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,
Daniel Roy,
Tim E. Darsaut,
Thanh N. Nguyen,
Jean Raymond
Affiliations
Robert Fahed
Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal
Stefanos Finitsis
Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal
Naim Khoury
Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal
Yan Deschaintre
Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal
Nicole Daneault
Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal
Laura Gioia
Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal
Gregory Jacquin
Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal
Céline Odier
Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal
Alexande Y. Poppe
Neurovascular Team, Division of Neurology, Department of Medicine, Centre hospitalier de l’Université de Montréal (CHUM), University of Montreal
Alain Weill
Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal
Daniel Roy
Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal
Tim E. Darsaut
Department of Surgery, Division of Neurosurgery, University of Alberta hospital, Mackenzie Health Sciences Center
Thanh N. Nguyen
Department of Neurology, Neurosurgery, and Radiology, Boston Medical Center
Jean Raymond
Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), University of Montreal
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.
