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.
Highlights
The Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice
The protocols of the seven thrombectomy trials that were registered in ClinicalTrials.gov and Current Controlled Trials and published prior to February 2017 [8, 9, 19,20,21,22,23] were reviewed in consensus agreement by three authors (RF, SF, and DR) for an item-by-item comparison with the EASI protocol, using the diagrammatic tool of the pragmatic-explanatory continuum indicator summary (PRECIS)-2 framework [24, 25]
Most criticisms from peer reviewers concerned the pragmatic choices of the EASI trial design, at the pragmatic end of the spectrum of recently published thrombectomy trials
Summary
The Endovascular Acute Stroke Intervention (EASI) trial was conceived as a pragmatic care trial, designed to integrate trial methods with clinical practice. Clinical research and care are commonly conceived as distinct activities that must be separated. This conception encourages the conduct of clinical trials on the model of preclinical studies, where patients are used in experiments designed to gain knowledge for the potential benefit of future patients or society, but the results of such explanatory trials are often poorly applicable in practice [1, 2]. The Endovascular Acute Stroke Intervention (EASI) trial is a care trial designed to offer thrombectomy to patients referred for acute stroke treatment [3]. Akin to many endovascular centers, and in the absence of randomized evidence for almost all
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