Development and validation of the Urticaria Control Test: A patient-reported outcome instrument for assessing urticaria control

Background Chronic urticaria is a frequent and debilitating skin disease. Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for...

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Veröffentlicht in:Journal of allergy and clinical immunology 2014-05, Vol.133 (5), p.1365-1372.e6
Hauptverfasser: Weller, Karsten, MD, Groffik, Adriane, MD, Church, Martin K., PhD, DSc, Hawro, Tomasz, MD, Krause, Karoline, MD, Metz, Martin, MD, Martus, Peter, PhD, Casale, Thomas B., MD, Staubach, Petra, MD, Maurer, Marcus, MD
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container_end_page 1372.e6
container_issue 5
container_start_page 1365
container_title Journal of allergy and clinical immunology
container_volume 133
creator Weller, Karsten, MD
Groffik, Adriane, MD
Church, Martin K., PhD, DSc
Hawro, Tomasz, MD
Krause, Karoline, MD
Metz, Martin, MD
Martus, Peter, PhD
Casale, Thomas B., MD
Staubach, Petra, MD
Maurer, Marcus, MD
description Background Chronic urticaria is a frequent and debilitating skin disease. Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for several days. Objective We sought to develop and validate a novel patient-reported outcome instrument to retrospectively assess urticaria control, the Urticaria Control Test (UCT). Methods Potential UCT items were developed by using established methods (literature research and expert and patient involvement). Subsequently, item reduction was performed by using a combined approach, applying impact and regression analysis. The resulting UCT instrument was then tested for its validity, reliability, and screening accuracy. Results A 4-item UCT with a recall period of 4 weeks was developed based on 25 potential UCT items tested in 508 patients with chronic urticaria. A subsequent validation study with the 4-item UCT in 120 patients with chronic urticaria demonstrated that this new tool exhibits good convergent and known-groups validity, as well as excellent test-retest reliability. In addition, the screening accuracy to identify patients with urticaria with insufficiently controlled disease was found to be high. Conclusions The UCT is the first valid and reliable tool to assess disease control in patients with chronic urticaria (spontaneous and inducible). Its retrospective approach and simple scoring system make it an ideal instrument for the management of patients with chronic urticaria in clinical practice.
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Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for several days. Objective We sought to develop and validate a novel patient-reported outcome instrument to retrospectively assess urticaria control, the Urticaria Control Test (UCT). Methods Potential UCT items were developed by using established methods (literature research and expert and patient involvement). Subsequently, item reduction was performed by using a combined approach, applying impact and regression analysis. The resulting UCT instrument was then tested for its validity, reliability, and screening accuracy. Results A 4-item UCT with a recall period of 4 weeks was developed based on 25 potential UCT items tested in 508 patients with chronic urticaria. A subsequent validation study with the 4-item UCT in 120 patients with chronic urticaria demonstrated that this new tool exhibits good convergent and known-groups validity, as well as excellent test-retest reliability. In addition, the screening accuracy to identify patients with urticaria with insufficiently controlled disease was found to be high. Conclusions The UCT is the first valid and reliable tool to assess disease control in patients with chronic urticaria (spontaneous and inducible). Its retrospective approach and simple scoring system make it an ideal instrument for the management of patients with chronic urticaria in clinical practice.</description><identifier>ISSN: 0091-6749</identifier><identifier>EISSN: 1097-6825</identifier><identifier>DOI: 10.1016/j.jaci.2013.12.1076</identifier><identifier>PMID: 24522090</identifier><identifier>CODEN: JACIBY</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Allergic diseases ; Allergies ; Allergy and Immunology ; Biological and medical sciences ; development ; disease activity ; Disease control ; Family physicians ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Germany - epidemiology ; Humans ; Immunopathology ; Likert scale ; Male ; Medical sciences ; Middle Aged ; Patients ; Regression analysis ; Retrospective Studies ; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis ; Skin allergic diseases. Stinging insect allergies ; urticaria ; Urticaria - epidemiology ; Urticaria - pathology ; Urticaria - therapy ; validation</subject><ispartof>Journal of allergy and clinical immunology, 2014-05, Vol.133 (5), p.1365-1372.e6</ispartof><rights>American Academy of Allergy, Asthma &amp; Immunology</rights><rights>2014 American Academy of Allergy, Asthma &amp; Immunology</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 American Academy of Allergy, Asthma &amp; Immunology. Published by Mosby, Inc. 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Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for several days. Objective We sought to develop and validate a novel patient-reported outcome instrument to retrospectively assess urticaria control, the Urticaria Control Test (UCT). Methods Potential UCT items were developed by using established methods (literature research and expert and patient involvement). Subsequently, item reduction was performed by using a combined approach, applying impact and regression analysis. The resulting UCT instrument was then tested for its validity, reliability, and screening accuracy. Results A 4-item UCT with a recall period of 4 weeks was developed based on 25 potential UCT items tested in 508 patients with chronic urticaria. A subsequent validation study with the 4-item UCT in 120 patients with chronic urticaria demonstrated that this new tool exhibits good convergent and known-groups validity, as well as excellent test-retest reliability. In addition, the screening accuracy to identify patients with urticaria with insufficiently controlled disease was found to be high. Conclusions The UCT is the first valid and reliable tool to assess disease control in patients with chronic urticaria (spontaneous and inducible). 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Stinging insect allergies</topic><topic>urticaria</topic><topic>Urticaria - epidemiology</topic><topic>Urticaria - pathology</topic><topic>Urticaria - therapy</topic><topic>validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weller, Karsten, MD</creatorcontrib><creatorcontrib>Groffik, Adriane, MD</creatorcontrib><creatorcontrib>Church, Martin K., PhD, DSc</creatorcontrib><creatorcontrib>Hawro, Tomasz, MD</creatorcontrib><creatorcontrib>Krause, Karoline, MD</creatorcontrib><creatorcontrib>Metz, Martin, MD</creatorcontrib><creatorcontrib>Martus, Peter, PhD</creatorcontrib><creatorcontrib>Casale, Thomas B., MD</creatorcontrib><creatorcontrib>Staubach, Petra, MD</creatorcontrib><creatorcontrib>Maurer, Marcus, MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of allergy and clinical immunology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weller, Karsten, MD</au><au>Groffik, Adriane, MD</au><au>Church, Martin K., PhD, DSc</au><au>Hawro, Tomasz, MD</au><au>Krause, Karoline, MD</au><au>Metz, Martin, MD</au><au>Martus, Peter, PhD</au><au>Casale, Thomas B., MD</au><au>Staubach, Petra, MD</au><au>Maurer, Marcus, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and validation of the Urticaria Control Test: A patient-reported outcome instrument for assessing urticaria control</atitle><jtitle>Journal of allergy and clinical immunology</jtitle><addtitle>J Allergy Clin Immunol</addtitle><date>2014-05-01</date><risdate>2014</risdate><volume>133</volume><issue>5</issue><spage>1365</spage><epage>1372.e6</epage><pages>1365-1372.e6</pages><issn>0091-6749</issn><eissn>1097-6825</eissn><coden>JACIBY</coden><abstract>Background Chronic urticaria is a frequent and debilitating skin disease. Its symptoms commonly fluctuate considerably from day to day. As of yet, the only reliable tool to assess disease activity is the Urticaria Activity Score, which prospectively documents the signs and symptoms of urticaria for several days. Objective We sought to develop and validate a novel patient-reported outcome instrument to retrospectively assess urticaria control, the Urticaria Control Test (UCT). Methods Potential UCT items were developed by using established methods (literature research and expert and patient involvement). Subsequently, item reduction was performed by using a combined approach, applying impact and regression analysis. The resulting UCT instrument was then tested for its validity, reliability, and screening accuracy. Results A 4-item UCT with a recall period of 4 weeks was developed based on 25 potential UCT items tested in 508 patients with chronic urticaria. A subsequent validation study with the 4-item UCT in 120 patients with chronic urticaria demonstrated that this new tool exhibits good convergent and known-groups validity, as well as excellent test-retest reliability. In addition, the screening accuracy to identify patients with urticaria with insufficiently controlled disease was found to be high. Conclusions The UCT is the first valid and reliable tool to assess disease control in patients with chronic urticaria (spontaneous and inducible). Its retrospective approach and simple scoring system make it an ideal instrument for the management of patients with chronic urticaria in clinical practice.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>24522090</pmid><doi>10.1016/j.jaci.2013.12.1076</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Adolescent
Adult
Aged
Aged, 80 and over
Allergic diseases
Allergies
Allergy and Immunology
Biological and medical sciences
development
disease activity
Disease control
Family physicians
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Germany - epidemiology
Humans
Immunopathology
Likert scale
Male
Medical sciences
Middle Aged
Patients
Regression analysis
Retrospective Studies
Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis
Skin allergic diseases. Stinging insect allergies
urticaria
Urticaria - epidemiology
Urticaria - pathology
Urticaria - therapy
validation
title Development and validation of the Urticaria Control Test: A patient-reported outcome instrument for assessing urticaria control
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