Reed R, Mehra M, Kirshblum S, Maier D, Lammertse D, Blight A, Rupp R, Jones L, Abel R, Weidner N, Curt A, Steeves J
ICORD, University of British Columbia and Vancouver General Hospital, Blusson Spinal Cord Centre, Vancouver, British Columbia, Canada.
Tigermed-MacroStat LLC, Gaithersburg, MD, USA.
Spinal Cord. 2017 Aug;55(8):730-738. doi: 10.1038/sc.2017.1. Epub 2017 Mar 21.
Retrospective statistical analysis of database.
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.
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.
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).
SCAR is a quantitative linear measure of volitional performance across an inclusive range of tetraplegic and paraplegic SCI.
数据库的回顾性统计分析。
脊髓损伤（SCI）临床试验在招募参与者方面面临挑战，且早期试验结果往往不明确。我们假设，一种专门设计的新型真正线性区间尺度结局测量方法，旨在同时跟踪广泛的SCI情况，将能够使更多参与者纳入试验，并对SCI后的功能变化进行有效的比较。
为定义单一的SCI测量框架，我们使用了现有测量方法中的项目。为评估该测量方法的线性和有效性，我们对欧洲多中心脊髓损伤研究（EMSCI）数据库中超过2500名创伤性SCI参与者（所有SCI水平和严重程度）的两个数据集进行了严格的心理测量Rasch分析。
发现意志表现是一种能够检测和跟踪中枢神经系统导向治疗效果的单维结构。除了上肢肌肉收缩的自主神经控制的早期证据外，意志表现最好通过日常生活中的目标导向活动来描述，当需要更多尾侧脊髓节段的活动时，这些活动越来越难以重新获得。通过Rasch分析证实了脊髓能力尺（SCAR）作为线性区间结构的有效性。所有测量项目排序合理，在临床相关组中精确且稳定。24个项目中只有5个存在一些不匹配。SCI后随时间推移靶向性良好，几乎没有差距，地板效应和天花板效应均较小（各为3%）。
SCAR是一种针对广泛的四肢瘫和截瘫SCI患者意志表现的定量线性测量方法。
