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 Jr; Omar G Ahmed

doi:10.1016/j.amjoto.2024.104575

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

Am J Otolaryngol. 2024 Dec 19;46(1):104575. doi: 10.1016/j.amjoto.2024.104575. Online ahead of print.

Authors

Affiliations

¹ Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA; Department of Otolaryngology - Head and Neck Surgery, Houston Methodist, Houston, TX, USA. Electronic address: [email protected].
² Department of Otolaryngology - Head and Neck Surgery, Houston Methodist, Houston, TX, USA.
³ Division of Biostatistics, Department of Population Health, New York University Grossman School of Medicine, NY, New York, USA.
⁴ Department of Otolaryngology-Head and Neck Surgery, University of Texas Medical Branch, Galveston, TX, USA.
⁵ Baylor College of Medicine, Houston, TX, USA.
⁶ Department of Otolaryngology - Head and Neck Surgery, Tulane University School of Medicine, New Orleans, LA, USA; Department of Otorhinolaryngology and Communication Sciences, Ochsner Clinic Foundation, New Orleans, LA, USA.
⁷ Department of Otolaryngology - Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.

PMID: 39740532
DOI: 10.1016/j.amjoto.2024.104575

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.

Keywords: Evidence based medicine; Fragility index; Randomized controlled trials; Research methodology; Rhinology; Rhinosinusitis; Sinus surgery; Statistical significance.