van de Berg Daniël J, Mooij Christiaan F, van Trotsenburg A S Paul, Jamaludin Faridi S, van Santen Hanneke M, Clement Sarah C, Vriens Menno R, Bruinstroop Eveline, Kruijff Schelto, Peeters Robin P, Verburg Frederik A, Netea-Maier Romana T, Seur Angelique, Nieveen van Dijkum Els J M, Engelsman Anton F, Derikx Joep P M
Department of Pediatric Surgery, Emma Children's Hospital, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands
Department of Pediatric Endocrinology, Emma Childrens' Hospital, Amsterdam UMC, Amsterdam, North Holland, The Netherlands.
BMJ Open. 2025 Jan 11;15(1):e084391. doi: 10.1136/bmjopen-2024-084391.
There is a lack of consensus on the optimal surgical strategy for differentiated thyroid cancer (DTC), partly due to inconsistent reporting of outcomes. This limits the ability to compare study results, hindering the ability to draw conclusions regarding novel treatment strategies. The development of a core outcome set (COS) reduces heterogeneity in the selection and reporting of clinical trial outcomes. Currently, there is no COS for the surgical treatment of DTC. We aim to reach a global consensus among patients and physicians on the COS for the surgical treatment for patients with DTC of all ages.
The DTC-COS development will consist of three phases: first, an extensive literature review will be performed to identify reported outcomes in studies regarding surgical treatment for DTC in patients of all ages. Second, a 2-step or 3-step Delphi procedure will be performed to identify a final set of core outcomes out of the selected outcomes from the literature review. For this Delphi survey, both healthcare professionals and patients will be invited. Third, an (online) expert meeting with participants from every stakeholder group is organised to ratify the final core outcome set. The final COS will be reported in accordance with the COS-Standards for Reporting statement.
The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. The study is registered in the COMET initiative database (registration number 2597). Results will be presented in peer-reviewed academic journals and at (international) conferences.
COMET initiative database 2597.
对于分化型甲状腺癌（DTC）的最佳手术策略，目前尚无共识，部分原因是结果报告不一致。这限制了比较研究结果的能力，阻碍了就新治疗策略得出结论。核心结局集（COS）的制定减少了临床试验结局选择和报告中的异质性。目前，尚无DTC手术治疗的COS。我们旨在就各年龄段DTC患者手术治疗的COS在患者和医生中达成全球共识。
DTC-COS的制定将包括三个阶段：首先，进行广泛的文献综述，以确定各年龄段DTC患者手术治疗研究中报告的结局。其次，将进行两步或三步德尔菲程序，从文献综述中选定的结局中确定最终的核心结局集。对于此次德尔菲调查，将邀请医疗保健专业人员和患者参与。第三，组织一次（在线）专家会议，让每个利益相关者群体的参与者参加，以批准最终的核心结局集。最终的COS将按照COS报告标准声明进行报告。
阿姆斯特丹大学医学中心的医学研究伦理委员会确认，荷兰涉及人类受试者的医学研究法案（WMO）不适用于本研究，无需委员会的全面批准。该研究已在COMET倡议数据库中注册（注册号2597）。结果将在同行评审的学术期刊和（国际）会议上公布。
COMET倡议数据库2597。
