罗莎临床试验和实践的核心领域集:一个共识声明.
McKenzie A Dirr1, Areeba Ahmed1, Daniel I Schlessinger1
1Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
在疹临床试验中标准化结果对于数据汇集至关重要. 开发了一个新的核心结果集 (COS),包括8个关键领域,用于在研究和临床实践中提供一致的报告.
科学领域:
- 皮肤病学和临床试验方法.
背景情况:
- 在疹临床试验中不一致的结果报告阻碍了数据聚合和元分析.
- 为了在粉红干预研究中进行可靠的评估,需要对结果进行标准化.
研究的目的:
- 开发一个全球相关的粉红病核心结果集 (COS).
- 建立罗莎临床试验和临床实践的最低结果清单.
主要方法:
- 对疹试验的系统文献综述,以确定离散的结果.
- 德尔菲过程涉及88名国际小组成员 (医生和患者) 评价结果.
- 共识会议以最终确定基于参与者评级的核心领域集.
主要成果:
- 最初的192个结果清单被改进到50个,然后最终确定为8个核心领域.
- 八个核心领域包括眼睛和皮肤症状,整体严重程度,患者满意度,生活质量,改善程度和不良事件.
- 还制定了用于临床应用的建议.
结论:
- 开发的核心领域集为粉红病研究提供了一个标准化的框架.
- 通过这种COS将提高未来疹试验的可比性和元分析潜力.
- 在临床实践中,COS也可以作为一个有价值的工具来评估粉红病的结果.
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