Evidence map›Paper›PMID 36414423›Full record

ArticleNeurology2023

Protocol for Deferral of Consent in Acute Stroke Trials.

Hannah Faris, Brian Dewar, Mark Fedyk, Dar Dowlatshahi, Bijoy Menon, Richard H Swartz, Michael D Hill, Michel Shamy

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology, 2023. 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. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Hannah FarisFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Brian DewarFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Mark FedykFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Dar DowlatshahiFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Bijoy MenonFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Richard H SwartzFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Michael D HillFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.ORCID 0000-0002-6269-1543
Michel ShamyFrom the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada. mshamy@toh.ca.ORCID 0000-0002-0085-6816

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, although it is not permitted in the United States. Deferral of consent offers several potential advantages-quicker door-to-randomization, increased enrolment, decreased selection bias-but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building on existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks.

Indexed as

Informed ConsentStrokeCanadaEuropeHumansRisk ManagementUnited States

Identifiers

PMID36414423
PMCPMC9946194

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.