129 results on '"Clinton J. Devin"'
Search Results
2. Optimal hemoglobin A1C target in diabetics undergoing elective cervical spine surgery
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Steven G. Roth, Hani Chanbour, Rishabh Gupta, Alex O'Brien, Claudia Davidson, Kristin R. Archer, Jacquelyn S. Pennings, Clinton J. Devin, Byron F. Stephens, Amir M. Abtahi, and Scott L. Zuckerman
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Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) - Published
- 2022
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
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Tyler Metcalf, Marissa Koscielski, J. Alex Sielatycki, Scott D. Hodges, S. Craig Humphreys, Jacquelyn S. Pennings, Kristin R. Archer, Robert Dunn, and Clinton J. Devin
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Adult ,musculoskeletal diseases ,medicine.medical_specialty ,medicine.medical_treatment ,Context (language use) ,Intervertebral Disc Degeneration ,03 medical and health sciences ,0302 clinical medicine ,Lumbar ,Discectomy ,Back pain ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Patient Reported Outcome Measures ,Prospective Studies ,Arthroplasty, Replacement ,Retrospective Studies ,030222 orthopedics ,Lumbar Vertebrae ,business.industry ,Minimal clinically important difference ,medicine.disease ,Spondylolisthesis ,Surgery ,Oswestry Disability Index ,Spinal Fusion ,Treatment Outcome ,Back Pain ,Facetectomy ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - 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
- Published
- 2021
4. Bouncing back after lumbar spine surgery: early postoperative resilience is associated with 12-month physical function, pain interference, social participation, and disability
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Lee H. Riley, Oran S. Aaronson, Jacquelyn S. Pennings, Christine M. Haug, Kristin R. Archer, Richard L. Skolasky, Joseph S. Cheng, Stephen T. Wegener, Clinton J. Devin, Payton E. Robinette, Rogelio A. Coronado, Brian J. Neuman, and Abigail L. Henry
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medicine.medical_specialty ,Patient-Reported Outcomes Measurement Information System ,medicine.medical_treatment ,Pain ,Context (language use) ,Disability Evaluation ,03 medical and health sciences ,0302 clinical medicine ,Back pain ,Humans ,Medicine ,Disabled Persons ,Orthopedics and Sports Medicine ,030222 orthopedics ,Lumbar Vertebrae ,Rehabilitation ,business.industry ,Social Participation ,Confidence interval ,Oswestry Disability Index ,Treatment Outcome ,Physical therapy ,Surgery ,Neurology (clinical) ,Outcomes research ,medicine.symptom ,business ,Psychosocial ,030217 neurology & neurosurgery - 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.
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- 2021
5. Why are patients dissatisfied after spine surgery when improvements in disability and pain are clinically meaningful?
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Inamullah Khan, Anthony L. Asher, Emily R. Oleisky, Steven G. Roth, Kristin R. Archer, Jacquelyn S. Pennings, Ahilan Sivaganesan, Mohamad Bydon, Clinton J. Devin, and Elizabeth R. Nolan
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medicine.medical_specialty ,medicine.medical_treatment ,Context (language use) ,Odds ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,Lumbar ,Rating scale ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Elective surgery ,Retrospective Studies ,030222 orthopedics ,Lumbar Vertebrae ,Rehabilitation ,business.industry ,Minimal clinically important difference ,Treatment Outcome ,Patient Satisfaction ,Physical therapy ,Surgery ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - 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 sub-population 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 (QOD). Patient Sample There were 32,076 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 (NASS) 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 Numerical Rating Scale) from baseline to 12-months after surgery. A generalized linear mixed model (GLMM) 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 1) 30% or greater improvement in disability only, 2) 30% or greater improvement in axial (back/neck) pain only, and 3) 30% or greater improvement in both disability and axial 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, worker's compensation claim, lower education, higher ASA grade, lumbar vs. cervical procedure, and increased axial pain, major complication within 90 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.
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- 2020
6. Using PROMIS-29 to predict Neck Disability Index (NDI) scores using a national sample of cervical spine surgery patients
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Kristin R. Archer, Clinton J. Devin, Anthony L. Asher, Robert Freitag, Claudia A. Davidson, Mohamad Bydon, Jacquelyn S. Pennings, and Inamullah Khan
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Male ,Cervical spine surgery ,medicine.medical_specialty ,Adolescent ,Context (language use) ,Correlation ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Patient Reported Outcome Measures ,Medical diagnosis ,Depression (differential diagnoses) ,Retrospective Studies ,030222 orthopedics ,Sleep disorder ,Neck Pain ,business.industry ,Middle Aged ,medicine.disease ,Cervical Vertebrae ,Physical therapy ,Anxiety ,Female ,Spinal Diseases ,Surgery ,Patient-reported outcome ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - 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.
- Published
- 2020
7. 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
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Anthony L. Asher, Sean D. Rundell, Clinton J. Devin, Inamullah Khan, Jacquelyn S. Pennings, Frank E. Harrell, Hui Nian, Mohamad Bydon, and Kristin R. Archer
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medicine.medical_specialty ,medicine.medical_treatment ,Context (language use) ,Personal Satisfaction ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,medicine ,Back pain ,Humans ,Orthopedics and Sports Medicine ,Retrospective Studies ,030222 orthopedics ,Lumbar Vertebrae ,business.industry ,Laminectomy ,Retrospective cohort study ,Prognosis ,Low back pain ,Confidence interval ,Oswestry Disability Index ,Treatment Outcome ,Patient Satisfaction ,Physical therapy ,Surgery ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - 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.
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- 2020
8. Identifying the most appropriate lumbar decompression patients for ambulatory surgery centers – A pilot study using inpatient and outpatient hospital data
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Clinton J. Devin, Nikita Lakomkin, Anthony L. Asher, Nishit Mummareddy, Scott L. Zuckerman, and Ranbir Ahluwalia
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Adult ,Data Analysis ,Male ,medicine.medical_specialty ,Decompression ,Preoperative risk ,Pilot Projects ,Logistic regression ,Neurosurgical Procedures ,Cohort Studies ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Lumbar ,Spine surgery ,Risk Factors ,Physiology (medical) ,Outpatients ,Health care ,medicine ,Humans ,Aged ,Inpatients ,business.industry ,General Medicine ,Length of Stay ,Middle Aged ,Decompression, Surgical ,Patient Discharge ,Surgery ,Hospitalization ,Ambulatory Surgical Procedures ,Neurology ,Elective Surgical Procedures ,030220 oncology & carcinogenesis ,Ambulatory ,Female ,Neurology (clinical) ,business ,Complication ,030217 neurology & neurosurgery - Abstract
To minimize healthcare related costs, ambulatory surgery centers (ASCs) have become increasingly favored venues for outpatient spine surgery. Using a national cohort of patients undergoing elective lumbar decompression (LD) in an inpatient or outpatient hospital setting, the current objectives were to: 1) outline specific factors that were associated with complications, and 2) describe potentially catastrophic complications.Adults who underwent LD between 2008 and 2014 were identified in the National Surgical Quality Improvement Program (NSQIP) database. Inclusion criteria were: principal procedure LD (CPT 63030), elective, neurologic/orthopaedic surgeons, length of stay (LOS) of 0/1 days, and discharged home. The primary outcome was presence of any complication. The secondary outcome was occurrence of potentially catastrophic complications. Univariate/multivariable logistic regression was performed.A total of 19,908 patients met the inclusion criteria. 564 (2.83%) patients experienced a complication. Cardiac intervention remained the only independent predictor of complications after multivariate testing (OR: 2.02, 95% CI: 1.00, 4.07, p = 0.049). Approximate comorbidity score cut-offs associated with2% risk of complication were: ASA ≤ 3, CCI ≤ 5, mFI ≤ 0.182. A total of 96 (0.48%) patients experienced potentially catastrophic complications.We utilized a national cohort of patients undergoing elective inpatient and outpatient LD in a hospital setting to identify preoperative risk factors for postoperative complications. Previous cardiac intervention was the sole independent predictor of complications. Although no patients treated at ASCs were studied, we believe these factors can aid in selecting patients most appropriate for ASCs and begin the process of selecting the best patients for an ambulatory setting.
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- 2020
9. Impact of occupational characteristics on return to work for employed patients after elective lumbar spine surgery
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Kristin R. Archer, Panagiotis Kerezoudis, Mohamad Bydon, Inamullah Khan, Clinton J. Devin, Anthony M. Asher, Anthony L. Asher, Kevin T Foley, Muhammad Ali Alvi, Christopher I. Shaffrey, Dan M. Spengler, Ahilan Sivaganesan, John J Knightly, and Erica F Bisson
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Adult ,Male ,medicine.medical_specialty ,Population ,Subgroup analysis ,Context (language use) ,Intervertebral Disc Degeneration ,Neurosurgical Procedures ,03 medical and health sciences ,Postoperative Complications ,Return to Work ,0302 clinical medicine ,Lumbar ,medicine ,Back pain ,Humans ,Orthopedics and Sports Medicine ,education ,Aged ,030222 orthopedics ,education.field_of_study ,Lumbar Vertebrae ,business.industry ,Middle Aged ,medicine.disease ,Low back pain ,Spondylolisthesis ,Oswestry Disability Index ,Elective Surgical Procedures ,Unemployment ,Physical therapy ,Female ,Surgery ,Neurology (clinical) ,medicine.symptom ,business ,Intervertebral Disc Displacement ,030217 neurology & neurosurgery - 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.
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- 2019
10. Utility of Anxiety/Depression Domain of EQ-5D to Define Psychological Distress in Spine Surgery
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Mohamad Bydon, Frank E. Harrell, Kristin R. Archer, Silky Chotai, Hui Nian, Anthony L. Asher, Inamullah Khan, Benjamin M. Weisenthal, and Clinton J. Devin
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Adult ,Male ,medicine.medical_specialty ,Depression scale ,Anxiety depression ,Anxiety ,Psychological Distress ,Logistic regression ,03 medical and health sciences ,0302 clinical medicine ,Spine surgery ,EQ-5D ,medicine ,Humans ,Patient Reported Outcome Measures ,Registries ,Depression (differential diagnoses) ,Aged ,Psychiatric Status Rating Scales ,Depression ,business.industry ,Psychological distress ,Middle Aged ,030220 oncology & carcinogenesis ,Preoperative Period ,Physical therapy ,Female ,Spinal Diseases ,Surgery ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Prospective patient-reported outcomes (PROs) registries are central to emerging evidence-driven reform models. These registries entail significant operator and responder burden to capture PROs data. It is important to limit the number of PROs administered. We sought to determine whether the anxiety/depression domain of EQ-5D could be used to define preoperative psychological distress in patients undergoing elective spine surgery.Patients undergoing elective spine surgery and enrolled into a prospective registry were analyzed. The 12-Item Short-Form Health Survey Mental Component Summary, Zung depression scale, Modified Somatic Perception Questionnaire, and EQ-5D were completed. The anxiety/depression domain of EQ-5D was used to define psychological distress; responses were captured as 1) not anxious or depressed, 2) moderately anxious or depressed, or 3) extremely anxious or depressed. Univariate correlation and proportional odds logistic regression analyses were conducted.Of 2470 included patients undergoing elective spine surgery, 45% (n = 1109) reported no psychological distress, 47% (n = 1168) reported moderate psychological distress, and 8% (n = 193) reported extreme psychological distress on EQ-5D. Psychological distress on EQ-5D had positive correlation with Zung depression scale (P0.0001, r = 0.620) and Modified Somatic Perception Questionnaire (P0.0001, r = 0.450) and negative correlation with 12-Item Short-Form Health Survey Mental Component Summary (P0.0001, r = -0.662). In proportional odds logistic regression models, EQ-5D psychological distress had significant correlations with 12-Item Short-Form Health Survey Mental Component Summary (P0.0001, C-index = 0.831), Zung depression scale (P0.0001, C-index = 0.802), and Modified Somatic Perception Questionnaire (P0.0001, C-index = 0.711).The anxiety/depression domain of EQ-5D could be used to categorize preoperative psychological distress. Spine registries could use this information to potentially limit the number of validated PROs administered.
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- 2019
11. Evaluation and workup in revision spine surgery
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Elliot Kim, Clinton J. Devin, Jeffrey M. Hills, and Inamullah Khan
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030222 orthopedics ,03 medical and health sciences ,medicine.medical_specialty ,0302 clinical medicine ,Spine surgery ,Strategic approach ,business.industry ,General surgery ,medicine ,Orthopedics and Sports Medicine ,Surgery ,business ,030217 neurology & neurosurgery - Abstract
The incidence of spine surgeries performed annually continues to rise and despite advances in instrumentation and surgical techniques, reoperation rates are still high. Common reasons for revision surgery include an incorrect preoperative diagnosis, technical error, complications of procedure or implants, or a poor surgical candidate for the index procedure. Identifying the source of symptoms can present a diagnostic challenge and requires a careful and strategic approach. Given that outcomes lessen with each subsequent spine surgery, spine surgeons must be cautious and meticulous when considering a revision spine surgery. This article will review a general diagnostic approach when evaluating a patient with persistent symptoms, along with a review of the more common indications for revision spine surgery.
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- 2019
12. Comparing different chronic preoperative opioid use definitions on outcomes after spine surgery
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Ahilan Sivaganesan, Inamullah Khan, Jacquelyn S. Pennings, Kristin R. Archer, Emily R. Oleisky, Jeffrey M. Hills, Richard Call, and Clinton J. Devin
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Adult ,Male ,medicine.medical_specialty ,Context (language use) ,03 medical and health sciences ,0302 clinical medicine ,Spine surgery ,Internal medicine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Patient Reported Outcome Measures ,Registries ,Medical prescription ,Pain, Postoperative ,030222 orthopedics ,business.industry ,Chronic pain ,Retrospective cohort study ,Guideline ,Middle Aged ,Opioid-Related Disorders ,medicine.disease ,Drug Utilization ,Spine ,Analgesics, Opioid ,Opioid ,Elective Surgical Procedures ,Preoperative Period ,Cohort ,Female ,Surgery ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,medicine.drug - 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 R2 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.
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- 2019
13. Value based spine care: Paying for outcomes, not volume
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Kristin R. Archer, Ahilan Sivaganesan, Benjamin M. Weisenthal, Jeffrey M. Hills, Mohamad Bydon, and Clinton J. Devin
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Service (business) ,030222 orthopedics ,business.industry ,media_common.quotation_subject ,Volume (computing) ,Outcome (game theory) ,03 medical and health sciences ,0302 clinical medicine ,Value (economics) ,Health care ,Liberian dollar ,Medicine ,Orthopedics and Sports Medicine ,Surgery ,Operations management ,Quality (business) ,business ,health care economics and organizations ,030217 neurology & neurosurgery ,Reimbursement ,media_common - Abstract
Spine pathology is among the most common, most disabling, and costliest disorders in the US health care system. Traditional reimbursement models in which volume of service rather than quality is incentivized has resulted in an unsustainable rise in cost. The focus for all stakeholders is now on value-based health care. Value is determined by the outcomes achieved per dollar spent to achieve those outcomes. Clinical registries and validated outcome tools are now making it possible for all spine practitioners to define and develop value-based care. Accurate measurement of outcomes and cost and identifying outliers are essential to improving the value in spine surgery.
- Published
- 2019
14. 183. Role of psychosocial factors on the effect of physical activity on physical function in patients after lumbar spine surgery
- Author
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Jacquelyn S. Pennings, Rogelio A. Coronado, Hiral Master, Brian J. Neuman, Joseph S. Cheng, Stephen T. Wegener, Richard L. Skolasky, Clinton J. Devin, Kristin R. Archer, Oran S. Aaronson, Renan C. Castillo, and Christine M. Haug
- Subjects
Mediation (statistics) ,medicine.medical_specialty ,business.industry ,Context (language use) ,Structural equation modeling ,law.invention ,Randomized controlled trial ,law ,Standardized coefficient ,Physical therapy ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Pain catastrophizing ,Neurology (clinical) ,business ,Psychosocial ,Depression (differential diagnoses) - Abstract
BACKGROUND CONTEXT Engaging in physical activity early after lumbar spine surgery has promising effects on long-term postoperative recovery, including improved physical function. However, whether this effect is mediated through improvement in psychosocial factors is yet to be established. PURPOSE The purpose of this study was to investigate the longitudinal postoperative relationship between physical activity, psychosocial factors, and physical function in patients undergoing lumbar spine surgery. STUDY DESIGN/SETTING Secondary analysis from randomized controlled trial. PATIENT SAMPLE This study included 248 participants (mean ± SD; age=62.2±11.9 years; BMI=32.4±6.6 kg/m2 and 51% females) who underwent surgery for a degenerative lumbar spine condition. OUTCOME MEASURES Physical activity, defined as steps per day, was measured using a triaxial accelerometer (Actigraph GT3X) worn for >10 hours for >1 day(s) at 6 weeks (6wk), 6 months (6M), 12 months (12M) and 24 months (24M) following spine surgery. Physical function, measured with Patient-Reported Outcomes Measurement Information System, and psychosocial factors pain self-efficacy [Pain Self-Efficacy Questionnare], depression [Patient Health Questionnaire-9] and fear of movement [Tampa Scale for Kinesiophobia]) were assessed at preoperative visit and 6wk, 6M, 12M and 24M after surgery. METHODS Structural equation modeling (SEM) was used to analyze data and compute standardized coefficients to determine the effects of physical activity, function and psychosocial factors. Multiple imputation accounted for missing data and pooled coefficients and p-values were calculated using Rubin's approach. The mediation effect of each psychosocial factor on the effect of physical activity on physical function were computed by dividing the direct effects with the indirect effects. All SEM models controlled for age, employment, comorbidities, prior spine surgery, and preoperative pain self-efficacy, depression, fear of movement, physical function, and back and leg pain. Each SEM models was tested for model fit by assessing the established fit indexes. RESULTS The overall standardized direct effect of physical activity (ie, steps per day) on physical function ranged from 0.08 to 0.19 (p CONCLUSIONS The findings of this study support the use of early postoperative strategies to address physical activity in order to improve long-term physical function. Pain self-efficacy did not have a mediating effect while depression and fear of movement had a very small mediating effect; therefore, additional work is needed to investigate other potential mediating factors such as pain catastrophizing, resilience and exercise self-efficacy. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2021
15. P142. Rating spine surgeons: Physician rating websites versus a patient reported outcomes derived ranking
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Inamullah Khan, Kristin R. Archer, Clinton J. Devin, Byearon F. Stephens, Hui Nian, Mohamad Bydon, Ahilan Sivaganesan, Amir M. Abtahi, John J Knightly, Steven D. Glassman, JP Wanner, Scott L. Zuckerman, and Jacquelyn S. Pennings
- Subjects
medicine.medical_specialty ,business.industry ,Physical therapy ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,Ranking (information retrieval) - Published
- 2021
16. 185. A clinical model to predict postoperative improvement in subdomains of the modified Japanese Orthopedic Association Score for degenerative cervical myelopathy
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Amir M. Abtahi, Clinton J. Devin, Hunter Waddell, Kristin R. Archer, Byron F. Stephens, Hui Nian, Jacquelyn S. Pennings, Mohamad Bydon, and Inamullah Khan
- Subjects
medicine.medical_specialty ,business.industry ,Context (language use) ,medicine.disease ,Ordinal regression ,Myelopathy ,Spinal cord compression ,Orthopedic surgery ,medicine ,Physical therapy ,Anxiety ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,medicine.symptom ,Elective surgery ,business ,Depression (differential diagnoses) - Abstract
BACKGROUND CONTEXT Longstanding and progressive compression of the cervical spinal cord can lead to irreversible loss of neurologic function due to demyelination and apoptosis of oligodendrocytes. A commonly used metric to quantify the severity of cervical myelopathy is the modified Japanese Orthopedic Association (mJOA) score. The mJOA score comprises six items to assess the impact of spinal cord compression on: (1) ability to feed oneself, (2) ability to walk, (3) loss of feeling or numbness in arms, (4) loss of feeling or numbness in legs, (5) loss of feeling or numbness in body and (6) ability to urinate. PURPOSE In the present study, the primary objective was to construct a clinical prediction model for improvement of mJOA subdomains at 12 months following surgery utilizing data from a longitudinal, multicenter clinical spine registry. STUDY DESIGN/SETTING This study was conducted using data from the cervical module of the Quality Outcomes Database (QOD), a longitudinal, multicenter, prospective spine outcomes registry. PATIENT SAMPLE A total of 5,000 patients who underwent elective surgery for cervical myelopathy were enrolled into the registry and had complete 12-month follow-up. OUTCOME MEASURES mJOA subdomain scores. METHODS This study was conducted using data from the cervical module of the Quality Outcomes Database (QOD). The outcomes of interest were the subdomains or items of the mJOA at 12 months following surgery. A multivariate multivariable proportional odds ordinal regression model was developed for patients with cervical myelopathy using a latent variable approach. The latent variables were assumed to follow a multivariate logistic distribution which was constructed by univariate logistic margins and a t copula. Patient demographic, clinical, and surgery covariates as well as baseline subdomain scores were included as the independent variables. The model was internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients. RESULTS A total of 5,000 patients who underwent elective surgery for cervical myelopathy were enrolled into the registry and had complete 12-month follow-up. The mean age for the patients was 60.9 (±11.4) years and comprised of 47% (n=2,339) females. Patients had statistically significant improvement from baseline to 12-months postsurgery on all the mJOA subdomains(p CONCLUSIONS In conclusion, our study has developed and validated a clinical prediction model for improvement in mJOA scores at 12-months following surgery. Results highlight the importance of assessing preoperative numbness symptoms and walking ability as well as the modifiable variables of anxiety/depression and smoking status prior to surgery. Additional patient demographic variables to consider are age, gender, race, employment status, duration of symptoms, and presence of listhesis when counseling patients prior to surgery. This prediction model has the potential to assist surgeons, patients and families when considering surgery for cervical myelopathy and provides clinically useful information in the preoperative setting. Future steps include prospective, external validation of the predictive model in order to assess the reproducibility and clinical utility of this work. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2021
17. Drivers of Cost in Adult Thoracolumbar Spine Deformity Surgery
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Byron F. Stephens, Ahilan Sivaganesan, Inamullah Khan, Clinton J. Devin, and Silky Chotai
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Adult ,Male ,medicine.medical_specialty ,Cost effectiveness ,medicine.medical_treatment ,Patient Readmission ,Thoracic Vertebrae ,03 medical and health sciences ,0302 clinical medicine ,Health care ,Deformity ,medicine ,Humans ,Longitudinal Studies ,Prospective Studies ,Registries ,Aged ,030222 orthopedics ,Lumbar Vertebrae ,Rehabilitation ,business.industry ,Thoracolumbar spine ,Health Care Costs ,Emergency department ,Middle Aged ,Surgery ,Elective Surgical Procedures ,Cost driver ,Population study ,Female ,Spinal Diseases ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
In an era of rising health care costs, it is prudent to consider effective use of resources. Given the rapidly expanding elderly population with an anticipated increase in adult spinal deformity, identifying the significant cost drivers for the surgical management is an important step in the process of increasing sustainability and cost-effectiveness of adult spinal deformity surgery.A total of 129 patients undergoing elective spine surgery for thoraco-lumbar deformity were enrolled in a prospective longitudinal registry. Patient-reported resource use during the 3-month postoperative period, including outpatient visits, spine-related diagnostic tests, injections, emergency department room visits, rehabilitation/skilled nursing facility utilization, and use of all medications, was collected in a single-center prospective registry. Multiple linear regression analysis was conducted to find the significant patient coefficient for the cost variability.The study population showed significant improvement (P0.001) in all patient-reported outcomes including disability (Oswestry Disability Index), pain (Numeric Rating Scale for Back Pain and Numeric Rating Scale for Leg Pain), and quality of life (Euro-Qol-5D). In risk-adjusted multiple patient comorbidities including chronic obstructive pulmonary disease and diabetes, preoperative deformity diagnosis, number of levels involved, length of surgery and hospital stay, 90-day readmission and use of inpatient rehabilitation were the significant drivers of the cost.Our study demonstrates that several patient-specific, surgery-related factors, 90-day readmission and postdischarge inpatient rehabilitation use, were associated with increased cost associated with the adult deformity spine surgery.
- Published
- 2018
18. Measuring costs related to spine surgery
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Mohamad Bydon, Ahilan Sivaganesan, Benjamin M. Weisenthal, Silky Chotai, Clinton J. Devin, and Jeffery Hills
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medicine.medical_specialty ,business.industry ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Spine surgery ,Health care ,medicine ,Cost analysis ,Orthopedics and Sports Medicine ,Operations management ,030212 general & internal medicine ,business ,030217 neurology & neurosurgery - Abstract
Treatment of spinal pathology is a significant contributor to the current rise in health care spending in the United States. To maximize value, the cost of spine care must be analyzed to assess for any inefficiencies. In parallel, outcomes must be tracked to ensure that any potential cost reductions do not have a negative impact on the efficacy of treatments. This article focuses on three primary topics in spinal care. We will begin with a general review of cost analysis methods, highlight specific drivers of cost, and finally offer broad solutions to help improve the value of spine care.
- Published
- 2018
19. Effect of pre-injection opioid use on post-injection patient-reported outcomes following epidural steroid injections for radicular pain
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Silky Chotai, Clinton J. Devin, Byron J Schneider, Ahilan Sivaganesan, Aaron J. Yang, Johnny J. Wei, and Kristin R. Archer
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Adult ,Male ,medicine.medical_treatment ,Injections, Epidural ,03 medical and health sciences ,0302 clinical medicine ,Back pain ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Aged ,Neck pain ,business.industry ,Epidural steroid injection ,Minimal clinically important difference ,Odds ratio ,Middle Aged ,medicine.disease ,humanities ,Oswestry Disability Index ,Analgesics, Opioid ,Opioid ,Back Pain ,Radicular pain ,Anesthesia ,Female ,Steroids ,Surgery ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,medicine.drug - 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.
- Published
- 2018
20. Healthcare burden of osteoporosis
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Clinton J. Devin, Benjamin M. Weisenthal, Jeffrey M. Hills, Silky Chotai, and Ahilan Sivaganesan
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medicine.medical_specialty ,Medical treatment ,business.industry ,Osteoporosis ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Cost driver ,Elderly population ,Health care ,medicine ,Physical therapy ,Orthopedics and Sports Medicine ,Surgery ,030212 general & internal medicine ,business ,Intensive care medicine ,030217 neurology & neurosurgery - Abstract
Osteoporosis is responsible for a global medical and economic burden that will grow as the elderly population doubles over the next 20 years. Measuring the cost of the effects of osteoporosis on treatment of spinal disorders is important as we prioritize distribution of resources in the healthcare community. This article examines the monetary cost of osteoporotic disorders associated with spinal care, specifically compression fractures, complications of spinal fusions, and medical treatment of osteoporosis. Examining these costs will allow us to focus further research into the primary cost drivers associated with osteoporosis.
- Published
- 2018
21. Outcomes and Value in Spine Surgery
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Silky Chotai, Ahilan Sivaganesan, Jeffrey M. Hills, and Clinton J. Devin
- Subjects
030222 orthopedics ,medicine.medical_specialty ,business.industry ,Disease ,03 medical and health sciences ,0302 clinical medicine ,Spine surgery ,Intervention (counseling) ,Measure outcomes ,Health care ,Physical therapy ,medicine ,Orthopedics and Sports Medicine ,Surgery ,Operations management ,Meaning (existential) ,business ,Value (mathematics) ,health care economics and organizations ,030217 neurology & neurosurgery ,Patient factors - Abstract
Health care costs are on an unsustainable upward trajectory and spine disorders are one of the most costly disease states worldwide. Value-based care is being implemented across all medical specialties. However, the true meaning of value and how to accurately and precisely measure value poses a significant challenge. The keys to identifying and optimizing value in spine care lies at the individual patient level. Analyzing drivers of cost from all perspectives and identifying patient factors, surgeon factors, and others that lead to increased cost and cost variation is critical to make improvements in value. Equally important, is the ability to accurately measure patient outcomes. Innovative methods are being developed for measuring patient outcomes and developing evidence to guide clinical decision-making. It can no longer be acceptable to only look at population based outcomes when evaluating the value of a spine intervention, rather the factors that drive variation in outcomes in the outliers must be identified and modified. Understanding what drives cost in spine surgery, the ability to accurately measure outcomes following spine intervention, and identifying factors that drive variation in cost and outcomes is critical to improving the value of health care. These concepts are essential in order to strive toward individualized care, which will not only lead to improved benefit to the patient, but also benefit to the surgeon, the hospital, the payer, and society as a whole.
- Published
- 2017
22. 23. Outcomes of direct vs indirect decompression for lumbar spondylolisthesis: A propensity matched cohort analysis
- Author
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Amir M. Abtahi, Jacquelyn S. Pennings, Hui Nian, Clinton J. Devin, Byron F. Stephens, Hunter Waddell, Mohamad Bydon, John J Knightly, Kristin R. Archer, and Lydia J McKeithan
- Subjects
medicine.medical_specialty ,Decompression ,business.industry ,medicine.medical_treatment ,Absolute risk reduction ,Laminectomy ,Context (language use) ,Oswestry Disability Index ,Surgery ,Lumbar ,Propensity score matching ,medicine ,Back pain ,Orthopedics and Sports Medicine ,Neurology (clinical) ,medicine.symptom ,business - Abstract
BACKGROUND CONTEXT Debate persists regarding the optimal surgical strategy to treat lumbar spondylolisthesis. The recent development of novel anterior approaches (direct lateral and oblique lumbar interbody fusion) has led to a rise in the utilization of anterior lumbar interbody fusion procedural codes. These new techniques rely on indirect decompression to treat the patient's neural compression, which is criticized by proponents of direct decompressive techniques. PURPOSE To compare 3- and 12-month outcomes between patients with lumbar spondylolisthesis treated with direct decompression (DD) vs indirect decompression (ID) and interbody fusion. STUDY DESIGN/SETTING Lumbar module of the Quality Outcomes Database (QOD), a national, multicenter prospective spine registry. PATIENT SAMPLE A total of 4,163 patients underwent DD (posterior lumbar laminectomy with interbody fusion) and 86 patients underwent ID (anterior lumbar interbody fusion and posterior instrumentation/fusion without laminectomy). OUTCOME MEASURES Oswestry Disability Index (ODI), NRS-back pain, NRS-leg pain, EQ5D, satisfaction, major complication, minor complication, readmission, and return to work at 3- and 12-months postsurgery, return to OR within 30 days. METHODS Propensity scores were estimated using logistic regression with surgical procedure as the dependent variable. Independent variables included the baseline covariates that are potentially associated with outcomes. Based on the logit of estimated propensity score, DD patients were one-to-one matched to ID patients using a greedy matching strategy without replacement. Binary outcomes between ID and DD propensity score matched patients were compared using McNemar's test. The estimates of risk difference and relative risk were determined as well as 95% confidence intervals using asymptotic score methods. Continuous outcomes were compared using two sample paired t-test. RESULTS In the propensity-matched analysis, the DD and ID cohorts did not differ with respect to their 12 month postoperative improvement in ODI (p=0.262), back pain (p=0.715), leg pain (p=0.144), EQ5D (0.384), satisfaction (0.423), readmission (p=1.00), return to OR within 30 days (p=0.317), return to work (p=0.366), or minor (p=1.00) / major (p=0.480) complication rates. The ID group did demonstrate a statistically-significant lower level of improvement in achieving a 30-percent reduction in leg pain at 3-months vs the DD cohort (p=0.05, RR 0.85, 95% CI 0.7091-0.9996). CONCLUSIONS DD and ID strategies to treat lumbar spondylolisthesis were similar in terms of 12-month PRO improvement, readmission, complications, return to work and satisfaction. The ID cohort did demonstrate a statistically-significant lower reduction in leg pain at 3 months, which was not maintained at 12 months. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2021
23. 5. Impact of racial and ethnic disparities on health outcomes following cervical spine surgery
- Author
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Jacquelyn S. Pennings, Clinton J. Devin, Claudia Davdsion, Kristin R. Archer, Hiral Master, and Rogelio A. Coronado
- Subjects
education.field_of_study ,medicine.medical_specialty ,business.industry ,Population ,Ethnic group ,Context (language use) ,Odds ratio ,Logistic regression ,Confidence interval ,Quality of life ,Physical therapy ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Elective surgery ,education ,business - Abstract
BACKGROUND CONTEXT Evidence suggests that Black non-Hispanic individuals are 39% to 44% more likely to have postoperative complications and prolonged length of stay after cervical spine surgery compared to White non-Hispanics. The long-term recovery of patient-reported health outcomes after cervical spine surgery among Hispanic and other non-Hispanic minorities (ie, Asian) remains unclear. Examining the postoperative recovery trajectory of Hispanic, Asian non-Hispanic, and Black non-Hispanic populations is important for identifying whether strategies are needed to reduce outcome disparities. PURPOSE The purpose of this study was to investigate the association of race and ethnicity with patient-reported health outcomes after cervical spine surgery. STUDY DESIGN/SETTING Retrospective analysis of data from the cervical module of a national spine registry, the Quality Outcomes Database (QOD). PATIENT SAMPLE Data from 14,136 QOD participants (mean±SD; age=56.8±11.5 years; BMI=30.2±6.4 kg/m2 and 49% females) across 28 states in the Unites States who underwent elective surgery for degenerative cervical spine disease and completed 1-year follow-up were analyzed. Participants self-identified as Hispanic (n=343), non-Hispanic Black (n=1,191), Asian (n=112) or White (n=12,490). OUTCOME MEASURES Patient-reported outcome measures (PROs) were used for assessing disability (Neck Disability Index: NDI), neck and arm pain (11-point Numeric Rating Scale), and health-related quality of life (EuroQol EQ-5D) at the preoperative and 1-year time point after surgery. Minimal symptom state at 1-year was defined as achieving a score of ≤20 on NDI, and neck and arm pain scores ≤2. Satisfaction was assessed using a single item question at 1-year after surgery (NASS scale). METHODS Multivariable linear and logistic regression analyses were conducted to compute effect estimates 95% confidence interval (CI) to determine the association of racial/ethnic groups with PROs. Covariates included sociodemographic items (eg, age, sex, BMI, insurance, education, employment status), US census regions, surgical variables (eg, surgical approach, pathology), opioid use and preop PROs. Multiple imputation using predictive mean matching was used to impute missing demographic characteristics ( RESULTS Of the 14,136 participants, 48% achieved minimal symptom state at 1-year. Black non-Hispanic had 57% (odds ratio [95%CI]: 1.57 [1.37, 1.81]) and Hispanics had 31% (1.31 [1.02, 1.69]) higher odds of not achieving minimal symptom state at 1-year follow-up compared to White non-Hispanic. Similar findings for Black or Hispanics vs White groups were observed for other PROs and satisfaction. There were no differences in any outcome measures between Asian and White. CONCLUSIONS Comparatively, White and Asian groups did not have increased likelihood, but Hispanics and Black groups did have increased likelihood of reporting poor outcomes following cervical spine surgery, even after adjusting for potential confounders. The findings of this study suggest the need to account for inherent racial and ethnic disparities to better understand the recovery trajectories following cervical spine surgery. Also, strategies to minimize racial and ethnic disparities are needed to ensure equitable access to postoperative care in this surgical population. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2021
24. 287. Early postoperative physical activity predicts clinical improvement in disability 1 year following spine surgery
- Author
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Kristin R. Archer, Oran S. Aaronson, Lee H. Riley, Richard L. Skolasky, Hiral Master, Christine M. Haug, Jacquelyn S. Pennings, Brian J. Neuman, Rogelio A. Coronado, Payton E. Robinette, Joseph S. Cheng, Stephen T. Wegener, and Clinton J. Devin
- Subjects
medicine.medical_specialty ,Receiver operating characteristic ,business.industry ,Physical activity ,Context (language use) ,Logistic regression ,Oswestry Disability Index ,law.invention ,Randomized controlled trial ,law ,Physical therapy ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Elective surgery ,business ,Body mass index - Abstract
BACKGROUND CONTEXT Walking at least 4,500 steps/day or engaging in at least 60 minutes of moderate-to-vigorous physical activity/week are known to provide multiple health benefits and prevent disability in adults with and without musculoskeletal pain. However, little is known about the impact of physical activity on outcomes following spine surgery. PURPOSE The primary objective of this study was to determine whether early postoperative physical activity is associated with clinically meaningful improvement in disability in patients undergoing spine surgery. A secondary objective was to investigate the physical activity threshold that best discriminates improvement in disability at one year following spine surgery. STUDY DESIGN/SETTING Secondary analysis of randomized controlled trial data. PATIENT SAMPLE A total of 248 participants undergoing elective surgery for a degenerative lumbar spine condition. OUTCOME MEASURES Clinically meaningful improvement in disability was considered a 30% reduction in Oswestry Disability Index (ODI) scores from baseline (6 weeks after surgery) to 1-year follow-up. METHODS Physical activity was measured using an accelerometer (Actigraph GT3X) worn for at least 10 hours/day for at least 3 days at 6-weeks following spine surgery. Physical activity was quantified as steps/day and time spent in moderate-to-vigorous physical activity (ie, at least 2,020 counts/minute). Multivariable logistic regression analysis was conducted to determine the association between steps/day at 6 weeks and clinically meaningful improvement in disability at 1 year, controlling for age, body mass index (BMI), education, race, sex, previous surgery, spinal procedure, baseline ODI score, and back and leg pain. Receiver operating characteristic curves were used to identify steps/day and moderate-to-vigorous physical activity/week that best discriminated the likelihood of achieving clinical improvement. RESULTS Of 248 participants, 216 participants (mean [SD]; age= 63[11] years, BMI= 32[7] kg/m2, 52% female) had physical activity for at least 3 valid days. Of 216 patients, 43% (n=93) achieved clinical improvement in ODI at 1-year following spine surgery. Each additional 1000 steps/day and additional 1 minute of moderate-to-vigorous physical activity/day were associated with 27% (OR=1.27, 95% CI=1.07, 1.51) and 4% (OR=1.04, 95% CI=1.01, 1.08) higher odds of achieving clinically meaningful improvement in ODI, respectively. At 6 weeks following spine surgery, walking less than 3000 steps/day (sensitivity = 68%, specificity = 52%) was associated with 66% (OR=0.34, 95% CI=0.16, 0.69) lower odds of achieving clinical improvement in disability compared to those who walked at least 3000 steps/day. In addition, engaging in less than 21 minutes of moderate-to-vigorous physical activity/week (sensitivity = 62%, specificity = 48%) was associated with a 46% (OR=0.54, 95% CI=0.29, 1.02) lower odds of achieving clinical improvement in disability at 1-year postoperative compared to those who engaged in at least 21 minutes of moderate-to-vigorous physical activity/week. CONCLUSIONS Walking at least 3,000 steps/day or engaging in at least 21 minutes of moderate-to-vigorous physical activity/week may serve as an initial recommendation for patients early after spine surgery. Results suggest that these early postoperative thresholds may optimize clinical improvement in disability at 1 year following spine surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2020
25. Effect of obesity on cost per quality-adjusted life years gained following anterior cervical discectomy and fusion in elective degenerative pathology
- Author
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J. Alex Sielatycki, Harrison L. Kay, Ahilan Sivaganesan, Scott L. Parker, David P. Stonko, Joseph B. Wick, Clinton J. Devin, Silky Chotai, and Matthew J. McGirt
- Subjects
Adult ,Male ,medicine.medical_specialty ,Cost effectiveness ,Cost-Benefit Analysis ,Subgroup analysis ,Anterior cervical discectomy and fusion ,Intervertebral Disc Degeneration ,03 medical and health sciences ,Indirect costs ,0302 clinical medicine ,Quality of life ,medicine ,Humans ,Orthopedics and Sports Medicine ,health care economics and organizations ,Aged ,030222 orthopedics ,Neck pain ,Lumbar Vertebrae ,business.industry ,Middle Aged ,Obesity, Morbid ,Quality-adjusted life year ,Spinal Fusion ,Cervical Vertebrae ,Quality of Life ,Physical therapy ,Female ,Surgery ,Quality-Adjusted Life Years ,Neurology (clinical) ,medicine.symptom ,business ,Body mass index ,030217 neurology & neurosurgery ,Diskectomy - Abstract
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.The aim of the present study was to determine cost-utility following anterior cervical discectomy and fusion (ACDF) in obese patients.This study analyzed prospectively collected data.Patients undergoing elective ACDF for degenerative cervical pathology at a single academic institution were included in the study.Cost and quality-adjusted life years (QALYs) were the outcome measures.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).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.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.
- Published
- 2016
26. Predictors of the efficacy of epidural steroid injections for structural lumbar degenerative pathology
- Author
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Matthew J. McGirt, Ahilan Sivaganesan, Anthony L. Asher, Silky Chotai, Scott L. Parker, and Clinton J. Devin
- Subjects
Adult ,Male ,Pathology ,medicine.medical_specialty ,medicine.medical_treatment ,Injections, Epidural ,03 medical and health sciences ,0302 clinical medicine ,Lumbar ,030202 anesthesiology ,Back pain ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Prospective Studies ,Prospective cohort study ,Aged ,business.industry ,Epidural steroid injection ,Minimal clinically important difference ,Area under the curve ,Middle Aged ,medicine.disease ,humanities ,Oswestry Disability Index ,Stenosis ,Treatment Outcome ,Back Pain ,Physical therapy ,Female ,Steroids ,Surgery ,Neurology (clinical) ,medicine.symptom ,business ,Intervertebral Disc Displacement ,030217 neurology & neurosurgery - 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.
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- 2016
27. 249. A novel posterior total joint replacement for the lumbar spine as an alternative to fusion: pilot data for the first 84 patients
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Scott D. Hodges, Tyler Metcalf, John A. Sielatycki, Jacquelyn S. Pennings, Robert Dunn, Marissa Koscielski, Steven C. Humphreys, and Clinton J. Devin
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medicine.medical_specialty ,business.industry ,Decompression ,Visual analogue scale ,medicine.medical_treatment ,Context (language use) ,medicine.disease ,Oswestry Disability Index ,Degenerative disc disease ,Surgery ,Lumbar ,Discectomy ,Facetectomy ,Medicine ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business - Abstract
BACKGROUND CONTEXT Effective alternatives to degenerative lumbar fusion have remained elusive. Fusion frequently results in adjacent level disease, reoperation, poor outcomes, and high costs. Anterior total disc replacement (TDR) does not address facet pathology or neural compression; thus, indications are limited. There is a need for a posterior-based motion-sparing option that allows for neural decompression, facetectomy, and disc replacement. PURPOSE To present the pilot data for the first 84 patients undergoing posterior lumbar total joint replacement for common degenerative conditions. STUDY DESIGN/SETTING Prospective case series. PATIENT SAMPLE Adult patients (age 18-79 years) with degenerative lumbar pathology were treated. Diagnoses included: degenerative spondylolisthesis, recurrent disc herniation, degenerative disc disease, foraminal stenosis, and central lumbar stenosis. Tumor, trauma, and infection cases were excluded. OUTCOME MEASURES Oswestry Disability Index (ODI), visual analogue scale (VAS) for back and leg pain, and opioid use. METHODS The implant is a motion-sparing lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral trans-foraminal (TLIF) approach with complete facetectomies. For this IRB-approved pilot study, 84 adult patients (mean age 52.49) with degenerative lumbar pathology were treated. Diagnoses included: degenerative spondylolisthesis, recurrent disc herniation, degenerative disc disease, foraminal stenosis, and central lumbar stenosis. Tumor, trauma, and infection cases were excluded. ODI, VAS for back and leg pain, and opioid use were collected at baseline, 3 months, 6 months, and 1 year, with radiographs obtained at each time point. To date, follow up data is available for 70 patients at 3 months, 54 at 6 months, and 38 patients at 1 year. RESULTS A total of 125 levels were treated: L4-5 (57), L5-S1 (41), L3-4 (22), L2-3 (4), and L1-2 (1). Forty-seven patients had one level, 33 had two levels, and four patients had three levels treated. ODI improved significantly at each time interval following surgery (46.58 preop, 23.91 at 3 months, 18.87 at 6 months, and 13.80 at 1 year). VAS back and leg pain (calculated as the highest reported VAS score multiplied by the frequency of that pain level) also improved at each time point, from an average value of 51.59 at baseline to 17.40 at 3 months, 13.64 at 6 months, and 11.39 at 1 year. Minimal symptom state (ODI ≤ 20 and VAS back and leg pain ≤ 20) was maintained by 18 out of 27 one-level patients (67%), and by 7 out of 10 two-level patients (70%) at 1 year. Opioid usage was CONCLUSIONS Here we present pilot data for the first 84 patients undergoing a novel, posterior-based total joint replacement for the lumbar spine using a TLIF approach with complete facetectomies. The approach 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. ODI and VAS back/leg pain scores improved significantly at each time interval following surgery. At 1 year, a high percentage (66%) of patients have maintained a minimal symptom state, which is a significant improvement compared with the fusion literature where a recent study reported 18% of 396 patients maintained a minimal symptom state after 1 year following fusion. The greatest theoretical benefit of this device is preservation of lumbar motion segments resulting in more physiologic lumbar motion and the potential to decrease the risk for adjacent segment disease. Ongoing long-term follow-up is underway to evaluate the durability of this procedure and the impact on adjacent segments. FDA DEVICE/DRUG STATUS 3Spine BalancedBack Lumbar Joint Replacement (Investigational/Not approved)
- Published
- 2020
28. 57. Resilience and self-efficacy are protective psychological factors for 12-month outcomes after lumbar spine surgery
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Jacquelyn S. Pennings, Joseph S. Cheng, Stephen T. Wegener, Clinton J. Devin, Christine M. Haug, Oran S. Aaronson, Richard L. Skolasky, Kristin R. Archer, Abigail L. Henry, Susan W. Vanston, Brian J. Neuman, Lee H. Riley, and Rogelio A. Coronado
- Subjects
Self-efficacy ,030222 orthopedics ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,Protective factor ,Context (language use) ,law.invention ,Oswestry Disability Index ,03 medical and health sciences ,0302 clinical medicine ,Lumbar ,Randomized controlled trial ,law ,Physical therapy ,Back pain ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Psychological resilience ,medicine.symptom ,business ,030217 neurology & neurosurgery ,media_common - Abstract
BACKGROUND CONTEXT Psychological factors such as fear of movement negatively influence outcomes after lumbar spine surgery. Positive psychological factors like resilience and self-efficacy are considered potential protective factors that can promote recovery. PURPOSE The purpose of this study was to examine the influence of early postoperative resilience and self-efficacy on 12-month physical function, disability, pain, and physical activity after lumbar spine surgery. STUDY DESIGN/SETTING Secondary analysis of prospectively-collected data from a randomized controlled trial. PATIENT SAMPLE A total of 248 patients (mean (SD) age=62.2 (11.9) years; 51% female) who underwent laminectomy with or without fusion for a degenerative lumbar condition. OUTCOME MEASURES The primary outcomes for this study were physical function (PROMIS Physical Function), disability (Oswestry Disability Index), pain interference (PROMIS Pain Interference), back pain intensity (Numeric Rating Scale), and physical activity (acceleromoter activity counts). METHODS This was a secondary analysis of data from a multisite randomized trial comparing a postoperative cognitive-behavioral physical therapy (n=124) and education program (n=124). The primary results of the trial showed no difference in 12-month outcomes in intent-to-treat analyses. Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery. Positive psychological factors measured at baseline were resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). To determine the influence of each factor independently, separate multivariable regressions (semi-partial r) were conducted for each outcome and psychological factor. Covariates in analyses included baseline outcome score, age, sex, study site, randomized group, fusion status, and fear of movement. A combined multivariable regression model was conducted for determining the most influential positive psychological factor. RESULTS In independent multivariable models, resilience was associated with 12-month physical function (r=0.19, p=0.001), disability (r=-0.14, p=0.009), pain interference (r=-0.16, p=0.006), back pain intensity (r=-0.14, p=0.02), and physical activity (r=0.12, p=0.01). Self-efficacy was associated with 12-month physical function (r=0.17, p=0.002), disability (r=-0.15, p=0.003), pain interference (r=-0.14, p = 0.01), and back pain intensity (r=-0.12, p=0.03). For both resilience and self-efficacy, higher levels were associated with higher physical function and lower disability and pain. In the combined multivariable model, only resilience was associated with 12-month physical function (r=0.12, p=0.02) and pain interference (r=-0.12, p=0.04). Both resilience (r=-0.10, p=0.05) and self-efficacy (r=-0.15, p=0.02) were associated with disability, with self-efficacy being the stronger predictor. CONCLUSIONS Early postoperative resilience and self-efficacy are consistently associated with pain-related outcomes after lumbar spine surgery, even after controlling for covariates including baseline outcome and fear of movement. When considered in a single model, resilience was the only protective factor associated with physical function and pain interference, while self-efficacy was the stronger protective factor for disability. Future work should consider how multidimensional screening tools that consider negative and positive psychological factors can enhance prognosis and treatment decision-making in patients undergoing spine surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
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- 2019
29. 83. Postoperative opioids and 1-year outcomes after spine surgery
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Jacquelyn S. Pennings, Catherine Carlile, Kristin R. Archer, Jeffrey M. Hills, and Clinton J. Devin
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medicine.medical_specialty ,business.industry ,Context (language use) ,Odds ratio ,Confidence interval ,Oswestry Disability Index ,Opioid ,Quality of life ,Internal medicine ,Medicine ,Anxiety ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,medicine.symptom ,business ,Depression (differential diagnoses) ,medicine.drug - Abstract
BACKGROUND CONTEXT Opioid use prior to spine surgery has been associated with worse patient-reported outcomes, complications, and sustained postoperative opioid use. However, studies thus far have not assessed the relationship between opioid use in the initial postoperative period with long-term clinical outcomes and chronic postoperative opioid use. PURPOSE Determine if longer duration and higher opioid dosage in the months following spine surgery is associated with 1-year patient-reported outcomes and chronic opioid use at 1 year. STUDY DESIGN/SETTING Using data from our prospective clinical spine registry linked with opioid prescription data from our state's prescription drug monitoring program, we conducted a longitudinal cohort study. PATIENT SAMPLE Patients undergoing elective lumbar or cervical spine surgery at a single academic center from January 2011 to February 2017, and living in the surgical institution's state. OUTCOME MEASURES Primary outcomes were meaningful improvements at 1 year (>30% from baseline) in axial and extremity pain (Numeric Rating Scale [NRS]), disability (Oswestry Disability Index [ODI] & Neck Disability Index [NDI]), quality of life (Euro-Qol 5D [EQ-5D]), satisfaction (North American Spine Society Satisfaction); and chronic opioid use at 1 year after surgery. METHODS The state database was queried to record the dosage (morphine milligram equivalents [MME]) and duration of every opioid prescription filled in the year before and after surgery to calculate the daily MME. The main exposure variables for this study were postoperative opioid use duration (classified as brief [ 60 MME/day) or low dosage. Multivariable logistic regression was used to identify associations between postoperative duration, and high-postoperative dosage with each outcome. Covariates were chosen a priori and included age, sex, race, smoking history, arthritis, anxiety, depression, insurance, symptom duration, ASA class, procedure, revision surgery, number of levels, preoperative pain and disability scores, and preoperative chronic opioid use. Adjusted odds ratios (aOR) with 95% confidence intervals (95% CI) were computed for the odds of a poor outcome associated with intermediate postoperative opioid use duration; and high-postoperative dosage. P-value RESULTS A total 2128 patients were included, with an overall 1-year satisfaction rate of 82%. Compared to patients with CONCLUSIONS In a risk-adjusted analysis of patients undergoing elective spine surgery, an active opioid prescription beyond 30 days was associated with significantly worse 1-year clinical outcomes and chronic opioid use. When considered in conjunction with the known dangers of opioids, our results can be used to develop postoperative opioid protocols to improve outcomes and minimize opioid dependence after spine surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2019
30. 233. Does postoperative physical therapy improve patient-reported outcomes at one-year following cervical spine surgery?
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Jacquelyn S. Pennings, Emily R. Oleisky, Daniel R. Verhotz, Rogelio A. Coronado, Kristin R. Archer, Inamullah Khan, JP Wanner, Ahilan Sivaganesan, and Clinton J. Devin
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medicine.medical_specialty ,Rehabilitation ,business.industry ,medicine.medical_treatment ,Minimal clinically important difference ,Laminectomy ,Anterior cervical discectomy and fusion ,Context (language use) ,Quality of life ,medicine ,Physical therapy ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,Body mass index ,Depression (differential diagnoses) - Abstract
BACKGROUND CONTEXT Pain and disability can persist after spinal surgery for which physical therapy (PT) is commonly prescribed. Currently, there is limited evidence to support the effectiveness of postoperative PT following cervical spine surgery. PURPOSE The purpose of this study was to examine the association between attending outpatient PT during the postoperative period and patient-reported outcomes at 1 year following cervical spine surgery. STUDY DESIGN/SETTING Retrospective evaluation of prospectively collected data from a single-center, spine registry. PATIENT SAMPLE A total of 767 participants undergoing anterior cervical discectomy and fusion (ACDF) or posterior laminectomy with or without fusion for a degenerative condition. OUTCOME MEASURES The primary outcomes for this study were disability (Neck Disability Index: NDI), quality of life (EQ-5D), and neck and arm pain (11-point Numeric Rating Scale: NRS). METHODS Participants were enrolled into a spine registry prior to surgery and completed a preoperative assessment. Follow-up assessments occurred at 3 months and 1 year after surgery. A categorical variable to describe PT over the 1-year period was created (No PT [reference], PT 0-3 months only, PT 0-3 and 3-12 months, PT 3-12 months only). Linear mixed-effects models were used to examine the effect of PT group on outcomes over time (3 months and 1 year). All analyses controlled for preoperative outcome scores, time, age, gender, race, smoking status, insurance type, body mass index, ambulation status, comorbidities, duration of symptoms, surgery type, revision, discharge status, number of levels, ASA grade and preoperative depression/anxiety and narcotic use. Significance was set at p RESULTS Over the 1-year period, 351 patients had no PT (46%), 193 had PT from 0-3 months only (25%), 138 had PT from 0-3 and 3-12 months (18%), and 85 had PT from 3-12 months only (11%). The mixed-effects models found no significant relationship between PT 0-3 months only and all patient-reported outcomes at 1-year compared to the No PT group (p > .05). Patients who had PT between 3-12 months only had NDI scores 5.8-points higher, EQ-5D scores 0.03-points lower, and neck and arm pain scores 0.98-points and 0.68-points higher than the No PT group (p CONCLUSIONS Results from a retrospective multivariable analysis suggest that there is no difference in 1-year patient-reported outcomes between patients who utilize PT during the first 3 months only and patients who have No PT after cervical spine surgery. However, attending postoperative PT later in recovery, between 3 and 12 months, appears to result in increased disability and pain at 1-year after surgery, after accounting for patient and clinical characteristics. While the differences between groups are statistically significant, they do not appear to be clinically significant based on established MCID values. Overall, results suggest that attending PT after surgery may not lead to improved patient-reported outcomes compared to No PT. Additional research is needed to determine subgroups of patients who might benefit from traditional PT or alternative rehabilitation approaches that are informed by a biopsychosocial model. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
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- 2019
31. 45. Trajectory of change in mJOA score within one year following surgery for degenerative cervical myelopathy
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Jacquelyn S. Pennings, Mohamad Bydon, JP Wanner, Inamullah Khan, Ahilan Sivaganesan, Clinton J. Devin, and Kristin R. Archer
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medicine.medical_specialty ,business.industry ,Context (language use) ,Cervical cord compression ,medicine.disease ,Surgery ,Natural history ,Myelopathy ,Orthopedic surgery ,medicine ,Orthopedics and Sports Medicine ,In patient ,Neurology (clinical) ,Elective surgery ,business ,Progressive disease - Abstract
BACKGROUND CONTEXT Degenerative cervical myelopathy (DCM) is a progressive disease resulting from cervical cord compression. The natural progression of DCM is variable; some patients experience periods of stability, while others rapidly deteriorate following disease onset. The majority of these patients require surgical decompression to halt disease progression and improve functionality. The modified Japanese Orthopedic Association (mJOA) is a patient-reported questionnaire commonly used to grade symptoms and is a validated tool for assessment of postoperative improvement in the surgical management of cervical myelopathy. However, literature describing the natural history of recovery following surgical decompression is limited, especially in the postsurgical period of 3 to 12 months. PURPOSE The aim of the study is to assess the trajectory of mJOA improvement in the postsurgical period of 3 to 12 months in patients who underwent surgery for cervical myelopathy. STUDY DESIGN/SETTING This study is a retrospective analysis of prospectively collected data from the cervical module of a national spine registry, the Quality Outcomes Database (QOD). PATIENT SAMPLE A total of 2,156 patients who underwent elective surgery for DCM and had complete 3- and 12-month follow-up data in the QOD registry were included in the study. OUTCOME MEASURES The mJOA score was used to define severity of myelopathic symptoms in patients who underwent surgery for cervical myelopathy. METHODS Patients were divided into mild (≥14), moderate (9-13), or severe ( RESULTS Patients improved significantly from baseline to 3 months on their mJOA scores, regardless of their baseline mJOA severity. Four hundred five (18.8%) showed improvement during the time period of 3- to 12-month postsurgical follow-up. After adjusting for the relevant baseline patient and surgery specific characteristics, the baseline mJOA categories had significant impact on whether a patient improves by 2 points in mJOA score from 3- to 12-month postsurgery (75.49% of the total Wald X2, p CONCLUSIONS In the surgical management of cervical myelopathy, most patients achieve improvement on a shorter follow-up; however, patients with severe symptoms keep improving until after a longer follow-up. Preoperative identification of such patients helps the clinician with setting realistic expectations for each follow-up time point. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2019
32. 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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Priya Sivasubramaniam, Akshitkumar M. Mistry, Stephen K. Mendenhall, Ahilan Sivaganesan, Matthew J. McGirt, and Clinton J. Devin
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Adult ,Male ,medicine.medical_specialty ,Pediatrics ,Adolescent ,Joint Dislocations ,Context (language use) ,Trauma Centers ,Quality of life ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Joint dislocation ,Aged ,business.industry ,Incidence (epidemiology) ,Trauma center ,Glasgow Coma Scale ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Surgery ,Atlanto-Occipital Joint ,Spinal Fusion ,Spinal Injuries ,Injury Severity Score ,Female ,Neurology (clinical) ,business - 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.
- Published
- 2015
33. Pain Sensitivity and Pain Catastrophizing Are Associated With Persistent Pain and Disability After Lumbar Spine Surgery
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Kristin R. Archer, Stephen T. Wegener, Clinton J. Devin, Steven Z. George, and Rogelio A. Coronado
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Male ,Pain Threshold ,musculoskeletal diseases ,medicine.medical_specialty ,Physical Therapy, Sports Therapy and Rehabilitation ,Article ,Disability Evaluation ,Spinal Stenosis ,Risk Factors ,Lumbar spine surgery ,medicine ,Humans ,Prospective Studies ,Aged ,Pain Measurement ,Pain, Postoperative ,Referred pain ,Catastrophization ,Persistent pain ,Rehabilitation ,Middle Aged ,Anesthesia ,Physical therapy ,Female ,Pain catastrophizing ,Psychology ,Low Back Pain - Abstract
To examine whether pain sensitivity and pain catastrophizing are associated with persistent pain and disability after lumbar spine surgery.Prospective observational cohort study.Academic medical center.Patients (N=68; mean age, 57.9±13.1y; 40 women [58.8%]) undergoing spine surgery for a degenerative condition from March 1, 2012 to April 30, 2013 were assessed 6 weeks, 3 months, and 6 months after surgery.Not applicable.The main outcome measures were persistent back pain intensity, pain interference, and disability. Patients with persistent back pain intensity, pain interference, or disability were identified as those patients reporting Brief Pain Inventory scores ≥4 and Oswestry Disability Index scores ≥21 at all postoperative time points.From 6 weeks to 6 months after surgery, approximately 12.9%, 24.2%, and 46.8% of patients reported persistent back pain intensity, pain interference, or disability, respectively. Increased pain sensitivity at 6 weeks was associated with having persistent back pain intensity (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.0-4.1) after surgery. Increased pain catastrophizing at 6 weeks was associated with having persistent back pain intensity (OR, 1.1; 95% CI, 1.0-1.2), pain interference (OR, 1.1; 95% CI, 1.0-1.2), and disability (OR, 1.3; 95% CI, 1.1-1.4). An interaction effect was not found between pain sensitivity and pain catastrophizing on persistent outcomes (P.05).The findings suggest the importance of early postoperative screening for pain sensitivity and pain catastrophizing to identify patients at risk for poor postoperative pain intensity, pain interference, and/or disability outcomes. Future research should consider the benefit of targeted therapeutic strategies for patients with these postoperative prognostic factors.
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- 2015
34. Best evidence in multimodal pain management in spine surgery and means of assessing postoperative pain and functional outcomes
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Clinton J. Devin and Matthew J. McGirt
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medicine.medical_specialty ,Narcotic ,medicine.medical_treatment ,MEDLINE ,Neuraxial blockade ,Physiology (medical) ,medicine ,Animals ,Humans ,Pain Management ,Ketamine ,Acetaminophen ,Analgesics ,Pain, Postoperative ,business.industry ,Anti-Inflammatory Agents, Non-Steroidal ,Multimodal therapy ,General Medicine ,Evidence-based medicine ,Perioperative ,Guideline ,Combined Modality Therapy ,Analgesics, Opioid ,Treatment Outcome ,Neurology ,Physical therapy ,Drug Therapy, Combination ,Spinal Diseases ,Surgery ,Neurology (clinical) ,business ,medicine.drug - Abstract
Multimodal approaches to pain management have arisen with the goal of improving postoperative pain and reducing opioid analgesic use. We performed a comprehensive literature review to determine grades of recommendation for commonly used agents in multimodal pain management and provide a best practice guideline. To evaluate common drugs used in multimodal treatment of pain, a search was performed on English language publications on Medline (PubMed; National Library of Medicine, Bethesda, MD, USA). Manuscripts were rated as Level I-V according to the North American Spine Society's (NASS) standardized levels of evidence tables. Grades of recommendation were assigned for each drug based on the NASS Clinical Guidelines for Multidisciplinary Spine Care. There is good (Grade A) evidence gabapentinoids, acetaminophen, neuraxial blockade and extended-release local anesthetics reduce postoperative pain and narcotic requirements. There is fair (Grade B) evidence that preemptive analgesia and nonsteroidal anti-inflammatory drugs (NSAID) result in reduced postoperative pain. There is insufficient and/or conflicting (Grade I) evidence that muscle relaxants and ketamine provide a significant reduction in postoperative pain or narcotic usage. There is fair (Grade B) evidence that short-term use of NSAID result in no long-term reduction in bone healing or fusion rates. Comprehensive assessment of the effectiveness of perioperative pain control can be accomplished through the use of validated measures. Multimodal pain management protocols have consistently been demonstrated to allow for improved pain control with less reliance on opioids. There is good quality evidence that supports many of the common agents utilized in multimodal therapy, however, there is a lack of evidence regarding optimal postoperative protocols or pathways.
- Published
- 2015
35. Thursday, September 27, 2018 1:05 PM–2:05 PM Understanding Anxiety and Depression when Performing Spine Surgery
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Rogelio A. Coronado, Lee H. Riley, Susan W. Vanston, Joseph S. Cheng, Richard L. Skolasky, Oran S. Aaronson, Jacquelyn S. Pennings, Stephen T. Wegener, Clinton J. Devin, Brian J. Neuman, Christine M. Haug, and Kristin R. Archer
- Subjects
030222 orthopedics ,medicine.medical_specialty ,Rehabilitation ,business.industry ,medicine.medical_treatment ,Context (language use) ,Oswestry Disability Index ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Multicenter trial ,Physical therapy ,Medicine ,Anxiety ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Brief Pain Inventory ,medicine.symptom ,business ,Psychosocial ,030217 neurology & neurosurgery - Abstract
BACKGROUND CONTEXT Studies have found that patient psychosocial characteristics are strongly related to surgical spine outcomes. Limited evidence exists on the potential benefit of physical therapist-delivered cognitive-behavioral therapy (CBT) treatments for patients following lumbar spine surgery. PURPOSE The purpose was to compare which of two treatments delivered by telephone – a CBT-based physical therapy program (CBPT) or an education program – are more effective for improving patient-centered outcomes after lumbar spine surgery. STUDY DESIGN/SETTING Randomized controlled clinical trial at two medical centers (NCT02184143). PATIENT SAMPLE A total of 248 patients undergoing surgery for a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy and degenerative spondylolisthesis) using laminectomy with or without arthrodesis were randomized into CBPT (n=124) or an attention-control education group (n=124). OUTCOME MEASURES Patient-reported outcomes were disability (Oswestry Disability Index [ODI]), pain intensity (Brief Pain Inventory), and physical and mental health (SF-12). Observed physical activity was assessed using accelerometers. Health care utilization was also recorded. METHODS Patient assessments occurred preoperatively and at 6 weeks (baseline) and 6 and 12 months after surgery. Assessors and patients were unaware of the treatment condition. Patients were randomized at baseline using a stratified design based on age and type of surgery. Six treatment sessions were delivered by a physical therapist over the telephone. The CBPT intervention focused on walking and functional goal setting, relaxation techniques, symptom management through problem solving, and replacing negative thoughts about activity with positive ones. Analyses were intent-to-treat using multivariable regression models that adjusted for the outcome at baseline, age, study site, depressive symptoms, and type of surgical procedure. Missing data were handled with multiple imputation. The level of significance was set at α=0.05. RESULTS Follow-up rate at 12 months was 93% and 88% for patient-reported outcomes and physical activity, respectively. CBPT participants were 69% less likely to have a rehospitalization compared to education participants between 6 weeks and 12 months after surgery (p=.02). Statistically significant differences across groups were also noted for disability and physical health, but only for those completing all six sessions of the CBPT treatment. CBPT participants had an ODI score 4.3-points lower [95%CI, −8.5 to −0.03] and a SF-12 physical health score 3.2-points higher [95%CI, 0.16 to 6.3] than the education group at 12 months (p CONCLUSIONS Results from a multicenter trial found that a physical therapist-delivered cognitive-behavioral intervention reduced the odds of rehospitalization and improved disability and physical health in patients who completed the 6-session program. Older adults were more likely to benefit from the CBPT treatment in terms of increased physical activity. Telephone delivery appears to be an effective platform for incorporating CBT-based strategies into rehabilitation. Future work is needed to determine how to implement the CBPT approach in a typical clinic setting. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2018
36. P139. Clinically relevant percent reduction (CRPR): a new definition of clinically significant change for lumbar spine surgery
- Author
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Clinton J. Devin, Anthony L. Asher, Ahilan Sivaganesan, Jacquelyn S. Pennings, Anthony M. Asher, Kristin R. Archer, Inamullah Khan, and Mohamad Bydon
- Subjects
medicine.medical_specialty ,business.industry ,Minimal clinically important difference ,Context (language use) ,medicine.disease ,humanities ,Spondylolisthesis ,Pseudarthrosis ,Stenosis ,Lumbar ,medicine ,Physical therapy ,Surgery ,Orthopedics and Sports Medicine ,Clinical significance ,Neurology (clinical) ,Elective surgery ,business - Abstract
BACKGROUND CONTEXT Minimal clinically important difference (MCID) represents the smallest, clinically relevant change in a patient-reported outcome (PRO) score. However, the literature suggests that an absolute change from baseline may not be a reliable marker of response to treatment for patients with a low or high baseline PRO score. An alternative to MCID is a threshold of clinical relevance defined by percent reduction from baseline PRO score. PURPOSE The purpose of this study was to determine whether a clinically relevant percent reduction (CRPR) of 30% in disability and pain scores is a valid method for determining clinical improvement at 12 months after lumbar spine surgery. STUDY DESIGN/SETTING Retrospective evaluation of prospectively collected data from a national surgical spine registry, the Quality Outcomes Database (QOD). PATIENT SAMPLE A total of 23,280 participants undergoing elective surgery for a lumbar degenerative condition (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). OUTCOME MEASURES Outcomes were disability (ODI), back and leg pain (NRS-BP/LP), and satisfaction (NASS scale). METHODS Participants completed a preoperative assessment and follow-up assessment at 1-year. The change in ODI and NRS-BP/LP scores were categorized as met CRPR (percent change ≥30%) or not met CRPR (percent change RESULTS Results from the satisfaction prediction models found that the OR for 30% ODI CRPR was 11.1 (10.2 to 12.1) and for ODI MCID was 7.8 (7.2 to 8.4), while 30% NRS-BP and NRS-LP CRPR was 7.9 (7.3 to 8.5) and 6.7 (6.2 to 7.2) compared to MCID ORs of 5.5 (5.1 to 5.9) and 5.6 (5.2 to 6.0) (p CONCLUSIONS CRPR may be a more clinically relevant method for identifying response to treatment since it can be applied to broad spinal surgery populations and takes into account the baseline PRO score. Furthermore, a 30% CRPR appears to outperform established MCID thresholds for patients with either low or high preoperative disability and pain scores. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2019
37. 11. Predicting disability and pain outcomes one year after elective surgery for degenerative cervical diseases: analysis from quality outcomes database
- Author
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Mohamad Bydon, Frank E. Harrell, Jacquelyn S. Pennings, Ahilan Sivaganesan, Clinton J. Devin, Inamullah Khan, Kristin R. Archer, and Hui Nian
- Subjects
medicine.medical_specialty ,Neck pain ,Database ,business.industry ,Arthrodesis ,medicine.medical_treatment ,Context (language use) ,computer.software_genre ,medicine.disease ,Myelopathy ,Cohort ,Orthopedic surgery ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Elective surgery ,medicine.symptom ,business ,computer ,Depression (differential diagnoses) - Abstract
BACKGROUND CONTEXT In the current era of value-based health care reform, engaging patients in shared decision-making for treatment planning is imperative. Predictive models capable of providing individualized predictions of patient-reported outcomes (PROs) following cervical spine surgery have the potential to be valuable tools for a shared decision-making process. PURPOSE The aim of the study is to develop and validate predictive models for 12-month postoperative disability, pain, and myelopathy outcomes in patients undergoing elective spine surgery for degenerative cervical diseases (radiculopathy and myelopathy). STUDY DESIGN/SETTING This study is a retrospective analysis of prospectively collected data from the cervical module of a national spine registry, the Quality Outcomes Database (QOD). PATIENT SAMPLE Patients undergoing cervical spine surgery for the diagnosis of radiculopathy or myelopathy with degenerative etiologies are eligible for inclusion in the QOD registry. OUTCOME MEASURES The outcomes of interest in this study were neck related disability (NDI), pain [NRS- neck pain (NP) and arm pain (AP)] and modified Japanese Orthopedic Association score for myelopathy (mJOA). METHODS Two distinct sets of multivariable proportional odds ordinal regression models were developed with the outcomes of interest of disability (NDI), pain (NRS-NP and NRS-AP) and myelopathy (mJOA) score in the myelopathy cohort and disability (NDI) and pain (NRS-NP and NRS-AP) in the radiculopathy cohort. Patient characteristics of age, gender, BMI, race, education level, smoking status, history of diabetes, anxiety and depression, symptom duration, motor deficit or numbness at presentation, preoperative imaging finding of listhesis, employment status, workers’ compensation, insurance status, and ambulatory ability, baseline PROs as well as surgery-specific variables of number of levels, arthrodesis, and surgical approach were included in the models. The models were internally validated using bootstrap resampling. RESULTS A total of 5,076 patients who underwent surgery for cervical radiculopathy and 2717 patients who underwent surgery for cervical myelopathy were included in fitting the models for the distinct set of outcomes. There was a significant improvement in all PROs at 12 months after surgery (P CONCLUSIONS These predictive models can provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical diseases. Novel predictive models constructed with these data hold the potential to guide individualized patient discussions on postsurgical outcomes and expectations. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
- Published
- 2019
38. Laminectomy and Extension of Instrumented Fusion Improves 2-Year Pain, Disability, and Quality of Life in Patients with Adjacent Segment Disease: Defining the Long-Term Effectiveness of Surgery
- Author
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Owoicho Adogwa, Matthew J. McGirt, Joseph S. Cheng, Clinton J. Devin, Scott L. Parker, Oran S. Aaronson, David N. Shau, and Stephen K. Mendenhall
- Subjects
Employment ,Male ,Reoperation ,medicine.medical_specialty ,Visual analogue scale ,Decompression ,medicine.medical_treatment ,Disability Evaluation ,Postoperative Complications ,Return to Work ,Quality of life ,EQ-5D ,Interquartile range ,medicine ,Humans ,Longitudinal Studies ,Aged ,Pain Measurement ,business.industry ,Laminectomy ,Middle Aged ,Decompression, Surgical ,Surgery ,Oswestry Disability Index ,Spinal Fusion ,Treatment Outcome ,Spinal fusion ,Quality of Life ,Physical therapy ,Female ,Neurology (clinical) ,business ,Low Back Pain ,Follow-Up Studies - Abstract
Objective Adjacent segment disease (ASD) may occur as a long-term consequence of spinal fusion and is associated with significant back and leg pain. Surgical management of symptomatic ASD consists of neural decompression and extension of fusion. However, conflicting results have been reported with respect to the long-term clinical effectiveness of revision surgery in this setting. We set out to comprehensively assess the long-term clinical outcome after revision surgery and determine its effectiveness in the treatment of adjacent segment disease. Methods Fifty patients undergoing revision surgery for ASD-associated back and leg pain were included in this study. Baseline and 2-year Visual Analog Scale–Back Pain (VAS-BP), Visual Analog Scale–Leg Pain (VAS-LP), Oswestry Disability Index, physical and mental quality of life (Short Form–12 [SF-12] physical and mental component score [PCS and MCS]) and health-state utility (EuroQol [EQ-5D]) were assessed. Results A sustained improvement in VAS-BP (8.72 ± 1.85 vs. 3.92 ± 2.84, P = 0.001), VAS-LP (6.30 ± 3.90 vs. 3.02 ± 3.03, P = 0.001), Oswestry Disability Index (28.72 ± 9.64 vs. 18.48 ± 11.31, P = 0.001), SF-12 PCS (26.89 ± 8.85 vs. 35.58 ± 11.97, P = 0.001) and SF-12 MCS (44.66 ± 12.85 vs. 53.16 ± 9.46, P = 0.001) was observed 2 years after revision surgery, with a cumulative mean 2-year gain of 0.76 quality-adjusted life-years (EQ-5D). Median (interquartile range) time to narcotic independence and return to work was 1.7 (1.0–8.0) months and 2.0 (1.0–4.75) months, respectively. Conclusions Patients undergoing decompression and extension of fusion for adjacent segment disease–associated back and leg pain reported long-term improvement in pain, disability, and both physical and mental quality of life, suggesting that revision surgery is a highly effective treatment strategy in this patient population.
- Published
- 2013
39. Determining the quality and effectiveness of surgical spine care: patient satisfaction is not a valid proxy
- Author
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Stephen K. Mendenhall, Anthony L. Asher, Clinton J. Devin, Matthew J. McGirt, Saniya S. Godil, Scott L. Parker, and Scott L. Zuckerman
- Subjects
Adult ,Male ,medicine.medical_specialty ,media_common.quotation_subject ,Context (language use) ,Logistic regression ,Sensitivity and Specificity ,Cohort Studies ,Patient satisfaction ,Quality of life (healthcare) ,Surveys and Questionnaires ,Humans ,Medicine ,Orthopedic Procedures ,Orthopedics and Sports Medicine ,Quality (business) ,Longitudinal Studies ,media_common ,business.industry ,Odds ratio ,Middle Aged ,Spine ,Confidence interval ,Oswestry Disability Index ,Treatment Outcome ,ROC Curve ,Patient Satisfaction ,Area Under Curve ,Quality of Life ,Physical therapy ,Female ,Surgery ,Neurology (clinical) ,business - 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.
- Published
- 2013
40. Surgeon-Level Variability in Cost and Outcomes for Elective Lumbar Decompression-Fusion
- Author
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Matthew J. McGirt, Kristin R. Archer, Clinton J. Devin, John A. Sielatycki, Silky Chotai, and Ahilan Sivaganesan
- Subjects
medicine.medical_specialty ,Decompression ,business.industry ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Lumbar ,030220 oncology & carcinogenesis ,medicine ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Published
- 2017
41. Pre-Injection Opioid Use as a Predictor of Adverse Postinjection Patient-Reported Outcomes following Epidural Steroid Injections for Degenerative Spine Disease
- Author
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Ahilan Sivaganesan, Kristin R. Archer, Silky Chotai, Clinton J. Devin, and Johnny J. Wei
- Subjects
Spine (zoology) ,medicine.medical_specialty ,Epidural steroid ,business.industry ,Anesthesia ,Opioid use ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Disease ,business - Published
- 2017
42. Comparative Effectiveness of Single-Level Anterior Cervical Discectomy and Fusion vs Posterior Cervical Foraminotomy for Patients with Cervical Radiculopathy: Analysis from Quality Outcome Database
- Author
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Matthew J. McGirt, Mohamad Bydon, Christopher I. Shaffrey, Kristin R. Archer, Hui Nian, Frank E. Harrell, Silky Chotai, Clinton J. Devin, Kevin T. Foley, Anthony L. Asher, Steven D. Glassman, and Ahilan Sivaganesan
- Subjects
Cervical radiculopathy ,medicine.medical_specialty ,business.industry ,Foraminotomy ,medicine.medical_treatment ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Anterior cervical discectomy and fusion ,Neurology (clinical) ,Single level ,business - Published
- 2017
43. Drivers of Cost in Adult Spinal Deformity Surgery
- Author
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Silky Chotai, Clinton J. Devin, Byron F. Stephens, and Ahilan Sivaganesan
- Subjects
medicine.medical_specialty ,business.industry ,Anesthesia ,Spinal deformity ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business - Published
- 2017
44. Predicting the Odds of Returning to Work for Patients Undergoing Elective Cervical Spine Surgery
- Author
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Elliott Kim, David P. Stonko, Clinton J. Devin, Ahilan Sivaganesan, Silky Chotai, and Joseph B. Wick
- Subjects
Cervical spine surgery ,medicine.medical_specialty ,Work (electrical) ,business.industry ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,Odds - Published
- 2017
45. Cost-effectiveness of multilevel hemilaminectomy for lumbar stenosis–associated radiculopathy
- Author
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Oran S. Aaronson, Joseph S. Cheng, Brandon J Davis, Clinton J. Devin, Scott L. Parker, Matthew J. McGirt, Erin C. Fulchiero, and Owoicho Adogwa
- Subjects
medicine.medical_specialty ,business.industry ,Cost effectiveness ,Context (language use) ,Lumbar vertebrae ,Oswestry Disability Index ,Quality-adjusted life year ,Indirect costs ,Physical medicine and rehabilitation ,Lumbar ,medicine.anatomical_structure ,Quality of life ,Physical therapy ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,health care economics and organizations - 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.
- Published
- 2011
46. Friday, September 28, 2018 8:00 AM–9:00 AM interdisciplinary spine forum: abstract presentations
- Author
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Silky Chotai, Jacquelyn S. Pennings, Inamullah Khan, Rogelio A. Coronado, Ashley Simone Maybin, Clinton J. Devin, and Kristin R. Archer
- Subjects
education.field_of_study ,medicine.medical_specialty ,business.industry ,Population ,Neurogenic claudication ,Context (language use) ,Oswestry Disability Index ,law.invention ,Lumbar ,Quality of life ,Randomized controlled trial ,law ,Physical therapy ,Back pain ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,medicine.symptom ,business ,education - Abstract
BACKGROUND CONTEXT Physical therapy (PT) is commonly used after lumbar spine surgery, without strong evidence for its effectiveness. Randomized controlled trials outside the United States have found no significant difference between PT and educational controls. Additional research is needed to understand the benefit of PT for postoperative management in order to justify its continued use for patients following spine surgery. PURPOSE The purpose of this study was to examine the association between attending outpatient PT during the postoperative period and patient-reported outcomes at 1 year following lumbar spine surgery. STUDY DESIGN/SETTING Retrospective evaluation of prospectively collected data from a longitudinal spine registry. PATIENT SAMPLE A total of 782 participants undergoing a lumbar laminectomy with or without fusion for a degenerative lumbar condition. OUTCOME MEASURES The primary outcomes for this study were disability (Oswestry Disability Index: ODI), quality of life (EQ-5D), and back pain (11-point Numeric Rating Scale: NRS). METHODS Participants were enrolled into a spine registry prior to surgery and completed a preoperative assessment. Follow-up assessments occurred at 3 months and 1 year after surgery. A categorical variable to describe PT over the 1 year period was created (No PT, PT 0–3 months, PT 0–3 and 3–12 months, PT 3–12 months). Linear mixed-effects models were used to examine the effect of PT group on outcomes over time (3 months and 1 year). All analyses controlled for baseline outcome scores, age, gender, smoking status, insurance type, body mass index, presence of neurogenic claudication, surgery type, number of levels, ASA grade, and preoperative depression and narcotic use. Significance was set at p RESULTS Over the 1-year period, 238 patients had no PT (31%), 285 had PT from 0 to 3 months only (36%), 197 had PT from 0 to 3 and 3 to 12 months (25%), and 62 had PT from 3 to 12 months only (8%). The mixed-effects models found a significant relationship between PT and all patient-reported outcomes, with patients in the PT 0-3 months only group having ODI scores 3.5-points higher, EQ-5D scores 0.03-points lower, and back pain scores 0.35-points higher than the No PT group (p CONCLUSIONS This retrospective analysis of prospectively collected registry data found that patients utilizing PT after lumbar spine surgery had worse postoperative outcomes at 1-year in terms of higher disability and pain and lower quality of life, after controlling for demographic and clinical characteristics. Traditional postoperative PT may not be the most effective rehabilitation approach after spine surgery. Randomized controlled trials have demonstrated that psychologically informed rehabilitation may be more appropriate due to the high levels of depression, anxiety and fear of movement found in this surgical patient population.
- Published
- 2018
47. Predictive Model for Discharge to Home after Elective Surgery for Lumbar Degenerative Disease: An Analysis from National Neurosurgery Quality Outcomes Database Registry
- Author
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Clinton J. Devin, Kristin R. Archer, Matthew J. McGirt, Hui Nian, Frank E. Harrell, Silky Chotai, Anthony L. Asher, and Mohamad Bydon
- Subjects
medicine.medical_specialty ,business.industry ,General surgery ,media_common.quotation_subject ,medicine.disease ,Lumbar ,Degenerative disease ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Quality (business) ,Neurology (clinical) ,Neurosurgery ,Elective surgery ,business ,Intensive care medicine ,media_common - Published
- 2016
48. Predictive Model for Return to Work after Elective Surgery for Lumbar Degenerative Disease: An Analysis From National Neurosurgery Quality Outcomes Database Registry
- Author
-
Kristin Archer, Clinton J. Devin, Silky Chotai, Mohamad Bydon, Matthew J. McGirt, Hui Nian, Frank E. Harrell, and Anthony L. Asher
- Subjects
Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) - Published
- 2016
49. Effect of Complications within 90 Days on Cost-Utility following Lumbar Decompression with and without Fusion for Degenerative Spine Disease
- Author
-
Clinton J. Devin, Matthew J. McGirt, John A. Sielatycki, Ahilan Sivaganesan, Joseph B. Wick, David P. Stonko, Silky Chotai, and Scott L. Parker
- Subjects
Spine (zoology) ,medicine.medical_specialty ,Lumbar ,business.industry ,Decompression ,Cost utility ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Disease ,business - Published
- 2016
50. Surgical Resection of Intradural Extramedullary Spinal Tumors: Patient-Reported Outcomes and Minimum Clinically Important Difference
- Author
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Joseph S. Cheng, Scott L. Zuckerman, David P. Stonko, Matthew J. McGirt, Scott L. Parker, Clinton J. Devin, Silky Chotai, Joseph B. Wick, and Andrew T. Hale
- Subjects
medicine.medical_specialty ,Neck pain ,business.industry ,Minimal clinically important difference ,Area under the curve ,humanities ,Quality-adjusted life year ,Oswestry Disability Index ,Quality of life ,medicine ,Numeric Rating Scale ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Radiology ,medicine.symptom ,business ,Relative validity - Abstract
Study design Analysis of prospectively collected longitudinal web-based registry data. Objective To determine relative validity, responsiveness, and minimum clinically important difference (MCID) thresholds in patients undergoing surgery for intradural extramedullary (IDEM) spinal tumors. Summary of background data Patient-reported outcomes (PROs) are vital in establishing the value of care in spinal pathology. There is limited availability of prospective, quality studies reporting PROs for IDEM spine tumors. Methods . A total of 40 patients were analyzed. Baseline, postoperative 3-month, and 12-month PROs were recorded: Oswestry Disability Index or Neck disability Index (ODI/NDI), Quality of life EuroQol-5D (EQ-5D), Short Form-12 (SF-12), Numeric Rating Scale (NRS)-pain scores. Responders were defined as those who achieved a level of improvement one or two, after surgery, on health transition index (HTI) of SF-36. Receiver-operating characteristic curves were generated to assess the validity of PROs, and the difference between standardized response means (SRMs) in responders versus nonresponders was utilized to determine the relative responsiveness of each PRO measure. MCID thresholds were derived using previously reported minimal detectable change approach. Results A significant improvement across all PROs at 3-months and 12-months follow up was noted. The derived MCID thresholds were 13.9 points: ODI/NDI, 0.14 quality adjusted life years: EQ-5D, 2.8 points: SF-12PCS and 10.7 points: SF-12MCS, 1.9 points: NRS-back/neck pain, and 1.8 points: NRS-leg/arm pain. SF-12PCS was most accurate discriminator of meaningful improvement (area under the curve, AUC-0.83) and most responsive (SRM-1.36) to postoperative improvement. EQ-5D, ODI/NDI, NRS-pain scores were all accurate discriminator (AUC-0.7-0.8) and responsive measures (0.97-0.67) of meaningful postoperative improvement. SF-12MCS was neither a valid discriminator (AUC-0.48) nor a responsive measure (SRM: -1.5) of outcome. Conclusion Surgical resection of IDEM spinal tumors provides significant and sustained improvement in quality of life, general health, disability, and pain at 12-month after surgery. The surgically resected IDEM-specific clinically meaningful thresholds are reported. All the PROs reported in this study can accurately discriminate responders and nonresponder based on SF-36 HTI index except for SF-12 MCS. Level of evidence 3.
- Published
- 2016
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