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Background Context: Perioperative pain management affects cost and outcomes in elective spine surgery., Purpose: This study investigated the association between liposomal bupivacaine (LB) and outpatient spine surgery outcomes, including perioperative, postoperative, and postdischarge opioid use and healthcare resource utilization., Study Design: This was a retrospective comparative study., Patient Sample: Eligibility criteria included adults with ≥6 months of continuous data before and after outpatient spine procedures including discectomy, laminectomy, or lumbar fusion. Patients receiving LB were matched 1:3 to patients receiving non-LB analgesia by propensity scores., Outcome Measures: Outcomes included (1) opioid use in morphine milligram equivalents (MMEs) during the perioperative and postdischarge periods and (2) postdischarge readmission and emergency department (ED) visits up to 3 months after surgery. Generalized linear mixed-effects modeling with appropriate distributions was used for analysis., Methods: Deidentified data from the IQVIA linkage claims databases (2016-2019) were used for the analysis. This study was funded by Pacira BioSciences, Inc., Results: In total, 381 patients received LB and 1143 patients received non-LB analgesia. Baseline characteristics were well balanced after propensity score matching. The LB cohort used fewer MMEs versus the non-LB cohort before discharge (80 vs 132 MMEs [mean difference, -52 MMEs; p=.0041]). Following discharge, there was a nonsignificant reduction in opioid use in the LB cohort versus the non-LB cohort within 90 days (429 vs 480 MMEs [mean difference, -50 MMEs; p=.289]) and from >90 days to 180 days (349 vs 381 MMEs [mean difference, -31 MMEs; p=.507]). The LB cohort had significantly lower rates of ED visits at 2 months after discharge versus the non-LB cohort (3.9% vs 7.6% [odds ratio, 0.50; p=.015]). Postdischarge readmission rates did not differ between cohorts., Conclusions: Use of LB for outpatient spine surgery was associated with reduced opioid use at the hospital and nonsignificant reduction in opioid use at all postoperative timepoints examined through 90 days after surgery versus non-LB analgesia. ED visit rates were significantly lower at 60 days after discharge. These findings support reduced cost and improved quality metrics in patients treated with LB versus non-LB analgesia for outpatient spine surgery., Competing Interests: Declaration of competing interest One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background Context: Failure to fuse following anterior cervical discectomy and fusion (ACDF) may result in symptomatic pseudoarthrosis. Traditional diagnosis involves computerized tomography to detect bridging bone and/or flexion-extension radiographs to assess whether segmental motion is above specific thresholds; however, there are currently no well-validated diagnostic tests. We propose a biomechanically rational approach to achieve a reliable diagnostic test for pseudoarthrosis., Purpose: Develop and test a biomechanically based approach to the diagnosis of pseudoarthrosis., Study Design: Literature review, development of theory, re-analysis of a previously published study with surgical exploration as the gold-standard, and retrospective analysis of pooled studies to understand time to fusion., Methods: Fully automated methods were used to measure disc space strains (change in disc space height divided by initial height). Measurement error combined with the reported failure strain of trabecular bone led to a proposed strain threshold for diagnosis of pseudoarthrosis following ACDF. We reanalyzed previously reported flexion-extension radiographs for asymptomatic volunteers to assess whether flexion-extension radiographs, in the absence of fusion surgery, can be expected to provide sufficient stress on motion segments to allow for reliable strain-based fusion assessment. The sensitivity and specificity of strain- and rotation-based pseudoarthrosis diagnosis were assessed by reanalysis of previously reported post-ACDF flexion-extension radiographs, where intraoperative fusion assessments were also available. Finally, we assessed changes in strain over time using 9,869 flexion-extension radiographs obtained 6 weeks to 84 months post-ACDF surgery from 1,369 patients., Results: The estimated error in automated measurement of disc space strain from radiographs was approximately 3%, and the reported failure strain of bridging bone was less than 2.5%. On that basis, we propose a 5% strain threshold for pseudoarthrosis diagnosis. Reanalysis of a study in which intraoperative fusion assessments were available revealed 67% sensitivity and 82% specificity for strain-based diagnosis of pseudoarthrosis, which was comparable to rotation-based diagnosis. Analysis of post-ACDF flexion-extension radiographs revealed rapid strain reduction for up to 24 months, followed by a slower decrease for up to 84 months. When rotation is less than 2 degrees, the strain-based diagnosis differed from the rotation-based diagnosis in approximately 14% of the cases., Conclusions: We propose steps for standardizing diagnosis of pseudoarthrosis based on the failure strain of bone, measurement error, and retrospective data. These steps include obtaining high-quality flexion-extension studies, the application of proposed diagnostic thresholds, and the use of image stabilization for conclusive diagnosis, when motion is near thresholds. The necessity for an accurate diagnosis with minimal radiation exposure underscores the need for further optimization and standardization in diagnosing pseudoarthrosis following ACDF surgery., Clinical Significance: In a symptomatic postspine fusion patient, it is important to diagnose or rule-out pseudoarthrosis. There are currently no well-validated diagnostic tests for this condition. Incorporating strain-based intervertebral motion analysis into the diagnosis could lead to a standardized and validated test for detecting spine pseudoarthrosis., Competing Interests: Declaration of Competing Interest One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background Context: The patient-reported outcomes measurement information system (PROMIS), created by the National institute of Health, is a reliable and valid survey for patients with lumbar spine pathology. Preoperative opioid use has been shown to be an important predictor variable of self-reported health status in legacy patient-reported outcome measures., Purpose: To investigate the impact of chronic preoperative opiate use on PROMIS survey scores., Study Design: Retrospective database analysis., Patient Sample: Between March 2019 and November 2021, 227 patients underwent lumbar decompression ± ≤ 2 level fusion. Fifty-seven patients (25.11%) had chronic preoperative opioid use., Outcome Measures: Oswestry disability index (ODI) and PROMIS survey scores., Methods: A retrospective analysis of a prospectively maintained single center patient-reported outcome database was performed with a minimum of 2 year follow-up. PROMIS Anxiety, Depression, Fatigue, Pain Interference (PI), Physical Function (PF), Sleep disturbance (SD), and Social Roles (SR) surveys were recorded at preoperative intake with subsequent follow-up at 6, 12, and 24 months postoperatively. Patients were grouped into chronic opioid users as defined by >6-month duration of use. Differences in mean survey scores were evaluated using Welch t-tests., Results: Two hundred and twenty-seven patients met our inclusion criteria of completed PROMIS surveys at the designated timepoints. A total of 57 (25.11%) were chronic opioid users (COU) prior to surgery. Analysis of patient-reported health outcomes shows that long term opioid use correlated with worse ODI and PROMIS scores at baseline compared to nonchronic users (NOU). At 1 and 2 year follow-up, the COU cohort continued to have significantly worse ODI, PROMIS Fatigue, PF, PI, SD, and SR scores. There is a statistical difference in the magnitude of change in health status between the 2 cohorts at 1 year follow-up in PROMIS Depression (-5.04±7.88 vs -2.49±8.73, p=.042), PF (6.25±7.11 vs 9.03±9.04, p=.019), and PI (-7.40±7.37 vs -10.58±9.87, p=.011) and 2 year follow-up in PROMIS PF (5.58±6.84 vs 7.99±9.64, p=.041) and PI (-6.71±8.32 vs -9.62±10.06, p=.032). Mean improvement in PROMIS scores for the COU cohort at 2 year follow-up exceeded minimal clinically important difference (MCID) in all domains except PROMIS Depression, SR and SD., Conclusion: Patients with chronic opioid use status have worse baseline PROMIS scores compared with patients who had nonchronic use. However, patients in the COU cohort displayed clinically significant postoperative improvement in multiple PROMIS domains. These results show that patients with chronic opioid use can benefit greatly from surgical intervention and will allow physicians to better set expectations with their patients., Competing Interests: Declaration of Competing Interest One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Commentary on: Eijgenraam SM, Boselie TF, Sieben JM, Bastiaenen CH, Willems PC, Arts JJ, Lataster A. Spine J 2015;September 26. pii: S1529-9430(15)01449-7., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background Context: The Neck Disability Index (NDI) is a commonly used disease-specific instrument for cervical spine disorders with good responsiveness and psychometric properties compared with general health status measures. However, NDI scores are unitless and do not have an intrinsic value that is comparable to other health status measures, and these scores have limited value in cost-utility analysis. The translation of disease-specific measures to Short Form-6 Dimensions (SF-6D) utility scores may be useful in cost-utility analysis., Purpose: The purpose of this study is to present a model for translating the NDI to SF-6D utility scores, permitting the use of NDI scores in the cost-utility analysis of cervical disorders., Study Design/setting: A secondary analysis of a multicenter prospective clinical trial of the Synthes ProDisc-C (Synthes, West Chester, PA, USA) was performed., Patient Sample: Patients included were randomized to receive either a total disc arthroplasty or anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease involving one vertebral level between C3 and C7. All subjects completed NDI and 36-Item Short Form Health Survey (SF-36) self-assessments at preoperative and postoperative follow-ups of 6 weeks, 3, 6, 12, 18, and 24 months., Outcome Measures: The NDI is a validated and widely used self-reported questionnaire designed to assess patient-determined disability resulting from neck pain, including pain level and effects on activities of daily living. The SF-6D is a preference-based health state classification system derived from six health dimensions of the SF-36 self-reported questionnaire, including the domains of physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality., Methods: The collected data points were divided into two cohorts: one for model formation and one for the assessment of model validity. SF-36 scores were converted to SF-6D utilities via three previously published methods. Correlation analyses and linear regression modeling between SF-6D and NDI created the models for translating scores. For validation, Spearman and Pearson correlations were calculated between the observed and predicted SF-6D utilities, and prediction errors were calculated., Results: Four hundred thirty patients with 2,137 time points were used for creation and validation of the model. Pearson and Spearman correlation coefficients between the NDI and the SF-6D derived from each conversion method were found to be between -0.8255 and -0.8504 (p<.01). R(2) values ranged from 0.68 to 0.71 and root mean squared error (RMSE) from 0.092 to 0.084. Correlations between estimated and observed SF-6D scores ranged from 0.8325 to 0.8372 (p<.01). The mean prediction error was less than 0.006, with standard deviation (SD) between 0.082 and 0.093., Discussion: Correlations between NDI and SF-6D utility scores are strong and statistically significant. The model has a large R(2) and small RMSE. The prediction models produce a small mean prediction error, but the SD of the prediction errors is large. High correlations between NDI and SF-6D permit these models to be used to calculate overall utilities, changes in utilities, and quality-adjusted life-years for large data samples. However, the relatively large observed prediction error SDs may limit the accuracy of translation of individual data points or small sample sizes., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background Context: Outcomes of spinal treatments are evaluated by clinical relevance: the proportion of patients who reach a minimum clinically important outcome change. Outcomes are evaluated through multiple measurements, and the inconsistency of outcome change across measurements is not known., Purpose: The primary purpose of this study was to illustrate outcome inconsistencies after spinal surgery. Secondary goals of this study were to develop an index of overall change that incorporates outcome inconsistencies, to relate the index of overall change to patients' global assessment and satisfaction with treatment, to relate the index of global change to an intuitively understandable outcome: the level of tolerable pain., Study Design: This study is a review of prospectively collected patient-reported outcomes data., Patient Sample: Four hundred sixty patients from a large multicenter database were chosen. Those patients were included in the sample because they had undergone lumbar surgery and had baseline and 1-year follow-up scores. Baseline and 1-year follow-up scores for Oswestry Disability Index (ODI), physical component summary (PCS) of the Medical Outcome Study Short Form-36 (SF-36), numerical back and leg pain scales, and 1-year scores for satisfaction with results were included in the study., Outcome Measures: The outcome measures of the study were preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item of the SF-36, and satisfaction with results scales., Methods: Oswestry Disability Index, SF-36, and pain scales were administered before and 1 year after spinal surgery. Satisfaction with results questionnaires were administered 1 year after surgery. The following threshold values were previously established and were used to evaluate outcome changes: minimum clinically important difference (MCID), substantial clinical benefit (SCB), and standard error of the mean. The following proportions of patients were determined according to outcome changes: "deteriorated," "no change," "below MCID," "above MCID," and "above SCB." The consistency of outcome change was determined amongst the four outcome measures. An index of overall change was developed and related to patients' answers to the health transition item of the SF-36 and to the satisfaction with results scale. The overall change index was also compared with the tolerable pain level., Results: Only 40.5% of patients report consistent outcome changes on all four measures. The overall change index was significantly correlated to the global change and satisfaction scale (rho=.67, p less than .001). The overall change index was clearly associated with the tolerable pain level., Conclusions: Efforts should be made to take into account the inconsistency of outcomes and to make clinical relevance more readily understandable by patients and clinicians.

Background Context: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method., Purpose: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery., Study Design: This study is a review of prospectively collected patient-reported outcomes data., Patient Sample: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study., Outcome Measures: Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales., Methods: ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale)., Results: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar., Conclusions: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain.