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Objectives: Since their introduction, electronic International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) calculators have evolved to powerful tools providing error-free ISNCSCI classifications in education, research and clinical practice. For increased accessibility and dissemination, a multilingual support is mandatory. The aim of this work was to setup a general multilingual framework for the freely available ISNCSCI calculator ( https://ais.emsci.org ) of the European Multicenter Study about Spinal Cord Injury (EMSCI)., Methods: The graphical user interface (GUI) and PDF export of the ISNCSCI worksheet were adapted for multilingual implementations. Their language-dependent content was identified. These two steps called internationalization have to be performed by a programmer in preparation of the translations of the English terms into the target language. This step following the internationalization is called localization and needs input by a bi-lingual clinical expert. Two EMSCI partners provided Standard Mandarin Chinese and Czech translations. Finally, the translations are made available in the application., Results: The GUI and PDF export of the ISNCSCI worksheet were internationalized. The default language of the calculator is set according to the user's preferences with the additional possibility for manual language selection. The Chinese as well as a Czech translation were provided freely to the SCI community., Conclusions: The possibility of multilingual implementations independent from software developers opens the use of ISNCSCI computer algorithms as an efficient training tool on a larger scale., (© 2021. The Author(s).)

Study Design: Prospective pre-post study., Objectives: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) represents the most frequently used assessment to determine the level and severity of a spinal cord injury (SCI). The guidelines for ISNCSCI are complex and challenging. Knowledge of its correct execution needs to be imparted precisely. The aim of this study was to investigate whether hands-on instructional courses can increase the knowledge of the ISNCSCI examination guidelines., Setting: European Multicenter Study about SCI., Methods: Before and after the instructional courses, participants were asked to complete questionnaires. The set of questions covered the most important aspects of the examination guidelines. Attendees were asked to self-rate their occupation and experience in ISNCSCI., Results: The comparison of pretest and posttest results of 164 attendees from 2014 to 2018 revealed an improvement of knowledge reflected by an increase of correct answers from 66 ± 17% before to 89 ± 11% after the course (p < 0.01). The improvement was not associated with occupation (p > 0.1). However, the correctness of pretest results differed concerning both the period of experience with ISNCSCI (p < 0.05) and the course language (p < 0.01), while the frequency of execution resulted in differences in the posttest (p = 0.01)., Conclusions: Instructional courses substantially improve knowledge of the ISNCSCI examination guidelines. Differences in knowledge present before the course leveled off after the course. Comprehensive theoretical training is strongly recommended to ensure reliability and validity of ISNCSCI examinations in clinical routine and research. Albeit being practiced in the instructional courses, the benefit of hands-on training still needs to be systematically evaluated in future studies., (© 2020. The Author(s).)

Study Design: Multicenter observational study., Objective: To describe the long-term outcome of functional independence and quality of life (QoL) for individuals with traumatic and ischemic SCI beyond the first year after injury., Setting: A multicenter study in Germany., Methods: Participants of the European multicenter study about spinal cord injury (EMSCI) of three German SCI centers were included and followed over time by the German spinal cord injury cohort study (GerSCI). Individuals' most recent spinal cord independence measure (SCIM) scores assessed by a clinician were followed up by a self-report (SCIM-SR) and correlated to selected items of the WHO short survey of quality of life (WHO-QoL-BREF)., Results: Data for 359 individuals were obtained. The average time passed the last clinical SCIM examination was 81.47 (SD 51.70) months. In total, 187 of the 359 received questionnaires contained a completely evaluable SCIM-SR. SCIM scores remained stable with the exception of reported management of bladder and bowel resulting in a slight decrease of SCIM-SR of -2.45 points (SD 16.81). SCIM-SR scores showed a significant correlation with the selected items of the WHO-QoL-BREF (p < 0.01) with moderate to strong influence., Conclusion: SCIM score stability over time suggests a successful transfer of acquired independence skills obtained during primary rehabilitation into the community setting paralleled by positively related QoL measurements but bladder and bowel management may need special attention., (© 2021. The Author(s).)

Study Design: Retrospective analysis of prospectively collected data., Objective: Central cord syndrome (CCS) is reported to have better outcomes than other cervical lesions, especially for ambulation and bladder recovery. However, a formal comparison between patients with CCS and other incomplete cervical spinal cord injuries (iCSCI) is lacking. Aim of the study is to investigate the neurological and functional outcomes in patients with or without CCS., Setting: European Multicenter Study., Methods: Data following SCI were derived from the European Multicenter Study about Spinal Cord Injury Database. CCS was diagnosed based on a difference of at least ten points of motor score in favour of the lower extremities. Patients were evaluated at 30 days, 6 months and 1 year from injury. The neurological and functional data were collected at each time point based on the International Standards for Neurological Classification of Spinal Cord injury (ISNSCI) and Spinal Cord Independence Measure (SCIM). Patients were selected with a matching procedure based on lesion severity, neurological level of injury (NLI) and age. Evaluation of the outcomes was performed by means of two-way Anova for repeated measures., Results: The matching produced 110 comparable dyads. At all time points, upper extremity motor scores remained lower than lower extremity motor scores in CCS compared with iCSCI. With regard to daily life independence, both cohorts achieved comparable improvements in self-care sub-scores between T0 and T2 (6.6 ± 6.5 in CCS vs 8.2 ± 6.9 in iCSCI, p = 0.15) but this sub-score was significantly lower in CCS compared with iCSCI (3.6 ± 5.2 in CCS vs 7.3 ± 7.0 in iCSCI at T0, 13.7 ± 6.2 vs 16.5 ± 5.7 at T2), while the other sub-scores were comparable., Conclusions: In contrast to previous reports, people with CCS have poorer outcomes of self-care ability compared with iCSCI.

Study Design: Multicenter prospective cohort., Objective: To discern neurological- and functional recovery in patients with a traumatic thoracic spinal cord injury (TSCI), conus medullaris syndrome (CMS), and cauda equina syndrome (CES)., Setting: Specialized spinal cord injury centers in Europe., Method: Lower extremity motor score (LEMS) and spinal cord independent measure (SCIM) scores from patients with traumatic TSCI, CMS, and CES were extracted from the EMSCI database. Scores from admittance and during rehabilitation at 1, 3, 6, and 12 months were compared. Linear mixed models were used to statistically analyse differences in outcome, which were corrected for the ASIA Impairment Scale (AIS) in the acute phase., Results: Data from 1573 individuals were analysed. Except for the LEMS in patients with a CES AIS A, LEMS, and SCIM significantly improved over time for patients with a TSCI, CMS, and CES. Irrespectively of the AIS score, recovery in 12 months after trauma as measured by the LEMS showed a statistically significant difference between patients with a TSCI, CMS, and CES. Analysis of SCIM score showed no difference between patients with TSCI, CMS, or CES., Conclusion: Difference in recovery between patients with a traumatic paraplegia is based on neurological (motor) recovery. Regardless the ceiling effect in CES patients, patients with a mixed upper and lower motor neuron syndrome (CMS) showed a better recovery compared with patients with a upper motor neuron syndrome (TSCI). These findings enable stratifications of patients with paraplegia according to the level and severity of SCI.

Study Design: A prospective single arm study., Objectives: Previously we have demonstrated that magnetic resonance (MR) defecography is feasible in participants with complete spinal cord injury (SCI). The main aim of this study is to evaluate whether MR defecography can provide objective parameters correlating with the clinical manifestations of neurogenic bowel dysfunction (NBD) in participants with SCI., Setting: A monocentric study in a comprehensive care university hospital Spinal Cord Injury Center., Methods: Previously published MR defecography parameters (anorectal angle (ARA), hiatal descent (M-line) and hiatal width (H-line)) of twenty participants with SCI were now compared to a standardized clinical assessment of NBD. Descriptive statistics, correlations and t-tests for independent samples were calculated., Results: The significantly higher values for the ARA at rest and M-line at rest in participants with SCI correlated with the clinical assessment of bowel incontinence. Furthermore, in nearly half of the investigated SCI cohort the normally positive difference between ARA, M-line and H-line at rest and during defecation became negative suggesting pelvic floor dyssynergia as a potential mechanism underlying constipation in people with complete SCI. In fact, these participants showed a more severe clinical presentation of NBD according to the total NBD score., Conclusions: MR defecography provides objective parameters correlating with clinical signs of NBD, such as constipation and bowel incontinence. Therefore, MR defecography can support pathophysiology-based decision-making with respect to specific therapeutic interventions, which should help to improve the management of NBD.

Study Design: Narrative review by individuals experienced in the recruitment of participants to neurotherapeutic clinical trials in spinal cord injury (SCI)., Objectives: To identify key problems of recruitment and explore potential approaches to overcoming them., Methods: Published quantitative experience with recruitment of large-scale, experimental neurotherapeutic clinical studies targeting central nervous system and using primary outcome assessments validated for SCI over the last 3 decades was summarized. Based on this experience, potential approaches to improving recruitment were elicited from the authors., Results: The rate of recruitment has varied between studies, depending on protocol design and other factors, but particularly inclusion/exclusion criteria. The recruitment rate also ranged over an order of magnitude between individual centers in a given study. In older multicenter studies, average recruitment rate was approximately one person per study center per month. More recent trials experienced lower rates of recruitment and potential reasons for this trend were examined. The current roles and potential of various stakeholder organizations in addressing problems of recruitment were explored. In addition, recent developments in methodology may help reduce the number of subjects required for well-powered studies., Conclusions: Several approaches are emerging to improve clinical trial design, efficacy outcome measures, and quantifiable surrogate markers, all of which should reduce the number of participants required for adequate statistical power. There is a growing sense of cooperation between various stakeholders but more should be done to bring together consumer and provider groups to improve recruitment and the effectiveness and relevance of neurotherapeutic clinical trials.

Study Design: Prospective observational multicenter study., Objectives: Investigation of content, duration and adjustment of physical therapy for the rehabilitation of ambulation in acute spinal cord injury (SCI)., Setting: European Multicenter Study of SCI (EMSCI)., Methods: Physical therapy interventions during acute in-patient rehabilitation of eighty incomplete SCI patients (AIS B, C, D all lesion levels) were recorded using the SCI - Intervention Classification System. Mobility was documented using the Spinal Cord Independence Measurement (SCIM III), demographics and clinical data were retrieved from the EMSCI database., Results: Overall recovery of locomotor function was categorized into three outcome groups (G1-G3). Of 76 initial wheelchair-using patients, 53.9% remained wheelchair user (G1), 25% regained moderate (G2) and 21.1% good walking (G3) capability. Strength training was the most frequently applied intervention of body function/-structure across all outcome groups (about 30% of all interventions), while interventions focusing on muscle tone and respiration were predominantly applied in wheelchair-dependent patients. Activity-focused interventions of transfer, transition, sitting were trained most intensively in outcome group G1, while walking and swimming were increasingly trained in patients with moderate and good walking outcomes. Physical therapy interventions of assistive and active trainings as well as corresponding training environments changed with the recovery of locomotor function., Conclusions: Physical therapy of locomotor function is targeted to individual patients' conditions and becomes adjusted to the progress of ambulation. Although the involved clinical sites were not following explicitly standardized rehabilitation programs, common patterns can be discerned which may form the basis of prospective standardized programs.

Study Design: Retrospective statistical analysis of database., Objective: Spinal cord injury (SCI) clinical trials are challenged to enroll participants, and early trial outcomes have often been equivocal. We hypothesized that a specifically designed novel true linear interval-scaled outcome measure targeted to simultaneously track a broad range of SCI will enable more inclusive enrollment of participants and valid comparisons of functional changes after SCI., Methods: To define a single SCI measurement framework, we used items from existing measures. To evaluate linearity and validity of the measure, we used rigorous psychometric Rasch analysis on two data sets from over 2500 traumatic SCI participants (all levels and severities of SCI) within the EMSCI (European Multicenter study about SCI) database., Results: Volitional performance was found to be the unidimensional construct that would detect and track a treatment effect from a central nervous system-directed therapeutic. Along with early evidence for voluntary neurological control of upper-extremity muscle contractions, volitional performance is best described by goal-directed activities of daily living that are increasingly difficult to re-acquire when activity within more caudal spinal segments is required. Validity of the Spinal Cord Ability Ruler (SCAR) as a linear interval construct was confirmed with Rasch analysis. All measurement items were properly ordered, as well as being precise and stable across clinically relevant groups. Only 5/24 items had some misfit. Targeting was excellent over time after SCI, with few gaps and only modest floor and ceiling effects (3% each)., Conclusions: SCAR is a quantitative linear measure of volitional performance across an inclusive range of tetraplegic and paraplegic SCI.

Objectives: Pressure ulcers impose a major lifetime medical problem to patients with high-grade spinal cord injury (SCI). For patients with stages 3-4 pressure ulcers, plastic surgery is often the only remaining treatment option. Despite considerable flap failure rates of around 30%, only sparse knowledge exists on predictors for flap failure. Hence, identification of predictors for flap failures is needed., Methods: We prospectively enrolled 38 SCI patients with stages 3-4 pressure ulcers scheduled for plastic surgery. Preoperative wound swabs, intraoperative tissue samples and postoperative drainage liquids were microbiologically analyzed. In multivariable logistic regression analyses, bacterial loads of deep tissue cultures of intraoperative samples as well as other clinical variables were analyzed with respect to the prediction of flap failures., Results: The flap failure rate was 27.5%. Bacterial loads of deep tissue cultures were not predictive for flap failure, neither was the colonization with a specific bacterial strain. We observed a considerable fluctuation of microbiological environment from initial swab cultures, intraoperative samples and postoperative drainage fluids. Antibioprophylaxis was sufficient in only 75% of deep tissue cultures and 69% of drainage fluids. Insufficient antibioprophylaxis was associated with a higher flap failure rates (odds ratio 6.3, confidence interval 1.2-41.0)., Conclusion: After inpatient wound conditioning, bacterial load analysis of intraoperative wound tissue cultures is ineffective in order to predict flap failure rates in SCI patients with stages 3-4 pressure ulcers after flap surgery. Instead, insufficient antibioprophylaxis might be a factor contributing to flap failure.

Study Design: This is a retrospective analysis., Objectives: The objective of this study was to describe and quantify the discrepancy in the classification of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) by clinicians versus a validated computational algorithm., Settings: European Multicenter Study on Human Spinal Cord Injury (EMSCI)., Methods: Fully documented ISNCSCI data sets from EMSCI's first years (2003-2005) classified by clinicians (mostly spinal cord medicine residents, who received in-house ISNCSCI training by senior SCI physicians) were computationally reclassified. Any differences in the scoring of sensory and motor levels, American Spinal Injury Association Impairment Scale (AIS) or the zone of partial preservation (ZPP) were quantified., Results: Four hundred and twenty ISNCSCI data sets were evaluated. The lowest agreement was found in motor levels (right: 62.1%, P=0.002; left: 61.8%, P=0.003), followed by motor ZPP (right: 81.6%, P=0.74; left 80.0%, P=0.27) and then AIS (83.4%, P=0.001). Sensory levels and sensory ZPP showed the best concordance (right sensory level: 90.8%, P=0.66; left sensory level: 90.0%, P=0.30; right sensory ZPP: 91.0%, P=0.18; left sensory ZPP: 92.2%, P=0.03). AIS B was most often misinterpreted as AIS C and vice versa (AIS B as C: 29.4% and AIS C as B: 38.6%)., Conclusion: Most difficult classification tasks were the correct determination of motor levels and the differentiation between AIS B and AIS C/D. These issues should be addressed in upcoming ISNCSCI revisions. Training is strongly recommended to improve classification skills for clinical practice, as well as for clinical investigators conducting spinal cord studies., Sponsorship: This study is partially funded by the International Foundation for Research in Paraplegia, Zurich, Switzerland.

Study Design: This is a review article., Objectives: This study discusses the following: (1) concepts and constraints for the determination of minimal clinically important difference (MCID), (2) the contrasts between MCID and minimal detectable difference (MDD), (3) MCID within the different domains of International Classification of Functioning, disability and health, (4) the roles of clinical investigators and clinical participants in defining MCID and (5) the implementation of MCID in acute versus chronic spinal cord injury (SCI) studies., Methods: The methods include narrative reviews of SCI outcomes, a 2-day meeting of the authors and statistical methods of analysis representing MDD., Results: The data from SCI study outcomes are dependent on many elements, including the following: the level and severity of SCI, the heterogeneity within each study cohort, the therapeutic target, the nature of the therapy, any confounding influences or comorbidities, the assessment times relative to the date of injury, the outcome measurement instrument and the clinical end-point threshold used to determine a treatment effect. Even if statistically significant differences can be established, this finding does not guarantee that the experimental therapeutic provides a person living with SCI an improved capacity for functional independence and/or an increased quality of life. The MDD statistical concept describes the smallest real change in the specified outcome, beyond measurement error, and it should not be confused with the minimum threshold for demonstrating a clinical benefit or MCID. Unfortunately, MCID and MDD are not uncomplicated estimations; nevertheless, any MCID should exceed the expected MDD plus any probable spontaneous recovery., Conclusion: Estimation of an MCID for SCI remains elusive. In the interim, if the target of a therapeutic is the injured spinal cord, it is most desirable that any improvement in neurological status be correlated with a functional (meaningful) benefit.

Study Design: Prospective, longitudinal cohort study., Objectives: To quantify the effect of formal training in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) on the classification accuracy and to identify the most difficult ISNCSCI rules., Settings: European Multicenter Study on Human Spinal Cord Injury (EMSCI)., Methods: EMSCI participants rated five challenging cases of full sensory, motor and anorectal examinations before (pre-test) and after (post-test) an ISNCSCI instructional course. Classification variables included sensory and motor levels (ML), completeness, ASIA Impairment Scale (AIS) and the zones of partial preservation., Results: 106 attendees were trained in 10 ISNCSCI workshops since 2006. The number of correct classifications increased significantly (P<0.00001) from 49.6% (2628 of 5300) in pre-testing to 91.5% (4849 of 5300) in post-testing. Every attendee improved, 12 (11.3%) achieved 100% correctness. Sensory levels (96.8%) and completeness (96.2%) are easiest to rate in post-testing, while ML (81.9%) and AIS (88.1%) are more difficult to determine. Most of the errors in ML determination arise from sensory levels in the high cervical region (C2-C4), where by convention the ML is presumed to be the same as the sensory level. The most difficult step in AIS classification is the determination of motor incompleteness., Conclusion: ISNCSCI training significantly improves the classification skills regardless of the experience in spinal cord injury medicine. These findings need to be considered for the appropriate preparation and interpretation of clinical trials in spinal cord injury.