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-Händel; Ana M. Gimenez-Arnau; Carole Guillet; Claudio Alberto S. Parisi; Constance H. Katelaris; Daria Fomina; Désirée Larenas-Linnemann; Elizabeth García; Emek Kocatürk; Frank Siebenhaar; Hermenio Lima; Igor Kaidashev; Iman Nasr; Isabel Ogueta Canales; Ivan Cherrez Ojeda; Jacques Hébert; Jean Bousquet; Jonathan 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 Gonçalo; Markus Magerl; Martijn van Doorn; Martin Metz; Maryam Khoshkhui; Michihiro Hide; Murat Türk; Nataļja Kurjāne; 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

doi:10.1111/all.16371

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-Händel
, Ana M. Gimenez-Arnau
, Carole Guillet
, Claudio Alberto S. Parisi
, Constance H. Katelaris
, Daria Fomina
, Désirée Larenas-Linnemann
, Elizabeth García
, Emek Kocatürk
, Frank Siebenhaar
, Hermenio Lima
, Igor Kaidashev
, Iman Nasr
, Isabel Ogueta Canales
, Ivan Cherrez Ojeda
, Jacques Hébert
, Jean Bousquet

Jonathan 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 Gonçalo, Markus Magerl, Martijn van Doorn, Martin Metz, Maryam Khoshkhui, Michihiro Hide, Murat Türk, Nataļja Kurjāne, 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

School of Medicine

University of Porto
Charité – Universitätsmedizin Berlin
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Pompeu Fabra University
University Hospital Zurich
Hospital Italiano de Buenos Aires
Campbelltown Hospital
Moscow Healthcare Department
Sechenov First Moscow State Medical University
Astana Medical University
Center of Excellence in Asthma and Allergy Larenas Hospital Médica Sur
Universidad de los Andes Colombia
Koc University
McMaster University
Poltava State Medical University
Royal Hospital Oman
Pontificia Universidad Católica de Chile
University Dermatological Center (DermaCDU)
Rancagua Regional Hospital
Universidad Espíritu Santo, Ecuador
Centre Hospitalier Université Laval/Centre Hospitalier Universitaire de Québec
University of Cincinnati
University of Cape Town
Universidad de Antioquia
Clinica San Felipe
Mahidol University
D Y Patil Group
Guy's and St Thomas' NHS Foundation Trust
Riga Stradins University
Grenoble University Hospital
Fudan University
Universidade Federal de São Paulo
University of Coimbra
Erasmus University Rotterdam
Mashhad University of Medical Sciences
Hiroshima University
Erciyes University
Paula Stradina Clinical University Hospital
Trinity College Dublin
Lebanese American University
University of Nicosia Medical School
Institut National de Santé Publique d'Épidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB)
Clinica San Carlo
Bogomolets National Medical University
Johannes Kepler University Linz
University of Copenhagen
Ajou University
University of Opole
Peking University

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

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 language	English
Pages (from-to)	750-761
Number of pages	12
Journal	Allergy: European Journal of Allergy and Clinical Immunology
Volume	80
Issue number	3
DOIs	https://doi.org/10.1111/all.16371
Publication status	Published - Mar 2025

Keywords

mHealth
patient-reported outcome measures
urticaria, chronic spontaneous urticaria

Access to Document

10.1111/all.16371

Cite this

Sousa-Pinto, B., Ramanauskaite, A., Neisinger, S., Witte-Händel, E., Gimenez-Arnau, A. M., Guillet, C., Parisi, C. A. S., Katelaris, C. H., Fomina, D., Larenas-Linnemann, D., García, E., Kocatürk, E., Siebenhaar, F., Lima, H., Kaidashev, I., Nasr, I., Canales, I. O., Ojeda, I. C., Hébert, J., ... Maurer, M. (2025). Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: a CRUSE® mobile health study. Allergy: European Journal of Allergy and Clinical Immunology, 80(3), 750-761. https://doi.org/10.1111/all.16371

@article{ea09d9fc4f264ba092f7a2916f828b1a,

title = "Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: a CRUSE{\textregistered} mobile health study",

abstract = "Background: CRUSE{\textregistered} 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{\textregistered} VASs. Methods: We evaluated the properties of three daily VASs: VAS for how much patients were affected by their CSU ({\textquoteleft}VAS urticaria{\textquoteright}), VAS for the impact of urticaria on work/school productivity ({\textquoteleft}VAS productivity{\textquoteright}) 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{\textregistered} app display high concurrent validity and intra-rater reliability and moderate-high test–retest reliability and responsiveness.",

keywords = "mHealth, patient-reported outcome measures, urticaria, chronic spontaneous urticaria",

author = "Bernardo Sousa-Pinto and Aiste Ramanauskaite and Sophia Neisinger and Ellen Witte-H{\"a}ndel and Gimenez-Arnau, \{Ana M.\} and Carole Guillet and Parisi, \{Claudio Alberto S.\} and Katelaris, \{Constance H.\} and Daria Fomina and D{\'e}sir{\'e}e Larenas-Linnemann and Elizabeth Garc{\'i}a and Emek Kocat{\"u}rk and Frank Siebenhaar and Hermenio Lima and Igor Kaidashev and Iman Nasr and Canales, \{Isabel Ogueta\} and Ojeda, \{Ivan Cherrez\} and Jacques H{\'e}bert and Jean Bousquet and Bernstein, \{Jonathan A.\} and Jonny Peter and Jorge Sanchez and Sousa, \{Jose Ignacio Larco\} and Kanokvalai Kulthanan and Karsten Weller and Kiran Godse and Krzysztof Rutkowski and Lasma Lapina and Laurence Bouillet and Han, \{Leo Lianyi\} and Ensina, \{Luis Felipe\} and Margarida Gon{\c c}alo and Markus Magerl and \{van Doorn\}, Martijn and Martin Metz and Maryam Khoshkhui and Michihiro Hide and Murat T{\"u}rk and Nataļja Kurjāne and Niall Conlon and Pascale Salameh and Pavel Kolkhir and Riccardo Asero and Roman Stepanenko and Sabine Altrichter and Sara Gil-Mata and Thomsen, \{Simon Francis\} and Torsten Zuberbier and Vladyslav Tsaryk and Ye, \{Young Min\} and Zenon Brzoza and Zuotao Zhao and Marcus Maurer",

year = "2025",

month = mar,

doi = "10.1111/all.16371",

language = "English",

volume = "80",

pages = "750--761",

journal = "Allergy: European Journal of Allergy and Clinical Immunology",

issn = "0105-4538",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "3",

}

Sousa-Pinto, B, Ramanauskaite, A, Neisinger, S, Witte-Händel, E, Gimenez-Arnau, AM, Guillet, C, Parisi, CAS, Katelaris, CH, Fomina, D, Larenas-Linnemann, D, García, E, Kocatürk, E, Siebenhaar, F, Lima, H, Kaidashev, I, Nasr, I, Canales, IO, Ojeda, IC, Hébert, J, Bousquet, J, Bernstein, JA, Peter, J, Sanchez, J, Sousa, JIL, Kulthanan, K, Weller, K, Godse, K, Rutkowski, K, Lapina, L, Bouillet, L, Han, LL, Ensina, LF, Gonçalo, M, Magerl, M, van Doorn, M, Metz, M, Khoshkhui, M, Hide, M, Türk, M, Kurjāne, N, Conlon, N, Salameh, P, Kolkhir, P, Asero, R, Stepanenko, R, Altrichter, S, Gil-Mata, S, Thomsen, SF, Zuberbier, T, Tsaryk, V, Ye, YM, Brzoza, Z, Zhao, Z & Maurer, M 2025, 'Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: a CRUSE® mobile health study', Allergy: European Journal of Allergy and Clinical Immunology, vol. 80, no. 3, pp. 750-761. https://doi.org/10.1111/all.16371

Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: a CRUSE® mobile health study. / Sousa-Pinto, Bernardo; Ramanauskaite, Aiste; Neisinger, Sophia et al.
In: Allergy: European Journal of Allergy and Clinical Immunology, Vol. 80, No. 3, 03.2025, p. 750-761.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring

T2 - a CRUSE® mobile health study

AU - Sousa-Pinto, Bernardo

AU - Ramanauskaite, Aiste

AU - Neisinger, Sophia

AU - Witte-Händel, Ellen

AU - Gimenez-Arnau, Ana M.

AU - Guillet, Carole

AU - Parisi, Claudio Alberto S.

AU - Katelaris, Constance H.

AU - Fomina, Daria

AU - Larenas-Linnemann, Désirée

AU - García, Elizabeth

AU - Kocatürk, Emek

AU - Siebenhaar, Frank

AU - Lima, Hermenio

AU - Kaidashev, Igor

AU - Nasr, Iman

AU - Canales, Isabel Ogueta

AU - Ojeda, Ivan Cherrez

AU - Hébert, Jacques

AU - Bousquet, Jean

AU - Bernstein, Jonathan A.

AU - Peter, Jonny

AU - Sanchez, Jorge

AU - Sousa, Jose Ignacio Larco

AU - Kulthanan, Kanokvalai

AU - Weller, Karsten

AU - Godse, Kiran

AU - Rutkowski, Krzysztof

AU - Lapina, Lasma

AU - Bouillet, Laurence

AU - Han, Leo Lianyi

AU - Ensina, Luis Felipe

AU - Gonçalo, Margarida

AU - Magerl, Markus

AU - van Doorn, Martijn

AU - Metz, Martin

AU - Khoshkhui, Maryam

AU - Hide, Michihiro

AU - Türk, Murat

AU - Kurjāne, Nataļja

AU - Conlon, Niall

AU - Salameh, Pascale

AU - Kolkhir, Pavel

AU - Asero, Riccardo

AU - Stepanenko, Roman

AU - Altrichter, Sabine

AU - Gil-Mata, Sara

AU - Thomsen, Simon Francis

AU - Zuberbier, Torsten

AU - Tsaryk, Vladyslav

AU - Ye, Young Min

AU - Brzoza, Zenon

AU - Zhao, Zuotao

AU - Maurer, Marcus

PY - 2025/3

Y1 - 2025/3

N2 - 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.

AB - 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.

KW - mHealth

KW - patient-reported outcome measures

KW - urticaria, chronic spontaneous urticaria

UR - https://www.scopus.com/pages/publications/85207494050

UR - https://go.openathens.net/redirector/westernsydney.edu.au?url=https://doi.org/10.1111/all.16371

U2 - 10.1111/all.16371

DO - 10.1111/all.16371

M3 - Article

C2 - 39445583

AN - SCOPUS:85207494050

SN - 0105-4538

VL - 80

SP - 750

EP - 761

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

IS - 3

ER -

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

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