Development of the cervical myelopathy severity index: a new patient reported outcome measure to quantify impairments and functional limitations.

BACKGROUND CONTEXT: Existing degenerative cervical myelopathy (DCM) severity scales have significant shortcomings, creating a strong impetus for the development of a practical measurement tool with sound psychometric properties. PURPOSE: This work reports the item generation and reduction of the Cervical Myelopathy Severity Index (CMSI), a new DCM patient-reported outcome measure of symptoms and functional limitations. DESIGN: Prospective observational study. PATIENT SAMPLE: Adult DCM patients belonging to one of three distinct treatment groups: (1) observation cohort, (2) preoperative surgical cohort, (3) 6 to 12 months postoperative cohort. OUTCOME MEASURES: Patient-reported outcome measure of symptoms and functional limitations. METHODS: Item generation was performed using semi-structured patient focus groups emphasizing symptoms experienced and functional limitations. Readability was assessed through think-aloud patient interviews. Item reduction involved surveys of DCM patients with a spectrum of disease severity and board-certified spine surgeons experienced in the treatment of DCM. A priori criteria for item removal included: patient median importance/severity <2 (of 4), 30% or more no severity (response of zero), item severity correlations ≤ 0.80 (Spearman), item severity reliability (weighted kappa <0.60) based on a 2-week interval and clinician median importance <2 with retention of items with very high clinical importance. RESULTS: There were 42 items generated from a combination of specialist input and patient focus groups. Items captured sensorimotor symptoms and limitations related to upper and lower extremities as well as sphincter dysfunction. Ninety-eight patients (43, 30, 25 observation, pre- and postsurgery respectively) and 51 surgeons completed the assessment. Twenty-three items remained after application of median importance and severity thresholds and weighted kappa cutoffs. After elimination of highly correlated (>0.80) items and combining two similar items, the final CMSI questionnaire list included 14 items. CONCLUSIONS: The CMSI is a new DCM patient-reported clinical measurement tool developed using patient and clinician input to inform item generation and reduction. Future work will evaluate the reliability, validity, and responsiveness of the CMSI in relation to existing myelopathy measurement indices.

Right Lobe Versus Left Lobe Living Donor Liver Transplantation: A Systematic Review and Meta-analysis of Donor and Recipient Outcomes.

BACKGROUND: Living donor liver transplantation (LDLT) is an established treatment for advanced liver disease. Whether right lobe (RL) or left lobe (LL) LDLT provides the best outcomes for donors and recipients remains contentious. METHODS: MedLine, Embase, PubMed, and Cochrane Central were searched to identify studies comparing RL- and LL-LDLT and reporting donor and/or recipient outcomes. Effect sizes were pooled using random-effect meta-analysis. Meta-regressions were used to explore heterogeneity. RESULTS: Sixty-seven studies were included. RL donors were more likely to experience major complications (relative risk [RR] = 1.63; 95% confidence interval [CI] = 1.30-2.05; I2 = 19%) than LL donors; however, no difference was observed in the risk of any biliary complication (RR = 1.41; 95% CI = 0.91-2.20; I2 = 59%), bile leaks (RR = 1.56; 95% CI = 0.97-2.51; I2 = 52%), biliary strictures (RR = 0.99; 95% CI = 0.43-1.88; I2 = 27%), or postoperative death (RR = 0.51; 95% CI = 0.25-1.05; I2 = 0%). Among recipients, the incidence of major complications (RR = 0.85; 95% CI = 0.68-1.06; I2 = 21%), biliary complications (RR = 1.10; 95% CI = 0.91-1.33; I2 = 8%), and vascular complications (RR = 0.79; 95% CI = 0.44-1.43; I2 = 0%) was similar. Although the rate of small for size syndrome (RR = 0.47; 95% CI = 0.30-0.74; I2 = 0%) and postoperative deaths (RR = 0.62; 95% CI = 0.44-0.87; I2 = 0%) was lower among RL-LDLT recipients, no differences were observed in long-term graft (hazard ratio = 0.87; 95% CI = 0.55-1.38; I2 = 74%) and overall survival (hazard ratio = 0.86; 95% CI = 0.60-1.22; I2 = 44%). CONCLUSIONS: LL donors experience fewer complications than RL donors, and LL-LDLT recipients had similar outcomes to RL-LDLT recipients. These findings suggest that LL-LDLT offers the best outcomes for living donors and similar outcomes for recipients when measures are taken to prevent small for size syndrome.

The Impact of Riluzole on Neurobehavioral Outcomes in Preclinical Models of Traumatic and Nontraumatic Spinal Cord Injury: Results From a Systematic Review of the Literature.

STUDY DESIGN: Systematic review. OBJECTIVE: To evaluate the impact of riluzole on neurobehavioral outcomes in preclinical models of nontraumatic and traumatic spinal cord injury (SCI). METHODS: An extensive search of the literature was conducted in Medline, EMBASE, and Medline in Process. Studies were included if they evaluated the impact of riluzole on neurobehavioral outcomes in preclinical models of nontraumatic and traumatic SCI. Extensive data were extracted from relevant studies, including sample characteristics, injury model, outcomes assessed, timing of evaluation, and main results. The SYRCLE checklist was used to assess various sources of bias. RESULTS: The search yielded a total of 3180 unique citations. A total of 16 studies were deemed relevant and were summarized in this review. Sample sizes ranged from 14 to 90, and injury models included traumatic SCI (n = 9), degenerative cervical myelopathy (n = 2), and spinal cord-ischemia (n = 5). The most commonly assessed outcome measures were BBB (Basso, Beattie, Besnahan) locomotor score and von Frey filament testing. In general, rats treated with riluzole exhibited significantly higher BBB locomotor scores than controls. Furthermore, riluzole significantly increased withdrawal thresholds to innocuous stimuli and tail flick latency following application of radiant heat stimuli. Finally, rats treated with riluzole achieved superior results on many components of gait assessment. CONCLUSION: In preclinical models of traumatic and nontraumatic SCI, riluzole significantly improves locomotor scores, gait function, and neuropathic pain. This review provides the background information necessary to interpret the results of clinical trials on the impact of riluzole in traumatic and nontraumatic SCI.

The discrepancy between functional outcome and self-reported health status after surgery for degenerative cervical myelopathy.

INTRODUCTION: Surgery for degenerative cervical myelopathy has shown not only to halt neurologic deterioration, but also to improve functional impairments. Despite these improvements, some patients may be dissatisfied with their outcomes. This study aims to (1) investigate discrepancies between postoperative clinical measures and self-reported health status, and (2) identify important predictors of such discrepancies. METHODS: Four hundred and seventy-nine surgical patients were prospectively enrolled in the CSM-International study at 16 global sites. At 1-year post-op, patients rated their general health status compared with their immediate preoperative status (much better, somewhat better, the same, somewhat worse, much worse). Descriptive analyses were conducted to evaluate the agreement between achieving a clinically important improvement (MCID) in function (modified Japanese Orthopedic Association [mJOA] scale) and self-reported health status. Agreement was defined as achieving the MCID on the mJOA and reporting general health as somewhat better or much better, whereas disagreement was defined as achieving MCID on the mJOA and reporting general health as the same, somewhat worse or much worse. Logistic regression analysis was used to determine factors that influence agreement between self-report of health status and functional outcomes. RESULTS: A total of 395 patients had complete follow-up data at 1-year and were included in this analysis. Based on patient self-reports, 56 (14.2%) were somewhat or much worse than a year ago, 80 (20.2%) patients were the same and 259 (65.6%) patients were somewhat or much better. Thirty percent of patients who reported being somewhat or much worse were found to achieve the MCID on the mJOA; 57.5% of patients who indicated their health status were the same as before surgery also exhibited clinically meaningful improvements in functional impairment. Based on multivariate analysis, there was an increased odds of observing an agreement between self-reports of health status and functional outcomes if the patient exhibited greater improvement in mJOA upper extremity motor function at 1-year (odds ratio [OR]: 1.41, 95% confidence interval [CI] 1.03-1.93, p=.033) and reduced odds of agreement with increased age (OR for every decade: 0.66, 95% CI 0.50-0.87, p=.0035) and increased bodily pain at 1-year (OR: 0.62, 95% CI 0.49-078, p<.0001). CONCLUSIONS: There was a discrepancy between changes in mJOA and self-reports of health status in patients undergoing surgery for degenerative cervical myelopathy. Increased bodily pain at 1-year, smaller improvements in postoperative upper extremity score and increased age were associated with worsened or unchanged general health status, despite clinically significant improvements in overall postoperative function.

Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

BACKGROUND CONTEXT: Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. PURPOSE: In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. STUDY DESIGN/SETTING: A systematic review was carried out to compare postoperative bracing and no postoperative bracing. METHODS: A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. RESULTS: Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. CONCLUSIONS: Based on limited evidence, postoperative bracing does not result in improved outcomes after spinal surgery. Future high-quality randomized trials will be required to confirm these findings.