Duff Susan V, He Jiaxiu, Nelsen Monica A, Lane Christianne J, Rowe Veronica T, Wolf Steve L, Dromerick Alexander W, Winstein Carolee J
Thomas Jefferson University, Philadelphia, PA, USA.
Northwestern University, Chicago, IL, USA.
Neurorehabil Neural Repair. 2015 Jun;29(5):436-43. doi: 10.1177/1545968314553030. Epub 2014 Oct 16.
One important objective for clinical trialists in rehabilitation is determining efficacy of interventions to enhance motor behavior. In part, limitation in the precision of measurement presents a challenge. The few valid, low-cost observational tools available to assess motor behavior cannot escape the variability inherent in test administration and scoring. This is especially true when there are multiple evaluators and raters, as in the case of multisite randomized controlled trials (RCTs). One way to enhance reliability and reduce variability is to implement rigorous quality control (QC) procedures.
This article describes a systematic QC process used to refine the administration and scoring procedures for the Wolf Motor Function Test (WMFT)-Functional Ability Scale (FAS).
The QC process, a systematic focus-group collaboration, was developed and used for a phase III RCT, which enlisted multiple evaluators and an experienced WMFT-FAS rater panel.
After 3 staged refinements to the administration and scoring instructions, we achieved a sufficiently high interrater reliability (weighted κ = 0.8).
A systematic focus-group process was shown to be an effective method to improve reliability of observational assessment tools for motor behavior in neurorehabilitation. A reduction in noise-related variability in performance assessments will increase power and potentially lower the number needed to treat. Improved precision of measurement can lead to more cost-effective and efficient clinical trials. Finally, we suggest that improved precision in measures of motor behavior may provide more insight into recovery mechanisms than a single measure of movement time alone.
康复领域临床试验人员的一个重要目标是确定增强运动行为的干预措施的疗效。在一定程度上,测量精度的限制带来了挑战。现有的用于评估运动行为的有效且低成本的观察工具,都无法避免测试实施和评分过程中固有的变异性。当存在多个评估者和评分者时,情况更是如此,例如在多中心随机对照试验(RCT)中。提高可靠性并减少变异性的一种方法是实施严格的质量控制(QC)程序。
本文描述了一种系统的质量控制过程,该过程用于完善狼运动功能测试(WMFT)-功能能力量表(FAS)的实施和评分程序。
质量控制过程是一种系统的焦点小组协作方式,已开发并应用于一项III期随机对照试验,该试验招募了多名评估者和一个经验丰富的WMFT-FAS评分者小组。
在对实施和评分说明进行了3个阶段的完善后,我们实现了足够高的评分者间信度(加权κ = 0.8)。
系统的焦点小组过程被证明是提高神经康复中运动行为观察评估工具可靠性的有效方法。减少性能评估中与噪声相关的变异性将提高效能,并可能降低所需的治疗人数。测量精度的提高可以带来更具成本效益和效率的临床试验。最后,我们建议,与仅单一测量运动时间相比,提高运动行为测量的精度可能会为恢复机制提供更多见解。