Can a quality-of-life instrument be developed and validated for assessing the physical problems, functional limitations, and emotional consequences associated with olfactory dysfunction (OD)?
In this survey creation and validation study among 283 patients, the newly created 28-item Olfactory Dysfunction Outcomes Rating (ODOR) was internally consistent, reliable, and valid. The minimal clinically important difference was 15 out of 112 total points.
The ODOR is a novel, concise, and valid patient-reported outcome measure of OD-associated quality of life that captures change after a given intervention; thus, it can be used as an outcome measure in future OD trials.
Olfactory dysfunction (OD) is an increasingly common and morbid condition, especially given the ongoing COVID-19 pandemic. Thus, the ability to reproducibly measure smell loss–associated quality of life (QOL) and its response to treatment is paramount.
To develop and validate a concise and visually appealing smell loss–associated QOL patient-reported outcome measure for OD.
Design, Setting, and Participants
A secondary analysis of comments to an online survey by 1000 patients with olfactory dysfunction published in 2013 was used as the primary source to generate items of the Olfactory Dysfunction Outcomes Rating (ODOR). In addition, 30 patients with OD enrolled in 2 clinical studies at a tertiary care medical center (Washington University) were asked to identify their main concerns associated with smell loss. And finally, 4 otolaryngologists reviewed the items generated from the online survey and the patients’ interviews to identify any additional items. Prospective study design was used for data collection from the 30 patients and 4 otolaryngologists. Prospective study design was used for survey validation. Validation of the ODOR was performed with 283 patients enrolled in several prospective studies at a single institution that completed the ODOR as an outcome measure.
Main Outcomes and Measures
Item generation and selection were the outcomes of ODOR development. The psychometric and clinimetric measures evaluated for validation were internal consistency, test-retest reliability, face and content validity, concurrent validity, and discriminant validity. Minimal clinically important difference was also determined.
The ODOR is a 28-item instrument with each item scored as either no difficulty or very rarely bothered (0) to complete difficulty or very frequently bothered (4) with a total instrument score range of 0 to 112 points. Higher scores indicate higher degree of dysfunction and limitation. Validation in the cohort of 283 patients (mean [SD] age, 47.0 [14.4] years; 198 female participants [73%]; 179 White participants [80%]) revealed that the instrument has high internal consistency (Cronbach α = 0.968), test-retest reliability (r = 0.90 [95% CI, 0.81-0.95]), face validity, content validity, concurrent validity (r = 0.87 [95% CI, 0.80-0.91] compared with the Questionnaire of Olfactory Disorders–Negative Statements; ρ = −0.76 [95% CI, −0.81 to −0.71] compared with a patient-reported symptom severity scale), and divergent validity (mean score difference, −33.9 [95% CI, −38.3 to −29.6] between normosmic patients and hyposmic/anosmic patients). The minimal clinically important difference was 15 points. The estimated time for survey completion was approximately 5 minutes.
Conclusions and Relevance
In this survey creation and validation study, the ODOR was shown to be a novel, concise, reliable, and valid patient-reported outcome measure of OD-associated QOL. It can be used to measure physical problems, functional limitations, and emotional consequences associated with OD and how they change after a given intervention, which is clinically applicable and particularly pertinent given the growing burden of OD associated with COVID-19.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: August 26, 2022.
Published Online: October 20, 2022. doi:10.1001/jamaoto.2022.3299
Corresponding Author: Jake J. Lee, MD, MSCI, 660 S Euclid Ave, Campus Box 8115, St Louis, MO 63110 (email@example.com).
Author Contributions: Drs Lee and Kallogjeri had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lee, Kallogjeri, Peterson, Piccirillo.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Lee, Mahadev, Peterson, Piccirillo.
Critical revision of the manuscript for important intellectual content: Kallogjeri, Peterson, Gupta, Khan, Jiramongkolchai, Schneider, Piccirillo.
Statistical analysis: Lee, Mahadev, Kallogjeri.
Obtained funding: Piccirillo.
Administrative, technical, or material support: Lee, Gupta, Khan, Jiramongkolchai.
Supervision: Lee, Piccirillo.
Conflict of Interest Disclosures: Dr Lee reported a copyright for the ODOR questionnaire filed through Washington University’s Office of Technology Management. Dr Kallogjeri reported personal fees for serving as Statistics Editor for JAMA Otolaryngology–Head & Neck Surgery outside the submitted work. Dr Piccirillo had a patent for SNOT and NOSE HHT with royalties paid from Washington University in St Louis . No other disclosures were reported.
Funding/Support: Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) under Award Number TL1TR002344. Funding for clinical research training was provided by a training grant from the NIH/National Institute on Deafness and Other Communication Disorders, T32DC000022: “Development of Clinician/Researchers in Academic ENT.”
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH (Mr Khan). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH (Dr Lee, Ms Mahadev, Dr Peterson, Ms Gupta, and Dr Jiramongkolchai). Dr Piccirillo is the Editor and Dr Kallogjeri is the Statistical Editor of JAMA Otolaryngology–Head & Neck Surgery, but they were not involved in any of the decisions regarding review of the manuscript or its acceptance.
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