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在大型死亡率试验中评估婴儿发育的精度和负担能力的平衡:随机对照试验的二次分析
Kristy P Robledo1, Ingrid Rieger2, Sarah Finlayson3
1NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia kristy.robledo@sydney.edu.au.
Archives of disease in childhood. Fetal and neonatal edition
|January 9, 2025
概括
年龄和阶段问卷 (ASQ-3) 可以查婴儿发育迟缓,但与贝利婴儿发育量表 (Bayley-III) 相比,需要更大的样本大小. 这种方法可以在大型试验中节省成本.
科学领域:
- 新生儿研究新生儿研究
- 发育儿科 发育儿科
- 临床试验方法论 临床试验方法论
背景情况:
- 大规模的死亡率试验需要对婴儿损伤进行可靠的二次评估.
- 年龄和阶段问卷 (ASQ-3) 是一个由家长填写的查工具.
- 婴儿发育的贝利尺度 (Bayley-III) 是临床医生管理的诊断工具.
研究的目的:
- 为了比较ASQ-3与Bayley-III在分类婴儿发育障碍方面的有效性.
- 评估在大型临床试验中使用查与诊断工具的成本效益.
主要方法:
- 从澳大利亚胎盘输血研究中对405名怀孕30周以下的婴儿进行二次分析.
- 儿童在2岁左右进行评估,年龄修正.
- 对ASQ-3 (查) 和Bayley-III (诊断) 进行损伤分类的比较.
主要成果:
- ASQ-3显示出对发育迟缓的良好预测能力 (AUC 0.75-0.99),灵敏度为57%-100%和特异性为88%-90%.
- 使用ASQ-3可以使样本大小增加一倍,但与Bayley-III相比,可以节省1300万美元的评估成本.
- 潜在的成本节约可能会被需要更大的样本大小和扩大规模所抵消.
结论:
- 在大型试验中,像Bayley-III这样的精确诊断工具的高成本可能是无法支付的.
- 使用不那么精确,校准选工具 (ASQ-3) 与更大的样本大小可以是一个更实惠的策略.
- 对评估精度,样本大小和总体成本的仔细考虑对于大规模临床试验至关重要.
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