the relative advantages and disadvantages for these treatments of CSM. The authors' goal was to provide a comprehensive review of the relative benefits of ventral versus dorsal fusion in terms of quality of life (QOL) outcomes, complications, and costs. They reviewed 7 studies on CSM published between 2003 and 2013 and summarized the findings for each category. Both procedures have been shown to lead to statistically significant improvement in clinical outcomes for patients. Ventral fusion surgery has been shown to yield better QOL outcomes than dorsal fusion surgery. Complication rates for ventral fusion surgery range from 11% to 13.6%, whereas those for dorsal fusion surgery range from 16.4% to 19%. Larger randomized controlled trials are needed, with particular emphasis on QOL and minimum clinically important differences.

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Mark N. Hadley

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Daniel Lubelski, Kalil G. Abdullah, Amy S. Nowacki, Matthew D. Alvin, Michael P. Steinmetz, Srita Chakka, Yumeng Li, Nicholas Gajewski, Edward C. Benzel and Thomas E. Mroz

Object

The goal of this study was to compare the urological complications in patients after anterior lumbar interbody fusion (ALIF) with and without the use of recombinant human bone morphogenetic protein–2 (rhBMP-2).

Methods

The authors retrospectively reviewed the medical records of all patients who underwent ALIF with and without rhBMP-2 between January 2002 and August 2010. Patient demographic, operative, and complication information was analyzed. Male patients who underwent ALIF between L-4 and S-1 were contacted to assess postoperative urological complications.

Results

Of the 110 male patients who underwent ALIF and were included in this study, 59 were treated with rhBMP-2 and 51 did not receive rhBMP-2. The mean follow-up duration was 17.5 months for the rhBMP-2 group and 30.8 months for the control group. No difference was found regarding the total number of urological complications in the rhBMP-2 group versus the control group (22% vs 20%, respectively; p = 1.0) or for retrograde ejaculation specifically (8% vs 8%, respectively; p = 1.0).

Conclusions

In this study, the use of rhBMP-2 with ALIF surgery was not associated with an increased incidence of urological complications and retrograde ejaculation when compared with control ALIF without rhBMP-2. Further prospective analyses that specifically look at these complications are warranted.