核心患者报告的脏病学试验结果
Anastasia Hughes1, Nicole Scholes-Robertson1, Angela Ju1
1Sydney School of Public Health, University of Sydney, Sydney, Australia; Centre for Kidney Research, Children's Hospital at Westmead, Sydney, Australia.
Seminars in nephrology
|September 17, 2024
概括
慢性病 (CKD) 试验往往缺乏与患者相关的结果. 腎病學標準化結果 (SONG) 倡議制定了核心成果集,優先考慮患者報告的疲勞和疼痛等結果,以提高試驗相關性.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 慢性病 (CKD) 试验的结果非常可变,并且经常使用未经验证的代用终点.
- 这种变异性和缺乏与患者相关的结果减少了试验对治疗决策的价值.
研究的目的:
- 解决CKD试验中患者为中心的结果的变化和缺乏.
- 介绍病研究的核心成果集的概念和开发.
- 突出临床试验中患者报告结果 (PRO) 的重要性和实施.
主要方法:
- 核心结果的开发通过患者,护理人员和卫生专业人员之间的共识来确定.
- 腎病學標準化成果 (SONG) 倡議為各種CKD階段建立了七個核心成果集.
- 确定患者报告的关键结果,如疲劳,生活参与和疼痛.
主要成果:
- 七个核心成果集已由SONG倡议开发,用于CKD的不同阶段.
- 每个核心结果集包括至少一个患者报告的结果.
- 已建立的PRO包括疲劳 (血液透析),生活参与 (脏移植,腹腔透析,早期CKD,儿科CKD,球性疾病) 和疼痛 (多囊脏病).
结论:
- 患者报告的结果对于改善病试验报告的相关性和一致性至关重要.
- 实施包括PRO在内的核心结果集将增强CKD试验对患者和护理人员的价值.
- 标准化结果报告对于推动病研究和患者护理至关重要.
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