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1.  Catheter Dwell Time and CLABSIs in Neonates With PICCs: A Multicenter Cohort Study 
Pediatrics  2013;132(6):e1609-e1615.
To determine whether the daily risk of central line–associated bloodstream infections (CLABSIs) increases over the dwell time of peripherally inserted central catheters (PICCs) in high-risk neonates.
Multicenter retrospective cohort including NICU patients with a PICC inserted between January 2005 and June 2010. We calculated incidence rates and used Poisson regression models to assess the risk of developing CLABSI as a function of PICC dwell time.
A total of 4797 PICCs placed in 3967 neonates were included; 149 CLABSIs occurred over 89 946 catheter-days (incidence rate 1.66 per 1000 catheter-days). In unadjusted analysis, PICCs with a dwell time of 8 to 13 days, 14 to 22 days, and ≥23 days each had an increased risk of infection compared with PICCs in place for ≤7 days (P < .05). In adjusted analysis, the average predicted daily risk of CLABSIs after PICC insertion increased during the first 2 weeks after PICC insertion and remained elevated for the dwell time of the catheter. There was an increased risk of CLABSIs in neonates with concurrent PICCs (adjusted incidence rate ratio 2.04, 1.12–3.71). The incidence of Gram-negative CLABSIs was greater in PICCs with dwell times >50 days (incidence rate ratio 5.26, 2.40–10.66).
The risk of CLABSIs increased during the 2 weeks after PICC insertion and then remained elevated until PICC removal. Clinicians should review PICC necessity daily, optimize catheter maintenance practices, and investigate novel CLABSI prevention strategies in PICCs with prolonged dwell times.
PMCID: PMC3838533  PMID: 24218474
infection; catheter-related infections; NICU; central venous catheters; peripheral venous catheterization
Sepsis biomarker research requires an infrastructure to identify septic patients efficiently and to collect and store specimens properly. We developed a novel infrastructure to study biomarkers of sepsis in children.
Patients in pediatric and neonatal intensive care units were enrolled prospectively; enrollment information was stored in a secure, remotely-accessible database. Researchers were notified of electronic medical record (EMR) orders for blood cultures (a surrogate for a diagnostic evaluation of suspected sepsis) by a page triggered by the order. Staff confirmed patient enrollment and remotely submitted an EMR order for collection of study specimens simultaneous with the blood culture. Specimens were processed and stored by a mobile clinical research unit.
Over 2 years, 2029 patients were admitted; 138 were enrolled. Staff received pages for 95% of blood cultures collected from enrolled patients. The median time between the blood culture order and collection was 34 minutes (range 9–241). Study specimens were collected simultaneously with 41 blood cultures. The median times between specimen collection and storage for flow cytometry and cytokine analysis were 33 minutes (range 0–82) and 52 minutes (range 28–98), respectively.
This novel infrastructure facilitated prompt, proper collection and storage of specimens for sepsis biomarker analysis.
PMCID: PMC3578308  PMID: 23399085
3.  Molecular Epidemiology of Methicillin-Resistant Staphylococcus aureus (MRSA) among Patients Admitted to Adult Intensive Care Units: the STAR*ICU Trial 
The multi-center cluster-randomized Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) trial was carried out in 18 U.S. adult intensive care units (ICUs) and evaluated the effectiveness of infection control strategies in reducing transmission of methicillin-resistant Staphylococcus aureus (MRSA) colonization and/or infection. Our study objective was to examine the molecular epidemiology of MRSA and assess the prevalence and risk factors for community acquired (CA)-MRSA genotype nasal carriage at the time of ICU admission.
Selected MRSA isolates were subjected to molecular typing using pulsed-field gel electrophoresis.
Among 5,512 ICU patient-admissions in the STAR*ICU trial during the intervention period, 626 (11%) had a positive nares culture for MRSA. 210/626 (34%) available isolates were selected by weighted random sampling for molecular typing. Of 210 patients, 123 (59%) were male; mean age was 63 years. Molecular typing revealed that 147 isolates (70%) were the USA100 clone; 26 (12%) USA300; 12 (6%) USA500; 8 (4%) USA800; 17 (8%) other. In multivariate analysis, patients with CA-MRSA genotype (USA300, USA400, or USA1000) colonization were less likely to have been hospitalized during the previous 12 months (PR=0.39; 95% C.I. 0.21–0.73) and less likely to have an older age (PR=0.97 per year; 0.95–0.98) compared to patients with a HA-MRSA genotype.
CA-MRSA genotypes have emerged as a cause of MRSA nares colonization among patients admitted to adult ICUs in the U.S. During the study period (2006), the predominant site of CA-MRSA genotype acquisition appeared to be in the community.
PMCID: PMC4149749  PMID: 22011531
MRSA; community-associated; healthcare-associated; ICU
4.  Training Mentors of Clinical and Translational Research Scholars: A Randomized Controlled Trial 
To determine whether a structured mentoring curriculum improves research mentoring skills.
The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors’ self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors’ awareness as measured by their self-reported retrospective change in MCA scores, mentees’ ratings of their mentors’ competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees.
A total of 283 mentor–mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors’ behavior (P = .002) than those paired with control mentors.
This RCT demonstrates that a competency-based research mentor training program can improve mentors’ skills.
PMCID: PMC4121731  PMID: 24667509
5.  The Epidemiology of Clostridium difficile Infection in Children: A Population-Based Study 
Clostridium difficile incidence in children increased significantly from 1991 through 2009. The majority of cases were community-acquired. Severe infection was more common in hospital-acquired than community-acquired cases. There were fewer treatment failures with vancomycin compared to metronidazole.
Background. The incidence of Clostridium difficile infection (CDI) is increasing, even in populations previously thought to be at low risk, including children. Most incidence studies have included only hospitalized patients and are thus potentially influenced by referral or hospitalization biases.
Methods. We performed a population-based study of CDI in pediatric residents (aged 0–18 years) of Olmsted County, Minnesota, from 1991 through 2009 to assess the incidence, severity, treatment response, and outcomes of CDI.
Results. We identified 92 patients with CDI, with a median age of 2.3 years (range, 1 month–17.6 years). The majority of cases (75%) were community-acquired. The overall age- and sex-adjusted CDI incidence was 13.8 per 100 000 persons, which increased 12.5-fold, from 2.6 (1991–1997) to 32.6 per 100 000 (2004–2009), over the study period (P < .0001). The incidence of community-acquired CDI was 10.3 per 100 000 persons and increased 10.5-fold, from 2.2 (1991–1997) to 23.4 per 100 000 (2004–2009) (P < .0001). Severe, severe-complicated, and recurrent CDI occurred in 9%, 3%, and 20% of patients, respectively. The initial treatment in 82% of patients was metronidazole, and 18% experienced treatment failure. In contrast, the initial treatment in 8% of patients was vancomycin and none of them failed therapy.
Conclusions. In this population-based cohort, CDI incidence in children increased significantly from 1991 through 2009. Given that the majority of cases were community-acquired, estimates of the incidence of CDI that include only hospitalized children may significantly underestimate the burden of disease in children.
PMCID: PMC3693491  PMID: 23408679
Clostridium difficile infection; epidemiology; pediatric; population-based; community-acquired
6.  Reliability of the Identification of the Systemic Inflammatory Response Syndrome in Critically Ill Infants and Children 
Pediatric Critical Care Medicine  2012;13(1):e55-e57.
To assess inter-observer reliability of the identification of episodes of the systemic inflammatory response syndrome (SIRS) in critically ill hospitalized infants and children.
Retrospective cross-sectional study of the application of the 2005 consensus definition of SIRS in infants and children by two independent trained reviewers using information in the electronic medical record.
18-bed pediatric multidisciplinary medical/surgical pediatric intensive care unit (PICU).
A randomly selected sample of children admitted consecutively to the PICU between May 1 and September 30, 2009.
Measurements and Main Results
60 infants and children were selected from a total of 343 admitted patients. Their median age was 3.9 years (interquartile range [IQR], 1.5–12.7), 57% were female, and 68% were Caucasian. 19 (32%) children were identified by both reviewers as having an episode of SIRS (88% agreement, 95% confidence interval [CI] 78–94; κ = 0.75, 95% CI, 0.59–0.92). Amongst those 19 children, agreement between the reviewers for individual SIRS criteria was: temperature (84%, 95% CI 60–97); white blood cell count (89%, 95% CI 67–99); respiratory rate (84%, 95% CI 60–97); heart rate (68%, 95% CI 33–87).
Episodes of SIRS in critically ill infants and children can be identified reproducibly using the consensus definition.
PMCID: PMC3243796  PMID: 21926661
systemic inflammatory response syndrome; inflammation; sepsis; intensive care units; pediatric; reproducibility; reliability
7.  Identifying and Aligning Expectations in a Mentoring Relationship 
The mentoring relationship between a scholar and their primary mentor is a core feature of research training. Anecdotal evidence suggests this relationship is adversely affected when scholar and mentor expectations are not aligned. We examined three questions: (1) What is the value in assuring that the expectations of scholars and mentors are mutually identified and aligned? (2) What types of programmatic interventions facilitate this process? (3) What types of expectations are important to identify and align? We addressed these questions through a systematic literature review, focus group interviews of mentors and scholars, a survey of Clinical and Translational Science Award (CTSA) KL2 program directors, and review of formal programmatic mechanisms used by KL2 programs. We found broad support for the importance of identifying and aligning the expectations of scholars and mentors and evidence that mentoring contracts, agreements, and training programs facilitate this process. These tools focus on aligning expectations with respect to the scholar’s research, education, professional development and career advancement as well as support, communication, and personal conduct and interpersonal relations. Research is needed to assess test the efficacy of formal alignment activities.
PMCID: PMC3476480  PMID: 22212226
mentors; mentoring; career development; faculty development; staff development
8.  Impact of enhanced infection control at two neonatal intensive care units in the Philippines 
The growing burden of neonatal mortality due to hospital acquired neonatal sepsis in the developing world creates an urgent need for low cost effective infection control measures in low resource settings.
Using a pre/post comparison design, we measured how rates of staff hand hygiene compliance, colonization with resistant pathogens (defined as ceftazidime- and/or gentamicin-resistant gram-negative rods (GNRs) and resistant gram-positive cocci), bacteremia, and overall mortality changed following the introduction of a simplified package of infection control measures at two neonatal intensive care units (NICUs) in Manila, the Philippines.
Of 1828 NICU neonates admitted, 45.6% became newly colonized with resistant bacteria, 19.6% became bacteremic (78.2% from GNRs), and 33.6% died. 2903 resistant colonizing bacteria were identified of which 85% were resistant GNRs (predominantly Klebsiella spp., Pseudomonas spp., and Acinetobacter spp.) and 14% were Methicillin-resistant Staphylococcus aureus. Contrasting control vs. intervention periods at each NICU, staff hand hygiene compliance improved (At NICU 1 RR=1.3, 95% CI 1.1–1.5; At NICU 2 RR=1.6, 95% CI 1.4–2.0) and overall mortality declined (NICU 1 RR=0.5, 95%CI 0.4–0.6; NICU 2 RR=0.8, 95% CI 0.7–0.9). However, colonization with resistant pathogens and sepsis rates did not change significantly at either NICU.
Nosocomial transmission of resistant pathogens was intense at these two Philippines NICUs and dominated by resistant GNRs. Infection control interventions are feasible and possibly effective in resource limited hospital settings.
PMCID: PMC3866590  PMID: 19025496
Infection Control; Philippines; NICU; Drug Resistance; Hand Hygiene
9.  Mentoring Translational Science Investigators 
PMCID: PMC3767996  PMID: 23168821
11.  Tracking the Impact of the National Institutes of Health Clinical and Translational Science Awards on Child Health Research: Developing and Evaluating a Measurement Strategy 
Pediatric research  2012;71(5):619-624.
Since 2006, the National Institutes of Health has provided institutional infrastructure grants, called Clinical and Translational Science Awards (CTSAs), to support adult and pediatric clinical and translational research in United States institutions. A CTSA Consortium Child Health Oversight Committee workgroup developed metrics to measure the impact of CTSAs on child health (CH) research. A cross-sectional survey to collect metric data was distributed to the 46 institutions that received CTSAs during 2006-09. Thirty-seven (80%) institutions responded to the survey. Data regarding 7 metrics were reported by >70% of responding institutions: the proportion of overall funding (median, interquartile range; 0.12, 0.06–0.19) and pilot grants (0.15, 0.11–0.21) supporting CH research; the proportion of active clinical research center studies involving children (0.23, 0.15–0.35); the proportion of IRB-approved (0.24, 0.16–0.30) and funded (0.22, 0.18–0.30) studies involving children; the proportion of mentored research training awards to CH investigators (0.18, 0.11–0.28); and, the proportion of CTSA leadership positions held by pediatricians (0.18, 0.12–0.28). CTSAs provide substantial support for CH research, although additional investment in CH research is needed to improve the health of children. These metrics provide an initial means to track the impact of CTSAs on CH research.
PMCID: PMC3582389  PMID: 22398699
12.  Predictors of indoor absolute humidity and estimated effects on influenza virus survival in grade schools 
Low absolute humidity (AH) has been associated with increased influenza virus survival and transmissibility and the onset of seasonal influenza outbreaks. Humidification of indoor environments may mitigate viral transmission and may be an important control strategy, particularly in schools where viral transmission is common and contributes to the spread of influenza in communities. However, the variability and predictors of AH in the indoor school environment and the feasibility of classroom humidification to levels that could decrease viral survival have not been studied.
Automated sensors were used to measure temperature, humidity and CO2 levels in two Minnesota grade schools without central humidification during two successive winters. Outdoor AH measurements were derived from the North American Land Data Assimilation System. Variability in indoor AH within classrooms, between classrooms in the same school, and between schools was assessed using concordance correlation coefficients (CCC). Predictors of indoor AH were examined using time-series Auto-Regressive Conditional Heteroskedasticity models. Classroom humidifiers were used when school was not in session to assess the feasibility of increasing indoor AH to levels associated with decreased influenza virus survival, as projected from previously published animal experiments.
AH varied little within classrooms (CCC >0.90) but was more variable between classrooms in the same school (CCC 0.81 for School 1, 0.88 for School 2) and between schools (CCC 0.81). Indoor AH varied widely during the winter (range 2.60 to 10.34 millibars [mb]) and was strongly associated with changes in outdoor AH (p < 0.001). Changes in indoor AH on school weekdays were strongly associated with CO2 levels (p < 0.001). Over 4 hours, classroom humidifiers increased indoor AH by 4 mb, an increase sufficient to decrease projected 1-hour virus survival by an absolute value of 30% during winter months.
During winter, indoor AH in non-humidified grade schools varies substantially and often to levels that are very low. Indoor results are predicted by outdoor AH over a season and CO2 levels (which likely reflects human activity) during individual school days. Classroom humidification may be a feasible approach to increase indoor AH to levels that may decrease influenza virus survival and transmission.
PMCID: PMC3568414  PMID: 23383620
Influenza; Humidity; Schools; Climate
13.  Intervention to Reduce Transmission of Resistant Bacteria in Intensive Care 
The New England journal of medicine  2011;364(15):1407-1418.
Intensive care units (ICUs) are high-risk settings for the transmission of methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE).
In a cluster-randomized trial, we evaluated the effect of surveillance for MRSA and VRE colonization and of the expanded use of barrier precautions (intervention) as compared with existing practice (control) on the incidence of MRSA or VRE colonization or infection in adult ICUs. Surveillance cultures were obtained from patients in all participating ICUs; the results were reported only to ICUs assigned to the intervention. In intervention ICUs, patients who were colonized or infected with MRSA or VRE were assigned to care with contact precautions; all the other patients were assigned to care with universal gloving until their discharge or until surveillance cultures obtained at admission were reported to be negative.
During a 6-month intervention period, there were 5434 admissions to 10 intervention ICUs, and 3705 admissions to 8 control ICUs. Patients who were colonized or infected with MRSA or VRE were assigned to barrier precautions more frequently in intervention ICUs than in control ICUs (a median of 92% of ICU days with either contact precautions or universal gloving [51% with contact precautions and 43% with universal gloving] in intervention ICUs vs. a median of 38% of ICU days with contact precautions in control ICUs, P<0.001). In intervention ICUs, health care providers used clean gloves, gowns, and hand hygiene less frequently than required for contacts with patients assigned to barrier precautions; when contact precautions were specified, gloves were used for a median of 82% of contacts, gowns for 77% of contacts, and hand hygiene after 69% of contacts, and when universal gloving was specified, gloves were used for a median of 72% of contacts and hand hygiene after 62% of contacts. The mean (±SE) ICU-level incidence of events of colonization or infection with MRSA or VRE per 1000 patient-days at risk, adjusted for baseline incidence, did not differ significantly between the intervention and control ICUs (40.4±3.3 and 35.6±3.7 in the two groups, respectively; P = 0.35).
The intervention was not effective in reducing the transmission of MRSA or VRE, although the use of barrier precautions by providers was less than what was required. (Funded by the National Institute of Allergy and Infectious Diseases and others; STAR*ICU number, NCT00100386.)
PMCID: PMC3410743  PMID: 21488763
14.  Dissemination of an Enterococcus Inc18-Like vanA Plasmid Associated with Vancomycin-Resistant Staphylococcus aureus▿  
Antimicrobial Agents and Chemotherapy  2010;54(10):4314-4320.
Of the 9 vancomycin-resistant Staphylococcus aureus (VRSA) cases reported to date in the literature, 7 occurred in Michigan. In 5 of the 7 Michigan VRSA cases, an Inc18-like vanA plasmid was identified in the VRSA isolate and/or an associated vancomycin-resistant Enterococcus (VRE) isolate from the same patient. This plasmid may play a critical role in the emergence of VRSA. We studied the geographical distribution of the plasmid by testing 1,641 VRE isolates from three separate collections by PCR for plasmid-specific genes traA, repR, and vanA. Isolates from one collection (phase 2) were recovered from surveillance cultures collected in 17 hospitals in 13 states. All VRE isolates from 2 Michigan institutions (n = 386) and between 60 and 70 VRE isolates (n = 883) from the other hospitals were tested. Fifteen VRE isolates (3.9%) from Michigan were positive for an Inc18-like vanA plasmid (9 E. faecalis [12.5%], 3 E. faecium [1.0%], 2 E. avium, and 1 E. raffinosus). Six VRE isolates (0.6%) from outside Michigan were positive (3 E. faecalis [2.7%] and 3 E. faecium [0.4%]). Of all E. faecalis isolates tested, 6.0% were positive for the plasmid, compared to 0.6% for E. faecium and 3.0% for other spp. Fourteen of the 15 plasmid-positive isolates from Michigan had the same Tn1546 insertion site location as the VRSA-associated Inc18-like plasmid, whereas 5 of 6 plasmid-positive isolates from outside Michigan differed in this characteristic. Most plasmid-positive E. faecalis isolates demonstrated diverse patterns by PFGE, with the exception of three pairs with indistinguishable patterns, suggesting that the plasmid is mobile in nature. Although VRE isolates with the VRSA-associated Inc18-like vanA plasmid were more common in Michigan, they remain rare. Periodic surveillance of VRE isolates for the plasmid may be useful in predicting the occurrence of VRSA.
PMCID: PMC2944587  PMID: 20660665
15.  Incidence of Invasive Pneumococcal Disease Among Children After Introduction of a 7-Valent Pneumococcal Conjugate Vaccine: A Population-Based Study in Olmsted County, Minnesota 
Mayo Clinic Proceedings  2009;84(10):871-875.
OBJECTIVE: To examine the effect of the 7-valent pneumococcal conjugate vaccine in a well-characterized population in Olmsted County, Minnesota, with a combination of urban and rural residents likely to have a relatively low risk of invasive pneumococcal disease (IPD).
PATIENTS AND METHODS: This population-based study analyzed data from children younger than 5 years to determine the incidence of IPD from January 1, 1995, to December 31, 2007.
RESULTS: From 1995 through 2007, 29 cases of IPD were identified in the study population, but 2 patients denied research authorization; thus, 27 cases were available for review. From 1995-1999 to 2001-2003, the incidence of IPD decreased from 33.5 (95% confidence interval [CI], 16.6-50.5) to 10.8 (95% CI, 0.0-23.0) cases per 100,000 person-years (68% decrease; P=.046). The incidence subsequently increased to 15.2 (95% CI, 3.0-27.4) cases per 100,000 person-years from 2004 through 2007; however this change was not significant (P=.62). All cases of IPD with available serotype data from 2002 through 2007 (n=5) were due to non-7-valent conjugate vaccine serotypes.
CONCLUSION: Although the baseline incidence of IPD was much lower than that reported in other populations, the overall incidence of IPD decreased significantly in children younger than 5 years after introduction of a 7-valent conjugate vaccine.
From 1995-1999 to 2001-2003, the incidence of invasive pneumococcal disease in children younger than 5 years decreased from 33.5 to 10.8 cases per 100,000 person-years. The incidence increased to 15.2 cases per 100,000 person-years from 2004-2007; however, this change was not significant. The overall incidence of invasive pneumococcal disease decreased significantly after introduction of a 7-valent conjugate vaccine.
PMCID: PMC2755806  PMID: 19797776
16.  Predicting Clearance of Colonization with Vancomycin-Resistant Enterococci and Methicillin-Resistant Staphylococcus aureus by Use of Weekly Surveillance Cultures▿  
Journal of Clinical Microbiology  2009;47(4):1229-1230.
We analyzed surveillance cultures for vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) collected during a multicenter trial to determine if three negative cultures collected at weekly intervals would predict clearance of VRE or MRSA from colonized patients. Seventy-two percent of VRE-colonized patients and 94% of MRSA-colonized patients were culture negative after three consecutive negative cultures.
PMCID: PMC2668339  PMID: 19244462

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