PMID- 38055971 OWN - NLM STAT- MEDLINE DCOM- 20240208 LR - 20240208 IS - 1945-8932 (Electronic) IS - 1945-8932 (Linking) VI - 38 IP - 2 DP - 2024 Mar TI - Validation of Minimal Clinically Important Difference (MCID) for University of Pennsylvania Smell Identification Test (UPSIT). PG - 123-132 LID - 10.1177/19458924231218037 [doi] AB - BACKGROUND: The University of Pennsylvania Smell Identification Test is widely used to measure change in olfactory function, but a minimal clinically important difference (MCID) has not been well-established. A study published in 1997 regarding patients with head trauma reported an MCID of 4 but did not detail the methods used in the calculation. OBJECTIVE: To validate the MCID for UPSIT in patients with postviral, sinusitis, and procedure-associated olfactory loss. METHODS: This was a secondary analysis of prospectively collected data from 5 clinical research studies related to olfactory function. Three studies included subjects with COVID-19-related olfactory dysfunction, one with chronic sinusitis subjects, and one with subjects undergoing transsphenoidal surgery. All subjects had completed a baseline and follow-up UPSIT, baseline and follow-up Clinical Global Impression-Severity (CGI-Severity), and a follow-up CGI-Improvement. Both distribution- and anchor-based methods were used to determine the MCID of UPSIT. Distribution-based method calculated MCID using half standard deviation of baseline UPSIT and delta UPSIT scores. Clinical-anchor method determined MCID by comparing delta UPSIT scores between consecutive CGI-I clinical categories ranging from very much better to very much worse. RESULTS: The study population comprised 295 subjects. Subjects had a mean (SD) baseline UPSIT score of 27 (7.5), and follow-up score of 28 (7.9), and a mean UPSIT change of 0.6 (5.8). Half the baseline UPSIT SD was 3.75 and half the delta UPSIT SD was 2.9. With the anchor-based approach, an MCID of 4 was defined as clinically meaningful by exploring the relationship between delta UPSIT and CGI-Improvement. Using a more conservative approach based on the MCID values identified from both methods, we determined that a change of 4 or greater is the appropriate MCID for UPSIT. CONCLUSION: Investigators in the future should use 4 as MCID for UPSIT and report the percentage of study subjects who achieve a clinically meaningful difference. LEVEL OF EVIDENCE: III. FAU - Mahadev, Ashna AU - Mahadev A AUID- ORCID: 0000-0003-0360-4398 AD - Department of Otolaryngology - Head and Neck Surgery, Washington University School of Medicine, St. Louis, MO, USA. FAU - Kallogjeri, Dorina AU - Kallogjeri D AD - Department of Otolaryngology - Head and Neck Surgery, Washington University School of Medicine, St. Louis, MO, USA. FAU - Piccirillo, Jay F AU - Piccirillo JF AD - Department of Otolaryngology - Head and Neck Surgery, Washington University School of Medicine, St. Louis, MO, USA. LA - eng PT - Journal Article DEP - 20231206 PL - United States TA - Am J Rhinol Allergy JT - American journal of rhinology & allergy JID - 101490775 SB - IM MH - Humans MH - *Smell MH - Minimal Clinically Important Difference MH - Chronic Disease MH - *Sinusitis/surgery OTO - NOTNLM OT - MCID OT - UPSIT OT - clinically important difference OT - clinically meaningful change OT - smell identification COIS- Declaration of Conflicting InterestsThe authors would like to declare the following conflict of interest with respect to the research, authorship, and/or publication of this article: Dr. Piccirillo receives royalty from Washington University for the licensing of SNOT for commercial uses. EDAT- 2023/12/06 18:42 MHDA- 2024/02/08 06:42 CRDT- 2023/12/06 17:27 PHST- 2024/02/08 06:42 [medline] PHST- 2023/12/06 18:42 [pubmed] PHST- 2023/12/06 17:27 [entrez] AID - 10.1177/19458924231218037 [doi] PST - ppublish SO - Am J Rhinol Allergy. 2024 Mar;38(2):123-132. doi: 10.1177/19458924231218037. Epub 2023 Dec 6.