Stiernman Mia, Klintö Kristina, Wiedel Anna-Paulina, Schaar-Johansson Malin, Cornefjord Måns, Schönmeyr Björn, Stålhand Gudrun, Korduner Mikael, Bengtsson Martin, Mani Maria, Hakelius Malin, Peroz Roshan, Zötterman Johan, Cajander Jenny, Sjöström Mats, Weinfeld Justin, Persson Christina, Harrison Conrad, Allori Alexander, Miroshnychenko Anna, Becker Magnus
Department of Plastic and Reconstructive Surgery, Skåne University Hospital, Malmö, Sweden.
Division of Surgery, Department of Clinical Sciences in Malmö, Lund University, Lund, Sweden.
PLoS One. 2025 May 7;20(5):e0321021. doi: 10.1371/journal.pone.0321021. eCollection 2025.
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.
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.
This study is registered at ClinicalTrials.gov under the ID 2021-06993-01.
唇腭裂患者对治疗的感知益处非常重要，因为它是唇腭裂护理发展的核心。CLEFT-Q是一份关于健康相关生活质量的唇腭裂专用问卷。CLEFT-Q的重测信度、反应性和可解释性方面尚未确定。本研究旨在调查CLEFT-Q的这些心理测量特征。
为了确定CLEFT-Q的重测信度，将以大约1周的间隔重复且独立地收集数据。对于重测研究，纳入约50名患者被认为是足够的。为了提高CLEFT-Q的可解释性，将收集来自无唇腭裂志愿者对照人群的常模数据。总共将从小学、高中和大学纳入约210名参与者。为了测试CLEFT-Q的反应性，患者将回答CLEFT-Q的选定子量表、纵向锚定问题，并在手术前后进行整体变化评分。为了确保结果可靠，每种治疗类型将招募约50名患者。如果发现CLEFT-Q有反应性，将把CLEFT-Q术前和术后得分的差异与基于本研究中唇腭裂护理专业人员评估的客观测量变化进行比较。为了评估可解释性，将使用基于锚定、基于分布和定性方法分析结果，以调查最小重要变化。
本研究已在ClinicalTrials.gov上注册，标识符为2021-06993-01。
