{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T08:43:03Z","timestamp":1761986583739,"version":"build-2065373602"},"reference-count":15,"publisher":"Oceanside Publications Inc.","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["allergy asthma proc"],"published-print":{"date-parts":[[2025,11,1]]},"abstract":"\n Background:<\/jats:bold>\n The Urticaria Patient Daily Diary (UPDD) assesses patient-reported symptoms (itch, hives, angioedema) and impacts in adults and adolescents with chronic spontaneous urticaria (CSU).\n Objective:<\/jats:bold>\n The objective was to adapt the UPDD for caregiver\n completion for patients ages 2\u201011 years.\n Methods:<\/jats:bold>\n To inform modification of the UPDD, two iterative rounds of hybrid concept-elicitation\/cognitive-debriefing interviews were conducted with clinical experts and caregivers of children with CSU recruited\n via<\/jats:italic>\n patient organizations in the United States and Canada. After concept elicitation, the participants reviewed a draft UPDD\u2010Caregiver Version with initial modifications for caregiver completion. Data were analyzed by using thematic analysis.\n Results:<\/jats:bold>\n Four clinicians\n and 12 caregivers were interviewed (round 1:4 clinicians, 5 caregivers; round 2:7 caregivers). Key symptoms reported by the caregivers were itch (n = 12), hives (n = 12), and swelling and\/or angioedema (n = 7). All four clinicians confirmed itch and hives to be key symptoms in children ages\n 2\u201011 years with CSU, with associated angioedema for some. Scratching was confirmed as the key observable sign of itch. Caregiver-reported impacts included waking in the night (n = 10); difficulty getting to sleep (n = 8); and daily life impacts, including activities at school (n = 10),\n play (n = 8), with family and\/or friends (n = 4), and sports (n = 3). After round 1, minor revisions were made to enhance comprehension of the UPDD\u2010Caregiver Version, and an overall symptom severity item was added. Relevance, acceptability, and comprehension of the final measure were\n confirmed by round 2 participants; no further changes were required.\n Conclusion:<\/jats:bold>\n The UPDD\u2010Caregiver Version is a relevant and acceptable measure for caregiver completion to assess symptoms and impacts of CSU in children ages 2\u201011 years.\n <\/jats:p>","DOI":"10.2500\/aap.2025.46.250062","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T04:32:17Z","timestamp":1761712337000},"page":"462-470","source":"Crossref","is-referenced-by-count":1,"title":["Adaptation of the urticaria patient daily diary for caregiver completion in pediatric chronic spontaneous urticaria"],"prefix":"10.2500","volume":"46","author":[{"given":"Diane","family":"Whalley","sequence":"first","affiliation":[{"name":"From the RTI Health Solutions, Patient-Centered Outcomes Assessment, Manchester, United Kingdom;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria-Magdalena","family":"Balp","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, HEOR International, Basel, Switzerland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christel","family":"Naujoks","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, HEOR International, Basel, Switzerland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donna D.","family":"Gardner","sequence":"additional","affiliation":[{"name":"Allergy and Asthma Network, Fairfax, Virginia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elaine","family":"Dery","sequence":"additional","affiliation":[{"name":"Canadian Chronic Urticaria Society, Quebec City, Canada;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karsten","family":"Weller","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charit\u00e9 -Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin, Berlin, Germany;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauri-Ann","family":"Van Der Poel","sequence":"additional","affiliation":[{"name":"Children\u2019s Allergy Service, The Medical Chambers, Kensington London, United Kingdom;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michel","family":"Erlewyn-Lajeunesse","sequence":"additional","affiliation":[{"name":"Children's Allergy Clinic, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weily","family":"Soong","sequence":"additional","affiliation":[{"name":"Allervie Health, Birmingham, Alabama, Virginia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1355","reference":[{"key":"B1","doi-asserted-by":"crossref","first-page":"734","DOI":"10.1111\/all.15090","article-title":"The international EAACI\/GA2LEN\/EuroGuiDerm\/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria","volume":"77","author":"Zuberbier","year":"2022","journal-title":"Allergy"},{"key":"B2","doi-asserted-by":"crossref","first-page":"2005","DOI":"10.1111\/all.13209","article-title":"The burden of chronic spontaneous urticaria is substantial: real-world evidence from ASSURE-CSU","volume":"72","author":"Maurer","year":"2017","journal-title":"Allergy"},{"key":"B3","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1111\/j.1365-2133.2006.07185.x","article-title":"A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases","volume":"155","author":"Beattie","year":"2006","journal-title":"Br J Dermatol"},{"key":"B4","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1111\/j.1365-2222.2007.02678.x","article-title":"BSACI guidelines for the management of chronic urticaria and angio-oedema","volume":"37","author":"Powell","year":"2007","journal-title":"Clin Exp Allergy"},{"key":"B5","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/j.1399-3038.2010.01120.x","article-title":"Chronic spontaneous urticaria in children: itching for insight","volume":"22","author":"Church","year":"2011","journal-title":"Pediatr Allergy Immunol"},{"key":"B6","doi-asserted-by":"crossref","first-page":"630","DOI":"10.1111\/pai.12910","article-title":"Prevalence and clinical characteristics of chronic spontaneous urticaria in pediatric patients","volume":"29","author":"Balp","year":"2018","journal-title":"Pediatr Allergy Immunol"},{"key":"B7","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1016\/j.anai.2010.06.011","article-title":"Development of a daily diary for patients with chronic idiopathic urticaria","volume":"105","author":"Mathias","year":"2010","journal-title":"Ann Allergy Asthma Immunol"},{"key":"B8","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.anai.2011.09.008","article-title":"Evaluating the minimally important difference of the urticaria activity score and other measures of disease activity in patients with chronic idiopathic urticaria","volume":"108","author":"Mathias","year":"2012","journal-title":"Ann Allergy Asthma Immunol"},{"key":"B9","doi-asserted-by":"crossref","first-page":"186","DOI":"10.2500\/aap.2012.33.3508","article-title":"Adaptation and validation of the Urticaria Patient Daily Diary for adolescents","volume":"33","author":"Mathias","year":"2012","journal-title":"Allergy Asthma Proc"},{"key":"B10","doi-asserted-by":"crossref","first-page":"394","DOI":"10.2500\/aap.2015.36.3873","article-title":"The minimal important difference for measures of urticaria disease activity: updated findings","volume":"36","author":"Mathias","year":"2015","journal-title":"Allergy Asthma Proc"},{"key":"B11","doi-asserted-by":"crossref","first-page":"461","DOI":"10.1016\/j.jval.2013.04.004","article-title":"Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force","volume":"16","author":"Matza","year":"2013","journal-title":"Value Health"},{"key":"B12","doi-asserted-by":"crossref","first-page":"1075","DOI":"10.1111\/j.1524-4733.2009.00603.x","article-title":"Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report","volume":"12","author":"Rothman","year":"2009","journal-title":"Value Health"},{"year":"2022","key":"B13","article-title":"Patient-focused drug development: selecting, developing, or modifying fit-for-purpose clinical outcome assessments. 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