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.

Details

Title
A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care
Author
Fahed, Robert 1 ; Finitsis, Stefanos 2 ; Khoury, Naim 2 ; Deschaintre, Yan 3 ; Daneault, Nicole 3 ; Gioia, Laura 3 ; Jacquin, Gregory 3 ; Odier, Céline 3 ; Poppe, Alexande Y. 3 ; Weill, Alain 2 ; Roy, Daniel 2 ; Darsaut, Tim E. 4 ; Nguyen, Thanh N. 5 ; Raymond, Jean 2   VIAFID ORCID Logo 

1  Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal, Department of Radiology, Service of Neuroradiology, Montreal, Canada (GRID:grid.14848.31) (ISNI:0000 0001 2292 3357); Rothschild Foundation Hospital, Department of Interventional Neuroradiology, Paris, France (GRID:grid.419339.5) 
2  Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal, Department of Radiology, Service of Neuroradiology, Montreal, Canada (GRID:grid.14848.31) (ISNI:0000 0001 2292 3357) 
3  University of Montreal, Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), Montreal, Canada (GRID:grid.14848.31) (ISNI:0000 0001 2292 3357) 
4  University of Alberta hospital, Mackenzie Health Sciences Center, Department of Surgery, Division of Neurosurgery, Edmonton, Canada (GRID:grid.241114.3) (ISNI:0000 0004 0459 7625) 
5  Boston Medical Center, Department of Neurology, Neurosurgery, and Radiology, Boston, USA (GRID:grid.239424.a) (ISNI:0000 0001 2183 6745) 
Pages
508
Publication year
2018
Publication date
Dec 2018
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-018-2870-6
ProQuest document ID
2795310752
Copyright
© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.