Evidence map›Paper›PMID 36709271›Full record

ArticleBMC palliative care2023

Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol.

Maaike Rijpstra, Kris Vissers, Carlos Centeno, Johan Menten, Lukas Radbruch, Sebastiano Mercadante, Michael Van der Elst, Claudio Adile, Maria Arantzamendi, Evelien Kuip and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC palliative care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04719702 (Palliative Sedation Across European Settings), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04719702 completednot on this map

Palliative Sedation Across European Settings: a Prospective Observational Multicentre Study

TypeobservationalSponsorRadboud University Medical CenterRan2021 to 2023Enrolled80ConditionsPalliative Sedation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 6 countries.

Maaike RijpstraDepartment of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands. Maaike.vanderLee-Rijpstra@radboudumc.nl.ORCID http://orcid.org/0000-0002-8747-3833
Kris VissersDepartment of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID https://orcid.org/0000-0002-2919-6356
Carlos CentenoDepartement of Palliative Medicine, Clínica Universidad de Navarra, Pamplona, Spain.ORCID https://orcid.org/0000-0003-3395-7039
Johan MentenDepartment of Oncology, Laboratory of Experimental Radiotherapy, Katholieke Universiteit Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0003-2805-1953
Lukas RadbruchDepartment of Palliative Medicine, Universitaetsklinikum Bonn, Bonn, Germany.ORCID https://orcid.org/0000-0001-9526-396X
Sebastiano MercadanteMain Regional Center of Supportive/Palliative Care, La Maddalena Cancer Center, Palermo, Italy.ORCID https://orcid.org/0000-0001-9859-6487
Michael Van der ElstDepartment of Oncology, Laboratory of Experimental Radiotherapy, Katholieke Universiteit Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0001-9381-7287
Claudio AdileMain Regional Center of Supportive/Palliative Care, La Maddalena Cancer Center, Palermo, Italy.ORCID https://orcid.org/0000-0002-0664-3520
Maria ArantzamendiInstitute for Culture and Society-ATLANTES, Universidad de Navarra, Pamplona, Spain.ORCID https://orcid.org/0000-0003-2406-0668
Evelien KuipDepartment of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID https://orcid.org/0000-0002-9114-643X
Sheila PayneInternational Observatory On End of Life Care, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.ORCID https://orcid.org/0000-0001-6982-9181
Nancy PrestonInternational Observatory On End of Life Care, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.ORCID https://orcid.org/0000-0003-2659-2342
Jeroen HasselaarDepartment of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands.ORCID https://orcid.org/0000-0002-8880-2029
Radboud University Nijmegen · NLKU Leuven · BELa Maddalena · ITLancaster University · GBNavarre Institute of Health Research · ESUniversity Hospital Bonn · DE

Funding

H2020 Health 825700
6 · The paper itself

Abstract

backgroundPalliative sedation involves the intentional lowering of consciousness at the end of life. It can be initiated to relieve a patient's burden caused by refractory symptoms at the end of life. The impact of palliative sedation needs to be clinically monitored to adjust the proper dose and regimen of sedative medication to ensure that patients are at ease and comfortable at the end of their lives. Although there is consensus among health care professionals and within guidelines that efficacy of palliative sedation needs to be closely monitored, there is no agreement about how, when, and by whom, this monitoring should be performed. The aim of this study is to evaluate the effects of palliative sedation by measuring the discomfort levels and sedation/agitation levels of the patients at regular timepoints. In addition, the clinical trajectories of those patients receiving palliative sedation will be monitored and recorded.

methodsThe study is an international prospective non-experimental observational multicentre study. Patients are recruited from in-patient palliative care settings in Belgium, Germany, Italy, Spain and the Netherlands. Adult patients with advanced cancer are monitored by using proxy observations of discomfort (DS-DAT) and depth of sedation/agitation levels (RASS-PAL) during palliative sedation. After the palliative sedation period, the care for the specific participant case is evaluated by one of the attending health care professionals and one relative via a questionnaire. DISCUSSION: This study will be the first international prospective multicenter study evaluating the clinical practice of palliative sedation including observations of discomfort levels and levels of sedation. It will provide valuable information about the practice of palliative sedation in European countries in terminally ill cancer patients. Results from this study will facilitate the formulation of recommendations for clinical practice on how to improve monitoring and comfort in patients receiving palliative sedation.

trial registrationThis study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

Indexed as

NeoplasmsTerminal CareAdultDeathHumansHypnotics and SedativesMulticenter Studies as TopicObservational Studies as TopicPainPalliative CareProspective StudiesHypnotics and SedativesAdvanced CancerEnd of life careMonitoringObservational studyPalliative sedation

Identifiers

PMID36709271
PMCPMC9883602
OpenAlexW4318332912

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.