ArticleCritical care medicine2012
Surrogate and patient discrepancy regarding consent for critical care research.
Article in Critical care medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.Annals of the American Thoracic Society · 2020Trial
- 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
- Review
- Evaluation of a Tablet-Based Emotion Regulation Intervention for Surrogate Decision-Makers of Patients With Critical Illness: Pilot Nonrandomized Trial.JMIR formative research · 2026Article
- Perspectives on advance research directives from individuals with mild cognitive impairment and family members: a qualitative interview study.Frontiers in psychiatry · 2024Article
- Article
- Surrogate Informed Consent: A Qualitative Analysis of Surrogate Decision Makers' Perspectives.Annals of the American Thoracic Society · 2021Article
- Article
- Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.Contemporary clinical trials · 2020Article
- Barriers and challenges in the process of including critically ill patients in clinical studies.Scandinavian journal of trauma, resuscitation and emergency medicine · 2020Observational
- Intensive care unit patients' opinion on enrollment in clinical research: A multicenter survey.PloS one · 2020Observational
- The Ethical Concerns of Seeking Consent from Critically Ill, Mechanically Ventilated Patients for Research - A Matter of Possessing Capacity or Surrogate Insight.Clinical ethics · 2018Article
- Review
- Strategies for Enhancing Family Participation in Research in the ICU: Findings From a Qualitative Study.Journal of pain and symptom management · 2017Article
- iCONCUR: informed consent for clinical data and bio-sample use for research.Journal of the American Medical Informatics Association : JAMIA · 2017Article
- Surrogate consent to non-beneficial research: erring on the right side when substituted judgments may be inaccurate.Theoretical medicine and bioethics · 2016Article
- Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.Annals of emergency medicine · 2016Article
- Perspectives of Decisional Surrogates and Patients Regarding Critical Illness Genetic Research.AJOB empirical bioethics · 2016Article
- Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
objectiveCritically ill patients frequently display impaired decision-making capacity due to their underlying illness and the use of sedating medications. Healthcare providers often rely on surrogates to make decisions for medical care and participation in clinical research. However, the accuracy of surrogate decisions for a variety of critical care research studies is poorly understood.
designCross-sectional observational study.
settingAcademic medical center. PATIENTS: Medical intensive care unit patients and their designated surrogates.
interventionPatients were asked whether they would consent to participate in hypothetical research studies of increasing complexity, and surrogates independently indicated whether they would consent to enroll the patient in the same scenarios.
resultsOverall, 69 medical intensive care unit patients were enrolled into the study. The majority of surrogates were either the spouse (58%) or parent (22%) of the patient. The percentage of patients that would agree to participate in a research study and the percentage of surrogates that would agree to have the patient enrolled into a research study both declined as the risk of the study increased (p < .001 for both analyses). In addition, the overall discrepancy, the false-negative rates, and the false-positive rates between patient and surrogates were greater as the risk of the study increased (p < .001, p < .001, and p = .049, respectively). κ values for all seven scenarios demonstrated less-than-moderate agreement (range 0.03-0.41).
conclusionsThere are significant discrepancies in the willingness to participate in various types of clinical research proposals between critically ill patients and their surrogate decision makers. The results of this study raise concerns about the use of surrogate consent for inclusion of critically ill patients into research protocols.
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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.