van der Goes Philip A J, Ombashi Saranda, van Roey Victor, Hakelius Malin, Mathijssen Irene M J, Mink van der Molen Aebele B, Versnel Sarah L
Department of Plastic, Reconstructive and Hand Surgery, Erasmus Medical Center, Rotterdam.
Department of Plastic Surgery and Maxillofacial Surgery, Uppsala University Hospital, Uppsala, Sweden.
J Craniofac Surg. 2024 May 23;35(6):1667-72. doi: 10.1097/SCS.0000000000010314.
The European Reference Network for Rare Craniofacial Aanomalies and Ear-Nose-Throat disorders aims to improve care for patients with such afflictions, including cleft lip and palate (CL/P) across Europe. Cleft treatment remains varied throughout European centers, inhibiting meaningful comparison of treatment outcomes. To overcome these issues, a European-wide common CL/P dataset and registry was developed, facilitating standardized treatment endpoints and outcome measures for international comparison and benchmarking of CL/P centers. Questionnaires and semi-structured interviews were used to determine the set-up of the registry. Previous CL/P initiatives were analyzed to create an initial dataset, refined through consensus meetings. In total, 87 cleft specialists working in specialized CL/P centers from 16 European nations participated. Consensus on a common dataset was reached. A "Level 1" dataset, with mandatory clinical and patient-reported outcome measures, and "Level 2" dataset with additional outcome measures. Finally, 2 dashboards were developed for data dissemination. The development of the European CL/P common dataset and registry tackled challenges with resource disparities, variations in specialists within CL/P teams, regulatory differences in patient data usage, patient-reported outcome measures availability in European languages, and use of assessment tools. This study described the successful development of the European Reference Network for Rare Craniofacial Aanomalies and Ear-Nose-Throat disorders CL/P common dataset and registry. This achievement will help improve patient care and outcomes for patients with CL/P in Europe. Furthermore, this study provides useful information for initiatives with similar aims.
欧洲罕见颅面畸形和耳鼻喉疾病参考网络旨在改善全欧洲此类疾病患者的护理,包括唇腭裂(CL/P)患者。在欧洲各中心,唇腭裂治疗方法仍然各不相同,这阻碍了对治疗结果进行有意义的比较。为克服这些问题,开发了一个全欧洲通用的唇腭裂数据集和登记系统,以促进标准化治疗终点和结果测量,用于唇腭裂治疗中心的国际比较和基准测试。通过问卷调查和半结构化访谈来确定登记系统的设置。对以前的唇腭裂项目进行了分析,以创建初始数据集,并通过共识会议进行完善。共有来自16个欧洲国家的87名在专门的唇腭裂治疗中心工作的腭裂专家参与其中。就通用数据集达成了共识。一个“一级”数据集,包含强制性临床和患者报告的结果测量指标,以及一个“二级”数据集,包含额外的结果测量指标。最后,开发了2个数据仪表板用于数据传播。欧洲唇腭裂通用数据集和登记系统的开发应对了资源差异、唇腭裂治疗团队内专家差异、患者数据使用的监管差异、欧洲语言中患者报告的结果测量指标可用性以及评估工具使用等挑战。本研究描述了欧洲罕见颅面畸形和耳鼻喉疾病参考网络唇腭裂通用数据集和登记系统的成功开发。这一成果将有助于改善欧洲唇腭裂患者的护理和治疗结果。此外,本研究为具有类似目标的项目提供了有用信息。
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