The MG Composite A valid and reliable outcome measure for myasthenia gravis

The MG Composite A valid and reliable outcome measure for myasthenia gravis
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DOI:
10.1212/wnl.0b013e3181dc1b1e
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发表时间:
2010-05-04
期刊:
影响因子:
9.9
通讯作者:
Sanders, Donald B.
Sanders, Donald B.
中科院分区:
医学1区
文献类型:
--
作者:
Burns, Ted M.;Conaway, Mark;Sanders, Donald B.

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目的:研究重症肌无力(MG)结果测量的实践环境中的并发性和构建效度以及重测信度。方法:11 个中心参与了重症肌无力综合量表(MGC)的验证研究。 MG 患者连续两次就诊进行评估。通过在其他 MG 特定结果测量的背景下评估 MGC 分数来评估 MGC 的并发有效性和构建有效性。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。弗吉尼亚大学对患者进行了信度重测。结果:2008年7月1日至2009年1月31日期间,11个中心共招募了175名重症肌无力患者。总共有151名患者接受随访。 MGC 总分与其他 MG 特定量表显示出优异的并发有效性。对 MGC 敏感性和特异性的分析表明,MGC 总分提高 3 分最能表明临床改善。 MGC 的 3 分改善似乎对大多数患者来说也代表了有意义的改善,正如 15 项重症肌无力生活质量量表 (MG-QOL15) 评分的改善所表明的那样。对于由患者认为最需要治疗的 2 个功能域组成的个体化子评分,心理测量特性也没有更好。 MGC 的重测信度系数为 98%,较低的 95% 置信区间为 97%,表明重测信度极佳。结论:重症肌无力综合测试仪是一种可靠、有效的工具,用于在实践环境和临床试验中测量重症肌无力患者的临床状态。神经病学(R)2010;74:1434-1440
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. Neurology (R) 2010;74:1434-1440