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Published in: Trials 1/2018

Open Access 01-12-2018 | Research

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

Authors: Robert Fahed, Stefanos Finitsis, Naim Khoury, Yan Deschaintre, Nicole Daneault, Laura Gioia, Gregory Jacquin, Céline Odier, Alexande Y. Poppe, Alain Weill, Daniel Roy, Tim E. Darsaut, Thanh N. Nguyen, Jean Raymond

Published in: Trials | Issue 1/2018

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Abstract

Background

The 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.

Methods

The 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).

Results

Main 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.

Conclusion

The 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.
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Metadata
Title
A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care
Authors
Robert Fahed
Stefanos Finitsis
Naim Khoury
Yan Deschaintre
Nicole Daneault
Laura Gioia
Gregory Jacquin
Céline Odier
Alexande Y. Poppe
Alain Weill
Daniel Roy
Tim E. Darsaut
Thanh N. Nguyen
Jean Raymond
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2870-6

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