The MG Composite
The MG Composite
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MG复合材料
作者：
T. Burns;M. Conaway;D. Sanders
目的：研究重症肌无力(MG)结局量表的并发效度、结构效度和重测信度。方法：11个中心参与重症肌无力综合评定量表(MGC)的验证研究。MG患者在连续2次就诊时进行评估。MGC的同时效度和结构效度是通过在其他MG特定结果测量的背景下评估MGC分数来评估的。我们使用了许多潜在的临床改善指标来评估MGC检测临床改善的敏感性和特异性。对弗吉尼亚大学的患者进行了重测可靠性测试。结果：从2008年7月1日至2009年1月31日，共有175名MG患者在11个地点入选。共有151名患者接受了随访。MGC总分与其他MG特定量表显示出很好的一致性。对MGC的敏感度和特异度分析显示，MGC总分提高3分是临床改善的最佳指标。从15项重症肌无力生活质量量表(MG-QOL15)得分的改善来看，MGC中3分的改善似乎也代表着对大多数患者的有意义的改善。心理测量学特性对于由患者确定为最重要的治疗的两个功能领域组成的个性化子评分来说并不是更好。MGC的重测信度系数为98%，95%可信区间为97%，具有良好的重测信度。结论：在实践环境和临床试验中，重症肌无力复合体是测量重症肌无力患者临床状态的可靠和有效的工具。
Objective: To study the concurrent and construct validity and test-retest reliability in the practice setting of an outcome measure for myasthenia gravis (MG). Methods: Eleven centers participated in the validation study of the Myasthenia Gravis Composite (MGC) scale. Patients with MG were evaluated at 2 consecutive visits. Concurrent and construct validities of the MGC were assessed by evaluating MGC scores in the context of other MG-specific outcome measures. We used numerous potential indicators of clinical improvement to assess the sensitivity and specificity of the MGC for detecting clinical improvement. Test-retest reliability was performed on patients at the University of Virginia. Results: A total of 175 patients with MG were enrolled at 11 sites from July 1, 2008, to January 31, 2009. A total of 151 patients were seen in follow-up. Total MGC scores showed excellent concurrent validity with other MG-specific scales. Analyses of sensitivities and specificities of the MGC revealed that a 3-point improvement in total MGC score was optimal for signifying clinical improvement. A 3-point improvement in the MGC also appears to represent a meaningful improvement to most patients, as indicated by improved 15-item myasthenia gravis quality of life scale (MG-QOL15) scores. The psychometric properties were no better for an individualized subscore made up of the 2 functional domains that the patient identified as most important to treat. The test-retest reliability coefficient of the MGC was 98%, with a lower 95% confidence interval of 97%, indicating excellent test-retest reliability. Conclusions: The Myasthenia Gravis Composite is a reliable and valid instrument for measuring clinical status of patients with myasthenia gravis in the practice setting and in clinical trials.