三种医生全球评估仪器在系统性硬化症中的比较
Laura Ross1, Dylan Hansen2, Susanna Proudman3
1The University of Melbourne, Melbourne, and St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.
Arthritis care & research
|September 4, 2024
概括
系统性硬化症 (SSc) 试验中的医生全球评估 (PhyGAs) 在50%的时间里显示出不一致的变化. 这表明PhyGA结果不能互换,强调在SSc研究中需要一个标准化的PhyGA.
科学领域:
- 风湿病学和临床免疫学
- 系统性硬化症 (SSc) 研究研究
- 临床试验方法论 临床试验方法论
背景情况:
- 医生全球评估 (PhyGA) 在全身性硬化症 (SSc) 临床试验中使用,但应用不一致.
- 在SSc中,不同PhyGA仪器的结果的可比性和可互换性尚未得到充分理解.
- 在PhyGA应用中的变化可能会影响临床试验结果的解释和可比性.
研究的目的:
- 评估三个不同的PhyGA仪器的结果的可比性,这些仪器同时应用于澳大利亚硬化皮肤炎队列研究 (ASCS).
- 为了评估研究访问之间的PhyGA分数变化的一致性.
- 使用有序逻辑回归来确定每个PhyGA的临床关联.
主要方法:
- 对1965名ASCS参与者的数据进行分析.
- 评估三个PhyGA评估之间的相关性:整体健康,活动和损伤.
- 通过后勤回归评估PhyGA得分一致性和临床关联.
主要成果:
- 绝对PhyGA评分在个别访问时有很强的相关性.
- 在约50%的研究访问间隔中,PhyGA得分发生了一致的变化.
- 患者报告的呼吸困难与所有三个PhyGA得分有关;其他症状与活动和损伤得分有不同的关联.
结论:
- 医生对SSc的整体健康,活动和损伤的全球评估与明显的临床特征有关.
- 在PhyGA得分变化中观察到的不一致性 (50%) 表明,从可变措辞的PhyGA中得到的结果不是直接可互换的.
- 这些发现强调了开发标准化PhyGA的必要性,以提高SSc临床试验的一致性和可比性.
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