Table 3. Summary of outcome data and other results from four studies examining experience with the CMS sepsis bundle performance measure (SEP-1).

Study	Time period	Study design	Number		Comparisons	Mortality	Other results
			Hosp.	Cases
Ramsdell [2017] (38)	4/2015–2/2016	RC	1	158	Compared patients before versus after SEP-1 introduction	In hospital mortality rates: before: 13 of 48 died: 27.1%; after: 16 of 110 died: 14.5%; unadjusted P=0.05	Significantly greater number of before patients had hypotension and increased creatinine levels at presentation (P≤0.01) in the after group
							3 h and 6 h bundles and overall SEP-1 compliance were increased in after group compared to before group (P<0.01)
Rhee [2018] (62)	11/2015–9/2017	RC	7	851	Compared compliant	In hospital mortality rates: noncompliant: 105 of 570 died: 18.4%; compliant: 31 of 281 died: 11.0%; odds ratio survival (95% CI): unadjusted: 1.82 (1.19-2.80), P=0.006; adjusted: 1.36 (0.85–2.18), P=0.21	Variables associated with survival*: age, non-white race, higher Elixhauser score, hospital-onset sepsis, septic shock, non-urinary infection source, vague presenting symptoms
					versus non-compliant patients		Time to antibiotics >3 h associated with death (adjusted OR 1.94, 95% CI: 1.04–3.62, P=0.038)
							Noncompliance with SEP-1 for any other reason not associated with death (1.10, 0.70–1.72, P=0.674)
Esposito [2018] (14)	1/2015–3/2015#	RC	1	1,802	Compared patients in the first 3 months of 2015 before and in the first 3 months of 2016 and of 2017 after SEP-1 introduction	Mortality rates: before [2015]: 86 of 615 died: 14.0%; after [2016]: 87 of 591 died: 14.7%; after [2017]: 91 of 596 died: 15.3%; unadjusted P≥0.53 for 2016 or 2017 vs. 2015	Over the 3-y period of study:
							• Pip/tazo use increased 24.7% (P=0.001)
							• Vanco use increased 24.5% (P=0.001)
							• Lactate orders increased 773% (P<0.001)
							• BC orders increased 41% (P<0.001)
							Approximate additional cost from 2015 to 2017:
							• Lactate levels: $23,661
							• Blood cultures: $10,040
							• Pip/tazo: $2.241
							• Vancomycin: $1.086
Whitfield [2019] (67)	12/2016–2/2018	RC	1	450	Compared patients before and after instituting an ACSP designed to increase SEP-1 compliance	In hospital mortality rates: before: 12 of 300 died: 4%; after: 0 of 150 died: 0%; unadjusted P=0.01	Before vs. after:
							• SEP-1 compliance: 31 vs. 71%, P<0.001
							• Median (IQR) total cost/case ($): 9,222 (6,216, 15,153) vs. 10,195 (6,499, 17,340) (P=0.11)
							• Median (IQR) direct variable cost/case ($): 4,906 (3,344, 8,300) vs. 5,436 (3,610, 9,871) (P=0.09)

*, based on multivariate analysis; ^#, compared data obtained during first three months of 2015 vs. 2016 vs. 2017. ACSP, Adult Code Sepsis Protocol; Hosp, hospitals; NYS, New York State; Pip/tazo, piperacillin/tazobactam; RC, retrospective cohort; Vanco, vancomycin.