评估集群随机试验的代表性:来自美国养老院的两项大型实用试验的证据
Nina R Joyce1,2, Sarah E Robertson3,4,5, Ellen McCreedy2,3
1Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.
Clinical trials (London, England)
|July 26, 2023
概括
集群随机试验的结果可能不适用于一般人群. 设施特征,而不仅仅是居民特征,必须评估在养老院试验中的概括性.
科学领域:
- 老年学是一门学科.
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
背景情况:
- 集群随机试验 (CRT) 容易受到选择偏差的影响,当根据影响治疗有效性的因素选择集群时.
- 这可能会限制试验结果对更广泛的目标人群的概括性.
- 养老院试验特别脆弱,因为设施级别的差异.
研究的目的:
- 在两个实用CRT中,比较随机选择的养老院的特征与符合条件的非随机选择和不符合条件的设施.
- 评估CRT中包含的设施和居民的代表性.
- 为CRT结果的解释及其适用性提供信息.
主要方法:
- 利用来自两个大型养老院CRT的数据:高剂量流感疫苗试验和阿尔茨海默病养老院居民的音乐和记忆实用试验 (METRICaL).
- 将试验数据与养老院评估和医疗保险服务费索赔联系起来.
- 采用标准化平均差异和后勤回归来比较随机组,合格非随机组和不合格组的设施和居民特征.
主要成果:
- 在高剂量试验中,只有29%的养老院符合条件,其中18%是随机选择的. 随机选择的设施在规模,营利性地位,连锁加盟和特殊护理单位的存在方面存在显著差异.
- 在METRICaL试验中,59%的养老院符合条件,其中50%是随机的. 在规模,资源贫困状况和特殊护理单位的存在方面注意到了差异.
- 在这两项试验中,随机化,符合条件的非随机化和不符合条件的设施中,居民特征在很大程度上是相似的.
结论:
- 在CRT中的随机化养老院的设施级特征往往与符合条件的非随机化和不符合条件的设施有很大差异.
- 居民级别的特征在各设施组之间变化较小.
- 研究人员必须评估集群 (设施) 特性,而不仅仅是个人 (居民) 特性,以确定CRT发现的概括性.
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