Outcome Modification and Disclosure Practices in Sinonasal Clinical Trials: A Registry-Based Cross-Sectional...

Area of Science:

• Clinical Trials Methodology
• Rhinology and Sinonasal Disease Research
• Evidence-Based Medicine

Background:

• Interventional trials for inflammatory sinonasal disease are critical for advancing treatment strategies.
• Prespecified outcomes in clinical trials are essential for unbiased interpretation of results.
• Understanding outcome modification patterns is key to assessing trial integrity.

Purpose of the Study:

• To analyze the frequency, nature, timing, and transparency of outcome modifications in interventional sinonasal disease trials.
• To identify factors influencing high-impact outcome modifications.
• To evaluate the documentation and disclosure of outcome changes in trial registries and publications.

Main Methods:

• Systematic review of interventional trials for inflammatory sinonasal disease registered on ClinicalTrials.gov with published results.
• Comparison of earliest and latest registry versions to identify substantive outcome modifications.
• Categorization of modifications by interpretive impact and timing; assessment of disclosure in registries and publications.

Main Results:

• Outcome modifications were highly frequent (94.4%), affecting primary outcomes in 81.9% of 72 trials.
• A median of seven substantive modifications per trial occurred, often after completion or publication.
• Disclosure of modifications was rare (4.4% in registry, 1.5% in publication).

Conclusions:

• Frequent and poorly documented outcome modifications in sinonasal trials challenge interpretability.
• Enhanced transparency in reporting outcome changes is crucial for reliable evidence synthesis in rhinology.
• Standardized reporting of outcome modifications is needed to ensure the validity of clinical trial findings.