Journal Club Summary
Methodology: 2.5/5
Usefulness: 2.5/5
IST-3 collaborative group, Sandercock P, Wardlaw JM, et al.
Lancet. 2012 Jun 23;379(9834):2352-63.
This international, multicenter, randomized, open-treatment trial was aimed at detecting benefits of tissue plasminogen activator (tPA) given in patients older than 80 years old and who had a time to onset of symptoms of greater than 4.5 hours and the results show no significant difference in primary outcome in the treatment versus the control group, and a higher number of early deaths in the treatment group. However, the authors claim that benefit in outcome was detected in the treatment group after a complex statistical analysis but due to the open-label nature of the study and seemingly unfounded claims about the benefits of tPA, the group felt that this study should not change practice.
By: Dr. Michael Hickey
By: Dr. Michael Hickey
(Presented December 2012)
Epi Lesson:
Allocation concealment is an important principle in RCT design as it helps ensure that study personnel and clinicians are unaware of how a study intervention or control is assigned. Historically, there have been instances where study personnel or clinicians have attempted to “guess” treatment allocation to ensure their patient gets assigned the “right” study group based on their own clinical biases. The robustness of an RCT is enhanced by clear reporting of how allocation was concealed, and even further if the adequacy of their concealment was evaluated.
By: Dr. Lisa Calder
