Interestingly, there was no significant difference between groups regarding the primary endpoint; that is, 60-day mortality (protocol-based EGDT: 21%, protocol-based standard therapy: 18.2%, usual care: 18.9%; each p >0.3).
Patients will be assessed for infections (surgical site and other), antibiotic-related complications, adverse events, serious adverse events, complications of wound healing, oncologic outcomes such as local recurrence and metastasis, reoperation, mortality and protocol deviations.
The CHEFS employed the same standard two-tiered mortality assessment protocol nationwide, and therefore may represent a more reliable source of age- and sex-specific cause of death estimates.
Cause of death was recorded prospectively by colorectal nurse specialists, consultant surgeons and the Clinical Effectiveness Unit of the hospital and the mortality coding protocol for the study categorised death as CRC-related or from other causes/non-CRC-related.
This study showed no differences in the microcirculation between the two groups and a trend towards an increased mortality in the protocol group.
Adhering to such a massive transfusion protocol, mortality was lower (P <0.001) despite higher injury scores during latter years.
In two studies that reported outcomes before and after implementation of an intensive glucose management protocol, mortality after implementation of the protocol was improved compared with prior to protocol implementation [ 21, 22].
Although one [ 43] of the four trials had calculated sample size according to 14-day mortality in the protocol, fewer patients were enrolled due to lower mortality and recruitment frequency than anticipated eventually.
One study, conducted in 762 critically ill patients, found no difference in overall mortality between the protocol and control groups, and neither was there any difference in mortality in the subgroup of patients with sepsis [ 21].
From 9 to 36 months of age after measles vaccination, the per protocol mortality rate ratio was 1.09 (0.75 to 1.59) for Edmonston-Zagreb vaccine (57/1841 children) compared with Schwarz vaccine (54/1825 children).
Finally, we considered the US UK comparability of a number of other factors including life table data (used by Adjuvant! to estimate other cause mortality), tumour staging protocol, and treatment effectiveness.
