Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey
Introduction 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...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e084391.full |
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| author | Anton F Engelsman Romana T Netea-Maier Christiaan F Mooij Robin P Peeters Menno R Vriens A S Paul van Trotsenburg Schelto Kruijff Joep P M Derikx Faridi S Jamaludin Daniël J van de Berg Hanneke M van Santen Sarah C Clement Eveline Bruinstroop Frederik A Verburg Angelique Seur Els J M Nieveen van Dijkum |
| author_facet | Anton F Engelsman Romana T Netea-Maier Christiaan F Mooij Robin P Peeters Menno R Vriens A S Paul van Trotsenburg Schelto Kruijff Joep P M Derikx Faridi S Jamaludin Daniël J van de Berg Hanneke M van Santen Sarah C Clement Eveline Bruinstroop Frederik A Verburg Angelique Seur Els J M Nieveen van Dijkum |
| author_sort | Anton F Engelsman |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number COMET initiative database 2597 |
| format | Article |
| id | doaj-art-1e5b9984910a4fa08f737d3de617403b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-1e5b9984910a4fa08f737d3de617403b2025-01-15T00:40:10ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-084391Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi surveyAnton F Engelsman0Romana T Netea-Maier1Christiaan F Mooij2Robin P Peeters3Menno R Vriens4A S Paul van Trotsenburg5Schelto Kruijff6Joep P M Derikx7Faridi S Jamaludin8Daniël J van de Berg9Hanneke M van Santen10Sarah C Clement11Eveline Bruinstroop12Frederik A Verburg13Angelique Seur14Els J M Nieveen van Dijkum15Department of Surgery, Amsterdam UMC, Amsterdam, North Holland, The Netherlands5 Department of Internal Medicine, Division of Endocrinology, Radboud University Medical Center, Nijmegen, The Netherlands1Institute of Metabolism and Systems Research, Centre for Endocrinology, Diabetes and Metabolism, University of Birmingham, Birmingham, UKDepartment of Medicine, Erasmus Medical Center, Rotterdam, The NetherlandsDepartment of Endocrine and Surgical Oncology, Cancer Center, UMC Utrecht, Utrecht, The Netherlands2 Department of Paediatric Endocrinology, Emma Children’s Hospital, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, SwedenDepartment of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Emma Childrens` Hospital UMC, Amsterdam, The Netherlands3 Medical Library AMC, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsDepartment of Pediatric Surgery, Emma Children`s Hospital, Amsterdam UMC, Amsterdam, Noord-Holland, The NetherlandsDepartment of Pediatric Endocrinology, Wilhelmina Children`s Hospital University Medical Center, Utrecht, Utrecht, The NetherlandsDepartment of Pediatric Endocrinology, Wilhelmina Children`s Hospital University Medical Center, Utrecht, Utrecht, The NetherlandsDepartment of Endocrinology, Amsterdam UMC Location AMC Department of Internal Medicine, Amsterdam, North Holland, The NetherlandsDepartment of Radiology & Nuclear Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, The NetherlandsSchildklierNL, Bussum, The NetherlandsDepartment of Surgery, Amsterdam UMC, Amsterdam, North Holland, The NetherlandsIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number COMET initiative database 2597https://bmjopen.bmj.com/content/15/1/e084391.full |
| spellingShingle | Anton F Engelsman Romana T Netea-Maier Christiaan F Mooij Robin P Peeters Menno R Vriens A S Paul van Trotsenburg Schelto Kruijff Joep P M Derikx Faridi S Jamaludin Daniël J van de Berg Hanneke M van Santen Sarah C Clement Eveline Bruinstroop Frederik A Verburg Angelique Seur Els J M Nieveen van Dijkum Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey BMJ Open |
| title | Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey |
| title_full | Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey |
| title_fullStr | Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey |
| title_full_unstemmed | Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey |
| title_short | Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey |
| title_sort | protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer a literature review and international delphi survey |
| url | https://bmjopen.bmj.com/content/15/1/e084391.full |
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