关于选择,开发和修改绩效结果评估的建议:ISPOR工作组的良好实践报告
Chris J Edgar1, Elizabeth Nicki Bush2, Heather R Adams3
1Cogstate Ltd, London, UK.
概括
绩效结果 (PerfO) 评估通过任务来衡量患者的功能,为临床益处提供了有价值的见解. 在PerfO开发和验证方面的良好实践对于以患者为中心的药物开发至关重要.
科学领域:
- 临床结果评估临床结果评估
- 患者报告的结果.
- 药物开发 药物开发
背景情况:
- 评估治疗干预措施需要评估患者临床上有意义的结果.
- 绩效结果 (PerfO) 评估通过标准化任务来衡量功能技能.
- 当任务执行与研究概念保持一致或自我报告有限时,PerfO评估是有价值的.
研究的目的:
- 突出临床试验中绩效结果 (PerfO) 评估的重要性.
- 概述PerfO评估的开发,验证和实施的最佳实践.
- 强调PerfO评估在以患者为中心的药物开发中的作用.
主要方法:
- 遵循临床结果评估的既定良好实践建议.
- 利用概念诱导作为PerfO开发的基本步骤.
- 采用结构化试点评估,认知面试和定量数据分析进行验证.
主要成果:
- PerfO评估提供了对身体,认知和感官功能的客观测量.
- 标准化,可行性和安全性是PerfO实用工具的关键考虑因素.
- 有证据支持在各种患者群体中使用PerfO评估,包括儿科和认知挑战患者.
结论:
- PerfO评估提供了大量机会来为临床益处评估提供信息.
- 在选择,开发,验证和实施PerfO时,坚持良好实践至关重要.
- 高标准的PerfO评估对于推进以患者为中心的药物开发至关重要.
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