在使用非可燃尼古丁产品的戒烟试验中报告口服不良事件:质量评估
Giusy Rita Maria La Rosa1, Cinzia Del Giovane2, Silvia Minozzi3
1Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
在非可燃尼古丁产品 (NCNP) 试验中,报告口服不良事件 (OAEs) 是不充分且不一致的. 标准化报告对于了解产品耐受性和支持戒烟工作至关重要.
科学领域:
- 临床试验方法
- 药物监督管理
- 尼古丁产品研究
背景情况:
- 评估非可燃尼古丁产品的随机对照试验 (RCT) 正在增加.
- 对口服不良事件 (OAEs) 进行全面报告对于评估产品的安全性和耐受性至关重要.
- 目前在NCNP试验中对OAE进行报告的做法需要评估.
研究的目的:
- 在NCNPRCT中评估OAE报告的完整性和质量.
- 为了确定OAE报告的做法是否随着时间的推移而有所改善.
- 确定需要改进的OAE报告领域.
主要方法:
- 关于NCNP (尼古丁替代疗法,电子烟,加热烟草,无烟烟) 的36项RCT的二次分析.
- 使用适应的CONSORT危害检查清单对OAE报告进行评估.
- 调整检查清单得分 (ACS) 的计算和研究级变量回归分析.
主要成果:
- 平均ACS为0.52,表明OAE报告的碎片化.
- 超过80%的人提供了一些定量数据,但只有53%的人使用了表格式的特定分支机构数据.
- 对OAE的定义,严重程度测量和统计计划很少得到报告.
结论:
- 在NCNP临床试验中,OAE报告有限且不一致.
- 缺乏明确的定义,标准化的评估和详细的方法阻碍了数据的解释.
- 建议改善OAE报告并支持牙科专业人员戒烟.
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