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.

Electrical stimulation enhances sciatic nerve regeneration using a silk-based conductive scaffold beyond traditional nerve guide conduits.

Despite recent advancements in peripheral nerve regeneration, the creation of nerve conduits with chemical and physical cues to enhance glial cell function and support axonal growth remains challenging. This study aimed to assess the impact of electrical stimulation (ES) using a conductive nerve conduit on sciatic nerve regeneration in a rat model with transection injury. The study involved the fabrication of conductive nerve conduits using silk fibroin and Au nanoparticles (AuNPs). Collagen hydrogel loaded with green fluorescent protein (GFP)-positive adipose-derived mesenchymal stem cells (ADSCs) served as the filling for the conduit. Both conductive and non-conductive conduits were applied with and without ES in rat models. Locomotor recovery was assessed using walking track analysis. Histological evaluations were performed using H&E, luxol fast blue staining and immunohistochemistry. Moreover, TEM analysis was conducted to distinguish various ultrastructural aspects of sciatic tissue. In the ES + conductive conduit group, higher S100 (p < 0.0001) and neurofilament (p < 0.001) expression was seen after 6 weeks. Ultrastructural evaluations showed that conductive scaffolds with ES minimized Wallerian degeneration. Furthermore, the conductive conduit with ES group demonstrated significantly increased myelin sheet thickness and decreased G. ratio compared to the autograft. Immunofluorescent images confirmed the presence of GFP-positive ADSCs by the 6th week. Locomotor recovery assessments revealed improved function in the conductive conduit with ES group compared to the control group and groups without ES. These results show that a Silk/AuNPs conduit filled with ADSC-seeded collagen hydrogel can function as a nerve conduit, aiding in the restoration of substantial gaps in the sciatic nerve with ES. Histological and locomotor evaluations indicated that ES had a greater impact on functional recovery compared to using a conductive conduit alone, although the use of conductive conduits did enhance the effects of ES.

Diffusion Tensor Imaging in Diagnosing and Evaluating Degenerative Cervical Myelopathy: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review. OBJECTIVE: Degenerative cervical myelopathy (DCM) is a common spinal cord disorder necessitating surgery. We aim to explore how effectively diffusion tensor imaging (DTI) can distinguish DCM from healthy individuals and assess the relationship between DTI metrics and symptom severity. METHODS: We included studies with adult DCM patients who had not undergone decompressive surgery and implemented correlation analyses between DTI parameters and severity, or compared healthy controls and DCM patients. RESULTS: 57 studies were included in our meta-analysis. At the maximal compression (MC) level, fractional anisotropy (FA) exhibited lower values in DCM patients, while apparent diffusion coefficient (ADC), mean diffusivity (MD), and radial diffusivity (RD) were notably higher in the DCM group. Moreover, our investigation into the diagnostic utility of DTI parameters disclosed high sensitivity, specificity, and area under the curve values for FA (.84, .80, .83 respectively) and ADC (.74, .84, .88 respectively). Additionally, we explored the correlation between DTI parameters and myelopathy severity, revealing a significant correlation of FA (.53, 95% CI:0.40 to .65) at MC level with JOA/mJOA scores. CONCLUSION: Current guidelines for DCM suggest decompressive surgery for both mild and severe cases. However, they lack clear recommendations on which mild DCM patients might benefit from conservative treatment vs immediate surgery. ADC's role here could be pivotal, potentially differentiating between healthy individuals and DCM. While it may not correlate with symptom severity, it might predict surgical outcomes, making it a valuable imaging biomarker for clearer management decisions in mild DCM.

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.

A Clinical Practice Guideline for Prevention, Diagnosis and Management of Intraoperative Spinal Cord Injury: Recommendations for Use of Intraoperative Neuromonitoring and for the Use of Preoperative and Intraoperative Protocols for Patients Undergoing Spine Surgery.

STUDY DESIGN: Development of a clinical practice guideline following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process. OBJECTIVE: The objectives of this study were to develop guidelines that outline the utility of intraoperative neuromonitoring (IONM) to detect intraoperative spinal cord injury (ISCI) among patients undergoing spine surgery, to define a subset of patients undergoing spine surgery at higher risk for ISCI and to develop protocols to prevent, diagnose, and manage ISCI. METHODS: All systematic reviews were performed according to PRISMA standards and registered on PROSPERO. A multidisciplinary, international Guidelines Development Group (GDG) reviewed and discussed the evidence using GRADE protocols. Consensus was defined by 80% agreement among GDG members. A systematic review and diagnostic test accuracy (DTA) meta-analysis was performed to synthesize pooled evidence on the diagnostic accuracy of IONM to detect ISCI among patients undergoing spinal surgery. The IONM modalities evaluated included somatosensory evoked potentials (SSEPs), motor evoked potentials (MEPs), electromyography (EMG), and multimodal neuromonitoring. Utilizing this knowledge and their clinical experience, the multidisciplinary GDG created recommendations for the use of IONM to identify ISCI in patients undergoing spine surgery. The evidence related to existing care pathways to manage ISCI was summarized and based on this a novel AO Spine-PRAXIS care pathway was created. RESULTS: Our recommendations are as follows: (1) We recommend that intraoperative neurophysiological monitoring be employed for high risk patients undergoing spine surgery, and (2) We suggest that patients at "high risk" for ISCI during spine surgery be proactively identified, that after identification of such patients, multi-disciplinary team discussions be undertaken to manage patients, and that an intraoperative protocol including the use of IONM be implemented. A care pathway for the prevention, diagnosis, and management of ISCI has been developed by the GDG. CONCLUSION: We anticipate that these guidelines will promote the use of IONM to detect and manage ISCI, and promote the use of preoperative and intraoperative checklists by surgeons and other team members for high risk patients undergoing spine surgery. We welcome teams to implement and evaluate the care pathway created by our GDG.

Prevention, Diagnosis, and Management of Intraoperative Spinal Cord Injury in the Setting of Spine Surgery: A Proposed Care Pathway.

STUDY DESIGN: This study is a mixed methods approach. OBJECTIVES: Intraoperative spinal cord injury (ISCI) is a challenging complication in spine surgery. Intra-operative neuromonitoring (IONM) has been developed to detect changes in neural function. We report on the first multidisciplinary, international effort through AO Spine and the Praxis Spinal Cord Institute to develop a comprehensive guideline and care pathway for the prevention, diagnosis, and management of ISCI. METHODS: Three literature reviews were registered on PROSPERO (CRD 42022298841) and performed according to PRISMA guidelines: (1) Definitions, frequency, and risk factors for ISCI, (2) Meta-analysis of the accuracy of IONM for diagnosis of ISCI, (3) Reported management approaches for ISCI and related events. The results were presented in a consensus session to decide the definition of IONM and recommendation of its use in high-risk cases. Based on a literature review of management strategies for ISCI, an intra-operative checklist and overall care pathway was developed by the study team. RESULTS: An operational definition and high-risk patient categories for ISCI were established. The reported incidence of deficits was documented to be higher in intramedullary tumour spine surgery. Multimodality IONM has a high sensitivity and specificity. A guideline recommendation of IONM to be employed for high-risk spine cases was made. The different sections of the intraoperative checklist include surgery, anaesthetic and neurophysiology. The care pathway includes steps (1) initial clinical assessment, (2) pre-operative planning, (3) surgical/anaesthetic planning, (4) intra-operative management, and (5) post-operative management. CONCLUSIONS: This is the first evidence based comprehensive guideline and care pathway for ISCI using the GRADE methodology. This will facilitate a reduction in the incidence of ISCI and improved outcomes from this complication. We welcome the wide implementation and validation of these guidelines and care pathways in prospective, multicentre studies.

Correlation Between Pre-Operative Diffusion Tensor Imaging Indices and Post-Operative Outcome in Degenerative Cervical Myelopathy: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review. OBJECTIVES: The correlation between pre-operative diffusion tensor imaging (DTI) metrics and post-operative clinical outcomes in patients with degenerative cervical myelopathy (DCM) has been widely investigated with different studies reporting varied findings. We conducted a systematic review to determine the association between DTI metric and clinical outcomes after surgery. METHODS: We identified relevant articles that investigated the relationship between pre-operative DTI indices and post-operative outcome in DCM patients by searching PubMed/MEDLINE, Web of Science, Scopus, and EMBASE from inception until October 2023. In addition, quantitative synthesis and meta-analyses were performed. RESULTS: FA was significantly correlated with postoperative JOA or mJOA across all age and follow up subgroups, changes observed in JOA or mJOA from preoperative to postoperative stages (Δ JOA or Δ mJOA) in subgroups aged 65 and above and in those with a follow-up period of 6 months or more, as well as recovery rate in all studies pooled together and also in the under-65 age bracket. Additionally, a significant correlation was demonstrated between recovery rate and ADC across all age groups. No other significant correlations were discovered between DTI parameters (MD, AD, and ADC) and post-operative outcomes. CONCLUSION: DTI is a quantitative noninvasive evaluation tool that correlates with severity of DCM. However, the current evidence is still elusive regarding whether DTI metric is a validated tool for predicting the degree of post-operative recovery, which could potentially be useful in patient selection for surgery.

The Prevalence of Asymptomatic Cervical Spinal Cord Compression in Individuals Presenting With Symptomatic Lumbar Spinal Stenosis: A Meta-Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: The aim of this study was to determine the prevalence of asymptomatic cervical spinal cord compression (CSCC) in individuals with lumbar spinal stenosis (LSS). METHODS: A systematic electronic search was conducted in Medline, EMBASE, Scopus, and Web of Science without language restriction, with no starting date limit to June 8, 2023, to define the prevalence of asymptomatic CSCC in symptomatic LSS patients. Asymptomatic CSCC was defined based on radiographic studies. All types of studies were included in the review. Meta-analysis was performed on the reported prevalence of asymptomatic CSCC in LSS. RESULTS: The database search yielded 10,272 articles. After a full-text review, five studies were included in the final review, comprising a total of 1043 cases. Two studies had a low risk for bias, two moderate, and one estimated to be high risk. The range of prevalence of asymptomatic CSCC in LSS in the five included studies was between 24% and 61%. Meta-analysis on the reported prevalence of asymptomatic CSCC patients with symptomatic LSS demonstrated that the random pooled prevalence was 35% (95% CI: 23 to 48). CONCLUSIONS: Asymptomatic CSCC appears to occur in a high number of patients, with this study noting its presence in one-third of patients with LSS. Based on these findings, we strongly recommend that spine surgeons exercise particular caution during the positioning of patients who are undergoing surgery for lumbar stenosis. Furthermore, it is imperative to monitor individuals with symptomatic LSS closely for any potential signs of emerging myelopathy.

Quality of in-hospital care in traumatic spinal column and cord injuries (TSC/SCI) in I.R Iran.

PURPOSE: This study aimed to implement the Quality of Care (QoC) Assessment Tool from the National Spinal Cord/Column Injury Registry of Iran (NSCIR-IR) to map the current state of in-hospital QoC of individuals with Traumatic Spinal Column and Cord Injuries (TSCCI). METHODS: The QoC Assessment Tool, developed from a scoping review of the literature, was implemented in NSCIR-IR. We collected the required data from two primary sources. Questions regarding health system structures and care processes were completed by the registrar nurse reviewing the hospital records. Questions regarding patient outcomes were gathered through patient interviews. RESULTS: We registered 2812 patients with TSCCI over six years from eight referral hospitals in NSCIR-IR. The median length of stay in the general hospital and intensive care unit was four and five days, respectively. During hospitalization 4.2% of patients developed pressure ulcers, 83.5% of patients reported satisfactory pain control and none had symptomatic urinary tract infections. 100%, 80%, and 90% of SCI registration centers had 24/7 access to CT scans, MRI scans, and operating rooms, respectively. Only 18.8% of patients who needed surgery underwent a surgical operation in the first 24 h after admission. In-hospital mortality rate for patients with SCI was 19.3%. CONCLUSION: Our study showed that the current in-hospital care of our patients with TSCCI is acceptable in terms of pain control, structure and length of stay and poor regarding in-hospital mortality rate and timeliness. We must continue to work on lowering rates of pressure sores, as well as delays in decompression surgery and fatalities.

Predictors of Outcome After Surgical Decompression for mild degenerative Cervical Myelopathy -A Systematic Review.

STUDY DESIGN: Systematic Reviews. OBJECTIVES: To investigate predictors of surgical outcomes for mild Degenerative Cervical Myelopathy (DCM) by reviewing all related studies conducted at this point. METHODS: An electronic search was carried out in PubMed, EMBASE, Scopus, and Web of Science until June 23, 2021. Full-text articles reporting surgical outcome predictors of mild DCM cases were eligible. We included studies with mild DCM which was defined as a modified Japanese Orthopaedic Association score of 15 to 17 or a Japanese Orthopaedic Association score of 13 to 16. Independent reviewers screened all the records, and discrepancies between the reviewers were solved in a session with the senior author. For risk of bias assessment, RoB 2 tool was used for randomized clinical trials and ROBINS-I for non-randomized studies. RESULTS: After screening 6 087 manuscripts, only 8 studies met the inclusion criteria. Lower pre-operative mJOA scores and quality-of-life measurement scores were reported by multiple studies to predict better surgical outcomes compared to other groups. High-intensity pre-operative T2 magnetic resonance imaging (MRI) was also reported to predict poor outcomes. Neck pain before intervention resulted in improved patient-reported outcomes. Two studies also reported motor symptoms prior to surgery as outcome predictors. CONCLUSION: Lower quality of life before surgery, neck pain, lower pre-operative mJOA scores, motor symptoms before surgery, female gender, gastrointestinal comorbidities, surgical procedure and surgeon's experience with specific techniques, and high signal intensity of cord in T2 MRI were the surgical outcome predictors reported in the literature. Lower Quality of Life (QoL) score and neck prior to surgery were reported as predictors of the more improved outcome, but high cord signal intensity in T2 MRI was reported as an unfavorable outcome predictor.

Post-discharge follow-up of patients with spine trauma in the National Spinal Cord Injury Registry of Iran during the COVID-19 pandemic: Challenges and lessons learned.

PURPOSE: The purpose of the National Spinal Cord Injury Registry of Iran (NSCIR-IR) is to create an infrastructure to assess the quality of care for spine trauma and in this study, we aim to investigate whether the NSCIR-IR successfully provides necessary post-discharge follow-up data for these patients. METHODS: An observational prospective study was conducted from April 11, 2021 to April 22, 2022 in 8 centers enrolled in NSCIR-IR, respectively Arak, Rasht, Urmia, Shahroud, Yazd, Kashan, Tabriz, and Tehran. Patients were classified into three groups based on their need for care resources, respectively: (1) non-spinal cord injury (SCI) patients without surgery (group 1), (2) non-SCI patients with surgery (group 2), and (3) SCI patients (group 3). The assessment tool was a self-designed questionnaire to evaluate the care quality in 3 phases: pre-hospital, in-hospital, and post-hospital. The data from the first 2 phases were collected through the registry. The post-hospital data were collected by conducting follow-up assessments. Telephone follow-ups were conducted for groups 1 and 2 (non-SCI patients), while group 3 (SCI patients) had a face-to-face visit. This study took place during the COVID-19 pandemic. Data on age and time interval from injury to follow-up were expressed as mean ± standard deviation (SD) and response rate and follow-up loss as a percentage. RESULTS: Altogether 1538 telephone follow-up records related to 1292 patients were registered in the NSCIR-IR. Of the total calls, 918 (71.05%) were related to successful follow-ups, but 38 cases died and thus were excluded from data analysis. In the end, post-hospital data from 880 patients alive were gathered. The success rate of follow-ups by telephone for groups 1 and 2 was 73.38% and 67.05% respectively, compared to 66.67% by face-to-face visits for group 3, which was very hard during the COVID-19 pandemic. The data completion rate after discharge ranged from 48% to 100%, 22%-100% and 29%-100% for groups 1 - 3. CONCLUSIONS: To improve patient accessibility, NSCIR-IR should take measures during data gathering to increase the accuracy of registered contact information. Regarding the loss to follow-ups of SCI patients, NSCIR-IR should find strategies for remote assessment or motivate them to participate in follow-ups through, for example, providing transportation facilities or financial support.

In-hospital mortality rate in subaxial cervical spinal cord injury patients: a systematic review and meta-analysis.

PURPOSE: To determine existing trends concerning in-hospital mortality in patients with traumatic subaxial cervical spinal cord injury (SCI) over the last four decades. METHODS: We searched MEDLINE and EMBASE to assess the role of the following factors on in-hospital mortality over the last four decades: neurological deficit, age, surgical decompression, use of computed tomography (CT) and magnetic resonance imaging (MRI), use of methylprednisolone in the acute post-injury period, and study location (developing versus developed countries). RESULTS: Among 3333 papers after deduplication, 21 studies met the eligibility criteria. The mortality rate was 17.88% [95% confidence interval (CI): 12.9-22.87%]. No significant trend in mortality rate was observed over the 42-year period (meta-regression coefficient = 0.317; p = 0.372). Subgroup analysis revealed no significant association between acute subaxial cervical SCI-related mortality when stratified by use of surgery, administration of methylprednisolone, use of MRI and CT imaging, study design (prospective versus retrospective study), and study location. The mortality rate was significantly higher in complete SCI (20.66%, p = 0.002) and American Spinal Injury Association impairment scale (AIS) A (20.57%) and B (9.28%) (p = 0.028). CONCLUSION: A very low level of evidence showed that in-hospital mortality in patients with traumatic subaxial cervical SCI did not decrease over the last four decades despite diagnostic and therapeutic advancements. The overall acute mortality rate following subaxial cervical SCI is 17.88%. We recommend reporting a stratified mortality rate according to key factors such as treatment paradigms, age, and severity of injury in future studies.

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.

Pressure ulcers and acute risk factors in individuals with traumatic spinal fractures with or without spinal cord injuries: A prospective analysis of the National Spinal Column/Cord Injury Registry of Iran (NSCIR-IR) data.

PURPOSE: To identify risk factors for developing pressure ulcers (PUs) in the acute care period of traumatic spinal fracture patients with or without spinal cord injuries (SCIs). METHODS: Data were collected prospectively in participating the National Spinal column/Cord Injury Registry of Iran (NSCIR-IR) from individuals with traumatic spinal fractures with or without SCIs, inclusive of the hospital stay from admission to discharge. Trained nursing staff examined the patients for the presence of PUs every 8 h during their hospital stay. The presence and grade of PUs were assessed according to the European Pressure Ulcer Advisory Panel classification. In addition to PU, following data were also extracted from the NSCIR-IR datasets during the period of 2015 - 2021: age, sex, Glasgow coma scale score at admission, having SCIs, marital status, surgery for a spinal fracture, American Spinal Injury Association impairment scale (AIS), urinary incontinence, level of education, admitted center, length of stay in the intensive care unit (ICU), hypertension, respiratory diseases, consumption of cigarettes, diabetes mellitus and length of stay in the hospital. Logistic regression models were used to estimate the unadjusted and adjusted odds ratio (OR) with 95% confidence intervals (CI). RESULTS: Altogether 2785 participants with traumatic spinal fractures were included. Among them, 87 (3.1%) developed PU during their hospital stay and 392 (14.1%) had SCIs. In the SCI population, 63 (16.1%) developed PU during hospital stay. Univariate logistic regression for the whole sample showed that marital status, having SCIs, urinary incontinence, level of education, treating center, number of days in the ICU, age, and Glasgow coma scale score were significant predictors for PUs. However, further analysis by multiple logistic regression only revealed the significant risk factors to be the treating center, marital status, having SCIs, and the number of days in the ICU. For the subgroup of individuals with SCIs, marital status, AIS, urinary incontinence, level of education, the treating center, the number of days in the ICU and the number of days in the hospital were significant predictors for PUs by univariate analysis. After adjustment in the multivariate model, the treating center, marital status (singles vs. marrieds, OR = 3.06, 95% CI: 1.55 - 6.03, p = 0.001), and number of days in the ICU (OR = 1.06, 95% CI: 1.04 - 1.09, p < 0.001) maintained significance. CONCLUSIONS: These data confirm that individuals with traumatic spinal fractures and SCIs, especially single young patients who suffer from urinary incontinence, grades A-D by AIS, prolonged ICU stay, and more extended hospitalization are at increased risk for PUs; as a result strategies to minimize PU development need further refinement.

Adopting and adapting clinical practice guidelines for timing of decompressive surgery in acute spinal cord injury from a developed world context to a developing region.

PURPOSE: The proper application of high-quality clinical practice guidelines improves trauma patients' care and outcomes. This study aimed to adopt and adapt guidelines on the timing of decompressive surgery in acute spinal cord injury (SCI) in Iranian clinical settings. METHODS: This study followed a systematic search and review of the literature to enter them into the selection process. The source guidelines' clinical suggestions were converted into clinical scenarios for clinical questions on the timing of decompressive surgery. After summarizing the scenarios, we prepared an initial list of recommendations based on the status of the Iranian patients and the health system. The ultimate conclusion was reached with the help of a national interdisciplinary expert panel comprising 20 experts throughout the country. RESULTS: A total of 408 records were identified. After title and abstract screening, 401 records were excluded, and the full texts of the remaining seven records were reviewed. Based on our screening process, only one guideline included recommendations on the topic of interest. All of the recommendations were accepted by the expert panel with slight changes due to resource availability in Iran. The final two recommendations were the consideration of early surgery (≤24 h) as a treatment option in adult patients with traumatic central cord syndrome and in adult patients with acute SCI regardless of the level of injury. CONCLUSION: Considering early surgery for adult patients with acute traumatic SCI regardless of the level of injury was the final recommendation for Iran. Although most of the recommendations are adoptable in developing countries, issues with infrastructure and availability of resources are the limitations.

The Role of Intraspinal Administration of Self-Assembled Peptide on Locomotion Recovery After Spinal Cord Injury: A Systematic Review and Meta-Analysis Study.

BACKGROUND: Spinal cord injury (SCI) treatment is still a challenge and new treatments that help these patients are being considered. Recent studies showed that the use of self-assembled peptide (SAP) can be useful in SCI treatment. MATERIALS AND METHODS: In this meta-analysis, we investigated the effect of SAP administration on locomotion recovery after SCI. Records were obtained from a comprehensive search of data bases. Articles were scrutinized for inclusion and exclusion criteria. Data were analyzed and results were reported as standardized mean difference (SMD) with 95% CI. Subgroup analysis was also performed. RESULTS: A total of 14 studies and 17 separate experiments were included in the final analysis. Treatment with SAP structures after SCI resulted in a significant improvement in animal motor function (SMD = 1.13; 95% CI: 0.68-1.58; p < 0.0001). SAP treatment facilitated axon sprouting (SMD = 0.76; 95% CI: 0.33-1.18; p < 0.0001) and reduction of glial scar (SMD = -1.02; 95% CI: -1.94 to -0.09; p = 0.03). The difference in SAP type, its concentration, follow-up time, and SCI model had no effect on SAP effectiveness. In addition, SAP administration had a similar effect on improving locomotion in all three immediate, acute, and subacute phases which gives the good news of using this treatment for patients who are in the chronic phase. CONCLUSION: SAP treatment can be considered as a potential treatment to help the motor recovery of SCI and axon regeneration.

Complete Versus Incomplete Surgical Resection in Intramedullary Astrocytoma: Systematic Review with Individual Patient Data Meta-Analysis.

STUDY DESIGN: Systematic reviewBackground: Considering the infiltrative nature of intramedullary astrocytoma, the goal of surgery is to have a better patient related outcome. OBJECTIVE: To compare the overall survival (OS) and neurologic outcomes of complete vs incomplete surgical resection for patients with intramedullary astrocytoma. METHODS: A comprehensive search of MEDLINE, CENTRAL and EMBASE was conducted by two independent reviewers. Individual patient data (IPD) analysis and multivariate Cox Proportional Hazard Model was developed to measure the effect of surgical strategies on OS, post-operative neurological improvement (PNI), and neurological improvement in the last follow up (FNI). RESULTS: We included 1079 patients from 35 studies. Individual patient data of 228 patients (13 articles) was incorporated into the integrative IPD analysis. Kaplan-Meier survival analysis showed complete resection (CR) significantly improved OS in comparison with the incomplete resection (IR) (log-rank test, P = .004). In the multivariate IPD analysis, three prognostic factors had significant effect on the OS: (1) Extent of Resection, (2) pathology grade, and (3) adjuvant therapy. We observed an upward trend in the popularity of chemotherapy, but CR, IR, and radiotherapy had relatively stable trends during three decades. CONCLUSION: Our study shows that CR can improve OS when compared to IR. Patients with spinal cord astrocytoma undergoing CR had similar PNI and FNI compared to IR. Therefore, CR should be the primary goal of surgery, but intraoperative decisions on the extent of resection should be relied on to prevent neurologic adverse events. Due to significant effect of adjuvant therapy on OS, PNI and FNI, it could be considered as the routine treatment strategy for spinal cord astrocytoma.

Comparing epidemiologic features, outcomes, and diagnostic and therapeutic procedures of traumatic patients before and during COVID-19 pandemic: Data from the National Trauma Registry of Iran.

PURPOSE: To prepare for future possible communicable disease epidemics/pandemics, health care providers should know how the COVID-19 pandemic influenced injured patients. This study aimed to compare epidemiologic features, outcomes, and diagnostic and therapeutic procedures of trauma patients admitted to a university-affiliated hospital before and during the pandemic. METHODS: This retrospective study was performed on data from the National Trauma Registry of Iran. All injured patients admitted to the hospital from July 25, 2016 to March 10, 2021 were included in the study. The patients were excluded if they had hospital length of stay less than 24 h. The injury outcomes, trauma mechanisms, and therapeutic and diagnostic procedures of the 2 periods: before (from July 25, 2016 to February 18, 2020) and during (from February 19, 2020 to March 10, 2021) COVID-19 pandemic were compared. All analyses were performed using STATA version 14.0 software (Stata Corporation, College Station, TX). RESULTS: Totally, 5014 patients were included in the registry. Of them, 773 (15.4%) were registered after the beginning of the COVID-19 pandemic on February 19, 2020, while 4241 were registered before that. Gender, education level, and cause of injury were significantly different among the patients before and after the beginning of the pandemic (p < 0.001). In the ≤ 15 years and ≥ 65 years age groups, injuries decreased significantly during the COVID-19 pandemic (p < 0.001). The frequency of intensive care unit (ICU) admission decreased from 694 (16.4%) to 88 (11.4%) (p < 0.001). The mean length of stay at the hospital (days) and at the ICU (days) declined as follow: 8.3 (SD = 17.2) vs. 5.5 (SD = 6.1), p < 0.001 and 7.5 (SD = 11.5) vs. 4.5 (SD = 6.3), p < 0.022. The frequency of diagnostic and therapeutic procedures before and during the pandemic was as follows, respectively: ultrasonography 905 (21.3%) vs. 417 (53.9%) (p < 0.001), echocardiography 313 (7.4%) vs. 107 (13.8%) (p < 0.001), angiography 1597 (37.7%) vs. 534 (69.1%) (p < 0.001), MRI 166 (3.9%) vs. 51 (6.6%) (p < 0.001), surgery 3407 (80.3%) vs. 654 (84.6%) (p < 0.001), and internal/external fixation 1215 (28.6%) vs. 336 (43.5%) (p < 0.001). CONCLUSION: The pandemic affected the epidemiology of traumatic patients in terms of gender, age, educational level, and trauma mechanism. It changed the outcomes of injured patients: ICU admission, length of stay at the hospital and ICU decreased. The patients received more diagnostic and therapeutic procedures during the pandemic. To be more precise, more research is needed on the details.

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.

Combined application of neural stem/progenitor cells and scaffolds on locomotion recovery following spinal cord injury in rodents: a systematic review and meta-analysis.

BACKGROUND: This present study evaluates the pre-clinical evidence on the efficacy of NS/PC and scaffold (NS/PC + scaffold) transplantation on locomotor recovery after traumatic spinal cord injury (SCI). METHOD: Two independent reviewers screened the records gathered through a systematic search in MEDLINE, Embase, Scopus, and Web of Sciences databases. Studies on rats/mice evaluating the efficacy of simultaneous transplantation of NS/PCs and scaffold in the treatment of SCI were included. The results were reported as standardized mean difference (SMD) and 95% confidence interval (95% CI). RESULTS: Forty-seven articles were retrieved. Analyses showed that NS/PC + scaffold transplantation significantly improved locomotion in animals with SCI compared to that of the non-treatment group (SMD = 2.71, 95% CI: 1.89 to 3.54; I2 = 95.15%, p < 0.0001), scaffold alone (SMD = 2.28; 95% CI: 1.56 to 3.00; I2 = 94.38%; p < 0.0001), and NS/PCs alone (SMD = 1.74, 95% CI: 0.64 to 2.83; I2 = 92.02%, p < 0.0001). Moreover, the effectiveness of the treatment significantly increases when PLGA-based scaffolds and antibiotics are used. In addition, the NS/PC + scaffold transplantation during the first week after injury led to a significant improvement in locomotion, while concomitant transplantation of NS/PC + scaffold did not improve locomotion in cervical lesions. CONCLUSION: The findings showed that using NS/PCs with scaffold not only improves locomotion recovery, but also is superior to NS/PCs alone and scaffold alone. Future experiments and translational clinical studies are recommended to focus on the assessment of the safety and efficacy of the application of NS/PC + scaffold on SCI recovery.