Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: A CRUSE® mobile health study
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. Bousquet J. Bernstein J.A. Peter J. Sanchez J. Sousa J.I.L. Kulthanan K. Weller K. Godse K. Rutkowski K. Lapina L. Bouillet L. Han L.L. Ensina L.F. 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 S.F. Zuberbier T. Tsaryk V. Ye Y.-M. Brzoza Z. Zhao Z. Maurer M.
March 2025John Wiley and Sons Inc
Allergy: European Journal of Allergy and Clinical Immunology
2025#80Issue 3750 - 761 pp.
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.
mHealth , patient-reported outcome measures , urticaria, chronic spontaneous urticaria
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MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
CINTESIS-Center for Health Technology and Services Research, University of Porto, Porto, Portugal
RISE-Health Research Network, University of Porto, Porto, Portugal
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
Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain
Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
Adult and Pediatric Allergy Sections of the Italian Hospital of Buenos Aires, Buenos Aires, Argentina
Department of Medicine, Campbelltown Hospital and Western Sydney University, Sydney, NSW, Australia
Moscow City Research and Practical Center of Allergoloy and Immunology, Clinical Hospital No 52, Moscow Healthcare Department, Angioedema/Urticaria Center of Reference and Excellence (ACARE, UCARE), Moscow, Russian Federation
Department of Clinical Immunology and Allergology, I.M., Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation
Department of Pulmonology, Astana Medical University, Astana, Kazakhstan
Center of Excellence in Asthma and Allergy Larenas Hospital Médica Sur, Mexico City, Mexico
Faculty of Medicine, Universidad de los Andes, Allergy Section, Fundación Santa Fe de Bogotá, UNIMEQ ORL, Bogotá, Colombia
Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Koç University School of Medicine, Istanbul, Turkey
LEADER Research Inc. and Division of Allergy and Clinic Immunology (UCARE), Medicine Department, McMaster University, Hamilton, ON, Canada
Poltava State Medical University, Poltava, Ukraine
Department of Clinical Immunology and Allergy, Royal Hospital, Muscat, Oman
Department of Dermatology, Faculty of Medicine, Pontifical Catholic University of Chile, Santiago, Chile
University Dermatological Center (DermaCDU), Las Condes, Chile
Unit of Dermatology, Rancagua Regional Hospital, Rancagua, Chile
Universidad Espíritu Santo, Samborondón, Ecuador, Respiralab Research Center, Guayaquil, Ecuador
Service dallergie, Centre Hospitalier Université Laval/Centre Hospitalier Universitaire de Québec, Quebec, QC, Canada
Division of Rheumatology, Allergy and Immunology, University of Cincinnati College of Medicine, Cincinnati, OH, United States
ACARE Centre, Division of Allergy and Clinical Immunology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa
Allergy and Immunology Unit, University of Cape Town Lung Institute, Cape Town, South Africa
Group of Clinical and Experimental Allergy, Hospital Alma Mater de Antioquia, University of Antioquia, Medellín, Colombia
Department of Allergy, UCARE, Clinica San Felipe, Lima, Peru
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Department of Dermatology, Dr D Y Patil Medical College and Hospital, Navi Mumbai, India
Urticaria Clinic, St Johns Institute of Dermatology, Guys and St Thomas Hospital, London, United Kingdom
Allergic Diseases Diagnosis and Treatment Center, Riga Stradins University, Pauls Stradins Clinical University Hospital, Riga, Latvia
French national Reference Center for Angioedema (CREAK), Internal Medicine Department, Grenoble University Hospital, Grenoble, France
Greater Bay Area Institute of Precision Medicine (Guangzhou), School of Life Sciences, Fudan University, Shanghai, China
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil
Dermatology, Faculty of Medicine, University of Coimbra and University Hospital, Coimbra Local health Unit, Coimbra, Portugal
Department of Dermatology, UCARE, Erasmus MC, Rotterdam, Netherlands
Allergy Research Center, Mashhad University Of Medical Sciences, Mashhad, Iran
Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Department of Dermatology, Hiroshima University, Hiroshima, Japan
Division of Allergy and Clinical Immunology, Erciyes University School of Medicine, Kayseri, Turkey
Pauls Stradiņš Clinical University Hospital, Children Clinical University Hospital, Riga Stradiņš University, Riga, Latvia
School of Medicine, Trinity College Dublin, St Jamess Hospital Dublin, Dublin, Ireland
Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon
Department of Primary Care and Population Health, University of Nicosia Medical School, Nicosia, Cyprus
Institut National de Santé Publique dÉpidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB), Beirut, Lebanon
Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano (MI), Italy
Department of Clinical and Laboratory Immunology, Allergology and Medical Genetics, Bogomolets National Medical University, Kyiv, Ukraine
Department of Dermatology and Venerology, UCARE, Kepler University Hospital, Linz, Austria
Faculty of Medicine, Center for Medical Research, Johannes Kepler University, Linz, Austria
Department of Biomedical Sciences, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark
Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, South Korea
Division of Allergology, Department of Internal Diseases, Institute of Medical Sciences, University of Opole, Opole, Poland
Department of Dermatology and Venerology, Peking University First Hospital, Beijing Key Laboratory of molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Diseases, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China
MEDCIDS-Department of Community Medicine
CINTESIS-Center for Health Technology and Services Research
RISE-Health Research Network
Institute of Allergology
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Department of Dermatology
Department of Dermatology
Adult and Pediatric Allergy Sections of the Italian Hospital of Buenos Aires
Department of Medicine
Moscow City Research and Practical Center of Allergoloy and Immunology
Department of Clinical Immunology and Allergology
Department of Pulmonology
Center of Excellence in Asthma and Allergy Larenas Hospital Médica Sur
Faculty of Medicine
Department of Dermatology
LEADER Research Inc. and Division of Allergy and Clinic Immunology (UCARE)
Poltava State Medical University
Department of Clinical Immunology and Allergy
Department of Dermatology
University Dermatological Center (DermaCDU)
Unit of Dermatology
Universidad Espíritu Santo
Service dallergie
Division of Rheumatology
ACARE Centre
Allergy and Immunology Unit
Group of Clinical and Experimental Allergy
Department of Allergy
Department of Dermatology
Department of Dermatology
Urticaria Clinic
Allergic Diseases Diagnosis and Treatment Center
French national Reference Center for Angioedema (CREAK)
Greater Bay Area Institute of Precision Medicine (Guangzhou)
Division of Allergy
Dermatology
Department of Dermatology
Allergy Research Center
Department of Dermatology
Division of Allergy and Clinical Immunology
Pauls Stradiņš Clinical University Hospital
School of Medicine
Gilbert and Rose-Marie Chagoury School of Medicine
Department of Primary Care and Population Health
Institut National de Santé Publique dÉpidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB)
Ambulatorio di Allergologia
Department of Clinical and Laboratory Immunology
Department of Dermatology and Venerology
Faculty of Medicine
Department of Biomedical Sciences
Department of Allergy and Clinical Immunology
Division of Allergology
Department of Dermatology and Venerology
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