Critical appraisal of http://www.ncbi.nlm.nih.gov/pubmed/20838118

1. Results of the CONTROL Trial: Efficacy and Safety of Recombinant Activated Factor VII in the Management of Refractory Traumatic Hemorrhage ( J Trauma. 2010;69:489–500)

7. Trial schematic

12. What is a noninferiority test?

13. Subject disposition

14. Demographics and baseline characteristics ITT population

15. Clinical outcomes 30 day ITT analysis

16. Transfusion requirements ITT population

17. AEs through day 90 Safety population

20. Did rFVIIa reduce the need for blood products in bleeding trauma patients?

25. Is rFVIIa safe?

29. In the aggregate, does rFVIIa help patients?

33. 1a. R- Was the assignment of patients to treatments randomised ?

34. 1b. R- Were the groups similar at the start of the trial?

35. 2a. A – Aside from the allocated treatment, were groups treated equally?

36. 2b. A – Were all patients who entered the trial accounted for? – and were they analysed in the groups to which they were randomised?

37. 3. M - Were measures objective or were the patients and clinicians kept “ blind ” to which treatment was being received?

38. How large was the treatment effect?

39. How precise was the estimate of the treatment effect?