在淋巴瘤临床试验中患者报告的结果测量选择的实用范式:快速审查研究
Jennifer D Guo1, Abraham Hartzema2, Jonathon B Cohen3
13ARx Solutions LLC, Boston, Massachusetts, USA jennifer.guo@3arxsolutions.com.
BMJ open
|October 21, 2025
概括
为淋巴瘤临床试验选择患者报告的结果措施 (PROM) 是一个挑战. 这项研究制定了一个务实的范式,并对31个PROM进行了分类,以帮助选择最适合成人淋巴瘤患者的措施.
科学领域:
- 血液学恶性瘤是什么
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 淋巴瘤治疗选择是复杂的,因为有许多选择.
- 患者报告的结果 (PROs) 为治疗差异化提供了宝贵的见解.
- 为临床试验选择合适的PRO措施 (PROM) 仍然是一个挑战.
研究的目的:
- 在成年淋巴瘤临床试验中选择PROM的务实范式.
- 促进临床研究人员与健康经济学和成果研究 (HEOR) 科学家之间的合作.
- 简化用于淋巴瘤研究的PROM选择过程.
主要方法:
- 在临床试验中对成年淋巴瘤患者的现有PROM进行了快速审查.
- 搜索了PubMed,谷歌学者和监管机构/HTA机构网站 (2009年 - 2024年7月).
- 确定了相关的指导方针,以支持实用性范式的发展.
主要成果:
- 将淋巴瘤的31个适用PROM分类为四个不同的组.
- 开发了一个五步实用范式,用于识别合适的PROM.
- 简化PROM选择以加强利益相关者之间的沟通.
结论:
- 实用性范式为在淋巴瘤试验中选择PROM提供了一种实际方法.
- 适当的PROM应与治疗目标保持一致,并可接受监管/HTA.
- 这种方法可以产生以患者为中心的数据,以改善淋巴瘤护理和生活质量.
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