在注册的随机糖尿病试验中,个体报告的结果:构造的映射审查
Maartje de Wit1,2, Selina van Luik1,2, David Marrero3
1Amsterdam UMC, Location Vrije Universiteit Amsterdam, Medical Psychology, Amsterdam, The Netherlands.
概括
个人报告结果 (PROs) 越来越多地用于糖尿病临床试验. 然而,PROs很少是主要的结果,特别是在药物试验中,突出了对标准化措施的需求.
科学领域:
- 临床试验和糖尿病研究
- 患者报告的结果 (PROs)
- 医疗保健服务研究 医疗服务研究
背景情况:
- 个人报告的结果 (PROs) 对于评估临床试验中的患者体验至关重要.
- 近年来,人们越来越重视将PRO纳入随机临床试验 (RCT).
- 了解目前在糖尿病RCT中使用PRO的情况,对于改善试验设计和报告至关重要.
研究的目的:
- 在五年内评估PROs在1型和2型糖尿病的注册RCT中的纳入状态.
- 将使用的 PRO 测量 (PROM) 映射到预定义的领域,以了解它们的应用.
- 确定糖尿病研究中使用PRO的趋势和差距.
主要方法:
- 在主要临床试验注册表 (ClinicalTrials.gov,ICTP,ISRCTN) 系统搜索涉及1型或2型糖尿病患者的RCT (2018-2023).
- 包括PRO的编码:PRO的存在,PRO作为主要结果,并将PROM映射到预定义的领域和干预类型.
- 对1543个符合纳入标准的确定RCT进行分析.
主要成果:
- 在1543项试验中,673项 (44%) 包含了PRO,使用了545种不同的措施.
- 在9.6%的试验中,PRO是主要结果;20%的药物试验和71%的行为干预包括PRO.
- 心理功能是被评估最多的领域 (21.6%),而社会和家庭功能是被评估最少的领域 (3%).
结论:
- 在糖尿病RCT中包含PRO的趋势越来越大.
- 有效试验很少被指定为主要结局,特别是在以药物为中心的试验中.
- 采用的各种PROM需要进行标准化努力,以获得一致的数据收集和解释.
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