• Harriëtte J van Esch, Sanne D Prins, Suzanne van de Vathorst, van der RijtCarin C DCCDDepartment of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, 3000 CA Rotterdam, The Netherlands., Agnes van der Heide, and Lia van Zuylen.
• Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, 3000 CA Rotterdam, The Netherlands; Laurens Cadenza, Oosterhagen 239, 3078 CL Rotterdam, The Netherlands; Department of Public Health, Erasmus MC, University Medical Center, 3000 CA Rotterdam, The Netherlands. Electronic address: h.vanesch@erasmusmc.nl.
• J Pain Symptom Manage. 2022 May 1; 63 (5): e545-e552.

AbstractA need exists for studies investigating symptom relief at the end of life. Randomised controlled trials (RCTs) are the gold standard for demonstrating efficacy of medication, but they are difficult to perform at the end of life due to barriers such as the vulnerability of patients, and gatekeeping by healthcare professionals. We analyzed and reflected on recruitment, participation, and strategies used in an RCT at the end of life. The SILENCE study, performed in six inpatient hospice facilities, was a placebo-controlled trial to study the effect of ScopolamIne butyLbromidE giveN prophylactiCally for dEath rattle in dying patients. We addressed patients' vulnerability by using an advance consent procedure, and potential gatekeeping by extensive training of health care professionals and the appointment of hospice doctors as daily responsible researchers. In almost three years, 1097 patients were admitted of whom 626 were eligible at first assessment. Of these, 119 (19%) dropped out because of physical deterioration before they could be informed about the study (44) or sign informed consent (75). Twenty-five (4%) patients were not asked to participate. In 24 cases (4%), relatives advised against the patient participating. Overall, 229 patients (37%) gave informed consent to participate. The vulnerability of patients was the most important barrier in this medication study at the end of life. Gatekeeping by HCPs and relatives occurred in a small number of patients. The robust design and applied strategies to facilitate patient recruitment in this study resulted in a successful study with sufficient participants.Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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