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

Bernardo Sousa-Pinto^{1

2

3}, Aiste Ramanauskaite^{4

5}, Sophia Neisinger^{4

5}, Ellen Witte-Händel^{4

5}, Ana M Gimenez-Arnau⁶, Carole Guillet⁷, Claudio Alberto S Parisi⁸, Constance H Katelaris⁹, Daria Fomina^{10

11

12}, Désirée Larenas-Linnemann¹³, Elizabeth García¹⁴, Emek Kocatürk^{4

5

15}, Frank Siebenhaar^{4

5}, Hermenio Lima¹⁶, Igor Kaidashev¹⁷, Iman Nasr¹⁸, Isabel Ogueta Canales^{19

20

21}, Ivan Cherrez Ojeda²², Jacques Hébert²³, Jean Bousquet^{4

5}, Jonathan A Bernstein²⁴, Jonny Peter^{25

26}, Jorge Sanchez²⁷, Jose Ignacio Larco Sousa²⁸, Kanokvalai Kulthanan²⁹, Karsten Weller^{4

5}, Kiran Godse³⁰, Krzysztof Rutkowski³¹, Lasma Lapina³², Laurence Bouillet³³, Leo Lianyi Han³⁴, Luis Felipe Ensina³⁵, Margarida Gonçalo³⁶, Markus Magerl^{4

5}, Martijn van Doorn³⁷, Martin Metz^{4

5}, Maryam Khoshkhui³⁸, Michihiro Hide³⁹, Murat Türk⁴⁰, Nataļja Kurjāne⁴¹, Niall Conlon⁴², Pascale Salameh^{4

5

43

44

45}, Pavel Kolkhir^{4

5}, Riccardo Asero⁴⁶, Roman Stepanenko⁴⁷, Sabine Altrichter^{4

5

48

49}, Sara Gil-Mata^{1

2

3}, Simon Francis Thomsen⁵⁰, Torsten Zuberbier^{4

5}, Vladyslav Tsaryk⁴⁷, Young-Min Ye⁵¹, Zenon Brzoza⁵², Zuotao Zhao⁵³, Marcus Maurer^{4

5}

Affiliations

¹ MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal.
² CINTESIS-Center for Health Technology and Services Research, University of Porto, Porto, Portugal.
³ RISE-Health Research Network, University of Porto, Porto, Portugal.
⁴ Institute of Allergology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
⁵ Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
⁶ Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain.
⁷ Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.
⁸ Adult and Pediatric Allergy Sections of the Italian Hospital of Buenos Aires, Buenos Aires, Argentina.
⁹ Department of Medicine, Campbelltown Hospital and Western Sydney University, Sydney, New South Wales, Australia.
¹⁰ 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, Russia.
¹¹ Department of Clinical Immunology and Allergology, I.M., Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
¹² Department of Pulmonology, Astana Medical University, Astana, Kazakhstan.
¹³ Center of Excellence in Asthma and Allergy Larenas Hospital Médica Sur, Mexico City, Mexico.
¹⁴ Faculty of Medicine, Universidad de los Andes, Allergy Section, Fundación Santa Fe de Bogotá, UNIMEQ ORL, Bogotá, Colombia.
¹⁵ Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Koç University School of Medicine, Istanbul, Turkey.
¹⁶ LEADER Research Inc. and Division of Allergy and Clinic Immunology (UCARE), Medicine Department, McMaster University, Hamilton, Ontario, Canada.
¹⁷ Poltava State Medical University, Poltava, Ukraine.
¹⁸ Department of Clinical Immunology and Allergy, Royal Hospital, Muscat, Oman.
¹⁹ Department of Dermatology, Faculty of Medicine, Pontifical Catholic University of Chile, Santiago, Chile.
²⁰ University Dermatological Center (DermaCDU), Las Condes, Chile.
²¹ Unit of Dermatology, Rancagua Regional Hospital, Rancagua, Chile.
²² Universidad Espíritu Santo, Samborondón, Ecuador, Respiralab Research Center, Guayaquil, Ecuador.
²³ Service d'allergie, Centre Hospitalier Université Laval/Centre Hospitalier Universitaire de Québec, Quebec, Québec, Canada.
²⁴ Division of Rheumatology, Allergy and Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
²⁵ ACARE Centre, Division of Allergy and Clinical Immunology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
²⁶ Allergy and Immunology Unit, University of Cape Town Lung Institute, Cape Town, South Africa.
²⁷ Group of Clinical and Experimental Allergy, Hospital "Alma Mater de Antioquia," University of Antioquia, Medellín, Colombia.
²⁸ Department of Allergy, UCARE, Clinica San Felipe, Lima, Peru.
²⁹ Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
³⁰ Department of Dermatology, Dr D Y Patil Medical College and Hospital, Navi Mumbai, India.
³¹ Urticaria Clinic, St John's Institute of Dermatology, Guy's and St Thomas' Hospital, London, UK.
³² Allergic Diseases Diagnosis and Treatment Center, Riga Stradins University, Pauls Stradins Clinical University Hospital, Riga, Latvia.
³³ French national Reference Center for Angioedema (CREAK), Internal Medicine Department, Grenoble University Hospital, Grenoble, France.
³⁴ Greater Bay Area Institute of Precision Medicine (Guangzhou), School of Life Sciences, Fudan University, Shanghai, China.
³⁵ Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.
³⁶ Dermatology, Faculty of Medicine, University of Coimbra and University Hospital, Coimbra Local health Unit, Coimbra, Portugal.
³⁷ Department of Dermatology, UCARE, Erasmus MC, Rotterdam, The Netherlands.
³⁸ Allergy Research Center, Mashhad University Of Medical Sciences, Mashhad, Iran.
³⁹ Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Department of Dermatology, Hiroshima University, Hiroshima, Japan.
⁴⁰ Division of Allergy and Clinical Immunology, Erciyes University School of Medicine, Kayseri, Turkey.
⁴¹ Pauls Stradiņš Clinical University Hospital, Children Clinical University Hospital, Riga Stradiņš University, Riga, Latvia.
⁴² School of Medicine, Trinity College Dublin, St James's Hospital Dublin, Dublin, Ireland.
⁴³ Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon.
⁴⁴ Department of Primary Care and Population Health, University of Nicosia Medical School, Nicosia, Cyprus.
⁴⁵ Institut National de Santé Publique d'Épidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB), Beirut, Lebanon.
⁴⁶ Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano (MI), Italy.
⁴⁷ Department of Clinical and Laboratory Immunology, Allergology and Medical Genetics, Bogomolets National Medical University, Kyiv, Ukraine.
⁴⁸ Department of Dermatology and Venerology, UCARE, Kepler University Hospital, Linz, Austria.
⁴⁹ Faculty of Medicine, Center for Medical Research, Johannes Kepler University, Linz, Austria.
⁵⁰ Department of Biomedical Sciences, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
⁵¹ Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.
⁵² Division of Allergology, Department of Internal Diseases, Institute of Medical Sciences, University of Opole, Opole, Poland.
⁵³ 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.

PMID: 39445583
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 et al. Allergy. 2025 Mar.

. 2025 Mar;80(3):750-761.

doi: 10.1111/all.16371. Epub 2024 Oct 24.

Authors

Affiliations

¹ MEDCIDS-Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal.
² CINTESIS-Center for Health Technology and Services Research, University of Porto, Porto, Portugal.
³ RISE-Health Research Network, University of Porto, Porto, Portugal.
⁴ Institute of Allergology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
⁵ Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
⁶ Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain.
⁷ Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.
⁸ Adult and Pediatric Allergy Sections of the Italian Hospital of Buenos Aires, Buenos Aires, Argentina.
⁹ Department of Medicine, Campbelltown Hospital and Western Sydney University, Sydney, New South Wales, Australia.
¹⁰ 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, Russia.
¹¹ Department of Clinical Immunology and Allergology, I.M., Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
¹² Department of Pulmonology, Astana Medical University, Astana, Kazakhstan.
¹³ Center of Excellence in Asthma and Allergy Larenas Hospital Médica Sur, Mexico City, Mexico.
¹⁴ Faculty of Medicine, Universidad de los Andes, Allergy Section, Fundación Santa Fe de Bogotá, UNIMEQ ORL, Bogotá, Colombia.
¹⁵ Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Koç University School of Medicine, Istanbul, Turkey.
¹⁶ LEADER Research Inc. and Division of Allergy and Clinic Immunology (UCARE), Medicine Department, McMaster University, Hamilton, Ontario, Canada.
¹⁷ Poltava State Medical University, Poltava, Ukraine.
¹⁸ Department of Clinical Immunology and Allergy, Royal Hospital, Muscat, Oman.
¹⁹ Department of Dermatology, Faculty of Medicine, Pontifical Catholic University of Chile, Santiago, Chile.
²⁰ University Dermatological Center (DermaCDU), Las Condes, Chile.
²¹ Unit of Dermatology, Rancagua Regional Hospital, Rancagua, Chile.
²² Universidad Espíritu Santo, Samborondón, Ecuador, Respiralab Research Center, Guayaquil, Ecuador.
²³ Service d'allergie, Centre Hospitalier Université Laval/Centre Hospitalier Universitaire de Québec, Quebec, Québec, Canada.
²⁴ Division of Rheumatology, Allergy and Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
²⁵ ACARE Centre, Division of Allergy and Clinical Immunology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
²⁶ Allergy and Immunology Unit, University of Cape Town Lung Institute, Cape Town, South Africa.
²⁷ Group of Clinical and Experimental Allergy, Hospital "Alma Mater de Antioquia," University of Antioquia, Medellín, Colombia.
²⁸ Department of Allergy, UCARE, Clinica San Felipe, Lima, Peru.
²⁹ Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
³⁰ Department of Dermatology, Dr D Y Patil Medical College and Hospital, Navi Mumbai, India.
³¹ Urticaria Clinic, St John's Institute of Dermatology, Guy's and St Thomas' Hospital, London, UK.
³² Allergic Diseases Diagnosis and Treatment Center, Riga Stradins University, Pauls Stradins Clinical University Hospital, Riga, Latvia.
³³ French national Reference Center for Angioedema (CREAK), Internal Medicine Department, Grenoble University Hospital, Grenoble, France.
³⁴ Greater Bay Area Institute of Precision Medicine (Guangzhou), School of Life Sciences, Fudan University, Shanghai, China.
³⁵ Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.
³⁶ Dermatology, Faculty of Medicine, University of Coimbra and University Hospital, Coimbra Local health Unit, Coimbra, Portugal.
³⁷ Department of Dermatology, UCARE, Erasmus MC, Rotterdam, The Netherlands.
³⁸ Allergy Research Center, Mashhad University Of Medical Sciences, Mashhad, Iran.
³⁹ Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Department of Dermatology, Hiroshima University, Hiroshima, Japan.
⁴⁰ Division of Allergy and Clinical Immunology, Erciyes University School of Medicine, Kayseri, Turkey.
⁴¹ Pauls Stradiņš Clinical University Hospital, Children Clinical University Hospital, Riga Stradiņš University, Riga, Latvia.
⁴² School of Medicine, Trinity College Dublin, St James's Hospital Dublin, Dublin, Ireland.
⁴³ Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon.
⁴⁴ Department of Primary Care and Population Health, University of Nicosia Medical School, Nicosia, Cyprus.
⁴⁵ Institut National de Santé Publique d'Épidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB), Beirut, Lebanon.
⁴⁶ Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano (MI), Italy.
⁴⁷ Department of Clinical and Laboratory Immunology, Allergology and Medical Genetics, Bogomolets National Medical University, Kyiv, Ukraine.
⁴⁸ Department of Dermatology and Venerology, UCARE, Kepler University Hospital, Linz, Austria.
⁴⁹ Faculty of Medicine, Center for Medical Research, Johannes Kepler University, Linz, Austria.
⁵⁰ Department of Biomedical Sciences, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
⁵¹ Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.
⁵² Division of Allergology, Department of Internal Diseases, Institute of Medical Sciences, University of Opole, Opole, Poland.
⁵³ 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.

PMID: 39445583
DOI: 10.1111/all.16371

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.

Keywords: mHealth; patient‐reported outcome measures; urticaria, chronic spontaneous urticaria.

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References

REFERENCES

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

Affiliations

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

Authors

Affiliations

Abstract

References

REFERENCES

MeSH terms

LinkOut - more resources

Full Text Sources