MASK-air研究中鼻炎和哮喘患者报告结局指标的同时效度、临界值及变化能力

Concurrent validity, cut-offs and ability to change of patient-reported outcome measures for rhinitis and asthma in MASK-air.

作者信息

Bousquet Jean, Sousa-Pinto Bernardo, Anto Josep M, Bedbrook Anna, Czarlewski Wienczyslawa, Ansotegui Ignacio J, Bergmann Karl-C, Braido Fulvio, Brussino Luisa, Cecchi Lorenzo, Loureiro Claudia Chaves, Cruz Alvaro A, Devillier Philippe, Fiocchi Alessandro, Gemicioglu Bilun, Haahtela Tari, Ivancevich Juan Carlos, Klimek Ludger, Kulus Marek, Kuna Piotr, Kupczyk Maciej, Kvedariene Violeta, Larenas-Linnemann Desiree E, Louis Gilles, Louis Renaud, Makris Michael, Morais-Almeida Mario, Niedoszytko Marek, Ohta Ken, Ollert Markus, Papadopoulos Nikolaos, Patella Vincenzo, Pétré Benoit, Pfaar Oliver, Puggioni Francesca, Quirce Santiago, Regateiro Frederico S, Roche Nicolas, Rouadi Philip W, Samolinski Boleslaw, Sastre Joaquin, Schleich Florence, Scichilone Nicola, Taborda-Barata Luis, Toppila-Salmi Sanna, Valiulis Arunas, Vardaloglu Koyuncu Ilgim, Ventura Maria Teresa, Yorgancioglu Arzu, Fonseca Joao A, Zuberbier Torsten

机构信息

Institute of Allergology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.

出版信息

Clin Transl Allergy. 2024 Sep;14(9):e12390. doi: 10.1002/clt2.12390.

DOI:10.1002/clt2.12390

PMID:39313483

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11419846/

Abstract

Patient-reported outcome measures (PROMs) are used to assess a patient's health status at a particular point in time. They are essential in the development of person-centred care. This paper reviews studies performed on PROMs for assessing AR and asthma control, in particular VAS scales that are included in the app MASK-air (Mobile Airways Sentinel networK) for asthma and rhinitis. VASs were initially developed on paper and pencil and tested for their criterion validity, cut-offs and responsiveness. Then, a multicentric, multinational, double-blind, placebo-controlled, randomised control trial (DB-PC-RCT) using an electronic VAS form was carried out. Finally, with the development of MASK-air in 2015, previously validated VAS questions were adapted to the digital format and further methodologic evaluations were performed. VAS for asthma, rhinitis, conjunctivitis, work and EQ-5D are included in the app. Additionally, two control-medication scores for allergic symptoms of asthma (e-DASTHMA) were validated for their criterion validity, cut-offs and responsiveness.

摘要

患者报告结局量表（PROMs）用于评估患者在特定时间点的健康状况。它们在以患者为中心的医疗发展中至关重要。本文回顾了关于使用PROMs评估变应性鼻炎（AR）和哮喘控制情况的研究，特别是应用于评估哮喘和鼻炎的应用程序MASK-air（移动气道哨兵网络）中的视觉模拟评分（VAS）量表。VAS最初是通过纸笔形式开发的，并对其效标效度、临界值和反应性进行了测试。然后，开展了一项使用电子VAS表格的多中心、跨国、双盲、安慰剂对照随机对照试验（DB-PC-RCT）。最后，随着2015年MASK-air的开发，先前验证过的VAS问题被调整为数字格式，并进行了进一步的方法学评估。该应用程序中包括了用于哮喘、鼻炎、结膜炎、工作情况以及EQ-5D的VAS。此外，针对哮喘过敏症状的两种对照药物评分（e-DASTHMA）的效标效度、临界值和反应性也得到了验证。