Determining the Minimal Clinically Important Difference of the 40-Item Smell Identification Test in People With Cystic Fibrosis.
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Oh Eugene, Miller Jessa E, Lee Michelle J, Zemke Anna, Baraghoshi David, Strand Matthew J, Alt Jeremiah A, Bodner Todd E, Chang Michael, Chowdhury Naweed I, Eshaghian Patricia H, Getz Anne E, Goralski Jennifer L, Gudis David A, Hwang Peter H, Khanwalkar Ashoke, Kimple Adam J, Lee Jivianne T, Li Douglas A, Mace Jess C, Nayak Jayakar V, Overdevest Jonathan B, Patel Zara, Safatian Daniella K, Schlosser Rodney J, Senior Brent, Stapleton Amanda L, Smith Timothy L, Soler Zachary M, Suh Jeffrey D, Turner Grant A, Wang Marilene B, Saavedra Milene T, Taylor-Cousar Jennifer L, Beswick Daniel M
Аннотация
METHODS: Data 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).
RESULTS: A 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).
CONCLUSIONS: This 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.