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RAPP-children:一种用于评估哮喘和鼻炎患者生活质量的新工具。

RAPP-children: A new tool for assessing quality of life in patients with asthma and rhinitis.

机构信息

Institute for Biomedical Research and Innovation, National Research Council, Palermo, Italy.

Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialities, University of Palermo, Palermo, Italy.

出版信息

Clin Exp Allergy. 2020 Jun;50(6):662-671. doi: 10.1111/cea.13599. Epub 2020 Mar 25.

Abstract

BACKGROUND

RhinAsthma Patient Perspective (RAPP) is a short, validated questionnaire for assessing health-related quality of life (HRQoL) in adult patients with comorbid asthma and rhinitis, while a paediatric version is still not available.

OBJECTIVE

The current study aimed to develop and validate the RAPP-children questionnaire.

METHODS

RAPP-children was derived by combining RhinAsthma-children subscales into five unique items. At baseline (T0) and after 30 days (T1), 150 children (6-11 years) with comorbid asthma (predominantly intermittent or mild persistent) and rhinitis were given the following: RAPP-children, RhinAsthma-children, Paediatric Asthma Quality of Life Questionnaire (PAQLQ, age >6 years), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Childhood Asthma Control Test (CACT), KiddyKindl (age 6 years) or KidKindl (age >6 years), and a Visual Analogue Scale for nasal symptoms (VAS). At the final visit, a Global Rating of Change (GRC) scale was administered. The approved study was registered on the central registration system ClinicalTrials.gov (ID: NCT03276416).

RESULTS

RAPP-children fairly reproduced RhinAsthma-children scores (concordance correlation coefficients between 0.91 and 0.95). RAPP-children showed adequate convergent validity (absolute Spearman's rho larger than 0.5 with PAQLQ, PRQLQ, CACT, KiddyKindl/KidKindl, and VAS), internal consistency (Cronbach's alpha > 0.70), repeatability (intra-cluster correlation coefficient between 0.61 and 0.8) in the presence of clinical stability (GRC = 0), discriminant validity (sensitivity to asthma control status and rhinitis severity), and sensitivity to symptom improvements (GRC > 1). The minimal important difference (MID) was -20. Floor and ceiling effects were minimal. RAPP-children showed fair usability also in younger children (6-8 years).

CONCLUSION & CLINICAL RELEVANCE: RAPP-children is a valid, five-item questionnaire for assessing HRQoL in children aged 6 to 11 years with concomitant asthma and rhinitis. Although further investigation is required in moderate and severe asthmatics, this tool can be useful in clinical trials and in routine medical practice for improving the management of respiratory allergy in children.

摘要

背景

RhinAsthma Patient Perspective(RAPP)是一种简短的、经过验证的问卷,用于评估合并哮喘和鼻炎的成年患者的健康相关生活质量(HRQoL),而儿科版本尚未问世。

目的

本研究旨在开发和验证 RAPP-children 问卷。

方法

通过将 RhinAsthma-children 子量表合并为五个独特的项目,得出 RAPP-children。在基线(T0)和 30 天后(T1),150 名患有合并哮喘(主要为间歇性或轻度持续性)和鼻炎的儿童(6-11 岁)接受了以下评估:RAPP-children、RhinAsthma-children、儿科哮喘生活质量问卷(PAQLQ,年龄>6 岁)、儿科鼻结膜炎生活质量问卷(PRQLQ)、儿童哮喘控制测试(CACT)、KiddyKindl(年龄 6 岁)或 KidKindl(年龄>6 岁)以及鼻症状视觉模拟量表(VAS)。在最后一次就诊时,进行了全球变化评级(GRC)量表评估。已批准的研究在中央注册系统 ClinicalTrials.gov 上进行了注册(ID:NCT03276416)。

结果

RAPP-children 相当准确地复制了 RhinAsthma-children 的评分(一致性相关系数在 0.91 到 0.95 之间)。RAPP-children 表现出足够的收敛效度(与 PAQLQ、PRQLQ、CACT、KiddyKindl/KidKindl 和 VAS 的绝对斯皮尔曼 rho 大于 0.5)、内部一致性(Cronbach's alpha>0.70)、重复性(在临床稳定(GRC=0)时,簇内相关系数在 0.61 到 0.8 之间)、判别效度(对哮喘控制状况和鼻炎严重程度的敏感性)和症状改善的敏感性(GRC>1)。最小有意义差异(MID)为-20。地板效应和天花板效应最小。RAPP-children 在年龄较小的儿童(6-8 岁)中也表现出良好的可用性。

结论与临床相关性

RAPP-children 是一种有效的五分量表问卷,用于评估 6 至 11 岁合并哮喘和鼻炎的儿童的 HRQoL。尽管在中度和重度哮喘患者中还需要进一步研究,但该工具可在临床试验和常规医疗实践中用于改善儿童呼吸道过敏的管理。

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