Generalizability of cognitive results from clinical trial participants to an older adult population: Addressing external validity.

Generalizability of cognitive results from clinical trial participants to an older adult population: Addressing external validity.
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DOI:
10.1002/dad2.12417
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发表时间:
2023-04
期刊:
Alzheimer's & dementia (Amsterdam, Netherlands)
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研究纳入标准和招募实践限制了随机对照试验(RCT)结果的普适性。统计建模可以增强结果的概括性。为了说明这一点,对老年女性目标人群进行了调整前后的认知-抑郁关系评估。这项研究包括来自四个随机对照试验的随机参与者和来自两个队列的非随机参与者。预测模型估计了从目标人群中随机进入试验的可能性。这些概率被用于相对于目标人群的逆赔率加权。采用加权线性回归方法评估抑郁与认知的关系。在组合随机样本中,不存在抑郁-认知关系。在对具有代表性的队列应用权重后,观察到负相关。在应用相对于非代表性队列的权重后,估计的偏差增加。使用具有代表性的样品来量化可运输性的方法可以解释为什么在随机对照试验中没有先验确定的关系。
Study inclusion criteria and recruitment practices limit the generalizability of randomized‐controlled trial (RCT) results. Statistical modeling could enhance generalizability of outcomes. To illustrate this, the cognition–depression relationship was assessed with and without adjustment relative to the target population of older women. Randomized participants from four RCTs and non‐randomized participants from two cohorts were included in this study. Prediction models estimated probability of being randomized into trials from target populations. These probabilities were used for inverse odds weighting relative to target populations. Weighted linear regression was used to assess the depression–cognition relationship. There was no depression–cognition relationship in the combined randomized sample. After applying weights relative to a representative cohort, negative relationships were observed. After applying weights relative to a non‐representative cohort, bias of estimates increased. Quantitative approaches to transportability using representative samples may explain the absence of a‐priori established relationships in RCTs.