ArticleCritical care (London, England)2006
Informed consent for research obtained during the intensive care unit stay.
Article in Critical care (London, England), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 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
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.PloS one · 2024Pooled it
- Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis.Bulletin of the World Health Organization · 2015Pooled it
- Trial
- Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial.BMC medical ethics · 2010Trial
- Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024Article
- Research Priorities in Critical Care Cardiology: JACC Expert Panel.Journal of the American College of Cardiology · 2023Review
- Patient and Proxy Recall After Providing Written or Oral Informed Consent to Participate in an Interventional Trial.JAMA network open · 2022Article
- Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research.Critical care research and practice · 2021Article
- The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research.Critical care research and practice · 2020Article
- Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement.JMIR research protocols · 2018Article
- Increasing participation in critical care studies: the need to understand surrogate decision-makers for critically ill patients.Intensive care medicine · 2015Article
- Ethical challenges and solutions regarding delirium studies in palliative care.Journal of pain and symptom management · 2014Review
- Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards.Annals of intensive care · 2011Article
- Empirical evaluation of the need for 'on-going consent' in clinical research.AIDS (London, England) · 2011Article
- Doing research on the ethics of doing research.Critical care (London, England) · 2007Article
- Year in review 2006: Critical Care--Resource management.Critical care (London, England) · 2007Review
- Research in critically ill patients: standards of informed consent.Critical care (London, England) · 2007Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPatients in the intensive care unit (ICU) may be in an inadequate condition to give their informed consent for research. The aim of this study was to analyse the ability to recall participation in a clinical trial for which ICU patients had given their consent.
methodsThe data presented are a two-step observational study: first, a protocolled informed consent procedure was conducted then the informed consent was given by the patient, and second, a patient interview was held 10 +/- 2 days later by the same investigator. The primary endpoints were the ability to recall their participation in the clinical trial, as well as its purpose and related risks. As secondary endpoints, we investigated whether asking questions about the clinical trial or reading the informative leaflet was related to the recall. To be included in the study, the patient had to have a Glasgow Coma Scale score of 15, be fully oriented and free of mechanical ventilation, and be judged competent by both the investigator and the attending physician. Patients admitted to the ICU after major surgery or trauma were eligible. However, patients who refused to participate, or those whose next-of-kin gave consent, were excluded.
resultsOf the 44 patients, 35 (80%) recognized, 10 to 12 days after informed consent had been obtained, that they had participated in the clinical trial, but only 14 out of 44 (32%) could recall the clinical trial purpose and its related risks. More patients with complete recall had read the informative leaflet or asked at least one question before signing the informed consent. Asking at least one question was associated with complete recall.
conclusionOur results confirm that obtaining informed consent for research during an ICU stay is associated with poor patient recall of participation in a clinical trial and its components (purpose and risk). Whether encouraging reading the informative leaflet and asking questions about the clinical trial improves the informed consent procedure remains to be fully investigated.
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Registered trials
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