开发一个核心结果集,用于干预研究,在成年人与喉喉狭窄症的发展
Gemma M Clunie1,2, Amy Freeman-Sanderson3,4,5,6, Chadwan Al-Yaghchi2
1Imperial College London, London, UK.
The Laryngoscope
|May 12, 2025
概括
研究人员为成人获得的喉狭窄症 (LTS) 建立了一个核心结果集 (COS),以标准化研究. 这一套包括七个关键结果,以提高临床决策的一致性和未来对LTS干预措施的研究.
科学领域:
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 呼吸系统医学 呼吸系统医学
- 临床试验方法论 临床试验方法论
背景情况:
- 成年人获得的喉支气管狭窄症 (LTS) 由于不同的治疗方法和症状负担而构成重大挑战.
- 不一致的结果选择和未经验证的措施阻碍了LTS研究中的数据合成.
- 标准化结果测量对于推动LTS临床决策至关重要.
研究的目的:
- 建立一个基于共识的核心结果集 (COS) 对于成年人获得的喉狭窄症 (LTS) 干预措施.
- 确定未来的LTS研究和临床试验的基本结果.
- 提高LTS研究数据的可比性和可靠性.
主要方法:
- 一项两轮修改后的e-Delphi研究,涉及一个由临床医生,研究人员和患有LTS.患者的国际专家小组.
- 对现有文献进行系统审查,以确定初始结果,并补充参与者生成的结果.
- 达成共识的会议和最后的投票轮,以最终确定核心结果.
主要成果:
- 共有575名参与者完成了e-Delphi调查的第二轮调查.
- 17名参与者参加了共识会议.
- 最终的核心结果集包括七个结果:喘息,发声,粘液管理,饮食能力,生活质量,心理健康和治疗频率.
结论:
- 一个严格的Delphi过程,涉及多个利益相关者,成功地确定了七个核心成果LTS研究.
- 该COS的实施将在未来的LTS研究中标准化结果测量,提高可比性.
- 需要进一步的研究来确定测量这些核心结果的最佳方法.
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