Clinical decision-making on palliative sedation in European palliative care settings: a prospective multicentre observational study (PALSED)

Decision-making about palliative sedation is both clinically and ethically complex, requiring the involvement of patients, relatives, and healthcare professionals. Despite its importance, prospective quantitative data describing how this process unfolds across different palliative care settings remain scarce. This study therefore aimed to explore how decision-making is organised in routine practice and how it differs between settings. In this prospective multicentre observational study, adult patients with advanced cancer were recruited from palliative care settings in five European countries. Patients in whom a decision-making process regarding palliative sedation was initiated were prospectively monitored. Healthcare professionals documented key elements of the process, including phases, timing, and stakeholder involvement, using structured case report forms. Relatives completed a questionnaire assessing satisfaction with decision-making. Differences between settings were analysed using non-parametric and categorical statistical tests, with post-hoc comparisons as appropriate. Data about decision-making was evaluated in 86 patients across hospice units ( n = 40), palliative care units ( n = 21), and hospital wards ( n = 25). Processes were structured, involving multiple phases, key stakeholders, and opportunities for reconsideration. Initiation was most often led by healthcare professionals, with variation across settings. Stakeholder involvement was high, although patient participation was lower in hospital wards (48%), with a greater role for relatives. Multidisciplinary meetings occurred in 36% of cases. After initial deliberation, palliative sedation was not initiated in 18 patients; this remained final in six cases, while a second round in 12 patients resulted in initiation in all. Sedation practices were consistent across settings. Satisfaction among responding relatives was high. In clinical practice, decision-making regarding palliative sedation is a structured, multidisciplinary process that is largely consistent across care settings, although patient and relative involvement varies. These findings highlight the importance of patient involvement and timely communication about palliative sedation, particularly in hospital settings. This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.