The development and validation of the Smell-Qx questionnaire, based on a systematic review of the literature and the COMET initiative on the development of core outcome sets for clinical trials in olfactory disorders

Lechner, Matt, Fjaeldstad, Alexander, Rehman, Umar, Liu, Jacklyn, Boniface, David, Boardman, Jim, Boak, Duncan, Altundag, Aytug, Frasnelli, Johannes, Gane, Simon, Holbrook, Eric, Hsieh, Julien, Huart, Caroline, Konstantinidis, Iordanis, Landis, Basile N., Lund, Valerie J., Macchi, Alberto, Mori, Eri, Mueller, Christian, Mullol, Joaquim, Negoias, Simona, Patel, Zara M., Pinto, Jayant M., Poletti, Sophia, Ramakrishnan, Vijay, Rombaux, Philippe, Vodicka, Jan, Welge-Luessen, Antje, Whitcroft, Katherine L., Yan, Carol, Philpott, Carl and Hummel, Thomas (2025) The development and validation of the Smell-Qx questionnaire, based on a systematic review of the literature and the COMET initiative on the development of core outcome sets for clinical trials in olfactory disorders. International Forum of Allergy & Rhinology. ISSN 2042-6976

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Abstract

Background: Olfactory dysfunction affects up to 22% of the population. Accurate assessment is vital for diagnosis and tracking outcomes, often using patient-reported outcome measures (PROMs).  Aims: We aimed to develop and validate a novel questionnaire for assessing olfactory and gustatory dysfunction.    Methods: A systematic review identified existing smell and taste questionnaires, followed by item generation and selection. After two Delphi cycles and consultation with a large panel of smell and taste experts, the Smell-Qx questionnaire was developed. A validation study recruited patients from smell and taste clinics (cases) and general ENT clinics (controls) to complete the Smell-Qx. Additionally, patients with smell and taste disorders underwent psychophysical testing using Sniffin' Stick Threshold, Discrimination, and Identification (TDI) tests.  Results: The Smell-Qx is an 11-domain instrument, with five core domains used for total score calculation and six history/quality-of-life domains for obtaining a comprehensive history. The validation study recruited 60 participants (32 patients with smell/taste disorders and 28 controls). Items showed acceptable to significant internal consistency (Cronbach's α: 0.64?0.97) and test-retest reliability (ICC: 0.65?0.99, p < 0.001). The Smell-Qx was effective at distinguishing patients with smell and taste disorders from controls (t = 9.99, df = 58, p < 0.0001). Concurrent criterion validity was good with overall SATD-related quality of life (r = 0.43, p = 0.015), as well as with the smell loss domain and overall smell TDI scores (r = ?0.54, p = 0.011).  Conclusion: The Smell-Qx is a reliable and valid PROM for assessing olfactory and self-reported gustatory disorders, capturing symptom severity and quality-of-life impact. It can integrate into a multi-modal assessment approach alongside psychophysical testing.

Item Type: Article
Additional Information: Data Availability Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request. Funding: The authors received no specific funding for this work.
Uncontrolled Keywords: gustatory dysfunction,olfactory dysfunction,patient-reported outcome measures
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
Faculty of Medicine and Health Sciences > Research Groups > Respiratory and Airways Group
Depositing User: LivePure Connector
Date Deposited: 09 May 2025 16:30
Last Modified: 09 May 2025 16:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/99234
DOI: 10.1002/alr.23604

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