ArticleIntensive care medicine2006
A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study.
Article in Intensive care medicine, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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.
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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.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Informed consent in dental care and research for the older adult population: A systematic review.Journal of the American Dental Association (1939) · 2017Pooled it
- Patients' preferences for enrolment into critical-care trials.Intensive care medicine · 2009Article
- Article
- Clinical research in critically ill patients: the situation in Italy.Intensive care medicine · 2008Article
- Year in review in Intensive Care Medicine, 2007. III. Ethics and legislation, health services research, pharmacology and toxicology, nutrition and paediatrics.Intensive care medicine · 2008Review
- Legislation on research involving patients who are (temporarily) unable to give informed consent: differences between European countries.Intensive care medicine · 2007Article
- Year in Review in Intensive Care Medicine, 2006. III. Circulation, ethics, cancer, outcome, education, nutrition, and pediatric and neonatal critical care.Intensive care medicine · 2007Review
- Year in review 2006: Critical Care--Resource management.Critical care (London, England) · 2007Review
- The European Directive 2001/20 for clinical research: friend or foe?Intensive care medicine · 2006Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo determine the effect of a change in the "Dutch Directive on Medical Research Involving Human Subjects" (DD) on the number of eligible intensive care unit (ICU) patients for medical research. In addition, we determined how family members experience their role as acting representative for giving informed consent, and in turn whether patients feel their representatives would do well representing them. DESIGN AND
settingProspective observational study in three Dutch ICUs.
participants714 consecutive ICU patients. Analysis was restricted to 211 patients who were incapacitated for more than 24h after ICU admission. MEASUREMENTS AND
resultsThe old DD left 45.5% of patients without a legal representative; with the new DD this figure declines to 8.1%. Older age was significantly associated with the impossibility of obtaining informed consent in the old DD; after the change there was no effect of age. The median grade of confidence that representatives had in giving informed consent for incapacitated patients was 8.0 (IQR 7.0-9.0) on a scale from 0 to 10. Patients gave an equal median grade to their representatives.
conclusionWhen patients' adult children are not legally allowed to give informed consent, older patients are excluded from medical research, causing selection bias. The change in the DD has increased the number of surrogates allowed to give informed consent. Representatives felt very confident in their ability to represent the patients. In turn patients were equally confident that their representatives were able to represent them.
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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.