Observational studyCanadian respiratory journal
Deferred consent in a minimal-risk study involving critically ill subarachnoid hemorrhage patients.
Observational study in Canadian respiratory journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis 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
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Informed consent in critically ill adults participating to a randomized trial.Brain and behavior · 2021Trial
- Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial.Resuscitation plus · 2026Article
- Consent models in Canadian critical care randomized controlled trials: a scoping review.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2022Article
- The Impact of Red Blood Cell Transfusion on Cerebral Tissue Oxygen Saturation in Severe Traumatic Brain Injury.Neurocritical care · 2017Observational
- Waiver of consent for low-risk studies.Canadian respiratory journalArticle
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAlterations from first-party and surrogate decision-maker consent can enhance the feasibility of research involving critically ill patients.
objectiveTo describe the use of a deferred-consent model to enable participation of critically ill patients in a minimal-risk biomarker study.
methodsA prospective observational study was conducted in which serum biomarker samples were collected three times daily over the first 14 days following aneurysmal subarachnoid hemorrhage. Sample collection was initiated on intensive care unit admission and consent was obtained when research personnel could approach the patient or the patient's surrogate decision maker.
resultsTwenty-seven patients were eligible for the study, of whom only five were capable of providing informed consent. Full consent was obtained for 21 (78%) patients through self- (n=4) and surrogate (n=17) consent. Partial consent or refusal (only permitting the collection of blood samples as a part of routine care or use of data) occurred in three patients. Among the 22 consents sought from surrogates, three (11%) refused participation. The refusals included the sickest patients in the cohort. Once consent was provided, no patient or surrogate withdrew consent before study completion. DISCUSSION: Use of a deferred consent model enabled participation of critically ill patients in a minimal-risk biomarker study with no withdrawals.
conclusionsFurther research and enhanced awareness of the potential utility of hybrid models, including deferred consent in addition to patient or surrogate consent, in the conduct of low-risk and minimally interventional time-sensitive studies of critically ill patients are required.
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