在鼻整形随机对照试验中报告并发症:使用CONSORT扩展危害检查清单进行分析
Christian Hemmerich1, Adam Corcoran2, Austin L Johnson3
1Department of Medical Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
概括
在鼻整形随机对照试验 (RCT) 中,不良事件报告不足. 这项研究发现,根据CONSORT扩展危害检查清单,报告中存在重大差距,影响了患者的安全.
科学领域:
- 整形外科研究 整形外科研究
- 临床试验方法论 临床试验方法论
- 患者安全 患者安全
背景情况:
- 报告不良事件 (AE) 对手术试验中的患者安全至关重要.
- 综合报告标准 (CONSORT) 对危害的扩展提供了全面AE报告的指导方针.
- 鼻美术是一种常见的美容手术,需要在其临床试验中进行彻底的安全报告.
研究的目的:
- 为了评估随机对照试验 (RCT) 中不良事件报告的完整性,用于鼻整形.
- 评估在已发表的鼻整形RCT中遵守CONSORT扩展危害检查清单.
主要方法:
- 用一个横截面研究设计来审查鼻整形RCT.
- 在2005年1月1日至2022年1月28日期间发表的研究来自PubMed.
- 评估了18项CONSORT扩展危害检查清单的遵守,并使用描述性统计数据分析了数据.
主要成果:
- 在包括的56个RCT中,没有一个完全遵守所有18个CONSORT-Harms项目.
- 所有RCT的平均遵守率为40.0% (18项中的7.2项).
- 项目10 (关于疗效和副作用的讨论平衡) 显示了最高的遵守率为80.4%.
结论:
- 根据CONSORT-Harms指南,鼻整形RCT显示在不良事件报告方面存在重大缺陷.
- 改善报告标准至关重要,以提高外科研究的透明度和患者安全.
- 更严格地执行CONSORT-Harms指南对于强大的鼻整形研究至关重要.
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