Evidence map›Paper›PMID 30231915›Full record

Trial reportTrials2018

A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care.

Robert Fahed, Stefanos Finitsis, Naim Khoury, Yan Deschaintre, Nicole Daneault, Laura Gioia, Gregory Jacquin, Céline Odier, Alexande Y Poppe, Alain Weill and 4 more

Open access · goldAbstract readComparative StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Pragmatic Clinical Trials in Osteoporosis.Current osteoporosis reports · 2019
    Review
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

14 authors at 4 institutions in 3 countries.

Robert FahedDepartment of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), University of Montreal, D03.5462B, 1000 Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.
Stefanos FinitsisDepartment of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), University of Montreal, D03.5462B, 1000 Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.
Naim KhouryDepartment of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), University of Montreal, D03.5462B, 1000 Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.
Yan DeschaintreNeurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Québec, Canada.
Nicole DaneaultNeurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Québec, Canada.
Laura GioiaNeurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Québec, Canada.
Gregory JacquinNeurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Québec, Canada.
Céline OdierNeurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Québec, Canada.
Alexande Y PoppeNeurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l'Université de Montréal (CHUM), University of Montreal, Montreal, Québec, Canada.
Alain WeillDepartment of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), University of Montreal, D03.5462B, 1000 Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.
Daniel RoyDepartment of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), University of Montreal, D03.5462B, 1000 Saint-Denis, Montreal, Quebec, H2X 0C1, Canada.
Tim E DarsautDepartment of Surgery, Division of Neurosurgery, University of Alberta hospital, Mackenzie Health Sciences Center, Edmonton, AB, Canada.
Thanh N NguyenDepartment of Neurology, Neurosurgery, and Radiology, Boston Medical Center, Boston, MA, USA.
Jean RaymondDepartment of Radiology, Service of Neuroradiology, Centre Hospitalier de l'Université de Montréal (CHUM), University of Montreal, D03.5462B, 1000 Saint-Denis, Montreal, Quebec, H2X 0C1, Canada. jean.raymond@umontreal.ca.ORCID http://orcid.org/0000-0003-1978-4274
Centre Hospitalier de l’Université de Montréal · CABoston Medical Center · USFondation de Rothschild · FRUniversity of Alberta Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice. Reporting the EASI experience was met with objections and criticisms during peer review concerning both scientific and ethical issues. Our goal is to discuss these criticisms in order to promote the pragmatic approach of care trials in outcome-based medical care.

methodsThe comments and criticisms of 11 reviewers from 5 journals were collected and analyzed. The EASI protocol was also compared to the protocols of seven thrombectomy trials using the pragmatic-explanatory continuum indicator summary (PRECIS).

resultsMain criticisms of EASI concerned selection criteria that were judged to be too vague and too inclusive, brain and vascular imaging methods that were not sufficiently prescribed by protocol, lack of blinding of outcome assessment, and lack of power. EASI was at the pragmatic end of the spectrum of thrombectomy trials.

conclusionThe pragmatic care trial methodology is not currently well-established. More work needs to be done to integrate scientific methods and ethical care in the best medical interest of current patients.

Indexed as

Clinical Trial Protocols as TopicEthics, ClinicalEthics, ResearchResearch DesignEndovascular ProceduresHumansPeer Review, ResearchPeriodicals as TopicStrokeThrombectomyTreatment OutcomeEthicsMethodologyStrokeThrombectomyTrial

Identifiers

PMID30231915
PMCPMC6146964
OpenAlexW2892097246

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.