结核病症状日记版本2.1的发展 (CDSD 2.1©) 测量了患者报告的结果
Kellee Howard1,2, Daniel Adelman3, Sonal Ghura4
1ICON plc, San Fransisco, CA, USA.
概括
开发了一个新的乳病症状日记 (CDSD) 2.1©,用于评估无质饮食 (GFD) 的乳病患者 (CeD) 的症状. 这种工具对于在临床试验中评估新疗法至关重要.
科学领域:
- 胃肠病学 胃肠病学
- 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:
- 乳病 (CeD) 管理依赖于严格的无质饮食 (GFD),但许多患者经历持续的症状影响生活质量.
- 新型CeD治疗的开发需要临床试验中验证的患者报告的结果措施.
研究的目的:
- 记录病症状日记 (CDSD) 的发展过程 2.1©.
- 在临床试验环境中建立一个可靠的工具来评估CeD症状.
主要方法:
- 定性和定量研究 (2010-2021) 涉及93名成人和青少年CeD患者和8名临床专家.
- 在美国食品和药物管理局和欧洲药物局的反下,CDSD的代开发.
主要成果:
- 乳症状日记 (CDSD) 2.1©是作为对关键乳症状的每日评估工具而开发的.
- CDSD 2.1©在成人和青少年CeD人群中展示了易于理解和内容有效性.
结论:
- CDSD 2.1©是一个与监管标准一致的内容有效的患者报告结果指标.
- 目前正在进行的研究将在临床试验中探索CDSD 2.1©对成人和青少年CeD患者的心理测量特性.
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