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基于对嗅觉障碍临床试验核心结局集文献的系统综述及COMET计划,开发并验证嗅觉问卷Smell-Qx

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.

作者信息

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, Hummel Thomas

机构信息

Division of Surgery and Interventional Science, UCL, London, UK.

UCL Cancer Institute, London, UK.

出版信息

Int Forum Allergy Rhinol. 2025 Sep;15(9):974-984. doi: 10.1002/alr.23604. Epub 2025 May 9.

DOI:10.1002/alr.23604
PMID:40344493
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12401079/
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.

摘要

背景

嗅觉功能障碍影响着高达22%的人口。准确评估对于诊断和追踪结果至关重要,通常使用患者报告结局测量指标(PROMs)。

目的

我们旨在开发并验证一种用于评估嗅觉和味觉功能障碍的新型问卷。

方法

通过系统综述确定现有的嗅觉和味觉问卷,随后进行条目生成和筛选。经过两轮德尔菲法以及与大量嗅觉和味觉专家小组的咨询,开发出了嗅觉功能问卷(Smell-Qx)。一项验证研究招募了来自嗅觉和味觉诊所的患者(病例组)以及普通耳鼻喉科诊所的患者(对照组)来完成Smell-Qx问卷。此外,患有嗅觉和味觉障碍的患者接受了使用嗅棒阈值、辨别和识别(TDI)测试的心理物理学测试。

结果

Smell-Qx是一种包含11个领域的工具,其中五个核心领域用于计算总分,六个病史/生活质量领域用于获取全面病史。验证研究招募了60名参与者(32名嗅觉/味觉障碍患者和28名对照组)。各条目显示出可接受至显著的内部一致性(克朗巴哈系数α:0.64 - 0.97)和重测信度(组内相关系数ICC:0.65 - 0.99,p < 0.001)。Smell-Qx能够有效地区分嗅觉和味觉障碍患者与对照组(t = 9.99,自由度df = 58,p < 0.0001)。与总体与嗅觉减退、味觉障碍相关的生活质量(r = 0.43,p = 0.015)以及嗅觉丧失领域和总体嗅觉TDI评分(r = -0.54,p = 0.011)的同时效度良好。

结论

Smell-Qx是一种可靠且有效的PROM,用于评估嗅觉和自我报告的味觉障碍,能够捕捉症状严重程度和对生活质量的影响。它可以与心理物理学测试一起纳入多模式评估方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/687f49897521/ALR-15-974-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/a6590d54c4ac/ALR-15-974-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/2cbe77645ad4/ALR-15-974-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/687f49897521/ALR-15-974-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/a6590d54c4ac/ALR-15-974-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/2cbe77645ad4/ALR-15-974-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e57/12401079/687f49897521/ALR-15-974-g002.jpg

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