The trial provided evidence to shift away from implementation of EGDT, which carried additional costs, in Australia. Eligible participants Outcome Primary outcomes Secondary outcomes Clinical context Main clinical assumptions if implemented There are no significant Patients admitted to All-cause mortality Survival time to 90 days; The trial has resulted in a Increased treatment costs for EGDT driven by transfusions, differences for mortality at ICU = 123,564 within 90 days after mortality; LOS in the shift away from using Early dobutamine and intravenous fluids, time and materials. 90 days, nor survival time, randomisation. ED, ICU, or hospital; Goal Directed Therapy for ED time is costed separately to the intervention as it was a Proportion diagnosed in-hospital mortality, mechanical ventilation, patients with early septic statistically significant finding. Change in ED time however, with severe sepsis = duration of organ support, vasopressor support, or shock. may be an artefact of patients from both groups being part of 3% and length of hospital stay. RRT; adverse events. Trial confirms control as the trial (and therefore experiencing more efficient care There is a marginal approach of choice. coordination). N= 3,648 reduction in time spent in the Emergency Department (ED), which is not considered to be sufficient to justify intervention with EGDT. Outcome Difference in N if Health Economic Impact on QALY Economic Total Economic Impact risk between implemented at service cost health service costs impact per impact on control and 65% per person or if implemented person QALYS if treatment day implemented Primary No statistically significant difference - - - - - - Secondary Duration in ED +0.6 +1,423 +$200 +$0.3m - - +$0.3m (hours) Change in intervention costs -$1.5m - Totals +$0.3m -$1.2m Columns may not sum due to rounding. Negative values are savings in the calculations. EGDT = early goal therapy. ED = emergency department. LOS = length of stay. ICU = intensive care unit. RRT = renal replacement therapy.
The trial provided evidence to shift away from implementation of EGDT, which carried additional costs, in Australia. Outcome Eligible participants if implemented Primary outcomes Secondary outcomes Clinical context Main clinical assumptions There are no significant differences for mortality at 90 days, nor survival time, in-hospital mortality, duration of organ support, and length of hospital stay. There is a marginal reduction in time spent in the Emergency Department (ED), which is not considered to be sufficient to justify intervention with EGDT. Patients admitted to ICU = 123,564 All-cause mortality within 90 days after randomisation. Survival time to 90 days; mortality; LOS in the ED, ICU, or hospital; mechanical ventilation, vasopressor support, or RRT; adverse events. The trial has resulted in a shift away from using Early Goal Directed Therapy for patients with early septic shock. Trial confirms control as approach of choice. Increased treatment costs for EGDT driven by transfusions, dobutamine and intravenous fluids, time and materials. ED time is costed separately to the intervention as it was a statistically significant finding. Change in ED time however, may be an artefact of patients from both groups being part of the trial (and therefore experiencing more efficient care coordination). Proportion diagnosed with severe sepsis = 3% N= 3,648 Outcome Difference in risk between control and treatment N if implemented at 65% Health service cost per person or day Economic Impact on health service costs if implemented QALY impact per person Economic impact on QALYS if implemented Total Economic Impact Primary No statistically significant difference - - - - - - Secondary Duration in ED (hours) +0.6 +1,423 +$200 +$0.3m - - +$0.3m Change in intervention costs Totals -$1.5m +$0.3m - -$1.2m Columns may not sum due to rounding. Negative values are savings in the calculations. EGDT = early goal therapy. ED = emergency department. LOS = length of stay. ICU = intensive care unit. RRT = renal replacement therapy.
Supplementary-Appendix-B-Economic-evaluation-of-investigator-initiated-clinical-trials-conducted-by-networks.docx