{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T01:39:35Z","timestamp":1782265175813,"version":"3.54.5"},"reference-count":41,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T00:00:00Z","timestamp":1746576000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009780","name":"Region Sk\u00e5ne","doi-asserted-by":"crossref","award":["2023-068"],"award-info":[{"award-number":["2023-068"]}],"id":[{"id":"10.13039\/501100009780","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Foundation for Plastic Surgery Research, Malm\u00f6, Sweden","award":["NA"],"award-info":[{"award-number":["NA"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objectives<\/jats:title>\n<jats:p>Patient perceived benefit of treatment for cleft lip and\/or palate is of great importance since it is central to development of cleft care. CLEFT-Q is a cleft-specific questionnaire on health-related quality of life. Test-retest reliability, aspects of responsiveness and interpretability are yet to be established for CLEFT-Q. This study aims to investigate these psychometric characteristics of CLEFT-Q.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>To establish the test-retest reliability of CLEFT-Q, data will be collected repeatedly and independently at approximately 1-week intervals. Inclusion of approximately 50 patients is considered adequate for a test-retest study. To improve the interpretability of CLEFT-Q norm data from a control population of volunteers without a cleft will be collected. A total of approximately 210 participants will be included from schools, high-schools and universities. To test the responsiveness of CLEFT-Q, patients will answer selected subscales of CLEFT-Q, longitudinal anchor questions and perform global ratings of change before and after surgery. To ensure robust results, approximately 50 patients for each type of treatment will be recruited. If CLEFT-Q is found to be responsive, the pre- and postoperative difference in scores of CLEFT-Q will be compared with the change in objective measurements based on assessments by professionals in cleft care obtained in this study. To evaluate interpretability, results will be analysed to investigate the minimal important change using anchor-based, distribution-based and qualitative approach.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Registration details<\/jats:title>\n<jats:p>This study is registered at ClinicalTrials.gov under the ID 2021-06993-01.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0321021","type":"journal-article","created":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T20:07:51Z","timestamp":1746648471000},"page":"e0321021","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["CLEFT-Q SwePsych protocol: A prospective observational study to investigate the psychometric characteristics test-retest reliability, responsiveness, and interpretability of CLEFT-Q"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2563-7679","authenticated-orcid":true,"given":"Mia","family":"Stiernman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Klint\u00f6","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna-Paulina","family":"Wiedel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malin","family":"Schaar-Johansson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00e5ns","family":"Cornefjord","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f6rn","family":"Sch\u00f6nmeyr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gudrun","family":"St\u00e5lhand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikael","family":"Korduner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0838-5737","authenticated-orcid":true,"given":"Martin","family":"Bengtsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Mani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malin","family":"Hakelius","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roshan","family":"Peroz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Z\u00f6tterman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny","family":"Cajander","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mats","family":"Sj\u00f6str\u00f6m","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Weinfeld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Persson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrad","family":"Harrison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Allori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Miroshnychenko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magnus","family":"Becker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,5,7]]},"reference":[{"issue":"5","key":"pone.0321021.ref001","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1016\/j.bjps.2011.11.004","article-title":"Quality of life of children treated for cleft lip and\/or palate: a systematic review","volume":"65","author":"AF Klassen","year":"2012","journal-title":"J Plast Reconstr Aesthet Surg"},{"issue":"7","key":"pone.0321021.ref002","doi-asserted-by":"crossref","first-page":"777","DOI":"10.1080\/08870446.2016.1143944","article-title":"Psychological adjustment to cleft lip and\/or palate: A narrative review of the literature","volume":"31","author":"NM Stock","year":"2016","journal-title":"Psychol Health"},{"issue":"1","key":"pone.0321021.ref003","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1597\/02-119.4.1","article-title":"The Eurocleft study: intercenter study of treatment outcome in patients with complete cleft lip and palate. Part 4: relationship among treatment outcome, patient\/parent satisfaction, and the burden of care","volume":"42","author":"G Semb","year":"2005","journal-title":"Cleft Palate Craniofac J"},{"issue":"3","key":"pone.0321021.ref004","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1016\/j.bjps.2017.11.015","article-title":"Outcome measurement in plastic surgery","volume":"71","author":"JCR Wormald","year":"2018","journal-title":"J Plast Reconstr Aesthet Surg"},{"issue":"3","key":"pone.0321021.ref005","doi-asserted-by":"crossref","first-page":"363","DOI":"10.1016\/j.bjps.2018.12.040","article-title":"Improving measurement 1: Harnessing the PROMise of outcome measures","volume":"72","author":"TD Dobbs","year":"2019","journal-title":"J Plast Reconstr Aesthet Surg"},{"issue":"3","key":"pone.0321021.ref006","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1016\/j.bjps.2018.07.042","article-title":"PART 2: Can improvement in outcome measurement in plastic surgery be achieved in today\u2019s health systems?","volume":"72","author":"L Geoghegan","year":"2019","journal-title":"J Plast Reconstr Aesthet Surg"},{"issue":"3","key":"pone.0321021.ref007","doi-asserted-by":"crossref","first-page":"442","DOI":"10.1177\/1055665617732854","article-title":"What Matters to Patients With Cleft Lip and\/or Palate: An International Qualitative Study Informing the Development of the CLEFT-Q","volume":"55","author":"KWY Wong Riff","year":"2018","journal-title":"Cleft Palate Craniofac J"},{"issue":"4","key":"pone.0321021.ref008","article-title":"Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip\/Palate","volume":"5","author":"E Tsangaris","year":"2017","journal-title":"Plast Reconstr Surg Glob Open"},{"issue":"15","key":"pone.0321021.ref009","doi-asserted-by":"crossref","DOI":"10.1503\/cmaj.170289","article-title":"Psychometric findings and normative values for the CLEFT-Q based on 2434 children and young adult patients with cleft lip and\/or palate from 12 countries","volume":"190","author":"AF Klassen","year":"2018","journal-title":"CMAJ"},{"issue":"6","key":"pone.0321021.ref010","doi-asserted-by":"crossref","first-page":"643","DOI":"10.1007\/s00238-018-1445-9","article-title":"Translation and cultural adaptation of the CLEFT-Q into Arabic, Dutch, Hindi, Swedish, and Turkish","volume":"41","author":"E Tsangaris","year":"2018","journal-title":"Eur J Plast Surg"},{"issue":"3","key":"pone.0321021.ref011","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1177\/10556656211062837","article-title":"Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity","volume":"60","author":"A Miroshnychenko","year":"2023","journal-title":"Cleft Palate Craniofac J"},{"issue":"5","key":"pone.0321021.ref012","doi-asserted-by":"crossref","first-page":"540","DOI":"10.1597\/15-292","article-title":"A Standard Set of Outcome Measures for the Comprehensive Appraisal of Cleft Care","volume":"54","author":"AC Allori","year":"2017","journal-title":"Cleft Palate Craniofac J"},{"issue":"12","key":"pone.0321021.ref013","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2023-071571","article-title":"What is the optimal assessment of speech? 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