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.

2nd Academic ORL Department Aristotle University of Thessaloniki Thessaloniki Greece

5th Sense Bicester UK

Department of Anatomy Université du Québec à Trois Rivières Trois Rivières Quebec Canada

Department of Clinical Medicine Aarhus University Øre Næse og Halskirurgi RHG Aarhus N Denmark

Department of Otolaryngology Head and Neck Surgery Biruni University School of Medicine Istanbul Turkey

Department of Otolaryngology Head and Neck Surgery Harvard Medical School Boston USA

Department of Otolaryngology Head and Neck Surgery Indiana University School of Medicine Indianapolis Indiana USA

Department of Otolaryngology Head and Neck Surgery Stanford University School of Medicine Stanford California USA

Department of Otolaryngology Head and Neck Surgery University of California San Diego School of Medicine La Jolla California USA

Department of Otorhinolaryngology and Head and Neck Surgery Regional Hospital Pardubice and Faculty of Health Studies University of Pardubice Pardubice Czech Republic

Department of Otorhinolaryngology Cliniques Universitaires Saint Luc Université Catholique de Louvain Brussels Belgium

Department of Otorhinolaryngology Head and Neck Surgery Cliniques Universitaires Saint Luc Brussels Belgium

Department of Otorhinolaryngology Head and Neck Surgery Geneva University Hospitals Geneva Switzerland

Department of Otorhinolaryngology Head and Neck Surgery Inselspital Bern University Hospital University of Bern Bern Switzerland

Department of Otorhinolaryngology Head and Neck Surgery Medical University of Vienna Vienna Austria

Department of Otorhinolaryngology Head and Neck Surgery University Hospital Basel Basel Switzerland

Department of Otorhinolaryngology Hospital Clínic Barcelona Barcelona Spain

Department of Otorhinolaryngology Hospital Unit West Central Denmark Region Hospital Unit West Holstebro Denmark

Department of Otorhinolaryngology Jikei University School of Medicine Tokyo Japan

Department of Otorhinolaryngology Smell and Taste Clinic Technische Universität Dresden Dresden Germany

Department of Surgery The University of Chicago Chicago Illinois USA

Division of Surgery and Interventional Science UCL London UK

Ear Nose and Throat Department James Paget University Hospital James Paget University Hospitals NHS Foundation Trust Great Yarmouth UK

ENT Department ASST Sette Laghi University of Insubria Varese Italy

Massachusetts Eye and Ear Boston USA

Royal National Ear Nose Throat and Eastman Dental Hospitals London UK

Sheffield Children's Hospital Sheffield UK

UCL Cancer Institute London UK

UCL Ear Institute University College London London UK

UCL London UK

University of East Anglia Medical School University of East Anglia Norwich UK

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