How infection present at time of surgery (PATOS) data impacts your surgical site infection (SSI) standardized infection ratios (SIR), with focus on the complex 30-day SSI SIR model.

This case study is part of a series centered on the Centers for Disease Control and Prevention's National Healthcare Safety Network's (NHSN) health care-associated infection (HAI) surveillance definitions. This is the first analytic case study published in AJIC since the CDC/ NHSN updated its HAI risk adjustment models and rebaselined the standardized infection ratios (SIRs) in 2015. This case describes a scenario that Infection Preventionists (IPs) have encountered during their analysis of surgical site infection (SSI) surveillance data. The case study is intended to illustrate how specific models can impact the SIR results by highlighting differences in the criteria for NHSN's older and newer risk models: the original versions and the updated models introduced in 2015. Understanding these differences provides insight into how SSI SIR calculations differ between the older and newer NHSN baseline models. NHSN plans to produce another set of HAI risk adjustment models in the future, using newer HAI incidence and risk factor data. While the timetable for these changes remains to be determined, the statistical methods used to produce future models and SIR calculations will continue the precedents that NHSN has established. An online survey link is provided where participants may confidentially answer questions related to the case study and receive immediate feedback in the form of correct answers, explanations, rationales, and summary of teaching points. Details of the case study, answers, and explanations have been reviewed and approved by NHSN staff. We hope that participants take advantage of this educational offering and thereby gain a greater understanding of the NHSN's HAI data analysis. There are 2 baselines available for SSI standardized infection ration (SIRs) in the National Healthcare Safety Network (NHSN); one based on the 2006-2008 national aggregate data and another based on the 2015 data. Each of the 2 baselines has a different set of inclusion criteria for the SSI data, which impact the calculation of the SIR. In this case study, we focused on the impact of the inclusion of PATOS in the calculation of the 2006-2008 baseline SSI SIR and the exclusion of PATOS from the calculation of the 2015 baseline SSI SIR. In the 2006-2008 baseline SSI SIRs, PATOS events and the procedures to which they are linked are included in the calculation of the SSI SIR whereas in the 2015 baseline SSI SIRs, PATOS events and the procedures to which they are linked are excluded from the calculation of the SSI SIR. Meaning, if we control for all other inclusion criteria other than PATOS data for both baselines, we will notice differences in the number of observed events as well as the number of predicted infections for the 2 baselines. For details of the 2015 baseline and risk adjustment calculation, please review the NHSN Guide to the SIR referenced below. For details of the 2006-2008 baseline4 and risk adjustment, please see the SHEA paper "Improving Risk-Adjusted Measures of Surgical Site Infection for the National Healthcare Safety Network" by author Yi Mu.

Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.

BACKGROUND: In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. METHODS: The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. RESULTS: We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. CONCLUSIONS: The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. TRIAL REGISTRATION: Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.

Healthcare-associated infections studies project: An American Journal of Infection Control and National Healthcare Safety Network data quality collaboration: Location mapping.

This case study is part of a series centered on the Centers for Disease Control and Prevention/National Healthcare Safety Network (NHSN) health care-associated infection (HAI) surveillance definitions. This specific case study focuses on appropriately mapping locations within an NHSN-enrolled facility. The intent of the case study series is to foster standardized application of the NHSN HAI surveillance definitions among IPs and encourage accurate determination of HAI events. An online survey link is provided where participants may confidentially answer questions related to the case study and receive immediate feedback in the form of correct answers and explanations and rationales. Details of the case study, answers, and explanations have been reviewed and approved by NHSN staff. We hope that participants take advantage of this educational offering and thereby gain a greater understanding of NHSN HAI surveillance definitions.

Health care-associated infections studies project: An American Journal of Infection Control and National Healthcare Safety Network data quality collaboration.

This case study is part of a series centered on the Centers for Disease Control and Prevention/National Healthcare Safety Network (NHSN) health care-associated infection (HAI) surveillance definitions. This specific case study focuses on the definitions and protocols used to make HAI infection determinations, such as the infection window period and secondary bloodstream infection attribution period. The case reflects the real-life and complex patient scenarios that infection preventionists (IPs) face when identifying and reporting HAIs to NHSN. The intent of the case study series is to foster standardized application of the NHSN HAI surveillance definitions among IPs and encourage accurate determination of HAI events. An online survey link is provided where participants may confidentially answer questions related to the case study and receive immediate feedback in the form of correct answers and explanations and rationales. Details of the case study, answers, and explanations have been reviewed and approved by NHSN staff. We hope that participants take advantage of this educational offering and thereby gain a greater understanding of NHSN HAI surveillance definitions.

Health care-associated infections studies project: An American Journal of Infection Control and National Healthcare Safety Network data quality collaboration.

This case study is part of a series centered on the Centers for Disease Control and Prevention's National Healthcare Safety Network's (NHSN) health care-associated infection (HAI) surveillance definitions. The intent of the case study series is to foster standardized application of the NHSN's HAI surveillance definitions among infection preventionists and accurate determination of HAI events. This specific case study focuses on the definitions found within the surgical site infection (SSI) protocol. It aims to reflect the real life and complex patient scenario surrounding a bloodstream infection that is secondary to an SSI and the application of the Present at the Time of Surgery event detail. An online survey link is provided where participants may confidentially answer questions related to the case study and receive immediate feedback in the form of correct answers and explanations and rationales. Details of the case study, answers, and explanations have been reviewed and approved by NHSN staff. We hope that participants take advantage of this educational offering and thereby gain a greater understanding of the NHSN's HAI surveillance definitions.

Targeted surveillance of methicillin-resistant Staphylococcus aureus and its potential use to guide empiric antibiotic therapy.

The present study aimed to determine the frequency of methicillin-resistant Staphylococcus aureus (MRSA)-positive clinical culture among hospitalized adults in different risk categories of a targeted MRSA active surveillance screening program and to assess the utility of screening in guiding empiric antibiotic therapy. We completed a prospective cohort study in which all adults admitted to non-intensive-care-unit locations who had no history of MRSA colonization or infection received targeted screening for MRSA colonization upon hospital admission. Anterior nares swab specimens were obtained from all high-risk patients, defined as those who self-reported admission to a health care facility within the previous 12 months or who had an active skin infection on admission. Data were analyzed for the subcohort of patients in whom an infection was suspected, determined by (i) receipt of antibiotics within 48 h of admission and/or (ii) the result of culture of a sample for clinical analysis (clinical culture) obtained within 48 h of admission. Overall, 29,978 patients were screened and 12,080 patients had suspected infections. A total of 46.4% were deemed to be at high risk on the basis of the definition presented above, and 11.1% of these were MRSA screening positive (colonized). Among the screening-positive patients, 23.8% had a sample positive for MRSA by clinical culture. Only 2.4% of patients deemed to be at high risk but found to be screening negative had a sample positive for MRSA by clinical culture, and 1.6% of patients deemed to be at low risk had a sample positive for MRSA by clinical culture. The risk of MRSA infection was far higher in those who were deemed to be at high risk and who were surveillance culture positive. Targeted MRSA active surveillance may be beneficial in guiding empiric anti-MRSA therapy.