在科中使用患者报告的结果和经验测量来评估医疗器械
Amanda Grandinetti1, Michelle M Richardson2
1College of Health and Human Sciences, Northern Illinois University, DeKalb, IL.
Seminars in nephrology
|September 5, 2024
概括
患者参与医疗器械开发对于更好的医疗保健至关重要. 患者报告结果 (PRO) 和患者偏好信息 (PPI) 是改善病患者设备的关键.
科学领域:
- 医疗器械开发 医疗器械开发
- 以患者为中心的评估.
- 腎臟病學 (nephrology) 是一種醫學.
背景情况:
- 整合患者的视角对于医疗器械开发至关重要.
- 患者报告的结果 (PRO),患者偏好信息 (PPI) 和定性调查放大了患者的声音.
- 病学在设备开发中仅限于使用PRO,PPI和定性调查.
研究的目的:
- 突出患者参与医疗器械开发的重要性.
- 解决脏病学中以患者为中心的方法的稀疏利用问题.
- 强调需要探索设备对患者幸福感的影响.
主要方法:
- 审查现有的以患者为中心的方法,如PRO和PPI.
- 对当前趋势的分析和FDA在科设备开发方面的指导.
- 识别使用PRO和PPI进行监管决策的独特考虑因素.
主要成果:
- 以患者为中心的评估对于有效的医疗器械至关重要.
- 在科设备开发中,PRO,PPI和定性调查的有限使用使得患者的影响未被探索.
- 具有前性的计划和FDA的指导正在促进脏病学中的PRO.
结论:
- 以患者为中心的倡议正在脏病学领域迅速发展.
- 确保医疗器械满足病患者的需求是必不可少的.
- 通过患者参与设备开发,可以提高护理质量.
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