ArticleIntensive care medicine2006
Informed consent in clinical trials in critical care: experience from the PAC-Man 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 26 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
26 citing papers in PubMed, 2 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
- Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.Substance abuse · 2022Trial
- Protocol for a randomised controlled trial of VAsopressin versus Noradrenaline as Initial therapy in Septic sHock (VANISH).BMJ open · 2014Trial
- Trial
- Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE): a mixed-methods study.BMJ open · 2026Article
- Article
- Barriers and challenges in the process of including critically ill patients in clinical studies.Scandinavian journal of trauma, resuscitation and emergency medicine · 2020Observational
- The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research.Critical care research and practice · 2020Article
- Emergency care research ethics in low-income and middle-income countries.BMJ global health · 2019Review
- Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit.Annals of translational medicine · 2017Article
- Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions.Science and engineering ethics · 2016Review
- Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe.Intensive care medicine · 2013Article
- Early revascularization is beneficial across all ages and a wide spectrum of cardiogenic shock severity: A pooled analysis of trials.Acute cardiac care · 2011Article
- Attitudes to drug trials among relatives of unconscious intensive care patients.BMC anesthesiology · 2010Article
- The 'Consent to Research' paradigm in critical care: challenges and potential solutions.Intensive care medicine · 2009Article
- Patients' preferences for enrolment into critical-care trials.Intensive care medicine · 2009Article
- 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
- Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?Intensive care medicine · 2007Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
objectivesTo identify the proportion of critically ill patients able to consent to participation in a randomised controlled trial (RCT) and to assess to what extent patient consent and relative assent processes could be conducted according to ethics committee permission.
designDescriptive study nested in an RCT.
settingFifty-six UK intensive care units participating in the PAC-Man trial. PATIENTS AND
participantsFirst 500 patients consecutively enrolled into PAC-Man. MEASUREMENT AND
resultsThe outcome measures were patient consent and/or relative assent. Of the 498 patients included, 13 (2.6%) provided consent before randomisation. Of the remaining 485 patients, relative assent was obtained for 394 patients (81.2%), and refused post-randomisation for 3 patients (0.6%). No relatives were available for 15 patients (3.1%), and it was unclear from documentation whether relative assent had been obtained for 73 patients (15.1%). Of the 482 patients who did not provide consent prior to randomisation, 188 (39%) survived. Of these, 175 (93.1%) gave retrospective informed consent, six (3.2%) refused, and seven (3.7%) did not regain mental competency.
conclusionsA very small proportion of patients were able to give consent before randomisation. Due to the high in-hospital mortality (60.6%), only around one third of the remaining patients could provide consent retrospectively. This study demonstrates difficulties experienced in obtaining consent from critically ill patients to participate in medical research and raises important issues about the ethical basis of the consent process in critical care.
Indexed as
Identifiers
17019555What 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.