Search

Objectives:Despite many years of research, there is currently no treatment available that results in major neurological or functional recovery after traumatic spinal cord injury (tSCI). In particular, no conclusive data related to the role of the timing of decompressive surgery, and the impact of injury severity on its benefit, have been published to date. This paper presents a protocol that was designed to examine the hypothesized association between the timing of surgical decompression and the extent of neurological recovery in tSCI patients.Study design:The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study. This study compares acute (<12 h) versus non-acute (>12 h, <2 weeks) decompressive surgery in patients with a traumatic spinal column injury and concomitant spinal cord injury. The sample size calculation was based on a representative European patient cohort of 492 tSCI patients. During a 4-year period, 300 patients will need to be enrolled from 10 trauma centers across Europe. The primary endpoint is lower-extremity motor score as assessed according to the 'International standards for neurological classification of SCI' at 12 months after injury. Secondary endpoints include motor, sensory, imaging and functional outcomes at 3, 6 and 12 months after injury.Conclusion:In order to minimize bias and reduce the impact of confounders, special attention is paid to key methodological principles in this study protocol. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centers result in important improvements in tSCI patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]