Ambiguous primary endpoint and late trial registration
Jim Thornton, University of Nottingham
8 November 2011
In addition to the potential bias, identified by the authors, arising from an open study and a subjective endpoint, I have two other worries.
The primary endpoint is reported as blood loss between T1 (time point 1) and two hours later. But T1 is described in different parts of the paper as either the time of delivery (Fig 1) or as the time of inclusion (text). Does "inclusion" mean randomisation or drug administration? If the staff recording blood loss ever took the time of drug administration in the treatment group as T1 they would be measuring blood loss over a shorter period than in controls.
Can the authors also explain why the date of trial registration on www.controlled-trials.com is dated 19 Feb 2011, three months after the trial paper was submitted to Critical Care, and three YEARS after the trial was completed! Can readers be confident that the primary endpoint, statistical methods and sample size were really pre-specified?
Ambiguous primary endpoint and late trial registration
8 November 2011
In addition to the potential bias, identified by the authors, arising from an open study and a subjective endpoint, I have two other worries.
The primary endpoint is reported as blood loss between T1 (time point 1) and two hours later. But T1 is described in different parts of the paper as either the time of delivery (Fig 1) or as the time of inclusion (text). Does "inclusion" mean randomisation or drug administration? If the staff recording blood loss ever took the time of drug administration in the treatment group as T1 they would be measuring blood loss over a shorter period than in controls.
Can the authors also explain why the date of trial registration on www.controlled-trials.com is dated 19 Feb 2011, three months after the trial paper was submitted to Critical Care, and three YEARS after the trial was completed! Can readers be confident that the primary endpoint, statistical methods and sample size were really pre-specified?
Competing interests
I have expanded on these comments here ripe-tomato.org