Title |
A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care
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Published in |
Trials, September 2018
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DOI | 10.1186/s13063-018-2870-6 |
Pubmed ID | |
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 |
Abstract |
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. 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). 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. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Canada | 1 | 33% |
Unknown | 2 | 67% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 67% |
Scientists | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 37 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 6 | 16% |
Other | 5 | 14% |
Researcher | 4 | 11% |
Student > Ph. D. Student | 3 | 8% |
Student > Bachelor | 2 | 5% |
Other | 7 | 19% |
Unknown | 10 | 27% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 14 | 38% |
Nursing and Health Professions | 4 | 11% |
Biochemistry, Genetics and Molecular Biology | 2 | 5% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 3% |
Social Sciences | 1 | 3% |
Other | 3 | 8% |
Unknown | 12 | 32% |