{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T20:44:16Z","timestamp":1792183456025,"version":"4.4.0"},"reference-count":0,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T00:00:00Z","timestamp":1792108800000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Chronic spontaneous urticaria\/chronic idiopathic urticaria (CSU\/CIU) trials increasingly evaluate biologics and targeted mast-cell therapies. Whether ClinicalTrials.gov-registered trials consistently capture patient-centred outcomes and disseminate results in a timely and linkable manner remains uncertain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To map registered outcome domains, patient-centred outcome breadth and reporting transparency among interventional CSU\/CIU trials in ClinicalTrials.gov.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ClinicalTrials.gov was searched using three CSU\/CIU-related queries, yielding 486 records and 168 unique NCT registrations after deduplication. Eligible interventional trials were coded for intervention category, trial purpose and nine registered outcome domains. A descriptive 0\u20138 patient-centred outcome score excluded safety. A stratified sample was independently recoded by a second author. Completed or terminated trials underwent manual registry\u2013publication linkage, with primary and secondary publications distinguished and reporting assessed at 12, 24 and 36 months after primary completion using a fixed data lock of 1 June 2026.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We included 128 eligible trials; 83 were completed or terminated. Disease activity\/UAS7 (78.1%), itch\/pruritus (65.6%) and wheals\/hives (59.4%) were commonly registered, whereas urticaria control\/UCT (28.1%), angioedema (30.5%), relapse\/remission\/rescue medication (24.2%) and explicit sleep\/daily activity (7.8%) were less frequent. The mean patient-centred score was 3.37 (SD 1.98), and 20 trials (15.6%) scored at least 6. Independent second coding showed 90.4% agreement across 270 domain-level decisions. Among 83 completed\/terminated trials, 32 (38.6%) had both posted results and a confirmed primary publication, whereas 15 (18.1%) had no qualifying public result identified. Any qualifying public result was available within 12, 24 and 36 months for 18.8%, 53.5% and 66.7% of trials with sufficient follow-up, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>ClinicalTrials.gov-registered CSU\/CIU trials show substantial heterogeneity in patient-centred outcome coverage. Distinguishing trial purpose, primary from secondary publications and reporting opportunity over time provides a more cautious assessment of the registered evidence base and highlights opportunities for more harmonised outcome selection and clearer result dissemination.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ced\/llag450","type":"journal-article","created":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T11:52:46Z","timestamp":1792065166000},"source":"Crossref","is-referenced-by-count":0,"title":["Outcome selection and reporting transparency in ClinicalTrials.gov-registered chronic spontaneous urticaria trials: a registry\u2013publication linkage study"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-8225-5327","authenticated-orcid":false,"given":"Yannan","family":"Liu","sequence":"first","affiliation":[{"name":"Affiliated Hospital of Nanjing University of Chinese Medicine , Nanjing, Jiangsu ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruhong","family":"Gao","sequence":"additional","affiliation":[{"name":"Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine , Yinchuan, Ningxia ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongjun","family":"Peng","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Nanjing University of Chinese Medicine , Nanjing, Jiangsu ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenli","family":"Ma","sequence":"additional","affiliation":[{"name":"Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine , Yinchuan, Ningxia ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengxia","family":"Lian","sequence":"additional","affiliation":[{"name":"Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine , Yinchuan, Ningxia ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,10,16]]},"container-title":["Clinical and Experimental Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ced\/advance-article-pdf\/doi\/10.1093\/ced\/llag450\/72051995\/llag450.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ced\/advance-article-pdf\/doi\/10.1093\/ced\/llag450\/72051995\/llag450.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T19:48:04Z","timestamp":1792180084000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ced\/advance-article\/doi\/10.1093\/ced\/llag450\/8931759"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,16]]},"references-count":0,"URL":"https:\/\/doi.org\/10.1093\/ced\/llag450","relation":{},"ISSN":["0307-6938","1365-2230"],"issn-type":[{"value":"0307-6938","type":"print"},{"value":"1365-2230","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,16]]},"article-number":"llag450"}}