Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit

Abstract

Studying patients during the end of life is important, as it has the potential to lead to improvements in care for the dying. For patients who die after a controlled withdrawal of life-sustaining therapies in the intensive care unit, information about the natural history of death and the process of removing life support has additionally led to advances in practice for deceased organ donation. However, this unique population of severely critically ill and imminently dying patients has been difficult to study, largely due to assumptions made by research teams and ethics boards alike about the logistical difficulties of obtaining consent and completing research procedures before or during the process of withdrawal of life-sustaining therapies. In this paper, we describe the ethics substudy of the first prospective observational research study in Canada to obtain consent and collect clinical data on patients during the process of withdrawal of life-sustaining therapies in the intensive care unit. We describe in detail the process of protocol development, review by five institutional research ethics boards and bedside staff satisfaction with the study. We conclude that prospective research on a critically ill and imminently dying population is feasible and can be conducted in an ethical manner. Further information is needed about the experiences and motivations of families and substitute decision makers who provide consent for research on critically ill intensive care unit patients at the end of life.

Exploring the experiences and perspectives of substitute decision-makers involved in decisions about deceased organ donation: a qualitative study protocol

“…All interviews will be conducted between 6 and 8 weeks after the patient’s death to minimise family burden, optimise research consent rates and avoid influencing the donation process. This approach was successful in previous studies involving bereaving families20–23 and is supported by our patient partners.…”

Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review

“…This review also does not extend to prospective research on deceased donation after circulatory death, for which prospective organ donors are alive at the time of research enrollment. At present, there are exceedingly few studies of donor management in this clinical situation (Levvey et al, 2008;Suntharalingam et al, 2009;Wind et al, 2012). Some authors have postulated that consenting to research may confer benefits to the family of organ donors by aiding them with the grieving process (van Beinum et al, 2017), and these investigators have qualitative research to address this hypothesis underway.…”

“…At present, there are exceedingly few studies of donor management in this clinical situation (Levvey et al, 2008; Suntharalingam et al, 2009; Wind et al, 2012). Some authors have postulated that consenting to research may confer benefits to the family of organ donors by aiding them with the grieving process (van Beinum et al, 2017), and these investigators have qualitative research to address this hypothesis underway. This review did not address challenges related to the consent of organ recipients in relation to research of neurologically deceased donors.…”

Improving quality of withdrawal of life-sustaining measures in organ donation: a framework and implementation toolkit

“…Several studies have clearly shown the feasibility of high-quality research in this area. 6,24,25 A summary of the generated research agenda can be found in eAppendix 9, available as ESM.…”