Department of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA, USA.
Department of Otolaryngology - Head and Neck Surgery, Yale University, New Haven, CT, USA.
J Laryngol Otol. 2024 Apr;138(4):451-456. doi: 10.1017/S0022215123001755. Epub 2023 Oct 5.
The fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials.
Studies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases.
Overall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were 103 (56-213) and 2 (0-5), respectively. The fragility index exceeded the number of patients lost to follow up in 42.3 per cent ( = 52) of studies. A higher fragility index correlated with higher sample size (r = 0.514, < 0.001), number of events (r = 0.449, < 0.001) and statistical significance via -value (r = -0.367, < 0.001).
Head and neck cancer randomised, controlled trials demonstrated low fragility index values, in which statistically significant results could be nullified by altering the outcomes of just two patients, on average. Future head and neck oncology randomised, controlled trials should report the fragility index in order to provide insight into statistical robustness.
脆弱指数表示将结果从统计学上显著转变为不显著所需的最小患者数量。本报告评估了头颈部癌症随机对照试验的脆弱指数。
从 PubMed/Medline、Scopus、Embase 和 Cochrane 数据库中提取研究。
共纳入 123 项随机对照试验。样本量和脆弱指数中位数（四分位间距）分别为 103（56-213）和 2（0-5）。在 42.3%（=52）的研究中，脆弱指数超过了失访患者的数量。更高的脆弱指数与更大的样本量（r = 0.514，<0.001）、更多的事件数（r = 0.449，<0.001）和通过 - 值表示的统计学意义（r = -0.367，<0.001）相关。
头颈部癌症的随机对照试验显示出较低的脆弱指数值，平均而言，只需改变两名患者的结局，就可能使统计学上显著的结果无效。未来的头颈部肿瘤学随机对照试验应报告脆弱指数，以深入了解统计稳健性。
