Observational studyInternational forum of allergy & rhinology2026
Determining the Minimal Clinically Important Difference of the 40-Item Smell Identification Test in People With Cystic Fibrosis.
Observational study in International forum of allergy & rhinology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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35 authors.
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Abstract
backgroundChronic rhinosinusitis (CRS) and olfactory dysfunction (OD) are highly prevalent among people with cystic fibrosis (PwCF) and negatively impact quality of life. The 40-item Smell Identification Test (SIT) is widely used to assess psychophysical olfaction, but a CF-specific minimal clinically important difference (MCID) has not been established. This study aimed to determine the SIT MCID in PwCF treated with elexacaftor/tezacaftor/ivacaftor (ETI) and/or endoscopic sinus surgery (ESS).
methodsData from three prospective, multi-institutional observational studies were pooled. Participants were ≥12 years old with confirmed CF and CRS who completed SIT at baseline and ≥1 follow-up (3, 6, 9, 12, or 24 months). Distribution-based MCIDs were calculated using four methods: standard error of measurement (SEM), minimal detectable change (MDC = 1.96 × SEM), 0.5 × baseline standard deviation (SD), and 0.5 × SD of change scores (ΔSD).
resultsA total of 122 participants were enrolled (mean age 32.9 years, 54% female). Of these, 99 contributed follow-up SIT scores (79 ETI, 20 ESS). SIT scores remained stable with ETI, with a small but statistically significant decline at 6 months (-1.4, p = 0.02). ESS was associated with mean gains of 3.1-4.5 points at early follow-up, though these did not reach significance. Pooled distribution-based MCID estimates ranged from 2 to 4 points, with an overall threshold of 3.1 (95% CI: 2.1-4.1).
conclusionsThis CF-specific SIT threshold provides a clinically interpretable cut-off for assessing olfaction. These findings establish a foundation for future work and highlight the importance of developing disease-specific MCIDs to guide clinical care and research.
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