{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T23:06:09Z","timestamp":1789340769005,"version":"build-2803163510"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,2,14]],"date-time":"2022-02-14T00:00:00Z","timestamp":1644796800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Study TR03 evaluated the safety and efficacy of nalbuphine ER for prurigo nodularis (PN; NCT02174419).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>We conducted supplementary analyses to assess the psychometric properties of the Worst Itch Numeric Rating Scale (WI\u2010NRS), the TR03 primary endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Study TR03 was a double\u2010blind, placebo\u2010controlled, phase 2 trial in PN patients with documented scores \u22655 on the WI\u2010NRS (0 [no itch]\u201310 [worst itch imaginable]) on \u22655 of 7\u2009days before baseline. Using TR03 data, the WI\u2010NRS's psychometric properties, including reliability, validity and ability to detect change, were evaluated. A responder threshold was estimated to facilitate interpretation of WI\u2010NRS score changes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Amongst 62 treated patients, improvements in mean [SD] (median) WI\u2010NRS scores were observed between baseline (8.2 [1.21] (8.1)) and week 10 (5.8 [2.43] (6.0)). The WI\u2010NRS had an intraclass correlation coefficient of 0.96 (95% confidence interval, 0.93\u20130.98) in 42 patients who had stable Itch verbal rating scale (VRS) scores from week 9\u201310, supporting strong test\u2013retest reliability. Construct validity was supported, with strong correlations at week 10 with Average Itch NRS (<jats:italic>r<\/jats:italic>\u2009=\u20090.87) and Itch VRS single\u2010day\/weekly mean scores (<jats:italic>r<\/jats:italic>\u2009=\u20090.81\/0.89) and moderate correlations with ItchyQoL\u2122 total\/domain scores (<jats:italic>r<\/jats:italic>\u2009=\u20090.41\u20130.43). The WI\u2010NRS discriminated between predefined severity subgroups based on the Itch VRS and detected changes in itching severity (effect\u2010size estimate: \u22122.05; standardized response mean: \u22121.21). An anchor\u2010based threshold based on a two\u2010category improvement in the single\u2010day Itch VRS suggests a responder threshold of \u22653.8 points (~40% improvement).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The WI\u2010NRS demonstrates good measurement properties, supporting its use in evaluating treatment change in PN.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.17870","type":"journal-article","created":{"date-parts":[[2021,12,15]],"date-time":"2021-12-15T12:14:15Z","timestamp":1639570455000},"page":"573-581","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation"],"prefix":"10.1111","volume":"36","author":[{"given":"S.","family":"St\u00e4nder","sequence":"first","affiliation":[{"name":"University Hospital M\u00fcnster M\u00fcnster Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9485-8627","authenticated-orcid":false,"given":"C.","family":"Zeidler","sequence":"additional","affiliation":[{"name":"University Hospital M\u00fcnster M\u00fcnster Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5649-2698","authenticated-orcid":false,"given":"M.","family":"Pereira","sequence":"additional","affiliation":[{"name":"University Hospital M\u00fcnster M\u00fcnster Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0766-6342","authenticated-orcid":false,"given":"J.C.","family":"Szepietowski","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venereology and Allergology Wroclaw Medical University Wroclaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7837-8033","authenticated-orcid":false,"given":"L.","family":"McLeod","sequence":"additional","affiliation":[{"name":"RTI Health Solutions Research Triangle NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Qin","sequence":"additional","affiliation":[{"name":"RTI Health Solutions Research Triangle NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Williams","sequence":"additional","affiliation":[{"name":"RTI Health Solutions Research Triangle NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Sciascia","sequence":"additional","affiliation":[{"name":"Trevi Therapeutics New Haven CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4026-8728","authenticated-orcid":false,"given":"M.","family":"Augustin","sequence":"additional","affiliation":[{"name":"University Medical Center Hamburg\u2014Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,2,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejp.767"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.det.2018.02.003"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.14570"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.15107"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.2147\/CCID.S188070"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.16929"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-3571"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-3726"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.17111"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.17816"},{"key":"e_1_2_7_12_1","unstructured":"Food and Drug Administration (FDA).Guidance for industry. 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