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Objective: To describe the safety, feasibility, and preliminary outcomes of an early telephone-supported home exercise program (HEP) performed within the first 6 weeks after anterior cervical discectomy and fusion (ACDF) surgery. Methods: Eight patients (mean ± SD age = 53.4 ± 14.9 years, 5 females) were enrolled in this case series. Immediately after surgery, patients began a 6-week HEP including daily walking, deep breathing, distraction techniques, and cervical and upper body exercises. The HEP was supported by weekly telephone calls by a physical therapist. Safety for performing early exercise was examined with radiographic imaging at 6 months. Adverse events were assessed through weekly calls with a physical therapist. HEP adherence and acceptability data were obtained by patient self-report. Clinical measures were assessed preoperatively, at 6 weeks and at 6 months, and included the Neck Disability Index, Numeric Rating Scale for pain, Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, and accelerometry for physical activity. Results: Early radiographic imaging showed no signs of nonunion at 6 months. There were no reports of serious adverse events. At 6 months, all patients reported clinically significant changes in pain catastrophizing. Seven (88%) patients had clinically significant changes in disability and arm pain, six (75%) patients for neck pain and pain self-efficacy, and five (53%) patients for fear of movement. Only three (43%) of seven patients showed increased physical activity at 6 months. Conclusion: Based on this small case series, an early telephone-supported HEP appears safe for patients, feasible to implement, and promising for clinical benefits. [ABSTRACT FROM AUTHOR]

Background Context: Effective alternatives to lumbar fusion for degenerative conditions have remained elusive. Anterior total disc replacement does not address facet pathology or central/recess stenosis, resulting in limited indications. A posterior-based motion-preserving option that allows for neural decompression, facetectomy, and reconstruction of the disc and facets may have a role.Purpose: The purpose was to compare one-year patient-reported outcomes for a novel, all-posterior, lumbar total joint replacement (LTJR - replacing both the disc and facet joints) against transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar conditions warranting fusion (degenerative spondylolisthesis, recurrent disc herniation, severe foraminal stenosis requiring facet removal, and adjacent segment degeneration).Study Design/setting: A retrospective analysis of prospectively collected data comparing outcomes for LTJR patients to TLIF patients at an academic teaching hospital.Patient Sample: Analysis was conducted on 156 adult TLIF patients who were propensity matched to the 52 LTJR patients for a total sample of 208.Outcome Measures: Self-reported Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back and leg pain were compared preoperatively, 3 months and 1 year after surgery.Methods: The implant is a motion-preserving lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral transforaminal approach with complete facetectomies. Adult patients with degenerative lumbar pathology undergoing either LTJR or open TLIF were analyzed. These degenerative conditions included: grade 1 degenerative spondylolisthesis, recurrent disc herniation, adjacent segment disease, disc degeneration with severe foraminal stenosis). Trauma, tumor, grade 2 or higher spondylolisthesis, spinal deformity, and infection cases were excluded. Propensity score matching was performed to ensure parity between the cohorts. Multivariable regression analyses were done to compare the 1-year results as measured by 3 different standards to assess procedure success.Results: At 3 months, both the LTJR and TLIF cohorts showed significant and similar improvements in ODI and NRS back and leg pain. At 1 year, the LTJR cohort showed continued improvement in ODI and NRS back pain, while the TLIF group showed a plateau for ODI, back and leg pain. In a series of three multivariable logistic regressions, LTJR was shown to provide 3.3 times greater odds of achieving the minimal clinical symptom state in disability and pain (ODI <20%, NRS back and leg pain <2) and 2.4 and 4.1 times greater odds of achieving substantial clinical benefit (18% reduction in ODI) and minimal clinically important difference (30% reduction in ODI) as compared to TLIF.Conclusions: Here we present a comparative analysis for the first 52 patients undergoing a novel, posterior-based LTJR for the lumbar spine versus TLIF for degenerative pathology. The approach for the LTJR allows for wide neural decompression, facetectomy, and complete discectomy, with the implant working to replace the function of the disc and facets to preserve motion. At 1 year, the LTJR cohort showed significant improvement in ODI and NRS back and leg pain as compared to TLIF. These results suggest that wide neural decompression combined with motion preservation using this novel LTJR may represent a viable alternative to TLIF for treating certain degenerative conditions. A prospective controlled trial is under development to further evaluate the efficacy, safety, and durability of this procedure. [ABSTRACT FROM AUTHOR]

Study Design: Pilot randomized controlled trial.Objective: To examine the acceptability and preliminary safety and outcome effects of an early self-directed home exercise program (HEP) performed within the first 6 weeks after anterior cervical discectomy and fusion (ACDF).Summary Of Background Data: Little is known regarding optimal postoperative management after ACDF.Methods: Thirty patients (mean ± standard deviation, age = 50.6 ± 11.0 years, 16 women) undergoing ACDF were randomized to receive an early HEP (n = 15) or usual care (n = 15). The early HEP was a 6-week self-directed program with weekly supportive telephone calls to reduce pain and improve activity. Treatment acceptability was assessed after the intervention period (6 weeks after surgery). Safety (adverse events, radiographic fusion, revision surgery) was determined at routine postoperative visits. Disability (Neck Disability Index), pain intensity (Numeric Rating Scale for neck and arm pain), physical and mental health (SF-12), and opioid use were assessed preoperatively, and at 6 weeks and 6 and 12 months after surgery by an evaluator blinded to group assignment.Results: Participants reported high levels of acceptability and no serious adverse events with the early HEP. No difference in fusion rate was observed between groups (P > 0.05) and no participants underwent revision surgery. The early self-directed HEP group reported lower 6-week neck pain than the usual care group (F = 3.3, P = 0.04, r = 0.3, mean difference = -1.7 [-3.4; -0.05]) and lower proportion of individuals (13% vs. 47%) using opioids at 12 months (P = 0.05). No other between-group outcome differences were observed (P > 0.05).Conclusion: An early self-directed HEP program was acceptable to patients and has the potential to be safely administered to patients immediately after ACDF. Benefits were noted for short-term neck pain and long-term opioid utilization. However, larger trials are needed to confirm safety with standardized and long-term radiograph assessment and treatment efficacy.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Purpose: The primary purpose was to examine the measurement properties of the PROMIS-29 to better understand its use in patients undergoing spine surgery. A secondary objective was to calculate a predictive equation between PROMIS-29 and ODI, to allow clinicians and researchers to determine a predicted ODI score based on PROMIS short form scores.Methods: 719 patients with PROMIS v2.0 and ODI responses were queried from the quality outcomes database. Validity was assessed using coefficient omega, ceiling/floor effects, and confirmatory factor analysis. Multivariable regression predicting ODI scores from PROMIS-29 domains was used to create a predictive equation. Predicted ODI scores were plotted against ODI scores to determine how well PROMIS-29 domains predicted ODI.Results: Results showed good reliability and validity of PROMIS-29 in patients undergoing lumbar spine surgery: convergent and discriminant validity, low floor/ceiling effects, and unidimensional domains. The conversion equation used 6 PROMIS-29 domains (ODI% =  37.847- 1.475*[PFraw] + 1.842*[PAINraw] + 0.557*[SDraw] - 0.642*[SRraw] + 0.478*[PIraw] + 0.295*[DEPraw]). Correlation between the predicted and actual ODI scores was R = 0.88, R2 = 0.78, suggesting that the equation predicted ODI scores that are strongly correlated with actual ODI scores.Conclusions: Good measurement properties support the use of PROMIS-29 in spine surgery patients. Findings suggest accurate ODI scores can be derived from PROMIS-29 domains. Clinicians who want to move from ODI to PROMIS-29 can use this equation to obtain estimated ODI scores when only collecting PROMIS-29. These results support the idea that PROMIS-29 domains have the potential to replace disease-specific traditional PROMs. [ABSTRACT FROM AUTHOR]

Study Design: This study retrospectively analyzes prospectively collected data.Objective: Here, we aim to determine the influence of preoperative and 12-month modified Japanese Orthopedic Association (mJOA) on satisfaction and understand the change in mJOA severity classification after surgical management of degenerative cervical myelopathy (DCM).Summary Of Background Data: DCM is a progressive degenerative spine 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 mJOA is commonly used to grade and categorize myelopathy symptoms, but its association with postoperative satisfaction has not been previously explored.Methods: The quality and outcomes database (QOD) was queried for patients undergoing elective surgery for DCM. Patients were divided into mild (≥14), moderate (9 to 13), or severe (<9) categories on the mJOA scores. A McNemar-Bowker test was used to assess whether a significant proportion of patients changed mJOA category between preoperative and 12 months postoperative. A multivariable proportional odds ordinal logistic regression model was fitted with 12-month satisfaction as the outcome of interest.Results: We identified 1963 patients who underwent elective surgery for DCM and completed 12-months follow-ups. Comparing mJOA severity level preoperatively and at 12 months revealed that 55% remained in the same category, 37% improved, and 7% moved to a worse category. After adjusting for baseline and surgery-specific variables, the 12-month mJOA category had the highest impact on patient satisfaction (P < 0.001).Conclusion: Patient satisfaction is an indispensable tool for measuring quality of care after spine surgery. In this sample, 12-month mJOA category, regardless of preop mJOA, was significantly correlated with satisfaction. Given these findings, it is important to advise patients of the probability that surgery will change their mJOA severity classification and the changes required to achieve postoperative satisfaction.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design: Secondary analysis of data from a prospective multicenter observational study.Objective: The aim of this study was to evaluate the occurrence of surgical site infection (SSI) in patients with and without intrawound vancomycin application controlling for confounding factors associated with higher SSI after elective spine surgery.Summary Of Background Data: SSI is a morbid and expensive complication associated with spine surgery. The application of intrawound vancomycin is rapidly emerging as a solution to reduce SSI following spine surgery. The impact of intrawound vancomycin has not been systematically studied in a well-designed multicenter study.Methods: Patients undergoing elective spine surgery over a period of 4 years at seven spine surgery centers across the United States were included in the study. Patients were dichotomized on the basis of whether intrawound vancomycin was applied. Outcomes were occurrence of SSI within postoperative 30 days and SSI that required return to the operating room (OR). Multivariable random-effect log-binomial regression analyses were conducted to determine the relative risk of having an SSI and an SSI with return to OR.Results: .: A total of 2056 patients were included in the analysis. Intrawound vancomycin was utilized in 47% (n = 966) of patients. The prevalence of SSI was higher in patients with no vancomycin use (5.1%) than those with use of intrawound vancomycin (2.2%). The risk of SSI was higher in patients in whom intrawound vancomycin was not used (relative risk (RR) -2.5, P < 0.001), increased number of levels exposed (RR -1.1, P = 0.01), and those admitted postoperatively to intensive care unit (ICU) (RR -2.1, P = 0.005). Patients in whom intrawound vancomycin was not used (RR -5.9, P < 0.001), increased number of levels were exposed (RR-1.1, P = 0.001), and postoperative ICU admission (RR -3.3, P < 0.001) were significant risk factors for SSI requiring a return to the OR.Conclusion: The intrawound application of vancomycin after posterior approach spine surgery was associated with a reduced risk of SSI and return to OR associated with SSI.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Background: Comprehensive assessment of quality of care includes patient-reported outcomes, safety of care delivered, and patient satisfaction. The impact of the patient-reported Oswestry Disability Index (ODI) scores at baseline and 12 months on satisfaction with outcomes following spine surgery is not well documented.Purpose: This study aimed to determine the impact of patient disability (ODI) scores at baseline and 12 months on satisfaction with outcomes following surgery.Study Design: Analysis of prospectively collected longitudinal web-based multicenter data.Patient Sample: Patients undergoing elective surgery for degenerative lumbar disease were entered into a prospective multicenter registry.Outcome Measures: Primary outcome measures were ODI, North American Spine Society satisfaction (NASS) questionnaire.Methods: Baseline and 12-month ODI scores were recorded. Satisfaction at 12 months after surgery was measured using NASS questionnaire. Multivariable proportional odds logistic regression analysis was conducted to determine the impact of baseline and 12-month ODI on satisfaction with outcomes.Results: Of the total 5,443 patients, 64% (n=3,460) were satisfied at a level where surgery met their expectations (NASS level 1) at 12 months after surgery. After adjusting for all baseline and surgery-specific variables, the 12-month ODI score had the highest impact (Wald χ2=1,555, 86% of the total χ2) on achieving satisfaction with outcomes compared with baseline ODI scores (Wald χ2=93, 5% of the total χ2). The level of satisfaction decreases with increasing 12-month ODI score. Greater change in ODI is required to achieve a better satisfaction level when the patient starts with a higher baseline ODI score.Conclusion: Absolute 12-month ODI following surgery had a significant association on satisfaction with outcomes 12 months after surgery. Patients with higher baseline ODI required a larger change in ODI score to achieve satisfaction. No single measure can be used as a sole yardstick to measure quality of care after spine surgery. Satisfaction may be used in conjunction with baseline and 12-month ODI scores to provide an assessment of the quality of spine surgery provided in a patient centric fashion. [ABSTRACT FROM AUTHOR]

The article focuses on the case of a fifty year old man who presented to an orthopedic spine clinic with a complaint of low back pain 19 years after having had a lumbar total disc replacement with osteolysis. A discussion of a diagnosis of chronic lumbar disc replacement failure which was given to the man, and of treatment which was provided to him, is presented.

Study Objectives: Successful ectopic gene therapy requires the transfection of the cells at the ectopic site, with local and systemic delivery of the gene product. This study aimed to evaluate the pleural mesothelial surface as a potential site for ectopic gene therapy.Design: A secreted placental alkaline phosphatase (PALP) plasmid was injected bilaterally into the pleural spaces of seven rabbits via a chest tube, while an irrelevant reporter plasmid was injected into seven control rabbits. Blood was collected at baseline and at 24, 48, and 72 h after the injections. Pleural fluid was collected by lavage at 24, 48, and 72 h after the injections. The PALP level was measured by chemiluminesence.Measurements and Results: Significant expressions of PALP proteins were observed in the serum of the treatment rabbits, with a threefold increase over baseline at 24 h, a ninefold increase at 48 h, and a twofold increase at 72 h. The serum PALP levels in the control rabbits remained at baseline levels at all time points. The pleural fluid PALP levels peaked at 24 h and decreased over the next 72 h. Mimicking the in vivo pattern, pleural mesothelial cells transfected in vitro demonstrated a similar increase in PALP levels.Conclusions: The results of the present short-term pilot study suggest that pleural mesothelial cells can be successfully transfected with plasmids, with increases in both the local and systemic levels of the gene product. The pleural space should be further evaluated for ectopic gene therapy. [ABSTRACT FROM AUTHOR]

An introduction to a series of articles on value-based spine disease is presented.

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. 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). This study is a retrospective analysis of prospectively collected data from the cervical module of a national spine registry, the Quality Outcomes Database (QOD). Patients undergoing cervical spine surgery for the diagnosis of radiculopathy or myelopathy with degenerative etiologies are eligible for inclusion in the QOD registry. 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). 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. 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<0.001). The most important predictors of the outcomes in both the models set were the respective baseline PROs scores. In addition, symptom duration, preoperative ambulatory status, patients' employment status, patients' education status, race and age of the patients had a statistically significant impact on the outcomes (p <0.001). Among the surgery-specific variables, surgical approach was the most important predictor for all outcomes across the models for radiculopathy and myelopathy (p<0.001). The models' discriminative performance (measured by overfitting-corrected c-index) were: NDI=0.688, NRS-NP=0.668, NRS-AP=0.645 for the radiculopathy and NDI=0.696, NRS-NP=0.682, NRS-AP=0.670, mJOA=0.717 for the myelopathy patients. 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. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective analysis of prospectively collected registry data.Objective: The aim of this study was to compare the performance of 30% reduction to established absolute point-change values for measures of disability and pain in patients undergoing elective cervical spine surgery.Summary Of Background Data: Recent studies recommend using a proportional change from baseline instead of an absolute point-change value to define minimum clinically important difference (MCID).Methods: Analyses included 13,179 patients who underwent cervical spine surgery for degenerative disease between April 2013 and February 2018. Participants completed a baseline and 12-month follow-up assessment that included questionnaires to assess disability (Neck Disability Index [NDI]), neck and arm pain (Numeric Rating Scale [NRS-NP/AP], and satisfaction [NASS scale]). Participants were classified as met or not met 30% reduction from baseline in each of the respective measures. The 30% reduction in scores at 12 months was compared to a wide range of established absolute point-change MCID values using receiver-operating characteristic curves, area under the receiver-operating characteristic curve (AUROC), and logistic regression analyses. These analyses were conducted for the entire patient cohort, as well as for subgroups based on baseline severity and surgical approach.Results: Thirty percent reduction in NDI and NRS-NP/AP scores predicted satisfaction with more accuracy than absolute point-change values for the total population and ACDF and posterior fusion procedures (P < 0.05). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0-20%: 16.8%) and bed-bound disability (ODI 81%-100%: 16.6%) categories. For pain, there was a 1.9% to 11% and 1.6% to 9.6% AUROC difference for no/mild neck and arm pain (NRS 0-4), respectively, in favor of a 30% reduction threshold.Conclusion: A 30% reduction from baseline is a valid method for determining MCID in disability and pain for patients undergoing cervical spine surgery.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design.: Delphi method. Objective.: To gain consensus on the following questions: (1) When should anticoagulation/antiplatelet (AC/AP) medication be stopped before elective spine surgery?; (2) When should AC/AP medication be restarted after elective spine surgery?; (3) When, how, and in whom should venous thromboembolism (VTE) chemoprophylaxis be started after elective spinal surgery? Summary of Background Data.: VTE can lead to significant morbidity after adult spine surgery, yet postoperative VTE prophylaxis practices vary considerably. The management of preoperative AC/AP medication is similarly heterogeneous. Materials and Methods.: Delphi method of consensus development consisting of three rounds (January 26, 2021, to June 21, 2021). Results.: Twenty-one spine surgeons were invited, and 20 surgeons completed all rounds of questioning. Consensus (>70% agreement) was achieved in 26/27 items. Group consensus stated that preoperative Direct Oral Anticoagulants should be stopped two days before surgery, warfarin stopped five days before surgery, and all remaining AC/AP medication and aspirin should be stopped seven days before surgery. For restarting AC/AP medication postoperatively, consensus was achieved for low-risk/medium-risk/high-risk patients in 5/5 risk factors (VTE history/cardiac/ambulation status/anterior approach/operation). The low/medium/high thresholds were POD7/POD5/POD2, respectively. For VTE chemoprophylaxis, consensus was achieved for low-risk/medium-risk/high-risk patients in 12/13 risk factors (age/BMI/VTE history/cardiac/cancer/hormone therapy/operation/anterior approach/staged separate days/staged same days/operative time/transfusion). The one area that did not gain consensus was same-day staged surgery. The low-threshold/medium-threshold/high-threshold ranges were postoperative day 5 (POD5) or none/POD3-4/POD1-2, respectively. Additional VTE chemoprophylaxis considerations that gained consensus were POD1 defined as the morning after surgery regardless of operating finishing time, enoxaparin as the medication of choice, and standardized, rather than weight-based, dose given once per day. Conclusions.: In the first known Delphi study to address anticoagulation/antiplatelet recommendations for elective spine surgery (preoperatively and postoperatively); our Delphi consensus recommendations from 20 spine surgeons achieved consensus on 26/27 items. These results will potentially help standardize the management of preoperative AC/AP medication and VTE chemoprophylaxis after adult elective spine surgery. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Context: Diabetes mellitus (DM) is a well-established risk factor for suboptimal outcomes following cervical spine surgery. Hemoglobin A1C (HbA1c), a surrogate for long-term glycemic control, is a valuable assessment tool in diabetic patients.Purpose: In patients undergoing elective cervical spine surgery, we sought to identify optimal HbA1c levels to: (1) maximize 1-year postoperative patient-reported outcomes (PROs), and (2) predict the occurrence of medical and surgical complications.Study Design/setting: A retrospective cohort study using prospectively collected data was performed in a single academic center.Patient Sample: Diabetic patients undergoing elective anterior cervical fusion and posterior cervical laminectomy and fusion (PCLF) between October 2010-March 2021 were included.Outcome Measures: Primary outcomes included Numeric Rating Scale (NRS)-Neck pain, NRS-Arm pain, and Neck Disability Index (NDI). Secondary outcomes included surgical site infection (SSI), complications, readmissions, and reoperations within 90-days postoperatively.Methods: HbA1c, demographic, comorbidity, and perioperative variables were gathered in diabetic patients only. PROs were analyzed as continuous variables and minimum clinically difference (MCID) was set at 30% improvement from baseline.Results: Of 1992 registry patients undergoing cervical surgery, 408 diabetic patients underwent cervical fusion surgery. Anterior: A total of 259 diabetic patients underwent anterior cervical fusion, 141 of which had an available HbA1c level within one year prior to surgery. Mean age was 55.8±10.1, and mean HbA1c value was 7.2±1.4. HbA1c levels above 6.1 were associated with failure to achieve MCID for NDI (AUC=0.77, 95%CI 0.70-0.84, p<.001), and HbA1c levels above 6.8 may be associated with increased odds of reoperation (AUC=0.61, 95%CI 0.52-0.69, p=.078). Posterior: A total of 149 diabetic patients underwent PCLF, 65 of which had an available HbA1c level within 1 year. Mean age was 63.6±9.2, and mean HbA1c value was 7.2±1.5. Despite a low AUC for NRS-Arm pain and readmission, HbA1c levels above 6.8 may be associated with failure to achieve MCID for NRS-Arm pain (AUC=0.61, 95%CI 0.49-0.73, p=.094), and HbA1c levels above 7.6 may be associated with higher readmission rate (AUC=0.63, 95%CI 0.50-0.75, p=.185).Conclusions: In a cohort of diabetic patients undergoing elective cervical spine surgery, HbA1c levels above 6.1 were associated with decreased odds of achieving MCID for NDI in anterior cervical fusion surgery. Though only moderate associations were seen for the select outcomes of reoperation (6.8), readmission (7.6), and MCID for NRS-Arm pain (6.8), preoperative optimization of HbA1c using these levels as benchmarks should be considered to reduce the risk of complications and maximize PROs for patients undergoing elective cervical spine surgery. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study.Objective: (a) Compare operative variables, complications, and patient-reported outcomes (PROs) in patients with an upper instrumented vertebrae (UIV) of C2 versus C3/4, and (b) assess outcomes based on C2 screw type.Summary Of Background Data: When performing elective posterior cervical laminectomy and fusion (PCLF), spine surgeons must choose the upper instrumented vertebrae (UIV) at the subaxial cervical spine (C3/4) versus C2. Differences in long-term complications and PROs remain unknown.Methods: A single-institution, retrospective cohort study from a prospective registry was conducted. All patients undergoing elective, degenerative PCLF from December 2010 to June 2018 were included. Patients were divided into a UIV of C2 versus C3/4. Groups were 2:1 propensity matched for fusion extending to the thoracic spine. Demographics, operative, perioperative, complications, and 1-year PRO data were collected.Results: One hundred seventeen patients underwent elective PCLF and were successfully propensity matched (39 C2 vs. 78 C3/4). Groups were similar in fusion extending to the thoracic spine (P = 0.588). Expectedly, the C2 group had more levels fused (5.63 ± 1.89) compared with the C3/4 group (4.50 ± 0.91) (P = 0.001). The C2 group had significantly longer operative time (P < 0.001), yet no differences were seen in estimated blood loss (EBL) (P = 0.494) or length of stay (LOS) (P = 0.424). Both groups significantly improved all PROs at 1-year (EQ-5D; NRS-NP/AP; NDI). Both groups had the same percentage of surgical adverse events at 6.8% (P = 1.00). Between C2 screw type, no differences were seen in operative time, EBL, LOS, complications, or PROs.Conclusion: In patients undergoing elective PCLF, those instrumented to C2 had only longer operative times compared with those stopping at C3/4. No differences were seen in EBL, LOS, 1-year PROs, and complications. Type of C2 screw had no impact on outcomes. Besides increased operative time, instrumenting to C2 had no detectable difference on surgical outcomes or adverse event rates.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background: We have recently demonstrated that transforming growth factor beta-2 ( TGF-β2 ) can produce effective pleurodesis. Whether this effect can be reproduced by the use of its downstream proteins is not known. This study compared the effectiveness of TGF-β2 and fibronectin in inducing pleurodesis in rabbits. Methodology: New Zealand white rabbits (1.5–2.0 kg) were given 1.7 μg of TGF-β2 (n = 5) or 2.0 mg of cellular fibronectin (n = 4) intrapleurally via a chest tube. The induced pleural fluid was collected and analyzed. The rabbits were sacrificed after 14 days. The pleurodesis was graded macroscopically from 1 (none) to 8 (symphysis > 50%). Results: All rabbits in the TGF-β2 group developed effective pleurodesis while none in the fibronectin group had scores > 2 (pleurodesis scores 7.0 ± 0.6 vs 1.3 ± 0.3, P < 0.001). Rabbits that received TGF-β2 produced large amounts of pleural fluid initially (< 4 days). Microscopically, the pleura of rabbits in the TGF-β2 group showed prominent spindle cell proliferation and collagen deposition, but no significant inflammation or mesothelial proliferation. Pleural tissues of rabbits in the fibronectin group had occasional thin collagen deposits only. The intrapleural administration of 2.0 mg of fibronectin, a downstream product of TGF-β, did not induce effective pleurodesis, as did the intrapleural administration of TGF-β2 . Conclusions: The present study suggests that the mechanism by which TGF-β2 induces pleurodesis is not predominantly dependent on the production of fibronectin. [ABSTRACT FROM AUTHOR]

Background: 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.Methods: We enrolled 248 participants undergoing surgery for a degenerative lumbar spine condition. Physical activity was measured using a triaxial accelerometer (Actigraph GT3X) at 6-weeks (6wk), 6-months (6M), 12-months (12M) and 24-months (24M) following spine surgery. Physical function (computerized adaptive test domain version of Patient-Reported Outcomes Measurement Information System) and psychosocial factors (pain self-efficacy, depression and fear of movement) were assessed at preoperative visit and 6wk, 6M, 12M and 24M after surgery. Structural equation modeling (SEM) techniques were utilized to analyze data, and results are represented as standardized regression weights (SRW). Overall SRW were computed across five imputed datasets to account for missing data. The mediation effect of each psychosocial factor on the effect of physical activity on physical function were computed [(SRW for effect of activity on psychosocial factor X SRW for effect of psychosocial factor on function) ÷ SRW for effect of activity on function]. Each SEM model was tested for model fit by assessing established fit indexes.Results: The overall effect of steps per day on physical function (SRW ranged from 0.08 to 0.19, p<0.05) was stronger compared to the overall effect of physical function on steps per day (SRW ranged from non-existent to 0.14, p<0.01 to 0.3). The effect of steps per day on physical function and function on steps per day remained consistent after accounting for psychosocial factors in each of the mediation models. Depression and fear of movement at 6M mediated 3.4% and 5.4% of the effect of steps per day at 6wk on physical function at 12M, respectively. Pain self-efficacy was not a statistically significant mediator.Conclusions: The findings of this study suggest that the relationship between physical activity and physical function is stronger than the relationship of function to activity. However, future research is needed to examine whether promoting physical activity during the early postoperative period may result in improvement of long-term physical function. Since depression and fear of movement had a very small mediating effect, additional work is needed to investigate other potential mediating factors such as pain catastrophizing, resilience and exercise self-efficacy. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. 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. 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 [<30 days], intermediate [active prescription until 30-59 days], or sustained [beyond 60 days]); and high- (>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 < 0.05 indicated significance. A total 2128 patients were included, with an overall 1-year satisfaction rate of 82%. Compared to patients with <30 days, patients with intermediate postoperative duration (30-59 days) were significantly less likely to be satisfied at 1 year (aOR:1.9 [1.4-2.6]), have meaningful improvements in extremity pain (aOR:1.8 [1.3-2.4]), axial pain (aOR:2.3 [1.7-2.9]), or disability (aOR:1.8 [1.4-2.3]); and significantly more likely to be on chronic opioids at 1 year (aOR:4.6 [2.9-7.3]). High postoperative dosage was not significantly associated with outcomes. A subgroup analysis of preoperative opioid naïve patients showed intermediate duration (30-59 days) was associated with significant risk of chronic opioids at 1 year (aOR: 6.3 [3.3-12]). 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. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Study Design: Secondary analysis of randomized controlled trial data.Objective: The aim of this study was to examine whether preoperative physical performance is an independent predictor of patient-reported disability and pain at 12 months after lumbar spine surgery.Summary Of Background Data: Patient-reported outcome measures (PROMs) are commonly used to assess clinical improvement after lumbar spine surgery. However, there is evidence in the orthopedic literature to suggest that PROMs should be supplemented with physical performance tests to accurately evaluate long-term outcomes.Methods: A total of 248 patients undergoing surgery for degenerative lumbar spine conditions were recruited from two institutions. Physical performance tests (5-Chair Stand and Timed Up and Go) and PROMs of disability (Oswestry Disability Index: ODI) and back and leg pain (Brief Pain Inventory) were assessed preoperatively and at 12 months after surgery.Results: Physical performance tests and PROMs significantly improved over 12 months following lumbar spine surgery (P < 0.01). Weak correlations were found between physical performance tests and disability and pain (ρ = 0.15 to 0.32, P < 0.05). Multivariable regression analyses controlling for age, education, preoperative outcome score, fusion, previous spine surgery, depressive symptoms, and randomization group found that preoperative 5-Chair Stand test was significantly associated with disability and back pain at 12-month follow-up. Each additional 10 seconds needed to complete the 5-Chair Stand test were associated with six-point increase in ODI (P = 0.047) and one-point increase in back pain (P = 0.028) scores. The physical performance tests identified an additional 14% to 19% of patients as achieving clinical improvement that were not captured by disability or pain questionnaires.Conclusion: Results indicate that physical performance tests may provide distinct information in both predicting and assessing clinical outcomes in patients undergoing lumbar spine surgery. Our findings suggest that the 5-Chair Stand test may be a useful test to include within a comprehensive risk assessment before surgery and as an outcome measure at long-term follow-up.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective analysis of prospectively collected registry data.Objective: To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery.Summary Of Background Data: Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care.Methods: This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients.Results: Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers' compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725.Conclusions: These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Objective Changing Behavior through Physical Therapy (CBPT), a cognitive-behavioral–based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study was to explore potential mediators underlying CBPT efficacy after spine surgery. Methods In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (12-Item Short-Form Health Survey), fear of movement (Tampa Scale for Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using Statistical Package for the Social Sciences (SPSS) were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months. Results Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = −2.0 [95% CI = −4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1]). Conclusions This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism. Impact Fear of movement and pain self-efficacy may be important mechanisms to consider when developing and testing psychologically informed physical therapy programs. [ABSTRACT FROM AUTHOR]

Background Context: Studies have found that most patients are satisfied after spine surgery, with rates ranging from 53% to 90%. Patient satisfaction appears to be closely related to achieving clinical improvement in pain and disability after surgery. While the majority of the literature has focused on patients who report both satisfaction and clinical improvement in disability and pain, there remains an important subpopulation of patients who have clinically relevant improvement but report being dissatisfied with surgery.Purpose: To examine why patients who achieve clinical improvement in disability or pain also report dissatisfaction at 1-year after spinal surgery.Study Design: Retrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database.Patient Sample: There were 34,076 participants undergoing elective surgery for degenerative spine pathology who had clinical improvement in disability or pain.Outcome Measures: Satisfaction with surgery was assessed with 1-item from the North American Spine Society lumbar spine outcome assessment. Participants with answer choices other than "treatment met my expectations" were classified as dissatisfied.Methods: Patients completed a baseline and 12-month postoperative assessment to evaluate disability, pain, and satisfaction. Clinical improvement was defined as patients who achieved a 30% or greater improvement in spine-related disability (Oswestry/Neck Disability Index) or extremity pain (11-point Numeric Rating Scale) from baseline to 12-month after surgery. A generalized linear mixed model was used to predict the odds of the patient being dissatisfied 1-year after surgery from demographic, clinical and surgical characteristics, postoperative complications and revision, and return to work and previous physical activity. Random effects were included to model the effect of both site and surgeon on dissatisfaction. Sensitivity analyses were conducted on samples who achieved 30% or greater improvement in (1) disability only, (2) axial (back/neck) pain only, (3) extremity (leg/arm)pain only, (4) both disability and axial pain, and (5) both disability and extremity pain. Results showed the same pattern of findings across all samples.Results: Twenty-eight percent of patients were classified as dissatisfied with their spine surgery and 72% classified as satisfied. For patients with clinical improvement in disability or extremity pain at 1-year, significant predictors of higher odds of dissatisfaction included baseline psychological distress, current smoking status, workers compensation claim, lower education, higher ASA grade, lumbar versus cervical procedure, and increased axial pain, major complication within 30 days, and revision surgery within 12-months. The most important contributors to dissatisfaction were return to work and return to previous physical activity, with the odds of dissatisfaction being over 2 times and 4 times higher for these variables. Site and surgeon explained 3.8% of the variance in dissatisfaction, with more of the variance attributed to site than to surgeon.Conclusions: Several modifiable factors, including psychological distress, current smoking status, and failure to return to work and physical activity, helped explain why patients report being dissatisfied with surgery despite clinical improvement in disability or pain. The findings of this study have the potential to help providers identify at-risk patients, set realistic expectations during preoperative counseling, and implement postoperative management strategies. A multidisciplinary approach to rehabilitation that includes functional goal setting or restoration may help to improve patients psychological distress as well as return to work and previous physical activity after spine surgery. [ABSTRACT FROM AUTHOR]

Study Design: Longitudinal Cohort Study OBJECTIVE.: Determine if duration of postoperative opioids is associated with long term outcomes, and if initial postoperative opioid dosage is associated with opioid cessation after spine surgery.Summary Of Background Data: Preoperative opioid use is associated with poor outcomes, but little evidence exists regarding the implications of opioid dosage and duration after spine surgery.Methods: Data from our state's prescription drug database was linked to our prospective clinical spine registry to analyze opioid dispensing and outcomes in elective surgical spine patients between 2010 and 2017. Patients were stratified based on preoperative chronic opioid use and multivariable regression was used to assess associations between duration of postoperative opioids and outcomes at one year, including satisfaction, chronic opioid use, and meaningful improvements in pain, disability, and quality of life. In a secondary aim, a Cox proportional hazards model was used to determine if initial postoperative opioid dosage was associated with time to opioid cessation.Results: Of 2172 patients included, 35% had preoperative chronic opioid use. In patients without preoperative chronic opioid use, a postoperative opioid duration of 31-60 days was associated with chronic opioid use at one year (aOR:4.1 [1.7-9.8]) and no meaningful improvement in extremity pain (aOR:1.8 [1.3-2.6]) or axial pain (aOR:1.6 [1.1-2.2]); cessation between 61-90 days was associated with no meaningful improvement in disability (aOR: 2 [1.3-3]) and dissatisfaction (aOR:1.8 [1-3.1]). In patients with preoperative chronic opioid use, postoperative opioids for ≥90 days was associated with dissatisfaction. Cox regression analyses showed lower initial postoperative opioid dosages were associated with faster opioid cessation in both groups.Conclusion: Our results suggest that a shorter duration of postoperative opioids may result in improved one-year patient reported outcomes, and that lower postoperative opioid dosages may lead to faster opioid cessation.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Study Design: This study retrospectively analyzes prospectively collected data.Objective: Here in this study we aim to determine the factors which impact a patient's ability to return to work (RTW) in the setting of cervical spine surgery in patients without worker's compensation status.Summary Of Background Data: Surgical management of degenerative cervical disease has proven cost-effectiveness and shown significant improvement in quality of life. However, the ability to RTW is an important clinical outcome for preoperatively employed patients.Methods: All adult patients undergoing elective surgery for cervical degenerative disease at our institution are enrolled in a prospective, web-based registry. A multivariable Cox proportional hazards regression model was built for time to RTW. The variables included in the model were age, sex, smoking status, occupation type, number of levels operated on, ASA grade, body mass index, history of diabetes, history of coronary artery disease (CAD), history of chronic obstructive pulmonary disease (COPD), anxiety, depression, myelopathy at presentation, duration of symptoms more than 12 months, diagnosis, type of surgery performed, and preoperative Neck Disability Index, EuroQol Five Dimensions, and Numeric Rating Scale pain scores for neck pain and arm pain scores.Results: Of the total 324 patients with complete 3-month follow-up data 83% (n = 269) returned to work following surgery. The median time to RTW was 35 days (range, 2-90 d). Patients with a labor-intensive occupation, higher ASA grade, history of CAD, and history of COPD were less likely to RTW. The likelihood of RTW was lower in patients with a diagnosis of disc herniation compared with cervical stenosis, patients undergoing cervical corpectomy compared laminectomy and fusion and patient with longer operative time.Conclusion: Our study identifies the various factors associated with a lower likelihood of RTW at 3 months after cervical spine surgery in the non-worker's compensation setting. This information provides expectations for the patient and employer when undergoing cervical spine surgery.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design: Longitudinal Cohort Study.Objective: Determine 1-year patient-reported outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosages in patients undergoing elective spine surgery.Summary Of Background Data: Back pain is the most disabling condition worldwide and over half of patients presenting for spine surgery report using opioids. Preoperative dosage has been correlated with poor outcomes, but published studies have not assessed the relationship of both preoperative chronic opioids and opioid dosage with patient-reported outcomes.Methods: For patients undergoing elective spine surgery between 2010 and 2017, our prospective institutional spine registry data was linked to opioid prescription data collected from our state's Prescription Drug Monitoring Program to analyze outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosage, while adjusting for confounders through multivariable regression analyses. Outcomes included 1-year meaningful improvements in pain, function, and quality of life. Additional outcomes included 1-year satisfaction, return to work, 90-day complications, and postoperative chronic opioid use.Results: Of 2128 patients included, preoperative chronic opioid therapy was identified in 21% and was associated with significantly higher odds (adjusted odds ratio [95% confidence interval]) of not achieving meaningful improvements at 1-year in extremity pain (aOR:1.5 [1.2-2]), axial pain (aOR:1.7 [1.4-2.2]), function (aOR:1.7 [1.4-2.2]), and quality of life (aOR:1.4 [1.2-1.9]); dissatisfaction (aOR:1.7 [1.3-2.2]); 90-day complications (aOR:2.9 [1.7-4.9]); and postoperative chronic opioid use (aOR:15 [11.4-19.7]). High-preoperative opioid dosage was only associated with postoperative chronic opioid use (aOR:4.9 [3-7.9]).Conclusion: Patients treated with chronic opioids prior to spine surgery are significantly less likely to achieve meaningful improvements at 1-year in pain, function, and quality of life; and less likely to be satisfied at 1-year with higher odds of 90-day complications, regardless of dosage. Both preoperative chronic opioid therapy and high-preoperative dosage are independently associated with postoperative chronic opioid use.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

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 (P < 0.0001, r = 0.620) and Modified Somatic Perception Questionnaire (P < 0.0001, r = 0.450) and negative correlation with 12-Item Short-Form Health Survey Mental Component Summary (P < 0.0001, 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 (P < 0.0001, C-index = 0.831), Zung depression scale (P < 0.0001, C-index = 0.802), and Modified Somatic Perception Questionnaire (P < 0.0001, 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Study Design: This study retrospectively analyzes prospectively collected data.Objective: The primary aim of this study is to present a scheme for patient-reported outcome (PRO)-based, risk-adjusted rankings of spine surgeons and sites that perform elective lumbar surgery, using the Quality and Outcomes Database (QOD).Summary Of Background Data: There is currently no means of determining which spine surgeons or centers are positive or negative outliers with respect to PROs for elective lumbar surgery. This is a critical gap as we move toward a value-based model of health care in which providers assume more accountability for the effectiveness of their treatments.Methods: Random effects regression models were fit for the following outcomes, with QOD site as a fixed effect but surgeon ID as a random effect: Oswestry Disability Index, EQ-5D, back pain and leg pain, and satisfaction. Hierarchical Bayesian models were also fit for each outcome, with QOD site as a random effect and surgeon as a nested random effect.Results: Our study cohort consists of 8834 patients who underwent surgery by 124 QOD surgeons, for the degenerative lumbar diseases. Nonoverlapping Bayesian credible intervals demonstrate that the variance attributed to QOD site was greater than the nested variance attributed to surgeon ID for the included PROs.Conclusion: This study presents a novel strategy for the risk-adjusted, PRO-based ranking of spine surgeons and practices. This can help identify positive and negative outliers, thereby forming the basis for large-scale quality improvement. Assuming adequate coverage of baseline risk adjustment, the choice of surgeon matters when considering PROs after lumbar surgery; however, the choice of site appears to matter more.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design: This study retrospectively analyzes prospectively collected data.Objective: Here we aim to develop predictive models for 3-month medical and surgical readmission after elective lumbar surgery, based on a multi-institutional, national spine registry.Summary Of Background Data: Unplanned readmissions place considerable stress on payers, hospitals, and patients. Medicare data reveals a 30-day readmission rate of 7.8% for lumbar-decompressions and 13.0% for lumbar-fusions, and hospitals are now being penalized for excessive 30-day readmission rates by virtue of the Hospital Readmissions Reduction Program.Methods: The Quality and Outcomes Database (QOD) was queried for patients undergoing elective lumbar surgery for degenerative diseases. The QOD prospectively captures 3-month readmissions through electronic medical record (EMR) review and self-reported outcome questionnaires. Distinct multivariable logistic regression models were fitted for surgery-related and medical readmissions adjusting for patient and surgery-specific variables.Results: Of the total 33,674 patients included in this study 2079 (6.15%) reported at least one readmission during the 90-day postoperative period. The odds of medical readmission were significantly higher for older patients, males versus females, African Americans versus Caucasion, those with higher American Society of Anesthesiologists (ASA) grade, diabetes, coronary artery disease, higher numbers of involved levels, anterior only or anterior-posterior versus posterior approach; also, for patients who were unemployed compared with employed patients and those with high baseline Oswestry Disability Index (ODI). The odds of surgery-related readmission were significantly greater for patients with a higher body mass index (BMI), a higher ASA grade, female versus male, and African Americans versus Caucasians; also, for patients with severe depression, more involved spinal levels, anterior-only surgical approaches and higher baseline ODI scores.Conclusion: In this study we present internally validated predictive models for medical and surgical readmission after elective lumbar spine surgery. These findings set the stage for targeted interventions with a potential to reduce unnecessary readmissions, and also suggest that medical and surgical readmissions be treated as distinct clinical events.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background Adult spinal deformity (ASD) operations are complex and often require a multisurgeon team. Simultaneously, it is the responsibility of academic spine surgeons to train future complex spine surgeons. Our objective was to assess the effect of resident and fellow involvement (RFI) on ASD surgery in 4 areas: 1) perioperative outcomes, 2) length of stay (LOS), 3) discharge status, and 4) complications. Methods Adults undergoing thoracolumbar spinal deformity correction from 2008 to 2014 were identified in the National Surgical Quality Improvement Program database. Cases were divided into those with RFI and those with attendings only. Outcomes were operative time, transfusions, LOS, discharge status, and complications. Univariate and multivariable regression modeling was used. Covariates included preoperative comorbidities, specialty, and levels undergoing instrumentation. Results A total of 1471 patients underwent ASD surgery with RFI in 784 operations (53%). After multivariable regression modeling, RFI was independently associated with longer operations (β = 66.01 minutes; 95% confidence interval [CI], 35.82–96.19; P < 0.001), increased odds of transfusion (odds ratio, 2.80; 95% CI, 1.81–4.32; P < 0.001), longer hospital stay (β = 1.76 days; 95% CI, 0.18–3.34; P = 0.030), and discharge to an inpatient rehabilitation or a skilled nursing facility (odds ratio, 2.02; 95% CI, 1.34–3.05; P < 0.001). However, RFI was not associated with any increase in major or minor complications. Conclusion RFI in ASD surgery was associated with increased operative time, the need for additional transfusions, longer LOS, and nonhome discharge. However, no increase in major, minor, or severe complications occurred. These data support the continued training of future deformity and complex spine surgeons without fear of worsening complications; however, areas of improvement exist. [ABSTRACT FROM AUTHOR]

Background 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. Methods 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. Results The study population showed significant improvement (P < 0.001) 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. Conclusions 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. Highlights • In an era of rising healthcare costs, it is prudent to consider effective use of resources. • We report prospective data identifying the significant cost drivers in corrective procedures for adult spine deformity. • This study is an important step for enhancing sustainability and cost-effectiveness of adult spinal deformity surgery. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective review of prospective patient outcomes and cost data.Objective: To analyze the contribution of surgeon-specific variability in cost and patient-reported outcomes (PROs) to overall variability in anterior cervical discectomy and fusion (ACDF), whereas adjusting for patient comorbidities.Summary Of Background Data: Cost reduction in surgical care has received increased attention. Patient factors contributing to cost variability in ACDF have been described; however, intersurgeon cost and outcome variability has received less attention in the literature.Methods: Adult patients undergoing elective primary ACDF by five different surgeons were analyzed from a prospective registry database. Direct and indirect 90-day costs were compared across each surgeon, along with PROs. Predicted costs were calculated based on patient co-morbidities, and an "observed versus expected" cost differential was measured for each surgeon; this O/E cost ratio was then compared with PROs.Results: A total of 431 patients were included in the analysis. There were no differences in comorbidities, age, smoking status, or narcotic use. There was significant variation between surgeons in total 90-day costs, as well as variation between each surgeon's observed versus expected cost ratio. Despite these surgeon-specific cost variations, there were no differences in PROs across the participating surgeons.Conclusion: Intersurgeon cost variation in elective ACDF persists even after adjusting for patient comorbidities. There was no apparent correlation between increased surgeon-specific costs and 90-day PROs. These findings show there is opportunity for improvement in inter-surgeon cost variation without compromise in PROs.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study.Objective: The aim of this study was to evaluate the causes, timing, and factors associated with unplanned 90-day readmissions following elective spine surgery.Summary Of Background Data: Unplanned readmissions after spine surgery are costly and an important determinant of the value of care. Several studies using database information have reported on rates and causes of readmission. However, these often lack the clinical detail and actionable data necessary to guide early postdischarge interventions.Methods: Patients undergoing elective spine surgery for degenerative disease at a major medical center were enrolled in a prospective longitudinal registry. Patient and surgery-specific characteristics, baseline, and 3-month patient-reported outcomes were prospectively recorded. Readmissions were reviewed retrospectively to establish the reason and time to readmission. A multivariable Cox proportional hazard model was created to analyze the independent effects of several factors on readmission.Results: Of 2761 patients with complete 3-month follow-up, 156 had unplanned 90-day readmissions (5.6%). The most common reason was surgery-related (52%), followed by medical complications (38%) and pain (10%). Pain readmissions presented with a median time of 6 days. Medical readmissions presented at 12 days. Surgical complications presented at various times with wound complications at 6 days, cerebrospinal fluid leaks at 12 days, surgical site infections at 23 days, and surgical failure at 38 days. A history of myocardial infarction, osteoporosis, higher baseline leg and arm pain scores, longer operative duration, and lumbar surgery were associated with readmission.Conclusion: Nearly half of all unplanned 90-day readmissions were because of pain and medical complications and occurred with a median time of 6 and 12 days, respectively. The remaining 52% of readmissions were directly related to surgery and occurred at various times depending on the specific reason. This timeline for pain and medical readmissions represents an opportunity for targeted postdischarge interventions to prevent unplanned readmissions following spine surgery.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]