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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number104575
JournalAmerican Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume46
Issue number1
DOIs
StatePublished - Jan 1 2025

Keywords

  • Evidence based medicine
  • Fragility index
  • Randomized controlled trials
  • Research methodology
  • Rhinology
  • Rhinosinusitis
  • Sinus surgery
  • Statistical significance

ASJC Scopus subject areas

  • Otorhinolaryngology

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