建立一个核心领域集,用于早期临床试验的电刺激干预措施的耳在成年人:在线Delphi研究
Bas Labree1,2, Derek Hoare3,2, Kathryn Fackrell3,2,4
1NIHR Nottingham Biomedical Research Centre, Nottingham, UK bas.labree1@nottingham.ac.uk.
BMJ open
|March 4, 2025
概括
研究人员为涉及电脑刺激的耳临床试验建立了一套标准的结果. 这一核心领域集确保了一致的报告,以便更好地比较研究.
科学领域:
- 神经科学是一个神经科学.
- 临床研究方法论 临床研究方法论
背景情况:
- 耳会影响10-15%的人口,有效的治疗方法有限.
- 电脑刺激是一种实验性耳干预措施.
- 缺乏标准化的结果措施阻碍了临床试验的评估.
研究的目的:
- 建立一个核心领域,用于评估耳干预措施.
- 确定电刺激对耳的临床试验的关键结果.
主要方法:
- 一个在线的,两轮的Delphi调查,涉及患者和专业人士.
- 随后的利益相关者协商一致会议将最终确定核心域名集.
主要成果:
- 在关键领域达成共识:无视能力,集中能力,治疗满意度,无助感和耳入侵性.
- 负面影响也被列入核心领域集合.
结论:
- 为评估对耳的电刺激干预措施而建立了一个核心领域集.
- 这一标准化套件将作为未来临床试验的最低报告标准.
- 标准化将提高研究结果在耳治疗中的可比性.
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