Evidence map›Paper›PMID 34611811›Full record

Trial reportNeurocritical care2022

Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey.

Inez Koopman, Dagmar Verbaan, W Peter Vandertop, Rieke van der Graaf, Erwin J O Kompanje, René Post, Bert A Coert, Martine C Ploem, Wouter M Sluis, Féline E V Scheijmans and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurocritical care, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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 · 2025
    Review
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Inez KoopmanDepartment of Neurology and Neurosurgery, University Medical Center Utrecht Brain Center, Matthias Van Geuns Building, Room 02.15, University Medical Center Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, The Netherlands. i.koopman-4@umcutrecht.nl.ORCID 0000-0001-9648-3024
Dagmar VerbaanNeurosurgical Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, The Netherlands.
W Peter VandertopNeurosurgical Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, The Netherlands.
Rieke van der GraafDepartment of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Erwin J O KompanjeDepartment of Intensive Care Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.
René PostNeurosurgical Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, The Netherlands.
Bert A CoertNeurosurgical Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, The Netherlands.
Martine C PloemSection of Health Law, Department of Social Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Wouter M SluisDepartment of Neurology and Neurosurgery, University Medical Center Utrecht Brain Center, Matthias Van Geuns Building, Room 02.15, University Medical Center Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, The Netherlands.
Féline E V ScheijmansDepartment of Neurology and Neurosurgery, University Medical Center Utrecht Brain Center, Matthias Van Geuns Building, Room 02.15, University Medical Center Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, The Netherlands.
Gabriel J E RinkelDepartment of Neurology and Neurosurgery, University Medical Center Utrecht Brain Center, Matthias Van Geuns Building, Room 02.15, University Medical Center Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, The Netherlands.
Mervyn D I VergouwenDepartment of Neurology and Neurosurgery, University Medical Center Utrecht Brain Center, Matthias Van Geuns Building, Room 02.15, University Medical Center Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, The Netherlands.
Utrecht University · NLAmsterdam UMC Location University of Amsterdam · NLAmsterdam University Medical Centers · NLErasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects.

methodsPaper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents' preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research.

resultsEighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients' or proxies' trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies.

conclusionsA large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.

Indexed as

PhysiciansStrokeCross-Sectional StudiesHumansInformed ConsentProxyCritical careDeferred consentEthicsPatientsPhysician perspectiveProxySubarachnoid hemorrhage

Identifiers

PMID34611811
PMCPMC8964548
OpenAlexW3202230067

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.