开发,分析和解释结果评估以改善传染病临床研究临床研究的终点
John H Powers1,2,3, Robert J O'Connell4
1Clinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
概括
这项研究指导了临床研究终点的发展,强调了患者报告的症状,功能和生活质量的结果. 它详细介绍了选择相关概念,测量特性和数据分析,以获得可靠的临床证据.
科学领域:
- 临床研究方法论 临床研究方法论
- 患者报告的结果
- 基于证据的医学基于证据的医学.
背景情况:
- 临床实践依赖于来自研究的证据,患者的价值观和经验.
- 了解研究研究的终点对于评估证据至关重要.
- 通过衡量生存,症状,功能和生活质量的终点,最好评估患者的益处.
研究的目的:
- 讨论开发临床研究研究的终点.
- 专注于患者报告的结果措施 (PROMs).
- 为指导临床研究PROM的选择和分析.
主要方法:
- 讨论确定哪些概念进行测量,重点关注患者相关性 (内容有效性).
- 解释谁进行测量以及使用哪些测量属性 (构造有效性).
- 涵盖了分析和解释所选测量的结果的方法.
主要成果:
- 为开发强大的以患者为中心的终点提供了一个框架.
- 强调了内容的重要性,并在PROM选择中构建有效性.
- 为临床研究提供数据分析和解释指南.
结论:
- 有效的终点开发是产生有意义的临床证据的关键.
- 患者报告的结果对于评估干预对患者福祉的影响至关重要.
- 该框架支持创建有效和可解释的临床研究终点.
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