Table 1 The seven most frequent criticisms regarding the EASI trial
Criticism | Number of journals | Number of reviewers | Examples of reviewers' comments |
|---|---|---|---|
Early interruption resulting in an underpowered trial | 2 | 4 | “The timing of the release of the data is unfortunate since the majority of high quality trials in this area have now been published” “The numbers are too small to permit any meaningful interpretation, especially having recruited only 16% of the sample size predicted to be required” |
Results inferior to other RCTs | 2 | 5 | “The rigorous application of well-validated and rigidly implemented imaging selection criteria in EXTEND-IA are a lesson in the importance of methodological standards, achieving a clear result in a smaller number of subjects than included in the present study” “The authors suggest that they have a more virtuous approach than more rigorous trialists who exclude patients who do not meet inclusion and exclusion criteria that may go beyond standard care: their results speak for themselves. Outcomes were not improved, mortality was higher, there were more SAEs in the IAT group […]” |
Lack of blinding for the mRS at 3 months | 3 | 4 | “Lack of outcome blinding using mRS is a major flaw” “Lack of blinding may preclude its use in some meta- analyses where this is a minimum prerequisite” |
No vascular imaging for patient selection | 3 | 6 | “The main distinguishing feature of the present study is the lack of vascular imaging as a qualifying criterion, something adopted post-IMS-3 by all endovascular trials” “The confirmation of large artery occlusion is not mandated in this design which is also another mandatory criteria” |
Brain imaging selection criteria “too vague” | 4 | 6 | “The selection criteria are very vague which is probably the point of a care trial” |
Population too heterogeneous. Inclusion of posterior-circulation strokes | 3 | 6 | “While some had similar small sample sizes, also because of early termination, most showed a strongly positive result due to more rigorous patient selection” “The wisdom of mixing anterior circulation cases with basilar artery occlusion patients is highly questionable, since the outcomes are very different” “The authors consider their design as “pragmatic care trial” with wide inclusion criteria. This might be a good idea once a method has shown its effect in a core publication. Such design could kill a therapy without giving in further chances for proving its worth.” |
Ethical concerns. Patients “wasted” in a small trial. | 2 | 4 | “What was the justification to perform […] a mono-center trial which would have never been able to recruit 480 patients in a time frame before the 5 ongoing studies would have been terminated?” “The study recruited patients in a single center in parallel to other studies, e.g. THRACE and SWIFT-PRIME. Their patients are “wasted” for a small study of limited validity with “parsimonious” data collection […] instead of enrolling the patients into larger trial efforts.” |