为评估糖尿病相关脚干预措施的研究开发一个核心成果集
Aleksandra Staniszewska1,2, Frances Game3, Jane Nixon4
1Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, U.K.
Diabetes care
|September 6, 2024
概括
一个新的核心结果集 (COS) 标准化了与糖尿病相关的足治疗措施. 这旨在提高研究的一致性和糖尿病足干预措施的比较有效性.
科学领域:
- 内分泌学和新陈代谢学
- 足科和伤口护理
- 临床试验方法论 临床试验方法论
背景情况:
- 糖尿病影响全球超过5.37亿人,其中很大一部分患有足部并发症.
- 与糖尿病相关的脚对全球健康造成了巨大的负担,需要标准化的证据来有效管理.
- 关于糖尿病足治疗方法的现有研究显示出结果异质性,阻碍了比较分析.
研究的目的:
- 为临床试验开发标准化的核心结果集 (COS),用于评估糖尿病相关脚的治疗方法.
- 确保对研究成果的一致测量,促进对干预措施的可靠比较.
- 解决糖尿病足治疗研究中结果报告的异质性.
主要方法:
- 使用了有效性试验 (COMET) 方法论中的核心结果措施.
- 进行了系统审查和患者采访,以确定候选结果.
- 采用了两轮的Delphi调查,对患者和专家进行了调查,随后举行了一次协商一致会议,批准了COS.
主要成果:
- 从最初的审查和面试中生成了103名候选人的结果.
- 在两轮Delphi测试中获得了52%的响应率,其中包括336名和176名参与者.
- 批准了8项COS,包括伤口愈合,愈合时间,感染,截肢,生活质量和死亡率.
结论:
- 已经建立了一个基于共识的核心结果集 (COS) 对于与糖尿病相关的足研究.
- 预计该COS的采用将加强对现有和新型治疗方法的比较有效性的评估.
- 标准化结果测量将提高糖尿病足研究证据的质量和可比性.
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