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What is the robustness of randomized controlled trials supporting rhinosinusitis guidelines?
Najm S Khan1, Aatin K Dhanda2, Masayoshi Takashima2
1Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA; Department of Otolaryngology - Head and Neck Surgery, Houston Methodist, Houston, TX, USA.
American Journal of Otolaryngology
|December 31, 2024
Summary
Randomized controlled trials supporting rhinosinusitis guidelines show low robustness. Future studies should report Fragility Index (FI) to contextualize findings.
Area of Science:
- Otolaryngology
- Clinical Trial Methodology
Background:
- The International Consensus Statement on Allergy and Rhinology: rhinosinusitis (ICAR-RS) guideline relies on randomized controlled trials (RCTs).
- Assessing the robustness of evidence is crucial for guideline validity.
Purpose of the Study:
- To evaluate the robustness of RCTs underpinning the current rhinosinusitis guideline (ICAR-RS).
Main Methods:
- Analyzed RCTs cited in ICAR-RS with dichotomous primary outcomes.
- Calculated the Fragility Index (FI) for statistically significant trials.
- Assessed associations between trial characteristics, FI, and patients lost to follow-up (LTF).
Main Results:
- 38 RCTs met criteria; 31% evaluated surgery, 24% were industry-sponsored.
- Median FI was 2.5, with 67% of trials having an FI ≤ 3, indicating low robustness.
- FI was not associated with industry support; 33% of trials had FI ≤ LTF.
Conclusions:
- RCTs supporting the ICAR-RS guideline demonstrate overall low robustness.
- Recommends future rhinosinusitis trials report FI for improved result interpretation.
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