225 Sites 165 160 153 123 76 54 57 34 Table 1 Inclusion in database by quarter Quarter Patients 2,791 2,709 2,945 1,945 1,435 935 940 509 quality of data entered, concern regarding this topic was the second most frequently discussed area among par- ticipants (following concern regarding roadblocks to achieving physician engagement). Two of the authors 1 (CS and SRT) served as primary references for all 2 questions regarding data collection and entry throughout 3 the Campaign, and provided training for each site when 4 requested. A bi-monthly electronic newsletter was pub- 56 lished to share successes, strategies, and events. 7 8 Bundle targets and clinical outcomes Analysis set construction The primary outcome measure was change in compliance with bundle targets over time. We deﬁned compliance as The analysis set was constructed from the subjects entered evidence that all bundle elements were achieved within the into the SSC database from its launch in January 2005 indicated time frame (i.e, 6 h for the resuscitation bundle; through March 2008. The a priori data analysis plan 24 h for the management bundle). As such, failure to limited inclusion to sites with at least 20 subjects and at comply might occur either because of the failure of the least 3 months of subject enrollment. Analysis presented physician to attempt to meet the target or the failure to reach here was limited to the ﬁrst 2 years of subjects at each site the target despite the clinician’s attempt. Secondary out- (Table 1). come measures included hospital mortality, hospital length Sites were characterized by: hospital size (\250, 250– of stay, and ICU length of stay. Ten performance measures 500, [500 beds); teaching status; ICU type (medical, were established, based on the individual elements of the medical/surgical, other); and geographic region (Europe, resuscitation bundle and the management bundle. North America, South America). Subjects were charac- terized by baseline severe sepsis information: location of enrollment (ED, ICU, ward); site of infection (pulmonary, Data collection urinary tract, abdominal, CNS, skin, bone, wound, cath- eter, cardiac, device, other); acute organ dysfunction Data were entered into the SSC database locally at indi- (cardiovascular, pulmonary, renal, hepatic, hematologic). vidual hospitals into pre-established, unmodiﬁable ﬁelds Subject age and gender were not collected in deference to documenting performance data and the time of speciﬁc country-speciﬁc privacy laws. actions and ﬁndings. Data on the local database contained Data were organized by quarter through 2 years, with private health information (PHI) that enabled individual the ﬁrst 3 months that a site entered subjects into the sites to audit and review local practice and compliance as database deﬁned as the ﬁrst quarter regardless of when well as provide feedback to clinicians involved in the those months occurred from January 2005 through March initiative. Data stripped of PHI were submitted every 2008. Results are presented by site quarter, comparing the 30 days to the secure master SSC server at the Society of initial quarter to the ﬁnal quarter for all sites and by Critical Care Medicine (Mount Prospect, Ill.) via ﬁle comparing the initial quarter to all subsequent quarters. transfer protocol (FTP) or as comma-delimited text ﬁles Because differences in bundle achievement and out- attached to e-mail submitted to the Campaign’s server. comes could be confounded by changes in the characteristics of subjects entered into the database, risk- adjustment logistic regression models were constructed to IRB approval control for baseline subject characteristics. All baseline characteristics present in the database were included in the The global SSC improvement initiative was reviewed and risk-adjustment models including location of enrollment, approved by the Cooper University Hospital Institutional acute organ dysfunctions, and site of infection. Site of Review Board (Camden, NJ) as meeting criteria for infection was reduced to pulmonary or non-pulmonary to exempt status. Individual hospitals were encouraged to decrease the number of covariate patterns in the data and refer to these documents and submit to their local IRBs increase the utility of the model residuals to assess model per local policy for documentation of exempt status or ﬁt. Because the collection of some bundle elements was waiver of consent. The US Department of Health and conditioned on subject characteristics, different models Human Services’ Ofﬁce for Human Research Protections were constructed for each subpopulation. The model clariﬁed that quality improvement activities such as SSC assessing the base set of elements applicable to all subjects often qualify for IRB exemption and do not require (lactate measurement, blood culture before antibiotic individual informed consent [31]. administration, broad spectrum antibiotic administration,