Symptoms such as pain, delirium, and dyspnea are often present in patients nearing death and can cause a lot of distress. In some cases, these symptoms become refractory, which means that treatment options are exhausted because they fail, the results are not available in due time, or the risk-benefit ratio is no longer acceptable to the patient. In such cases, palliative sedation can be considered as a last resort option of palliative care.1 However, a range of ethical challenges have been identified for palliative sedation,2 including the potential for shortening life,3,4 existential distress as an indication of palliative sedation5-7 or whether to substitute fluids and nutrition when using deep palliative sedation.
The EAPC has published a framework on palliative sedation following extensive discussions among board members and a wide range of experts.8 The work group developing this paper had been chaired by Nathan Cherny and Lukas Radbruch, in 2007. The framework paper defined palliative sedation as “the monitored use of medications intended to induce a state of decreased or absent awareness (unconsciousness) in order to relieve the burden of otherwise intractable suffering in a manner that is ethically acceptable to the patient, family and health-care providers.”8
However, in the last 10 years a number of guidelines on palliative sedation have been published, and the methodology of the EAPC framework paper has been criticized, describing weaknesses in the domains of stakeholder involvement, applicability and editorial independence in the AGREE II instrument.9 The definition, and especially the ethical condition in the last part of the definition has also been challenged. The definition had been part of the consensus process for the EAPC white paper on euthanasia and assisted suicide10, but the statement on the definition did not reach consensus. The literature shows a wide range of practices of and attitudes towards palliative sedation across Europe.11-15
The EU-funded project “Palliative Sedation – The use of proportional palliative sedation for the relief of refractory symptoms: an international multicenter study” (Topic: SC1-BHC-23-2018, project number 825700) takes a broader and modified perspective towards palliative sedation. The PallSed project uses the term proportional palliative sedation as it considers palliative sedation as a continuum from light to deep sedation and from intermittent to continuous sedation. Patient comfort is the aim, not deep sedation as such. The project will perform a clinical study into proportional palliative sedation in five European palliative care centers, with patient comfort as primary outcome measure. It also will study the decision making process during and after the assessment of refractory symptoms, evaluate the medical and ethical discussion using the dilemma method and produce a cost consequence analysis with a policy workshop with national palliative care associations.
The project plan also includes a revision of the EAPC framework for palliative sedation, using a strict multistep consensus process (work package 6 of the PallSed project). The Delphi methodology will be used to describe the broadest consensus among clinicians and researchers with the wide range of attitudes on and clinical practices of palliative sedation described in European countries. The revised framework together with an ebook and an online education programme will support dissemination and communication.
This EAPC taskforce is aligned with the work plan of work package 6 of the PallSed project with the aim to produce a consensus-based comprehensive clinical and ethical guidance on palliative sedation by revising the EAPC framework paper.
Provide consensus-based guidance on palliative sedation for palliative caregivers and health care decision makers in Europe
- Establish a consensus panel of clinical experts on palliative sedation
- Perform a methodologically strict multi-step consensus process based on the EAPC framework paper on palliative sedation and the research in the PallSed project
- Draft an EAPC white paper based on the revised framework recommendations
- Birgit Jaspers (Germany)
- Eduardo Garralda (Spain)
- Antonella Cardone (Belgium)
- Sheila Payne (UK)
- Daniela Mosoiu (Romania)
- Ágnes Csikos (Hungary)
- Carlos Centeno (Spain)
- Johan Menten (Belgium)
- Nathan Cherny (Israel)
MS 1 List of participants of expert panel (finalised in October 2019)
MS 2 Overview of components/statements (February 2020)
MS 3 Report on Delphi rounds 2 and 3 (December 2021)
MS 4 Revised framework, accepted by steering group (September 2022)
The PallSed projects combines an epidemiological survey with qualitative research on clinical practice of palliative sedation. Based on these results, in work package 6 a consensus process will be used to update the EAPC guidance on palliative sedation. This taskforce is aligned with the work plan of WP6.
A formal consensus process will be used, based on the Delphi methodology, with full consideration of the CREDES recommendations on methodology and reporting.16 The online survey methodology in the Delphi rounds will comply with all items of the Checklist for Reporting Results of Internet E-Surveys (CHERRIES).17
The steering group will:
- coordinate the consensus process and discuss critical issues
- draft statements based on the EAPC framework paper
- suggest additional statements where needed.
The expert group will:
- provide input on the statements and accompanying explanatory texts
- rate the statements and suggest additional statements
- revise the draft of the consensus paper following the two Delphi rounds.
The Delphi panel will include clinicians and experts. This panel will be selected to represent the European regions as well as gender and professions. The panel will be asked to provide consensus ratings with the statements in two Delphi rounds, resulting in broad and representative consensus on the final statements.
The final paper will be presented to the EAPC board of directors for approval as an EAPC white paper.
Members of the Expert Group (n=28) represent all European regions (North, South, East and West Europe) different professional backgrounds and genders. membership also includes renowned experts from outside of Europe.
The Delphi Panel will comprise the following groups:
1. Expert Group
2. Previous EAPC Board (2015-2019)
3. Additional experts, selected by literature search, recommendations, snowballing
The Delphi Panel will include a broader range of countries compared to the expert panel. The final list of Delphi panelists will be confirmed in 2020, and candidates will then be invited to participate via email.
The steering committee of the TF will be linked to the project palliative sedation and will meet regularly (at least once per year) during project meetings, at the EAPC congresses 2020-2022, or via skype and email.
The consensus-based recommendations on palliative sedation, based on the revised EAPC framework recommendations, will be submitted to the EAPC board for approval as a formal white paper providing maximum authority towards palliative caregivers and health care decision makers. The EAPC white paper will be submitted for open access publication in a scientific journal.
Publications from Palliative Sedation project
Clinical Aspects of Palliative Sedation in Prospective Studies. A Systematic Review
Maria Arantzamendi, RN, PhD, Alazne Belar, RN, PhD, Sheila Payne, RN, PhD, Maaike Rijpstra, MSc, Nancy Preston, RN, PhD, Johan Menten, MD, PhD, Michael Van der Elst, MSc, Lukas Radbruch, MD, PhD, Jeroen Hasselaar, PhD and Carlos Centeno, MD, PhD Journal of pain and symptom management, 2020-09-19
1. Jaspers B, Nauck F, Lindena G, Elsner F, Ostgathe C, Radbruch L. Palliative sedation in Germany: how much do we know? A prospective survey. J Palliat Med 2012; 15(6): 672-80.
2. Alt-Epping B, Nauck F, Jaspers B. What is problematic with palliative sedation?: a review. Ethik in Der Medizin 2015; 27(3): 219-31.
3. Barathi B, Chandra PS. Palliative Sedation in Advanced Cancer Patients: Does it Shorten Survival Time? – A Systematic Review. Indian J Palliat Care 2013; 19(1): 40-7.
4. Maltoni M, Scarpi E, Rosati M, et al. Palliative sedation in end-of-life care and survival: a systematic review. J Clin Oncol 2012; 30(12): 1378-83.
5. Rodrigues P, Menten J, Gastmans C. Physicians’ perceptions of palliative sedation for existential suffering: a systematic review. BMJ Support Palliat Care 2019.
6. Ciancio AL, Mirza RM, Ciancio AA, Klinger CA. The Use of Palliative Sedation to Treat Existential Suffering: A Scoping Review on Practices, Ethical Considerations, and Guidelines. J Palliat Care 2019: 825859719827585.
7. Rodrigues P, Crokaert J, Gastmans C. Palliative Sedation for Existential Suffering: A Systematic Review of Argument-Based Ethics Literature. J Pain Symptom Manage 2018; 55(6): 1577-90.
8. Cherny NI, Radbruch L. European Association for Palliative Care (EAPC) recommended framework for the use of sedation in palliative care. Palliat Med 2009; 23(7): 581-93.
9. Schildmann E, Schildmann J. Palliative sedation therapy: a systematic literature review and critical appraisal of available guidance on indication and decision making. J Palliat Med 2014; 17(5): 601-11.
10. Radbruch L, Leget C, Bahr P, et al. Euthanasia and physician-assisted suicide: A white paper from the European Association for Palliative Care. Palliative Med 2016; 30(2): 104-16.
11. Abarshi E, Rietjens J, Robijn L, et al. International variations in clinical practice guidelines for palliative sedation: a systematic review. BMJ Support Palliat Care 2017; 7(3): 223-9.
12. Stiel S, Nurnus M, Ostgathe C, Klein C. Palliative sedation in Germany: factors and treatment practices associated with different sedation rate estimates in palliative and hospice care services. BMC Palliat Care 2018; 17(1): 48.
13. Benitez-Rosario MA, Morita T. Palliative sedation in clinical scenarios: results of a modified Delphi study. Support Care Cancer 2019; 27(5): 1647-54.
14. Gurschick L, Mayer DK, Hanson LC. Palliative Sedation: An Analysis of International Guidelines and Position Statements. Am J Hosp Palliat Care 2015; 32(6): 660-71.
15. Seymour J, Rietjens J, Bruinsma S, et al. Using continuous sedation until death for cancer patients: a qualitative interview study of physicians’ and nurses’ practice in three European countries. Palliat Med 2015; 29(1): 48-59.
16. Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliative Med 2017; 31(8): 684-706.
17. Eysenbach G. Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res 2004; 6(3): e34.
18. Junger S, Brearley S, Payne S, et al. Consensus building on access to controlled medicines: a four-stage delphi consensus procedure. J Pain Symptom Manage 2013; 46(6): 897-910.
19. Junger S, Payne S, Brearley S, Ploenes V, Radbruch L. Consensus building in palliative care: a Europe-wide delphi study on common understandings and conceptual differences. J Pain Symptom Manage 2012; 44(2): 192-205.