26 results on '"Devin, Clinton J."'
Search Results
2. Optimal hemoglobin A1C target in diabetics undergoing elective cervical spine surgery.
- Author
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Roth SG, Chanbour H, Gupta R, O'Brien A, Davidson C, Archer KR, Pennings JS, Devin CJ, Stephens BF, Abtahi AM, and Zuckerman SL
- Subjects
- Aged, Cervical Vertebrae surgery, Glycated Hemoglobin, Humans, Middle Aged, Neck Pain surgery, Retrospective Studies, Treatment Outcome, Diabetes Mellitus epidemiology, Spinal Fusion adverse effects
- Abstract
Background Context: Diabetes mellitus (DM) is a well-established risk factor for suboptimal outcomes following cervical spine surgery. Hemoglobin A1C (HbA1c), a surrogate for long-term glycemic control, is a valuable assessment tool in diabetic patients., Purpose: In patients undergoing elective cervical spine surgery, we sought to identify optimal HbA1c levels to: (1) maximize 1-year postoperative patient-reported outcomes (PROs), and (2) predict the occurrence of medical and surgical complications., Study Design/setting: A retrospective cohort study using prospectively collected data was performed in a single academic center., Patient Sample: Diabetic patients undergoing elective anterior cervical fusion and posterior cervical laminectomy and fusion (PCLF) between October 2010-March 2021 were included., Outcome Measures: Primary outcomes included Numeric Rating Scale (NRS)-Neck pain, NRS-Arm pain, and Neck Disability Index (NDI). Secondary outcomes included surgical site infection (SSI), complications, readmissions, and reoperations within 90-days postoperatively., Methods: HbA1c, demographic, comorbidity, and perioperative variables were gathered in diabetic patients only. PROs were analyzed as continuous variables and minimum clinically difference (MCID) was set at 30% improvement from baseline., Results: Of 1992 registry patients undergoing cervical surgery, 408 diabetic patients underwent cervical fusion surgery. Anterior: A total of 259 diabetic patients underwent anterior cervical fusion, 141 of which had an available HbA1c level within one year prior to surgery. Mean age was 55.8±10.1, and mean HbA1c value was 7.2±1.4. HbA1c levels above 6.1 were associated with failure to achieve MCID for NDI (AUC=0.77, 95%CI 0.70-0.84, p<.001), and HbA1c levels above 6.8 may be associated with increased odds of reoperation (AUC=0.61, 95%CI 0.52-0.69, p=.078). Posterior: A total of 149 diabetic patients underwent PCLF, 65 of which had an available HbA1c level within 1 year. Mean age was 63.6±9.2, and mean HbA1c value was 7.2±1.5. Despite a low AUC for NRS-Arm pain and readmission, HbA1c levels above 6.8 may be associated with failure to achieve MCID for NRS-Arm pain (AUC=0.61, 95%CI 0.49-0.73, p=.094), and HbA1c levels above 7.6 may be associated with higher readmission rate (AUC=0.63, 95%CI 0.50-0.75, p=.185)., Conclusions: In a cohort of diabetic patients undergoing elective cervical spine surgery, HbA1c levels above 6.1 were associated with decreased odds of achieving MCID for NDI in anterior cervical fusion surgery. Though only moderate associations were seen for the select outcomes of reoperation (6.8), readmission (7.6), and MCID for NRS-Arm pain (6.8), preoperative optimization of HbA1c using these levels as benchmarks should be considered to reduce the risk of complications and maximize PROs for patients undergoing elective cervical spine surgery., (Copyright © 2022 Elsevier Inc. All rights reserved.)
- Published
- 2022
- Full Text
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3. A novel lumbar total joint replacement may be an improvement over fusion for degenerative lumbar conditions: a comparative analysis of patient-reported outcomes at one year.
- Author
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Alex Sielatycki J, Devin CJ, Pennings J, Koscielski M, Metcalf T, Archer KR, Dunn R, Craig Humphreys S, and Hodges S
- Subjects
- Adult, Back Pain, Humans, Lumbar Vertebrae surgery, Patient Reported Outcome Measures, Prospective Studies, Retrospective Studies, Treatment Outcome, Arthroplasty, Replacement, Intervertebral Disc Degeneration surgery, Spinal Fusion, Spondylolisthesis surgery
- Abstract
Background Context: Effective alternatives to lumbar fusion for degenerative conditions have remained elusive. Anterior total disc replacement does not address facet pathology or central/recess stenosis, resulting in limited indications. A posterior-based motion-preserving option that allows for neural decompression, facetectomy, and reconstruction of the disc and facets may have a role., Purpose: The purpose was to compare one-year patient-reported outcomes for a novel, all-posterior, lumbar total joint replacement (LTJR - replacing both the disc and facet joints) against transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar conditions warranting fusion (degenerative spondylolisthesis, recurrent disc herniation, severe foraminal stenosis requiring facet removal, and adjacent segment degeneration)., Study Design/setting: A retrospective analysis of prospectively collected data comparing outcomes for LTJR patients to TLIF patients at an academic teaching hospital., Patient Sample: Analysis was conducted on 156 adult TLIF patients who were propensity matched to the 52 LTJR patients for a total sample of 208., Outcome Measures: Self-reported Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back and leg pain were compared preoperatively, 3 months and 1 year after surgery., Methods: The implant is a motion-preserving lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral transforaminal approach with complete facetectomies. Adult patients with degenerative lumbar pathology undergoing either LTJR or open TLIF were analyzed. These degenerative conditions included: grade 1 degenerative spondylolisthesis, recurrent disc herniation, adjacent segment disease, disc degeneration with severe foraminal stenosis). Trauma, tumor, grade 2 or higher spondylolisthesis, spinal deformity, and infection cases were excluded. Propensity score matching was performed to ensure parity between the cohorts. Multivariable regression analyses were done to compare the 1-year results as measured by 3 different standards to assess procedure success., Results: At 3 months, both the LTJR and TLIF cohorts showed significant and similar improvements in ODI and NRS back and leg pain. At 1 year, the LTJR cohort showed continued improvement in ODI and NRS back pain, while the TLIF group showed a plateau for ODI, back and leg pain. In a series of three multivariable logistic regressions, LTJR was shown to provide 3.3 times greater odds of achieving the minimal clinical symptom state in disability and pain (ODI <20%, NRS back and leg pain <2) and 2.4 and 4.1 times greater odds of achieving substantial clinical benefit (18% reduction in ODI) and minimal clinically important difference (30% reduction in ODI) as compared to TLIF., Conclusions: Here we present a comparative analysis for the first 52 patients undergoing a novel, posterior-based LTJR for the lumbar spine versus TLIF for degenerative pathology. The approach for the LTJR allows for wide neural decompression, facetectomy, and complete discectomy, with the implant working to replace the function of the disc and facets to preserve motion. At 1 year, the LTJR cohort showed significant improvement in ODI and NRS back and leg pain as compared to TLIF. These results suggest that wide neural decompression combined with motion preservation using this novel LTJR may represent a viable alternative to TLIF for treating certain degenerative conditions. A prospective controlled trial is under development to further evaluate the efficacy, safety, and durability of this procedure., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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4. Bouncing back after lumbar spine surgery: early postoperative resilience is associated with 12-month physical function, pain interference, social participation, and disability.
- Author
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Coronado RA, Robinette PE, Henry AL, Pennings JS, Haug CM, Skolasky RL, Riley LH, Neuman BJ, Cheng JS, Aaronson OS, Devin CJ, Wegener ST, and Archer KR
- Subjects
- Disability Evaluation, Humans, Lumbar Vertebrae surgery, Pain, Treatment Outcome, Disabled Persons, Social Participation
- Abstract
Background Context: Positive psychosocial factors early after surgery, such as resilience and self-efficacy, may be important characteristics for informing individualized postoperative care., Purpose: To examine the association of early postoperative resilience and self-efficacy on 12-month physical function, pain interference, social participation, disability, pain intensity, and physical activity after lumbar spine surgery., Study Design/setting: Pooled secondary analysis of prospectively collected trial data from two academic medical centers., Patient Sample: Two hundred and forty-eight patients who underwent laminectomy with or without fusion for a degenerative lumbar condition., Outcome Measures: Physical function, pain inference, and social participation (ability to participate in social roles and activities) were measured using the Patient Reported Outcomes Measurement Information System. The Oswestry Disability Index, Numeric Rating Scale, and accelerometer activity counts were used to measure disability, pain intensity, and physical activity, respectively., Methods: Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery. Baseline positive psychosocial factors included resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Multivariable linear regression analyses were used to assess the associations between early postoperative psychosocial factors and 12-month outcomes adjusting for age, sex, study site, randomized group, fusion status, fear of movement (Tampa Scale for Kinesiophobia), and outcome score at baseline. This study was funded by Patient-Centered Outcomes Research Institute and Foundation for Physical Therapy Research. There are no conflicts of interest., Results: Resilience at 6 weeks after surgery was associated with 12-month physical function (unstandardized beta=1.85 [95% confidence interval [CI]: 0.29; 3.40]), pain interference (unstandardized beta=-1.80 [95% CI: -3.48; -0.12]), social participation (unstandardized beta=2.69 [95% CI: 0.97; 4.41]), and disability (unstandardized beta=-3.03 [95% CI: -6.04; -0.02]). Self-efficacy was associated with 12-month disability (unstandardized beta=-0.21 [95% CI: -0.37; -0.04]., Conclusions: Postoperative resilience and pain self-efficacy were associated with improved 12-month patient-reported outcomes after spine surgery. Future work should consider how early postoperative screening for positive psychosocial characteristics can enhance risk stratification and targeted rehabilitation management in patients undergoing spine surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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5. Classifying chronic opioid use before spine surgery: comparison of self-report and prescription drug monitoring program (PDMP) reporting.
- Author
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Pennings JS, Khan I, Hills JM, Coronado RA, Devin CJ, and Archer KR
- Published
- 2020
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6. Why are patients dissatisfied after spine surgery when improvements in disability and pain are clinically meaningful?
- Author
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Sivaganesan A, Khan I, Pennings JS, Roth SG, Nolan ER, Oleisky ER, Asher AL, Bydon M, Devin CJ, and Archer KR
- Subjects
- Humans, Prospective Studies, Retrospective Studies, Treatment Outcome, Lumbar Vertebrae surgery, Patient Satisfaction
- Abstract
Background Context: Studies have found that most patients are satisfied after spine surgery, with rates ranging from 53% to 90%. Patient satisfaction appears to be closely related to achieving clinical improvement in pain and disability after surgery. While the majority of the literature has focused on patients who report both satisfaction and clinical improvement in disability and pain, there remains an important subpopulation of patients who have clinically relevant improvement but report being dissatisfied with surgery., Purpose: To examine why patients who achieve clinical improvement in disability or pain also report dissatisfaction at 1-year after spinal surgery., Study Design: Retrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database., Patient Sample: There were 34,076 participants undergoing elective surgery for degenerative spine pathology who had clinical improvement in disability or pain., Outcome Measures: Satisfaction with surgery was assessed with 1-item from the North American Spine Society lumbar spine outcome assessment. Participants with answer choices other than "treatment met my expectations" were classified as dissatisfied., Methods: Patients completed a baseline and 12-month postoperative assessment to evaluate disability, pain, and satisfaction. Clinical improvement was defined as patients who achieved a 30% or greater improvement in spine-related disability (Oswestry/Neck Disability Index) or extremity pain (11-point Numeric Rating Scale) from baseline to 12-month after surgery. A generalized linear mixed model was used to predict the odds of the patient being dissatisfied 1-year after surgery from demographic, clinical and surgical characteristics, postoperative complications and revision, and return to work and previous physical activity. Random effects were included to model the effect of both site and surgeon on dissatisfaction. Sensitivity analyses were conducted on samples who achieved 30% or greater improvement in (1) disability only, (2) axial (back/neck) pain only, (3) extremity (leg/arm)pain only, (4) both disability and axial pain, and (5) both disability and extremity pain. Results showed the same pattern of findings across all samples., Results: Twenty-eight percent of patients were classified as dissatisfied with their spine surgery and 72% classified as satisfied. For patients with clinical improvement in disability or extremity pain at 1-year, significant predictors of higher odds of dissatisfaction included baseline psychological distress, current smoking status, workers compensation claim, lower education, higher ASA grade, lumbar versus cervical procedure, and increased axial pain, major complication within 30 days, and revision surgery within 12-months. The most important contributors to dissatisfaction were return to work and return to previous physical activity, with the odds of dissatisfaction being over 2 times and 4 times higher for these variables. Site and surgeon explained 3.8% of the variance in dissatisfaction, with more of the variance attributed to site than to surgeon., Conclusions: Several modifiable factors, including psychological distress, current smoking status, and failure to return to work and physical activity, helped explain why patients report being dissatisfied with surgery despite clinical improvement in disability or pain. The findings of this study have the potential to help providers identify at-risk patients, set realistic expectations during preoperative counseling, and implement postoperative management strategies. A multidisciplinary approach to rehabilitation that includes functional goal setting or restoration may help to improve patients psychological distress as well as return to work and previous physical activity after spine surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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7. Using PROMIS-29 to predict Neck Disability Index (NDI) scores using a national sample of cervical spine surgery patients.
- Author
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Pennings JS, Khan I, Davidson CA, Freitag R, Bydon M, Asher AL, Devin CJ, and Archer KR
- Subjects
- Adolescent, Cervical Vertebrae surgery, Female, Humans, Male, Middle Aged, Neck Pain diagnosis, Neck Pain surgery, Retrospective Studies, Patient Reported Outcome Measures, Spinal Diseases diagnosis, Spinal Diseases surgery
- Abstract
Background Context: Patient reported outcome measures (PROMs) are valuable tools for evaluating the success of spine surgery, with the Neck Disability Index (NDI) commonly used to assess pain-related disability. Recently, patient-reported outcomes measurement information system (PROMIS) has gained attention in its ability to measure PROs across general patient populations. However, PROMIS is not condition-specific so spine researchers are reluctant to incorporate it in place of common legacy measures., Purpose: To compare the PROMIS-29 (v2.0) to the NDI and compute a conversion equation., Study Design: This study retrospectively analyzes prospectively collected data from the cervical module of national spine registry, the Quality Outcomes Database (QOD)., Patient Sample: The QOD was queried for cervical spine surgery patients with PROMIS-29 and NDI scores. The cervical module of QOD includes patients undergoing primary or revision surgery for cervical degenerative spine diseases. Exclusion criteria included age under 18 years and diagnoses of infection, tumor, or trauma as the cause of cervical-related pain., Outcome Measures: The outcome of interest for this study was a conversion equation from PROMIS-29 to NDI., Methods: The PROMIS-29 includes seven 4-item domains each rated on a 5-point scale: Physical function, depression, anxiety, fatigue, sleep disturbance, ability to participate in social roles and activities (social roles), and pain interference plus one stand-alone pain intensity item. The NDI contains 10 pain-related questions scored from 0 (no pain) to 5 (most severe pain). Outcomes were collected prior to surgery and at 3- and 12-month post surgery. Patients were included in the current analysis if they had outcome data available at one or more time points. Multivariable mixed effects regression models predicting NDI scores from PROMIS-29 domains were conducted in a development data set and validated in a separate data set. Predicted NDI scores were plotted against NDI scores to determine how well PROMIS-29 domains predicted NDI. Conversion equations were created from the PROMIS-29 regression coefficients., Results: 2,018 patients from 18 US hospitals were included (mean age=57 years (SD=12)) with 48% female, 87% Caucasian, and 11% had revision surgery. Strong correlations were found between NDI and pain interference (r=0.79), pain intensity (r=0.74), social roles (r=-0.71), physical function (r=-0.69), sleep disturbance (r=0.63), fatigue (r=0.63), and anxiety (r=0.54). Correlation between NDI and depression (r=0.49) was slightly weaker. The pattern of correlations was consistent across timepoints. Four conversion equations were created for NDI using (1) only pain interference, (2) only physical function, (3) pain interference and physical function, and (4) the five statistically significant domains of pain interference, physical function, social roles, sleep disturbance, and anxiety, plus the pain intensity item. Equations 1, 3, and 4 were the best predictors of NDI, predicting approximately 80% of NDI scores within 15 points in the validation data set. Equation 4 (NDI
% =18.897+0.855*[pain interferenceraw ]-0.694*[physical functionraw ]+2.010*[pain intensityraw ]-0.663*[social rolesraw ]+0.732*[sleep disturbanceraw ]+0.426*[anxietyraw ]) predicted NDI most accurately with an R2 between the predicted and actual NDI scores of 0.72. Model 1 (R2 = 0.62; NDI% =-4.055+3.164*[pain interferenceraw ])) and Model 3 (R2 =0.65; NDI%=17.321+2.543*[pain interferenceraw ]-1.012*[physical functionraw ]) also had good accuracy., Conclusions: Findings suggest accurate NDI scores can be derived from PROMIS-29 domains. Clinicians who want to move from NDI to PROMIS-29 can use this equation to obtain estimated NDI scores when only collecting PROMIS-29. These results support the use of PROMIS-29 in cervical surgery populations and underscore the idea that PROMIS-29 domains have the potential to replace disease-specific traditional PROMs., (Copyright © 2020 Elsevier Inc. All rights reserved.)- Published
- 2020
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8. Adding 3-month patient data improves prognostic models of 12-month disability, pain, and satisfaction after specific lumbar spine surgical procedures: development and validation of a prediction model.
- Author
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Rundell SD, Pennings JS, Nian H, Harrell FE Jr, Khan I, Bydon M, Asher AL, Devin CJ, and Archer KR
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- Humans, Lumbar Vertebrae surgery, Prognosis, Retrospective Studies, Treatment Outcome, Patient Satisfaction, Personal Satisfaction
- Abstract
Background Context: Prognostic models including early postoperative variables may provide optimal estimates of long-term outcomes and help direct postoperative care., Purpose: To develop and validate prognostic models for 12-month disability, back pain, leg pain, and satisfaction among patients undergoing microdiscectomy, laminectomy, and laminectomy with fusion for degenerative lumbar conditions., Study Design/setting: Retrospective cohort study using the Quality Outcomes Database., Patient Sample: Patients receiving elective lumbar spine surgery due to degenerative spine conditions., Outcome Measures: Oswestry Disability Index, pain numerical rating scale, and NASS Patient Satisfaction Index., Methods: Prognostic models were developed using proportional odds ordinal logistic regression using patient characteristics and baseline and 3-month patient-reported outcome scores. Models were fit for each outcome stratified by type of surgical procedure. Adjusted odds ratio and 95% confidence intervals were reported for all predictors by procedure. Models were internally validated using bootstrap resampling. Discrimination was reported as the c-index and calibration was presented using the calibration slope. We compared the performance of models with and without 3-month patient-reported variables. This research was supported by the Foundation for Physical Therapy's Center of Excellence in Physical Therapy Health Services, and Health Policy Research and Training grant., Results: The sample consisted of 5,840 patients receiving a microdiscectomy (n=2,085), laminectomy (n=1,837), or laminectomy with fusion (n=1,918). The 3-month Oswestry score was the strongest and most consistent predictor associated with 12-month outcomes. All prognostic models performed well with overfitting-corrected c-index values ranging from 0.718 to 0.795 and all optimism corrected calibration slopes over 0.92. The increase in c-index values ranged from 0.09 to 0.21 when adding 3-month patient-reported outcome scores., Conclusions: Models had good discrimination and were well calibrated for estimating 12-month disability, back pain, leg pain, and satisfaction. Patient-reported outcomes at 3 months after surgery, especially 3-month Oswestry scores, improved the 12-month performance of all prognostic models beyond using only baseline variables., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2020
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9. Impact of occupational characteristics on return to work for employed patients after elective lumbar spine surgery.
- Author
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Khan I, Bydon M, Archer KR, Sivaganesan A, Asher AM, Alvi MA, Kerezoudis P, Knightly JJ, Foley KT, Bisson EF, Shaffrey C, Asher AL, Spengler DM, and Devin CJ
- Subjects
- Adult, Aged, Elective Surgical Procedures adverse effects, Female, Humans, Intervertebral Disc Degeneration epidemiology, Intervertebral Disc Displacement epidemiology, Lumbar Vertebrae surgery, Male, Middle Aged, Neurosurgical Procedures adverse effects, Unemployment statistics & numerical data, Elective Surgical Procedures statistics & numerical data, Intervertebral Disc Degeneration surgery, Intervertebral Disc Displacement surgery, Neurosurgical Procedures statistics & numerical data, Postoperative Complications epidemiology, Return to Work statistics & numerical data
- Abstract
Background Context: Low back pain has an immense impact on the US economy. A significant number of patients undergo surgical management in order to regain meaningful functionality in daily life and in the workplace. Return to work (RTW) is a key metric in surgical outcomes, as it has profound implications for both individual patients and the economy at large., Purpose: In this study, we investigated the factors associated with RTW in patients who achieved otherwise favorable outcomes after lumbar spine surgery., Study Design/setting: This study retrospectively analyzes prospectively collected data from the lumbar module of national spine registry, the Quality Outcomes Database (QOD)., Patient Sample: The lumbar module of QOD includes patients undergoing lumbar surgery for primary stenosis, disc herniation, spondylolisthesis (Grade I) and symptomatic mechanical disc collapse or revision surgery for recurrent same-level disc herniation, pseudarthrosis, and adjacent segment disease. Exclusion criteria included age under 18 years and diagnoses of infection, tumor, or trauma as the cause of lumbar-related pain., Outcome Measures: The outcome of interest for this study was the return to work 12-month after surgery., Methods: The lumbar module of QOD was queried for patients who were employed at the time of surgery. Good outcomes were defined as patients who had no adverse events (readmissions/complications), had achieved 30% improvement in Oswestry disability index (ODI) and were satisfied (NASS satisfaction) at 3-month post-surgery. Distinct multivariable logistic regression models were fitted with 12-month RTW as outcome for a. overall population and b. the patients with good outcomes. The variables included in the models were age, gender, race, insurance type, education level, occupation type, currently working/on-leave status, workers' compensation, ambulatory status, smoking status, anxiety, depression, symptom duration, number of spinal levels, diabetes, motor deficit, and preoperative back-pain, leg-pain and ODI score., Results: Of the total 12,435 patients, 10,604 (85.3%) had successful RTW at 1-year postsurgery. Among patients who achieved good surgical outcomes, 605 (7%) failed to RTW. For both the overall and subgroup analysis, older patients had lower odds of RTW. Females had lower odds of RTW compared with males and patients with higher back pain and baseline ODI had lower odds of RTW. Patients with longer duration of symptoms, more physically demanding occupations, worker's compensation claim and those who had short-term disability leave at the time of surgery had lower odds of RTW independent of their good surgical outcomes., Conclusions: This study identifies certain risk factors for failure to RTW independent of surgical outcomes. Most of these risk factors are occupational; hence, involving the patient's employer in treatment process and setting realistic expectations may help improve the patients' work-related functionality., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2019
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10. Comparing different chronic preoperative opioid use definitions on outcomes after spine surgery.
- Author
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Oleisky ER, Pennings JS, Hills J, Sivaganesan A, Khan I, Call R, Devin CJ, and Archer KR
- Subjects
- Adult, Analgesics, Opioid adverse effects, Analgesics, Opioid therapeutic use, Elective Surgical Procedures methods, Female, Humans, Male, Middle Aged, Opioid-Related Disorders etiology, Opioid-Related Disorders prevention & control, Pain, Postoperative epidemiology, Patient Reported Outcome Measures, Preoperative Period, Registries, Analgesics, Opioid administration & dosage, Drug Utilization, Elective Surgical Procedures adverse effects, Opioid-Related Disorders epidemiology, Pain, Postoperative drug therapy, Spine surgery
- Abstract
Background Context: No consensus exists for defining chronic preoperative opioid use. Most spine studies rely solely on opioid duration to stratify patients into preoperative risk categories., Purpose: The purpose of this study is to compare established opioid definitions that contain both duration and dosage to opioid models that rely solely on duration, including the CDC Guideline for Prescribing Opioids for Chronic Pain, in patients undergoing spine surgery., Study Design: This was a retrospective cohort study that used opioid data from the Tennessee Controlled Substance Monitoring Database and prospective clinical data from a single-center academic spine registry., Patient Sample: The study cohort consisted of 2,373 patients who underwent elective spine surgery for degenerative conditions between January 2011 and February 2017 and who completed a follow-up assessment at 12 months after surgery., Outcome Measures: Postoperative opioid use and patient-reported satisfaction (NASS Satisfaction Scale), disability (Oswestry/Neck Disability Index), and pain (Numeric Rating Scale) at 12 month follow-up., Methods: Six different chronic preoperative opioid use variables were created based on the number of times a prescription was filled and/or daily morphine milligram equivalent for the one year before surgery. These variables defined chronic opioid use as 1) most days for > 3 months (CDC), 2) continuous use for ≥ 6 months (Schoenfeld), 3) >4,500 mg for at least 9 months (Svendsen wide), 4) >9,000 mg for 12 months (Svendsen intermediary), 5) >18,000 mg for 12 months (Svendsen strict), 6) low-dose chronic (1-36 mg for >91 days), medium-dose chronic (36-120 mg for >91 days), and high-dose chronic (>120 mg for >91 days) (Edlund). Multivariable regression models yielding C-index and R
2 values were used to compare chronic preoperative opioid use definitions by postoperative outcomes, adjusting for type of surgery., Results: Chronic preoperative opioid use was reported in 470 to 725 (19.8% to 30.6%) patients, depending on definition. The Edlund definition, accounting for duration and dosage, had the highest predictive ability for postoperative opioid use (77.5%), followed by Schoenfeld (75.7%), CDC (72.6%), and Svendsen (59.9% to 72.5%) definitions. A combined Edlund and Schoenfeld duration and dosage definition in post-hoc analysis, that included 3 and 6 month duration cut-offs, performed the best overall with a C-index of 78.4%. Both Edlund and Schoenfeld definitions explained similar amounts of variance in satisfaction, disability, and pain (4.2% to 8.5%). Svendsen and CDC definitions demonstrated poorer performance for patient-reported outcomes (1.4% to 7.2%)., Conclusions: The Edlund definition is recommended for identifying patients at highest risk for postoperative opioid use. When opioid dosage is unavailable, the Schoenfeld definition is a reasonable choice with similar predictive ability. For patient-reported outcomes, either the Edlund or Schoenfeld definition is recommended. Future work should consider combing dosage and duration, with 3 and 6 month cutoffs, into chronic opioid use definitions., (Copyright © 2019. Published by Elsevier Inc.)- Published
- 2019
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11. Effect of pre-injection opioid use on post-injection patient-reported outcomes following epidural steroid injections for radicular pain.
- Author
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Wei JJ, Chotai S, Sivaganesan A, Archer KR, Schneider BJ, Yang AJ, and Devin CJ
- Subjects
- Adult, Aged, Analgesics, Opioid administration & dosage, Analgesics, Opioid therapeutic use, Female, Humans, Injections, Epidural, Male, Middle Aged, Steroids administration & dosage, Analgesics, Opioid adverse effects, Back Pain drug therapy, Patient Reported Outcome Measures, Steroids therapeutic use
- Abstract
Background Context: Chronic opioid therapy is associated with worse patient-reported outcomes (PROs) following spine surgery. However, little literature exists on the relationship between opioid use and PROs following epidural steroid injections for radicular pain., Purpose: We evaluated the association between pre-injection opioid use and PROs following spine epidural steroid injection., Study Design: This study is a retrospective analysis of a prospective longitudinal registry database., Patient Sample: A total of 392 patients within our database who were undergoing epidural steroid injections (ESIs) at our institution for degenerative structural spine diagnoses and met our inclusion criteria were included in this study., Outcome Measures: Patient-reported outcomes for disability (Oswestry Disability Index/Neck Disability Index [ODI/NDI)]), quality of life (EuroQol-5D [EQ-5D]), and pain (Numerical Rating Scale scores for back pain, neck pain, leg pain, and arm pain [NRS-BP/NP/LP/AP]) were assessed at baseline and at 3 and 12 months post-injection., Methods: Multivariable proportional odds logistic regression models were created to examine the relationship between pre-injection opioid use and post-injection PROs. A logistic regression with Bayesian Markov chain Monte Carlo parameter estimation was used to investigate a possible cutoff value of pre-injection opioid use above which the effectiveness of ESI (as measured by minimum clinically important difference [MCID] for ODI/NDI) decreases., Results: A total of 276 patients with complete 12-month follow-up following ESI were analyzed. The mean pre-injection daily morphine equivalent amount (MEA) was 14.7 mg (95% confidence interval [CI] 12.4 mg-19.1 mg) for the cohort. Pre-injection opioid use was associated with slightly higher odds of worse disability (odds ratio [OR] 1.03, p=.03) and leg/arm pain (OR 1.01, p=.04) scores at 3 months post-injection only. No significant association between pre-injection opioid use and MCID for ODI/NDI was found, although a cutoff of 55.5 mg/day might serve as a significant threshold., Conclusion: Increased pre-injection opioid use does not impact long-term outcomes after ESIs for degenerative spine diseases. A pre-injection MEA around 50 mg/day may represent a threshold above which the 3-month effectiveness of ESI for back- and neck-related disability decreases. Epidural steroid injection is an effective treatment modality for pain in patients using opioids, and can be part of a multimodal strategy for opioid independence., (Copyright © 2017. Published by Elsevier Inc.)
- Published
- 2018
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12. Effect of patients' functional status on satisfaction with outcomes 12 months after elective spine surgery for lumbar degenerative disease.
- Author
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Chotai S, Devin CJ, Archer KR, Bydon M, McGirt MJ, Nian H, Harrell FE Jr, Dittus RS, and Asher AL
- Subjects
- Adult, Aged, Elective Surgical Procedures adverse effects, Female, Humans, Lumbar Vertebrae surgery, Male, Middle Aged, Prospective Studies, Registries, Surveys and Questionnaires, Elective Surgical Procedures psychology, Intervertebral Disc Degeneration surgery, Patient Satisfaction
- Abstract
Background: Comprehensive assessment of quality of care includes patient-reported outcomes, safety of care delivered, and patient satisfaction. The impact of the patient-reported Oswestry Disability Index (ODI) scores at baseline and 12 months on satisfaction with outcomes following spine surgery is not well documented., Purpose: This study aimed to determine the impact of patient disability (ODI) scores at baseline and 12 months on satisfaction with outcomes following surgery., Study Design: Analysis of prospectively collected longitudinal web-based multicenter data., Patient Sample: Patients undergoing elective surgery for degenerative lumbar disease were entered into a prospective multicenter registry., Outcome Measures: Primary outcome measures were ODI, North American Spine Society satisfaction (NASS) questionnaire., Methods: Baseline and 12-month ODI scores were recorded. Satisfaction at 12 months after surgery was measured using NASS questionnaire. Multivariable proportional odds logistic regression analysis was conducted to determine the impact of baseline and 12-month ODI on satisfaction with outcomes., Results: Of the total 5,443 patients, 64% (n=3,460) were satisfied at a level where surgery met their expectations (NASS level 1) at 12 months after surgery. After adjusting for all baseline and surgery-specific variables, the 12-month ODI score had the highest impact (Wald χ
2 =1,555, 86% of the total χ2 ) on achieving satisfaction with outcomes compared with baseline ODI scores (Wald χ2 =93, 5% of the total χ2 ). The level of satisfaction decreases with increasing 12-month ODI score. Greater change in ODI is required to achieve a better satisfaction level when the patient starts with a higher baseline ODI score., Conclusion: Absolute 12-month ODI following surgery had a significant association on satisfaction with outcomes 12 months after surgery. Patients with higher baseline ODI required a larger change in ODI score to achieve satisfaction. No single measure can be used as a sole yardstick to measure quality of care after spine surgery. Satisfaction may be used in conjunction with baseline and 12-month ODI scores to provide an assessment of the quality of spine surgery provided in a patient centric fashion., (Copyright © 2017. Published by Elsevier Inc.)- Published
- 2017
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13. Effect of obesity on cost per quality-adjusted life years gained following anterior cervical discectomy and fusion in elective degenerative pathology.
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Chotai S, Sielatycki JA, Parker SL, Sivaganesan A, Kay HL, Stonko DP, Wick JB, McGirt MJ, and Devin CJ
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- Adult, Aged, Cervical Vertebrae surgery, Female, Humans, Intervertebral Disc Degeneration complications, Lumbar Vertebrae surgery, Male, Middle Aged, Obesity, Morbid complications, Quality of Life, Cost-Benefit Analysis, Diskectomy economics, Intervertebral Disc Degeneration surgery, Obesity, Morbid economics, Quality-Adjusted Life Years, Spinal Fusion economics
- Abstract
Background: Obese patients have greater comorbidities along with higher risk of complications and greater costs after spine surgery, which may result in increased cost and lower quality of life compared with their non-obese counterparts., Purpose: The aim of the present study was to determine cost-utility following anterior cervical discectomy and fusion (ACDF) in obese patients., Study Design: This study analyzed prospectively collected data., Patient Sample: Patients undergoing elective ACDF for degenerative cervical pathology at a single academic institution were included in the study., Outcome Measures: Cost and quality-adjusted life years (QALYs) were the outcome measures., Methods: One- and two-year medical resource utilization, missed work, and health state values (QALYs) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Total cost (direct+indirect) was used to compute cost per QALY gained. Patients were defined as obese for body mass index (BMI) ≥35 based on the WHO definition of class II obesity. A subgroup analysis was conducted in morbidly obese patients (BMI≥40)., Results: There were significant improvements in pain (neck pain or arm pain), disability (Neck Disability Index), and quality of life (EuroQol-5D and Short Form-12) at 2 years after surgery (p<.001). There was no significant difference in post-discharge health-care resource utilization, direct cost, indirect cost, and total cost between obese and non-obese patients at postoperative 1-year and 2-year follow-up. Mean 2-year direct cost for obese patients was $19,225±$8,065 and $17,635±$6,413 for non-obese patients (p=.14). There was no significant difference in the mean total 2-year cost between obese ($23,144±$9,216) and non-obese ($22,183±$10,564) patients (p=.48). Obese patients had a lower mean cumulative gain in QALYs versus non-obese patients at 2-years (0.34 vs. 0.42, p=.32). Two-year cost-utility in obese ($68,070/QALY) versus non-obese patients ($52,816/QALY) was not significantly different (p=.11). Morbidly obese patients had lower QALYs gained (0.17) and higher cost per QALYs gained ($138,094/QALY) at 2 years., Conclusions: Anterior cervical discectomy and fusion provided a significant gain in health state utility in obese patients, with a mean 2-year cost-utility of $68,070 per QALYs gained, which can be considered moderately cost-effective. Morbidly obese patients had lower cost-effectiveness; however, surgery does provide a significant improvement in outcomes. Obesity, and specifically morbid obesity, should to be taken into consideration as physician and hospital reimbursements move toward a bundled model., (Copyright © 2016 Elsevier Inc. All rights reserved.)
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- 2016
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14. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology.
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Sivaganesan A, Chotai S, Parker SL, Asher AL, McGirt MJ, and Devin CJ
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- Adult, Aged, Back Pain diagnosis, Female, Humans, Intervertebral Disc Displacement diagnosis, Male, Middle Aged, Prospective Studies, Steroids adverse effects, Steroids therapeutic use, Treatment Outcome, Back Pain drug therapy, Injections, Epidural adverse effects, Intervertebral Disc Displacement drug therapy, Steroids administration & dosage
- Abstract
Background: Lumbar epidural steroid injection (LESI) is a valuable therapeutic option when administered to the appropriate patient, for the appropriate disease process, at the appropriate time. There is considerable variability in patient-reported outcomes (PROs) after LESI, creating uncertainty as to who will benefit from the therapy and who will not., Purpose: We set out to identify patient attributes, which are important predictors for the achievement of a minimum clinically important difference (MCID) in the Oswestry Disability Index (ODI) after LESI., Study Design: A prospective cohort study was carried out., Patient Sample: A total of 239 consecutive patients undergoing LESI for back-related disability, back pain (BP), and leg pain (LP) associated with degenerative pathology comprised the patient sample., Outcome Measures: Baseline and 3-month patient self-reported ODI, numeric rating scale-BP and LP, Euro-Qol-5D, and Short Form (SF)-12 scores were recorded., Methods: A total of 239 consecutive patients undergoing LESI for degenerative pathology over a period of 2 years who were enrolled into a prospective web-based registry were included in the study. Using the previously reported anchor-based approach, an MCID threshold of 7.1% was established for ODI after LESI. Each enrolled patient was then dichotomized as a "responder" (achieving MCID) or a "non-responder." Multiple logistic regression analysis was then performed, with the achievement of MCID serving as the outcome of interest. Candidate variables included in the regression analyses were age, gender, employment, insurance type, smoking status, preoperative ambulation, preinjection narcotic use, comorbidities, predominant LP or BP symptoms, symptom duration, diagnosis, number of levels, prior surgery, baseline PROs, type of stenosis (central, lateral recesses, or foraminal), injection route (transforaminal, interlaminar, or caudal), and number of injections. Subsequently, we also randomly selected 80% of the patients to serve as the training data for a multiple logistic regression model. Once this predictive model was built, it was validated using the remaining 20% of patients., Results: There were 124 (62%) patients who achieved MCID for ODI. The existence of central stenosis (p=.006), TF or IL injection route (p=.02) compared with caudal epidural steroid injection, higher baseline ODI (p=.00001), and a diagnosis of disc herniation (p=.02) increase the odds of achieving MCID for ODI at 3 months. Symptom duration for over a year (p=.006), prior surgery (p=.08), and preinjection anxiety (p=.001) decrease the odds of achieving MCID. The area under the curve (AUC) for our predictive model's receiver-operator characteristic was 0.81 when using the 80% training data set, and the AUC was 0.72 when using the 20% validation data., Conclusion: We have identified patient attributes that are important predictors for the achievement of MCID in ODI 3 months after LESI. The use of these attributes, in the form of a predictive model for LESI efficacy, has the potential to improve decision making around LESI. Spine care providers can use the information to gain insight into the likelihood that a particular patient will experience a meaningful benefit from LESI., (Copyright © 2015 Elsevier Inc. All rights reserved.)
- Published
- 2016
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15. Is more lordosis associated with improved outcomes in cervical laminectomy and fusion when baseline alignment is lordotic?
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Sielatycki JA, Armaghani S, Silverberg A, McGirt MJ, Devin CJ, and O'Neill K
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- Aged, Female, Humans, Lordosis epidemiology, Male, Middle Aged, Postoperative Complications, Cervical Vertebrae surgery, Decompression, Surgical adverse effects, Laminectomy adverse effects, Lordosis surgery, Posture, Spinal Cord Diseases surgery, Spinal Fusion adverse effects
- Abstract
Background Context: In cervical spondylotic myelopathy (CSM), cervical sagittal alignment (CSA) is associated with disease severity. Increased kyphosis and C2-C7 sagittal vertical axis (SVA) correlate with worse myelopathy and poor outcomes. However, when alignment is lordotic, it is unknown whether these associations persist., Purpose: The study aimed to investigate the associations between CSA parameters and patient-reported outcomes (PROs) following posterior decompression and fusion for CSM when baseline lordosis is maintained., Study Design/setting: This is an analysis of a prospective surgical cohort at a single academic institution., Patient Sample: The sample includes adult patients undergoing primary cervical laminectomy and fusion for CSM over a 3-year period., Outcome Measures: The PROs included EuroQol-5D, Short-Form-12 (SF-12) physical composite (PCS) and mental composite scales (MCS), Neck Disability Index, and the modified Japanese Orthopaedic Association scores. Radiographic CSA parameters measured included C1-C2 Cobb, C2-C7 Cobb, C1-C7 Cobb, C2-C7 SVA, C1-C7 SVA, and T1 slope., Methods: The PROs were recorded at baseline and at 3 and 12 months postoperatively. The CSA parameters were measured on standing radiographs in the neutral position at baseline and 3 months. Wilcoxon rank test was used to test for changes in PROs and CSA parameters, and Pearson correlation coefficients were calculated for CSA parameters and PROs preoperatively and at 12 months. No external sources of funding were used for this work., Results: There were 45 patients included with an average age of 63 years who underwent posterior decompression and fusion of 3.7±1.3 levels. Significant improvements were found in all PROs except SF-12 MCS (p=.06). Small but statistically significant changes were found in C2-C7 Cobb (mean change: +3.6°; p=.03) and C2-C7 SVA (mean change: +3 mm; p=.01). At baseline, only C2-C7 SVA associated with worse SF-12 PCS scores (r=-0.34, p=.02). Postoperatively, there were no associations found between PROs and any CSA parameters. Similarly, no CSA parameters were associated with changes in PROs., Conclusions: Although creating more lordosis and decreasing SVA are associated with improved myelopathy and outcomes in patients with kyphosis, our study did not find such associationsin patients with lordosis undergoing posterior laminectomy and fusion for CSM. This suggests that any amount of lordosis may be sufficient., (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Published
- 2016
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16. A response to comments by Dr. Manchikanti and Dr. Hirsch.
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Devin CJ and Sivaganesan A
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- 2016
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17. Matched-pair cohort study of 1-year patient-reported outcomes following pelvic fixation.
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Kelly PD, Sivaganesan A, Chotai S, Parker SL, McGirt MJ, and Devin CJ
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- Adult, Case-Control Studies, Female, Humans, Length of Stay, Male, Middle Aged, Patient Reported Outcome Measures, Postoperative Complications, Postoperative Period, Retrospective Studies, Spinal Fusion methods, Pelvis surgery, Spinal Fusion adverse effects
- Abstract
Background Context: Pelvic fixation improves fusion and stability for thoracolumbar constructs that extend across the L5-S1 junction. No patient-reported outcomes have been published to evaluate patients' functional outcomes following these procedures compared with pelvis-sparing procedures., Purpose: The goal of this study is to identify the effect of pelvic fixation on both objective and patient-reported outcomes., Study Design/setting: This was a retrospective, matched cohort study., Patient Sample: The sample comprised adult patients undergoing spine surgery at our institution who had complete 1-year postoperative follow-up., Outcome Measures: Patient-reported outcome instruments (Oswestry Disability Index [ODI], Short-Form 12-item survey, and EuroQol-5D) and objective measures (length of hospital stay, discharge disposition, postoperative complications, and readmission rates) were considered., Methods: We identified patients in our outcomes registry undergoing instrumented spinal fusion involving the pelvis between October 2010 and May 2014 who had 1-year follow-up data. Nearest-neighbor 1:1 matched controls were identified using propensity scoring from the cohort of patients undergoing any spinal procedure which extended caudally to the lumbar spine or sacrum. Objective and patient-reported outcomes were compared between cases and controls., Results: There were 44 patients who underwent spinal procedures involving the pelvis and had 1-year follow-up data. An equal number of controls were identified and had similar baseline demographic and clinical characteristics. No significant differences were found among operative variables or objective complication rates. Patients undergoing pelvic fixation had moderately greater improvement at 3 months as measured by ODI, but this difference was not present at 1 year. Other patient-reported outcome measures were equivocal between groups., Conclusions: This matched cohort study demonstrates that inclusion of the pelvis in spinal hardware constructs is not associated with increased complications and may slightly improve patient disability at 1 year. Given that pelvic fixation may reduce L5-S1 breakdown and improve biomechanics, surgeons should more readily include the pelvis in instrumented fusion procedures., (Copyright © 2016 Elsevier Inc. All rights reserved.)
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- 2016
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18. Traumatic atlantooccipital dislocation: comprehensive assessment of mortality, neurologic improvement, and patient-reported outcomes at a Level 1 trauma center over 15 years.
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Mendenhall SK, Sivaganesan A, Mistry A, Sivasubramaniam P, McGirt MJ, and Devin CJ
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- Adolescent, Adult, Aged, Atlanto-Occipital Joint surgery, Female, Humans, Joint Dislocations epidemiology, Male, Middle Aged, Spinal Fusion adverse effects, Spinal Injuries epidemiology, Atlanto-Occipital Joint injuries, Joint Dislocations surgery, Spinal Fusion statistics & numerical data, Spinal Injuries surgery, Trauma Centers statistics & numerical data
- Abstract
Background Context: Only Level 3 evidence exists for the diagnosis and treatment of atlantooccipital dislocation (AOD) with few studies examining mortality, neurologic improvement, and patient-reported outcomes (PROs)., Purpose: First, the aim was to determine: the incidence of AOD, 90-day surgical morbidity and mortality after AOD, patient factors that may be associated with delayed or missed diagnosis, and factors that were associated with mortality and neurologic improvement after AOD. Secondly, the aim was to quantify the pain, disability, and quality of life experienced by patients surviving AOD., Study Design/setting: This was a retrospective cohort study., Patient Sample: A total of 5,337 consecutive spine computed tomography traumagrams from 1997 to 2012 were included., Outcome Measures: Mortality, neurologic improvement, complications, EuroQol five dimensions (EQ-5D), Neck Disability Index (NDI), Numeric Rating Scale (NRS)-neck, NRS-arm, and return-to-work were the outcome measures., Methods: Patients were considered to have AOD if they met one of the following radiographic criteria: basion-dens interval greater than 10 mm; basion-axial interval: anterior displacement greater than 12 mm or posterior displacement greater than 4 mm between the basion and posterior C2 line; and condyle to C1 interval greater than 1.4 mm. Linear regression analysis was performed to identify factors associated with 90-day mortality, neurologic improvement, and missed diagnosis. Patient-reported outcomes were assessed via phone interview., Results: Thirty-one patients met radiographic criteria for AOD; an incidence of 0.6% over 15 years. Twenty-one (68%) patients were treated with occipital cervical fusion. At 90 days postoperatively, there were no new neurologic deficits or reoperations. Eight (26%) patients died within 90 days. All patients who died had no documented AOD diagnosis and were not treated surgically. Missed AOD diagnosis was the strongest predictor of mortality. Younger age, lower Glasgow Coma Score, lower Injury Severity Score (ISS) score, and worse initial American Spinal Injury Association (ASIA) score were significantly associated with greater neurologic improvement. Higher ISS score and better ASIA score were significantly associated with missed AOD diagnosis. The average PROs metrics at time of telephone follow-up were as follows: EQ-5D=0.73±0.19, NDI=30.89±18.57, NRS-neck=2.33±2.21, NRS-arm=2.00±2.54. Of the patients with follow-up data, four were employed full-time, and five were receiving disability., Conclusions: Our work suggests that failure to diagnose AOD is a powerful predictor of mortality. Higher ISS scores and better neurologic presentation were significantly associated with missed diagnosis. Craniocervical arthrodesis preserved neurologic function with low complication rate and unexpectedly high PROs and return-to-work. These results must be carefully interpreted because it is unclear whether missed AOD diagnosis accompanies another death-causing injury (eg, traumatic brain injury) or if failure to treat AOD contributes to mortality in a multifactorial manner., (Copyright © 2015 Elsevier Inc. All rights reserved.)
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- 2015
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19. How often are interfacility transfers of spine injury patients truly necessary?
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Bible JE, Kadakia RJ, Kay HF, Zhang CE, Casimir GE, and Devin CJ
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- Adolescent, Adult, Aged, 80 and over, Emergency Service, Hospital statistics & numerical data, Female, Humans, Male, Middle Aged, Patient Transfer standards, Trauma Centers statistics & numerical data, Patient Transfer statistics & numerical data, Spinal Injuries therapy
- Abstract
Background Context: Traumatic spine injuries are often transferred to regional tertiary trauma centers from outside hospitals (OSHs) and subsequently discharged from the trauma center's emergency department (ED) suggesting secondary overtriage of such injuries., Purpose: The aim of the study was to investigate the definitive treatment and disposition of traumatic spine injuries transferred from OSH, particularly those without other trauma injuries or neurologic symptoms., Study Design: This was a retrospective study., Patient Sample: Adult patients presenting to a single Level 1 trauma center with spine injuries were included., Outcome Measures: The outcome measures considered in the study were appropriateness of transfer, treatment, and cost., Methods: Four thousand five-hundred consecutive adult patients presenting to a single Level 1 trauma center with spine injuries (isolated or polytrauma) were reviewed. This consisted of 1,427 patients (32%) transferred from an OSH ED. All OSH, emergency medical services, and receiving institution (RI) patient records and imaging were reviewed., Results: Patients who were neurologically intact, nonpolytrauma, and without critical medical issues at the OSH (isolated intact spine transfers) comprised 29% of transfers. Helicopters transported 13% of these patients. The most frequent injuries were compression (26%), burst (17%), and transverse process (10%) fractures. Seventy-eight percent were discharged directly from the RI's ED. Similarly, 15% were not given any formal treatment, 13% had surgery, and 72% given orthosis treatment. The average cost for transportation and ED costs for those discharged from the RI ED were $1,863 and $12,895, respectively. Of the isolated intact spine transfers, 42% were considered to be inappropriate to warrant transfer. This was defined as those sent from an OSH with an orthopedic or neurosurgeon on staff and clearly stable injuries with minimal chance of progressing to instability. Isolated intact spine transfers whose OSH spine imaging was not considered unstable was 25% of transfers with a helicopter used to transport 14% of these patients. Eighty-seven percent were discharged from the ED, whereas only 3% went onto surgery., Conclusions: This study is the first to investigate interfacility transfers with spine injuries and found high rate of secondary overtriage of neurologically intact patients with isolated spine injuries. Potential solutions include increasing spine coverage in community EDs, increasing direct communication between the OSH and the spine specialist at the tertiary center, and utilization of teleradiology., (Copyright © 2014 Elsevier Inc. All rights reserved.)
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- 2014
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20. Determining the quality and effectiveness of surgical spine care: patient satisfaction is not a valid proxy.
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Godil SS, Parker SL, Zuckerman SL, Mendenhall SK, Devin CJ, Asher AL, and McGirt MJ
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- Adult, Area Under Curve, Cohort Studies, Female, Humans, Longitudinal Studies, Male, Middle Aged, ROC Curve, Sensitivity and Specificity, Surveys and Questionnaires, Orthopedic Procedures, Patient Satisfaction, Quality of Life, Spine surgery, Treatment Outcome
- Abstract
Background Context: Given the unsustainable costs of the US health-care system, health-care purchasers, payers, and hospital systems are adopting the concept of value-based purchasing by shifting care away from low-quality providers or hospitals. Legislation now allows public reporting of these quality rankings. True measures of quality, such as surgical morbidity and validated questionnaires of effectiveness, are burdensome and costly to collect. Hence, patients' satisfaction with care has emerged as a commonly used metric as a proxy for quality because of its feasibility of collection. However, patient satisfaction metrics have yet to be validated as a measure of overall quality of surgical spine care., Purpose: We set out to determine whether patient satisfaction is a valid measure of safety and effectiveness of care in a prospective longitudinal spine registry., Study Design: Prospective longitudinal cohort study., Patient Population: All patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center., Outcome Measures: Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry disability index [ODI], neck disability index [NDI], short-form 12-item survey [SF-12], Euro-Qol-5D [EQ-5D], Zung depression scale, and Modified Somatic Perception Questionnaire [MSPQ] anxiety scale), return to work, patient satisfaction with outcome, and patient satisfaction with provider care., Methods: All patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center were enrolled into a prospective longitudinal registry. Data collected on all patients included demographics, disease characteristics, treatment variables, readmissions/reoperations, and all 90-day surgical morbidity. Patient-reported outcome instruments (NRS, ODI, NDI, SF-12, EQ-5D, Zung depression scale, and MSPQ anxiety scale), return to work, patient satisfaction with outcome, and patient satisfaction with provider care were recorded at baseline and 3 months after treatment. Receiver-operating characteristic (ROC) curve analysis was performed to determine whether extent of improvement in quality of life (SF-12 physical component summary [PCS]) and disability (ODI/NDI) accurately predicted patient satisfaction versus dissatisfaction. Standard interpretation of area under the curve (AUC) was used: less than 0.7, poor; 0.7 to 0.8, fair; and greater than 0.8, good accuracy. Multivariate logistic regression analysis was performed to determine if surgical morbidity (quality) or improvement in disability and quality of life (effectiveness of care) were independently associated with patient satisfaction., Results: Four hundred twenty-two (84%) patients completed all questionnaires 3 months after surgery during the reviewed time period (mean age 55±14 years). Lumbar surgery was performed in 287 (68%) and cervical surgery in 135 (32%) patients. There were 51 (12.1%) 90-day complications, including 21 (5.0%) readmissions and 12 (2.8%) return to operating room. Three hundred fifty-eight (84.8%) patients were satisfied with provider care and 288 (68.2%) with their outcome. Satisfaction with provider care: In ROC analyses, extent of improvement in quality of life (SF-12) and disability (ODI/NDI) differentiated satisfaction versus dissatisfaction with care with very poor accuracy (AUC 0.49-0.69). In regression analysis, 3-month morbidity (odds ratio [95% confidence interval]: 1.45 [0.79-2.66]), readmission (0.66 [0.24-1.80]), improvement in quality of life (SF-12 PCS), or improvement in general health (health transition index) were not associated with satisfaction with care. Satisfaction with outcome: In ROC analyses, improvement in quality of life (SF-12) and disability (ODI/NDI) failed to differentiate satisfaction with good accuracy (AUC 0.76). Neither 90-day morbidity (1.05 [0.46-2.34]) nor 90-day readmission (0.27 [0.04-2.04]) was associated with satisfaction with outcome in regression analysis., Conclusions: Patient satisfaction is not a valid measure of overall quality or effectiveness of surgical spine care. Patient satisfaction metrics likely represent the patient's subjective contentment with health-care service, a distinct aspect of care. Satisfaction metrics are important patient-centered measures of health-care service but should not be used as a proxy for overall quality, safety, or effectiveness of surgical spine care., (Copyright © 2013 Elsevier Inc. All rights reserved.)
- Published
- 2013
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21. Implant contamination during spine surgery.
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Bible JE, O'Neill KR, Crosby CG, Schoenecker JG, McGirt MJ, and Devin CJ
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- Humans, Postoperative Complications prevention & control, Surgical Wound Infection prevention & control, Equipment Contamination prevention & control, Infection Control methods, Internal Fixators microbiology, Spinal Fusion instrumentation
- Abstract
Background Context: Postoperative spine infections have been reported to occur in 1% to 15% of patients and subsequently lead to significant morbidity and cost, with an elevated risk for instrumented cases. Every effort should be made to minimize the risk of intraoperative wound contamination. Consequently, certain practices are followed in the operating room to prevent contamination, many of which are not evidence based. Conversely, certain objects believed to be sterile are frequently overlooked as potential sources of contamination., Purpose: To assess to what degree contamination of spinal implants occurs during spine surgery and evaluate whether coverage of implants alters the rate of contamination., Study Design: Prospective study., Study Sample: This study included 105 consecutive noninfection surgical cases performed by a single spine surgeon that required the use of instrumentation., Outcome Measure: Spinal implant contamination., Methods: Cases were randomized to have all implant trays either remain uncovered (n=54) or covered (n=51) with sterile surgical towels on opening until implants were required for the case. After the last implant was placed, a sterile culture swab was used to obtain a sample from all open implants that had been present at the start of the case. The paper outer wraps of the implant trays were sampled in each case as a positive control, and an additional 105 swabs were capped immediately after they were opened to obtain negative controls. Swab samples were assessed for bacterial growth on 5% sheep blood Columbia agar plates. Of note, only departmental funding was used and no applicable financial relationships exist with any author., Results: No growth was observed on any of the 105 negative controls, whereas 99.1% of positive controls demonstrated obvious contamination. Cultures from implant samples demonstrated a 9.5% overall rate of contamination with 2.0% (n=1) of covered implants versus 16.7% (n=9) of uncovered implants demonstrating contamination. Length of time implant trays were open before sample collection; implant type (plate, rods, vs. polyetheretherketone), number of scrubbed personnel, and number of implants used were all not found to be significantly associated with implant contamination (p>.05). However, coverage of implants was found to significantly reduce the implant contamination rate (p=.016)., Conclusions: The contamination of sterile implants during spine surgery was found to occur. However, this contamination was independent of the amount of time the implant trays remained open. Coverage of implants significantly reduces this contamination. Therefore, no matter the expected duration of a case, implant coverage is a simple modifiable way to reduce the risk of intraoperative wound contamination and potentially reduce postoperative infections., (Copyright © 2013 Elsevier Inc. All rights reserved.)
- Published
- 2013
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22. Determination of minimum clinically important difference (MCID) in pain, disability, and quality of life after revision fusion for symptomatic pseudoarthrosis.
- Author
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Parker SL, Adogwa O, Mendenhall SK, Shau DN, Anderson WN, Cheng JS, Devin CJ, and McGirt MJ
- Subjects
- Adult, Aged, Back Pain etiology, Disability Evaluation, Female, Humans, Male, Middle Aged, Pseudarthrosis complications, Reoperation, Retrospective Studies, Treatment Outcome, Back Pain surgery, Pain Measurement methods, Patient Satisfaction, Pseudarthrosis surgery, Quality of Life, Spinal Fusion
- Abstract
Background Context: Spinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis., Purpose: To determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis. STUDY DESIGN/ SETTING: Retrospective cohort study., Methods: In 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index)., Results: All patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0-3.2; ODI: 4.0%-16.6%; SF-12 PCS: 3.2-6.1; and EQ-5D: 0.14-0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state., Conclusions: Using subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements., (Copyright © 2012 Elsevier Inc. All rights reserved.)
- Published
- 2012
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23. Preoperative Zung Depression Scale predicts outcome after revision lumbar surgery for adjacent segment disease, recurrent stenosis, and pseudarthrosis.
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Adogwa O, Parker SL, Shau DN, Mendenhall SK, Aaronson OS, Cheng JS, Devin CJ, and McGirt MJ
- Subjects
- Decompression, Surgical psychology, Female, Humans, Male, Middle Aged, Neuropsychological Tests, Pain Measurement, Preoperative Period, Pseudarthrosis complications, Recovery of Function, Spinal Stenosis complications, Treatment Outcome, Depression complications, Lumbar Vertebrae surgery, Pseudarthrosis surgery, Spinal Fusion psychology, Spinal Stenosis surgery
- Abstract
Background Context: Persistent back pain and leg pain after index surgery is distressing to patients and spinal surgeons. Revision surgical treatment is technically challenging and has been reported to yield unpredictable outcomes. Recently, affective disorders, such as depression and anxiety, have been considered potential predictors of surgical outcomes across many disease states of chronic pain. There remains a paucity of studies assessing the predictive value of baseline depression on outcomes in the setting of revision spine surgery., Purpose: To assess the predictive value of preoperative depression on 2-year postoperative outcome after revision lumbar surgery for symptomatic pseudarthrosis, adjacent segment disease (ASD), and same-level recurrent stenosis., Study Design: Retrospective cohort study., Patient Sample: One hundred fifty patients undergoing revision surgery for symptomatic ASD, pseudarthrosis, and same-level recurrent stenosis., Outcome Measures: Patient-reported outcome measures were assessed using an outcomes questionnaire that included questions on health-state values (EQ-5D), disability (Oswestry Disability Index [ODI]), pain (visual analog scale), depression (Zung Self-Rating Depression Scale), and 12-Item Short Form Health Survey physical and mental component scores., Methods: One hundred fifty patients undergoing revision neural decompression and instrumented fusion for ASD (n=50), pseudarthrosis (n=47), or same-level recurrent stenosis (n=53) were included in this study. Preoperative Zung Self-Reported Depression Scale score was assessed for all patients. Preoperative and 2-year postoperative visual analog scale for back pain and leg pain scores and ODI were assessed. The association between preoperative Zung Depression Scale score and 2-year improvement in disability was assessed via multivariate regression analysis., Results: Compared to preoperative status, VAS-BP was significantly improved 2 years after surgery for ASD (8.72±1.85 vs. 3.92±2.84, p=.001), pseudoarthrosis (7.31±0.81 vs. 5.06±2.64, p=.001), and same-level recurrent stenosis (9.28±1.00 vs. 5.00±2.94, p=.001). Two-year ODI was also significantly improved after surgery for ASD (28.72±9.64 vs. 18.48±11.31, p=.001), pseudoarthrosis (29.74±5.35 vs. 25.42±6.00, p=.001), and same-level recurrent stenosis (36.01±6.00 vs. 21.75±12.07, p=.001). Independent of age, BMI, symptom duration, smoking, comorbidities, and level of preoperative pain and disability, increasing preoperative Zung depression score was significantly associated with less 2-year improvement in disability (ODI) after revision surgery for ASD, pseudoarthrosis, and recurrent stenosis., Conclusions: Our study suggests that the extent of preoperative depression is an independent predictor of functional outcome after revision lumbar surgery for ASD, pseudoarthrosis, and recurrent stenosis. Future comparative effectiveness studies assessing outcomes after revision lumbar surgery should account for depression as a potential confounder. The Zung depression questionnaire may help risk stratify patients presenting for revision lumbar surgery., (Copyright © 2012 Elsevier Inc. All rights reserved.)
- Published
- 2012
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24. Diagnostic abilities of magnetic resonance imaging in traumatic injury to the posterior ligamentous complex: the effect of years in training.
- Author
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Crosby CG, Even JL, Song Y, Block JJ, and Devin CJ
- Subjects
- Education, Medical, Fellowships and Scholarships, Female, Humans, Internship and Residency, Ligamentum Flavum injuries, Magnetic Resonance Imaging, Male, Observer Variation, Sensitivity and Specificity, Spinal Injuries epidemiology, Clinical Competence, Ligamentum Flavum pathology, Orthopedics standards, Radiology standards, Spinal Injuries diagnosis
- Abstract
Background Context: The integrity of the posterior ligamentous complex (PLC) has been proposed to be an integral aspect in the treatment algorithm for spinal trauma. Magnetic resonance imaging (MRI) has been reported as the ideal tool to determine the integrity of the PLC. The ability to assess disruption of the PLC by reviewers of differing levels of training has not been described. In addition, the MRI sequence most suggestive of injury for each component of the PLC has not been clearly determined., Purpose: This study was designed to determine the ability of reviewers with differing levels of training (fellowship-trained spine surgeon, fellowship-trained musculoskeletal radiologist, senior orthopedic surgery resident, and junior orthopedic surgery resident) to accurately interpret the results of MRI. The secondary purpose was to evaluate the MRI sequence that was most indicative of injury to the components of the PLC., Study Design: This is a prospective radiological study comparing reviewers of MRI to determine integrity of the PLC components using intraoperative notation as the gold standard for integrity., Patient Sample: Forty-five consecutive spinal trauma patients who underwent operative fixation after obtaining MRI., Outcome Measures: No patient outcome measures were used., Methods: The sensitivity, specificity, and accuracy for each MRI reviewer in regard to MRI integrity were compared with the gold standard of intraoperative observation. In addition, the MRI sequence most suggestive of integrity of the PLC was noted by each reviewer for each component of the PLC., Results: Forty-five patients (29 men and 16 women) with traumatic spine injuries were enrolled in the study. The sensitivity and accuracy of the surgeon were 0.83 (0.66, 0.92) and 0.81 (0.70, 0.88), respectively. The sensitivity and accuracy of the attending spine surgeon were not statistically significantly different from the other reviewers (p value=.2317 and .2582). However, the specificity of the surgeon was statistically significantly higher than that of the other reviewers (p=.0043). In the cervical, thoracic, and lumbar spine, the reviewers reached a 93% agreement that the sagittal short-tau inversion recovery (STIR) sequences were most helpful in visualizing injury to the supraspinous ligament (SSL), interspinous ligament (ISL), ligamentum flavum (LF), and the cervical facet capsules. The reviewers attained a 95% agreement that visualization of injury to the lumbar facet capsules is most optimal in the T2 axial sequences., Conclusions: The interpretation of traumatic MRI is very sensitive and accurate regardless of years of training of the observer. The attending-level spine surgeon was statistically more specific in the evaluation of injury MRIs. The fluid-weighted STIR sagittal sequences are most useful in determining injury to the SSL, ISL, LF, and cervical facets capsules. Lumbar facet capsules are best evaluated with axial T2 MRI. The evaluation of the PLC on MRI can be accurately and efficiently interpreted by physicians at multiple levels of training, thus providing a key imaging modality in determining stability and need for stabilization., (Copyright © 2011 Elsevier Inc. All rights reserved.)
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- 2011
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25. Cost-effectiveness of multilevel hemilaminectomy for lumbar stenosis-associated radiculopathy.
- Author
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Parker SL, Fulchiero EC, Davis BJ, Adogwa O, Aaronson OS, Cheng JS, Devin CJ, and McGirt MJ
- Subjects
- Cost-Benefit Analysis, Decompression, Surgical economics, Female, Humans, Laminectomy methods, Lumbar Vertebrae, Male, Middle Aged, Quality of Life, Quality-Adjusted Life Years, Radiculopathy economics, Radiculopathy etiology, Radiculopathy surgery, Recovery of Function, Spinal Stenosis complications, Surveys and Questionnaires, Laminectomy economics, Outcome Assessment, Health Care economics, Spinal Stenosis economics, Spinal Stenosis surgery
- Abstract
Background Context: Laminectomy for lumbar stenosis-associated radiculopathy is associated with improvement in pain, disability, and quality of life. However, given rising health-care costs, attention has been turned to question the cost-effectiveness of lumbar decompressive procedures. The cost-effectiveness of multilevel hemilaminectomy for radiculopathy remains unclear., Purpose: To assess the comprehensive medical and societal costs of multilevel hemilaminectomy at our institution and determine its cost-effectiveness in the treatment of degenerative lumbar stenosis., Study Design: Prospective single cohort study., Patient Sample: Fifty-four consecutive patients undergoing multilevel hemilaminectomy for lumbar stenosis-associated radiculopathy after at least 6 months of failed conservative therapy were included., Outcome Measures: Self-reported measures were assessed using an outcomes questionnaire that incorporated total back-related medical resource utilization, missed work, and improvement in leg pain (visual analog scale for leg pain [VAS-LP]), disability (Oswestry Disability Index [ODI]), quality of life (Short Form-12 [SF-12]), and health state values (quality-adjusted life years [QALYs], calculated from EuroQuol 5D [EQ-5D] with US valuation)., Methods: Over a 2-year period, total back-related medical resource utilization, missed work, and improvement in leg pain (VAS-LP), disability (ODI), quality of life (SF-12), and health state values (QALYs, calculated from 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 multilevel hemilaminectomy was assessed., Results: Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in VAS-LP, ODI, and SF-12 (physical and mental components) was observed 2 years after multilevel hemilaminectomy, with a mean 2-year gain of 0.72 QALYs. Mean±standard deviation total 2-year cost of multilevel hemilaminectomy was $24,264±10,319 (surgery cost, $10,220±80.57; outpatient resource utilization cost, $3,592±3,243; and indirect cost, $10,452±9,364). Multilevel hemilaminectomy was associated with a mean 2-year cost per QALY gained of $33,700., Conclusions: Multilevel hemilaminectomy improved pain, disability, and quality of life in patients with lumbar stenosis-associated radiculopathy. Total cost per QALY gained for multilevel hemilaminectomy was $33,700 when evaluated 2 years after surgery with Medicare fees, suggesting that multilevel hemilaminectomy is a cost-effective treatment of lumbar radiculopathy., (Copyright © 2011 Elsevier Inc. All rights reserved.)
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- 2011
- Full Text
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26. Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder.
- Author
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O'Neill KR, Smith JG, Abtahi AM, Archer KR, Spengler DM, McGirt MJ, and Devin CJ
- Subjects
- Adult, Anti-Bacterial Agents administration & dosage, Female, Humans, Male, Middle Aged, Powders, Retrospective Studies, Surgical Wound Infection drug therapy, Treatment Outcome, Vancomycin administration & dosage, Anti-Bacterial Agents therapeutic use, Antibiotic Prophylaxis methods, Spinal Fusion adverse effects, Spinal Injuries surgery, Surgical Wound Infection prevention & control, Vancomycin therapeutic use
- Abstract
Background Context: Despite improvements through the use of prophylactic systemic antibiotics, surgical site infections remain a significant problem in the treatment of traumatic spine injuries. Infection rates as high as 10% have been reported in this population. The impact on patients and cost of treating such infections is profound. Local delivery of antibiotics has been found to be efficacious in animal and human studies as an adjunct to systemic antibiotics in surgical site infection prophylaxis., Purpose: To evaluate the efficacy of using vancomycin powder in surgical sites to prevent infections., Study Design: Retrospective case review., Patient Sample: Patients who underwent posterior spine fusions for traumatic injuries over a 2-year period at a single academic center., Outcome Measures: Clinical outcome determined was the incidence of either superficial or deep postoperative wound infections., Methods: A retrospective review of 110 patients with traumatic spine injuries treated with instrumented posterior spine fusions over a 2-year period at a single academic center was performed. One group (control group) received standard systemic prophylaxis only, whereas another (treatment group) received vancomycin powder in the surgical wound in addition to systemic prophylaxis. Patient demographics and perioperative information obtained included history of previous spine surgeries, substance use, diabetes, body mass index, level of injury, presence of neurologic deficit, operative time, and estimated blood loss. Incidence of infection was the primary outcome evaluated., Results: The control (N=54) and treatment groups (N=56) were statistically similar. A statistically significant difference in infection rate was found between the treatment group (0%) and control group (13%, p=.02) without any adverse events. No adverse effects were noted from use of the vancomycin powder., Conclusions: The use of vancomycin powder in surgical wounds may significantly reduce the incidence of infection in patients with traumatic spine injuries treated with instrumented posterior spine fusion. Applying vancomycin powder to surgical wounds is a promising means of preventing costly and harmful postoperative wound infections in high-risk populations., (Copyright © 2011 Elsevier Inc. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
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