{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T16:38:22Z","timestamp":1789749502770,"version":"4.0.1"},"reference-count":45,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,11,11]],"date-time":"2023-11-11T00:00:00Z","timestamp":1699660800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Pyoderma gangrenosum (PG) is a rare ulcerative skin condition with no current standardized outcomes or outcome measures. With a rich investigational therapeutic pipeline, standardization of outcomes and improvement of data quality and interpretability will promote the appropriate and consistent evaluation of potential new therapies. Core outcome sets (COS) are agreed, standardized sets of outcomes that represent the minimum that should be measured and reported in all clinical trials of a specific condition.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To identify and reach a consensus on which domains (what to be measured) should be included in the Understanding Pyoderma Gangrenosum: Review and Analysis of Disease Effects (UPGRADE) core domain set for clinical trials in PG.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Collaborative discussions between patients and PG experts, and a systematic review of the literature identified items and prospective domains. A three-round international eDelphi exercise was performed to prioritize the domains and refine the provisional items (consensus: \u2265 70% of participants rating a domain as \u2018extremely important\u2019 and &amp;lt; 15% of participants voting \u2018not important\u2019), followed by an international meeting to reach consensus on the core domain set (consensus: &amp;lt; 30% disagreement). Item-generation discussions and consensus meetings were hosted via online videoconferences. The eDelphi exercise and consensus voting were performed using Qualtrics survey software. Participants were adults with PG, healthcare professionals, researchers and industry representatives.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Collaborative discussions and systematic reviews yielded 115 items, which were distilled into 15 prospective domains. The eDelphi exercise removed the three lowest-priority domains (\u2018laboratory tests\u2019, \u2018treatment costs\u2019 and \u2018disease impact on family\u2019) and ranked \u2018pain\u2019, \u2018quality of life\u2019 and \u2018physical symptoms\u2019 as the highest-priority prospective domains. Consensus was reached on the domains of \u2018pain\u2019, \u2018quality of life\u2019 and \u2018clinical signs\u2019. The domain of \u2018disease course\/disease progression\u2019 narrowly failed to reach consensus for inclusion in the core set (32% of participants voted \u2018no\u2019). Refinement of this domain definition will be required and presented for consideration at future consensus meetings.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The UPGRADE core domain set for clinical trials in PG has been agreed by international multistakeholder consensus. Future work will develop and\/or select outcome measurement instruments for these domains to establish a COS.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljad420","type":"journal-article","created":{"date-parts":[[2023,11,12]],"date-time":"2023-11-12T13:45:11Z","timestamp":1699796711000},"page":"392-401","source":"Crossref","is-referenced-by-count":6,"title":["A core domain set for pyoderma gangrenosum trial outcomes: an international eDelphi and consensus study from the UPGRADE initiative"],"prefix":"10.1093","volume":"190","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4105-1958","authenticated-orcid":false,"given":"Michael E","family":"Jacobson","sequence":"first","affiliation":[{"name":"Department of Dermatology, Oregon Health and Science University , Portland, OR , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan W","family":"Rick","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Arkansas for 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