Evidence map›Paper›PMID 39357897›Full record

ArticleStroke and vascular neurology2025

Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study.

Ubong Udoh, Rena Seeger, Brian Dewar, Emma Cummings, Sophia Gocan, Stuart Nicholls, Mark Fedyk, Victoria Shepherd, Jeff Perry, Robert Fahed and 8 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Stroke and vascular neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Trial
  2. 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

18 authors.

Ubong UdohOttawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0003-2306-0199
Rena SeegerDepartment of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Brian DewarOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Emma CummingsOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Sophia GocanOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Stuart NichollsOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Mark FedykSchool of Medicine, University of California, Davis, Sacramento, California, USA.ORCID 0000-0002-0815-662X
Victoria ShepherdCardiff University, Cardiff, UK.
Jeff PerryOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Robert FahedOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Tim RamsayOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Jamie BrehautOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Michael D HillDepartment of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.
Alexandre Y PoppeUniversité de Montréal, Montreal, Quebec, Canada.
Bijoy K MenonDepartment of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.
Richard H SwartzDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Dar DowlatshahiOttawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0003-1379-3612
Michel ShamyOttawa Hospital Research Institute, Ottawa, Ontario, Canada mshamy@toh.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionObtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the hospital in a state of incapacitation. Adaptations to standard consenting approaches-such as the use of surrogate consent or deferral of consent-have significant limitations. This feasibility study aims to test a new consenting approach in acute stroke care that we call advance consent. Advance consent has the potential to render emergency trial enrolment faster, fairer and more transparent, leading to more generalisable results. METHODS AND

designWe will conduct a five-part study at The Ottawa Hospital, a quaternary care stroke centre: (1) administering questionnaires in the Ottawa Hospital Stroke Prevention Clinic that will examine patients' perspectives on research participation and advance consent; (2) inviting participants to consent in advance to any or both currently enrolling acute stroke trials; (3) tracking patient enrolment into these trials over 1 year; (4) administering a follow up questionnaire to participants at 1 year and (5) administering a questionnaire to participating hospital staff in order to interrogate their experiences with advance consent. Outcomes include but are not limited to eligibility rate, recruitment rate, withdrawal rate and the proportion of patients whose advance consent results in trial enrolment.

conclusionThis study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.

Indexed as

Clinical Trials as TopicInformed ConsentPatient SelectionResearch SubjectsStrokeFeasibility StudiesHealth Knowledge, Attitudes, PracticeHumansOntarioResearch DesignSurveys and QuestionnairesTime FactorsProspective StudiesStroke

Identifiers

PMID39357897
PMCPMC12230221

What OpenQuestion holds

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LicenceCC BY-NC
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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.