Implantable Vagus Nerve Stimulator–Paired Neurorehabilitation for Upper Limb Function After Ischemic Stroke: Evidence From a Systematic Review and Meta-Analysis With Best Practice Recommendations
BACKGROUND AND OBJECTIVES: Upper limb motor recovery is limited and affects functional outcomes in stroke survivors. Recent randomized controlled trials have assessed the role of combining vagus nerve stimulation with standard neurorehabilitation. The aim of this review was to evaluate the effectiveness of pairing implanted vagus nerve stimulation (I-VNS) with rehabilitation therapy in ischemic stroke patients and to provide a framework for its integration into standard clinical practice. METHODS: We searched PubMed, Scopus, CINAHL Plus, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews for articles published from inception to July 2024. Randomized controlled trials and follow-up studies assessing the efficacy and/or safety of I-VNS in stroke rehabilitation were included. The outcomes included upper limb motor function and adverse events related to intervention. The risk of bias was assessed using the Cochrane risk-of-bias tool, and a random-effects model was generated for the meta-analysis using the Meta package in R. RESULTS: The final analysis included 8 studies, with a cumulative sample size of n = 498 patients who underwent I-VNS–paired rehabilitation for upper extremity weakness in unilateral supratentorial stroke. The intervention group (I-VNS) included 245 patients (49.1%) whereas the control group had 252 patients (50.6%). The mean age was 59.0 ± 10.01 years in the intervention group and 61.0 ± 9.7 years in the control group. The intervention group included 155 male patients (63.2%), and the control group had 165 male patients (64.4%). The meta-analyses showed statistically significant improvement in upper limb motor function in the I-VNS–paired rehabilitation group with a mean difference of 2.73 (95% CI: 1.32-4.13; P = .04) in the Fugl-Meyer Assessment for Upper Extremity score. Only one study reported a serious adverse event. CONCLUSION: A systematic review and meta-analysis of the current literature provides high-level evidence that I-VNS–paired rehabilitation improves functional outcomes and has a favorable safety profile in patients with poststroke upper extremity weakness.
Impact of Unplanned Readmission on Patient-Reported Outcomes After Cervical Spine Surgery: A National Study of 13 355 Patients
BACKGROUND AND OBJECTIVES: Although risk factors for unplanned readmission after cervical spine surgery have been widely reported, less is known about how readmission itself affects patient-reported outcome measures (PROMs). Using the Quality Outcomes Database registry of patients undergoing elective cervical spine surgery, we sought to (1) determine the impact of unplanned readmission on PROMs and (2) compare the effect of specific readmission reasons on PROMs. METHODS: An observational study was performed using a multi-institution, retrospective registry for patients undergoing cervical spine surgery. The occurrence of 90-day unplanned readmission classified into medical, surgical, pain only, and no readmissions was the exposure variable. Outcome variables included 12-month PROMs of Neck Disability Index (NDI), Numeric Rating Scale (NRS)-neck/arm pain, EuroQol-5D (EQ-5D), and patient dissatisfaction. Multivariable models predicting each PROM were built using readmission reasons controlling for demographics, clinical characteristics, and preoperative PROMs. RESULTS: Data from 13 355 patients undergoing elective cervical spine surgery (82% anterior approach and 18% posterior approach) were analyzed. Unplanned readmission within 90 days of surgery occurred in 3.8% patients, including medical (1.6%), surgical (1.8%), and pain (0.3%). Besides medical reasons, wound infection/dehiscence was the most common reason for unplanned readmission for the total cohort (0.5%), dysphagia in the anterior approach (0.6%), and wound infection/dehiscence in the posterior approach (1.5%). Based on multivariable regression, surgical readmission was significantly associated with worse 12-month NDI, NRS-neck pain, NRS-arm pain, EQ-5D, and higher odds of dissatisfaction. Pain readmissions were associated with worse 12-month NDI and NRS-neck pain scores, and worse dissatisfaction. For specific readmission reasons, pain, surgical site infection/wound dehiscence, hematoma/seroma, revision surgery, deep vein thrombosis, and pulmonary embolism were significantly associated with worsened 12-month PROMs. CONCLUSION: In patients undergoing elective cervical spine surgery, 90-day unplanned surgical and pain readmissions were associated with worse 12-month PROMs compared with patients with medical readmissions and no readmissions.
Clinically Meaningful Improvement Following Cervical Spine Surgery: 30% Reduction Versus Absolute Point-change MCID Values
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
Development and Validation of Cervical Prediction Models for Patient-Reported Outcomes at 1 Year After Cervical Spine Surgery for Radiculopathy and Myelopathy
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.
Impact of Dominant Symptom on 12-Month Patient-Reported Outcomes for Patients Undergoing Lumbar Spine Surgery
Abstract BACKGROUND The impact of symptom characteristics on outcomes of spine surgery remains elusive. OBJECTIVE To determine the impact of symptom location, severity, and duration on outcomes following lumbar spine surgery. METHODS We queried the Quality Outcomes Database (QOD) for patients undergoing elective lumbar spine surgery for lumbar degenerative spine disease. Multivariable regression was utilized to determine the impact of preoperative symptom characteristics (location, severity, and duration) on improvement in disability, quality of life, return to work, and patient satisfaction at 1 yr. Relative predictor importance was determined using an importance metric defined as Wald χ 2 penalized by degrees of freedom. RESULTS A total of 22 022 subjects were analyzed. On adjusted analysis, we found patients with predominant leg pain were more likely to be satisfied ( P < .0001), achieve minimum clinically important difference (MCID) in Oswestry Disability Index (ODI) ( P = .002), and return to work ( P = .03) at 1 yr following surgery without significant difference in Euro-QoL-5D (EQ-5D) ( P = .09) [ref = predominant back pain]. Patients with equal leg and back pain were more likely to be satisfied ( P < .0001), but showed no significant difference in achieving MCID ( P = .22) or return to work ( P = .07). Baseline numeric rating scale-leg pain and symptom duration were most important predictors of achieving MCID and change in EQ-5D. Predominant symptom was not found to be an important determinant of return to work. Worker's compensation was found to be most important determinant of satisfaction and return to work. CONCLUSION Predominant symptom location is a significant determinant of functional outcomes following spine surgery. However, pain severity and duration have higher predictive importance. Return to work is more dependent on sociodemographic features as compared to symptom characteristics.
Predictors of patient satisfaction following 1- or 2-level anterior cervical discectomy and fusion: insights from the Quality Outcomes Database
OBJECTIVE Patient satisfaction with treatment outcome is gaining an increasingly important role in assessing the value of surgical spine care delivery. Nationwide data evaluating the predictors of patient satisfaction in elective cervical spine surgery are lacking. The authors sought to decipher the impacts of the patient, surgical practice, and surgeon on satisfaction with outcome following anterior cervical discectomy and fusion (ACDF). METHODS The authors queried the Quality Outcomes Database for patients undergoing 1- to 2-level ACDF for degenerative spine disease since 2013. Patient satisfaction with the surgical outcome as measured by the North American Spine Society (NASS) scale comprised the primary outcome. A multivariable proportional odds logistic regression model was constructed with adjustments for baseline patient characteristics and surgical practice and surgeon characteristics as fixed effects. RESULTS A total of 4148 patients (median age 54 years, 48% males) with complete 12-month NASS satisfaction data were analyzed. Sixty-seven percent of patients answered that “surgery met their expectations” (n = 2803), while 20% reported that they “did not improve as much as they had hoped but they would undergo the same operation for the same results” (n = 836). After adjusting for a multitude of patient-specific as well as hospital- and surgeon-related factors, the authors found baseline Neck Disability Index (NDI) score, US geographic region of hospital, patient race, insurance status, symptom duration, and Workers’ compensation status to be the most important predictors of patient satisfaction. The discriminative ability of the model was satisfactory (c-index 0.66, overfitting-corrected estimate 0.64). CONCLUSIONS The authors’ results found baseline NDI score, patient race, insurance status, symptom duration, and Workers’ compensation status as well as the geographic region of the hospital to be the most important predictors of long-term patient satisfaction after a 1- to 2-level ACDF. The findings of the present analysis further reinforce the role of preoperative discussion with patients on setting treatment goals and realistic expectations.
Trajectory of Improvement in Myelopathic Symptoms From 3 to 12 Months Following Surgery for Degenerative Cervical Myelopathy
Abstract BACKGROUND Degenerative cervical myelopathy (DCM) is a progressive disease resulting from cervical cord compression. The modified Japanese Orthopaedic Association (mJOA) is commonly used to grade myelopathic symptoms, but its persistent postoperative improvement has not been previously explored. OBJECTIVE To utilize the Quality Outcomes Database (QOD) to evaluate the trajectory of outcomes in those operatively treated for DCM. METHODS This study is a retrospective analysis of prospectively collected data. The QOD was queried for patients undergoing elective surgery for DCM. Patients were divided into mild (≥14), moderate (9-13), or severe (<9) categories for their baseline severity of myelopathic symptoms (mJOA scores). A parsimonious multivariable logistic regression model was fitted with 2 points improvement on mJOA from 3- to 12-mo follow-up as the outcome of interest. RESULTS A total of 2156 patients who underwent elective surgery for DCM and had complete 3- and 12-mo follow-up were included in our analysis. Patients improved significantly from baseline to 3-mo on their mJOA scores, regardless of their baseline mJOA severity. After adjusting for the relevant preoperative characteristics, the baseline mJOA categories had significant impact on outcome of whether a patient keeps improving in mJOA score from 3 to 12 mo postsurgery. Patient with severe mJOA score at baseline had a higher likelihood of improvement in their myelopathic symptoms, compared to patients with mild mJOA score in. CONCLUSION Most patients achieve improvement on a shorter follow-up; however, patients with severe symptoms keep on improving until after a longer follow-up. Preoperative identification of such patients helps the clinician settling realistic expectations for each follow-up timepoint.
Does Neck Disability Index Correlate With 12-Month Satisfaction After Elective Surgery for Cervical Radiculopathy? Results From a National Spine Registry
Abstract BACKGROUND Modern healthcare reforms focus on identifying and measuring the quality and value of care. Patient satisfaction is particularly important in the management of degenerative cervical radiculopathy (DCR) since it leads to significant neck pain and disability primarily affecting the patients’ quality of life. OBJECTIVE To determine the association of baseline and 12-mo Neck Disability Index (NDI) with patient satisfaction after elective surgery for DCR. METHODS The Quality Outcomes Database cervical module was queried for patients who underwent elective surgery for DCR. A multivariable proportional odds regression model was fitted with 12-mo satisfaction as the outcome. The covariates for this model included patients’ demographics, surgical characteristics, and baseline and 12-mo patient reported outcomes (PROs). Wald-statistics were calculated to determine the relative importance of each independent variable for 12-mo patient satisfaction. RESULTS The analysis included 2206 patients who underwent elective surgery for DCR. In multivariable analysis, after adjusting for baseline and surgery specific variables, the 12-mo NDI score showed the highest association with 12-mo satisfaction (Waldχ2-df = 99.17, 58.1% of total χ2). The level of satisfaction increases with decrease in 12-mo NDI score regardless of the baseline NDI score. CONCLUSION Our study identifies 12-mo NDI score as a very influential driver of 12-mo patient satisfaction after surgery for DCR. In addition, there are lesser contributions from other 12-mo PROs, baseline Numeric Rating Scale for arm pain and American Society of Anesthesiologists (ASA) grade. The baseline level of disability was found to be irrelevant to patients. They seemed to only value their current level of disability, compared to baseline, in rating satisfaction with surgical outcome.
Factors Associated With Return-to-Work Following Cervical Spine Surgery in Non-Worker's Compensation Setting
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
Effect of Modified Japanese Orthopedic Association Severity Classifications on Satisfaction With Outcomes 12 Months After Elective Surgery for Cervical Spine Myelopathy
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