Bacci E D, Wyrwich K W, Phillips G A, Vollmer T, Guo S
Evidera Inc, Outcomes Research, USA.
Biogen, Value-Based Medicine, USA.
Mult Scler J Exp Transl Clin. 2016 Oct 9;2:2055217316673235. doi: 10.1177/2055217316673235. eCollection 2016 Jan-Dec.
Investigations using classical test theory support the psychometric properties of the original version of the Multiple Sclerosis Impact Scale (MSIS-29v1), a disease-specific measure of multiple sclerosis (MS) impact (physical and psychological subscales). Later, assessments of the MSIS-29v1 in an MS community-based sample using Rasch analysis led to revisions of the instrument's response options (MSIS-29v2).
The objective of this paper is to evaluate the psychometric properties of the MSIS-29v1 in a clinical trial cohort of relapsing-remitting MS patients (RRMS).
Data from 600 patients with RRMS enrolled in the SELECT clinical trial were used. Assessments were performed at baseline and at Weeks 12, 24, and 52. In addition to traditional psychometric analyses, Item Response Theory (IRT) and Rasch analysis were used to evaluate the measurement properties of the MSIS-29v1.
Both MSIS-29v1 subscales demonstrated strong reliability, construct validity, and responsiveness. The IRT and Rasch analysis showed overall support for response category threshold ordering, person-item fit, and item fit for both subscales.
Both MSIS-29v1 subscales demonstrated robust measurement properties using classical, IRT, and Rasch techniques. Unlike previous research using a community-based sample, the MSIS-29v1 was found to be psychometrically sound to assess physical and psychological impairments in a clinical trial sample of patients with RRMS.
使用经典测试理论进行的研究支持了多发性硬化症影响量表原始版本(MSIS - 29v1)的心理测量特性,该量表是一种针对多发性硬化症(MS)影响(身体和心理子量表)的疾病特异性测量工具。后来,在一个基于MS社区的样本中使用拉施分析对MSIS - 29v1进行评估后,对该工具的反应选项进行了修订(MSIS - 29v2)。
本文的目的是评估复发缓解型MS患者(RRMS)临床试验队列中MSIS - 29v1的心理测量特性。
使用了SELECT临床试验中600例RRMS患者的数据。在基线以及第12、24和52周进行评估。除了传统的心理测量分析外,还使用项目反应理论(IRT)和拉施分析来评估MSIS - 29v1的测量特性。
MSIS - 29v1的两个子量表均显示出很强的信度、结构效度和反应度。IRT和拉施分析总体上支持两个子量表的反应类别阈值排序、人 - 项目拟合和项目拟合。
使用经典、IRT和拉施技术,MSIS - 29v1的两个子量表均显示出稳健的测量特性。与之前使用基于社区样本的研究不同,发现MSIS - 29v1在RRMS患者的临床试验样本中评估身体和心理损伤时具有良好的心理测量学特性。