Periodic Reporting for period 3 - PalliativeSedation (The use of proportional palliative sedation for the relief of refractory symptoms: an international multicenter study)
Periodo di rendicontazione: 2022-01-01 al 2023-06-30
The call identifies a major need to strengthen the evidence of available and high quality palliative care interventions to improve quality of life in the last phase of life. Due to the increasing number of patients with advanced cancer and multiple chronic diseases, the number of patients with complex end-of-life care needs and refractory symptoms, is expected to increase dramatically.
Symptoms like 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. Palliative sedation has been defined in different ways but core components involve the deliberate lowering, by medication, of the consciousness of a patient in the last phase of life. Until now, guidelines for palliative sedation are mostly based on expert consensus because data from prospective clinical studies are scarce.
The five year project (2019-2023) called ‘Palliative Sedation’ - The use of proportional palliative sedation for the relief of refractory symptoms, aims to investigate the use of palliative sedation in several European countries. The project will investigate current practices and guidelines, will contain a prospective clinical study about palliative sedation and furthermore focuses on the similarities and differences in both the clinical and ethical aspects of practice across Europe and will formulate recommendations for an updated European Association for Palliative Care (EAPC) framework for palliative sedation. An online learning programme is foreseen together with a policy workshop for further development and implementation.
Palliative sedation has raised a lot of controversy, especially continuous deep sedation. It has been discussed if 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 and its success should be studied in terms of reduction of patient distress with sedation as a means. Patient comfort is the aim, not deep sedation as such. Therefore palliative sedation can be regarded as a continuum from light to deep sedation and from intermittent to continuous sedation. Although mentioned in most guidelines, most research and current practices are focused on continuous deep sedation. We aim to show that for the treatment of refractory symptoms a proportional application of palliative sedation is needed and possible.The international consortium bringing together many experts in the field, aims to support an updated international consensus framework.
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
Symptoms like 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. Palliative sedation has been defined in different ways but core components involve the deliberate lowering, by medication, of the consciousness of a patient in the last phase of life. Until now, guidelines for palliative sedation are mostly based on expert consensus because data from prospective clinical studies are scarce.
The five year project (2019-2023) called ‘Palliative Sedation’ - The use of proportional palliative sedation for the relief of refractory symptoms, aims to investigate the use of palliative sedation in several European countries. The project will investigate current practices and guidelines, will contain a prospective clinical study about palliative sedation and furthermore focuses on the similarities and differences in both the clinical and ethical aspects of practice across Europe and will formulate recommendations for an updated European Association for Palliative Care (EAPC) framework for palliative sedation. An online learning programme is foreseen together with a policy workshop for further development and implementation.
Palliative sedation has raised a lot of controversy, especially continuous deep sedation. It has been discussed if 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 and its success should be studied in terms of reduction of patient distress with sedation as a means. Patient comfort is the aim, not deep sedation as such. Therefore palliative sedation can be regarded as a continuum from light to deep sedation and from intermittent to continuous sedation. Although mentioned in most guidelines, most research and current practices are focused on continuous deep sedation. We aim to show that for the treatment of refractory symptoms a proportional application of palliative sedation is needed and possible.The international consortium bringing together many experts in the field, aims to support an updated international consensus framework.
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
M1-18
Two reviews about palliative sedation have been prepared, a survey has been drafted and executed (WP1). A study protocol for a prospective multicenter clinical study has been completed (WP2), together with a study protocol for an interview study (WP3). For WP4 about moral case deliberation sessions, a study protocol has been prepared. For WP6, regarding the revision of the EAPC framework, a taskforce and expert panel have been established.
M19-36
WP1 has researched and published the current state of the art surrounding palliative sedation based on the literature and expert survey.
Start of patient recruitment (WP2) was severely delayed due to the COVID pandemic. After site initiation visits, recruitment opened in spring 2021.
Interviews with family members and health care providers (WP3) were equally delayed but have now started.
The moral case deliberations (WP4) are almost finished.
The cost and staff time template of WP5 is part of the data collection of the clinical study (WP2) (ongoing).
To update the EAPC framework on palliative sedation, a four-step Delphi procedure was developed and undertaken online (WP6).
The WP7 team has drafted a plan for the online course.
WP8 continued coordinating a record of all dissemination/exploitation activities.
M37-54
The WP1 literature reviews and surveys about palliative sedation were published in international journals.
The clinical study (WP2) has finished recruitment and the research database has been completed.
Caregiver and bereaved family member interviews have been performed (WP3).
The WP4 moral case deliberation study has been completed.
WP5 held a consensus workshop and prepared the list of attendees for the forthcoming policy workshop.
The WP6 framework revision has been completed (White paper accepted by the EAPC).
Online education programme (WP7) has been designed and prepared.
Dissemination activities are ongoing, with international publications, presentations and congresses.
An eBook, supportive to the online education programme, has been developed and delivered.
Two reviews about palliative sedation have been prepared, a survey has been drafted and executed (WP1). A study protocol for a prospective multicenter clinical study has been completed (WP2), together with a study protocol for an interview study (WP3). For WP4 about moral case deliberation sessions, a study protocol has been prepared. For WP6, regarding the revision of the EAPC framework, a taskforce and expert panel have been established.
M19-36
WP1 has researched and published the current state of the art surrounding palliative sedation based on the literature and expert survey.
Start of patient recruitment (WP2) was severely delayed due to the COVID pandemic. After site initiation visits, recruitment opened in spring 2021.
Interviews with family members and health care providers (WP3) were equally delayed but have now started.
The moral case deliberations (WP4) are almost finished.
The cost and staff time template of WP5 is part of the data collection of the clinical study (WP2) (ongoing).
To update the EAPC framework on palliative sedation, a four-step Delphi procedure was developed and undertaken online (WP6).
The WP7 team has drafted a plan for the online course.
WP8 continued coordinating a record of all dissemination/exploitation activities.
M37-54
The WP1 literature reviews and surveys about palliative sedation were published in international journals.
The clinical study (WP2) has finished recruitment and the research database has been completed.
Caregiver and bereaved family member interviews have been performed (WP3).
The WP4 moral case deliberation study has been completed.
WP5 held a consensus workshop and prepared the list of attendees for the forthcoming policy workshop.
The WP6 framework revision has been completed (White paper accepted by the EAPC).
Online education programme (WP7) has been designed and prepared.
Dissemination activities are ongoing, with international publications, presentations and congresses.
An eBook, supportive to the online education programme, has been developed and delivered.
This project aims to study palliative sedation as a proportional intervention for refractory symptoms in palliative care, based on 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.
Progress beyond state of the art:
1. Perform literature reviews to update the state of the art of proportional application of palliative sedation including monitoring measures
2. Generate multicenter evidence for the effectiveness of proportional palliative sedation. Describe clinical practices in the partner countries by means of clinical data and interviews of professional caregivers and relatives
3. Investigation of the moral case deliberation method to facilitate decision making in case of refractory symptoms
4. Generate new and easy to access online educational material for refractory symptoms/palliative sedation
5. Revision of the 2009 EAPC framework for palliative sedation
6. Organize a policy workshop for further implementation in order to decrease professional and public misconceptions
Expected Impact:
1. Reduction of symptom burden and suffering of patients in need of end-of-life care and their formal and informal caregivers
2. Improved clinical guidelines and policy recommendations with respect to palliative sedation and refractory symptoms in palliative patients
3. Improved quality, effectiveness and cost-effectiveness of palliative/end-of-life care services as well as access to care
4. Reduced economic and wider societal burden arising from increased numbers of patients in need of palliative/end-of-life care
Progress beyond state of the art:
1. Perform literature reviews to update the state of the art of proportional application of palliative sedation including monitoring measures
2. Generate multicenter evidence for the effectiveness of proportional palliative sedation. Describe clinical practices in the partner countries by means of clinical data and interviews of professional caregivers and relatives
3. Investigation of the moral case deliberation method to facilitate decision making in case of refractory symptoms
4. Generate new and easy to access online educational material for refractory symptoms/palliative sedation
5. Revision of the 2009 EAPC framework for palliative sedation
6. Organize a policy workshop for further implementation in order to decrease professional and public misconceptions
Expected Impact:
1. Reduction of symptom burden and suffering of patients in need of end-of-life care and their formal and informal caregivers
2. Improved clinical guidelines and policy recommendations with respect to palliative sedation and refractory symptoms in palliative patients
3. Improved quality, effectiveness and cost-effectiveness of palliative/end-of-life care services as well as access to care
4. Reduced economic and wider societal burden arising from increased numbers of patients in need of palliative/end-of-life care