ArticleIntensive care medicine2009
Patients' preferences for enrolment into critical-care trials.
Article in Intensive care medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01232621 (A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit: The Approach Study
Who cites it
21 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
- Pooled it
- Pooled it
- Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis.BMC medical research methodology · 2024Trial
- Trial
- Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study).Intensive care medicine · 2015Trial
- Scoping review and thematic analysis of informed consent in humanitarian emergencies.BMC medical ethics · 2024Article
- Article
- Surrogate Informed Consent: A Qualitative Analysis of Surrogate Decision Makers' Perspectives.Annals of the American Thoracic Society · 2021Article
- Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.Contemporary clinical trials · 2020Article
- Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit.Annals of translational medicine · 2017Article
- Enrollment Challenges in Critical Care Nursing Research.American journal of critical care : an official publication, American Association of Critical-Care Nurses · 2017Article
- An Alternative Consent Process for Minimal Risk Research in the ICU.Critical care medicine · 2017Article
- Research to inform the consent-to-research process.Intensive care medicine · 2013Article
- ICU research: the impact of invasiveness on informed consent.Intensive care medicine · 2013Article
- Research participants' opinions of delayed consent for a randomised controlled trial of glucose control in intensive care.Intensive care medicine · 2013Article
- Surrogate decision makers' attitudes towards research decision making for critically ill patients.Intensive care medicine · 2012Article
- Attitudes to drug trials among relatives of unconscious intensive care patients.BMC anesthesiology · 2010Article
- Year in review in Intensive Care Medicine 2009. Part III: mechanical ventilation, acute lung injury and respiratory distress syndrome, pediatrics, ethics, and miscellanea.Intensive care medicine · 2010Review
- Deferred consent in a minimal-risk study involving critically ill subarachnoid hemorrhage patients.Canadian respiratory journalObservational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMost critically ill patients are incapable of providing informed consent for research.
objectiveWe sought to determine patients' preferences for different consent frameworks for enrolling incapable patients into critical-care trials.
designProspective observational and structured interview study.
settingFive university-affiliated hospitals in Ontario. PATIENTS: Two-hundred and forty consecutive capable and consenting survivors of critical illness.
interventionParticipants considered four frameworks for enrolling incapable patients into clinical trials using a baseline scenario and three permutations for: risk (very low vs. high), treatment type (new vs. currently available), and availability of substitute decision-maker (yes vs. no). MEASUREMENTS AND MAIN
resultsFor each scenario, patients chose their preferred framework and rated the acceptability of each framework using a seven-point Likert scale. Most (180/240; 76%) patients selected "consent by substitute prior to enrolment" as their preferred framework; this also received the highest baseline acceptability ratings ("acceptable" or "highly acceptable" 207/240; 87%). Modifying risk or treatment type did not substantially change these ratings. A minority of patients rated delayed consent as unacceptable or highly unacceptable in both the baseline scenario (48/240, 20% delayed to substitute; 57/240, 24% delayed to patient) and when a substitute was unavailable (34/240; 15%).
conclusionsMost survivors of critical illness found the usual practice of obtaining informed consent from a substitute decision-maker prior to enrolment in a clinical trial to be acceptable. Nearly half of patients considered foregoing informed consent to be unacceptable, whereas a minority considered enrolment followed by delayed consent to be unacceptable even when a substitute was unavailable. These approaches should, therefore, only be considered when deviating from the usual practice of obtaining consent from a substitute decision-maker is truly justified, such as where treatments being tested need to be delivered as soon as possible in order to be effective.
Indexed as
Identifiers
19551372What OpenQuestion holds
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.