In case of untreatable suffering at the end of life, continuous sedation until death (CSD) may be the only treatment option left. Because these patients cannot communicate anymore, caregivers have to rely on behavioral observation to assess the patient’s comfort. Recently, however, a number of studies from the neurosciences have shown that sometimes consciousness and pain are undetectable with these traditional behavioral methods. The aim of this study was to find out if subjective caregiver assessments of consciousness and pain would be confirmed by objective neurophysiological measures.

In this prospective observational study, we observed patients from the start of palliative sedation until death. Subjective caregiver assessments of level of consciousness and pain based on behavioral observations were compared with objective measures from neurophysiological monitoring devices.

We collected and analyzed 108 subjective caregiver assessments in a sample of 12 patients and 32 assessments by traditionally used observational scales. We compared these with objective neurophysiological measures. Sensitivity and specificity of caregivers’ subjective assessments of consciousness was 23.6 and 91.1% respectively, with an accuracy of 54.0% and interrater reliability (κ) of 0.13. For pain, this was 0 and 94.79%, respectively, an accuracy of 88%, and an inter-rater reliability (κ) of − 0.063. Agreement between caregivers’ subjective assessments and objective neurophysiological measures of consciousness and pain was very poor.

Caregivers’ subjective assessment of level of consciousness and pain during CSD is unreliable compared with objective neurophysiological monitoring. Our results suggest that assessments of patient comfort during CSD could have been improved substantially by including objective monitoring of level of consciousness and pain.

Trial Registration
The protocol for this observational study has been registered retrospectively at (ID NCT03273244).
Originele taal-2English
Pagina's (van-tot)377-390
Aantal pagina's14
TijdschriftPain and Therapy
Nummer van het tijdschrift1
StatusPublished - jun 2021

Bibliografische nota

Funding Information:
The authors would like to thank Mdoloris Medical Systems for providing the ANI monitor free of charge for the duration of the study, upon the condition that two boxes of electrodes were purchased. The study is funded by a government grant (G.0566.15N) from the Research Foundation—Flanders (FWO). The Rapid Service Fee was funded by the authors. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Stefaan Six, Steven Laureys, Jan Poelaert, Olivier Maîresse, Peter Theuns, Johan Bilsen and Reginald Deschepper have nothing to disclose. This study was performed in accordance with the principles of the Declaration of Helsinki of 1964 and its subsequent revisions. Ethical approval for this study was obtained from the biomedical ethics committee of the University and University Hospital of Brussels (BUN 14320136504). All study information and patient consent forms were approved by the ethics committee. Written informed consent was obtained from the patient or his/her substitute decision-maker. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Publisher Copyright:
© 2020, The Author(s).

Copyright 2021 Elsevier B.V., All rights reserved.


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