{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T11:33:17Z","timestamp":1789039997104,"version":"build-2803163510"},"reference-count":37,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","award":["NCT02898454"],"award-info":[{"award-number":["NCT02898454"]}],"id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","award":["NCT02912468"],"award-info":[{"award-number":["NCT02912468"]}],"id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives\/Hypothesis<\/jats:title>\n                    <jats:p>Clinical trials of biologics to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) have evaluated objective outcomes (e.g., University of Pennsylvania Smell Identification Test [UPSIT], nasal polyps score [NPS], and computed tomography Lund\u2010Mackay score [CT\u2010LMK]) and patient\u2010reported symptoms (e.g., nasal congestion\/obstruction [NC], loss of smell [LoS], and total symptom score [TSS]). We estimated anchor\u2010based thresholds for clinically meaningful change in objective and patient\u2010reported outcomes in patients with CRSwNP using data from LIBERTY NP SINUS\u201024 and SINUS\u201052 trials (NCT02912468; NCT02898454).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Target patient\u2010reported outcomes were NC, LoS, and TSS; target objective outcomes were UPSIT, NPS, and CT\u2010LMK. Anchor measures were the 22\u2010item sinonasal outcome test (SNOT\u201022) rhinologic symptoms domain and total score and rhinosinusitis visual analog scale (VAS). The appropriateness of each anchor measure was evaluated by reviewing correlations between change in anchor measures and target outcomes and descriptive scores on target outcomes by levels of change in the anchor measure. Established thresholds for anchor measures (3.8 points for SNOT\u201022 rhinologic symptoms, 8.9 points for SNOT\u201022 total, 1\u2010category improvement for rhinosinusitis VAS) were used to estimate clinically meaningful score changes for each target outcome.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Based on correlations between change in anchor measures and target outcomes, SNOT\u201022 rhinologic symptoms domain was deemed the most appropriate anchor measure. Using this anchor measure, thresholds for clinically meaningful within\u2010patient change were NC: 1 point; LoS: 1 point; TSS: 3 points; UPSIT: 8 points; NPS: 1 point; and CT\u2010LMK: 5 points.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These thresholds support interpretation of efficacy results for target outcomes in CRSwNP trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>\n                      2\n                      <jats:italic>Laryngoscope<\/jats:italic>\n                      , 132:265\u2013271, 2022\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lary.29888","type":"journal-article","created":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T07:45:59Z","timestamp":1638344759000},"page":"265-271","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Estimating Clinically Meaningful Change of Efficacy Outcomes in Inadequately Controlled Chronic Rhinosinusitis with Nasal Polyposis"],"prefix":"10.1002","volume":"132","author":[{"given":"Joseph K.","family":"Han","sequence":"first","affiliation":[{"name":"Department of Otolaryngology &amp; Head and Neck Surgery Eastern Virginia Medical School  Norfolk Virginia U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus","family":"Bachert","sequence":"additional","affiliation":[{"name":"Upper Airways Research Laboratory and Department of Otorhinolaryngology Ghent University  Ghent Belgium"},{"name":"Division of ENT Diseases CLINTEC, Karolinska Institutet  Stockholm Sweden"},{"name":"First Affiliated Hospital Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stella E.","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Otolaryngology\u2014Head &amp; Neck Surgery Brigham and Women's Hospital, Harvard Medical School  Boston Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Hopkins","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology \u2013 Head and Neck Surgery Guy's and St Thomas' NHS Foundation Trust  London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Heffler","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences Humanitas University  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter W.","family":"Hellings","sequence":"additional","affiliation":[{"name":"Upper Airways Research Laboratory and Department of Otorhinolaryngology Ghent University  Ghent Belgium"},{"name":"Department of Otorhinolaryngology \u2013 Head and Neck Surgery University Hospitals Leuven  Leuven Belgium"},{"name":"Department of Otorhinolaryngology Amsterdam University Medical Centres, Location AMC  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anju T.","family":"Peters","sequence":"additional","affiliation":[{"name":"Allergy\u2010Immunology Division and the Sinus and Allergy Center, Feinberg School of Medicine Northwestern University  Evanston Illinois U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddhesh","family":"Kamat","sequence":"additional","affiliation":[{"name":"Medical Affairs Regeneron Pharmaceuticals, Inc.  Tarrytown New York U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Whalley","sequence":"additional","affiliation":[{"name":"Patient\u2010Centered Outcome Assessment RTI Health Solutions  Manchester United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanshan","family":"Qin","sequence":"additional","affiliation":[{"name":"Patient\u2010Centered Outcome Assessment RTI Health Solutions  Research Triangle Park North Carolina U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Nelson","sequence":"additional","affiliation":[{"name":"Patient\u2010Centered Outcome Assessment RTI Health Solutions  Research Triangle Park North Carolina U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahid","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"Medical Affairs Regeneron Pharmaceuticals, Inc.  Tarrytown New York U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asif H.","family":"Khan","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Sanofi  Chilly\u2010Mazarin France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongtao","family":"Li","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Respiratory Sanofi  Bridgewater New Jersey U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leda P.","family":"Mannent","sequence":"additional","affiliation":[{"name":"Global Clinical Development Sanofi  Chilly\u2010Mazarin France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Guillemin","sequence":"additional","affiliation":[{"name":"Patient Reported Outcomes Sanofi  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0895-4998","authenticated-orcid":false,"given":"Chien\u2010Chia","family":"Chuang","sequence":"additional","affiliation":[{"name":"Health Economics and Value Assessment Sanofi  Cambridge Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,12]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"1","article-title":"SEAIC\u2010SEORL. 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