"残疾"作为临床试验的排除标准:一个范围审查
Guido Camanni1, Ornella Ciccone2, Alessandro Lepri2
1Rehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy guidocamanni@serafico.it.
BMJ global health
|November 2, 2023
概括
由于广泛或不清楚的标准,残疾人经常被排除在临床试验之外. 这项研究揭示了高排斥率,强调需要更具包容性的研究设计,以确保PWD参与.
科学领域:
- 生物医学研究伦理学
- 临床试验方法论 临床试验方法论
- 关于残疾人的研究.
背景情况:
- 残疾人 (PWDs) 在生物医学研究中面临着严重的排斥.
- 缺乏关于PWD参与临床试验的全面数据.
- 这项研究解决了评估PWDs在医学研究中的排斥率的需要.
研究的目的:
- 评估在临床试验中对残疾人应用的排除标准的频率和性质.
- 分析与试验目标相关的排除标准的适当性.
主要方法:
- 按照PRISMA-ScR指南进行系统范围审查.
- 在ClinicalTrials.gov (2010-2020) 上注册的干预性临床试验分析了全球残疾调整寿命年数的前十大原因.
- 显式排除标准 (残疾,身体,认知,精神,沟通,感官障碍) 和隐式标准 (未定义的并发症,研究人员自由裁量权) 的分类.
主要成果:
- 在分析的2710项试验中,35.3%使用了明确的排除标准,行为或精神疾病是最常见的 (61.4%).
- 96%的明确排除标准被认为是"相对的",只有3%是"绝对的",1%是"可疑的".
- 在44.5%的试验中存在隐性排除标准.
结论:
- 生物医学研究显示,残疾人的排斥率很高.
- 普遍使用模糊或过于广泛的排除标准阻碍了PWD参与.
- 更具包容性的临床试验设计对于公平的研究代表性至关重要.
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