ClinSearch, Malakoff, France.
Laboratoire Conception de Produits et Innovation (LCPI), Arts et Métiers ParisTech, Paris, France.
J Pharm Pharmacol. 2018 Jan;70(1):42-50. doi: 10.1111/jphp.12829. Epub 2017 Oct 26.
Our novel tool to standardise the evaluation of medicine acceptability was developed using observational data on medicines use measured in a paediatric population included for this purpose (0-14 years). Using this tool, any medicine may be positioned on a map and assigned to an acceptability profile. The present exploration aimed to verify its statistical reliability.
Permutation test has been used to verify the significance of the relationships among measures highlighted by the acceptability map. Bootstrapping has been used to demonstrate the accuracy of the model (map, profiles and scores of acceptability) regardless of variations in the data. Lastly, simulations of enlarged data sets (×2; ×5; ×10) have been built to study the model's consistency.
Permutation test established the significance of the meaningful pattern identified in the data and summarised in the map. Bootstrapping attested the accuracy of the model: high RV coefficients (mean value: 0.930) verified the mapping stability, significant Adjusted Rand Indexes and Jaccard coefficients supported clustering validity (with either two or four profiles), and agreement between acceptability scores demonstrated scoring relevancy. Regarding enlarged data sets, these indicators reflected a very high consistency of the model.
These results highlighted the reliability of the model that will permit its use to standardise medicine acceptability assessments.
我们开发了一种新的工具,用于标准化药物可接受性的评估,该工具使用了为该目的纳入的儿科人群中测量的药物使用观察数据(0-14 岁)。使用该工具,任何药物都可以在地图上定位,并分配到可接受性特征中。本研究旨在验证其统计学可靠性。
通过置换检验验证了可接受性图谱中突出的措施之间的关系的显著性。Bootstrapping 用于证明模型(图谱、特征和可接受性评分)的准确性,无论数据存在变化。最后,构建了放大数据集(×2;×5;×10)的模拟,以研究模型的一致性。
置换检验确立了数据中识别出的有意义模式的显著性,并在图谱中进行了总结。Bootstrapping 验证了模型的准确性:高 RV 系数(平均值:0.930)验证了映射的稳定性,显著的调整兰德指数和杰卡德系数支持聚类有效性(无论采用两个还是四个特征),以及可接受性评分之间的一致性表明评分的相关性。对于放大的数据集,这些指标反映了模型的高度一致性。
这些结果突出了该模型的可靠性,这将使其能够用于标准化药物可接受性评估。