在儿童湿疹中捕获和报告局部治疗使用:在湿疹试验中收集数据的教训
Katherine E Memory1, Stephanie J MacNeill2, Kim S Thomas3
1Population Health Sciences Institute, Bristol Medical School, University of Bristol, Bristol, UK.
Clinical and experimental dermatology
|August 18, 2024
概括
第二个问卷版本改善了儿童湿疹试验中的软化剂使用数据收集. 这种版本,报告每周一天的使用情况,比第一个软化剂使用版本的完成率更高,这对于准确的局部治疗报告至关重要.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验方法论 临床试验方法论
- 儿科医生湿疹管理管理
背景情况:
- 局部治疗,如软化剂和局部皮质类固醇 (TCS) 对于管理湿疹爆发至关重要.
- 目前用于记录局部治疗使用的临床试验方法不一致,缺乏标准化的报告.
- 需要就研究中捕获和总结热点治疗数据的最佳策略达成共识.
研究的目的:
- 评估和比较不同的方法来捕获和报告儿科湿疹临床试验中的局部治疗使用情况.
- 确定最有效的问卷设计,以收集准确的软化剂和局部皮质类固醇 (TCS) 使用数据.
- 为在未来的湿疹研究中收集局部治疗数据提供最佳实践信息.
主要方法:
- 从BEE试验中对450名参与者的二次分析.
- 两种用于记录局部治疗使用的问卷版本的比较:版本1 (每日报告) 和版本2 (每周一天报告).
- 对16周的软化剂和TCS的问卷填写率和数据完整性的评估,其中版本2接受了更严格的测试.
主要成果:
- 随着时间的推移,缓解剂和局部皮质类固醇 (TCS) 使用的问卷填写量都下降了.
- 与第一个版本相比,第二个调查问卷版本的软化剂使用完成率显著更高 (87.9%与33.5%相比).
- 在两种问卷版本中,TCS使用的完成率在两种问卷版本之间都是相似的,这表明两种治疗类型的数据采集都很稳定.
结论:
- 第二个问卷版本,捕捉了每周一天的使用情况,改善了儿科湿疹试验中软化剂使用数据的完整性.
- 设计问卷需要平衡细节和复杂性,特别是在作为次要结果收集数据时.
- 在设计和报告局部治疗使用数据收集方法时,未来的湿疹研究应该仔细考虑试验目标.
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