Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: A CRUSE® mobile health study

Bernardo Sousa-Pinto*, Aiste Ramanauskaite, Sophia Neisinger, Ellen Witte-Haendel, Ana M. Gimenez-Arnau, Carole Guillet, Claudio Alberto S. Parisi, Constance H. Katelaris, Daria Fomina, Desiree Larenas-Linnemann, Elizabeth Garcia, Emek Kocaturk, Frank Siebenhaar, Hermenio Lima, Igor Kaidashev, Iman Nasr, Isabel Ogueta Canales, Ivan Cherrez Ojeda, Jacques Hebert, Jean BousquetJonathan A. Bernstein, Jonny Peter, Jorge Sanchez, Jose Ignacio Larco Sousa, Kanokvalai Kulthanan, Karsten Weller, Kiran Godse, Krzysztof Rutkowski, Lasma Lapina, Laurence Bouillet, Leo Lianyi Han, Luis Felipe Ensina, Margarida Goncalo, Markus Magerl, Martijn van Doorn, Martin Metz, Maryam Khoshkhui, Michihiro Hide, Murat Turk, Niall Conlon, Pascale Salameh, Pavel Kolkhir, Riccardo Asero, Roman Stepanenko, Sabine Altrichter, Sara Gil-Mata, Simon Francis Thomsen, Torsten Zuberbier, Vladyslav Tsaryk, Young-Min Ye, Zenon Brzoza, Zuotao Zhao, Marcus Maurer

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: CRUSE® is an app that allows patients with chronic spontaneous urticaria (CSU) to monitor their daily disease activity through the use of visual analogue scales (VASs). We aimed to determine the concurrent validity, reliability, responsiveness and minimal important difference (MID) of CRUSE® VASs. Methods: We evaluated the properties of three daily VASs: VAS for how much patients were affected by their CSU (‘VAS urticaria’), VAS for the impact of urticaria on work/school productivity (‘VAS productivity’) and the VAS of EQ-5D. Concurrent validity was assessed by measuring the association between each VAS and the Urticaria Activity Score (UAS). Intra-rater reliability was determined based on the data of users providing multiple daily questionnaires within the same day. Test–retest reliability and responsiveness (ability to change), respectively, were tested in clinically stable and clinically unstable users. MIDs were determined using distribution-based methods. Results: We included 5938 patients (67,380 days). Concurrent validity was high, with VAS urticaria being more strongly associated with the UAS score than the remaining VASs. Intra-rater reliability was also high, with intraclass correlation coefficients (ICC) being above 0.950 for all VASs. Moderate-high test–retest reliability and responsiveness were observed, with reliability ICC being highest for VAS EQ-5D and responsiveness being highest for VAS urticaria. The MID for VAS urticaria was 17 (out of 100) units, compared to 15 units for VAS productivity and 11 units for VAS EQ-5D. Conclusion: Daily VASs for CSU available in the CRUSE® app display high concurrent validity and intra-rater reliability and moderate-high test–retest reliability and responsiveness.

Original languageEnglish
Article numberall.16371
Number of pages12
JournalAllergy
Early online date24 Oct 2024
DOIs
Publication statusE-pub ahead of print - 24 Oct 2024

Bibliographical note

Publisher Copyright:
© 2024 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

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