临床益处规模的ESMO-大小2.0版本 (ESMO-MCBS v2.0)
N I Cherny1, S F Oosting2, U Dafni3
1Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel.
概括
更新的ESMO-临床益处量表 (ESMO-MCBS) v2.0完善了癌症治疗益处评估. 关键的变化包括修订治疗设置的评分和改进的毒性评估,提高临床效用.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 卫生经济学和研究成果研究成果
背景情况:
- 欧洲医学瘤学会-临床益处规模 (ESMO-MCBS) 是评估新癌症疗法的关键工具.
- 版本2.0 (v2.0) 是为了解决发现的缺陷而开发的,并纳入v1.1.0的用户反.
研究的目的:
- 描述改版ESMO-MCBS v2.0.0.版本的系统开发和实施情况.
- 提高尺度的准确性,区分能力和评估临床益处的实用性.
主要方法:
- 一个九步修订过程,包括批评审查,解决方案起草,现场测试和多阶段的同行评审.
- 纳入ESMO教师,ESMO指南委员会和ESMO-MCBS工作组的反.
主要成果:
- 进行了13项修正,影响了13.6%的评估研究的评分 (10.5%降级,3.1%升级).
- 在治疗环境中,无病生存现在被认为更为保守,并添加了急性/持久性毒性注释.
- 非治疗性设置的修订提高了生存曲线差异的统计有效性,并完善了毒性评估.
结论:
- ESMO-MCBS v2.0引入了重要的修订,包括对45.5%的治疗研究的毒性注释.
- 更新后的尺度表现出更好的区分能力和用于评估癌症疗法临床益处的大小的实用性.
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