Reflections on Including Patients in a Randomized Placebo-Controlled Multicentre Trial in the Dying Phase – the SILENCE Study

Esch, Harriëtte J. van; Prins, Sanne D.; Vathorst, Suzanne van de; Rijt, C.C.D. van der; Heide, Agnes van der; Zuylen, Lia van

doi:10.1016/j.jpainsymman.2021.12.018

Cited by 3 publications

(1 citation statement)

References 35 publications

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“…[1][2][3] A recent study addressed the difficulties of recruiting patients with palliative care needs to placebo-controlled trials; of 1097 patients admitted to specialised palliative care, only 157 were included in the per protocol analysis. 4 Furthermore, pooled data in a systematic meta-analysis of barriers to clinical cancer trials established that only 8% of eligible patients were enrolled in trials. However, trials were also only available for one in four patients with cancer, highlighting the need for adjustment of organisational structures to promote clinical research.…”

Section: Introductionmentioning

confidence: 99%

Patient experiences of randomised placebo-controlled trial participation during end-of-life palliative cancer care

Klasson,

Helde Frankling,

Lundh Hagelin

et al. 2024

BMJ Support Palliat Care

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BackgroundPerforming clinical trials in palliative cancer care is known to be challenging.ObjectiveThis study aimed to explore how patients with advanced cancer experienced their participation in a randomised, placebo-controlled trial while receiving palliative cancer care at end of life.MethodA descriptive design with a qualitative approach was used. 14 patients who had participated in the ‘Palliative-D’ study were interviewed. Data were analysed using content analysis.ResultsThree categories were identified understanding the study design, willingness to participate and collaboration with the research team alongside standard care. Being randomised, with the risk of receiving placebo, was perceived as non-problematic since it was understood as being important for the quality of the research. Patients showed a willingness to participate for the sake of others and also for their own sake, hoping for a cure or at least to live as long as possible. Patients felt proud of being useful and contributing to research. Consent to participate was made autonomously without discussing with others. Patients considered the study design uncomplicated and well-integrated into the standard care.ConclusionStudy participation in a randomised, placebo-controlled trial can be a positive and meaningful experience for patients despite advanced cancer in end of life. Participation may support patients’ autonomy and give hope, and therefore, might have a positive effect on quality of life. A carefully planned and simple study design, well integrated into standard care, can facilitate the feasibility of clinical studies in specialised palliative home care.

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Section: Introductionmentioning

confidence: 99%

Patient experiences of randomised placebo-controlled trial participation during end-of-life palliative cancer care

Klasson,

Helde Frankling,

Lundh Hagelin

et al. 2024

BMJ Support Palliat Care

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Pharmacological treatment of pain, dyspnea, death rattle, fever, nausea, and vomiting in the last days of life in older people: A systematic review

Biesbrouck,

Jennes,

Van Den Noortgate

et al. 2024

Palliat Med

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Background: Evidence based guidelines for treatment of physical symptoms during the last days of life in older people are not available. Aim: We wanted to synthesize the existing evidence on the pharmacological treatment of pain, dyspnea, death rattle, fever, nausea, and vomiting during the last days of life in older people to develop recommendations that can help guide clinical practice. Design: A systematic review was conducted (PROSPERO #CRD42023406100) and reported in accordance with PRISMA guidelines. Data sources: MEDLINE and EMBASE were searched from inception till March 2023, together with national and international guideline databases. Results: Four predominantly descriptive studies on opioid use were included for the treatment of pain and four for dyspnea, without clear evidence for the choice of one specific opioid, nor a specific opioid dose. For death rattle, five randomized controlled trials and two retrospective studies were included. These provide evidence for the prophylactic treatment of death rattle with hyoscine butylbromide. For fever, nausea, and vomiting, no articles met the inclusion criteria. Conclusion: Limited evidence exists to guide the pharmacological treatment of pain, dyspnea, death rattle, fever, nausea, and vomiting in the last days of life of older people. Other than the use of opioids for treatment of pain and dyspnea and prophylactic administration of hyoscine butylbromide to decrease the likelihood of developing death rattle, no specific recommendations can be formulated for use in clinical practice. This demonstrates the challenging nature of research in the last days of life of older people, despite its pressing need.

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Midazolam Indications and Dosing in Palliative Medicine: Results from a Multinational Survey

Tranung,

Solheim,

Løhre

et al. 2024

Current Oncology

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Despite sparse evidence and limited guidance on indications, use, and dosing, midazolam is widely used in palliative care. We aimed to describe and compare the use of midazolam in three different countries to improve clinical practice in palliative care. We performed an online survey among palliative care physicians in Norway, Denmark, and the United Kingdom (UK). The focus was indications, dosing, administration, and concomitant drugs. A web-based questionnaire was distributed to members of the respective national palliative medicine associations. The total response rate was 9.4%. Practices in the UK, Norway, and Denmark were overall similar regarding the indications of midazolam for anxiety, dyspnoea, and pain treatment in combination with opioids. However, physicians in the UK used a higher starting dose for anxiety, dyspnoea, and pain treatment compared to Norway and Denmark, as well as a higher maximum dose. Danish physicians preferred, to a higher degree, on-demand midazolam administration. Despite practice similarities in the UK, Norway, and Denmark, differences exist for midazolam dosing and administration in palliative medicine. We demonstrated a lack of consensus on how midazolam should be used in palliative care, setting the stage for future studies on the topic.

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Reflections on Including Patients in a Randomized Placebo-Controlled Multicentre Trial in the Dying Phase – the SILENCE Study

Cited by 3 publications

References 35 publications

Patient experiences of randomised placebo-controlled trial participation during end-of-life palliative cancer care

Patient experiences of randomised placebo-controlled trial participation during end-of-life palliative cancer care

Pharmacological treatment of pain, dyspnea, death rattle, fever, nausea, and vomiting in the last days of life in older people: A systematic review

Midazolam Indications and Dosing in Palliative Medicine: Results from a Multinational Survey

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