Alison Tse Kawai

Health Care-Associated Infections Among Critically Ill Children in the US, 2007-2012

BACKGROUND: Health care–associated infections (HAIs) are harmful and costly and can result in substantial morbidity for hospitalized children; however, little is known about national trends in HAIs in neonatal and pediatric populations. Our objective was to determine the incidence of HAIs among a large sample of hospitals in the United States caring for critically ill children from 2007 to 2012. METHODS: In this cohort study, we included NICUs and PICUs located in hospitals reporting data to the Centers for Disease Control and Prevention’s National Healthcare Safety Network for central line–associated bloodstream infections (CLABSIs), ventilator-associated pneumonias, and catheter-associated urinary tract infections. We used a time-series design to evaluate changes in HAI rates. RESULTS: A total of 173 US hospitals provided data from NICUs, and 64 provided data from PICUs. From 2007 to 2012, rates of CLABSIs decreased in NICUs from 4.9 to 1.5 per 1000 central-line days (incidence rate ratio (IRR) per quarter = 0.96, 95% confidence interval 0.94–0.97) and in PICUs from 4.7 to 1.0 per 1000 central-line days (IRR per quarter = 0.96 [0.94–0.98]). Rates of ventilator-associated pneumonias decreased in NICUs from 1.6 to 0.6 per 1000 ventilator days (IRR per quarter = 0.97 [0.93–0.99]) and PICUs from 1.9 to 0.7 per 1000 ventilator-days (IRR per quarter = 0.95 [0.92–0.98]). Rates of catheter-associated urinary tract infections did not change significantly in PICUs. CONCLUSIONS: Between 2007 and 2012 there were substantial reductions in HAIs among hospitalized neonates and children.

Absence of associations between influenza vaccines and increased risks of seizures, Guillain–Barré syndrome, encephalitis, or anaphylaxis in the 2012–2013 season

We conducted weekly surveillance for pre‐specified adverse events following receipt of the 2012–2013 influenza vaccines in the Vaccine Safety Datalink (VSD).

A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program

The Postlicensure Rapid Immunization Safety Monitoring Program, the vaccination safety monitoring component of the US Food and Drug Administrations Mini-Sentinel project, is currently the largest cohort in the US general population for vaccine safety surveillance. We developed a study design selection framework to provide a roadmap and description of methods that may be utilized to evaluate potential associations between vaccines and health outcomes of interest in the Postlicensure Rapid Immunization Safety Monitoring Program and other systems using administrative data. The strengths and weaknesses of designs for vaccine safety monitoring, including the cohort design, the case-centered design, the risk interval design, the case-control design, the self-controlled risk interval design, the self-controlled case series method, and the case-crossover design, are described and summarized in tabular form. A structured decision table is provided to aid in planning of future vaccine safety monitoring activities, and the data components comprising the structured decision table are delineated. The study design selection framework provides a starting point for planning vaccine safety evaluations using claims-based data sources.

Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data☆

ongenital anomalies: Case definition and guidelines for data ollection, analysis, and presentation of immunization safety data alini DeSilvaa, Flor M. Munozb, Mark Mcmillanc,d, Alison Tse Kawaie, Helen Marshalld, ristine K. Macartneyf,g, Jyoti Joshih, Martina Onekoi, Annette Elliott Rose j, Helen Dolkk, rancesco Trotta l, Hans Spiegelm, Sylvie Tomczykn, Anju Shresthao, Sonali Kochharp, lyse O. Kharbandaa,∗, The Brighton Collaboration Congenital Anomalies Working Group1

Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons

The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre‐specified adverse events following receipt of influenza vaccines during the 2013–2014 and 2014–2015 seasons in the Vaccine Safety Datalink (VSD).

Impact of the Centers for Medicare and Medicaid Services Hospital-Acquired Conditions Policy on Billing Rates for 2 Targeted Healthcare-Associated Infections.

BACKGROUND The 2008 Centers for Medicare & Medicaid Services hospital-acquired conditions policy limited additional payment for conditions deemed reasonably preventable. OBJECTIVE To examine whether this policy was associated with decreases in billing rates for 2 targeted conditions, vascular catheter-associated infections (VCAI) and catheter-associated urinary tract infections (CAUTI). STUDY POPULATION Adult Medicare patients admitted to 569 acute care hospitals in California, Massachusetts, or New York and subject to the policy. DESIGN We used an interrupted times series design to assess whether the hospital-acquired conditions policy was associated with changes in billing rates for VCAI and CAUTI. RESULTS Before the policy, billing rates for VCAI and CAUTI were increasing (prepolicy odds ratio per quarter for VCAI, 1.17 [95% CI, 1.11-1.23]; for CAUTI, 1.19 [1.16-1.23]). The policy was associated with an immediate drop in billing rates for VCAI and CAUTI (odds ratio for change at policy implementation for VCAI, 0.75 [95% CI, 0.69-0.81]; for CAUTI, 0.87 [0.79-0.96]). In the postpolicy period, we observed a decreasing trend in the billing rate for VCAI and a leveling-off in the billing rate for CAUTI (postpolicy odds ratio per quarter for VCAI, 0.98 [95% CI, 0.97-0.99]; for CAUTI, 0.99 [0.97-1.00]). CONCLUSIONS The Centers for Medicare & Medicaid Services hospital-acquired conditions policy appears to have been associated with immediate reductions in billing rates for VCAI and CAUTI, followed by a slight decreasing trend or leveling-off in rates. These billing rates, however, may not correlate with changes in clinically meaningful patient outcomes and may reflect changes in coding practices.

Stillbirth: Case definition and guidelines for data collection, analysis, and presentation of maternal immunization safety data ☆

No abstract available Keywords: Adverse event; Case definition; Fetal death; Guidelines; Immunization; Stillbirth.

Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System

To develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini‐Sentinel Pilot), a Food and Drug Administration‐sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly.

Impact of Medicare’s Hospital-Acquired Condition Policy on Infections in Safety Net and Non–Safety Net Hospitals

BACKGROUND Policymakers may wish to align healthcare payment and quality of care while minimizing unintended consequences, particularly for safety net hospitals. OBJECTIVE To determine whether the 2008 Centers for Medicare and Medicaid Services Hospital-Acquired Conditions policy had a differential impact on targeted healthcare-associated infection rates in safety net compared with non-safety net hospitals. DESIGN Interrupted time-series design. SETTING AND PARTICIPANTS Nonfederal acute care hospitals that reported central line-associated bloodstream infection and ventilator-associated pneumonia rates to the Centers for Disease Control and Preventions National Health Safety Network from July 1, 2007, through December 31, 2013. RESULTS We did not observe changes in the slope of targeted infection rates in the postpolicy period compared with the prepolicy period for either safety net (postpolicy vs prepolicy ratio, 0.96 [95% CI, 0.84-1.09]) or non-safety net (0.99 [0.90-1.10]) hospitals. Controlling for prepolicy secular trends, we did not detect differences in an immediate change at the time of the policy between safety net and non-safety net hospitals (P for 2-way interaction, .87). CONCLUSIONS The Centers for Medicare and Medicaid Services Hospital-Acquired Conditions policy did not have an impact, either positive or negative, on already declining rates of central line-associated bloodstream infection in safety net or non-safety net hospitals. Continued evaluations of the broad impact of payment policies on safety net hospitals will remain important as the use of financial incentives and penalties continues to expand in the United States.

Febrile Seizures After 2010-2011 Trivalent Inactivated Influenza Vaccine.

OBJECTIVES: In the Post-Licensure Rapid Immunization Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010–2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP). Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination. METHODS: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0–1 days) versus control interval (14–20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records. RESULTS: No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95% confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95% CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95% CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100 000 with same day administration, 95% CI −5.68 to 6.09). CONCLUSIONS: No statistically significant increased risk of FS was found for 2010–2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination.