Department of Pediatrics, Section of Pediatric Critical Care Medicine, The University of Chicago Medicine and Comer Children's Hospital, Chicago, IL.
Center for Healthcare Delivery Science and Innovation, The University of Chicago Medicine, Chicago, IL.
Pediatr Crit Care Med. 2019 Jun;20(6):e258-e262. doi: 10.1097/PCC.0000000000001922.
The Fragility Index measures the number of events on which the statistical significance of a result depends and has been suggested as an adjunct statistical assessment for interpretation of trial results. This study aimed to assess the robustness of statistically significant results from pediatric critical care randomized controlled trials with dichotomous outcomes.
A previously published scoping review of pediatric critical care randomized controlled trials (www.PICUtrials.net).
A total of 342 trials were screened for inclusion. After applying inclusion/exclusion criteria, 43 fulfilled eligibility criteria and were included in the analysis.
Calculation of Fragility Index for trials reporting a statistically significant dichotomous outcome, and analysis of the relationship between trial characteristics and Fragility Index.
The median Fragility Index was 2 (interquartile range, 1-6). The median sample size was 98 (interquartile range, 50-148) and sample size demonstrated a strong correlation with the Fragility Index (r = 0.729; n = 43; p < 0.001). The median number of outcome events was 8 (interquartile range, 4-15) and the total number of outcome events also showed a strong correlation with the Fragility Index (r = 0.728; n = 43; p < 0.001).
Results from pediatric critical care randomized controlled trials with dichotomous outcomes reporting statistically significant findings often hinge on a small number of outcome events. Clinicians should exercise caution when interpreting results of trials with a low Fragility Index.
脆弱指数衡量结果的统计学意义所依赖的事件数量，并已被提议作为解释试验结果的辅助统计评估。本研究旨在评估具有二分类结局的儿科重症监护随机对照试验中统计学显著结果的稳健性。
先前发表的儿科重症监护随机对照试验的范围综述（www.PICUtrials.net）。
共筛选了 342 项试验以纳入。在应用纳入/排除标准后，有 43 项符合纳入标准并纳入分析。
计算报告统计学显著二分类结局的试验的脆弱指数，并分析试验特征与脆弱指数之间的关系。
脆弱指数的中位数为 2（四分位距，1-6）。中位数样本量为 98（四分位距，50-148），样本量与脆弱指数呈强相关性（r = 0.729；n = 43；p < 0.001）。结局事件的中位数数量为 8（四分位距，4-15），总结局事件数也与脆弱指数呈强相关性（r = 0.728；n = 43；p < 0.001）。
具有统计学显著发现的二分类结局的儿科重症监护随机对照试验的结果往往取决于少数几个结局事件。当解释脆弱指数较低的试验结果时，临床医生应谨慎行事。
