开发用于治疗口腔下纤维化 (OSFCOS) 的试验的核心结果集:一个共识研究协议
Shailesh M Gondivkar1, Monal Yuwanati2, Sachin C Sarode3
1Department of Oral Medicine & Radiology, Government Dental College & Hospital, Nagpur, Maharashtra, India.
PloS one
|July 30, 2025
概括
本研究旨在为口腔下粘膜纤维化 (OSF) 治疗试验开发标准化的核心结果集 (COS). 该OSFCOS将改善研究的一致性和基于证据的临床指南,用于管理OSF.
科学领域:
- 口腔医学是指口腔医学.
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 口腔下纤维化 (OSF) 治疗的有效性是通过各种结果措施来评估的,这阻碍了研究比较和证据综合.
- 结果评估中的异质性使得开发基于证据的OSF管理临床实践指南变得复杂.
- 一个核心结果集 (COS) 标准化了在临床试验中进行一致测量和报告的结果.
研究的目的:
- 建立一个核心结果集 (OSFCOS),专门用于评估口腔下纤维化 (OSF) 管理的疗效试验.
- 在OSF临床研究中标准化结果测量,以提高结果的可比性和综合性.
主要方法:
- 对OSF治疗的随机对照试验的系统审查,以确定潜在的结果.
- 一个e-Delphi过程,涉及包括OSF患者和口腔健康专家在内的各种利益相关者.
- 多轮在线调查问卷,提供反,以建立共识,以确定结果的重要性和包容性.
主要成果:
- 研究协议概述了开发OSFCOS的结构化方法.
- 在代评级轮之后,将通过预定义的标准达成共识.
- 该过程确保了核心结果选择的包容性和系统方法.
结论:
- 开发的OSFCOS将为OSF临床试验中的结果选择提供标准化的框架.
- 实施OSFCOS将提高对OSF治疗的系统审查和基于证据的建议的质量.
- 这一倡议旨在改善临床实践和患者在口腔下纤维化管理的结果.
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