The use of proportional palliative sedation for the relief of refractory symptoms: an international multicenter study

Deliverables

Task 44 Vignette study MCD using professional caregiver focus groups M18M25The first case will be a fictive case vignette for refractory symptoms and the role of palliative sedation including medical cultural and ethically sensitive issues The case will be discussed at each site in a focus group setting with an interdisciplinary setting of physicians nurses and other caregivers in the team This will allow for comparison of local teams and the cultural and local differences in discussions about palliative sedation between the different palliative teams in the several countries The focus groups will be recorded transcribed verbatim and translated in English

List of recruited participants

Task 6.1 – Steering group and expert panel (M3-6) A steering group of 3-5 persons will be formed from members of the consortium, led by Lukas Radbruch and Birgit Jaspers. Experts on the topic of palliative sedation will then be identified from a literature search and via the national hospice and palliative care organiziations and the European Association for Palliative Care (EAPC). Experts will be asked for other experts in the field using a snowball technique. Expert selection will also consider regional distribution, including adequate numbers of experts from northern, southern, eastern and western European countries. Care will be take that the panel represents multiple professions and cultural and religious affiliations. Invitation of the expert panel will be via email, and the consultation will be done with an online survey (Surveymonkey).

List of materials/no. subscriptions

Task 73 Advertising and promoting the online educational programme M42M50A flyer advertising the programme will be prepared and widely disseminated via the project website and links to the partners websites and via the EAPC We will prepare an EAPC blog to attract interest in the programmeA video advertisement of the programme will be prepared and linked in to the promotional materialRegistration for the programme will be managed via a web link and will record basic sociodemographic age gender country and where relevant professional affiliations

Integrative review

Task 1.4. An integrative review to identify how to measure the potential effects (including valid instruments but not only) and possible complications of palliative sedation in main refractory symptoms (M9-M18) This review will summarize the empirical or theoretical literature to provide a more comprehensive understanding of the question of how to evaluate the sedation procedures in palliative care patiens. This integrative review, thus, has the potential to inform the prospective study that the group will carry out in the next workpackage. Experts in qualitative methods of the University of Navarra will support the search a broad kind of articles with all methodologies in order to capture the context, processes and subjective elements of the topic. To listen the patients perspectives we will invite to participate in the analysis and discussion to the European Patient Forum, an umbrella organisation that works with patients’ groups in public health and health advocacy across Europe. A report on tools to measure different ways and instruments to measure the effects of palliative sedation will be produced and will be discussed in the consensus meeting (see task 1.5)

Report on status of posting results

Task 26 Analysis of results M3341 Results will be stored in the online research database CASTOR After closure of the study the database will be checked for completeness and closed Data will be anonymously transported into SPSS for further analysis at Radboudumc Results will be discussed in the project group and prepared for a scientific publication

eport on experiences real cases

Task 45 Moral case deliberation for refractory symptoms based on a real patient case M20M28The second case will be a complex real case that the palliative care providers are dealing with in their respective centers This case is intended to provide an indepth view of moral and medical debates regarding the treatment of refractory symptoms and the role acceptability and appearance of palliative sedation at each individual site The focus groups will be recorded transcribed verbatim and translated in English

Letter Completion content

Task 72 Preparing the content of the online education about palliative sedation M13M47The content of the programme will be prepared in multidisciplinary meetings drawing upon the systematic review the vignette study of clinicians views the observational study of clinical practices and the outcomes of the Delphi consensus processes underpinning the updated EAPC Framework of sedationShort lectures from international speakers will highlight important topics in an accessible style short films of best practices and all open access resources compiledCourse content will be edited and uploaded on to the online platform

Dissemination plan (PDER)

Task 8.2 Plan of dissemination and exploitation of results (M3-M8) The Plan of Dissemination and Exploitation of Results (PDER) (D 7.2) has been drafted and will be further refined at regular points during the project. This will include scientific papers (at least one per work package except management), blogs (at least two per workpackage except management), congress abstracts and presentations (at least two at every EAPC congress during the project)

Draft publication

Task 46 Cross country data analysis and synthesis M28M40The outcomes between the two cases will be examined and comparisons between the patient case discussions across clinical centers will be made also taking into account medical cultural and moral differences in the approach of refractory symptoms and palliative sedation The outcomes of the EUROMCD and the burnout scale will be analysed Additionally a comparison between the case deliberations of the theoretical and the real cases can be drawn All data gathered will be handled confidentially after informed consent professional care providers participate voluntarily and data will be analysed anonymously Professional focus groups will be evaluated with content analysis using a qualitative data analysis software eg NVivo or ATLASTI

Focus group protocol

Task 4.1 Devising the research protocol (M12-M15). The research protocol will be developed by UP in communication with moral case deliberation experts from UNAV and Radboudumc. The research protocol will be agreed by the consortium to structure the moral case deliberations in the participating centers.

First study subject approvals package

Task 25 Inclusion of patients in the study M16M33The clinical study will run at the five study sites UK Bonn Radboudumc UNAV Palermo KU Leuven Patients who fulfill the submission criteria will be asked for informed consent and will be included in the study Patients will remain in the study for the duration of sedation or until death For more details about the study design see methodology section Part B 13 and Template for the clinical study Interim reports to EU will be provided

Study protocol

Task 2.1 Drafting of the protocol. (M3-9) Because palliative sedation has been a confusing topic from a research perspective, a thorough and agreed multicenter research protocol is needed. The protocol will involve terms and terminology (drawn from WP1) as well as the primary and secondary outcome measures, the inclusion criteria, the case report form-CRF, the informed consent form, conform Good Clinical Practice. For the patients at least the following observational scales are foreseen: ESAS for numerical rating of symptoms, DS-DAT for patient discomfort, and RASS for levels of sedation. For the family members the CRA about burden and rewards of informal caring and the CanhelpLITE-sv for satisfaction with care. See for study details the PalliativeSedation clinical study appendix. Partner Radboudumc will lead this.

Letter completion of interviews

Task 32 Performing caregiver and family member interviews M1632Based on the interview guide respondents will be approached based on the palliative sedation cases from WP2 10 palliative sedation cases per setting will be selected Selection will be balanced as to get enough variation in cases with regard to for example disease background type of refractory symptoms type of sedation light deep etc based on thorough consultation with clinical centers as the study progresses For the cases interviews with the involved caregivers and family members will be held after the palliative sedation episode Data will be transcribed verbatim

Systematic review

Task 1.2 Performance of a systematic review of prospective clinical studies on refractory symptoms in palliative patients (M3-15) The researchers at the University of Navarra will lead a review of the literature on prospective clinical studies on refractory symptoms in palliative patients and the role of palliative sedation. The review will include clinical predictors, assessment procedures (process of decision making, involvement of palliative care specialists, expertise and experience to judge the symptom as refractory), and treatment strategies (first line medications and alternatives, initial dose, titration strategies, concomitant use of hydration, monitoring and documenting). The initial results will be send to the collaborating centers asking for their critical suggestions and comments. All the beneficiaries will finally be invited to participate in a consensus meeting on the provisional report to reach an agreement for the content the final drafts of the report. The analysis of the available literature will be useful as a starting point for a further international consensus process on refractory symptoms within the European Association of Palliative Care (EAPC).

List of identified stakeholders

Task 54 Identify stakeholders and draft policy recommendations M40M44Palliative sedation is a complex intervention aimed to relive suffering generated by refractory symptoms at end of life Alongside the patient and the family the health care professionals and health managers health funders are obvious stakeholder but also due to the cultural and religious diversity among Europe opinion leaders national palliative care associations and the general public may play an important role in the way palliative care sedation is used and perceived MethodRecommendations based on results of the present WP but also WP 2 3 4 6 will be prepared for the stakeholder meeting HCS together with Radboudumc will draft policy recommendation and send them in the consortium for consensus Stakeholder identification WP lead will Collaborate with EAPC to identify national palliative care association representative Europe WP lead will contact national palliative care association representatives across Europe and invite them to express their interest in taking part in a policy workshop concerning palliative care sedation and identify at least one representative for each of following stakeholders groups in his her country leading health care professionals involved in palliative care managers of representative palliative care facilities in their countries patients groups advocating for palliative care health funders supportive for palliative care faith public leaders supportive of palliative care National association representatives will send the contact information of these persons after obtaining their agreements

Protocol for search strategy

Task 1.1 Definition of search strategy and the protocol (M1-3) This phase will produce a protocol for the collection and analysis of literature information. The protocol will describe the rationale, hypothesis, and planned methods. The protocol will be registered in a registry such as PROSPERO. Objective 1 will be covered by a systematic review of domains of refractory symptoms and palliative sedation; objective 2 would need the design of an on-line survey using appropriate software (i.e. Survey Monkey); objective 3 will be covered by a integrative review. The review will follow PRISMA guidance. Literature search will be based on scientific databases like Pubmed, Medline, and Embase. In addition grey literature including non-english literature will be collected for the participating countries via an online survey. The design will be lead by University of Navarra with the collaboration of Pecs university together with experts in literature review methods from the Lancaster University group. The experience of partner Leuven in leading systematic research in the previous FP7-Insup-C project will be an added value for the design of the strategy.

List of participating centers

Task 4.2 Selecting the two clinical centers per country (M12-15) Each consortium partner selects two clinical centers in the country that are willing to participate in the moral case deliberation. In each center two multidisciplinary case deliberations will be organized.

Report survey results

Task 1.3 On-line international survey for the collection of existing local guidelines for palliative sedation, regulations and equipments and to study the use and level of integration in health care practice in the participant countries (M6-18) To understand the levels of integration of pallliative sedation on healthcare the project will develop an internacional survey. The experience of University of Navarra developing mapping studies through experts will be useful here. The survey will be addressed to experts clinicians and key persons indentified by the group in each participating country. The survey will request most used guidelines, applicable regulations and equipment available for performing palliative sedation in each country (medication, devices for drugs administration, etc.). The survey will be done in English but requested documentation will be in any language including grey literature. Partner Bonn (Lukas Radbruch), who will lead the work package of the EAPC framework on sedation, will be coordinating the analysis of local guidelines with a researcher within each partner group, building further on previous reviews like Schildmann & Schildmann (2014), and Abarshi et al. (2017). The analysis will include definitions and terminology, the evidence of the recommendations, and the overall quality evaluation according to the Appraisal of Guidelines for Research and Evaluation II instrument (AGREE II). The survey will also include the exploration of the process of implementation, extended use and updating, and also will include questions on barriers and opportunities for the extended use of guidelines in the country and on the existing regulations and equipment. All the information will be described and compared. The analysis of regulation and equipment will be done in collaboration with the group of Pecs University. The overview of local guidelines with the experiences learned in participating countries will serve as an input for the intended update of previous international recommendations on palliative sedation in a later workpackage lead by partner Bonn. The results of the international survey will be presented as a scientific report with comparative analysis using perspectives and methods of health geography.

E-book

Task 83 Coordination of ebook delivery M36M51An ebook containing clinical and ethical guidance on the management of refractory symptoms and palliative sedation D 73 will be prepared by the project partners Coordination will be done by WP8 Radboudumc This book has the aim to inform a broad public beyond palliative care experts about current practices terminology ethical sensitivities and European differences

Design of online program

Task 7.1 Designing the content of the online educational programme, including identifying educational needs about palliative sedation of clinicians working in palliative care, patients, family caregivers and the public. (M7-M12) Identification of the educational needs about refractory symptom management and palliative sedation of clinicians, patients, family caregivers and the public will be elicited in WP4, using vignettes and in focus group discussions, and in PPI activities (involvement of European Cancer Patient Coalition). In addition, we will draw upon findings from the Delphi consensus processes underlining the revised EAPC Framework on Palliative Sedation (WP6). The following teaching approaches will be used: • The programme will involve a combination of on-line content supported by short videos. These will be interviews on camera with leading experts in palliative care from the countries involved in the project. An example is provided here http://www.eupace.eu/videos • We also plan to create short (3 minute) films in different countries to illustrate best practice elements of the treatment of refractory symptoms using palliative sedation. Countries include: the UK, Italy, Spain, Germany, Belgium, Hungary, Romania and the Netherlands. • We will also make a short film of an ‘ethical case’ multidisciplinary discussion in the Netherlands to demonstrate a clinical decision making processes. • The content will be supported by access to relevant academic and professional papers (where published in open access journals) • A range of practical exercises presented within the programme, will be available to enable participants to prepare their own action plans for implementation will be integrated into the activities, and to recognize opportunities and barriers to change, recognising cultural, religious, ethical and legal differences. • Exercises will be incorporated throughout the three weeks resulting in a summative assessment at the end of the course to demonstrate improved knowledge.

Cost consequence format

Task 5.1 Design the framework for cost consequence analysis as a ‘balance sheet’ with elements of cost of the intervention (palliative care sedation) and its consequences - monetary, quantitative, and descriptive. (M3-M6). HCS as lead partner for this WP together with support from a health economist from partner UP will develop this framework and the list with elements of cost . This balance sheet will include a format to list costs related to palliative sedation intervention in terms of: health care staff, family meetings, interdisciplinary meetings, expert consultation costs, equipment (pumps). This cost format will serve as an imput for the clinical workpackage (WP6). This will be discussed and refined in the first consortium meeting

sed and consented framework

Task 64 Approval procedure of framework revision M36M44The last step 4 involves the smaller expert panel from Step 2 and the project consortium Participants will be asked to review the revised draft Using the feedback from this round a final revision of the paper will be prepared Quantitative statistical analysis in the Delphi rounds of the ratings on the fivepoint Likert scales will include percentages and median values as indicators of agreement on the fivepoint scales as well as variances and interquartile ranges IQRs as indicators of consensus with a low variance of responses and an IQR 1 showing high consensus Thresholds and definitions of consensus are based on values used in previous studies Confidentiality and privacy will be assured at all times to the participants Information on privacy protection the estimated length of time of the survey the investigators and the purpose of the study will be provided in the invitation email as well as on the first page of the online survey The respondents emails and retrieved data from the survey will be stored in the password protected computers of the principal investigatorsIn the revision of the paper those statements that do not reach consensus will be revised in accordance with the comments of the participants However the writing group may decide to keep statements even if formal consensus is not achieved but this lack of full consensus will be marked in the final publication The final draft will be submitted for open access publication in a scientific journal

Letter with logo/website

Task 8.1 Logo, website, media releases (M1-3) A high quality engaging logo and website will be designed by partner ULANC. In addition, we will prepare templates for presentations and other output to promote the visual identity of the project. Press releases and media summaries will be used to communicate the launch of the project, which will be followed up at appropriate times to announce the outcomes of specific studies and raise the profile of the project.

Publications

Palliative Sedierung. revision der EAPC Letlinie von 2009

Author(s): Holger Brunsch Séverine Surges Jeroen Hasselaar Lukas Radbruch Birgit Jaspers
Published in: 2020
Publisher: Deutsche Gesellschaft für Palliativmedizin (DGP)

Sedação paliativa: como avaliar osprocessos que utilizamosHow to evaluate palliative sedation

Author(s): Carlos Centeno Alazne Belar María Arantzamendi
Published in: 2020
Publisher: 3-curso-internacional-avancado-de-cuidados-paliativos

How to assess pallaitive sedation: an integrative review

Author(s): Arantzamendi M. Belar, A Preston, N Payne, S Centeno C Hasselaar J.
Published in: https://journals.sagepub.com/doi/full/10.1177/0269216320958098, 2020
Publisher: Sage Publications - Palliative Medicine

How to measure the effects and potential adverse events of palliative sedation? An integrative review

Author(s): Alazne Belar; María Arantzamendi; Sheila Payne; Nancy Preston; Maaike Rijpstra; Jeroen Hasselaar; Lukas Radbruch; Michael Vanderelst; Julie Ling; Carlos Centeno
Published in: 2021 Feb;35(2):295-314, 2021, ISSN 1477-030X
Publisher: Palliative Medicine
DOI: 10.1177/0269216320974264

Regulations on palliative sedation: an international survey across eight European countries

Author(s): Garralda, E.; Busa, C.; Pozsgai, É.; Osztromok-Lukacs, V.; Csikós, A.; Radbruch, L.; Hasselaar, J.; Hasselaar, J.; Menten, J.; Payne, S.; Adile, C.; Hurducas, F.; Centeno, C.
Published in: urn:issn:1101-1262, Issue 3, 2024, ISSN 1464-360X
Publisher: Eur J Public Health
DOI: 10.1093/eurpub/ckac153

An analysis of the experiences of bereaved relatives and health care providers following palliative sedation: a study protocol for a qualitative international multicenter case study

Author(s): M. Van der Elst; S. Payne; M. Arantzamendi; N. Preston; J. Hasselaar; C. Centeno; A. Belar; B. Jaspers; H. Brunsch; S. Surges; C. Adile; J. Menten
Published in: BMC Palliative Care, Vol 21, Iss 1, Pp 1-8 (2022), Issue 30, 2022, ISSN 1472-684X
Publisher: BioMed Central
DOI: 10.1186/s12904-022-01117-w

Revised European Association for Palliative Care (EAPC) recommended framework on palliative sedation: An international Delphi study

Author(s): Séverine M Surges; Holger Brunsch; Birgit Jaspers; Kathi Apostolidis; Antonella Cardone; Carlos Centeno; Nathan Cherny; Àgnes Csikós; Robin Fainsinger; Eduardo Garralda; Julie Ling; Johan Menten; Sebastiano Mercadante; Daniela Mosoiu; Sheila Payne; Nancy Preston; Lieve Van den Block; Jeroen Hasselaar; Lukas Radbruch
Published in: Palliative Medicine, 38, 2, pp. 213-228, Issue 7, 2024, ISSN 1477-030X
Publisher: Palliative Medicine
DOI: 10.1177/02692163231220225

Clinical Aspects of Palliative Sedation in Prospective Studies. A Systematic Review

Author(s): Maria Arantzamendi, Alazne Belar, Sheila Payne, Maaike Rijpstra, Nancy Preston, Johan Menten, Michael Van der Elst, Lukas Radbruch, Jeroen Hasselaar, Carlos Centeno
Published in: Journal of Pain and Symptom Management, 2020, ISSN 0885-3924
Publisher: Elsevier BV
DOI: 10.1016/j.jpainsymman.2020.09.022

Picturing palliative sedation: A new European investigation

Author(s): Jeroen Hasselaar (Radboud University Medical Center), Sheila Payne (International Observatory on End of Life Care at Lancaster University) and Julie Ling (European Association for Palliative Care – EAPC)
Published in: EAPC BLOG, Issue 20 May 2019, 2019
Publisher: EAPC

Palliative sedation in the context of COVID-19: Expert opinions from the Palliative Sedation project

Author(s): Dr Jeroen Hasselaar, (Project Coordinator), Prof Dr K Vissers (Netherlands), Prof Dr S Mercadante (Italy), Prof Dr C Centeno (Spain), Prof S Payne (UK), Prof N Preston (UK), Prof Dr L Radbruch (Germany), M van der Lee, MSc (Netherlands), Dr A Csikós, (Hungary) and Prof Dr J Menten (Belgium),
Published in: EAPC BLOG, Issue 20/04/2020, 2020
Publisher: EAPC

Deliverables

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