Making a dead woman pregnant? A critique of the thought experiment of Anna Smajdor

In a thought-provoking article – or how she herself named it, ‘a thought experiment’ – the philosopher-medical ethicist Anna Smajdor analyzed in this journal the idea of whole-body gestational donation (WBGD) in brain-dead female patients, as an alternative means of gestation for prospective women who cannot or prefer not to become pregnant themselves. We have serious legal, economical, medical and ethical concerns about this proposal. First, consent for eight months of ICU treatment can never be assumed to be derived from consent for post-mortem organ donation; these two are of an incomparable and entirely different medical and ethical order. Moreover, the brain-dead woman is very likely to be medically unfit for high-tech surrogacy and the brain-dead state poses a high risk for deficient embryo/fetal development. Second, from a scarcity perspective, occupying an ICU bed for eight months appears to be unjust. The costs for eight months of ICU treatment are far too high compared to the costs of surrogacy for a living, selected, and healthy woman. Neither insurance companies nor prospective parents will want to pay these exceptionally high costs for a dead woman if a living surrogate mother can be hired for a considerably lower amount. Third, there is an increased risk for harm of the child to be in WBGD. And finally, WBGD risks violating the brain-dead woman’s dignity and harming the interests of her loved ones. In short, there is simply no need for brain-dead women as surrogates.</p

Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results

PURPOSE: To illustrate the impact on the validity of trial results due to excluding patients from a randomized controlled trial for whom no deferred consent could be obtained after randomization because study procedures had already been finished. METHODS: The unadjusted and adjusted primary outcome measures of a recent randomized controlled multicentre study in the field of intensive care medicine were compared, including (n = 348) or excluding (n = 289) patients with missing deferred consent. RESULTS: Thirty-nine patients (11%) died early, before the patient or his/her proxy could be approached and consent be obtained. In another 20 patients (6%), it was not possible to inform proxies and ask consent within the period of study procedures. A significant treatment effect (p = 0.006) in the adjusted analysis became non-significant (p = 0.35) when the patients with missing deferred consent were excluded. CONCLUSIONS: Exclusion of patients without obtained deferred consent can reduce statistical power, introduce selection bias, make randomization asymmetrical, decrease external validity and thereby jeopardize study results. This may have implications for emergency research in various disciplines

A study protocol to develop and test an e-health intervention in follow-up service for intensive care survivors' relatives

Background: The negative impact on long-term health-related outcomes among relatives of critically ill patients in the intensive care unit (ICU) has been well described. High-quality ICU specialized follow-up care, which is easily accessible with digital innovation and which is designed by and with relevant stakeholders (i.e., ICU patients' relatives and nurses), should be considered to reduce these impairments in the psychological and social domains. Aim: The programme's aim is to develop and test an e-health intervention in a follow-up service to support ICU patients' relatives. Here, the protocol for the overall study programme will be described. Study Design: The overall study comprises a mixed-methods, multicentre research design with qualitative and quantitative study parts. The study population is ICU patients' adult relatives and ICU nurses. The main outcomes are the experiences of these stakeholders with the newly developed e-health intervention. There will be no predefined selection based on age, gender, and level of education to maximize diversity throughout the study programme. After the participants provide informed consent, data will be gathered through focus groups (n = 5) among relatives and individual interviews (n = 20) among nurses exploring the needs and priorities of a digital follow-up service. The findings will be explored further for priority considerations among members of the patient/relative organization (aiming n = 150), which will serve as a basis for digital prototypes of the e-health intervention. Assessment of the intervention will be followed during an iterative process with investigator-developed questionnaires. Finally, symptoms of anxiety and depression will be measured with the 14-item Dutch version of the ‘Hospital Anxiety and Depression Scale’, and symptoms of posttraumatic stress will be measured with the 21-item Dutch version of the ‘Impact of Events Scale-Revised’ to indicate the effectiveness of digital support among ICU patients' relatives. Relevance to Clinical Practice: The e-health intervention to be developed during this research programme can possibly bridge the gap in integrated ICU follow-up care by providing relevant information, self-monitoring and stimulating self-care among ICU patients' relatives