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

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.