{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T13:52:37Z","timestamp":1770817957902,"version":"3.50.1"},"reference-count":29,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,2,9]],"date-time":"2024-02-09T00:00:00Z","timestamp":1707436800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Generalized pustular psoriasis (GPP) is a rare, chronic, inflammatory skin disease associated with considerable patient burden. The Psoriasis Symptom Scale (PSS), Functional Assessment of Chronic Illness Therapy\u2013Fatigue (FACIT\u2010Fatigue) and pain\u2010Visual Analogue Scale (pain\u2010VAS) are patient\u2010reported outcomes (PROs) that have not yet been validated in patients with GPP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the psychometric properties of the PSS, FACIT\u2010Fatigue and pain\u2010VAS using data from Effisayil 1, a randomised trial of spesolimab in patients with moderate\u2010to\u2010severe GPP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Inter\u2010item correlations and confirmatory factor analysis (CFA) were performed using Week 1 data. Internal consistency was assessed with Cronbach's \u03b1 coefficient using baseline and Week 1 data. Test\u2013retest reliability was assessed using intraclass correlation coefficients (ICCs); change data for the GPP Physician Global Assessment total score and pustulation subscore were used to define a stable population. Convergent validity was assessed at baseline and Week 1 using Spearman's rank\u2010order correlations. Known\u2010groups validity was measured by analysis of variance using Week 1 data. Ability to detect change from baseline to Week 1 was evaluated by analysis of covariance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Inter\u2010item and item\u2010to\u2010total correlations were moderate or strong for most PSS and FACIT\u2010Fatigue items. CFA demonstrated the unidimensionality of the PSS and FACIT\u2010Fatigue, with high factor loadings for most items (PSS range, 0.75\u20130.94; FACIT\u2010Fatigue range, 0.11\u20130.93) and acceptable fit statistics. Both scores demonstrated internal consistency (Cronbach's \u03b1, 0.71 and 0.95, respectively). The PSS, FACIT\u2010Fatigue and pain\u2010VAS demonstrated test\u2013retest reliability (ICCs \u22650.70) and good evidence of convergent validity. Furthermore, the PROs could differentiate between known groups of varying symptom severity (range, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001\u20130.0225) and detect changes in symptom severity from baseline to Week 1 (range, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001\u20130.0002).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Overall, these results support the reliability, validity and ability to detect change of the PSS, FACIT\u2010Fatigue and pain\u2010VAS as PROs in patients with GPP.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.19830","type":"journal-article","created":{"date-parts":[[2024,2,9]],"date-time":"2024-02-09T11:44:05Z","timestamp":1707479045000},"page":"1383-1390","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Psychometric validation of the Psoriasis Symptom Scale, Functional Assessment of Chronic Illness Therapy\u2013Fatigue and <scp>pain\u2010Visual<\/scp> Analogue Scale in patients with generalized pustular psoriasis"],"prefix":"10.1111","volume":"38","author":[{"given":"A. David","family":"Burden","sequence":"first","affiliation":[{"name":"School of Infection and Immunity University of Glasgow  Glasgow UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5927-6587","authenticated-orcid":false,"given":"Robert","family":"Bissonnette","sequence":"additional","affiliation":[{"name":"Innovaderm Research Inc  Montr\u00e9al Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Milena","family":"Anatchkova","sequence":"additional","affiliation":[{"name":"Evidera  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ismail","family":"Budhiarso","sequence":"additional","affiliation":[{"name":"Evidera  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne M.","family":"Skalicky","sequence":"additional","affiliation":[{"name":"Evidera  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana C. S.","family":"Liberato","sequence":"additional","affiliation":[{"name":"Evidera PPD  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Na","family":"Hu","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim (China) Investment Co. Ltd  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Thoma","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH  Ingelheim Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tristan","family":"Gloede","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH  Ingelheim Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Kohlmann","sequence":"additional","affiliation":[{"name":"Institute for Community Medicine, Medical University Greifswald  Greifswald Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark G.","family":"Lebwohl","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,9]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-021-00652-1"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.14386"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijd.12070"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.18851"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-3388"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16084"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/24755303221079814"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.18999"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-021-00653-0"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.14664"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13622"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2111563"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-022-00736-8"},{"key":"e_1_2_9_15_1","unstructured":"US Food and Drug Administration.Guidance for industry. 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