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

mHealth patient‐reported outcome measures urticaria, chronic spontaneous urticaria

Journal

Allergy
ISSN: 1398-9995
Titre abrégé: Allergy
Pays: Denmark
ID NLM: 7804028

Informations de publication

Date de publication:
24 Oct 2024
Historique:
revised: 22 08 2024
received: 30 07 2024
accepted: 11 09 2024
medline: 24 10 2024
pubmed: 24 10 2024
entrez: 24 10 2024
Statut: aheadofprint

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 39445583
doi: 10.1111/all.16371
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

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

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Auteurs

Bernardo Sousa-Pinto (B)

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.

Aiste Ramanauskaite (A)

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.

Sophia Neisinger (S)

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.

Ellen Witte-Händel (E)

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.

Ana M Gimenez-Arnau (AM)

Department of Dermatology, Urticaria Center of Reference, and Excellence (UCARE), Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain.

Carole Guillet (C)

Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.

Claudio Alberto S Parisi (CAS)

Adult and Pediatric Allergy Sections of the Italian Hospital of Buenos Aires, Buenos Aires, Argentina.

Constance H Katelaris (CH)

Department of Medicine, Campbelltown Hospital and Western Sydney University, Sydney, New South Wales, Australia.

Daria Fomina (D)

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.
Department of Clinical Immunology and Allergology, I.M., Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
Department of Pulmonology, Astana Medical University, Astana, Kazakhstan.

Désirée Larenas-Linnemann (D)

Center of Excellence in Asthma and Allergy Larenas Hospital Médica Sur, Mexico City, Mexico.

Elizabeth García (E)

Faculty of Medicine, Universidad de los Andes, Allergy Section, Fundación Santa Fe de Bogotá, UNIMEQ ORL, Bogotá, Colombia.

Emek Kocatürk (E)

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), Koç University School of Medicine, Istanbul, Turkey.

Frank Siebenhaar (F)

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.

Hermenio Lima (H)

LEADER Research Inc. and Division of Allergy and Clinic Immunology (UCARE), Medicine Department, McMaster University, Hamilton, Ontario, Canada.

Igor Kaidashev (I)

Poltava State Medical University, Poltava, Ukraine.

Iman Nasr (I)

Department of Clinical Immunology and Allergy, Royal Hospital, Muscat, Oman.

Isabel Ogueta Canales (IO)

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.

Ivan Cherrez Ojeda (IC)

Universidad Espíritu Santo, Samborondón, Ecuador, Respiralab Research Center, Guayaquil, Ecuador.

Jacques Hébert (J)

Service d'allergie, Centre Hospitalier Université Laval/Centre Hospitalier Universitaire de Québec, Quebec, Québec, Canada.

Jean Bousquet (J)

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.

Jonathan A Bernstein (JA)

Division of Rheumatology, Allergy and Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.

Jonny Peter (J)

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.

Jorge Sanchez (J)

Group of Clinical and Experimental Allergy, Hospital "Alma Mater de Antioquia," University of Antioquia, Medellín, Colombia.

Jose Ignacio Larco Sousa (JIL)

Department of Allergy, UCARE, Clinica San Felipe, Lima, Peru.

Kanokvalai Kulthanan (K)

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Karsten Weller (K)

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.

Kiran Godse (K)

Department of Dermatology, Dr D Y Patil Medical College and Hospital, Navi Mumbai, India.

Krzysztof Rutkowski (K)

Urticaria Clinic, St John's Institute of Dermatology, Guy's and St Thomas' Hospital, London, UK.

Lasma Lapina (L)

Allergic Diseases Diagnosis and Treatment Center, Riga Stradins University, Pauls Stradins Clinical University Hospital, Riga, Latvia.

Laurence Bouillet (L)

French national Reference Center for Angioedema (CREAK), Internal Medicine Department, Grenoble University Hospital, Grenoble, France.

Leo Lianyi Han (LL)

Greater Bay Area Institute of Precision Medicine (Guangzhou), School of Life Sciences, Fudan University, Shanghai, China.

Luis Felipe Ensina (LF)

Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.

Margarida Gonçalo (M)

Dermatology, Faculty of Medicine, University of Coimbra and University Hospital, Coimbra Local health Unit, Coimbra, Portugal.

Markus Magerl (M)

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.

Martijn van Doorn (M)

Department of Dermatology, UCARE, Erasmus MC, Rotterdam, The Netherlands.

Martin Metz (M)

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.

Maryam Khoshkhui (M)

Allergy Research Center, Mashhad University Of Medical Sciences, Mashhad, Iran.

Michihiro Hide (M)

Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Department of Dermatology, Hiroshima University, Hiroshima, Japan.

Murat Türk (M)

Division of Allergy and Clinical Immunology, Erciyes University School of Medicine, Kayseri, Turkey.

Nataļja Kurjāne (N)

Pauls Stradiņš Clinical University Hospital, Children Clinical University Hospital, Riga Stradiņš University, Riga, Latvia.

Niall Conlon (N)

School of Medicine, Trinity College Dublin, St James's Hospital Dublin, Dublin, Ireland.

Pascale Salameh (P)

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.
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 d'Épidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB), Beirut, Lebanon.

Pavel Kolkhir (P)

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.

Riccardo Asero (R)

Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano (MI), Italy.

Roman Stepanenko (R)

Department of Clinical and Laboratory Immunology, Allergology and Medical Genetics, Bogomolets National Medical University, Kyiv, Ukraine.

Sabine Altrichter (S)

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 and Venerology, UCARE, Kepler University Hospital, Linz, Austria.
Faculty of Medicine, Center for Medical Research, Johannes Kepler University, Linz, Austria.

Sara Gil-Mata (S)

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.

Simon Francis Thomsen (SF)

Department of Biomedical Sciences, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

Torsten Zuberbier (T)

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.

Vladyslav Tsaryk (V)

Department of Clinical and Laboratory Immunology, Allergology and Medical Genetics, Bogomolets National Medical University, Kyiv, Ukraine.

Young-Min Ye (YM)

Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.

Zenon Brzoza (Z)

Division of Allergology, Department of Internal Diseases, Institute of Medical Sciences, University of Opole, Opole, Poland.

Zuotao Zhao (Z)

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.

Marcus Maurer (M)

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.

Classifications MeSH