Department of Anesthesia and Pain Medicine, The Hospital for Sick Children (SickKids), 555 University Avenue, Toronto, ON, M5G 1X8, Canada.
Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada.
Can J Anaesth. 2023 Sep;70(9):1449-1460. doi: 10.1007/s12630-023-02513-3. Epub 2023 Jun 8.
The P value is a widely used measure of statistical importance but has many drawbacks and limitations, one being that it does not reflect the robustness of the results of a clinical trial. The Fragility Index (FI) was developed as a measure of how many outcome events would need to change to nonevents to render a significant P value nonsignificant (P ≥ 0.05). The FI of trials from other medical specialties is typically < 5. We aimed to determine the FI of pediatric anesthesiology randomized controlled trials (RCT) and to test for association with various characteristics of the included trials.
We conducted a comprehensive systematic search of high-impact anesthesia, surgical, and medical journals from the last 25 years for trials comparing an intervention between two groups with a statistically significant P value (< 0.05) for a dichotomous outcome. We also compared FI values for variables that reflect the quality and importance of a trial.
The median [interquartile range] FI was 3 [1-7] and correlated positively with the number of participants (r = 0.41; P < 0.001) and events (r = 0.42; P < 0.001), and negatively with the P value (r = -0.36; P < 0.001). Other measures of trial quality and impact or importance were not strongly associated with the FI.
The FI of published trials in pediatric anesthesiology is similarly low as in other medical specialties. Larger trials with more events and P values ≤ 0.01 were associated with a higher FI.
P 值是一种广泛使用的统计显著性度量标准，但它有许多缺点和局限性，其中之一是它不能反映临床试验结果的稳健性。脆弱指数（FI）是作为衡量需要改变多少个结局事件才能使有统计学意义的 P 值变得无统计学意义（P≥0.05）的指标而开发的。其他医学专业的试验的 FI 通常<5。我们旨在确定儿科麻醉学随机对照试验（RCT）的 FI，并检验其与纳入试验的各种特征之间的关联。
我们对过去 25 年的高影响力麻醉、外科和医学期刊进行了全面的系统检索，以寻找比较两种干预措施的 RCT，这些干预措施在二分类结局上具有统计学意义的 P 值（<0.05）。我们还比较了反映试验质量和重要性的变量的 FI 值。
中位数[四分位数范围]FI 为 3[1-7]，与参与者数量呈正相关（r=0.41；P<0.001）和事件数量呈正相关（r=0.42；P<0.001），与 P 值呈负相关（r=-0.36；P<0.001）。其他试验质量和影响或重要性的衡量标准与 FI 相关性不强。
发表的儿科麻醉学 RCT 的 FI 与其他医学专业相似较低。具有更多事件和 P 值≤0.01 的较大试验与较高的 FI 相关。
