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

Project Information

PalliativeSedation

Grant agreement ID: 825700

DOI

10.3030/825700

Project closed

EC signature date 26 November 2018

Start date 1 January 2019

End date 30 June 2024

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 4 033 520,75

EU contribution

€ 4 033 520,25

Coordinated by

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands

Periodic Reporting for period 4 - PalliativeSedation (The use of proportional palliative sedation for the relief of refractory symptoms: an international multicenter study)

Reporting period: 2023-07-01 to 2024-06-30

Summary of the context and overall objectives of the project

The ‘Palliative Sedation’ project addresses a major need to strengthen the evidence on available and high-quality palliative care interventions to improve quality of life in the last phase of life. There are increasing number of patients with advanced cancer with complex end-of-life care needs and refractory symptoms. Symptoms like pain, delirium, and dyspnoea are often present in patients nearing death and they can cause a lot of distress. These symptoms become refractory because treatment options are exhausted because they are ineffective, the effects are not available in sufficient time, or the risk-benefit ratio is no longer acceptable to the patient. In such cases, palliative sedation can be considered. Palliative sedation involves the deliberate lowering of the consciousness of a patient in the last phase of life, using appropriate medication. Previously, guidelines for palliative sedation have been mostly based on expert consensus because data from prospective clinical studies are scarce.
Palliative sedation has raised a lot of controversy, especially continuous deep sedation. There are concerns that palliative sedation shortens life or even can be used as a hidden euthanasia. Application of palliative sedation across Europe widely varies. The administration of sedatives for refractory symptoms should be based on what is needed for symptom relief.
Our five-year project called ‘Palliative Sedation’ (2019-2023) - The use of proportional palliative sedation for the relief of refractory symptoms, aimed to investigate the use of palliative sedation in several European countries. The project investigated current practices and guidelines, conducted a prospective clinical study about palliative sedation and examined the similarities and differences in both the clinical and ethical aspects of practice across Europe.
Overall objectives of the project:
1) To evidence and investigate the practice of proportional palliative sedation using
a. An observational clinical study
b. A multiple case study
2) To investigate the use of moral case deliberation for palliative sedation
3) To revise the 2009 EAPC recommended framework for palliative sedation
4) To increase public and professional understanding of palliative sedation by delivery of: an online education programme; policy recommendations about costs and effects; an ebook with best practice examples and patient summary of framework; a congress/webinar for professionals.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In WP1 literature reviews about palliative sedation were published in international journals. Surveys with experts resulted in an inventory of guidelines for palliative sedation in Europe, and availability and use of medication for palliative sedation in Europe.

In WP2 a prospective multicentre observational study was conducted amongst 248 patients including 78 sedations, to investigate the performance of palliative sedation in clinical practice in Belgium, Germany, Italy, Spain and the Netherlands.
WP3 investigated the experiences of relatives and healthcare professionals regarding palliative sedation using qualitative methods. Thirty-three cases were recruited in seven palliative care services in Belgium, Germany, Italy, the Netherlands, and Spain.
WP4 carried out moral case deliberations among 232 healthcare professionals in 16 centres in Belgium, the Netherlands, Hungary, Romania, England, Italy, Spain, Germany.
WP5 developed a cost consequence framework for palliative sedation at a two days-workshop which resulted in policy recommendations for palliative sedation relevant at a European level.
In WP6 the revised European Association for Palliative Care (EAPC) recommendations involved 91 experts from 28 countries using a four-stage Delphi procedure.
WP7 developed an online facilitated educational programme to help health professionals, patients, families and interested people understand more about palliative sedation. It was delivered to over 2024 participants from 110 countries.
WP8 delivered on dissemination including an in-person Symposium (16th April 2024 in Brussels) and Webinar (24th April), and an eBook available online incorporating the Brussels statement on Palliative Sedation. The project's website presents a public infographic in several European languages.
Despite the COVID pandemic challenges, with a no-cost extension, it is clear that the synergic impact of our project will be significant. For example, the eBook and revised framework are translated into several languages, and the webinar and Symposium in Brussels were successful. The project has made a major contribution to pan-European discussion on palliative care and palliative sedation. Major publications are forthcoming and will offer cross country perspectives on palliative sedation practices. The education programme is ongoing and attracts many attendees from all over the world. Finally, our project is mentioned in a forthcoming policy brief on palliative care in cancer based in the EU mission on cancer programme.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This project has investigated palliative sedation as a proportional intervention for refractory symptoms in palliative care contexts, based on seeking to enhance patient comfort. The hypothesis is that palliative sedation can be a proportional intervention in palliative care that can be applied along a continuum of light to deep sedation, and intermittent towards continuous sedation. It aims to correct a predominant perception of palliative sedation focused on continuous deep sedation until death surrounded by ethical controversies.
We highlight the following progress achieved during the project:
1. Published literature reviews designed to update knowledge of the proportional application of palliative sedation including recommendations on the use of measures for monitoring outcomes such as patient comfort.
2. Generate multicentre evidence for the effectiveness of proportional palliative sedation. Describe clinical practices in the partner countries by means of clinical data, and interviews with healthcare professional and bereaved relatives.
3. Investigation of the use of the moral case deliberation method to facilitate decision making in clinical teams in cases where refractory symptoms are present.
4. Generate new, free, and easy to access online educational material for the management of refractory symptoms using palliative sedation.

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