The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol
Background: The practice of palliative sedation (PS) in end-of-life care has generated significant debate due to concerns about improper application and communication issues. Previous efforts to assess and enhance the practice have often focused on single outcomes, resulting in incomplete evaluation...
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2025-07-01
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| Series: | Palliative Care and Social Practice |
| Online Access: | https://doi.org/10.1177/26323524251340706 |
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| author | Lenzo Robijn Indra Albrecht Joni Gilissen Peter Pype Jeroen Hasselaar Luc Deliens Kenneth Chambaere |
| author_facet | Lenzo Robijn Indra Albrecht Joni Gilissen Peter Pype Jeroen Hasselaar Luc Deliens Kenneth Chambaere |
| author_sort | Lenzo Robijn |
| collection | DOAJ |
| description | Background: The practice of palliative sedation (PS) in end-of-life care has generated significant debate due to concerns about improper application and communication issues. Previous efforts to assess and enhance the practice have often focused on single outcomes, resulting in incomplete evaluations. There is currently no consensus on the core outcomes needed to assess PS effectively. Aim: This study aims to develop a core outcome set (COS) for PS in end-of-life care to enable comprehensive evaluation and improve clinical practice. Design: The study follows the four-stage Core Outcome Measures in Effectiveness Trials (COMET) initiative approach to develop the set of core outcomes. Methods and analysis: First, we will conduct a scoping review to identify potentially relevant outcomes reported in existing peer-reviewed and gray literature. Second, we will employ qualitative methods to explore outcomes valued by patients, their proxies, and healthcare professionals. Third, experts, including researchers, healthcare providers and bereaved relatives, and patient advocates will assess the importance of these outcomes through a Delphi study. Finally, a consensus meeting with stakeholder representatives will refine the COS. Concurrently, measurement instruments for these core outcomes will be identified. Ethics: Ethical clearance was obtained by the Ghent University Hospital Ethics Committee for the whole study (ONZ-2023-0050). Discussion: This study is crucial for establishing a gold-standard measurement instrument to evaluate the multifaceted practice of PS in all its complexity. Providing a standardized set of outcomes will facilitate the design and evaluation of clinical trials, support effective quality improvement initiatives, and inform evidence-based decision-making in healthcare. Engaging all key stakeholders, including dying persons and their families, significantly improving patient care. Furthermore, internationally validated, clinically relevant endpoints will further strengthen research impact and promote consistent, high-quality PS practices worldwide. |
| format | Article |
| id | doaj-art-2ca6fca41b4841538dde4e766cbf6590 |
| institution | DOAJ |
| issn | 2632-3524 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Palliative Care and Social Practice |
| spelling | doaj-art-2ca6fca41b4841538dde4e766cbf65902025-08-20T03:17:08ZengSAGE PublishingPalliative Care and Social Practice2632-35242025-07-011910.1177/26323524251340706The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocolLenzo Robijn0Indra Albrecht1Joni Gilissen2Peter Pype3Jeroen Hasselaar4Luc Deliens5Kenneth Chambaere6Center for Interprofessional Collaboration in Education, Research and Practice, Ghent University, BelgiumDepartment of Family Medicine and Chronic Care, Vrije Universiteit Brussel, BelgiumResearch Centre Care in Connection, Department of Nursing and Midwifery, Karel de Grote University of Applied Sciences and Arts, Antwerp, BelgiumCenter for Interprofessional Collaboration in Education, Research and Practice, Ghent University, BelgiumDepartment of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, Nijmegen, The NetherlandsDepartment of Family Medicine and Chronic Care, Vrije Universiteit Brussel, BelgiumDepartment of Family Medicine and Chronic Care, Vrije Universiteit Brussel, BelgiumBackground: The practice of palliative sedation (PS) in end-of-life care has generated significant debate due to concerns about improper application and communication issues. Previous efforts to assess and enhance the practice have often focused on single outcomes, resulting in incomplete evaluations. There is currently no consensus on the core outcomes needed to assess PS effectively. Aim: This study aims to develop a core outcome set (COS) for PS in end-of-life care to enable comprehensive evaluation and improve clinical practice. Design: The study follows the four-stage Core Outcome Measures in Effectiveness Trials (COMET) initiative approach to develop the set of core outcomes. Methods and analysis: First, we will conduct a scoping review to identify potentially relevant outcomes reported in existing peer-reviewed and gray literature. Second, we will employ qualitative methods to explore outcomes valued by patients, their proxies, and healthcare professionals. Third, experts, including researchers, healthcare providers and bereaved relatives, and patient advocates will assess the importance of these outcomes through a Delphi study. Finally, a consensus meeting with stakeholder representatives will refine the COS. Concurrently, measurement instruments for these core outcomes will be identified. Ethics: Ethical clearance was obtained by the Ghent University Hospital Ethics Committee for the whole study (ONZ-2023-0050). Discussion: This study is crucial for establishing a gold-standard measurement instrument to evaluate the multifaceted practice of PS in all its complexity. Providing a standardized set of outcomes will facilitate the design and evaluation of clinical trials, support effective quality improvement initiatives, and inform evidence-based decision-making in healthcare. Engaging all key stakeholders, including dying persons and their families, significantly improving patient care. Furthermore, internationally validated, clinically relevant endpoints will further strengthen research impact and promote consistent, high-quality PS practices worldwide.https://doi.org/10.1177/26323524251340706 |
| spellingShingle | Lenzo Robijn Indra Albrecht Joni Gilissen Peter Pype Jeroen Hasselaar Luc Deliens Kenneth Chambaere The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol Palliative Care and Social Practice |
| title | The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol |
| title_full | The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol |
| title_fullStr | The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol |
| title_full_unstemmed | The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol |
| title_short | The development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice: The COSEDATION study protocol |
| title_sort | development of a core outcome set for evaluating and enhancing palliative sedation in clinical research and practice the cosedation study protocol |
| url | https://doi.org/10.1177/26323524251340706 |
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