Table A2:
Author, Year | Allocation Concealments | Blindingb | Complete Accounting of Patients and Outcome Events | Selective Reporting Bias | Other Limitationsc |
---|---|---|---|---|---|
Berkhemer et al, 201527 | No limitations | No limitations | No limitations | Limitationsd | No limitations |
Campbell et al, 201528 | No limitations | No limitations | No limitations | No limitations | Limitationse |
Goyal et al, 201529 | No limitations | No limitations | No limitations | Limitationsd | Limitationse |
Jovin et al, 201530 | No limitations | No limitations | No limitations | No limitations | Limitationse |
Saver et al, 201531 | No limitations | No limitations | No limitations | No limitations | Limitationse |
Abbreviations: RCT, randomized controlled trial.
All five RCTs used a web-based randomized minimization procedure.
All five included RCTs had blind outcome evaluation, but physicians conducting the intervention were aware of treatment assignment. This was appropriate, as a sham procedure was not ethical, and the standard of care is intravenous thrombolysis, which is a more appropriate comparator.
All five studies had grant support from Covidien/ev3 (the company that manufactures the Solitaire FR stent retriever) and/or other manufacturers/industry support.
Protocol states the functional outcome measured by the Academic Linear Disability Scale would be collected at 90 days, but this outcome was not reported in the published article.
After the Berkhemer et al (28) study was published, the four following RCTs stopped early based on prespecified boundaries for efficacy during interim analysis.
Protocol states the functional outcome measured by miFUNCTION scale would be collected, but this outcome was not reported in the published article.