间歇性囊炎/膀疼痛综合征患者相关结果 临床试验和一般泌尿病学实践的建议
Byron Hayes1, Mary Namugosa2, Robert J Evans2
1Howard Hughes Medical Institute, Ashburn, Virginia, USA.
Neurourology and urodynamics
|July 7, 2025
概括
开发更好的患者报告结果措施 (PROMs) 对于间歇性囊炎/膀疼痛综合征 (IC/BPS) 是至关重要的. 目前的PROM可用,但需要进一步的研究来改进IC/BPS结果措施.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 患者报告的结果
- 临床试验 临床试验
背景情况:
- 间歇性囊炎/膀疼痛综合征 (IC/BPS) 影响着众多患者,需要标准化的结局措施.
- 与患者相关的结果 (PROs) 对于评估IC/BPS治疗疗效和患者经验至关重要.
研究的目的:
- 为在IC/BPS研究和临床实践中使用PRO和PRO措施 (PROM) 建立共识建议.
- 确定IC/BPS的结果评估中需要改进的关键领域.
主要方法:
- IC/BPS共识小组的一个委员会审查了文献,并使用PICO (人口,干预,比较,结果) 问题讨论了优先领域.
- 在委员会讨论和反的基础上,关于PRO和PROM的建议达成了共识.
主要成果:
- 关于IC/BPS研究和临床实践的结果,提出了12项建议.
- 讨论了四个关键领域:PROs,初级终点,二级终点PROMs和一般实践问卷.
- 对于使用客观无偏的患者定性研究开发的经过验证的,针对IC/BPS的PRO,存在重大未满足的需求.
结论:
- 目前的PROM可用于临床试验和实践,但需要加强措施.
- 建议的主要终点包括数值评分/VAS疼痛量表,空白日记和全球反应评估.
- 建议使用生殖尿路疼痛指数 (GUPI) 作为IC/BPS特定的复合PROM,并使用间歇性囊炎症状指数/问题指数进行试验比较.
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