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

Deliverables

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).

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)

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)

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.

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.

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).

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.

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.

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

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Publications

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

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