The Multiple Sclerosis Impact Scale (MSIS-29) - A new patient-based outcome measure
The Multiple Sclerosis Impact Scale (MSIS-29) - A new patient-based outcome measure
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DOI：
10.1093/brain/124.5.962
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发表时间：
2001-05-01
期刊：
影响因子：
14.5
通讯作者：
Thompson, A
中科院分区：
文献类型：
--
作者：
Hobart, J;Lamping, D;Thompson, A
卫生政策的变化强调了循证临床实践和严格评估患者结局的重要性。由于以患者为基础的结果测量在多发性硬化症的治疗试验中特别重要，最近已经开发了一些疾病特异性工具。这些工具的一个局限性是，没有一个是使用标准的心理测量方法来减少多发性硬化症患者产生的大项目池。因此，多发性硬化症的临床试验，是疾病特异性和严格的心理测量方法相结合的患者的角度将补充现有的工具。这项研究的目的就是制定这样一项措施。采用标准的心理测量方法。通过对30名多发性硬化症患者的访谈、专家意见和文献回顾，共产生了129个问卷项目。调查问卷通过邮寄调查的方式对从多发性硬化症协会成员数据库中随机选择的1530人进行管理。删除了冗余项目和测量属性有限的项目。其余的项目（n = 41）进行了分组到规模使用因素分析，然后完善，形成多发性硬化症的影响量表（MSIS-29），一个工具测量的物理（20项）和心理（9项）的影响多发性硬化症。MSIS-29（数据质量，缩放假设，可接受性，可靠性和有效性）的五个心理测量特性进行了检查，在一个单独的邮政调查1250多发性硬化症协会成员。在55名接受康复和静脉内类固醇治疗复发的患者中进行了MSIS-29的初步反应性研究。MSIS-29满足所有心理测量标准。数据质量非常好，缺失数据很低（最高3.9%），项目测试-再测试可靠性很高（r = 0.65-0.90），98%以上的受访者可以生成量表评分。项目描述性统计，项目收敛和判别效度，以及因素分析表明，它是合法的MSIS-29量表的得分通过求和项目。MSIS-29量表具有良好的变异性、较小的下限效应和上限效应、较高的内部一致性（Cronbach 'salpha ≤ 0.91）和较高的重测信度（组内相关≤ 0.87）。与其他措施的相关性和组间差异的分析提供了证据表明，MSIS-29措施的身体和心理的影响多发性硬化症。效应大小（物理量表= 0.82，心理量表= 0.66）证明了良好反应性的初步证据。这些结果表明，MSIS-29是一种临床上有用的，科学上合理的基于患者的多发性硬化症影响的结果测量，适用于临床试验和流行病学研究。
Changes in health policy have underlined the importance of evidence-based clinical practice and rigorous evaluation of patient-based outcomes. As patient-based outcome measurement is particularly important in treatment trials of multiple sclerosis, a number of disease-specific instruments have been developed recently. One limitation of these instruments is that none was developed using the standard psychometric approach of reducing a large item pool generated from people with multiple sclerosis. Consequently, an outcome measure for clinical trials of multiple sclerosis that is disease specific and combines patient perspective with rigorous psychometric methods will complement existing instruments. The aim of this study was to develop such a measure. Standard psychometric methods were used. A pool of 129 questionnaire items was generated from interviews with 30 people with multiple sclerosis, expert opinion and literature review. The questionnaire was administered by postal survey to 1530 people selected randomly from the Multiple Sclerosis Society membership database. Redundant items and those with limited measurement properties were removed. The remaining items (n = 41) were grouped into scales using factor analysis, and then refined to form the Multiple Sclerosis Impact Scale (MSIS-29), an instrument measuring the physical (20 items) and psychological (nine items) impact of multiple sclerosis. Five psychometric properties of the MSIS-29 (data quality, scaling assumptions, acceptability, reliability and validity) were examined in a separate postal survey of 1250 Multiple Sclerosis Society members. A preliminary responsiveness study of the MSIS-29 was undertaken in 55 people admitted for rehabilitation and intravenous steroid treatment of relapses. The MSIS-29 satisfied all psychometric criteria. Data quality was excellent, missing data were low (maximum 3.9%), item test-re-test reliability was high (r = 0.65-0.90) and scale scores could be generated for >98% of respondents. Item descriptive statistics, item convergent and discriminant validity, and factor analysis indicated that it was legitimate to generate scores for MSIS-29 scales by summing items. MSIS-29 scales showed good variability, small floor and ceiling effects, high internal consistency (Cronbach's alpha less than or equal to0.91) and high test-re-test reliability (intraclass correlation less than or equal to0.87). Correlations with other measures and the analysis of group differences provided evidence that the MSIS-29 measures the physical and psychological impact of multiple sclerosis. Effect sizes (physical scale = 0.82, psychological scale = 0.66) demonstrated preliminary evidence of good responsiveness. These results indicate the MSIS-29 is a clinically useful and scientifically sound patient-based outcome measure of the impact of multiple sclerosis suitable for clinical trials and epidemiological studies.