Do relatives think there should be research trials with dying patients?

Although all research requires ethical approval, some people may feel that those who are dying should not be asked if they want to participate in research.  But what do relatives of those dying think about this? For December’s Palliative Medicine’s Editor’s Choice, Harriëtte van Esch and colleagues share with us their important research asking relatives their experiences and feelings about patients being asked to participate in research at this difficult time.


Photo credit: ‘Pieta’ by Karmen Loncarek.

From April 2017 till December 2020, we undertook a randomised placebo-controlled trial (RCT) to investigate the effect of medication given to prevent noisy breathing at the end of life. This is a common symptom and can be called the ‘death rattle’. Although it has been suggested that patients are not affected by the death rattle, the actual effect on the patient experience is unknown. Literature does show that relatives can find the sound stressful.

Our study was conducted in six inpatient hospice facilities in the Netherlands. We found that the occurrence of the death rattle was significantly lower in patients who were given scopolaminebutyl bromide compared to the placebo group, with no substantial difference in adverse events .1 We asked the nurses to rate the quality of life of the last three days of all participating patients and they perceived a significantly better quality of life for those who were given scopolaminebutyl bromide.2

Little is known of the perceptions of patients and relatives about participating in such an end-of-life studies. We wanted to understand the experiences of relatives, and the patient’s decision-making process about participating in this research, and so we included a questionnaire for relatives and interviewed some relatives. We asked relatives about the decision making process of the patient as this gave us useful insight as we were not able to ask patients who by then had died.3 One hundred and four relatives completed the questionnaire about burden and/or stress during the study, and sixteen relatives were interviewed.

The majority of relatives did not experience burden or stress related to this research trial. Those who did mention some burden mostly indicated that this was related to the sound of ‘death rattle’ rather than participation in the study. Relatives believed that the quality of dying was unchanged, or even improved, during the study and they valued being involved with this research.

Patients were asked if they would want to take part in this research when they were admitted to the hospice.  We often saw that patients involved their relatives in the decision about whether they should participate. Considerations around participation were discussed and the decision was sometimes truly made together, sometimes by the patient alone, but almost always after consultation with their relatives. It is known that in general the opinions of relatives are valued by patients when decisions have to be made at the end of life.4

We hope that the insights from this study could help to optimise future informed consent procedures, in particular in providing information which would be supportive for relatives to help them understand about the research study. Indeed, our research has shown that it is important to involve relatives from the first moment patients are approached for participation in end-of-life studies. In addition, we found that taking part in this RCT did not put any burden or stress on the majority of the relatives. In fact, relatives expressed that they valued research at this time, and so this study may serve as an example to initiate more RCTs to inform evidence-based care at the end of life.

READ THE FULL ARTICLE IN ‘PALLIATIVE MEDICINE’!

‘When a dying patient is asked to participate in a double-blind, placebo-controlled clinical trial on symptom control: the decision-making process and experiences of relatives’ Harriëtte J van Esch, Arianne Stoppelenburg, Lia van Zuylen, Carin CD van der Rijt & Agnes van der Heide. First published: Palliative Medicine 2022, Vol. 36(10) 1552–1558.

EAPC members can access a FREE copy from the EAPC website here.

References

1.            van Esch HJ, van Zuylen L, Geijteman ECT, et al. The SILENCE Randomized Clinical Trial. ‘Effect of Prophylactic Subcutaneous Scopolamine Butylbromide on Death Rattle in Patients at the End of Life: The SILENCE Randomized Clinical Trial’. JAMA. Oct 5 2021;326(13):1268-1276.

2.            van Esch HJ, van der Heide A, van Zuylen L, van der Rijt CCD. ‘Quality of Life and Quality of Death Outcomes of the SILENCE Study‘. J Pain Symptom Manage. Sep 2022;64(3):e177-e179.

3.            Higginson I, Priest P, McCarthy M. Are bereaved family members a valid proxy for a patient’s assessment of dying? Soc Sci Med. Feb 1994;38(4):553-7.

4.            Witkamp E, Droger M, Janssens R, van Zuylen L, van der Heide A. How to Deal With Relatives of Patients Dying in the Hospital? Qualitative Content Analysis of Relatives’ Experiences. J Pain Symptom Manage. Aug 2016;52(2):235-42.

Links and resources

  • Read other Palliative Medicine Editor’s Choice posts on the EAPC blog.
  • Follow Palliative Medicine on Twitter: @palliativemedj

About the author

Harriette van Esch is an elderly care physician and PhD student based in Rotterdam whose research focuses on multidimensional aspects of death rattle. Facebook: Jet van Esch. Orcid number: 0000-0003-3234-8135.


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This entry was posted in EAPC-LINKED JOURNALS, Journal of Palliative Medicine, Palliative Medicine: Editor's Choice, PATIENT & FAMILY CARE, RESEARCH. Bookmark the permalink.

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