Study protocol

Task 2.1 Drafting of the protocol. (M3-9) Because palliative sedation has been a confusing topic from a research perspective, a thorough and agreed multicenter research protocol is needed. The protocol will involve terms and terminology (drawn from WP1) as well as the primary and secondary outcome measures, the inclusion criteria, the case report form-CRF, the informed consent form, conform Good Clinical Practice. For the patients at least the following observational scales are foreseen: ESAS for numerical rating of symptoms, DS-DAT for patient discomfort, and RASS for levels of sedation. For the family members the CRA about burden and rewards of informal caring and the CanhelpLITE-sv for satisfaction with care. See for study details the PalliativeSedation clinical study appendix. Partner Radboudumc will lead this.