What is the robustness of randomized controlled trials supporting rhinosinusitis guidelines?

IF 1.8 4区医学 Q2 OTORHINOLARYNGOLOGY

American Journal of Otolaryngology Pub Date : 2025-01-01 DOI:10.1016/j.amjoto.2024.104575

Najm S. Khan , Aatin K. Dhanda , Masayoshi Takashima , Richard Liu , Yuki Yoshiyasu , Wenbo Wu , Whitney Jin , Edward D. McCoul , Murugappan Ramanathan Jr. , Omar G. Ahmed

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引用次数: 0

Abstract

Purpose

To determine the robustness of randomized controlled trials (RCTs) supporting the current rhinosinusitis guideline; International Consensus Statement on Allergy and Rhinology: rhinosinusitis (ICAR-RS).

Materials & methods

RCTs referenced by ICAR-RS with primary dichotomous outcomes were analyzed. The Fragility Index (FI) was calculated for trials with statistically significant findings. Trial characteristics, the FI, and FI minus number lost to follow-up (LTF) were assessed for associations.

Results

A total of 317 RCTs were identified, with 38 trials possessing a primary dichotomous outcome. Thirty-one percent evaluated surgical interventions and 24 % were industry-sponsored. The mean sample size was 116 with 9 patients, on average, LTF. Sixty-three percent were eligible for FI calculation and had a median FI of 2.5 (IQR 1, 4.25). Sixty-seven percent of trials had an FI ≤ 3, indicating low robustness. No difference in FI was observed between trials with and without industry support (p = 0.577). The FI was less than or equal to the number of patients LTF in 33 % of trials (n = 8). Higher FI was strongly correlated with higher sample size, total number of events, p-value, and grade of recommendation (p < 0.001). After adjusting for covariates, higher sample size and total number of events were associated with higher FI.

Conclusion

The RCTs used to support the ICAR-RS have an overall low robustness and future rhinosinusitis trials should report FI measures to provide improved context of their results.

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支持鼻窦炎指南的随机对照试验的稳健性是什么？

目的：确定支持当前鼻窦炎指南的随机对照试验（rct）的稳健性；过敏和鼻科学国际共识声明：鼻窦炎（ICAR-RS）。材料与方法：采用ICAR-RS参考的随机对照试验（rct）进行主要二分类结果分析。脆弱性指数（FI）计算具有统计学显著结果的试验。评估试验特征、FI和FI减去随访损失数（LTF）的相关性。结果：共有317项随机对照试验被确定，其中38项试验具有主要的二分类结果。31%的人评估手术干预，24%的人是行业赞助的。平均样本量为116例，9例患者，平均为LTF。63%的患者符合FI计算条件，FI中位数为2.5 （IQR 1,4.25）。67%的试验FI≤3，表明稳健性较低。在有和没有行业支持的试验中，FI没有差异（p = 0.577）。在33%的试验中，FI小于或等于LTF患者的数量（n = 8）。较高的FI与较高的样本量、事件总数、p值和推荐等级密切相关(p结论：用于支持ICAR-RS的随机对照试验总体上具有较低的鲁棒性，未来的鼻窦炎试验应报告FI措施，以提供更好的结果背景。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Otolaryngology 医学-耳鼻喉科学

CiteScore

4.40

自引率

4.00%

发文量

378

审稿时长

41 days

期刊介绍： Be fully informed about developments in otology, neurotology, audiology, rhinology, allergy, laryngology, speech science, bronchoesophagology, facial plastic surgery, and head and neck surgery. Featured sections include original contributions, grand rounds, current reviews, case reports and socioeconomics.