Department of Health Sciences and Technology (D-HEST), ETH Zurich, Zürich, Switzerland.
SIB Swiss Institute of Bioinformatics, Lausanne, Switzerland.
BMC Med. 2022 Jun 14;20(1):225. doi: 10.1186/s12916-022-02395-0.
The epidemiological international landscape of traumatic spinal cord injury (SCI) has evolved over the last decades along with given inherent differences in acute care and rehabilitation across countries and jurisdictions. However, to what extent these differences may influence neurological and functional recovery as well as the integrity of international trials is unclear. The latter also relates to historical clinical data that are exploited to inform clinical trial design and as potential comparative data.
Epidemiological and clinical data of individuals with traumatic and ischemic SCI enrolled in the European Multi-Center Study about Spinal Cord Injury (EMSCI) were analyzed. Mixed-effect models were employed to account for the longitudinal nature of the data, efficiently handle missing data, and adjust for covariates. The primary outcomes comprised demographics/injury characteristics and standard scores to quantify neurological (i.e., motor and sensory scores examined according to the International Standards for the Neurological Classification of Spinal Cord Injury) and functional recovery (walking function). We externally validated our findings leveraging data from a completed North American landmark clinical trial.
A total of 4601 patients with acute SCI were included. Over the course of 20 years, the ratio of male to female patients remained stable at 3:1, while the distribution of age at injury significantly shifted from unimodal (2001/02) to bimodal distribution (2019). The proportional distribution of injury severities and levels remained stable with the largest percentages of motor complete injuries. Both, the rate and pattern of neurological and functional recovery, remained unchanged throughout the surveillance period despite the increasing age at injury. The findings related to recovery profiles were confirmed by an external validation cohort (n=791). Lastly, we built an open-access and online surveillance platform ("Neurosurveillance") to interactively exploit the study results and beyond.
Despite some epidemiological changes and considerable advances in clinical management and rehabilitation, the neurological and functional recovery following SCI has remained stable over the last two decades. Our study, including a newly created open-access and online surveillance tool, constitutes an unparalleled resource to inform clinical practice and implementation of forthcoming clinical trials targeting neural repair and plasticity in acute spinal cord injury.
过去几十年中，创伤性脊髓损伤（SCI）的国际流行病学格局发生了变化，这与各国和司法管辖区在急性护理和康复方面的固有差异有关。然而，这些差异在多大程度上可能影响神经和功能恢复以及国际试验的完整性尚不清楚。后者还涉及到历史临床数据，这些数据被用来为临床试验设计提供信息，并作为潜在的比较数据。
分析了欧洲多中心脊髓损伤研究（EMSCI）中纳入的创伤性和缺血性 SCI 患者的流行病学和临床数据。采用混合效应模型来解释数据的纵向性质，有效地处理缺失数据，并调整协变量。主要结果包括人口统计学/损伤特征和标准评分，以量化神经（即根据国际脊髓损伤神经分类标准检查的运动和感觉评分）和功能恢复（行走功能）。我们利用已完成的北美标志性临床试验的数据对外验证了我们的发现。
共纳入 4601 例急性 SCI 患者。在 20 年的时间里，男女患者的比例保持在 3:1，而受伤时的年龄分布从单峰（2001/02）显著转变为双峰分布（2019）。损伤严重程度和水平的比例分布保持稳定，最大百分比为运动完全损伤。尽管受伤时的年龄增加，但神经和功能恢复的速度和模式在整个监测期间保持不变。在外部验证队列（n=791）中也证实了恢复特征的发现。最后，我们构建了一个开放访问和在线监测平台（“神经监测”），以互动方式利用研究结果和其他信息。
尽管在临床管理和康复方面取得了一些进展，但过去二十年中 SCI 后的神经和功能恢复仍然保持稳定。我们的研究包括一个新创建的开放访问和在线监测工具，是一个无与伦比的资源，可以为临床实践提供信息，并为针对急性脊髓损伤的神经修复和可塑性的即将到来的临床试验提供信息。
