在精神病临床试验中对抑郁症评级的质量保证
Michael T Sapko1, Cortney Kolesar1, Ian R Sharp
1From the NRx Pharmaceuticals, Inc, Wilmington, DE.
Journal of clinical psychopharmacology
|December 23, 2024
概括
在临床试验中,使用评级程序管理器 (RPMs) 的新内源模型为蒙哥马利-阿斯伯格抑郁评级表 (MADRS) 实现了高的评级者间可靠性 (IRR),证明了可行的3点差异标准.
科学领域:
- 临床试验方法论 临床试验方法论
- 精神病学评估 精神病学评估
- 药理学研究药理学研究
背景情况:
- 维持评分器间可靠性 (IRR) 对于可靠的抗抑郁药临床试验结果至关重要.
- 传统的合同研究组织通常会接受网站和中央评级者之间的6分差距.
- 使用专用评级程序管理器 (RPM) 开发了一个内部模型,以测试更严格的3点差异标准.
研究的目的:
- 评估3分差异标准在临床试验中的评分一致性的可行性.
- 评估通过与评级程序管理员 (RPMs) 的内部模型实现的评级者间可靠性 (IRR).
主要方法:
- 网站评级人员对蒙哥马利-阿斯伯格抑郁症评分表 (MADRS) 采访进行了评分.
- 评分程序管理员 (RPM) 在24-48小时内独立审查和评分音频文件.
- 一致性被定义为≤3分差;≥4分触发了讨论和培训.
主要成果:
- 在236个评级中,网站评级者和RPM之间的总体评级者间可靠性 (IRR) 为94.49%.
- 在各次访问中,一致率有所改善,从基线的87.93%提高到6次访问后的100.00%.
- 平均MADRS分数的绝对差异为1.77分,具有较高的类内相关性 (0.984).
结论:
- 通过RPM的严格评级员培训和实时监控,可以在MADRS上实现高的评级间可靠性 (IRR).
- 内部采购的模型成功地证明了评级一致性可行的3点差异标准.
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