{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T03:03:08Z","timestamp":1791946988500,"version":"4.3.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2023,6,4]],"date-time":"2023-06-04T00:00:00Z","timestamp":1685836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Otol Rhinol Laryngol"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>The Nasal Polyposis Symptom Diary (NPSD) is a novel and short patient-reported outcome (PRO) tool specifically developed to assess important and relevant symptoms reported by patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). We evaluated the psychometric properties of 4 predefined NPSD-derived scores intended to support symptom-improvement assessments of investigational therapies for inclusion in product labeling.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Five hundred eighteen patients with severe CRSwNP from a Phase III clinical trial (NCT03401229) completed the NPSD, comprising 11 items: 8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance. The psychometric characteristics of 3 single-item symptom scores (Nasal Blockage Score [NBS], Nasal Congestion Score [NCS], and Difficulty with Sense of Smell Score [DSS]) and a Total Symptom Score (TSS, summary of the 8 symptom-specific items) were evaluated for reliability, validity, and ability to detect change. Within-patient meaningful change thresholds (MCTs) were established using anchor- and distribution-based methods. Comparative PROs included the 22-item Sino-Nasal Outcome Test (SNOT-22) and Patient Global Impression of Severity (PGI-S).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The TSS exhibited strong internal consistency (Cronbach \u03b1\u2009=\u2009.88) and test-retest reliability (intraclass correlation coefficient &gt;.80). Correlation between the TSS and SNOT-22 total score indicated good convergent validity ( r\u2009=\u2009.70). All 4 NPSD scores demonstrated known-groups validity (significant differences among subgroups of patients with predetermined disease severity levels based on PGI-S categories) and were sensitive to detect change in patients\u2019 clinical status (significant differences among subgroups of patients with reported changes between 2 time-points in PGI-S and Patient Global Impression of Change scores). MCTs for improvement were established at 1.0 point for NBS, NCS, and DSS, and 4.0 points for TSS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>These findings support the reliability, validity, and suitability of the 4 NPSD-derived scores for evaluating treatment effect on CRSwNP symptoms and their use in clinical trials with predetermined MCTs for improvement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/00034894231177769","type":"journal-article","created":{"date-parts":[[2023,6,5]],"date-time":"2023-06-05T01:16:41Z","timestamp":1685927801000},"page":"1638-1648","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Psychometric Validation and Meaningful Change Thresholds of the New Nasal Polyposis Symptom Diary"],"prefix":"10.1177","volume":"132","author":[{"given":"Vivian H.","family":"Shih","sequence":"first","affiliation":[{"name":"AstraZeneca, Gaithersburg, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley F.","family":"Slagle","sequence":"additional","affiliation":[{"name":"Aspen Consulting, LLC, Steamboat Springs, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Ivanescu","sequence":"additional","affiliation":[{"name":"IQVIA Real World Solutions, Patient Centered Solutions, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio","family":"Flore","sequence":"additional","affiliation":[{"name":"IQVIA Real World Solutions, Patient Centered Solutions, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oren","family":"Meyers","sequence":"additional","affiliation":[{"name":"IQVIA Real World Solutions, Patient Centered Solutions, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Kreindler","sequence":"additional","affiliation":[{"name":"AstraZeneca, Gaithersburg, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ubaldo J.","family":"Martin","sequence":"additional","affiliation":[{"name":"AstraZeneca, Gaithersburg, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viktoria","family":"Werkstr\u00f6m","sequence":"additional","affiliation":[{"name":"AstraZeneca, Gaithersburg, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,6,4]]},"reference":[{"key":"bibr1-00034894231177769","doi-asserted-by":"publisher","DOI":"10.4193\/Rhin20.601"},{"key":"bibr2-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1007\/s40629-017-0048-5"},{"key":"bibr3-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2005.00725.x"},{"issue":"5","key":"bibr4-00034894231177769","first-page":"343","volume":"57","author":"Khan A","year":"2019","journal-title":"Rhinology"},{"key":"bibr5-00034894231177769","doi-asserted-by":"publisher","DOI":"10.2147\/JAA.S290424"},{"key":"bibr6-00034894231177769","doi-asserted-by":"publisher","DOI":"10.2147\/PROM.S156279"},{"key":"bibr7-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2015.10.012"},{"key":"bibr8-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-4486.2009.01995.x"},{"key":"bibr9-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2003.00420.x"},{"key":"bibr10-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/alr.22952"},{"key":"bibr11-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/alr.21866"},{"key":"bibr12-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/lary.26157"},{"key":"bibr13-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/lary.27470"},{"key":"bibr14-00034894231177769","unstructured":"US Department of Health and Human Services. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. US Food and Drug Administration. 2009. Accessed July 18, 2022. https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm193282.pdf"},{"key":"bibr15-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2021.08.030"},{"key":"bibr16-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-008-0587-y"},{"key":"bibr17-00034894231177769","doi-asserted-by":"publisher","DOI":"10.4193\/Rhino10.049"},{"key":"bibr18-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/lary.23671"},{"key":"bibr19-00034894231177769","doi-asserted-by":"publisher","DOI":"10.2500\/ajra.2015.29.4178"},{"key":"bibr20-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1080\/00016489.2017.1366052"},{"key":"bibr21-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1067\/mhn.2002.121022"},{"key":"bibr22-00034894231177769","volume-title":"User\u2019s Manual for the SF-36V2 Health Survey","author":"Maruish ME","year":"2011","edition":"3"},{"key":"bibr23-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2004.10.008"},{"key":"bibr24-00034894231177769","volume-title":"Applied Multivariate Research: Design and Interpretation","author":"Meyers LS","year":"2006"},{"key":"bibr25-00034894231177769","volume-title":"Statistical Power Analysis for the Behavioral Sciences","author":"Cohen J","year":"1988","edition":"2"},{"key":"bibr26-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1037\/0033-2909.112.1.155"},{"key":"bibr27-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/9780470024522"},{"key":"bibr28-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1002\/9781118032923"},{"key":"bibr29-00034894231177769","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-017-1616-3"}],"container-title":["Annals of Otology, Rhinology &amp; Laryngology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/00034894231177769","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/00034894231177769","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/00034894231177769","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:30:34Z","timestamp":1777375834000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.sagepub.com\/doi\/10.1177\/00034894231177769"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,4]]},"references-count":29,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1177\/00034894231177769"],"URL":"https:\/\/doi.org\/10.1177\/00034894231177769","relation":{},"ISSN":["0003-4894","1943-572X"],"issn-type":[{"value":"0003-4894","type":"print"},{"value":"1943-572X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,4]]}}}