ArticleIntensive care medicine2013
Research participants' opinions of delayed consent for a randomised controlled trial of glucose control in intensive care.
Article in Intensive care medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06288724 (Potentially MOdifiable Factors To ImproVe Outcomes of Mechanically Ventilated Patients in ICUs in a Low-income Country), which is not on this map. Cited by 26 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.
Potentially MOdifiable Factors To ImproVe Outcomes of Mechanically Ventilated Patients in ICUs in a Low-income Country: Rationale and Protocol for a Registry-embedded Prospective Observational Study
Who cites it
26 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
- Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey.Neurocritical care · 2022Trial
- Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial.BMC emergency medicine · 2020Trial
- An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study.Health expectations : an international journal of public participation in health care and health policy · 2020Trial
- Patients' perspectives of enrollment in research without consent: the patients' experiences in emergency research-progesterone for the treatment of traumatic brain injury study.Critical care medicine · 2015Trial
- Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial.Resuscitation plus · 2026Article
- The influence of consent models on recruitment rates in randomised trials in critical care: A systematic review.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025Review
- Potentially MOdifiable factors To ImproVe outcomes of mechanically Ventilated patients in a low-income country Intensive Care Units (MOTIVATE-ICU): rationale and protocol for a registry-embedded prospective observational study.Critical care science · 2025Article
- [Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2024Review
- Protocol for Deferral of Consent in Acute Stroke Trials.Neurology · 2023Article
- Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.BMJ open · 2022Article
- Article
- The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa.PloS one · 2022Article
- Emergency care research ethics in low-income and middle-income countries.BMJ global health · 2019Review
- An Alternative Consent Process for Minimal Risk Research in the ICU.Critical care medicine · 2017Article
- Prognostication in critically ill patients with severe traumatic brain injury: the TBI-Prognosis multicentre feasibility study.BMJ open · 2017Article
- Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.Clinical trials (London, England) · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCritically ill patients are often unable to give informed consent to participate in clinical research. A process of delayed consent, enrolling patients into clinical trials and obtaining consent as soon as practical from either the participant or their substitute decision maker, has sometimes been used. The objective of this study was to determine the opinion of participants, previously enrolled in the NICE-SUGAR study, of the delayed consent process.
methodsThis observational study was conducted from 2009 to 2010 in the ICU of a tertiary referral hospital in Australia. Participants who were enrolled in the NICE-SUGAR study with delayed consent who survived, were cognitively intact, and proficient in English were posted a questionnaire regarding their opinion of the delayed consent process. The questionnaire was returned by post, fax, email, or completed during a telephone interview.
resultsOf 298 eligible participants, 210 responded, with an overall response rate of 79 %. Delayed consent to participate in the NICE-SUGAR study was obtained from participants (57/210; 27.1 %) or the substitute decision maker (152/210; 72.4 %). Most respondents (195/204; 95.6 %) would have consented to participate in the NICE-SUGAR study if asked before enrolment; most (163/198; 82.3 %) ranked first "the person who consented on their behalf for the NICE Study" as most preferred to make decisions, should they be unable; and most (177/202; 87.6 %) agreed with the decision made by their relative.
conclusionDelayed consent to participate in a clinical trial that includes critically ill patients is acceptable from research participant's perspectives.
Indexed as
Identifiers
23096429What 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.