Dr Kexin Ang, Consultant, Department of Neurology, National Neuroscience Institute, Singapore, explains the background to a longer article published in the March/April issue of the European Journal of Palliative Care.
As is widely known, randomised controlled trials (RCTs) are among the gold standard in research design for evaluating the efficiency of medical treatment because of their minimisation of bias and the effects of confounding variables. They provide high-quality evidence and accurate information to guide healthcare professionals in their application of ethical principles in practice.
The idea of using RCTs to inform future practice for people nearing death is not new, and the objections to such use of RCTs can be sorted into two mainstream ethical issues:
- The use of a control group, which is integral to RCT use, will lead to automatic failure of adequate enrolment, (1) because the beneficial treatment will be withheld from the control group as a matter of course and this will discourage participation;
- The greater objection relates to the patient’s capacity to give consent, or lack thereof. The presence and continuation of capacity cannot be taken to be given in people with terminal conditions, whether such loss of capacity is due to disease progression, or the patient’s medication, (2) or existing conditions/side-effects that impact the patient’s capacity.
For clarification, we are looking at RCTs because other innovative designs, such as n of 1 trials, may not always be as appropriate for the target audience of people nearing death, since they may not survive for the next stage of treatment.
Such complications affect initial capacity to consent, and may arise in the ‘later’ stages prior to death to vitiate the initial consent given, even when such initial consent was validly given at the time. There is also the perception that people nearing death are especially vulnerable and susceptible to external suggestions, such as entry into RCTs, which might prolong life or quality of life, and raise concerns if the consent was properly obtained.
Nevertheless, there are equally a number of proponents favouring RCTs for those nearing death, which is motivated by concern that such a group deserves an equal right to have their condition represented and addressed in research.
In our view, objections to RCTs for people nearing death can be overcome, in a reasoned and principled manner. This paves the way to formulate insights in treatment that will benefit such groups and indirectly the entire patient community. The benefits arise as to breadth (benefiting other areas of similar interest, such as intensive care research, dementia or A&E (Accident and Emergency) research), and depth (the means to overcome objections to RCTs can apply to other research objections).
In this regard, it can be seen that applying the established ‘four principles plus scope’ approach (3) – respect for autonomy, beneficence, non-maleficence and justice, plus reflective concern for scope of application – ameliorates the major objections to RCTs for people nearing death. The four principles by themselves do not provide methods and ideology for choosing; instead, concern for scope of application reflected through a common set of moral commitments and language guide the proper application of the four principles. A basic moral analytical framework (4) is established that enables healthcare professionals in their decision-making process, whether it be for patients nearing death or other patient groups, to resolve the objections of unclear benefit and capacity to consent to RCTs. In this manner, by overcoming these two main objections to RCTs, the question of whether people nearing death should be enrolled in RCTs is revised into a question of how to do so, and no longer whether it should be done.
- Buss MK, Arnold RM. Challenges in palliative care research: one experience. J Palliat Med 2004; 7: 405–407.
- Cassell EJ, Leon AC, Kaufman SG. Preliminary evidence of impaired thinking in sick patients. Ann Intern Med 2001; 134: 1120–1123.
- Gillon R. Medical ethics: four principles plus attention to scope. BMJ 1994; 309: 184–188.
- Foster C. The ethics of medical research on humans. Cambridge: Cambridge University Press, 2001.
This post relates to a longer article, ‘Randomised controlled trials involving people nearing death: proposed solutions to ethical challenges’ by Kexin Ang and Ivan Mun Hong Woo, published in the March/April 2017 edition of the European Journal of Palliative Care (vol. 24.2).
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Read more posts relating to articles published in the European Journal of Palliative Care on the EAPC Blog.