Journal Club Summary
Methodology Score: 4/5
Usefulness Score: 4/5
Holst LB et al for the TRISS Trial Group and the Scandinavian Critical Care Trials Group.
N Engl J Med. 2014 Oct 9;371(15):1381-91
Transfusion Threshold of 7 g per Deciliter — The New Normal
Paul C. Hébert, M.D., and Jeffrey L. Carson, M.D.
N Engl J Med 2014; 371:1459-1461
This multicenter, randomized trial of ICU patients with septic shock, found no significant difference in mortality at 90 days or in secondary outcomes for a hemoglobin transfusion threshold of 7 g/dL compared to 9 g/dL. This was a well-conducted study with high relevance in critical care, and JC attendees felt that the results aligned with both the landmark TRICC trial advocating restrictive transfusion thresholds, and recent literature in sepsis showing that “down-stream” interventions (e.g., EGDT) may have less importance in influencing clinical outcomes.
By: Dr. George Mastoras
(Presented January 2015)
Intention-to-treat (ITT) Analyses
Intention-to-treat (ITT) analyses are widely recommended as the preferred approach to the analysis of most clinical trials. The basic intention-to-treat principle is that participants in trials should be analysed in the groups to which they were randomized, regardless of whether they received or adhered to the allocated intervention. This particularly becomes a problem when patients are lost to follow-up and no outcome values are available. Authors must clearly indicate how many patients have such values missing. The alternate approach is a per protocol analysis which only includes patients for whom the protocol was followed.
By: Dr. Ian Stiell