对帕金森病的失调干预 (COS-DIP) 核心成果集的开发:研究协议
Julia Hirschwald1, Sallyanne Duncan2, Tobias Warnecke3
1Clinical Speech and Language Studies, Trinity College Dublin, Dublin, Ireland hirschwj@tcd.ie.
BMJ open
|February 10, 2024
概括
目前正在开发一个标准化的Dysphagia Interventions in Parkinson's disease (COS-DIP) 的核心结果集. 这将确保在帕金森病 (PD) 吞障碍的临床试验中进行一致的结果测量.
科学领域:
- 神经学 神经学
- 临床试验方法论 临床试验方法论
- 语音和语言治疗治疗
背景情况:
- 吞障碍 (吞障碍) 在帕金森病 (PD) 中很常见,影响生活质量.
- 目前对PD缺食症的临床试验使用了各种结果,阻碍了比较研究.
- 患者和临床医生对试验结果的看法在历史上一直被忽视.
研究的目的:
- 开发一个标准化的核心结果集,用于帕金森病的失调干预 (COS-DIP).
- 为所有PD失消症试验建立一套系统测量和报告的最低结果.
- 提供有关结果定义,测量工具和时间表的指导.
主要方法:
- 一个五阶段的方法,包括范围审查,调查,焦点小组,Delphi调查和共识会议.
- 涉及多达200个关键利益相关者,包括患者,护理人员和临床医生.
- 对现有试验结果进行系统审查,然后对利益相关者的投入进行评估,以确定并就核心结果达成一致.
主要成果:
- 这项研究正处于COS-DIP的开发阶段.
- 该方法确保了来自不同利益相关者的全面投入.
- 该研究已在COMET倡议中注册.
结论:
- 该COS-DIP的目的是标准化PD失调试验中的结果报告.
- 这种标准化将促进比较有效性研究.
- 开发的套件将提高试验结果对患者和临床医生的相关性和适用性.
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