寒性荨麻疹患者疾病严重程度指数的建立与验证。

IF 6.6 1区医学 Q1 ALLERGY

Journal of Allergy and Clinical Immunology-In Practice Pub Date : 2025-09-01 DOI:10.1016/j.jaip.2025.04.047

Tatjana Altunergil MD , Manuel P. Pereira MD, PhD , Sabine Altrichter MD , Annika Gutsche MSc , Dalia M. Ahsan MD , Lena Fox , Eva Grekowitz MD , Hanna Bonnekoh MD , Karsten Weller MD , Marcus Maurer MD , Pascale Salameh PhD , Dorothea Terhorst-Molawi MD

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引用次数: 0

摘要

背景：冷性荨麻疹（ColdU）是一种常见类型的慢性诱导性荨麻疹（CIndU），其中寒冷诱发皮疹和/或血管性水肿，根据症状、日常负担、对治疗的一般反应、避免寒冷的需要和紧急治疗的使用，疾病严重程度范围很广，从非常轻微到改变生命和危及生命。目前还没有有效的工具来客观评估ColdU患者的疾病严重程度。目的：建立并验证ColdU （SICU）的疾病特异性严重程度指标。方法：SICU的发展分为四个阶段：1。2.概念框架；3.项目生成项目缩减4。最后的编辑。在项目产生阶段和项目减少阶段分别对7名和8名患者进行了访谈。然后，对75例患者进行了验证性研究，包括结构、结构、收敛和已知组效度评估以及信度表征（内部一致性和重测）。结果：初步工具包括24个项目。减少项目后，最终SICU包括13个项目和4个领域：“触发因素”、“体征和症状”、“生活质量”和“治疗和效率”。验证研究结果显示，本研究具有适当的结构效度和建构效度，具有良好的样本充分性、适当的收敛效度、适当的已知组效度、高内部一致性和高重测信度。结论：SICU是第一个经过验证的用于评估ColdU疾病严重程度的疾病特异性PROM。这种PROM将通过评估疾病严重程度，从而更好地告知医生和患者适当的治疗方法，从而促进患者护理。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Development and Validation of a Disease Severity Index for Patients With Cold Urticaria

Background

Cold urticaria (ColdU) is a common type of chronic inducible urticaria where cold induces wheals and/or angioedema, with a wide range of disease severity, from very mild to life-changing and life-threatening, based on symptoms, day-to-day burden, general response to therapies, the need for cold avoidance, and the use of emergency treatment. There are no validated instruments to objectively assess disease severity in patients with ColdU.

Objective

To develop and validate a disease-specific Severity Index for ColdU (SICU).

Methods

The development of the SICU followed 4 phases: (1) conceptual framework, (2) item generation, (3) item reduction, and (4) final editing. Seven and eight patients were interviewed in the item generation phase and in the item reduction phase, respectively. Then, a validation study with 75 patients was performed, which included construct, structural, convergent, and known-group validity assessments as well as the characterization of reliability (internal consistency and test-retest).

Results

The preliminary tool consisted of 24 items. After item reduction, the final SICU included 13 items and 4 domains: “trigger factors,” “signs and symptoms,” “quality of life,” and “therapy and efficiency.” The validation study revealed appropriate structural and construct validity with excellent measures of sample adequacy, appropriate convergent validity, as well as an adequate known-group validity, high internal consistency, and high test-retest reliability.

Conclusions

The SICU is the first validated disease-specific patient-reported outcome measure (PROM) for assessing ColdU disease severity. This PROM will facilitate patient care by evaluating disease severity and consequently better informing physicians and patients on an appropriate therapeutic approach.

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来源期刊

Journal of Allergy and Clinical Immunology-In Practice ALLERGYIMMUNOLOGY-IMMUNOLOGY

CiteScore

11.10

自引率

9.60%

发文量

683

审稿时长

50 days

期刊介绍： JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases. This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders. The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.