开发一个适合目的的综合症状评分,作为恶性多叶膜间皮瘤患者临床试验的症状负担终点
Charles S Cleeland1,2, Karen N Keating3, Brian Cuffel3
1Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Scientific reports
|June 27, 2024
概括
一个新的综合症状评分 (CSS) 有效地测量了恶性多间皮瘤 (MPM) 患者的症状负担随着时间的推移. 这种验证的得分通过简化症状评估来帮助临床试验和患者护理.
科学领域:
- 在瘤学瘤学.
- 患者报告的结果
- 临床试验方法论 临床试验方法论
背景情况:
- 恶性多层层层瘤 (MPM) 呈现出显著的症状负担.
- 现有的症状评估工具对于频繁使用可能是漫长而复杂的.
研究的目的:
- 开发和验证一个简短的综合症状评分 (CSS) 以跟踪MPM患者的症状负担.
- 建立CSS作为临床试验和实践的可靠结果衡量标准.
主要方法:
- 在IIB期研究中,使用MD Anderson MPM症状目录 (MDASI-MPM) 的239名MPM患者的长度数据.
- 专家审查委员会选择关键症状 (疼痛,疲劳,呼吸短促,肌肉虚弱,咳) 用于CSS.
- 与完整的MDASI-MPM和肺癌症状尺度-间皮瘤的相关性分析.
主要成果:
- CSS与完整的MDASI-MPM (0.92-0.94) 和肺癌症状尺度-间皮瘤 (0.79-0.87) 显示出强烈的相关性.
- CSS对疾病进展和生活质量的变化表现出良好的敏感性.
- 五个症状的CSS有效地捕获了整体症状负担.
结论:
- MDASI-MPM CSS是一种经过验证的,简短的工具,适合在MPM临床试验和实践中频繁使用.
- CSS简化了症状评估,解决了多重性问题,并且可以适应其他晚期癌症.
- 这一分数提高了捕捉症状轨迹和评估MPM治疗反应的能力.
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