CLEFT-Q SwePsych protocol: a prospective observational study to investigate the psychometric characteristics test-retest reliability, responsiveness, and interpretability of CLEFT-QDepartment of Plastic and Reconstructive Surgery, Skåne University Hospital, Malmö, Sweden, Division of Surgery, Department of Clinical Sciences in Malmö, Lund University, Lund, Sweden.
Division of Surgery, Department of Clinical Sciences in Malmö, Lund University, Lund, Sweden, Plastic- and Craniofacial Surgery, Karolinska University Hospital, Stockholm, Sweden.
Maxillofacial Unit in Linköping, Linköping, Sweden, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Department of Oral and Maxillofacial Surgery, Skåne University Hospital, Lund, Sweden, Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.
Department of Oral and Maxillofacial Surgery, Skåne University Hospital, Lund, Sweden, Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden, Department of Plastic Surgery and Maxillofacial Surgery, Uppsala University Hospital, Uppsala, Sweden.
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden, Department of Plastic Surgery and Maxillofacial Surgery, Uppsala University Hospital, Uppsala, Sweden.
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden, Department of Hand and Plastic Surgery and Burns, Linköping University Hospital, Linköping, Sweden.
Division of Hand- and Plastic Surgery, Umeå University Hospital, Umeå, Sweden, Division of Surgery, Department of Surgical and Perioperative Science in Umeå, Norrland University Hospital, Umeå, Sweden.
Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Institute of Neuroscience and Physiology, Speech and Language Pathology Unit, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Division of Plastic, Maxillofacial, and Oral Surgery, Duke University, Durham, North Carolina, United States of America.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Department of Plastic and Reconstructive Surgery, Skåne University Hospital, Malmö, Sweden, Division of Surgery, Department of Clinical Sciences in Malmö, Lund University, Lund, Sweden.
Show others and affiliations
2025 (English)In: PLOS ONE, E-ISSN 1932-6203, Vol. 20, no 5, article id e0321021
Article in journal (Refereed) Published
Abstract [en]
OBJECTIVES: 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.
METHODS: 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.
REGISTRATION DETAILS: This study is registered at ClinicalTrials.gov under the ID 2021-06993-01.
Place, publisher, year, edition, pages
Public Library of Science (PLoS), 2025. Vol. 20, no 5, article id e0321021
National Category
Surgery Odontology
Identifiers
URN: urn:nbn:se:umu:diva-238536DOI: 10.1371/journal.pone.0321021PubMedID: 40334197Scopus ID: 2-s2.0-105004763014OAI: oai:DiVA.org:umu-238536DiVA, id: diva2:1957003
Funder
Region Skåne, 2023-0682025-05-082025-05-082025-05-19Bibliographically approved