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New Instrument for the Evaluation of Prodromes and Attacks of Hereditary Angioedema (HAE-EPA)
Clinical Reviews in Allergy & Immunology ( IF 9.1 ) Pub Date : 2021-02-04 , DOI: 10.1007/s12016-021-08843-8
Iris Leibovich-Nassi 1, 2 , Hava Golander 2 , Raz Somech 3 , Dov Har-Even 4 , Avner Reshef 1
Affiliation  

A disease-specific, patient-reported outcome instrument suitable for evaluation of prodromes and attacks of hereditary angioedema (HAE) is a clinical unmet need. We constructed such instrument and examined its validity, acceptability, and discriminative ability. Sixty-six patients participated in a survey addressing their demographics, social, and medical status. Discriminant content validity involved: (1) construct definition by in-depth cognitive debriefing interviews, (2) item selection identifying relevant categories, and (3) judgment of the format whereby questionnaires were tested on experienced patients and its content/reliability was validated. Prodromes and attacks affecting certain body systems (domains) were organized in “clusters”. Internal consistency, content, and convergent validities were analyzed. Analyses of variance and regression models were used to evaluate the discriminative ability of the instrument to differentiate between attacks and prodromes. The study demonstrates very high internal consistency (Cronbach’s α: attacks 0.88–0.98, prodromes 0.78–0.98). Analysis of variance confirmed significant differences between all dimensions and in pre-defined clusters (F (4, 61) = 45.74, p < 0.001, Eta2 = 0.77). Significant correlations were found between dimensions of prodromes and attacks. Prodromes are associated but differentiated from attacks. Correlations in severity were high for all domains. Interactions were found between prodromes and patients' experience in illness. In conclusion, the new Prodrome-Attack Evaluation questionnaire (HAE-EPA) is capable of distinguishing attacks and prodromes of HAE, as well as determining associations between the two interrelated phenomena. The new instrument achieves the required discriminative ability, acceptability, and content validity/reliability and therefore can be used as a reliable tool for the investigation of prodromes, attacks, and their relationships.



中文翻译:

用于评估遗传性血管性水肿的前驱症状和发作的新工具 (HAE-EPA)

一种适用于评估遗传性血管性水肿 (HAE) 的前驱症状和发作的疾病特异性、患者报告的结果工具是临床未满足的需求。我们构建了这样的工具并检查了它的有效性、可接受性和辨别能力。66 名患者参与了一项关于其人口统计、社会和医疗状况的调查。判别内容效度涉及:(1)通过深度认知汇报访谈构建定义,(2)确定相关类别的项目选择,以及(3)对有经验的患者测试问卷并验证其内容/可靠性的格式的判断。影响某些身体系统(域)的前驱症状和攻击被组织成“集群”。分析了内部一致性、内容和收敛效度。方差分析和回归模型用于评估仪器区分发作和前驱症状的辨别能力。该研究证明了非常高的内部一致性(Cronbach'sα:攻击 0.88-0.98,前驱症状 0.78-0.98)。方差分析证实了所有维度和预定义集群之间的显着差异(F (4, 61) = 45.74, p  < 0.001, Eta 2 = 0.77)。在前驱症状和攻击的维度之间发现了显着的相关性。前驱症状是相关的,但与攻击不同。所有领域的严重性相关性都很高。在前驱症状和患者的疾病经历之间发现了相互作用。总之,新的前驱症状-攻击评估问卷 (HAE-EPA) 能够区分 HAE 的攻击和前驱症状,并确定这两种相关现象之间的关联。新工具实现了所需的辨别能力、可接受性和内容有效性/可靠性,因此可用作调查前驱症状、攻击及其关系的可靠工具。

更新日期:2021-02-04
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