A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study.

BACKGROUND: Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further "how" these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research. METHODS AND FINDINGS: A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery. CONCLUSIONS: The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS.

An Update of a Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role and Timing of Decompressive Surgery.

STUDY DESIGN: Clinical practice guideline development. OBJECTIVES: Acute spinal cord injury (SCI) can result in devastating motor, sensory, and autonomic impairment; loss of independence; and reduced quality of life. Preclinical evidence suggests that early decompression of the spinal cord may help to limit secondary injury, reduce damage to the neural tissue, and improve functional outcomes. Emerging evidence indicates that "early" surgical decompression completed within 24 hours of injury also improves neurological recovery in patients with acute SCI. The objective of this clinical practice guideline (CPG) is to update the 2017 recommendations on the timing of surgical decompression and to evaluate the evidence with respect to ultra-early surgery (in particular, but not limited to, <12 hours after acute SCI). METHODS: A multidisciplinary, international, guideline development group (GDG) was formed that consisted of spine surgeons, neurologists, critical care specialists, emergency medicine doctors, physical medicine and rehabilitation professionals, as well as individuals living with SCI. A systematic review was conducted based on accepted methodological standards to evaluate the impact of early (within 24 hours of acute SCI) or ultra-early (in particular, but not limited to, within 12 hours of acute SCI) surgery on neurological recovery, functional outcomes, administrative outcomes, safety, and cost-effectiveness. The GRADE approach was used to rate the overall strength of evidence across studies for each primary outcome. Using the "evidence-to-recommendation" framework, recommendations were then developed that considered the balance of benefits and harms, financial impact, patient values, acceptability, and feasibility. The guideline was internally appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. RESULTS: The GDG recommended that early surgery (≤24 hours after injury) be offered as the preferred option for adult patients with acute SCI regardless of level. This recommendation was based on moderate evidence suggesting that patients were 2 times more likely to recover by ≥ 2 ASIA Impairment Score (AIS) grades at 6 months (RR: 2.76, 95% CI 1.60 to 4.98) and 12 months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24 hours compared to after 24 hours. Furthermore, patients undergoing early surgery improved by an additional 4.50 (95% 1.70 to 7.29) points on the ASIA Motor Score compared to patients undergoing surgery after 24 hours post-injury. The GDG also agreed that a recommendation for ultra-early surgery could not be made on the basis of the current evidence because of the small sample sizes, variable definitions of what constituted ultra-early in the literature, and the inconsistency of the evidence. CONCLUSIONS: It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24 hours after injury when medically feasible. Future research is required to determine the differential effectiveness of early surgery in different subpopulations and the impact of ultra-early surgery on neurological recovery. Moreover, further work is required to define what constitutes effective spinal cord decompression and to individualize care. It is also recognized that a concerted international effort will be required to translate these recommendations into policy.

Secondary analysis of a James Lind Alliance priority setting partnership to facilitate knowledge translation in degenerative cervical myelopathy (DCM): insights from AO Spine RECODE-DCM.

OBJECTIVES: To explore whether a James Lind Alliance Priority Setting Partnership could provide insights on knowledge translation within the field of degenerative cervical myelopathy (DCM). DESIGN: Secondary analysis of a James Lind Alliance Priority Setting Partnership process for DCM. PARTICIPANTS AND SETTING: DCM stake holders, including spinal surgeons, people with myelopathy and other healthcare professionals, were surveyed internationally. Research suggestions submitted by stakeholders but considered answered were identified. Sampling characteristics of respondents were compared with the overall cohort to identify subgroups underserved by current knowledge translation. RESULTS: The survey was completed by 423 individuals from 68 different countries. A total of 22% of participants submitted research suggestions that were considered 'answered'. There was a significant difference between responses from different stakeholder groups (p<0.005). Spinal surgeons were the group which was most likely to submit an 'answered' research question. Respondents from South America were also most likely to submit 'answered' questions, when compared with other regions. However, there was no significant difference between responses from different stakeholder regions (p=0.4). CONCLUSIONS: Knowledge translation challenges exist within DCM. This practical approach to measuring knowledge translation may offer a more responsive assessment to guide interventions, complementing existing metrics.

Diffusion-weighted MRI of the spinal cord in cervical spondylotic myelopathy after instrumented fusion.

Introduction: This study investigated tissue diffusion properties within the spinal cord of individuals treated for cervical spondylotic myelopathy (CSM) using post-decompression stabilization hardware. While previous research has indicated the potential of diffusion-weighted MRI (DW-MRI) markers of CSM, the metallic implants often used to stabilize the decompressed spine hamper conventional DW-MRI. Methods: Utilizing recent developments in DW-MRI metal-artifact suppression technologies, imaging data was acquired from 38 CSM study participants who had undergone instrumented fusion, as well as asymptomatic (non-instrumented) control participants. Apparent diffusion coefficients were determined in axial slice sections and split into four categories: a) instrumented levels, b) non-instrumented CSM levels, c) adjacent-segment (to instrumentation) CSM levels, and d) non-instrumented control levels. Multi-linear regression models accounting for age, sex, and body mass index were used to investigate ADC measures within each category. Furthermore, the cord diffusivity within CSM subjects was correlated with symptom scores and the duration since fusion procedures. Results: ADC measures of the spinal cord in CSM subjects were globally reduced relative to control subjects (p = 0.005). In addition, instrumented levels within the CSM subjects showed reduced diffusivity relative to controls (p = 0.003), while ADC within non-instrumented CSM levels did not statistically deviate from control levels (p = 0.107). Discussion: Multi-spectral DW-MRI technology can be effectively employed to evaluate cord diffusivity near fusion hardware in subjects who have undergone surgery for CSM. Leveraging this advanced technology, this study had identified significant reductions in cord diffusivity, relative to control subjects, in CSM patients treated with conventional metallic fusion instrumentation.

Variability in Early Surgery for Acute Cervical Spinal Cord Injury Patients: An Opportunity for Enhanced Care Delivery.

Data supporting the benefits of early surgical intervention in acute spinal cord injury (SCI) is growing. For early surgery to be accomplished, understanding the causes of variabilities that effect the timing of surgery is needed to achieve this goal. The purpose of this analysis is to determine factors that affect the timing of surgery for acute cervical SCI within the North American Clinical Trials Network (NACTN) for SCI registry. Patients in the NACTN SCI registry from 2005 to 2019 with a cervical SCI, excluding acute traumatic central cord syndrome, were analyzed for time elapsed from injury to arrival to the hospital, and time to surgery. Two categories were defined: 1) Early Arrival with Early Surgery (EAES) commenced within 24 h of injury, and 2) Early Arrival but Delayed Surgery (EADS), with surgery occurring between 24 to 72 h post-injury. Patients' demographic features, initial clinical evaluation, medical comorbidities, neurological status, surgical intervention, complications, and outcome data were correlated with respect to the two arrival groups. Of the 222 acute cervical SCI patients undergoing surgery, 163 (73.4%) were EAES, and 59 (26.6%) were EADS. There was no statistical difference in arrival time between the EAES and EADS groups. There was a statistical difference in the median arrival time to surgery between the EAES group (9 h) compared with the EADS group (31 h; p < 0.05). There was no statistical difference in race, sex, age, mechanism of injury, Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II scores, or medical comorbidities between the two groups, but the EAES group did present with a significantly lower systolic blood pressure (p < 0.05). EADS patients were more likely to present as an American Spinal Injury Association Impairment Scale (AIS) D than EAES (p < 0.05). Early surgery was statistically more likely to occur if the injury occurred over the weekend (p < 0.05). There were variations in the rates of early surgery between the eight NACTN sites within the study, ranging from 57 to 100%. Of the 114 patients with 6-month outcome data, there was no significant change between the two groups regarding AIS grade change and motor/pin prick/light touch score recovery. A trend towards improved motor scores with early surgery was not statistically significant (p = 0.21). Although there is data that surgery within 24 h of injury improves outcomes and can be performed safely, there remain variations in care outside of clinical trials. In the present study of cervical SCI, NACTN achieved its goal of early surgery in 73.4% of patients from 2005-2019 who arrived within 24 h of their injury. Variability in achieving this goal was related to severity of neurological injury, the day of the week, and the treating NACTN center. Evaluating variations within our network improves understanding of potential systemic limitations and our decision-making process to accomplish the goal of early surgery.

Interhospital Transfer Delays Care for Spinal Cord Injury Patients: A Report from the North American Clinical Trials Network for Spinal Cord Injury.

Abstract The North America Clinical Trials Network (NACTN) for Spinal Cord Injury (SCI) is a consortium of tertiary medical centers that has maintained a prospective SCI registry since 2004, and it has espoused that early surgical intervention is associated with improved outcome. It has previously been shown that initial presentation to a lower acuity center and necessity of transfer to a higher acuity center reduce rates of early surgery. The NACTN database was evaluated to examine the association between interhospital transfer (IHT), early surgery, and outcome, taking into account distance traveled and site of origin for the patient. Data from a 15-year period of the NACTN SCI Registry were analyzed (years 2005-2019). Patients were stratified into transfers directly from the scene to a Level 1 trauma center (NACTN site) versus IHT from a Level 2 or 3 trauma facility. The main outcome was surgery within 24 hours of injury (yes/no), whereas secondary outcomes were length of stay, death, discharge disposition, and 6-month American Spinal Injury Association Impairment Scale (AIS) grade conversion. For the IHT patients, distance traveled for transfer was calculated by measuring the shortest distance between origin and NACTN hospital. Analysis was performed with Brown-Mood test and chi-square tests. Of 724 patients with transfer data, 295 (40%) underwent IHT and 429 (60%) were admitted directly from the scene of injury. Patients who underwent IHT were more likely to have a less severe SCI (AIS D; p = 0.002), have a central cord injury (p = 0.004), and have a fall as their mechanism of injury (p < 0.0001) than those directly admitted to an NACTN center. Of the 634 patients who had surgery, direct admission to an NACTN site was more likely to result in surgery within 24 hours compared with IHT patients (52% vs. 38%) (p < 0.0003). Median IHT distance was 28 miles (interquartile range [IQR] = 13-62 miles). There was no significant difference in death, length of stay, discharge to a rehab facility versus home, or 6-month AIS grade conversion rates between the two groups. Patients who underwent IHT to an NACTN site were less likely to have surgery within 24 hours of injury, compared with those directly admitted to the Level 1 trauma facility. Although there was no difference in mortality rates, length of stay, or 6-month AIS conversion between groups, patients with IHT were more likely be older with a less severe level of injury (AIS D). This study suggests there are barriers to timely recognition of SCI in the field, appropriate admission to a higher level of care after recognition, and challenges related to the management of individuals with less severe SCI.

Bulbocavernosus Reflex Has No Prognostic Features During the Acute Evaluation of Spinal Cord Injuries.

The bulbocavernosus reflex (BCR) has been used during the initial evaluation of a spinal cord injury patient as a metric to determine prognosis and whether the patient is in "spinal shock." This reflex has been less utilized over the last decade, and therefore a review was performed to assess the value of BCR in patient prognosis. The North American Clinical Trials Network (NACTN) for Spinal Cord Injury (SCI) is a consortium of tertiary medical centers that includes a prospective SCI registry. The NACTN registry data was analyzed to evaluate the prognostic implication of the BCR during the initial evaluation of a spinal cord injury patient. SCI patients were divided into those with an intact or absent BCR during their initial evaluation. Associations of participants' descriptors and neurological status on follow-up were performed, followed by associations with the presence of a BCR. A total of 769 registry patients with recorded BCRs were included in the study. The median age was 49 years (32-61 years), and the majority were male (n = 566, 77%) and white (n = 519, 73%). Among included patients, high blood pressure was the most common comorbidity (n = 230, 31%). Cervical spinal cord injury was the most common (n = 470, 76%) with fall (n = 320, 43%) being the most frequent mechanism of injury. BCR was present in 311 patients (40.4%), while 458 (59.6%) had a negative BCR within 7 days of injury or before surgery. At 6 months post-injury, 230 patients (29.9%) followed up, of which 145 had a positive BCR, while 85 had a negative BCR. The presence/absence of BCR was significantly different in patients with cervical (p = 0.0015) or thoracic SCI (p = 0.0089), or conus medullaris syndrome (p = 0.0035), and in those who were American Spinal Injury Association Impairment Scale grade A (p = 0.0313). No significant relationship was observed between BCR results and demographics, AIS grade conversion, motor score changes (p = 0.1669), and changes in pin prick (p = 0.3795) and light touch scores (p = 0.8178). In addition, cohorts were not different in surgery decision (p = 0.7762) and injury to surgery time (p = 0.0681). In our review of the NACTN spinal cord registry, the BCR did not provide prognostic utility in the acute evaluation of spinal cord injury patients. Therefore, it should not be used as a reliable marker for predicting neurological outcomes post-injury.

Evolving Profile of Acute Spinal Cord Injury Demographics, Outcomes, and Surgical Treatment in North America: Analysis of a Prospective Multi-Center Dataset of 989 Patients.

Changes in demography and injury patterns have altered the profile and outcome of acute spinal cord injury (SCI) over time. This study sought to describe recent trends in epidemiology and early clinical outcomes using the multi-center North American Clinical Trial Network (NACTN) for Spinal Cord Injury Registry. All participants with blunt acute traumatic SCI (n = 782) were grouped into three five-year time intervals from 2005 to 2019 (2005-2009, 2010-2014, and 2015-2019). Baseline demographics, clinical scores, medical co-morbidities, as well as early clinical outcomes were extracted. Categorical and continuous variables were analyzed to determine between-group differences. Subgroup analysis was performed for participants <50 and ≥50 years of age. Over the duration of the study period, there was an increase in age at presentation (p = 0.0077) as well as a greater incidence of falls as the mechanism of injury. Participants who were ≥50 years of age were more likely to sustain incomplete SCI (<0.0003) and central cord syndrome (< 0.0001). In the most recent period (2015-2019), a greater proportion of NACTN participants underwent surgery within 24 h of injury (63% vs. 41% vs. 41%, p = 0.0001). There was a statistically significant increase in cardiac complications (p < 0.0001) and decrease in pulmonary complications (p < 0.0001) during the study period. Data from the NACTN registry shows that the age of participants with acute SCI is increasing, falls have become the major mechanism of injury, and central cord injury is becoming increasingly prevalent. While early surgical intervention for acute SCI is more common in recent years, cardiac complications are more prevalent while pulmonary complications are less prevalent.

A Practical Classification System for Acute Cervical Spinal Cord Injury Based on a Three-Phased Modified Delphi Process From the AOSpine Spinal Cord Injury Knowledge Forum.

STUDY DESIGN: A modified Delphi study. OBJECTIVE: To assess current practice patterns in the management of cervical spinal cord injury (SCI) and develop a simplified, practical classification system which offers ease of use in the acute setting, incorporates modern diagnostic tools and provides utility in determining treatment strategies for cervical SCI. METHODS: A three-phase modified Delphi procedure was performed between April 2020 and December 2021. During the first phase, members of the AOSpine SCI Knowledge forum proposed variables of importance for classifying and treating cervical SCI. The second phase involved an international survey of spine surgeons gauging practices surrounding the role and timing of surgery for cervical SCI and opinions regarding factors which most influence these practices. For the third phase, information obtained from phases 1 and 2 were used to draft a new classification system. RESULTS: 396 surgeons responded to the survey. Neurological status, spinal stability and cord compression were the most important variables influencing decisions surrounding the role and timing of surgery. The majority (>50%) of respondents preferred to perform surgery within 24 hours post-SCI in clinical scenarios in which there was instability, severe cord compression or severe neurology. Situations in which <50% of respondents were inclined to operate early included: SCI with mild neurological impairments, with cord compression but without instability (with or without medical comorbidities), and SCI without cord compression or instability. CONCLUSIONS: Spinal stability, cord compression and neurological status are the most important variables influencing surgeons' practices surrounding the surgical management of cervical SCI. Based on these results, a simplified classification system for acute cervical SCI has been proposed.

Establishing the Socio-Economic Impact of Degenerative Cervical Myelopathy Is Fundamental to Improving Outcomes [AO Spine RECODE-DCM Research Priority Number 8].

STUDY DESIGN: Literature Review (Narrative). OBJECTIVE: To contextualize AO Spine RECODE-DCM research priority number 5: What is the socio-economic impact of DCM? (The financial impact of living with DCM to the individual, their supporters, and society as a whole). METHODS: In this review, we introduce the methodology of health-economic investigation, including potential techniques and approaches. We summarize the current health-economic evidence within DCM, so far focused on surgical treatment. We also cover the first national estimate, in partnership with Myelopathy.org from the United Kingdom, of the cost of DCM to society. We then demonstrate the significance of this question to advancing care and outcomes in the field. RESULTS: DCM is a common and often disabling condition, with a significant lack of recognition. While evidence demonstrates the cost-effectives of surgery, even among higher income countries, health inequalities exist. Further the prevalent residual disability in myelopathy, despite treatment affects both the individual and society as a whole. A report from the United Kingdom provides the first cost-estimate to their society; an annual cost of ∼£681.6 million per year, but this is likely a significant underestimate. CONCLUSION: A clear quantification of the impact of DCM is needed to raise the profile of a common and disabling condition. Current evidence suggests this is likely to be globally substantial.

Optimizing the Application of Surgery for Degenerative Cervical Myelopathy [AO Spine RECODE-DCM Research Priority Number 10].

STUDY DESIGN: Literature Review (Narrative). OBJECTIVE: To introduce the number 10 research priority for Degenerative Cervical Myelopathy: Individualizing Surgery. METHODS: This article summarizes the current recommendations and indications for surgery, including how known prognostic factors such as injury time, age, disease severity, and associated comorbidities impact surgical outcome. It also considers key areas of uncertainty that should be the focus of future research. RESULTS: While a small proportion of conservatively managed patients may remain stable, the majority will deteriorate over time. To date, surgical decompression is the mainstay of treatment, able to halt disease progression and improve neurologic function and quality of life for most patients. Whilst this recognition has led to recommendations on when to offer surgery, there remain many uncertainties including the type of surgery, or timing in milder and/or asymptomatic cases. Their clarification has the potential to transform outcomes, by ensuring surgery offers each individual its maximum benefit. CONCLUSION: Developing the evidence to better guide surgical decision-making at the individual patient level is a research priority for Degenerative Cervical Myelopathy.

Improving Awareness Could Transform Outcomes in Degenerative Cervical Myelopathy [AO Spine RECODE-DCM Research Priority Number 1].

STUDY DESIGN: Literature Review (Narrative). OBJECTIVE: To introduce the number one research priority for Degenerative Cervical Myelopathy (DCM): Raising Awareness. METHODS: Raising awareness has been recognized by AO Spine RECODE-DCM as the number one research priority. This article reviews the evidence that awareness is low, the potential drivers, and why this must be addressed. Case studies of success from other diseases are also reviewed, drawing potential parallels and opportunities for DCM. RESULTS: DCM may affect as many as 1 in 50 adults, yet few will receive a diagnosis and those that do will wait many years for it. This leads to poorer outcomes from surgery and greater disability. DCM is rarely featured in healthcare professional training programs and has received relatively little research funding (<2% of Amyotrophic Lateral Sclerosis or Multiple Sclerosis over the last 25 years). The transformation of stroke and acute coronary syndrome services, from a position of best supportive care with occasional surgery over 50 years ago, to avoidable disability today, represents transferable examples of success and potential opportunities for DCM. Central to this is raising awareness. CONCLUSION: Despite the devastating burden on the patient, recognition across research, clinical practice, and healthcare policy are limited. DCM represents a significant unmet need that must become an international public health priority.

Are Lumbar Fusion Guidelines Followed? A Survey of North American Spine Surgeons.

OBJECTIVE: To evaluate the use of guidelines for lumbar spine fusions among spine surgeons in North America. METHODS: An anonymous survey was electronically sent to all AO Spine North America members. Survey respondents were asked to indicate their opinion surrounding the suitability of instrumented fusion in a variety of clinical scenarios. Fusion indications in accordance with North America Spine Society (NASS) guidelines for lumbar fusion were considered NASS-concordant answers. Respondents were considered to have a NASS-concordant approach if ≥ 70% (13 of 18) of their answers were NASS-concordant answers. Comparisons were performed using bivariable statistics. RESULTS: A total of 105 responses were entered with complete data available on 70. Sixty percent of the respondents (n = 42) were considered compliant with NASS guidelines. NASS-discordant responses did not differ between surgeons who stated that they include the NASS guidelines in their decision-making algorithm (5.10 ± 1.96) and those that did not (4.68 ± 2.09) (p = 0.395). The greatest number of NASS-discordant answers in the United States. was in the South (5.75 ± 2.09), with the lowest number in the Northeast (3.84 ± 1.70) (p < 0.01). For 5 survey items, rates of NASS-discordant answers were ≥ 40%, with the greatest number of NASS-discordant responses observed in relation to indications for fusion in spinal deformity (80%). Spine surgeons utilizing a NASS-concordant approach had a significant lower number of NASS-discordant answers for synovial cysts (p = 0.03), axial low back pain (p < 0.01), adjacent level disease (p < 0.01), recurrent stenosis (p < 0.01), recurrent disc herniation (p = 0.01), and foraminal stenosis (p < 0.01). CONCLUSION: This study serves an important role in clarifying the rates of uptake of clinical practice guidelines in spine surgery as well as to identify barriers to their implementation.

Utility of prediction model score: a proposed tool to standardize the performance and generalizability of clinical predictive models based on systematic review.

OBJECTIVE: The objective of this study was to evaluate the characteristics and performance of current prediction models in the fields of spine metastasis and degenerative spine disease to create a scoring system that allows direct comparison of the prediction models. METHODS: A systematic search of PubMed and Embase was performed to identify relevant studies that included either the proposal of a prediction model or an external validation of a previously proposed prediction model with 1-year outcomes. Characteristics of the original study and discriminative performance of external validations were then assigned points based on thresholds from the overall cohort. RESULTS: Nine prediction models were included in the spine metastasis category, while 6 prediction models were included in the degenerative spine category. After assigning the proposed utility of prediction model score to the spine metastasis prediction models, only 1 reached the grade of excellent, while 2 were graded as good, 3 as fair, and 3 as poor. Of the 6 included degenerative spine models, 1 reached the excellent grade, while 3 studies were graded as good, 1 as fair, and 1 as poor. CONCLUSIONS: As interest in utilizing predictive analytics in spine surgery increases, there is a concomitant increase in the number of published prediction models that differ in methodology and performance. Prior to applying these models to patient care, these models must be evaluated. To begin addressing this issue, the authors proposed a grading system that compares these models based on various metrics related to their original design as well as internal and external validation. Ultimately, this may hopefully aid clinicians in determining the relative validity and usability of a given model.

Comparison between quantitative measurements of diffusion tensor imaging and T2 signal intensity in a large series of cervical spondylotic myelopathy patients for assessment of disease severity and prognostication of recovery.

OBJECTIVE: Cervical spondylotic myelopathy (CSM) is a common cause of spinal cord dysfunction. Recently, it has been shown that diffusion tensor imaging (DTI) may be a better biomarker than T2-weighted signal intensity (T2SI) on MRI for CSM. However, there is very little literature on a comparison between the quantitative measurements of DTI and T2SI in the CSM patient population to determine disease severity and recovery. METHODS: A prospective analysis of 46 patients with both preoperative DTI and T2-weighted MRI was undertaken. Normalized T2SI (NT2SI), regardless of the presence or absence of T2SI at the level of maximum compression (LMC), was determined by calculating the T2SI at the LMC/T2SI at the level of the foramen magnum. Regression analysis was performed to determine the relationship of fractional anisotropy (FA), a quantitative measure derived from DTI, and NT2SI individually as well their combination with baseline preoperative modified Japanese Orthopaedic Association (mJOA) score and ∆mJOA score at the 3-, 6-, 12-, and 24-month follow-ups. Goodness-of-fit analysis was done using residual diagnostics. In addition, mixed-effects regression analysis was used to evaluate the impact of FA and NT2SI individually. A p value < 0.05 was selected to indicate statistical significance. RESULTS: Regression analysis showed a significant positive correlation between FA at the LMC and preoperative mJOA score (p = 0.041) but a significant negative correlation between FA at the LMC and the ΔmJOA score at the 12-month follow-up (p = 0.010). All other relationships between FA at the LMC and the baseline preoperative mJOA score or ∆mJOA score at the 3-, 6-, and 24-month follow-ups were not statistically significant. For NT2SI and the combination of FA and NT2SI, no significant relationships with preoperative mJOA score or ∆mJOA at 3, 6, and 24 months were seen on regression analysis. However, there was a significant correlation of combined FA and NT2SI with ∆mJOA score at the 12-month follow-up. Mixed-effects regression revealed that FA measured at the LMC was the only significant predictor of ΔmJOA score (p = 0.03), whereas NT2SI and time were not. Goodness-of-fit analysis did not show any evidence of lack of fit. CONCLUSIONS: In this large prospective study of CSM patients, FA at LMC appears to be a better biomarker for determining long-term outcomes following surgery in CSM patients than NT2SI or the combination values at LMC.

AOSpine Global Survey: International Trends in Utilization of Magnetic Resonance Imaging/Computed Tomography for Spinal Trauma and Spinal Cord Injury across AO Regions.

The aim of this study was to determine the current trends in magnetic resonance imaging (MRI)/computed tomography (CT) utilization for spine trauma in various clinical scenarios. We conducted a survey across six AO regions and preformed pair-wise comparisons between responses obtained from different AO regions. The survey was sent to 5813 surgeons and had a 9.6% response rate with the majority being orthopedic followed by neurosurgeons. In a neurologically intact patient, the predominant imaging modality for all AO regions was CT. For patients with spinal cord injury (SCI), the predominant choice for all AO regions was CT + MRI + x-ray except North America, which was CT + MRI; pair-wise comparisons revealed significant differences involving LATAM (Latin America) versus (Asia-Pacific [APAC], Europe [EU], and Middle East [MEA]) and APAC versus (LATAM and North America [NA]). In a patient with incomplete SCI (ISCI) who presented within 4 h and had CT, the predominant choice for all AO regions was "forgo MRI and proceed to operating room (OR)." Similar to ISCI, in a patient with complete SCI, the predominant option for all AO regions was the same as ISCI, but the range was lower. Pair-wise comparisons noted significant differences between MEA and APAC, with both exhibiting differences compare to NA, LATAM, and EU for complete and ISCI. Most AO regions obtained post-operative MRI only if there was a new deficit. In summary, decisions about the use of a particular imaging modality across AO regions appears to be influenced by the neurological status of the patient upon admission and the presence of neurological deficits post-surgery. Type of residency training and fellowship training did not have an influence on choosing the appropriate imaging modality for both intact and impaired patients. Further study is needed to determine whether accessibility to MRI would change surgeons' attitude toward obtaining MRI in patients with SCI.

Association of Pneumonia, Wound Infection, and Sepsis with Clinical Outcomes after Acute Traumatic Spinal Cord Injury.

Pneumonia, wound infections, and sepsis (PWS) are the leading causes of acute mortality after traumatic spinal cord injury (SCI). However, the impact of PWS on neurological and functional outcomes is largely unknown. The present study analyzed participants from the prospective North American Clinical Trials Network (NACTN) registry and the Surgical Timing in Acute SCI Study (STASCIS) for the association between PWS and functional outcome (assessed as Spinal Cord Independence Measure subscores for respiration and indoor ambulation) at 6 months post-injury. Neurological outcome was analyzed as a secondary end-point. Among 1299 participants studied, 180 (14%) developed PWS during the acute admission. Compared with those without PWS, participants with PWS were mostly male (76% vs. 86%; p = 0.007), or presented with mostly American Spinal Injury Association Impairment Scale (AIS) grade A injury (36% vs. 61%; p < 0.001). There were no statistical differences between participants with or without PWS with respect to time from injury to surgery, and administration of steroids. Dominance analysis showed injury level, baseline AIS grade, and subject pre-morbid medical status collectively accounted for 77.7% of the predicted variance of PWS. Regression analysis indicated subjects with PWS demonstrated higher odds for respiratory (odds ratio [OR] 3.91, 95% confidence interval [CI]: 1.42-10.79) and ambulatory (OR 3.94, 95% CI: 1.50-10.38) support at 6 month follow-up in adjusted analysis. This study has shown an association between PWS occurring during acute admission and poorer functional outcomes following SCI.

Great Hospitals in North America: The Medical College of Wisconsin Neurological Surgery.

The Medical College of Wisconsin Department of Neurosurgery delivers subspecialty adult and pediatric neurosurgical care that is patient-centered, evidence-informed, and value-based. Medical College of Wisconsin research advances the science of neurological disease with the goal of a positive translational effect on clinical care. The department supports an environment of education and scholarship for trainees, faculty, and staff alike. The journey to become a neurosurgical center of excellence was accomplished with the leadership and foresight of the men and women who turned their dreams into reality. The establishment and rise of the department as a national force for neurosurgery and spine is an elegant example of the combination of individual leadership and foresight with synergistic institutional support.

Clinical Outcomes from a Multi-Center Study of Human Neural Stem Cell Transplantation in Chronic Cervical Spinal Cord Injury.

Human neural stem cell transplantation (HuCNS-SC®) is a promising central nervous system (CNS) tissue repair strategy in patients with stable neurological deficits from chronic spinal cord injury (SCI). These immature human neural cells have been demonstrated to survive when transplanted in vivo, extend neural processes, form synaptic contacts, and improve functional outcomes after experimental SCI. A phase II single blind, randomized proof-of-concept study of the safety and efficacy of HuCNS-SC transplantation into the cervical spinal cord was undertaken in patients with chronic C5-7 tetraplegia, 4-24 months post-injury. In Cohort I (n = 6) dose escalation from 15,000,000 to 40,000,000 cells was performed to determine the optimum dose. In Cohort II an additional six participants were transplanted at target dose (40,000,000) and compared with four untreated controls. Within the transplant group, there were nine American Spinal Injury Association Impairment Scale (AIS) B and three AIS A participants with a median age at transplant of 28 years with an average time to transplant post-injury of 1 year. Immunosuppression was continued for 6 months post-transplant, and immunosuppressive blood levels of tacrolimus were achieved and well tolerated. At 1 year post-transplantation, there was no evidence of additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging. In summary, the incremental dose escalation design established surgical safety, tolerability, and feasibility in Cohort I. Interim analysis of Cohorts I and II demonstrated a trend toward Upper Extremity Motor Score (UEMS) and Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) motor gains in the treated participants, but at a magnitude below the required clinical efficacy threshold set by the sponsor to support further development resulting in early study termination.