Trial reportIntensive care medicine2010
Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results.
Trial report in Intensive care medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- When is it impractical to ask informed consent? A systematic review.Clinical trials (London, England) · 2022Pooled it
- Pooled it
- Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey.Neurocritical care · 2022Trial
- Informed consent in critically ill adults participating to a randomized trial.Brain and behavior · 2021Trial
- Trial
- Insufficient balloon size limits the interpretation of REBOARREST.Critical care (London, England) · 2026Article
- Parent views on a two-step consent process used in emergency neonatal research in the delivery room in Eastern Uganda.BMC medical ethics · 2026Article
- Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE): a mixed-methods study.BMJ open · 2026Article
- Acute Care Research Requires an Adapted Consent Procedure to Safeguard Participants' Autonomy and Rights While Limiting the Risk of Consent-Bias.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026Article
- Data-driven sudden cardiac arrest research in Europe: Experts' perspectives on ethical challenges and governance strategies.Resuscitation plus · 2023Review
- Protocol for Deferral of Consent in Acute Stroke Trials.Neurology · 2023Article
- Insisting on prospective consent in paediatric critical care research may be throwing the baby out with the bathwater.Journal of paediatrics and child health · 2022Article
- Article
- Barriers and challenges in the process of including critically ill patients in clinical studies.Scandinavian journal of trauma, resuscitation and emergency medicine · 2020Observational
- Article
- Ethical challenges in resuscitation.Intensive care medicine · 2018Review
- Observational
- Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit.Annals of translational medicine · 2017Article
- Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.BMC medical ethics · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo 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.
methodsThe 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.
resultsThirty-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.
conclusionsExclusion 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.