Dr. Grace Lee is Professor of Pediatrics at Stanford University School of Medicine and Associate Chief Medical Officer for Practice Innovation at Stanford Children’s Health. In her current role, Dr. Lee primarily serves as a clinical and administrative leader for the health system focused on bridging quality, research and implementation for the organization. She previously served as the Principal Investigator (PI) on the CDC-funded Vaccine Safety Datalink project, Associate Director of the FDA-funded Mini-Sentinel Project, PI of an AHRQ-funded grant to develop a national surveillance definition for pediatric ventilator-associated events and to identify potential intervention bundles to improve quality of care, and PI of an AHRQ-funded grant to evaluate the health and economic impact of the CMS Hospital-Acquired Conditions and Value-Based Purchasing policies. Dr. Lee previously served as a member on the Institute of Medicine Committee (IOM) to Review Priorities in the National Vaccine Plan, the IOM Committee on the Ethical and Scientific Issues in Studying the Safety of Approved Drugs, NASEM's Vaccine Research and Development Recommendations for Advancing Pandemic and Seasonal Influenza Preparedness and Response, and AHRQ's Healthcare Safety and Quality Improvement Research Study Section. Dr. Lee also served as a Board Member for the Society for Healthcare Epidemiology of America (SHEA), Pediatric Infectious Diseases Society (PIDS), and the National Academy of Medicine Board on Population Health and Public Practice. She is currently the Chair of the U.S. Advisory Committee on Immunization Practices (ACIP) that sets recommendations for the use of vaccines in the U.S. population, including COVID-19 vaccines, and liaison to the Board of Scientific Counselors for CDC's Deputy Director for Infectious Diseases.
- Pediatric Infectious Diseases
- Healthcare associated infections
- Public Health Surveillance
- Health policy
- Implementation science
Professor - University Medical Line, Pediatrics - Infectious Diseases
Chair, Advisory Committee on Immunization Practices (2021 - Present)
Associate Chief Medical Officer for Practice Innovation, Stanford Children's Health (2017 - Present)
Boards, Advisory Committees, Professional Organizations
Member, Advisory Committee on Immunization Practices (2016 - 2021)
Executive Committee, Board of Trustees, Society for Healthcare Epidemiology of America (2017 - 2019)
Ventilator-Associated Events Hospital-Acquired Conditions Workgroup, Leadership Team, Children’s Hospitals’ Solutions for Patient Safety National Children’s Network (2016 - 2019)
Board of Directors, Pediatric Infectious Diseases Society (PIDS) (2015 - 2019)
Member, Board on Population Health and Public Practice, National Academies of Medicine (2013 - 2019)
Fellowship: Boston Children's Hospital (2003) MA
Board Certification: American Board of Pediatrics, Pediatric Infectious Diseases (2003)
Medical Education: Perelman School of Medicine University of Pennsylvania (1997) PA
Residency: Boston Children's Hospital (Combined Residency in Pediatrics) (2000)
Projected risks and health benefits of vaccination against herpes zoster and related complications in US adults.
Human vaccines & immunotherapeutics
The Advisory Committee on Immunization Practices (ACIP) recommends recombinant zoster vaccine (RZV) to prevent against herpes zoster (HZ) and related complications in immunocompetent adults ≥50y and immunocompromised adults ≥19y. In 2019, a statistical safety signal for Guillain-Barre syndrome (GBS) following RZV was identified using data from the Vaccine Safety Datalink (VSD). Subsequently, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and collaborators undertook additional analyses using Centers for Medicare & Medicaid Services (CMS) Medicare data to further investigate the potential risk of GBS following RZV. Concurrently, epidemiologic data suggested a potentially elevated risk of GBS following HZ in U.S. adults. Using data from these sources and a published simulation model, this study evaluated the health benefits and risks associated with vaccinating immunocompetent adults ≥50y with RZV compared to no vaccination. In the base case analysis, RZV vaccination averted 43,000-63,000 cases of HZ, including GBS complications, per million vaccinated per 10-y age cohort compared to 3-6 additional cases of GBS projected following RZV per million vaccinated in the same population. This analysis highlights the projected health benefits of RZV vaccination compared to the relatively low potential risk of GBS following RZV.
View details for DOI 10.1080/21645515.2022.2060668
View details for PubMedID 35476029
Immunisation rates and predictors of undervaccination in infants with CHD.
Cardiology in the young
Vaccination coverage for infants with CHD is unknown, yet these patients are at high risk for morbidity and mortality associated with vaccine-preventable illnesses. We determined vaccination rates for this population and identified predictors of undervaccination. We prospectively enrolled infants with CHD born between 1 January, 2012 and 31 December, 2015, seen in a single-centre cardiology clinic between 15 February, 2016 and 28 February, 2017. We assessed vaccination during the first year of life. Subjects who by age 1 year received all routine immunisations recommended during the first 6 months of life were considered fully vaccinated. We also evaluated influenza vaccination during subjects' first eligible influenza season. We obtained immunisation histories from primary care providers and collected demographic and clinical data via a parent survey and chart review. We used multivariable logistic regression to identify predictors of undervaccination. Among 260 subjects, only 60% were fully vaccinated. Vaccination rates were lowest for influenza (64.6%), rotavirus (71.1%), and Haemophilus influenzae type b (79.3%). Cardiac surgery with cardiopulmonary bypass during the first year of life was associated with undervaccination (51.5% versus 76.4% fully vaccinated, adjusted odds ratio 2.1 [95% confidence interval 1.1-3.9]). Other predictors of undervaccination were out-of-state primary care (adjusted odds ratio 2.7 [1.5-4.9]), multiple comorbidities (≥2 versus 0-1, adjusted odds ratio 2.0 [1.1-3.6]), and hospitalisation for >25% of the first year of life (>25% versus ≤25%, adjusted odds ratio 2.1 [1.1-3.9]). Targeted quality improvement initiatives focused on improving vaccination coverage for these infants, especially surrounding cardiac surgery, are needed.
View details for DOI 10.1017/S104795112200052X
View details for PubMedID 35411845
Cardiac Complications After SARS-CoV-2 Infection and mRNA COVID-19 Vaccination - PCORnet, United States, January 2021-January 2022
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2022; 71 (14): 517-523
Cardiac complications, particularly myocarditis and pericarditis, have been associated with SARS-CoV-2 (the virus that causes COVID-19) infection (1-3) and mRNA COVID-19 vaccination (2-5). Multisystem inflammatory syndrome (MIS) is a rare but serious complication of SARS-CoV-2 infection with frequent cardiac involvement (6). Using electronic health record (EHR) data from 40 U.S. health care systems during January 1, 2021-January 31, 2022, investigators calculated incidences of cardiac outcomes (myocarditis; myocarditis or pericarditis; and myocarditis, pericarditis, or MIS) among persons aged ≥5 years who had SARS-CoV-2 infection, stratified by sex (male or female) and age group (5-11, 12-17, 18-29, and ≥30 years). Incidences of myocarditis and myocarditis or pericarditis were calculated after first, second, unspecified, or any (first, second, or unspecified) dose of mRNA COVID-19 (BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) vaccines, stratified by sex and age group. Risk ratios (RR) were calculated to compare risk for cardiac outcomes after SARS-CoV-2 infection to that after mRNA COVID-19 vaccination. The incidence of cardiac outcomes after mRNA COVID-19 vaccination was highest for males aged 12-17 years after the second vaccine dose; however, within this demographic group, the risk for cardiac outcomes was 1.8-5.6 times as high after SARS-CoV-2 infection than after the second vaccine dose. The risk for cardiac outcomes was likewise significantly higher after SARS-CoV-2 infection than after first, second, or unspecified dose of mRNA COVID-19 vaccination for all other groups by sex and age (RR 2.2-115.2). These findings support continued use of mRNA COVID-19 vaccines among all eligible persons aged ≥5 years.
View details for Web of Science ID 000784787000001
View details for PubMedID 35389977
View details for PubMedCentralID PMC8989373
Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021.
BACKGROUND AND OBJECTIVES: High transmissibility of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant led to increased coronavirus disease 2019 (COVID-19) cases, but its effect on severe illness among children is less clear. This study evaluated changes in COVID-19 severity from March 1, 2020, to December 30, 2021.METHODS: We examined electronic health record data from encounters that occurred in outpatient and inpatient settings in 9 health systems participating in PEDSnet. The study sample included children aged <18 years with a positive viral test for SARS-CoV-2. Severity was categorized as asymptomatic, mild (symptoms), moderate (moderately severe COVID-19-related conditions such as gastroenteritis, dehydration, and pneumonia), or severe (unstable COVID-19-related conditions, ICU admission, or mechanical ventilation).RESULTS: The number of patients classified as asymptomatic was 54948 (66.4%), with 22303 (26.9%) being mild, 3781 (4.6%) being moderate, and 1766 (2.1%) being severe. In 2021, patients with moderate to severe illness peaked in June (13.5%), declining to December (8.1%). Compared with July 2020 to February 2021, the adjusted odds ratio for moderate to severe illness was highest in June 2021 (adjusted odds ratio, 2.8; 95% confidence interval, 2.2-3.6) and lower in July to December 2021, when the Delta variant predominated. The adjusted odds ratio for moderate to severe illness among children with complex chronic conditions was 4.2 (95% confidence interval, 3.9-4.5).CONCLUSIONS: Although 1 in 16 children infected with the SARS-CoV-2 virus experienced moderate or severe illness, the risk of severe disease did not change with the emergence of the Delta variant, despite its high transmissibility.
View details for DOI 10.1542/peds.2021-055765
View details for PubMedID 35322270
The Advisory Committee on Immunization Practices' Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged >= 18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines - United States, February 2022
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2022; 71 (11): 416-421
The mRNA-1273 (Moderna) COVID-19 vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. During December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use among persons aged ≥18 years (1), which was adopted by CDC. During December 19, 2020-January 30, 2022, approximately 204 million doses of Moderna COVID-19 vaccine were administered in the United States (2) as a primary series of 2 intramuscular doses (100 μg [0.5 mL] each) 4 weeks apart. On January 31, 2022, FDA approved a Biologics License Application (BLA) for use of the Moderna COVID-19 vaccine (Spikevax, ModernaTX, Inc.) in persons aged ≥18 years (3). On February 4, 2022, the ACIP COVID-19 Vaccines Work Group conclusions regarding recommendations for the use of the Moderna COVID-19 vaccine were presented to ACIP at a public meeting. The Work Group's deliberations were based on the Evidence to Recommendation (EtR) Framework,* which incorporates the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach† to rank evidence quality. In addition to initial clinical trial data, ACIP considered new information gathered in the 12 months since issuance of the interim recommendations, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. ACIP also considered comparisons of mRNA vaccine effectiveness and safety in real-world settings when first doses were administered 8 weeks apart instead of the original intervals used in clinical trials (3 weeks for BNT162b2 [Pfizer-BioNTech] COVID-19 vaccine and 4 weeks for Moderna COVID-19 vaccine). Based on this evidence, CDC has provided guidance that an 8-week interval might be optimal for some adolescents and adults. The additional information gathered since the issuance of the interim recommendations increased certainty that the benefits of preventing symptomatic and asymptomatic SARS-CoV-2 infection, hospitalization, and death outweigh vaccine-associated risks of the Moderna COVID-19 vaccine. On February 4, 2022, ACIP modified its interim recommendation to a standard recommendation§ for use of the fully licensed Moderna COVID-19 vaccine in persons aged ≥18 years.
View details for Web of Science ID 000773341200001
View details for PubMedID 35298454
View details for PubMedCentralID PMC8942305
Factors Influencing Health Equity of Influenza Vaccination in Pediatric Patients.
Pediatric quality & safety
2022; 7 (2): e543
Social factors can be a determinate for multiple health outcomes. We evaluated the association of numerous social factors on rates of influenza nonvaccination in a large pediatric primary and subspecialty care system.Methods: During the 2019-2020 influenza vaccination season, we calculated the nonvaccination rate for a pediatric healthcare system with both subspecialty and primary care practices. We compared influenza vaccination rates for factors that might affect health equity (patient gender, language preference, health insurance payer category, race and ethnicity, and estimated median household income based on zip code analysis) by creating simultaneous 95% confidence intervals using the Wilson method with continuity correction and a Bonferroni adjustment for the number of categories compared.Results: The overall influenza nonvaccination rate was 58.0% (59,375 not vaccinated of 102,377). Statistically significant differences in nonvaccination rate were present for the following health equity indicators: Spanish (75.6%) and Chinese Dialects (78.0%) > English (55.9%) speaking; Hispanic (70.1%) > many other race and ethnicities; Asian (51%) < many other race and ethnicities; Commercial (53.5%) < Public (71.2%) or Self (81.4%) pay; and lower (67.6%-79.1%) > higher median household income (52.9%-56.4%).Conclusions: Non-English language preference, Hispanic ethnicity, public insurance, and lower median household income are associated with a decreased likelihood of influenza vaccination. We are using these data to inform our key drivers to improve influenza vaccination in our system.
View details for DOI 10.1097/pq9.0000000000000543
View details for PubMedID 35369420
- Use of recombinant zoster vaccine in immunocompromised adults aged ≥19 years: Recommendations of the Advisory Committee on Immunization Practices-United States, 2022. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2022; 22 (3): 986-990
National Healthcare Safety Network 2018 Baseline Neonatal Standardized Antimicrobial Administration Ratios.
BACKGROUND: The microbiologic etiologies, clinical manifestations, and antimicrobial treatment of neonatal infections differ substantially from infections in adult and pediatric patient populations. In 2019, the Centers for Disease Control and Prevention developed neonatal-specific (Standardized Antimicrobial Administration Ratios SAARs), a set of risk-adjusted antimicrobial use metrics that hospitals participating in the National Healthcare Safety Network's (NHSN's) antimicrobial use surveillance can use in their antibiotic stewardship programs (ASPs).METHODS: The Centers for Disease Control and Prevention, in collaboration with the Vermont Oxford Network, identified eligible patient care locations, defined SAAR agent categories, and implemented neonatal-specific NHSN Annual Hospital Survey questions to gather hospital-level data necessary for risk adjustment. SAAR predictive models were developed using 2018 data reported to NHSN from eligible neonatal units.RESULTS: The 2018 baseline neonatal SAAR models were developed for 7 SAAR antimicrobial agent categories using data reported from 324 neonatal units in 304 unique hospitals. Final models were used to calculate predicted antimicrobial days, the SAAR denominator, for level II neonatal special care nurseries and level II/III, III, and IV NICUs.CONCLUSIONS: NHSN's initial set of neonatal SAARs provides a way for hospital ASPs to assess whether antimicrobial agents in their facility are used at significantly higher or lower rates compared with a national baseline or whether an individual SAAR value is above or below a specific percentile on a given SAAR distribution, which can prompt investigations into prescribing practices and inform ASP interventions.
View details for DOI 10.1542/hpeds.2021-006253
View details for PubMedID 35075483
Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2022; 71 (3): 90-95
On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.
View details for Web of Science ID 000746214000001
View details for PubMedID 35051137
View details for PubMedCentralID PMC8774160
Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged >= 19 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2022; 71 (3): 80-84
Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline [GSK]) is a 2-dose (0.5 mL each) subunit vaccine containing recombinant glycoprotein E in combination with adjuvant (AS01B) that was licensed in the United States for prevention of herpes zoster for adults aged ≥50 years by the Food and Drug Administration (FDA) and recommended for immunocompetent adults aged ≥50 years by the Advisory Committee on Immunization Practices (ACIP) in 2017* (1). On July 23, 2021, the FDA expanded the indication for recombinant zoster vaccine (RZV) to include adults aged ≥18 years who are or will be at increased risk for herpes zoster because of immunodeficiency or immunosuppression caused by known disease or therapy (2). On October 20, 2021, ACIP recommended 2 doses of RZV for the prevention of herpes zoster and related complications in adults aged ≥19 years† who are or will be immunodeficient or immunosuppressed because of disease or therapy. RZV is the first herpes zoster vaccine approved for use in immunocompromised persons. With moderate to high vaccine efficacy and an acceptable safety profile, RZV has the potential to prevent considerable herpes zoster incidence and related complications. This report updates previous ACIP recommendations for the prevention of herpes zoster (1,3).
View details for Web of Science ID 000745711800001
View details for PubMedID 35051134
View details for PubMedCentralID PMC8774159
Infectious Diseases Society of America Guidelines on Infection Prevention for Healthcare Personnel Caring for Patients with Suspected or Known COVID-19.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
BACKGROUND: Since its emergence in late 2019, SARS-CoV-2 continues to pose a risk to healthcare personnel (HCP) and patients in healthcare settings. Although all clinical interactions likely carry some risk of transmission, human actions like coughing and care activities like aerosol-generating procedures likely have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 continues to create significant challenges in healthcare facilities, particularly with shortages of personal protective equipment (PPE) used by HCP. Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care continue to be needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators.OBJECTIVE: Develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known COVID-19.METHODS: IDSA formed a multidisciplinary guideline panel including frontline clinicians, infectious disease specialists, experts in infection control, and guideline methodologists with representation from the disciplines of public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations.RESULTS: The IDSA guideline panel agreed on eight recommendations, including two updated recommendations and one new recommendation added since the first version of the guideline. Narrative summaries of other interventions undergoing evaluations are also included.CONCLUSIONS: Using a combination of direct and indirect evidence, the panel was able to provide recommendations for eight specific questions on the use of PPE for HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 and PPE recommendations may need to be modified in response to new evidence. These recommendations should serve as a minimum for PPE use in healthcare facilities and do not preclude decisions based on local risk assessments or requirements of local health jurisdictions or other regulatory bodies.
View details for DOI 10.1093/cid/ciab953
View details for PubMedID 34791102
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (45): 1579-1583
The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 vaccine is also recommended for adolescents aged 12-15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 μg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥12 years in the United States.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5-11 years, administered as 2 doses (10 μg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years for the prevention of COVID-19. To guide its deliberations regarding recommendations for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework§ and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.¶ The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5-11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community transmission of SARS-CoV-2.
View details for Web of Science ID 000718549900001
View details for PubMedID 34758012
View details for PubMedCentralID PMC8580204
The Advisory Committee on Immunization Practices' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (44): 1545-1552
Three COVID-19 vaccines are currently approved under a Biologics License Application (BLA) or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP) in the United States: the 2-dose mRNA-based Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines and the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine (1,2) (Box 1). In August 2021, FDA amended the EUAs for the two mRNA COVID-19 vaccines to allow for an additional primary dose in certain immunocompromised recipients of an initial mRNA COVID-19 vaccination series (1). During September-October 2021, FDA amended the EUAs to allow for a COVID-19 vaccine booster dose following a primary mRNA COVID-19 vaccination series in certain recipients aged ≥18 years who are at increased risk for serious complications of COVID-19 or exposure to SARS-CoV-2 (the virus that causes COVID-19), as well as in recipients aged ≥18 years of Janssen COVID-19 vaccine (1) (Table). For the purposes of these recommendations, an additional primary (hereafter additional) dose refers to a dose of vaccine administered to persons who likely did not mount a protective immune response after initial vaccination. A booster dose refers to a dose of vaccine administered to enhance or restore protection by the primary vaccination, which might have waned over time. Health care professionals play a critical role in COVID-19 vaccination efforts, including for primary, additional, and booster vaccination, particularly to protect patients who are at increased risk for severe illness and death.
View details for Web of Science ID 000717212000001
View details for PubMedID 34735422
View details for PubMedCentralID PMC8568093
Assessment of Federal Value-Based Incentive Programs and In-Hospital Clostridioides difficile Infection Rates.
JAMA network open
2021; 4 (10): e2132114
Importance: Health care facility-onset Clostridioides difficile infection (HO-CDI) rates reported to the US Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN) became a target quality metric for 2 Centers for Medicare & Medicaid Services (CMS) value-based incentive programs (VBIPs) in October 2016. The association of VBIPs with HO-CDI rates is unknown.Objective: To examine the association between VBIP implementation and HO-CDI rates.Design, Setting, and Participants: This interrupted time series study evaluated HO-CDI rates among adults hospitalized from January 2013 to March 2019 at 265 acute-care hospitals.Interventions: Implementation of VBIPs in October 2016.Main Outcomes and Measures: Quarterly rates of HO-CDI per 10 000 patient-days, as reported to NHSN by participating hospitals, were evaluated. Generalized estimating equations were used to fit negative binomial regression models to estimate immediate program effect size (ie, level change) and changes in the slope of HO-CDI rates, controlling for each hospital's predominant method of CDI testing (ie, nucleic acid amplification test [NAAT], enzyme immunoassay [EIA] for toxin, or other testing methods).Results: The study cohort included 24 332 938 admissions, 109 371 136 patient-days, and 74 681 HO-CDI events at 265 hospitals (145 [55%] with 100-399 beds; 205 [77%] not-for-profit hospitals; 185 [70%] teaching hospitals; 229 [86%] in metropolitan areas). Compared with EIA, rates of HO-CDI were higher when detected by NAAT (adjusted incidence rate ratio [aIRR], 1.55; 95% CI, 1.40-1.70; P<.001) and other testing methods (aIRR, 1.47; 95% CI, 1.26-1.71; P<.001). There were no significant changes in testing methods used by hospitals immediately after VBIP implementation. Controlling for CDI testing method, VBIP implementation was associated with a 6% level decline in HO-CDI rates in the immediate postpolicy quarter (aIRR, 0.94; 95% CI, 0.89-0.99; P=.01) and a 4% decline in slope per quarter (aIRR, 0.96; 95% CI, 0.95-0.97; P<.001). Results were similar in a sensitivity analysis using a 1-year roll-in period accounting for the period after the announcement of the HO-CDI VBIP policy and prior to its implementation.Conclusions and Relevance: In this study, VBIP implementation was associated with improvements in HO-CDI rates, independent of CDI testing method. Given that CMS payment policies have not previously been associated with improvements in other targeted health care-associated infection rates, future research should focus on elucidating the specific processes that contributed to improvement in HO-CDI rates to inform the design of future VBIP interventions.
View details for DOI 10.1001/jamanetworkopen.2021.32114
View details for PubMedID 34714336
Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged >= 16 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (38): 1344-1348
The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. In December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) as well as an interim recommendation for use among persons aged ≥16 years by the Advisory Committee on Immunization Practices (ACIP) (1). In May 2021, the EUA and interim ACIP recommendations for Pfizer-BioNTech COVID-19 vaccine were extended to adolescents aged 12-15 years (2). During December 14, 2020-September 1, 2021, approximately 211 million doses of Pfizer-BioNTech COVID-19 vaccine were administered in the United States.* On August 23, 2021, FDA approved a Biologics License Application for use of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (3). The ACIP COVID-19 Vaccines Work Group's conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at a public meeting on August 30, 2021. To guide its deliberations regarding the Pfizer-BioNTech COVID-19 vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,† and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.§ In addition to initial clinical trial data, ACIP considered new information gathered in the 8 months since issuance of the interim recommendation for Pfizer-BioNTech COVID-19 vaccine, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. The additional information increased certainty that benefits from prevention of asymptomatic infection, COVID-19, and associated hospitalization and death outweighs vaccine-associated risks. On August 30, 2021, ACIP issued a recommendation¶ for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.
View details for Web of Science ID 000701940200006
View details for PubMedID 34555007
View details for PubMedCentralID PMC8459897
Assessment of Allergic and Anaphylactic Reactions to mRNA COVID-19 Vaccines With Confirmatory Testing in a US Regional Health System.
JAMA network open
2021; 4 (9): e2125524
Importance: As of May 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths. Anaphylactic reactions associated with the Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines have been reported.Objective: To characterize the immunologic mechanisms underlying allergic reactions to these vaccines.Design, Setting, and Participants: This case series included 22 patients with suspected allergic reactions to mRNA COVID-19 vaccines between December 18, 2020, and January 27, 2021, at a large regional health care network. Participants were individuals who received at least 1 of the following International Statistical Classification of Diseases and Related Health Problems, Tenth Revision anaphylaxis codes: T78.2XXA, T80.52XA, T78.2XXD, or E949.9, with documentation of COVID-19 vaccination. Suspected allergy cases were identified and invited for follow-up allergy testing.Exposures: FDA-authorized mRNA COVID-19 vaccines.Main Outcomes and Measures: Allergic reactions were graded using standard definitions, including Brighton criteria. Skin prick testing was conducted to polyethylene glycol (PEG) and polysorbate 80 (P80). Histamine (1 mg/mL) and filtered saline (negative control) were used for internal validation. Basophil activation testing after stimulation for 30 minutes at 37 °C was also conducted. Concentrations of immunoglobulin (Ig) G and IgE antibodies to PEG were obtained to determine possible mechanisms.Results: Of 22 patients (20 [91%] women; mean [SD] age, 40.9 [10.3] years; 15 [68%] with clinical allergy history), 17 (77%) met Brighton anaphylaxis criteria. All reactions fully resolved. Of patients who underwent skin prick tests, 0 of 11 tested positive to PEG, 0 of 11 tested positive to P80, and 1 of 10 (10%) tested positive to the same brand of mRNA vaccine used to vaccinate that individual. Among these same participants, 10 of 11 (91%) had positive basophil activation test results to PEG and 11 of 11 (100%) had positive basophil activation test results to their administered mRNA vaccine. No PEG IgE was detected; instead, PEG IgG was found in tested individuals who had an allergy to the vaccine.Conclusions and Relevance: Based on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy. Immunological testing suggests non-IgE-mediated immune responses to PEG may be responsible in most individuals.
View details for DOI 10.1001/jamanetworkopen.2021.25524
View details for PubMedID 34533570
- The Importance of Context in Covid-19 Vaccine Safety. The New England journal of medicine 2021
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (32): 1094-1099
In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public.
View details for Web of Science ID 000685284200006
View details for PubMedID 34383735
View details for PubMedCentralID PMC8360272
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (27): 977-982
In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,† and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.§ In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,¶ which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. On June 23, 2021, after reviewing available evidence including that for risks of myocarditis, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA's EUA clearly outweigh the risks in all populations, including adolescents and young adults. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis.
View details for Web of Science ID 000682951000004
View details for PubMedID 34237049
View details for PubMedCentralID PMC8312754
Development and Implementation of a Real-time Bundle-adherence Dashboard for Central Line-associated Bloodstream Infections.
Pediatric quality & safety
2021; 6 (4): e431
Introduction: Central line-associated bloodstream infections (CLABSIs) are the most common hospital-acquired infection in pediatric patients. High adherence to the CLABSI bundle mitigates CLABSIs. At our institution, there did not exist a hospital-wide system to measure bundle-adherence. We developed an electronic dashboard to monitor CLABSI bundle-adherence across the hospital and in real time.Methods: Institutional stakeholders and areas of opportunity were identified through interviews and data analyses. We created a data pipeline to pull adherence data from twice-daily bundle checks and populate a dashboard in the electronic health record. The dashboard was developed to allow visualization of overall and individual element bundle-adherence across units. Monthly dashboard accesses and element-level bundle-adherence were recorded, and the nursing staff's feedback about the dashboard was obtained.Results: Following deployment in September 2018, the dashboard was primarily accessed by quality improvement, clinical effectiveness and analytics, and infection prevention and control. Quality improvement and infection prevention and control specialists presented dashboard data at improvement meetings to inform unit-level accountability initiatives. All-element adherence across the hospital increased from 25% in September 2018 to 44% in December 2019, and average adherence to each bundle element increased between 2018 and 2019.Conclusions: CLABSI bundle-adherence, overall and by element, increased across the hospital following the deployment of a real-time electronic data dashboard. The dashboard enabled population-level surveillance of CLABSI bundle-adherence that informed bundle accountability initiatives. Data transparency enabled by electronic dashboards promises to be a useful tool for infectious disease control.
View details for DOI 10.1097/pq9.0000000000000431
View details for PubMedID 34235355
Post-vaccination SARS-CoV-2 infections and incidence of presumptive B.1.427/B.1.429 variant among healthcare personnel at a northern California academic medical center.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
BACKGROUND: Although mRNA-based SARS-CoV-2 vaccines report ≥90% efficacy, breakthrough infections occur. Little is known about the effectiveness of these vaccines against SARS-CoV-2 variants, including the highly-prevalent B.1.427/B.1.429 variant in California..METHODS: In this quality improvement project, we collected demographic and clinical information from post-vaccine SARS-CoV-2 cases (PVSCs), defined as health care personnel (HCP) with positive SARS-CoV-2 NAAT after receiving ≥1 vaccine dose. Available specimens were tested for L452R, N501Y and E484K mutations by RT-PCR. Mutation prevalence was compared among unvaccinated, early post-vaccinated (<=14 days after dose 1), partially vaccinated (positive test >14 days after dose 1 and ≤14 days after dose 2) and fully vaccinated (>14 days after dose 2) PVSCs.RESULTS: From December 2020-April 2021, >=23,090 HCPS received at least1 dose of an mRNA-based SARS-CoV-2 vaccine, and 660 HCP cases of SARS-CoV-2 occurred of which 189 were PVSCs. Among the PVSCs, 114 (60.3%), 49 (25.9%) and 26 (13.8%) were early post-vaccination, partially vaccinated, and fully vaccinated, respectively. Of 261 available samples from vaccinated and unvaccinated HCP, 103 (39.5%), including 42 PVSCs (36.5%), had L452R mutation presumed to be B.1.427/B.1.429,. When adjusted for community prevalence of B.1.427/B.1.429, PVSCs did not have significantly elevated risk for infection with B.1.427/B.1.429 compared with unvaccinated HCP.CONCLUSIONS: Most PVSCs occurred prior to expected onset of full, vaccine-derived immunity. Presumptive B.1.427/B.1.429 was not more prevalent in post-vaccine cases than in unvaccinated SARS-CoV-2 HCP. Continued infection control measures, particularly ≤14 days post-vaccination, and continued variant surveillance in PVSCs is imperative to control future SARS-CoV-2 surges.
View details for DOI 10.1093/cid/ciab554
View details for PubMedID 34137815
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years - United States, May 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (20): 749-752
The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged ≥16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,§ using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.¶ The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥12 years under an EUA is interim and will be updated as additional information becomes available.
View details for DOI 10.15585/mmwr.mm7020e1
View details for Web of Science ID 000652325700004
View details for PubMedID 34014913
View details for PubMedCentralID PMC8136423
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 70 (17): 651–56
On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS.
View details for Web of Science ID 000646770100009
View details for PubMedID 33914723
- The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Janssen COVID-19 Vaccine - United States, February 2021 MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT 2021; 70 (9): 329–32
Implementation of clinical practice changes in the PICU: a qualitative study using and refining the iPARIHS framework.
Implementation science : IS
2021; 16 (1): 15
Like in many settings, implementation of evidence-based practices often fall short in pediatric intensive care units (PICU). Very few prior studies have applied implementation science frameworks to understand how best to improve practices in this unique environment. We used the relatively new integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework to assess practice improvement in the PICU and to explore the utility of the framework itself for that purpose.We used the iPARIHS framework to guide development of a semi-structured interview tool to examine barriers, facilitators, and the process of change in the PICU. A framework approach to qualitative analysis, developed around iPARIHS constructs and subconstructs, helped identify patterns and themes in provider interviews. We assessed the utility of iPARIHS to inform PICU practice change.Fifty multi-professional providers working in 8 U.S. PICUs completed interviews. iPARIHS constructs shaped the development of a process model for change that consisted of phases that include planning, a decision to adopt change, implementation and facilitation, and sustainability; the PICU environment shaped each phase. Large, complex multi-professional teams, and high-stakes work at near-capacity impaired receptivity to change. While the unit leaders made decisions to pursue change, providers' willingness to accept change was based on the evidence for the change, and provider's experiences, beliefs, and capacity to integrate change into a demanding workflow. Limited analytic structures and resources frustrated attempts to monitor changes' impacts. Variable provider engagement, time allocated to work on changes, and limited collaboration impacted facilitation. iPARIHS constructs were useful in exploring implementation; however, we identified inter-relation of subconstructs, unique concepts not captured by the framework, and a need for subconstructs to further describe facilitation.The PICU environment significantly shaped the implementation. The described process model for implementation may be useful to guide efforts to integrate changes and select implementation strategies. iPARIHS was adequate to identify barriers and facilitators of change; however, further elaboration of subconstructs for facilitation would be helpful to operationalize the framework.Not applicable, as no health care intervention was performed.
View details for DOI 10.1186/s13012-021-01080-9
View details for PubMedID 33509190
Factors Influencing Implementation of Blood Transfusion Recommendations in Pediatric Critical Care Units.
Frontiers in pediatrics
1800; 9: 800461
Purpose: Risks of red blood cell transfusion may outweigh benefits for many patients in Pediatric Intensive Care Units (PICUs). The Transfusion and Anemia eXpertise Initiative (TAXI) recommendations seek to limit unnecessary and potentially harmful transfusions, but use has been variable. We sought to identify barriers and facilitators to using the TAXI recommendations to inform implementation efforts. Materials and Methods: The integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework guided semi-structured interviews conducted in 8 U.S. ICUs; 50 providers in multiple ICU roles completed interviews. Adapted Framework analysis, a form of content analysis, used the iPARIHS innovation, recipient, context and facilitation constructs and subconstructs to categorize data and identify patterns as well as unique informative statements. Results: Providers perceived that the TAXI recommendations would reduce transfusion rates and practice variability, but adoption faced challenges posed by attitudes around transfusion and care in busy and complex units. Development of widespread buy-in and inclusion in implementation, integration into workflow, designating committed champions, and monitoring outcomes data were expected to enhance implementation. Conclusions: Targeted activities to create buy-in, educate, and plan for use are necessary for TAXI implementation. Recognition of contextual challenges posed by the PICU environment and an approach that adjusts for barriers may optimize adoption.
View details for DOI 10.3389/fped.2021.800461
View details for PubMedID 34976903
The prevalence of COVID-19 in healthcare personnel in an adult and pediatric academic medical center.
American journal of infection control
2021; 49 (5): 542–46
BACKGROUND: It is vital to know which healthcare personnel (HCP) have a higher chance of testing positive for severe acute respiratory syndrome coronavirus 2 (COVID-19).METHODS: A retrospective analysis was conducted at Stanford Children's Health (SCH) and Stanford Health Care (SHC) in Stanford, California. Analysis included all HCP, employed by SCH or SHC, who had a COVID-19 reverse transcriptase polymerase chain reaction (RT-PCR) test resulted by the SHC Laboratory, between March 1, 2020 and June 15, 2020. The primary outcome was the RT-PCR percent positivity and prevalence of COVID-19 for HCP and these were compared across roles.RESULTS: SCH and SHC had 24,081 active employees, of which 142 had at least 1 positive COVID-19 test. The overall HCP prevalence of COVID-19 was 0.59% and percent positivity was 1.84%. Patient facing HCPs had a significantly higher prevalence (0.66% vs 0.43%; P = .0331) and percent positivity (1.95% vs 1.43%; P = .0396) than nonpatient facing employees, respectively. Percent positivity was higher in food service workers (9.15%), and environmental services (5.96%) compared to clinicians (1.93%; P < .0001) and nurses (1.46%; P < .0001), respectively.DISCUSSION AND CONCLUSION: HCP in patient-facing roles and in support roles had a greater chance of being positive of COVID-19.
View details for DOI 10.1016/j.ajic.2021.01.004
View details for PubMedID 33896582
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 69 (51-52): 1653–56
On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
View details for DOI 10.15585/mmwr.mm695152e1
View details for Web of Science ID 000606436700005
View details for PubMedID 33382675
The Advisory Committee on Immunization Practices' Updated Interim Recommendation for Allocation of COVID-19 Vaccine - United States, December 2020
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2021; 69 (51-52): 1657–60
The first vaccines for prevention of coronavirus disease 2019 (COVID-19) in the United States were authorized for emergency use by the Food and Drug Administration (FDA) (1) and recommended by the Advisory Committee on Immunization Practices (ACIP) in December 2020.* However, demand for COVID-19 vaccines is expected to exceed supply during the first months of the national COVID-19 vaccination program. ACIP advises CDC on population groups and circumstances for vaccine use.† On December 1, ACIP recommended that 1) health care personnel§ and 2) residents of long-term care facilities¶ be offered COVID-19 vaccination first, in Phase 1a of the vaccination program (2). On December 20, 2020, ACIP recommended that in Phase 1b, vaccine should be offered to persons aged ≥75 years and frontline essential workers (non-health care workers), and that in Phase 1c, persons aged 65-74 years, persons aged 16-64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b should be offered vaccine.** These recommendations for phased allocation provide guidance for federal, state, and local jurisdictions while vaccine supply is limited. In its deliberations, ACIP considered scientific evidence regarding COVID-19 epidemiology, ethical principles, and vaccination program implementation considerations. ACIP's recommendations for COVID-19 vaccine allocation are interim and might be updated based on changes in conditions of FDA Emergency Use Authorization, FDA authorization for new COVID-19 vaccines, changes in vaccine supply, or changes in COVID-19 epidemiology.
View details for DOI 10.15585/mmwr.mm695152e2
View details for Web of Science ID 000606436700006
View details for PubMedID 33382671
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2020; 69 (50): 1922–24
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.§ The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP's interim recommendation for allocating initial supplies of COVID-19 vaccines (2). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
View details for Web of Science ID 000600946300008
View details for PubMedID 33332292
View details for PubMedCentralID PMC7745957
The Advisory Committee on Immunization Practices' Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2020; 69 (49): 1857–59
The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic that has disrupted all sectors of society. Less than 1 year after the SARS-CoV-2 genome was first sequenced, an application* for Emergency Use Authorization for a candidate vaccine has been filed with the Food and Drug Administration (FDA). However, even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program. The Advisory Committee on Immunization Practices (ACIP) advises CDC on population groups and circumstances for vaccine use.† ACIP convened on December 1, 2020, in advance of the completion of FDA's review of the Emergency Use Authorization application, to provide interim guidance to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both 1) health care personnel§ and 2) residents of long-term care facilities (LTCFs)¶ be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a**).†† In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles.§§ The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization.
View details for DOI 10.15585/mmwr.mm6949e1
View details for Web of Science ID 000600945300004
View details for PubMedID 33301429
View details for PubMedCentralID PMC7737687
The Advisory Committee on Immunization Practices' Ethica Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2020; 69 (47): 1782–86
To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure (1). ACIP's recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine's safety and efficacy as well as consideration of other factors, including implementation (2). Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility: 1) maximize benefits and minimize harms; 2) promote justice; 3) mitigate health inequities; and 4) promote transparency. These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.
View details for Web of Science ID 000596482400006
View details for PubMedID 33237895
View details for PubMedCentralID PMC7727606
Pediatric research priorities in healthcare-associated infections and antimicrobial stewardship.
Infection control and hospital epidemiology
OBJECTIVE: To develop a pediatric research agenda focused on pediatric healthcare-associated infections and antimicrobial stewardship topics that will yield the highest impact on child health.PARTICIPANTS: The study included 26 geographically diverse adult and pediatric infectious diseases clinicians with expertise in healthcare-associated infection prevention and/or antimicrobial stewardship (topic identification and ranking of priorities), as well as members of the Division of Healthcare Quality and Promotion at the Centers for Disease Control and Prevention (topic identification).METHODS: Using a modified Delphi approach, expert recommendations were generated through an iterative process for identifying pediatric research priorities in healthcare associated infection prevention and antimicrobial stewardship. The multistep, 7-month process included a literature review, interactive teleconferences, web-based surveys, and 2 in-person meetings.RESULTS: A final list of 12 high-priority research topics were generated in the 2 domains. High-priority healthcare-associated infection topics included judicious testing for Clostridioides difficile infection, chlorhexidine (CHG) bathing, measuring and preventing hospital-onset bloodstream infection rates, surgical site infection prevention, surveillance and prevention of multidrug resistant gram-negative rod infections. Antimicrobial stewardship topics included beta-lactam allergy de-labeling, judicious use of perioperative antibiotics, intravenous to oral conversion of antimicrobial therapy, developing a patient-level "harm index" for antibiotic exposure, and benchmarking and or peer comparison of antibiotic use for common inpatient conditions.CONCLUSIONS: We identified 6 healthcare-associated infection topics and 6 antimicrobial stewardship topics as potentially high-impact targets for pediatric research.
View details for DOI 10.1017/ice.2020.1267
View details for PubMedID 33239122
- Postapproval Vaccine Safety Surveillance for COVID-19 Vaccines in the US. JAMA 2020
- Association Between Federal Value-Based Incentive Program Implementation and Hospital-Onset C. difficile Infection Rates CAMBRIDGE UNIV PRESS. 2020: S133
- Cost Savings Associated With Decolonization of Postdischarge MRSA Carriers: Results From the CLEAR Randomized Trial CAMBRIDGE UNIV PRESS. 2020: S28–S29
Infectious Diseases Society of America Guidelines on Infection Prevention for Health Care Personnel Caring for Patients with Suspected or Known COVID-19.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
BACKGROUND: SARS-CoV-2 is a highly transmissible virus that can infect health care personnel and patients in health care settings. Specific care activities, in particular aerosol-generating procedures, may have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 has created significant challenges in health care facilities, particularly with severe shortages of personal protective equipment (PPE) used to protect health care personnel (HCP). Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care are needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators.OBJECTIVE: Develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known COVID-19.METHODS: IDSA formed a multidisciplinary guideline panel including front-line clinicians, infectious disease specialists, experts in infection control and guideline methodologists with representation from the disciplines of preventive care, public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations.RESULTS: The IDSA guideline panel agreed on eight recommendations and provided narrative summaries of other interventions undergoing evaluations.CONCLUSIONS: Using a combination of direct and indirect evidence, the panel was able to provide recommendations for eight specific questions on the use of PPE for HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 and PPE recommendations may need to be modified in response to new evidence.
View details for DOI 10.1093/cid/ciaa1063
View details for PubMedID 32716496
The current state of antifungal stewardship among pediatric antimicrobial stewardship programs.
Infection control and hospital epidemiology
OBJECTIVE: To characterize the current state of antifungal stewardship practices and perceptions of antifungal use among pediatric antimicrobial stewardship programs (ASPs).DESIGN: We developed and distributed an electronic survey, which included 17 closed-ended questions about institutional antifungal stewardship practices and perceptions, among pediatric ASPs.PARTICIPANTS: ASP physicians and pharmacists of 74 hospitals participating in the multicenter Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative.RESULTS: We sent surveys to 74 hospitals and received 68 unique responses, for a response rate of 92%. Overall, 63 of 68 the respondent ASPs (93%) reported that they conduct 1 or more antifungal stewardship activities. Of these 68 hospital ASPs, 43 (63%) perform prospective audit and feedback (PAF) of antifungals. The most common reasons reported for not performing PAF of antifungals were not enough time or resources (19 of 25, 76%) and minimal institutional antifungal use (6 of 25, 24%). Also, 52 hospitals (76%) require preauthorization for 1 or more antifungal agents. The most commonly restricted antifungals were isavuconazole (42 of 52 hospitals, 80%) and posaconazole (39 of 52 hospitals, 75%). Furthermore, 33 ASPs (48%) agreed or strongly agreed that antifungals are inappropriately used at their institution, and only 25 of 68 (37%) of ASPs felt very confident making recommendations about antifungals.CONCLUSIONS: Most pediatric ASPs steward antifungals, but the strategies employed are highly variable across surveyed institutions. Although nearly half of respondents identified inappropriate antifungal use as a problem at their institution, most ASPs do not feel confident making recommendations about antifungals. Future studies are needed to determine the rate of inappropriate antifungal use and the best antifungal stewardship strategies.
View details for DOI 10.1017/ice.2020.306
View details for PubMedID 32662383
Reduction of Central Line-associated Bloodstream Infection Through Focus on the Mesosystem: Standardization, Data, and Accountability.
Pediatric quality & safety
2020; 5 (2): e272
Introduction: Efforts to reduce central line-associated bloodstream infection (CLABSI) rates require strong microsystems for success. However, variation in practices across units leads to challenges in ensuring accountability. We redesigned the organization's mesosystem to provide oversight and alignment of microsystem efforts and ensure accountability in the context of the macrosystem. We implemented an A3 framework to achieve reductions in CLABSI through adherence to known evidence-based bundles.Methods: We conducted this CLABSI reduction improvement initiative at a 395-bed freestanding, academic, university-affiliated children's hospital. A mesosystem-focused A3 emphasized bundle adherence through 3 key drivers (1) practice standardization, (2) data transparency, and (3) accountability. We evaluated the impact of this intervention on CLABSI rates during the pre-intervention (01/15-09/17) and post-intervention (07/18-06/19) periods using a Poisson model controlling for baseline trends.Results: Our quarterly CLABSI rates during the pre-intervention period ranged from 1.0 to 2.3 CLABSIs per 1,000 central line-days. With the mesosystem in place, CLABSI rates ranged from 0.4 to 0.7 per 1,000 central line days during the post-intervention period. Adjusting for secular trends, we observed a statistically significant decrease in the post versus pre-intervention CLABSI rate of 71%.Conclusion: Our hospital-wide CLABSI rate declined for the first time in many years after the redesign of the mesosystem and a focus on practice standardization, data transparency, and accountability. Our approach highlights the importance of alignment across unit-level microsystems to ensure high-fidelity implementation of practice standards throughout the healthcare-delivery system.
View details for DOI 10.1097/pq9.0000000000000272
View details for PubMedID 32426638
The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines.
BACKGROUND: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons.METHODS: Using claims data and a self-controlled risk interval design, we compared the febrile seizure rate in a risk interval (0-1 days) versus control interval (14-20 days). In exploratory analyses, we assessed whether the effect of IIV was modified by concomitant PCV13 administration.RESULTS: Adjusted for age, calendar time and concomitant administration of the other vaccine, the incidence rate ratio (IRR) for risk of febrile seizures following IIV was 1.12 (95% CI 0.80, 1.56) and following PCV13 was 1.80 (95% CI 1.29, 2.52). The attributable risk for febrile seizures following PCV13 ranged from 0.33 to 5.16 per 100,000 doses by week of age. The age and calendar-time adjusted IRR comparing exposed to unexposed time was numerically larger for concomitant IIV and PCV13 (IRR 2.80, 95% CI 1.63, 4.83), as compared to PCV13 without concomitant IIV (IRR 1.54, 95% CI 1.04, 2.28), and the IRR for IIV without concomitant PCV13 suggested no independent effects of IIV (IRR 0.94, 95% CI 0.63, 1.42). Taken together, this suggests a possible interaction between IIV and PCV13, though our study was not sufficiently powered to provide a precise estimate of the interaction.CONCLUSIONS: We found an elevated risk of febrile seizures after PCV13 vaccine but not after IIV. The risk of febrile seizures after PCV13 is low compared to the overall risk in this population of children, and the risk should be interpreted in the context of the importance of preventing pneumococcal infections.
View details for DOI 10.1016/j.vaccine.2020.01.046
View details for PubMedID 32019703
- Differences in Central Line-Associated Bloodstream Infection Rates Based on the Criteria Used to Count Central Line Days. JAMA 2020; 323 (2): 183–85
Health Care-Associated Infections Among Critically Ill Children in the US, 2013-2018.
Central catheter-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) increase morbidity, mortality, and health care costs in pediatric patients.To examine changes over time in CLABSI and CAUTI rates between 2013 and 2018 in neonatal intensive care units (NICUs) and pediatric intensive care units (PICUs) using prospective surveillance data from community hospitals, children's hospitals, and pediatric units within general hospitals.This time series study included 176 US hospitals reporting pediatric health care-associated infection surveillance data to the National Healthcare Safety Network from January 1, 2013, to June 30, 2018. Patients aged 18 years or younger admitted to PICUs or level III NICUs were included in the analysis.The primary outcomes were device-associated rates of CLABSI in NICUs and PICUs and CAUTI in PICUs (infections per 1000 device-days). Secondary outcomes included population-based rates (infections per 10 000 patient-days) and device utilization (device-days per patient-days). Regression models were fit using generalized estimating equations to assess yearly changes in CLABSI and CAUTI rates, adjusted for birth weight (≤1500 vs >1500 g) in neonatal models.Of the 176 hospitals, 132 hospitals with NICUs and 114 hospitals with PICUs contributed data. Of these, NICUs reported 6 064 172 patient-days and 1 363 700 central line-days and PICUs reported 1 999 979 patient-days, 925 956 central catheter-days, and 327 599 indwelling urinary catheter-days. In NICUs, there were no significant changes in yearly trends in device-associated (incidence rate ratio [IRR] per year, 0.99; 95% CI, 0.95-1.03) and population-based (IRR, 0.96; 95% CI, 0.92-1.00) CLABSI rates or central catheter utilization (odds ratio [OR], 0.97; 95% CI, 0.95-1.00). Results were similar in PICUs, with device-associated (IRR, 1.03; 95% CI, 0.99-1.07) and population-based (IRR, 1.03; 95% CI, 0.99-1.07) CLABSI rates and central catheter utilization (OR, 0.99; 95% CI, 0.97-1.01) remaining stable. While device-associated CAUTI rates in PICUs also remained unchanged over time (IRR, 0.97; 95% CI, 0.91-1.03), population-based CAUTI rates significantly decreased by 8% per year (IRR, 0.92; 95% CI, 0.86-0.98) and indwelling urinary catheter utilization significantly decreased by 6% per year (OR, 0.94; 95% CI, 0.91-0.96).Recent trends in CLABSI rates noted in this study among critically ill neonates and children in a large cohort of US hospitals indicate that past gains have held, without evidence of further improvements, suggesting novel approaches for CLABSI prevention are needed. Modest improvements in population-based CAUTI rates likely reflect more judicious use of urinary catheters.
View details for DOI 10.1001/jamapediatrics.2020.3223
View details for PubMedID 33017011
- Scientific and Ethical Principles Underlying Recommendations From the Advisory Committee on Immunization Practices for COVID-19 Vaccination Implementation. JAMA 2020
- Institutional quality and patient safety programs: An overview for the healthcare epidemiologist. Infection control and hospital epidemiology 2020: 1–12
Preventing infections in children and adults with asplenia.
Hematology. American Society of Hematology. Education Program
2020; 2020 (1): 328–35
An estimated 1 million people in the United States have functional or anatomic asplenia or hyposplenia. Infectious complications due to encapsulated organisms such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae can lead to fulminant sepsis and death, particularly in young children, in the period shortly after splenectomy, and in immunocompromised patients. Patients with asplenia are also at risk for less common infections due to Capnocytophaga, Babesia, and malaria. Antibiotic prophylaxis, vaccines, and patient and family education are the mainstays of prevention in these at-risk patients. Recommendations for antibiotic prophylaxis typically target high-risk periods, such as 1 to 3 years after splenectomy, children ≤5 years of age, or patients with concomitant immunocompromise. However, the risk for sepsis is lifelong, with infections occurring as late as 40 years after splenectomy. Currently available vaccines recommended for patients with asplenia include pneumococcal vaccines (13-valent pneumococcal conjugate vaccine followed by the 23-valent pneumococcal polysaccharide vaccine), meningococcal vaccines (meningococcal conjugate vaccines for serogroups A, C, Y and W-135 and serogroup B meningococcal vaccines), H. influenzae type b vaccines, and inactivated influenza vaccines. Ongoing booster doses are also recommended for pneumococcal and meningococcal vaccines to maintain protection. Despite the availability of prevention tools, adherence is often a challenge. Dedicated teams or clinics focused on patient education and monitoring have demonstrated substantial improvements in vaccine coverage rates for individuals with asplenia and reduced risk of infection. Future efforts to monitor the quality of care in patients with asplenia may be important to bridge the know-do gap in this high-risk population.
View details for DOI 10.1182/hematology.2020000117
View details for PubMedID 33275684
Large-Scale Testing of Asymptomatic Healthcare Personnel for Severe Acute Respiratory Syndrome Coronavirus 2.
Emerging infectious diseases
2020; 27 (1)
Large-scale, 1-time testing of >12,000 asymptomatic healthcare personnel in California, USA, during April-June 2020 showed that prevalence of severe acute respiratory syndrome coronavirus 2 was low (<1%). Testing might identify asymptomatic and presymptomatic persons, including some with high viral burden, enabling prompt implementation of measures to limit nosocomial spread.
View details for DOI 10.3201/eid2701.203892
View details for PubMedID 33256889
Association Between Federal Value-Based Incentive Programs and Health Care-Associated Infection Rates in Safety-Net and Non-Safety-Net Hospitals.
JAMA network open
2020; 3 (7): e209700
In the US, federal value-based incentive programs are more likely to penalize safety-net institutions than non-safety-net institutions. Whether these programs differentially change the rates of targeted health care-associated infections in safety-net vs non-safety-net hospitals is unknown.To assess the association of Hospital-Acquired Condition Reduction Program (HACRP) and Hospital Value-Based Purchasing (HVBP) implementation with changes in rates of targeted health care-associated infections and disparities in rates among safety-net and non-safety-net hospitals.This interrupted time series included all US acute care hospitals enrolled in the Preventing Avoidable Infectious Complications by Adjusting Payment study that participated in mandatory reporting to the National Healthcare Safety Network from January 1, 2013, through June 30, 2018. Hospital characteristics were obtained from the 2015 American Hospital Association annual survey. Penalty statuses for 2015 to 2018 were obtained from Hospital Compare. Data were analyzed between July 9, 2018, and October 1, 2019.HACRP and HVBP implementation in fiscal year 2015 or 2016.The primary outcomes were rates of 4 health care-associated infections: central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), surgical site infection (SSI) after colon surgical procedures, and SSI after abdominal hysterectomy procedures. Regression models were fit using generalized estimating equations to assess the association of HACRP and HVBP implementation with health care-associated infection rates and disparities in infection rates.Of the 618 acute care hospitals included in this study, 473 (76.5%) were non-safety net and 145 (23.5%) were considered safety net. In these hospitals, HACRP and HVBP implementation was not associated with improvements in level or trend for any health care-associated infection examined (eg, CAUTI in safety-net hospitals: incidence rate ratio [IRR] for level change, 0.98 [95% CI, 0.79-1.23; P = .89]; IRR for change in slope, 1.00 [95% CI, 0.97-1.03; P = .80]). Before program implementation, infection rates were statistically significantly higher for safety-net than for non-safety-net hospitals for CLABSI (IRR, 1.23; 95% CI, 1.07-1.42; P = .004), CAUTI (IRR, 1.38; 95% CI, 1.16-1.64; P < .001), and SSI after colon surgical procedure (odds ratio [OR], 1.26; 95% CI, 1.06-1.50; P = .009). The disparity persisted over time when comparing the last year of the study with the first year (CLABSI: ratio of ratios [ROR], 0.93 [95% CI, 0.77-1.13; P = .48]; CAUTI: ROR, 0.90 [95% CI, 0.73-1.10; P = .31]; SSI after colon surgical procedures: ROR, 0.96 [95% CI, 0.78-1.20; P = .75]). Rates of SSI after abdominal hysterectomy procedure were similar in safety-net and non-safety-net hospitals before implementation (OR, 1.13; 95% CI, 0.91-1.40; P = .27) but higher after implementation (OR, 1.43; 95% CI, 1.11-1.83; P = .006), although this change was not significant (ROR, 1.20; 95% CI, 0.91-1.59; P = .20).This study found that HACRP and HVBP implementation was not associated with any improvements in targeted health care-associated infections among safety-net or non-safety-net hospitals or with changes in disparities in infection rates. Given the persistent health care-associated infection rate disparities, these programs appear to function as a disproportionate penalty system for safety-net hospitals that offer no measurable benefits for patients.
View details for DOI 10.1001/jamanetworkopen.2020.9700
View details for PubMedID 32639568
- The Advisory Committee on Immunization Practices and Its Role in the Pandemic Vaccine Response. JAMA 2020
Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >= 65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT
2019; 68 (46): 1069–75
Two pneumococcal vaccines are currently licensed for use in adults in the United States: a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Pfizer, Inc.]) and a 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax 23, Merck and Co., Inc.]). In 2014, the Advisory Committee on Immunization Practices (ACIP)* recommended routine use of PCV13 in series with PPSV23 for all adults aged ≥65 years based on demonstrated PCV13 safety and efficacy against PCV13-type pneumonia among adults aged ≥65 years (1). At that time, ACIP recognized that there would be a need to reevaluate this recommendation because it was anticipated that PCV13 use in children would continue to reduce disease burden among adults through reduced carriage and transmission of vaccine serotypes from vaccinated children (i.e., PCV13 indirect effects). On June 26, 2019, after having reviewed the evidence accrued during the preceding 3 years (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html), ACIP voted to remove the recommendation for routine PCV13 use among adults aged ≥65 years and to recommend administration of PCV13 based on shared clinical decision-making for adults aged ≥65 years who do not have an immunocompromising condition,† cerebrospinal fluid (CSF) leak, or cochlear implant, and who have not previously received PCV13. ACIP recognized that some adults aged ≥65 years are potentially at increased risk for exposure to PCV13 serotypes, such as persons residing in nursing homes or other long-term care facilities and persons residing in settings with low pediatric PCV13 uptake or traveling to settings with no pediatric PCV13 program, and might attain higher than average benefit from PCV13 vaccination. When patients and vaccine providers§ engage in shared clinical decision-making for PCV13 use to determine whether PCV13 is right for a particular person, considerations might include both the person's risk for exposure to PCV13 serotypes and their risk for developing pneumococcal disease as a result of underlying medical conditions. All adults aged ≥65 years should continue to receive 1 dose of PPSV23. If the decision is made to administer PCV13, it should be given at least 1 year before PPSV23. ACIP continues to recommend PCV13 in series with PPSV23 for adults aged ≥19 years with an immunocompromising condition, CSF leak, or cochlear implant (2).
View details for Web of Science ID 000497772100005
View details for PubMedID 31751323
- Mind the Gap: Spanning the Great Divide Between Perceived and Measured Value of Infectious Disease Physicians JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY 2019; 8 (3): 276–78
- Recommended Adult Immunization Schedule, United States, 2019 ANNALS OF INTERNAL MEDICINE 2019; 170 (3): 182-+
- Comparison of hospital surgical site infection rates and rankings using claims versus National Healthcare Safety Network surveillance data INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY 2019; 40 (2): 208–10
A National Approach to Pediatric Sepsis Surveillance.
Pediatric sepsis is a major public health concern, and robust surveillance tools are needed to characterize its incidence, outcomes, and trends. The increasing use of electronic health records (EHRs) in the United States creates an opportunity to conduct reliable, pragmatic, and generalizable population-level surveillance using routinely collected clinical data rather than administrative claims or resource-intensive chart review. In 2015, the US Centers for Disease Control and Prevention recruited sepsis investigators and representatives of key professional societies to develop an approach to adult sepsis surveillance using clinical data recorded in EHRs. This led to the creation of the adult sepsis event definition, which was used to estimate the national burden of sepsis in adults and has been adapted into a tool kit to facilitate widespread implementation by hospitals. In July 2018, the Centers for Disease Control and Prevention convened a new multidisciplinary pediatric working group to tailor an EHR-based national sepsis surveillance approach to infants and children. Here, we describe the challenges specific to pediatric sepsis surveillance, including evolving clinical definitions of sepsis, accommodation of age-dependent physiologic differences, identifying appropriate EHR markers of infection and organ dysfunction among infants and children, and the need to account for children with medical complexity and the growing regionalization of pediatric care. We propose a preliminary pediatric sepsis event surveillance definition and outline next steps for refining and validating these criteria so that they may be used to estimate the national burden of pediatric sepsis and support site-specific surveillance to complement ongoing initiatives to improve sepsis prevention, recognition, and treatment.
View details for DOI 10.1542/peds.2019-1790
View details for PubMedID 31776196
Validation of febrile seizures identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program.
The Sentinel Initiative was established in 2008 to monitor the safety of FDA-regulated medical products. We evaluated the positive predictive value (PPV) of ICD-9 codes for post-vaccination febrile seizures to identify optimal algorithms for use in post-market safety surveillance.We identified ICD-9 diagnosis codes for fever and seizures in the emergency department or inpatient setting after vaccinations of interest from July 1, 2010 to June 30, 2011. Medical record review was conducted to verify febrile seizure events.Of 216 potential febrile seizures identified with one or more seizure codes (the broadest algorithm), 152 were chart-confirmed (i.e., documentation of fever within 24 h of seizure or clinician diagnosis of febrile seizure; PPV 70%, 95% CI 64, 76%). Two codes specific for febrile seizures produced the highest PPV (PPV 91%, 95% CI 85, 95%) and accounted for 140 confirmed febrile seizures. In the absence of febrile seizure codes, other seizure codes yielded much lower PPVs, regardless of the presence of fever codes.Our results indicate that ICD-9 diagnosis codes in the inpatient and emergency department settings have high predictive value for identifying febrile seizures within the Sentinel Distributed Database. While the PPV of the algorithm based on any diagnosis code for seizure is moderate, the algorithm limited to febrile seizure codes has a high PPV (>90%) and captures the vast majority of confirmed cases identified by the broadest algorithm, suggesting that the narrower algorithm limited to febrile seizure codes may be preferred.
View details for DOI 10.1016/j.vaccine.2019.05.042
View details for PubMedID 31186192
- Variability in antimicrobial use in pediatric ventilator-associated events INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY 2019; 40 (1): 32–39
The impact of measurement changes on evaluating hospital performance: The case of catheter-associated urinary tract infections.
Infection control and hospital epidemiology
Catheter-associated urinary tract infections in 592 hospitals immediately declined after federal value-based incentive program implementation, but this was fully attributable to a concurrent surveillance case definition revision. Post revision, more hospitals had favorable standardized infection ratios, likely leading to artificial inflation of their performance scores unrelated to changes in patient safety.
View details for DOI 10.1017/ice.2019.240
View details for PubMedID 31522693
Association Between Value-Based Incentive Programs and Catheter-Associated Urinary Tract Infection Rates in the Critical Care Setting.
2019; 321 (5): 509–11
View details for PubMedID 30721286
Using NHSN's Antimicrobial Use Option to Monitor and Improve Antibiotic Stewardship in Neonates.
The Antimicrobial Use (AU) Option of the Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN) is a surveillance resource that can provide actionable data for antibiotic stewardship programs. Such data are used to enable measurements of AU across hospitals and before, during, and after stewardship interventions.We used monthly AU data and annual facility survey data submitted to the NHSN to describe hospitals and neonatal patient care locations reporting to the AU Option in 2017, examine frequencies of most commonly reported agents, and analyze variability in AU rates across hospitals and levels of care. We used results from these analyses in a collaborative project with Vermont Oxford Network to develop neonatal-specific Standardized Antimicrobial Administration Ratio (SAAR) agent categories and neonatal-specific NHSN Annual Hospital Survey questions.As of April 1, 2018, 351 US hospitals had submitted data to the AU Option from at least 1 neonatal unit. In 2017, ampicillin and gentamicin were the most frequently reported antimicrobial agents. On average, total rates of AU were highest in level III NICUs, followed by special care nurseries, level II-III NICUs, and well newborn nurseries. Seven antimicrobial categories for neonatal SAARs were created, and 6 annual hospital survey questions were developed.A small but growing percentage of US hospitals have submitted AU data from neonatal patient care locations to NHSN, enabling the use of AU data aggregated by NHSN as benchmarks for neonatal antimicrobial stewardship programs and further development of the SAAR summary measure for neonatal AU.
View details for PubMedID 31036758
- Enhanced central venous catheter bundle for pediatric parenteral-dependent intestinal failure AMERICAN JOURNAL OF INFECTION CONTROL 2018; 46 (11): 1284–89
Costs of Quality and Safety in Radiology.
Radiographics : a review publication of the Radiological Society of North America, Inc
2018; 38 (6): 1682–87
With the movement toward at-risk population health management-related payment models, a core factor for the success and survival of health care organizations has become understanding and decreasing costs. In medical specialties such as radiology, understanding models for procedure-based costing will become increasingly important. Using bottom-up models for procedure-based costing, such as time-driven activity-based costing, is more advantageous than using the inaccurate ratio of costs to charges approach; however, these approaches are more resource intensive when compared to top-down approaches. Understanding the costs of quality is also important for creating an accounting and budgeting process that reflects the total cost of quality. The costs of quality are divided into two main categories: the cost of control (also referred to as the costs of conformance) and the costs of failure of control (also referred to as the costs of nonconformance). The costs of control are the expenditures that occur to ensure quality. The costs of noncontrol are the expenses that arise from the lack of quality and safety. The cost of control has two subcategories: prevention costs and appraisal costs. The cost of noncontrol also has two subcategories: internal failure costs and external failure costs. Adopting a mind-set that takes into account the costs of control, or the costs to ensure high-quality care, and the costs of noncontrol, or the hidden costs of poor-quality care, will be essential for successful health care organizations in the future. ©RSNA, 2018.
View details for PubMedID 30303806
Impact of the 2012 Medicaid Health Care-Acquired Conditions Policy on Catheter-Associated Urinary Tract Infection and Vascular Catheter-Associated Infection Billing Rates.
Open forum infectious diseases
2018; 5 (9): ofy204
In July 2012, the Centers for Medicare & Medicaid Services ceased hospital Medicaid reimbursements for certain health care-acquired conditions. Using billing data from 2008-2014, we found no impact of this policy on rates of 2 targeted conditions, vascular catheter-associated infections and catheter-associated urinary tract infections, among Medicaid or non-Medicaid patients.
View details for PubMedID 30191157
Centers for medicare and medicaid services hospital-acquired conditions policy for central line-associated bloodstream infection (CLABSI) and cather-associated urinary tract infection (CAUTI) shows minimal impact on hospital reimbursement
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2018; 39 (8): 897–901
In 2008, the Centers for Medicare and Medicaid Services (CMS) stopped reimbursing for hospital-acquired conditions (HACs) not present on admission (POA). We sought to understand why this policy did not impact central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) trends.Retrospective cohort study.Acute-care hospitals in the United States.ParticipantsFee-for-service Medicare patients discharged January 1, 2007, through December 31, 2011.Using inpatient Medicare claims data, we analyzed billing practices before and after the HAC policy was implemented, including the use and POA designation of codes for CLABSI or CAUTI. For the 3-year period following policy implementation, we determined the impact on diagnosis-related groups (DRG) determining reimbursement as well as hospital characteristics associated with the reimbursement impact.During the study period, 65,205,607 Medicare fee-for-service hospitalizations occurred at 3,291 acute-care, nonfederal US hospitals. Based on coding, CLABSI and CAUTI affected 0.23% and 0.06% of these hospitalizations, respectively. In addition, following the HAC policy, 82% of the CLABSI codes and 91% of the CAUTI codes were marked POA, which represented a large increase in the use of this designation. Finally, for the small numbers of CLABSI and CAUTI coded as not POA, financial impacts were detected on only 0.4% of the hospitalizations with a CLABSI code and 5.7% with a CAUTI code.Part of the reason the HAC policy did not have its intended impact is that billing codes for CLABSI and CAUTI were rarely used, were commonly listed as POA in the postpolicy period, and infrequently impacted hospital reimbursement.
View details for PubMedID 29950185
Multifaceted but Invisible: Perceptions of the Value of a Pediatric Cognitive Specialty.
2018; 8 (7): 385–93
BACKGROUND: Systems for standardizing physician payment have been shown to undervalue cognitive clinical encounters. Because health care reform emphasizes value-based approaches, we need an understanding of the way pediatric cognitive specialties are used to contribute to the provision of high-value care. We sought to investigate how clinical and administrative stakeholders perceive the value of pediatric infectious disease (PID) specialists.METHODS: We conducted qualitative interviews with a purposive sample of physicians and administrators from 5 hospitals across the United States in which children are cared for. All interviews were transcribed and systematically analyzed for common themes.RESULTS: We interviewed 97 stakeholders. Analysis revealed the following 3 domains of value: clinical, organizational, and communicative. Clinically, PID specialists were perceived to be highly valuable in treating patients with unusual infections that respond poorly to therapy, in optimizing the use of antimicrobial agents and in serving as outpatient homes for complex patients. Respondents perceived that PID specialists facilitate communication with patients and their families, the health care team and the media. PID specialists were perceived to generate value by participating in systemwide activities, including antimicrobial stewardship and infection prevention. Despite this, much of the valuable work PID specialists perform is difficult to measure causing some administrative stakeholders to question how many PID specialists are necessary to achieve high-quality care.CONCLUSIONS: With our findings, we suggest that pediatric cognitive specialties contribute value in multiple ways to the health care delivery system. Many of these domains are difficult to capture by using current metrics, which may lead administrators to overlook valuable work and to under-allocate resources.
View details for PubMedID 29946040
The Impact of the Medicaid Healthcare-Associated Condition Program on Mediastinitis Following Coronary Artery Bypass Graft.
Infection control and hospital epidemiology
2018; 39 (6): 694–700
OBJECTIVEIn 2012, the Centers for Medicare and Medicaid Services expanded a 2008 program that eliminated additional Medicare payment for mediastinitis following coronary artery bypass graft (CABG) to include Medicaid. We aimed to evaluate the impact of this Medicaid program on mediastinitis rates reported by the National Healthcare Safety Network (NHSN) compared with the rates of a condition not targeted by the program, deep-space surgical site infection (SSI) after knee replacement.DESIGNInterrupted time series with comparison group.METHODSWe included surveillance data from nonfederal acute-care hospitals participating in the NHSN and reporting CABG or knee replacement outcomes from January 2009 through June 2017. We examined the Medicaid program's impact on NHSN-reported infection rates, adjusting for secular trends. The data analysis used generalized estimating equations with robust sandwich variance estimators.RESULTSDuring the study period, 196 study hospitals reported 273,984 CABGs to the NHSN, resulting in 970 mediastinitis cases (0.35%), and 294 hospitals reported 555,395 knee replacements, with 1,751 resultant deep-space SSIs (0.32%). There was no significant change in incidence of either condition during the study. Mediastinitis models showed no effect of the 2012 Medicaid program on either secular trend during the postprogram versus preprogram periods (P=.70) or an immediate program effect (P=.83). Results were similar in sensitivity analyses when adjusting for hospital characteristics, restricting to hospitals with consistent NHSN reporting or incorporating a program implementation roll-in period. Knee replacement models also showed no program effect.CONCLUSIONSThe 2012 Medicaid program to eliminate additional payments for mediastinitis following CABG had no impact on reported mediastinitis rates.Infect Control Hosp Epidemiol 2018;39:694-700.
View details for PubMedID 29669607
Enhanced central venous catheter bundle for pediatric parenteral-dependent intestinal failure.
American journal of infection control
BACKGROUND: Central line-associated bloodstream infections (CLABSIs) cause substantial morbidity and increase antimicrobial use and length of stay among hospitalized children in the United States. CLABSI occurs more frequently among high-risk pediatric patients, such as those with intestinal failure (IF) who are parenteral nutrition (PN) dependent. Following an increase in CLABSI rates, a quality improvement (QI) initiative was implemented.METHODS: Using QI methodology, an enhanced central venous catheter (CVC) maintenance bundle was developed and implemented on 2 units for pediatric PN-dependent patients with IF. CLABSI rates were prospectively monitored pre- and postimplementation, and bundle element adherence was monitored. Enhanced bundle elements included chlorhexidine-impregnated patch, daily bathing, ethanol locks, 2 nurses for CVC care in a distraction-free zone, peripheral laboratory draws, bundling routine laboratory tests, and PN administration set changes every 24 hours.RESULTS: Adherence to enhanced bundle elements increased to >90% over 3 months. CLABSI rates averaged 1.41 per 1,000 central line days preimplementation compared with 0.40 per 1,000 device days postimplementation (P=.003), an 85% absolute reduction in CLABSI rates over 12 months.CONCLUSIONS: Patients with IF are at an increased risk for CLABSI. Enhanced CVC maintenance bundles that specifically target prevention practices in this population may be beneficial.
View details for PubMedID 29778436
Updated Framework for Development of Evidence-Based Recommendations by the Advisory Committee on Immunization Practices.
MMWR. Morbidity and mortality weekly report
2018; 67 (45): 1271–72
The Advisory Committee on Immunization Practices (ACIP)* is a federal advisory committee that provides expert advice to the Director of CDC and the Secretary of the U.S. Department of Health and Human Services in the form of recommendations on the use of vaccines and related agents for control of vaccine-preventable diseases in the U.S. civilian population (1,2). Work groups that gather, analyze, and prepare scientific information assist in the recommendation formulation process and present options for recommendations based on the scientific evidence they have assessed. Recommendations that are approved by a majority of ACIP's voting members are then reviewed by the Director of CDC and published in MMWR if approved by the director. This report briefly summarizes an update to the ACIP process for developing evidence-based recommendations that ACIP adopted at its February 2018 meeting.
View details for DOI 10.15585/mmwr.mm6745a4
View details for PubMedID 30439877
Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines.
MMWR. Morbidity and mortality weekly report
2018; 67 (3): 103–8
On October 20, 2017, Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline, [GSK] Research Triangle Park, North Carolina), a 2-dose, subunit vaccine containing recombinant glycoprotein E in combination with a novel adjuvant (AS01B), was approved by the Food and Drug Administration for the prevention of herpes zoster in adults aged ≥50 years. The vaccine consists of 2 doses (0.5 mL each), administered intramuscularly, 2-6 months apart (1). On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) recommended the recombinant zoster vaccine (RZV) for use in immunocompetent adults aged ≥50 years.
View details for DOI 10.15585/mmwr.mm6703a5
View details for PubMedID 29370152
View details for PubMedCentralID PMC5812314
Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines.
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
2018; 18 (3): 756–62
View details for PubMedID 29462512
The safety of live attenuated influenza vaccine in children and adolescents 2 through 17 years of age: A Vaccine Safety Datalink study.
Pharmacoepidemiology and drug safety
2018; 27 (1): 59–68
To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age.The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between September 1, 2003 and March 31, 2013. Eighteen pre-specified adverse event groups were studied, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Incident rate ratios (IRRs) were calculated for each adverse event, using self-controlled case series analyses. For adverse events with a statistically significant increase in risk, or an IRR > 2.0 regardless of statistical significance, manual medical record review was performed to confirm case status.During the study period, 396 173 children received 590 018 doses of LAIV. For 13 adverse event groups, there was no significant increased risk of adverse events following LAIV. Five adverse event groups (anaphylaxis, syncope, Stevens-Johnson syndrome, adverse effect of drug, and respiratory failure) met criteria for manual medical record review. After review to confirm cases, 2 adverse event groups remained significantly associated with LAIV: anaphylaxis and syncope. One confirmed case of anaphylaxis was observed following LAIV, a rate of 1.7 per million LAIV doses. Five confirmed cases of syncope were observed, a rate of 8.5 per million doses.In a study of trivalent LAIV safety in a large cohort of children, few serious adverse events were detected. Anaphylaxis and syncope occurred following LAIV, although rarely. These data provide reassurance regarding continued LAIV use.
View details for PubMedID 29148124
- Immunization, Antibiotic Use, and Pneumococcal Colonization Over a 15-Year Period PEDIATRICS 2017; 140 (5)
Surveillance of pneumococcal colonization and invasive pneumococcal disease reveals shift in prevalent carriage serotypes in Massachusetts' children to relatively low invasiveness.
2017; 35 (32): 4002-4009
Following the introduction of pneumococcal conjugate vaccines (PCV), overall nasopharyngeal colonization rates have not changed significantly, however a dramatic and sustained decline in invasive pneumococcal disease (IPD) in children was observed in every setting where the PCVs were implemented. We aimed to describe the differences in invasive disease potential of serotypes that are common colonizers in pre- and post-vaccine eras in order to provide further insight in our understanding of dynamic epidemiology of pneumococcal diseases.Using data from surveillance of nasopharyngeal carriage and enhanced surveillance for IPD, a serotype specific "invasive capacity (IC)" was computed by dividing the incidence of IPD due to serotype x by the carriage prevalence of that same serotype in children <7years of age in Massachusetts. We have evaluated the serotype specific invasive capacity in two periods; pre-PCV13 (2001/02, 2003/04, 2006/07, 2008/09) and post-PCV13 (2010/11 and 2013/14), and by age groups; <24monthsvs. ≥24months.An approximate 50-fold variation in the point estimate was observed between the serotypes having the highest (7F, 38, 19A, 3, 33F) and the lowest (6C, 35B, 21, 11A, 23B and 23A) computed serotype specific invasive disease potential. In the post-PCV13 era (6C, 35B, 11A, 23B and 23A), 5 of the 7 most common serotypes colonizing the nasopharynx were serotypes with the lowest invasive capacity. Serotype specific invasive capacity trended down in older children for majority of the serotypes, and serotypes 3, 10A and 19A had significantly lower invasive capacity in children older than 24months of age compared to younger children.Invasive capacity differs among serotypes and likely by age. Point estimates of IC for most of the common serotypes colonizing children in Massachusetts in post-PCV13 era were low and likely explain the continued reduction in IPD from the pre-PCV era in the absence of specific protection against these serotypes.
View details for DOI 10.1016/j.vaccine.2017.05.077
View details for PubMedID 28645717
Maternal Tdap vaccination and risk of infant morbidity.
2017; 35 (29): 3655-3660
An increased risk of diagnosed chorioamnionitis in women vaccinated with Tdap during pregnancy was previously detected at two Vaccine Safety Datalink (VSD) sites. The clinical significance of this finding related to infant outcomes remains uncertain.Retrospective cohort study of singleton live births born to women who were continuously insured from 6months prior to their last menstrual period through 6weeks postpartum, with ≥1 outpatient visit during pregnancy from January 1, 2010 to November 15, 2013 at seven integrated United States health care systems part of the VSD. We re-evaluated the association between maternal Tdap and chorioamnionitis and evaluated whether specific infant morbidities differ among infants born to mothers who did and did not receive Tdap during pregnancy. We focused on 2 Tdap exposure windows: the recommended 27-36weeks gestation or anytime during pregnancy. We identified inpatient diagnostic codes for transient tachypnea of the newborn (TTN), neonatal sepsis, neonatal pneumonia, respiratory distress syndrome (RDS), and newborn convulsions associated with an infant's first hospitalization. A generalized linear model with Poisson distribution and log-link was used to estimate propensity score adjusted rate ratios (ARR) with 95% confidence intervals (CI).The analyses included 197,564 pregnancies. Chorioamnionitis was recorded in 6.4% of women who received Tdap vaccination any time during pregnancy and 5.2% of women who did not (ARR [95% CI]: 1.23 [1.17, 1.28]). Compared with unvaccinated women, there were no significant increased risks (ARR [95% CI]) for TTN (1.04 [0.98, 1.11]), neonatal sepsis (1.06 [0.91, 1.23]), neonatal pneumonia (0.94 [0.72, 1.22]), RDS (0.91 [0.66, 1.26]), or newborn convulsions (1.16 [0.87, 1.53]) in infants born to Tdap-vaccinated women.Despite an observed association between maternal Tdap vaccination and maternal chorioamnionitis, we did not find increased risk for clinically significant infant outcomes associated with maternal chorioamnionitis.
View details for DOI 10.1016/j.vaccine.2017.05.041
View details for PubMedID 28552511
First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring.
journal of pediatrics
To examine risks for major structural birth defects in infants after first trimester inactivated influenza vaccine (IIV) exposures.In this observational study, we used electronic health data from 7 Vaccine Safety Datalink sites to examine risks for selected major structural defects in infants after maternal IIV exposure. Vaccine exposures for women with continuous insurance enrollment through pregnancy who delivered singleton live births between 2004 and 2013 were identified from standardized files. Infants with continuous insurance enrollment were followed to 1 year of age. We excluded mother-infant pairs with other exposures that potentially increased their background risk for birth defects. Selected cardiac, orofacial or respiratory, neurologic, ophthalmologic or otologic, gastrointestinal, genitourinary and muscular or limb defects were identified from diagnostic codes in infant medical records using validated algorithms. Propensity score adjusted generalized estimating equations were used to estimate prevalence ratios (PRs).We identified 52 856 infants with maternal first trimester IIV exposure and 373 088 infants whose mothers were unexposed to IIV during first trimester. Prevalence (per 100 live births) for selected major structural birth defects was 1.6 among first trimester IIV exposed versus 1.5 among unexposed mothers. The adjusted PR was 1.02 (95% CI 0.94-1.10). Organ system-specific PRs were similar to the overall PR.First trimester maternal IIV exposure was not associated with an increased risk for selected major structural birth defects in this large cohort of singleton live births.
View details for DOI 10.1016/j.jpeds.2017.04.039
View details for PubMedID 28550954
Live attenuated influenza vaccine use and safety in children and adults with asthma
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY
2017; 118 (4): 439-444
Live attenuated influenza vaccine (LAIV) might increase the risk of wheezing in persons with asthma or children younger than 5 years with a history of recurrent wheezing.To describe the use and assess the safety of LAIV in persons with asthma in the Vaccine Safety Datalink population.We identified persons with asthma using diagnosis codes and medication records in 7 health care organizations over 3 influenza seasons (2008-2009 through 2010-2011) and determined their influenza vaccination rates. Using the self-controlled risk interval method, we calculated the incidence rate ratio of medically attended respiratory events in the 14 days after LAIV compared with 29 to 42 days after vaccination in persons 2 through 49 years old.In our population of 6.3 million, asthma prevalence was 5.9%. Of persons with asthma, approximately 50% received any influenza vaccine but less than 1% received LAIV. The safety study included 12,354 LAIV doses (75% in children; 93% in those with intermittent or mild persistent asthma). The incidence rate ratio for inpatient and emergency department visits for lower respiratory events (including asthma exacerbation and wheezing) was 0.98 (95% confidence interval 0.63-1.51) and the incidence rate ratio for upper respiratory events was 0.94 (95% confidence interval 0.48-1.86). The risk of lower respiratory events was similar for intermittent and mild persistent asthma, across age groups, and for seasonal trivalent LAIV and 2009 H1N1 pandemic monovalent LAIV.LAIV use in asthma was mostly in persons with intermittent or mild persistent asthma. LAIV was not associated with an increased risk of medically attended respiratory adverse events.
View details for DOI 10.1016/j.anai.2017.01.030
View details for Web of Science ID 000398936900010
View details for PubMedID 28390584
Identifying birth defects in automated data sources in the Vaccine Safety Datalink
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
2017; 26 (4): 412-420
The Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large healthcare organizations, aims to monitor safety of vaccines administered in the USA. We present definitions and prevalence estimates for major structural birth defects to be used in studies of maternal vaccine safety.In this observational study, we created and refined algorithms for identifying major structural birth defects from electronic healthcare data, conducted formal chart reviews for severe cardiac defects, and conducted limited chart validation for other defects. We estimated prevalence for selected defects by VSD site and birth year and compared these estimates to those in a US and European surveillance system.We developed algorithms to enumerate >50 major structural birth defects from standardized administrative and healthcare data based on utilization patterns and expert opinion, applying criteria for number, timing, and setting of diagnoses. Our birth cohort included 497 894 infants across seven sites. The period prevalence for all selected major birth defects in the VSD from 2004 to 2013 was 1.7 per 100 live births. Cardiac defects were most common (65.4 per 10 000 live births), with one-fourth classified as severe, requiring emergent intervention. For most major structural birth defects, prevalence estimates were stable over time and across sites and similar to those reported in other population-based surveillance systems.Our algorithms can efficiently identify many major structural birth defects in large healthcare datasets and can be used in studies evaluating the safety of vaccines administered to pregnant women. Copyright © 2017 John Wiley & Sons, Ltd.
View details for DOI 10.1002/pds.4153
View details for Web of Science ID 000398540200007
View details for PubMedID 28054412
A Pediatric Approach to Ventilator-Associated Events Surveillance
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2017; 38 (3): 327-333
OBJECTIVE Adult ventilator-associated event (VAE) definitions include ventilator-associated conditions (VAC) and subcategories for infection-related ventilator-associated complications (IVAC) and possible ventilator-associated pneumonia (PVAP). We explored these definitions for children. DESIGN Retrospective cohort SETTING Pediatric, cardiac, or neonatal intensive care units (ICUs) in 6 US hospitals PATIENTS Patients ≤18 years old ventilated for ≥1 day METHODS We identified patients with pediatric VAC based on previously proposed criteria. We applied adult temperature, white blood cell count, antibiotic, and culture criteria for IVAC and PVAP to these patients. We matched pediatric VAC patients with controls and evaluated associations with adverse outcomes using Cox proportional hazards models. RESULTS In total, 233 pediatric VACs (12,167 ventilation episodes) were identified. In the cardiac ICU (CICU), 62.5% of VACs met adult IVAC criteria; in the pediatric ICU (PICU), 54.2% of VACs met adult IVAC criteria; and in the neonatal ICU (NICU), 20.2% of VACs met adult IVAC criteria. Most patients had abnormal white blood cell counts and temperatures; we therefore recommend simplifying surveillance by focusing on "pediatric VAC with antimicrobial use" (pediatric AVAC). Pediatric AVAC with a positive respiratory diagnostic test ("pediatric PVAP") occurred in 8.9% of VACs in the CICU, 13.3% of VACs in the PICU, and 4.3% of VACs in the NICU. Hospital mortality was increased, and hospital and ICU length of stay and duration of ventilation were prolonged among all pediatric VAE subsets compared with controls. CONCLUSIONS We propose pediatric AVAC for surveillance related to antimicrobial use, with pediatric PVAP as a subset of AVAC. Studies on generalizability and responsiveness of these metrics to quality improvement initiatives are needed, as are studies to determine whether lower pediatric VAE rates are associated with improvements in other outcomes. Infect Control Hosp Epidemiol 2017;38:327-333.
View details for DOI 10.1017/ice.2016.277
View details for Web of Science ID 000395452000011
View details for PubMedID 27917737
Immunization, Antibiotic Use, and Pneumococcal Colonization Over a 15-Year Period.
2017; 140 (5)
Rates of invasive pneumococcal disease have declined since widespread introduction of pneumococcal conjugate vaccines (PCVs) in the United States. We evaluated the impact of immunization status and recent antibiotic use on an individual child's risk of colonization.This study extends previously reported data from children <7 years of age seen for well child or acute care visits in Massachusetts communities. Nasopharyngeal swabs were collected during 6 surveillance seasons from 2000 to 2014. Parent surveys and medical record reviews confirmed immunization status and recent antibiotic use. We estimated the proportions of children colonized with PCV7-included, additional PCV13-included, and non-PCV13 serotypes. Risk factors for colonization with additional PCV13-included and non-PCV13 serotypes were assessed by using generalized linear mixed models adjusted for clustering by community.Among 6537 children, 19A emerged as the predominant serotype in 2004, with substantial reductions in 2014. Among non-PCV serotypes, 15B/C, 35B, 23B, 11A, and 23A were most common in 2014. We observed greater odds for both additional PCV13 and non-PCV13 colonization in younger children, those with more child care exposure, and those with a concomitant respiratory tract infection. Adjusted odds for additional PCV13 colonization was lower (odds ratio 0.48 [95% confidence interval 0.31-0.75]) among children up-to-date for PCV13 vaccines. Recent antibiotic use was associated with higher odds of additional PCV13 colonization but substantially lower odds of non-PCV13 colonization.Despite the success of pneumococcal vaccines in reducing colonization and disease due to targeted serotypes, ongoing community-based surveillance will be critical to evaluate the impact of interventions on pneumococcal colonization and disease.
View details for PubMedID 28978716
View details for PubMedCentralID PMC5654389
Maternal and Infant Outcomes After Human Papillomavirus Vaccination in the Periconceptional Period or During Pregnancy.
Obstetrics and gynecology
2017; 130 (3): 599–608
To evaluate whether quadrivalent human papillomavirus vaccine (4vHPV) administered during the periconceptional period or during pregnancy was associated with increased risks for adverse obstetric events, adverse birth outcomes, or selected major structural birth defects.We conducted a retrospective, observational cohort study using administrative and health care data from the Vaccine Safety Datalink. Insured women 13-27 years old with singleton pregnancies and a live birth from January 1, 2007, through September 1, 2013, who received 4vHPV during the periconceptional period (2 weeks before to 2 weeks after their last menstrual period), during pregnancy, or during both periods combined were compared with women who had a live birth during the same time period and received 4vHPV 4-18 months before their last menstrual period. We examined risks of gestational diabetes, hypertensive disorders of pregnancy, chorioamnionitis, preterm birth, small-for-gestational-age birth, and selected major structural birth defects in offspring. We estimated relative risks associated with receipt of 4vHPV during the periconceptional period, during pregnancy, and both exposure periods combined using a generalized linear model with Poisson distribution including a propensity score that included relevant maternal demographic and pregnancy characteristics.Of 92,579 potentially eligible pregnant women, 720 received 4vHPV during the periconceptional period, 638 received 4vHPV during pregnancy, and 8,196 received 4vHPV during the comparison period. Administration of 4vHPV during pregnancy was not associated with increased risk of adverse obstetric events, birth outcomes. Preterm birth occurred in 7.9% of pregnancies with vaccine exposures during pregnancy compared with 7.6% of pregnancies with vaccination in the comparison period (adjusted relative risk 0.97, 95% CI 0.72-1.3). Major structural birth defects were diagnosed in 2.0% of pregnancies with vaccine exposure during pregnancy compared with 1.8% of pregnancies with vaccine exposure during the comparison period (adjusted prevalence ratio 1.0, 95% CI 0.52-1.9). Results were similar for 4vHPV exposure during the periconceptional period.Quadrivalent HPV vaccine inadvertently administered in pregnancy or during the periconceptional period was not associated with adverse pregnancy or birth outcomes.
View details for PubMedID 28796684
Factors Associated With Pediatric Ventilator-Associated Conditions in Six U.S. Hospitals: A Nested Case-Control Study.
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
2017; 18 (11): e536–e545
A newly proposed surveillance definition for ventilator-associated conditions among neonatal and pediatric patients has been associated with increased morbidity and mortality among ventilated patients in cardiac ICU, neonatal ICU, and PICU. This study aimed to identify potential risk factors associated with pediatric ventilator-associated conditions.Retrospective cohort.Six U.S. hospitals PATIENTS:: Children less than or equal to 18 years old ventilated for greater than or equal to 1 day.None.We identified children with pediatric ventilator-associated conditions and matched them to children without ventilator-associated conditions. Medical records were reviewed for comorbidities and acute care factors. We used bivariate and multivariate conditional logistic regression models to identify factors associated with ventilator-associated conditions. We studied 192 pairs of ventilator-associated conditions cases and matched controls (113 in the PICU and cardiac ICU combined; 79 in the neonatal ICU). In the PICU/cardiac ICU, potential risk factors for ventilator-associated conditions included neuromuscular blockade (odds ratio, 2.29; 95% CI, 1.08-4.87), positive fluid balance (highest quartile compared with the lowest, odds ratio, 7.76; 95% CI, 2.10-28.6), and blood product use (odds ratio, 1.52; 95% CI, 0.70-3.28). Weaning from sedation (i.e., decreasing sedation) or interruption of sedation may be protective (odds ratio, 0.44; 95% CI, 0.18-1.11). In the neonatal ICU, potential risk factors included blood product use (odds ratio, 2.99; 95% CI, 1.02-8.78), neuromuscular blockade use (odds ratio, 3.96; 95% CI, 0.93-16.9), and recent surgical procedures (odds ratio, 2.19; 95% CI, 0.77-6.28). Weaning or interrupting sedation was protective (odds ratio, 0.07; 95% CI, 0.01-0.79).In mechanically ventilated neonates and children, we identified several possible risk factors associated with ventilator-associated conditions. Next steps include studying propensity-matched cohorts and prospectively testing whether changes in sedation management, transfusion thresholds, and fluid management can decrease pediatric ventilator-associated conditions rates and improve patient outcomes.
View details for PubMedID 28914722
Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship: Use of Administrative and Surveillance Databases
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2016; 37 (11): 1278-1287
Administrative and surveillance data are used frequently in healthcare epidemiology and antimicrobial stewardship (HE&AS) research because of their wide availability and efficiency. However, data quality issues exist, requiring careful consideration and potential validation of data. This methods paper presents key considerations for using administrative and surveillance data in HE&AS, including types of data available and potential use, data limitations, and the importance of validation. After discussing these issues, we review examples of HE&AS research using administrative data with a focus on scenarios when their use may be advantageous. A checklist is provided to help aid study development in HE&AS using administrative data. Infect Control Hosp Epidemiol 2016;1-10.
View details for DOI 10.1017/ice.2016.189
View details for Web of Science ID 000386404400003
View details for PubMedID 27572516
Febrile Seizure Risk After Vaccination in Children 6 to 23 Months
2016; 138 (1)
An increased risk of febrile seizure (FS) was identified with concomitant administration of trivalent inactivated influenza vaccine (IIV3) and pneumococcal conjugate vaccine (PCV) 13-valent during the 2010-2011 influenza season. Our objective was to determine whether concomitant administration of IIV3 with other vaccines affects the FS risk.We examined the risk of FS 0 to 1 day postvaccination for all routinely recommended vaccines among children aged 6 through 23 months during a period encompassing 5 influenza seasons (2006-2007 through 2010-2011). We used a population-based self-controlled risk interval analysis with a control interval of 14 to 20 days postvaccination. We used multivariable regression to control for receipt of concomitant vaccines and test for interaction between vaccines.Only PCV 7-valent had an independent FS risk (incidence rate ratio [IRR], 1.98; 95% confidence interval [CI], 1.00 to 3.91). IIV3 had no independent risk (IRR, 0.46; 95% CI, 0.21 to 1.02), but risk was increased when IIV3 was given with either PCV (IRR, 3.50; 95% CI, 1.13 to 10.85) or a diphtheria-tetanus-acellular-pertussis (DTaP)-containing vaccine (IRR, 3.50; 95% CI, 1.52 to 8.07). The maximum estimated absolute excess risk due to concomitant administration of IIV3, PCV, and DTaP-containing vaccines compared with administration on separate days was 30 FS per 100 000 persons vaccinated.The administration of IIV3 on the same day as either PCV or a DTaP-containing vaccine was associated with a greater risk of FS than when IIV3 was given on a separate day. The absolute risk of postvaccination FS with these vaccine combinations was small.
View details for DOI 10.1542/peds.2016-0320
View details for Web of Science ID 000378853100046
View details for PubMedID 27273711
Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
2016; 25 (5): 481-492
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.Three Data Partners provided their earliest available ("fresh") cumulative claims data on influenza vaccination and health outcomes 3-4 times on a staggered basis during the 2013-2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4 years of age using both a self-controlled risk interval design (primary) and a cohort design (secondary). After each data update, we conducted sequential analysis for inactivated (IIV) and live (LAIV) influenza vaccines using the Maximized Sequential Probability Ratio Test, adjusting for data-lag.Most of the 10 sequential analyses were conducted within 6 weeks of the last care-date in the cumulative dataset. A total of 6 682 336 doses of IIV and 782 125 doses of LAIV were captured. The primary analyses did not identify any statistical signals following IIV or LAIV. In secondary analysis, the risk of seizures was higher following concomitant IIV and PCV13 than historically after IIV in 6- to 23-month-olds (relative risk = 2.7), which requires further investigation.The Sentinel System can implement a sequential analysis system that uses fresh data for medical product safety surveillance. Active surveillance using sequential analysis of fresh data holds promise for detecting clinically significant health risks early. Limitations of employing fresh data for surveillance include cost and the need for careful scrutiny of signals. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
View details for DOI 10.1002/pds.3908
View details for Web of Science ID 000375615900001
View details for PubMedID 26572776
View details for PubMedCentralID PMC5019152
Diagnosing sepsis is subjective and highly variable: a survey of intensivists using case vignettes
Sepsis is the focus of national quality improvement programs and a recent public reporting measure from the Centers for Medicare and Medicaid Services. However, diagnosing sepsis requires interpreting nonspecific signs and can therefore be subjective. We sought to quantify interobserver variability in diagnosing sepsis.We distributed five case vignettes of patients with suspected or confirmed infection and organ dysfunction to a sample of practicing intensivists. Respondents classified cases as systemic inflammatory response syndrome, sepsis, severe sepsis, septic shock, or none of the above. Interobserver variability was calculated using Fleiss' κ for the five-level classification, and for answers dichotomized as severe sepsis/septic shock versus not-severe sepsis/septic shock and any sepsis category (sepsis, severe sepsis, or septic shock) versus not-sepsis.Ninety-four physicians completed the survey. Most respondents (88%) identified as critical care specialists; other specialties included pulmonology (39%), anesthesia (19%), surgery (9%), and emergency medicine (9%). Respondents had been in practice for a median of 8 years, and 90% practiced at academic hospitals. Almost all respondents (83%) felt strongly or somewhat confident in their ability to apply the traditional consensus sepsis definitions. However, overall interrater agreement in sepsis diagnoses was poor (Fleiss' κ 0.29). When responses were dichotomized into severe sepsis/septic shock versus not-severe sepsis/septic shock or any sepsis category versus not-sepsis, agreement was still poor (Fleiss' κ 0.23 and 0.18, respectively). Seventeen percent of respondents classified one of the five cases as severe sepsis/septic shock, 27.7% rated two cases, 33.0% respondents rated three cases, 19.2% rated four cases, and 3.2% rated all five cases as severe sepsis/septic shock. Among respondents who felt strongly confident in their ability to use sepsis definitions (n = 45), agreement was no better (Fleiss' κ 0.28 for the five-category classification, and Fleiss' κ 0.21 for the dichotomized severe sepsis/septic shock classification). Cases were felt to be extremely or very realistic in 74% of responses; only 3% were deemed unrealistic.Diagnosing sepsis is extremely subjective and variable. Objective criteria and standardized methodology are needed to enhance consistency and comparability in sepsis research, surveillance, benchmarking, and reporting.
View details for DOI 10.1186/s13054-016-1266-9
View details for Web of Science ID 000373670400001
View details for PubMedID 27048508
Risk of anaphylaxis after vaccination in children and adults
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
2016; 137 (3): 868-878
Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children.We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis.Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines.We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a nonsignificant female predominance. Vaccine-specific rates included 1.35 (95% CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95% CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases).Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat.
View details for DOI 10.1016/j.jaci.2015.07.048
View details for Web of Science ID 000371897500031
View details for PubMedID 26452420
View details for PubMedCentralID PMC4783279
Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013
2016; 34 (7): 968-973
Since October 2012, the combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) has been recommended in the United States during every pregnancy.In this observational study from the Vaccine Safety Datalink, we describe receipt of Tdap during pregnancy among insured women with live births across seven health systems. Using a retrospective matched cohort, we evaluated risks for selected medically attended adverse events in pregnant women, occurring within 42 days of vaccination. Using a generalized estimating equation, we calculated adjusted incident rate ratios (AIRR).Our vaccine coverage cohort included 438,487 live births between January 1, 2007 and November 15, 2013. Across the coverage cohort, 14% received Tdap during pregnancy. By 2013, Tdap was administered during pregnancy in 41.7% of live births, primarily in the 3rd trimester. Our vaccine safety cohort included 53,885 vaccinated and 109,253 matched unvaccinated pregnant women. There was no increased risk for a composite outcome of medically attended acute adverse events within 3 days of vaccination. Similarly, across the safety cohort, over a 42 day window, incident neurologic events, thrombotic events, and new onset proteinuria did not differ by maternal receipt of Tdap. Among women receiving Tdap at 20 weeks gestation or later, as compared to their matched controls, there was no increased risk for gestational diabetes or cardiac events while venous thromboembolic events and thrombocytopenia were diagnosed within 42 days of vaccination at slightly decreased rates.Tdap coverage during pregnancy increased from 2007 through 2013, but was still below 50%. No acute maternal safety signals were detected in this large cohort.
View details for DOI 10.1016/j.vaccine.2015.12.046
View details for Web of Science ID 000370087500013
View details for PubMedID 26765288
Impact of Hospital Operating Margin on Central Line-Associated Bloodstream Infections Following Medicare's Hospital-Acquired Conditions Payment Policy.
Infection control and hospital epidemiology
2016; 37 (1): 100-103
In October 2008, Medicare ceased additional payment for hospital-acquired conditions not present on admission. We evaluated the policy's differential impact in hospitals with high vs low operating margins. Medicare's payment policy may have had an impact on reducing central line-associated bloodstream infections in hospitals with low operating margins. Infect. Control Hosp. Epidemiol. 2015;37(1):100-103.
View details for DOI 10.1017/ice.2015.250
View details for PubMedID 26526631
Ventilator-Associated Events in Neonates and Children-A New Paradigm
CRITICAL CARE MEDICINE
2016; 44 (1): 14-22
To identify a pediatric ventilator-associated condition definition for use in neonates and children by exploring whether potential ventilator-associated condition definitions identify patients with worse outcomes.Retrospective cohort study and a matched cohort analysis.Pediatric, cardiac, and neonatal ICUs in five U.S. hospitals.Children 18 years old or younger ventilated for at least 1 day.None.We evaluated the evidence of worsening oxygenation via a range of thresholds for increases in daily minimum fraction of inspired oxygen (by 0.20, 0.25, and 0.30) and daily minimum mean airway pressure (by 4, 5, 6, and 7 cm H2O). We required worsening oxygenation be sustained for at least 2 days after at least 2 days of stability. We matched patients with a ventilator-associated condition to those without and used Cox proportional hazard models with frailties to examine associations with hospital mortality, hospital and ICU length of stay, and duration of ventilation. The cohort included 8,862 children with 10,209 hospitalizations and 77,751 ventilator days. For the fraction of inspired oxygen 0.25/mean airway pressure 4 definition (i.e., increase in minimum daily fraction of inspired oxygen by 0.25 or mean airway pressure by 4), rates ranged from 2.9 to 3.2 per 1,000 ventilator days depending on ICU type; the fraction of inspired oxygen 0.30/mean airway pressure 7 definition yielded ventilator-associated condition rates of 1.1-1.3 per 1,000 ventilator days. All definitions were significantly associated with greater risk of hospital death, with hazard ratios ranging from 1.6 (95% CI, 0.7-3.4) to 6.8 (2.9-16.0), depending on thresholds and ICU type. Each definition was associated with prolonged hospitalization, time in ICU, and duration of ventilation, among survivors. The advisory board of the study proposed using the fraction of inspired oxygen 0.25/mean airway pressure 4 thresholds to identify pediatric ventilator-associated conditions in ICUs.Pediatric patients with ventilator-associated conditions are at substantially higher risk for mortality and morbidity across ICUs, regardless of thresholds used. Next steps include identification of risk factors, etiologies, and preventative measures for pediatric ventilator-associated conditions.
View details for DOI 10.1097/CCM.0000000000001372
View details for Web of Science ID 000366605100003
View details for PubMedID 26524075
Febrile Seizures After 2010-2011 Trivalent Inactivated Influenza Vaccine
2015; 136 (4): E848-E855
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.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.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).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.
View details for DOI 10.1542/peds.2015-0635
View details for Web of Science ID 000362944300009
View details for PubMedID 26371192
- Ongoing Attention to Injurious Inpatient Falls and Pressure Ulcers JAMA INTERNAL MEDICINE 2015; 175 (9): 1581-1582
Impact of the Centers for Medicare and Medicaid Services Hospital-Acquired Conditions Policy on Billing Rates for 2 Targeted Healthcare-Associated Infections
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2015; 36 (8): 871-877
The 2008 Centers for Medicare & Medicaid Services hospital-acquired conditions policy limited additional payment for conditions deemed reasonably preventable.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).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.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]).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.
View details for DOI 10.1017/ice.2015.86
View details for Web of Science ID 000358391800001
View details for PubMedID 25906824
Impact of Medicare's Hospital-Acquired Condition Policy on Infections in Safety Net and Non-Safety Net Hospitals
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2015; 36 (6): 649-655
Policymakers may wish to align healthcare payment and quality of care while minimizing unintended consequences, particularly for safety net hospitals.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.Interrupted time-series design.Nonfederal acute care hospitals that reported central line-associated bloodstream infection and ventilator-associated pneumonia rates to the Centers for Disease Control and Prevention's National Health Safety Network from July 1, 2007, through December 31, 2013.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).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.
View details for DOI 10.1017/ice.2015.38
View details for Web of Science ID 000354981400006
View details for PubMedID 25732568
GROUP A STREPTOCOCCAL BACTEREMIA WITHOUT A SOURCE IS ASSOCIATED WITH LESS SEVERE DISEASE IN CHILDREN
PEDIATRIC INFECTIOUS DISEASE JOURNAL
2015; 34 (4): 447-449
We analyzed characteristics of 86 Group A streptococcal bacteremia cases at Boston Children's Hospital from 1992 to 2012. Twenty-three percent of children had severe disease, using intensive care unit admission (18), disability (7) or death (2) as indicators. Children with bacteremia without a source (30% of cases) were less likely to have severe disease than children with focal infections in adjusted models.
View details for DOI 10.1097/INF.0000000000000587
View details for Web of Science ID 000351007900024
View details for PubMedID 25319760
Stability of the pneumococcal population structure in Massachusetts as PCV13 was introduced
BMC INFECTIOUS DISEASES
The success of 7-valent pneumococcal conjugate vaccination (PCV-7) introduced to the US childhood immunization schedule in 2000 was partially offset by increases in invasive pneumococcal disease (IPD) and pneumococcal carriage due to non-vaccine serotypes, in particular 19A, in the years that followed. A 13-valent conjugate vaccine (PCV-13) was introduced in 2010. As part of an ongoing study of the response of the Massachusetts pneumococcal population to conjugate vaccination, we report the findings from the samples collected in 2011, as PCV-13 was introduced.We used multilocus sequence typing (MLST) to analyze 367 pneumococcal isolates carried by Massachusetts children (aged 3 months-7 years) collected during the winter of 2010-11 and used eBURST software to compare the pneumococcal population structure with that found in previous years.One hundred and four distinct sequence types (STs) were found, including 24 that had not been previously recorded. Comparison with a similar sample collected in 2009 revealed no significant overall difference in the ST composition (p = 0.39, classification index). However, we describe clonal dynamics within the important replacement serotypes 19A, 15B/C, and 6C, and clonal expansion of ST 433 and ST 432, which are respectively serotype 22F and 21 clones.While little overall change in serotypes or STs was evident, multiple changes in the frequency of individual STs and or serotypes may plausibly be ascribed to the introduction of PCV-13. This 2011 sample documents the initial impact of PCV-13 and will be important for comparison with future studies of the evolution of the pneumococcal population in Massachusetts.
View details for DOI 10.1186/s12879-015-0797-z
View details for Web of Science ID 000349868300002
View details for PubMedID 25887323
View details for PubMedCentralID PMC4336693
Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006
2015; 33 (2): 382-387
Kawasaki disease is a childhood vascular disorder of unknown etiology. Concerns have been raised about vaccinations being a potential risk factor for Kawasaki disease.Data from the Vaccine Safety Datalink were collected on children aged 0-6 years at seven managed care organizations across the United States. Defining exposure as one of several time periods up to 42 days after vaccination, we conducted Poisson regressions controlling for age, sex, season, and managed care organization to determine if rates of physician-diagnosed and verified Kawasaki disease were elevated following vaccination compared to rates during all unexposed periods. We also performed case-crossover analyses to control for unmeasured confounding.A total of 1,721,186 children aged 0-6 years from seven managed care organizations were followed for a combined 4,417,766 person-years. The rate of verified Kawasaki disease was significantly lower during the 1-42 days after vaccination (rate ratio=0.50, 95% CL=0.27-0.92) and 8-42 days after vaccination (rate ratio=0.45, 95% CL=0.22-0.90) compared to rates during unexposed periods. Breaking down the analysis by vaccination category did not identify a subset of vaccines which was solely responsible for this association. The case-crossover analyses revealed that children with Kawasaki disease had lower rates of vaccination in the 42 days prior to symptom onset for both physician-diagnosed Kawasaki disease (rate ratio=0.79, 95% CL=0.64-0.97) and verified Kawasaki disease (rate ratio=0.38, 95% CL=0.20-0.75).Childhood vaccinations' studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.
View details for DOI 10.1016/j.vaccine.2014.10.044
View details for Web of Science ID 000348268500017
View details for PubMedID 25444786
Accuracy of administrative data for surveillance of healthcare-associated infections: a systematic review
2015; 5 (8)
Measuring the incidence of healthcare-associated infections (HAI) is of increasing importance in current healthcare delivery systems. Administrative data algorithms, including (combinations of) diagnosis codes, are commonly used to determine the occurrence of HAI, either to support within-hospital surveillance programmes or as free-standing quality indicators. We conducted a systematic review evaluating the diagnostic accuracy of administrative data for the detection of HAI.Systematic search of Medline, Embase, CINAHL and Cochrane for relevant studies (1995-2013). Methodological quality assessment was performed using QUADAS-2 criteria; diagnostic accuracy estimates were stratified by HAI type and key study characteristics.57 studies were included, the majority aiming to detect surgical site or bloodstream infections. Study designs were very diverse regarding the specification of their administrative data algorithm (code selections, follow-up) and definitions of HAI presence. One-third of studies had important methodological limitations including differential or incomplete HAI ascertainment or lack of blinding of assessors. Observed sensitivity and positive predictive values of administrative data algorithms for HAI detection were very heterogeneous and generally modest at best, both for within-hospital algorithms and for formal quality indicators; accuracy was particularly poor for the identification of device-associated HAI such as central line associated bloodstream infections. The large heterogeneity in study designs across the included studies precluded formal calculation of summary diagnostic accuracy estimates in most instances.Administrative data had limited and highly variable accuracy for the detection of HAI, and their judicious use for internal surveillance efforts and external quality assessment is recommended. If hospitals and policymakers choose to rely on administrative data for HAI surveillance, continued improvements to existing algorithms and their robust validation are imperative.
View details for DOI 10.1136/bmjopen-2015-008424
View details for Web of Science ID 000363479100057
View details for PubMedID 26316651
View details for PubMedCentralID PMC4554897
Cost-Effectiveness of Strategies to Prevent Methicillin-Resistant Staphylococcus aureus Transmission and Infection in an Intensive Care Unit
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2015; 36 (1): 17-27
OBJECTIVE To create a national policy model to evaluate the projected cost-effectiveness of multiple hospital-based strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) transmission and infection. DESIGN Cost-effectiveness analysis using a Markov microsimulation model that simulates the natural history of MRSA acquisition and infection. PATIENTS AND SETTING Hypothetical cohort of 10,000 adult patients admitted to a US intensive care unit. METHODS We compared 7 strategies to standard precautions using a hospital perspective: (1) active surveillance cultures; (2) active surveillance cultures plus selective decolonization; (3) universal contact precautions (UCP); (4) universal chlorhexidine gluconate baths; (5) universal decolonization; (6) UCP + chlorhexidine gluconate baths; and (7) UCP+decolonization. For each strategy, both efficacy and compliance were considered. Outcomes of interest were: (1) MRSA colonization averted; (2) MRSA infection averted; (3) incremental cost per colonization averted; (4) incremental cost per infection averted. RESULTS A total of 1989 cases of colonization and 544 MRSA invasive infections occurred under standard precautions per 10,000 patients. Universal decolonization was the least expensive strategy and was more effective compared with all strategies except UCP+decolonization and UCP+chlorhexidine gluconate. UCP+decolonization was more effective than universal decolonization but would cost $2469 per colonization averted and $9007 per infection averted. If MRSA colonization prevalence decreases from 12% to 5%, active surveillance cultures plus selective decolonization becomes the least expensive strategy. CONCLUSIONS Universal decolonization is cost-saving, preventing 44% of cases of MRSA colonization and 45% of cases of MRSA infection. Our model provides useful guidance for decision makers choosing between multiple available hospital-based strategies to prevent MRSA transmission.
View details for DOI 10.1017/ice.2014.12
View details for Web of Science ID 000348588800004
View details for PubMedID 25627757
View details for PubMedCentralID PMC4311265
Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study
2014; 9 (12)
Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system.We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons.Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3:1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior.The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior.
View details for DOI 10.1371/journal.pone.0115553
View details for Web of Science ID 000348563300048
View details for PubMedID 25536228
View details for PubMedCentralID PMC4275236
Evaluation of the Association of Maternal Pertussis Vaccination With Obstetric Events and Birth Outcomes
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2014; 312 (18): 1897-1904
In 2010, due to a pertussis outbreak and neonatal deaths, the California Department of Health recommended that the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) be administered during pregnancy. Tdap is now recommended by the Advisory Committee on Immunization Practices for all pregnant women, preferably between 27 and 36 weeks' gestation. Limited data exist on Tdap safety during pregnancy.To evaluate whether maternal Tdap vaccination during pregnancy is associated with increased risks of adverse obstetric events or adverse birth outcomes.Retrospective, observational cohort study using administrative health care databases from 2 California Vaccine Safety Datalink sites.Of 123,494 women with singleton pregnancies ending in a live birth between January 1, 2010, and November 15, 2012, 26,229 (21%) received Tdap during pregnancy and 97,265 did not.Risks of small-for-gestational-age (SGA) births (<10th percentile), chorioamnionitis, preterm birth (<37 weeks' gestation), and hypertensive disorders of pregnancy were evaluated. Relative risk (RR) estimates were adjusted for site, receipt of another vaccine during pregnancy, and propensity to receive Tdap during pregnancy. Cox regression was used for preterm delivery, and Poisson regression for other outcomes.Vaccination was not associated with increased risks of adverse birth outcomes: crude estimates for preterm delivery were 6.3% of vaccinated and 7.8% of unvaccinated women (adjusted RR, 1.03; 95% CI, 0.97-1.09); 8.4% of vaccinated and 8.3% of unvaccinated had an SGA birth (adjusted RR, 1.00; 95% CI, 0.96-1.06). Receipt of Tdap before 20 weeks was not associated with hypertensive disorder of pregnancy (adjusted RR, 1.09; 95% CI, 0.99-1.20); chorioamnionitis was diagnosed in 6.1% of vaccinated and 5.5% of unvaccinated women (adjusted RR, 1.19; 95% CI, 1.13-1.26).In this cohort of women with singleton pregnancies that ended in live birth, receipt of Tdap during pregnancy was not associated with increased risk of hypertensive disorders of pregnancy or preterm or SGA birth, although a small but statistically significant increased risk of chorioamnionitis diagnosis was observed.
View details for DOI 10.1001/jama.2014.14825
View details for Web of Science ID 000344532600019
View details for PubMedID 25387187
Central Line-Associated Bloodstream Infections in Neonates with Gastrointestinal Conditions: Developing a Candidate Definition for Mucosal Barrier Injury Bloodstream Infections
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2014; 35 (11): 1391-1399
To develop a candidate definition for central line-associated bloodstream infection (CLABSI) in neonates with presumed mucosal barrier injury due to gastrointestinal (MBI-GI) conditions and to evaluate epidemiology and microbiology of MBI-GI CLABSI in infants.Multicenter retrospective cohort study.Neonatal intensive care units from 14 US children's hospitals and pediatric facilities.A multidisciplinary focus group developed a candidate MBI-GI CLABSI definition based on presence of an MBI-GI condition, parenteral nutrition (PN) exposure, and an eligible enteric organism. CLABSI surveillance data from participating hospitals were supplemented by chart review to identify MBI-GI conditions and PN exposure.During 2009-2012, 410 CLABSIs occurred in 376 infants. MBI-GI conditions and PN exposure occurred in 149 (40%) and 324 (86%) of these 376 neonates, respectively. The distribution of pathogens was similar among neonates with versus without MBI-GI conditions and PN exposure. Fifty-nine (16%) of the 376 initial CLABSI episodes met the candidate MBI-GI CLABSI definition. Subsequent versus initial CLABSIs were more likely to be caused by an enteric organism (22 of 34 [65%] vs 151 of 376 [40%]; P = .009) and to meet the candidate MBI-GI CLABSI definition (19 of 34 [56%] vs 59 of 376 [16%]; P < .01).While MBI-GI conditions and PN exposure were common, only 16% of initial CLABSIs met the candidate definition of MBI-GI CLABSI. The high proportion of MBI-GI CLABSIs among subsequent infections suggests that infants with MBI-GI CLABSI should be a population targeted for further surveillance and interventional research.
View details for DOI 10.1086/678410
View details for Web of Science ID 000344316700010
View details for PubMedID 25333434
View details for PubMedCentralID PMC4551075
Cost Savings of Universal Decolonization to Prevent Intensive Care Unit Infection: Implications of the REDUCE MRSA Trial
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2014; 35: S23-S31
To estimate and compare the impact on healthcare costs of 3 alternative strategies for reducing bloodstream infections in the intensive care unit (ICU): methicillin-resistant Staphylococcus aureus (MRSA) nares screening and isolation, targeted decolonization (ie, screening, isolation, and decolonization of MRSA carriers or infections), and universal decolonization (ie, no screening and decolonization of all ICU patients).Cost analysis using decision modeling.We developed a decision-analysis model to estimate the health care costs of targeted decolonization and universal decolonization strategies compared with a strategy of MRSA nares screening and isolation. Effectiveness estimates were derived from a recent randomized trial of the 3 strategies, and cost estimates were derived from the literature.In the base case, universal decolonization was the dominant strategy and was estimated to have both lower intervention costs and lower total ICU costs than either screening and isolation or targeted decolonization. Compared with screening and isolation, universal decolonization was estimated to save $171,000 and prevent 9 additional bloodstream infections for every 1,000 ICU admissions. The dominance of universal decolonization persisted under a wide range of cost and effectiveness assumptions.A strategy of universal decolonization for patients admitted to the ICU would both reduce bloodstream infections and likely reduce healthcare costs compared with strategies of MRSA nares screening and isolation or screening and isolation coupled with targeted decolonization.
View details for DOI 10.1086/677819
View details for Web of Science ID 000341939700005
View details for PubMedID 25222894
Health Care-Associated Infections Among Critically III Children in the US, 2007-2012
2014; 134 (4): 705-712
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.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.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.Between 2007 and 2012 there were substantial reductions in HAIs among hospitalized neonates and children.
View details for DOI 10.1542/peds.2014-0613
View details for Web of Science ID 000343140500053
View details for PubMedID 25201802
The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety
2014; 32 (42): 5390-5398
The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety of vaccines used in the United States. Large linked databases are used to identify and evaluate adverse events in over 9 million individuals annually. VSD generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns. VSD monitors safety of seasonal influenza vaccines in near-real time, and provided essential information on the safety of influenza A (H1N1) 2009 monovalent vaccine during the recent pandemic. VSD investigators have published important studies demonstrating that childhood vaccines are not associated with autism or other developmental disabilities. VSD prioritizes evaluation of new vaccines; searches for possible unusual health events after vaccination; monitors vaccine safety in pregnant women; and has pioneered development of biostatistical research methods.
View details for DOI 10.1016/j.vaccine.2014.07.073
View details for Web of Science ID 000343346200005
View details for PubMedID 25108215
Monovalent H1N1 influenza vaccine safety in pregnant women, risks for acute adverse events
2014; 32 (39): 4985-4992
To assess risks for acute adverse events and pregnancy complications in pregnant women following monovalent 2009 H1N1 inactivated influenza (MIV) vaccination.Within the Vaccine Safety Datalink, we compared rates of pre-specified medically attended events (MAE) occurring within 42 days of MIV vaccination to those occurring in matched cohorts that at the same gestational age were either unvaccinated or received seasonal trivalent inactivated influenza (TIV) vaccine. Using generalized estimating equation method, with a Poisson distribution and log link, we calculated adjusted incident rate ratios (AIRR).Among 9349 women receiving MIV in any trimester, only one MAE occurred 0-3 days following MIV, an allergic reaction. No cases of Guillain-Barré syndrome, Bell's palsy, or transverse myelitis occurred 1-42 days after MIV. Compared to women receiving TIV and to unvaccinated women, risks for acute MAEs were not increased following MIV for any outcome. Hyperemesis was the most common adverse event in the MIV, TIV, and unvaccinated groups, occurring at a rate of about 4% over a 42-day period in all groups. Over a 42-day window, among all groups, incident gestational diabetes occurred at a rate of 3% and thrombocytopenia occurred at a rate of approximately 0.3%. Among women receiving MIV during pregnancy, increased risks for these and other less common obstetric events were not detected.In this large cohort of pregnant women no acute safety signals were identified within 6 weeks of receipt of MIV.
View details for DOI 10.1016/j.vaccine.2014.07.017
View details for Web of Science ID 000341559300015
View details for PubMedID 25045808
- Strategies to Prevent Ventilator-Associated Pneumonia in Acute Care Hospitals: 2014 Update INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY 2014; 35: 915-936
Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update.
Infection control and hospital epidemiology
2014; 35: S133-54
View details for PubMedID 25376073
- Strategies to Prevent Ventilator-Associated Pneumonia in Acute Care Hospitals: 2014 Update INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY 2014; 35 (8): 915-936
Timely Versus Delayed Early Childhood Vaccination and Seizures
2014; 133 (6): E1492-E1499
Little is known regarding the timing of childhood vaccination and postvaccination seizures.In a cohort of 323 247 US children from the Vaccine Safety Datalink born from 2004 to 2008, we analyzed the association between the timing of childhood vaccination and the first occurrence of seizure with a self-controlled case series analysis of the first doses of individual vaccines received in the first 2 years of life.In infants, there was no association between the timing of infant vaccination and postvaccination seizures. In the second year of life, the incident rate ratio (IRR) for seizures after receipt of the first measles-mumps-rubella vaccine (MMR) dose at 12 to 15 months was 2.65 (95% confidence interval [CI] 1.99-3.55); the IRR after an MMR dose at 16 to 23 months was 6.53 (95% CI 3.15-13.53). The IRR for seizures after receipt of the first measles-mumps-rubella-varicella vaccine (MMRV) dose at 12 to 15 months was 4.95 (95% CI 3.68-6.66); the IRR after an MMRV dose at 16 to 23 months was 9.80 (95% CI 4.35 -22.06).There is no increased risk of postvaccination seizure in infants regardless of timing of vaccination. In year 2, delaying MMR vaccine past 15 months of age results in a higher risk of seizures. The strength of the association is doubled with MMRV vaccine. These findings suggest that on-time vaccination is as safe with regard to seizures as delayed vaccination in the first year of life, and that delayed vaccination in the second year of life is associated with more postvaccination seizures than on-time vaccination.
View details for DOI 10.1542/peds.2013-3429
View details for Web of Science ID 000337172600002
View details for PubMedID 24843064
Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barre syndrome, encephalitis, or anaphylaxis in the 2012-2013 season
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
2014; 23 (5): 548-553
We conducted weekly surveillance for pre-specified adverse events following receipt of the 2012-2013 influenza vaccines in the Vaccine Safety Datalink (VSD).For each outcome, risk intervals (i.e., period after vaccination with a potentially increased risk) were defined on the basis of biologic plausibility and prior literature. Seizures following inactivated influenza vaccine (IIV) were monitored in children in three age groups (6-23 months, 24-59 months, and 5-17 years) using a self-controlled risk interval design. We also monitored for Guillain-Barré syndrome, encephalitis, and anaphylaxis following IIV in patients ≥6 months of age using a cohort design with historical controls. In the risk intervals following live attenuated influenza vaccine (LAIV), we collected weekly counts of Guillain-Barré syndrome, encephalitis, and anaphylaxis in patients ages 2-49. Among LAIV vaccinees, numbers of expected events based on rates in historical controls were calculated, adjusted for age and site.At the end of surveillance, approximately 3.6 million first doses of IIV and 250 000 first doses of LAIV had been administered in the VSD. No elevated risks were identified in risk intervals following 2012-2013 IIV, as compared with a self-matched control interval or to historical controls. For each outcome, fewer than three events occurred in the risk interval following 2012-2013 LAIV, and we thus were unable to estimate measures of relative risks.No increased risk was identified for any of the pre-specified outcomes following 2012-2013 influenza vaccinations in the VSD. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
View details for DOI 10.1002/pds.3575
View details for Web of Science ID 000333948300012
View details for PubMedID 24497128
Impact of 13-Valent Pneumococcal Conjugate Vaccination on Streptococcus pneumoniae Carriage in Young Children in Massachusetts.
Journal of the Pediatric Infectious Diseases Society
2014; 3 (1): 23-32
In April 2010, a 13-valent pneumococcal conjugate vaccine (PCV13) replaced PCV7 for use in the United States. We evaluated rates of pneumococcal colonization, by serotype and antibiotic resistance, in Massachusetts communities where serial cross-sectional surveillance has been conducted for the past decade.Nasopharyngeal swabs were obtained from children 0 to <7 years of age and seen by primary care providers for well child or acute illness visits in 2001, 2004, 2007, 2009, and 2011. Pneumococcal isolates were serotyped by Quellung reaction and classified as PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), additional PCV13 serotypes (1, 3, 5, 6A, 7F, 19A), or non-PCV13 serotypes. Changes in colonization and impact of PCV13 were assessed using generalized linear mixed models, adjusting for known risk factors and accounting for clustering by community.Introduction of PCV13 did not affect the rate of overall pneumococcal colonization (31% in 2011). Colonization with non-PCV13 serotypes increased between 2001 and 2011 for all children (odds ratio [OR] per year, 1.12; 95% confidence interval [CI], 1.10, 1.15; P < .0001). 19A remained the second most common serotype in 2011, although a decline from 2009 was observed. Penicillin (7%), erythromycin (28%), ceftriaxone (10%), and clindamycin (10%) nonsusceptibility were commonly identified, concentrated among a small number of serotypes (including 19A, 35B, 15B/C, and 15A). Among healthy children 6-23 months old, colonization with PCV13 serotypes was lower among recipients of PCV13 vaccine (adjusted OR, 0.30; 95% CI, 0.11, 0.78). This effect was not observed in 6- to 23-month-old children with a concomitant respiratory tract infection (adjusted OR 1.36; 95% CI, 0.66, 2.77) or children 2 to <7 years old (adjusted OR, 1.17; 95% CI, 0.58, 2.34).13-Valent pneumococcal conjugate vaccine reduced the prevalence of colonization with PCV13 serotypes among children 6-23 months old, but its efficacy was not shown among older children.
View details for DOI 10.1093/jpids/pit057
View details for PubMedID 24567842
Intussusception risk after rotavirus vaccination in U.S. infants.
New England journal of medicine
2014; 370 (6): 503-512
International postlicensure studies have identified an increased risk of intussusception after vaccination with the second-generation rotavirus vaccines RotaTeq (RV5, a pentavalent vaccine) and Rotarix (RV1, a monovalent vaccine). We studied this association among infants in the United States.The study included data from infants 5.0 to 36.9 weeks of age who were enrolled in three U.S. health plans that participate in the Mini-Sentinel program sponsored by the Food and Drug Administration. Potential cases of intussusception and vaccine exposures from 2004 through mid-2011 were identified through procedural and diagnostic codes. Medical records were reviewed to confirm the occurrence of intussusception and the status with respect to rotavirus vaccination. The primary analysis used a self-controlled risk-interval design that included only vaccinated children. The secondary analysis used a cohort design that included exposed and unexposed person-time.The analyses included 507,874 first doses and 1,277,556 total doses of RV5 and 53,638 first doses and 103,098 total doses of RV1. The statistical power for the analysis of RV1 was lower than that for the analysis of RV5. The number of excess cases of intussusception per 100,000 recipients of the first dose of RV5 was significantly elevated, both in the primary analysis (attributable risk, 1.1 [95% confidence interval, 0.3 to 2.7] for the 7-day risk window and 1.5 [95% CI, 0.2 to 3.2] for the 21-day risk window) and in the secondary analysis (attributable risk, 1.2 [95% CI, 0.2 to 3.2] for the 21-day risk window). No significant increase in risk was seen after dose 2 or 3. The results with respect to the primary analysis of RV1 were not significant, but the secondary analysis showed a significant risk after dose 2.RV5 was associated with approximately 1.5 (95% CI, 0.2 to 3.2) excess cases of intussusception per 100,000 recipients of the first dose. The secondary analysis of RV1 suggested a potential risk, although the study of RV1 was underpowered. These risks must be considered in light of the demonstrated benefits of rotavirus vaccination. (Funded by the Food and Drug Administration.).
View details for DOI 10.1056/NEJMoa1303164
View details for PubMedID 24422676
Do community-level predictors of pneumococcal carriage continue to play a role in the conjugate vaccine era?
EPIDEMIOLOGY AND INFECTION
2014; 142 (2): 379-387
This paper examined whether previously identified community-level factors (high proportion of crowded households and/or persons below the poverty level) remained associated with childhood pneumococcal carriage in the heptavalent pneumococcal conjugate vaccine (PCV7) era. Using logistic regression, individual factors were used to develop base models to which community-level factors were added to evaluate impact on pneumococcal carriage within two paediatric study cohorts from Massachusetts (urban Boston, outside Boston). Six years after introduction of universal childhood PCV7 vaccination, we found no consistent evidence that census tract characteristics (e.g. population size and density, age and race distribution, percent participating in group childcare, parental education, percent lacking in-unit plumbing, poverty, and community stability) affected odds of pneumococcal carriage when added to individual predictors (e.g. younger age, current respiratory tract infections, and attendance in group childcare). How community-level factors influence pneumococcal carriage continues to change in the era of increasing immunization coverage.
View details for DOI 10.1017/S0950268813000794
View details for Web of Science ID 000332524300018
View details for PubMedID 23731707
View details for PubMedCentralID PMC3849242
Impact of Medicare's Payment Policy on Mediastinitis Following Coronary Artery Bypass Graft Surgery in US Hospitals
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2014; 35 (2): 144-151
The Centers for Medicare and Medicaid Services (CMS) implemented a policy in October 2008 to eliminate additional Medicare payment for mediastinitis following coronary artery bypass graft (CABG) surgery.To evaluate the impact of this policy on mediastinitis rates, using Medicare claims and National Healthcare Safety Network (NHSN) prospective surveillance data.We used an interrupted time series design to compare mediastinitis rates before and after the policy, adjusted for secular trends. Billing rates came from Medicare inpatient claims following 638,761 CABG procedures in 1,234 US hospitals (January 2006-September 2010). Prospective surveillance rates came from 151 NHSN hospitals in 29 states performing 94,739 CABG procedures (January 2007-September 2010). Logistic regression mixed-effects models estimated trends for mediastinitis rates.We found a sudden drop in coding for index admission mediastinitis at the time of policy implementation (odds ratio, 0.36 [95% confidence interval (CI), 0.23-0.57]) and a decreasing trend in coding for index admission mediastinitis in the postintervention period compared with the preintervention period (ratio of slopes, 0.83 [95% CI, 0.74-0.95]). However, we saw no impact of the policy on infection rates as measured using NHSN data. Our results were not affected by changes in patient risk over time, heterogeneity in hospital demographics, or timing of hospital participation in NHSN.The CMS policy of withholding additional Medicare payment for mediastinitis on the basis of claims-based evidence of infection was associated with changes in coding for infections but not with changes in actual infection rates during the first 2 years after policy implementation.
View details for DOI 10.1086/674861
View details for Web of Science ID 000329873000006
View details for PubMedID 24442076
Post-licensure rapid immunization safety monitoring program (PRISM) data characterization
2013; 31: K98-K112
The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data.We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates.The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data. Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases.PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring.
View details for DOI 10.1016/j.vaccine.2013.04.088
View details for Web of Science ID 000329684600012
View details for PubMedID 24331080
Initial Antibiotic Choice in the Treatment of Group A Streptococcal Pharyngitis and Return Visit Rates.
Journal of the Pediatric Infectious Diseases Society
2013; 2 (4): 361-367
Our objectives were to describe the incidence of return visits for children with Group A Streptococcal (GAS) pharyngitis (ie, clinical treatment failure) and to assess whether initial treatment with amoxicillin or penicillin was associated with the rate of retreatment for GAS pharyngitis.This analysis was a retrospective cohort study of 5533 children 0-17 years from a multisite practice. Eligible visits (n = 6585) were associated with a positive test for GAS, receipt of antibiotics within 7 days, no allergies to penicillins or cephalosporins, and no codiagnoses requiring antibiotic treatment. Retreatment for GAS pharyngitis was defined as an index visit followed by another visit within 1-4 weeks. Five hundred episodes (250 treatment failures and 250 controls) were randomly selected for chart review to validate cases.Amoxicillin or penicillin was the initial antibiotic treatment at 76.1% of visits, and retreatment for GAS pharyngitis occurred after 5.8% of initial visits. Children initially prescribed amoxicillin or penicillin had higher odds of retreatment of GAS pharyngitis even after adjusting for age, sex, symptoms, and community-level covariates such as race, income, and education (odds ratio, 1.51; 95% confidence interval, 1.07-2.13).Retreatment for GAS pharyngitis was uncommon and associated with receipt of amoxicillin or penicillin, although the impact of GAS carriage is unknown. Recommendations for initial treatment of GAS pharyngitis should reflect both individual and societal considerations, including the potential impact on antibiotic resistance in the community.
View details for DOI 10.1093/jpids/pit043
View details for PubMedID 26619498
Association Between Undervaccination With Diphtheria, Tetanus Toxoids, and Acellular Pertussis (DTaP) Vaccine and Risk of Pertussis Infection in Children 3 to 36 Months of Age
2013; 167 (11): 1060-1064
Undervaccination is an increasing trend that potentially places children and their communities at an increased risk for serious infectious diseases.To examine the association between undervaccination and pertussis in children 3 to 36 months of age.Matched case-control study with conditional logistic regression analysis.Eight managed care organizations of the Vaccine Safety Datalink between 2004 and 2010.Each laboratory-confirmed case of pertussis (72 patients) was matched to 4 randomly selected controls (for a total of 288 controls). The case patients were matched to controls by managed care organization site, sex, and age at the index date. The index date was defined as the date of pertussis diagnosis for the case patients.Undervaccination for the diphtheria, tetanus toxoids, and acellular pertussis (DTaP) vaccine. Undervaccination was defined as the number of doses of DTaP vaccine that was either missing or delayed by the index date. Case patients and controls could be undervaccinated by 0, 1, 2, 3, or 4 doses of DTaP vaccine. Children undervaccinated by 0 doses were considered age-appropriately vaccinated by the index date.Pertussis.Of the 72 case patients with pertussis, 12 (16.67%) were hospitalized, and 34 (47.22%) were undervaccinated for DTaP vaccine by the date of pertussis diagnosis. Of the 288 matched controls, 64 (22.22%) were undervaccinated for DTaP vaccine. Undervaccination was strongly associated with pertussis. Children undervaccinated for 3 or 4 doses of DTaP vaccine were 18.56 (95% CI, 4.92-69.95) and 28.38 (95% CI, 3.19-252.63) times more likely, respectively, to have received a diagnosis of pertussis than children who were age-appropriately vaccinated.Undervaccination with DTaP vaccine increases the risk of pertussis among children 3 to 36 months of age.
View details for DOI 10.1001/jamapediatrics.2013.2353
View details for Web of Science ID 000329842300019
View details for PubMedID 24019039
International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccines
2013; 31 (40): 4448-4458
The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination.The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach.We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach.This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines.
View details for DOI 10.1016/j.vaccine.2013.06.032
View details for Web of Science ID 000324510500027
View details for PubMedID 23770307
Health and Economic Burden of Post-Partum Staphylococcus aureus Breast Abscess
2013; 8 (9)
To determine the health and economic burdens of post-partum Staphylococcus aureus breast abscess.We conducted a matched cohort study (N = 216) in a population of pregnant women (N = 32,770) who delivered at our center during the study period from 10/1/03-9/30/10. Data were extracted from hospital databases, or via chart review if unavailable electronically. We compared cases of S. aureus breast abscess to controls matched by delivery date to compare health services utilization and mean attributable medical costs in 2012 United States dollars using Medicare and hospital-based estimates. We also evaluated whether resource utilization and health care costs differed between cases with methicillin-resistant and -susceptible S. aureus isolates.Fifty-four cases of culture-confirmed post-partum S. aureus breast abscess were identified. Breastfeeding cessation (41%), milk fistula (11.1%) and hospital readmission (50%) occurred frequently among case patients. Breast abscess case patients had high rates of health services utilization compared to controls, including high rates of imaging and drainage procedures. The mean attributable cost of post-partum S. aureus breast abscess ranged from $2,340-$4,012, depending on the methods and data sources used. Mean attributable costs were not significantly higher among methicillin-resistant vs. -susceptible S. aureus cases.Post-partum S. aureus breast abscess is associated with worse health and economic outcomes for women and their infants, including high rates of breastfeeding cessation. Future study is needed to determine the optimal treatment and prevention of these infections.
View details for DOI 10.1371/journal.pone.0073155
View details for Web of Science ID 000324481600055
View details for PubMedID 24039877
View details for PubMedCentralID PMC3764182
Inactivated Influenza Vaccine During Pregnancy and Risks for Adverse Obstetric Events
OBSTETRICS AND GYNECOLOGY
2013; 122 (3): 659-667
To compare risks for adverse obstetric events between females who did and did not receive trivalent inactivated influenza vaccine during pregnancy.This retrospective, observational cohort study was conducted at seven Vaccine Safety Datalink sites. Pregnancies were identified from administrative and claims data using a validated algorithm. Females vaccinated while pregnant from 2002 to 2009 were matched one-to-two with replacement to unvaccinated pregnant females. Using a generalized estimating equation method with a Poisson distribution and log link, we evaluated the association of trivalent inactivated influenza vaccine with 13 outcomes. Given our large sample size and multiple comparisons (19 contrasts), a cutoff for significance of P<.005 was selected a priori.Our cohort included 74,292 vaccinated females matched on age, site, and pregnancy start date with 144,597 unvaccinated females. We did not observe increased risks within 42 days of vaccination for hyperemesis, chronic hypertension, gestational hypertension, gestational diabetes, proteinuria, or urinary tract infection. Using a risk window from vaccination through pregnancy end, we did not observe increased risks after vaccination for proteinuria, urinary tract infection, gestational hypertension, preeclampsia or eclampsia, chorioamnionitis, puerperal infection, venous complications, pulmonary embolism, or peripartum cardiomyopathy. A reduced risk for gestational diabetes after vaccination was detected (adjusted hazard rate ratio 0.88, 95% confidence interval 0.83-0.93), likely as a result of healthy vaccine bias or earlier detection among vaccinees.In this large cohort, influenza vaccination during pregnancy was not associated with increased risks for medically attended adverse obstetric events.II.
View details for DOI 10.1097/AOG.0b013e3182a1118a
View details for Web of Science ID 000330444300023
View details for PubMedID 23921876
Mortality Rates and Cause-of-Death Patterns in a Vaccinated Population
AMERICAN JOURNAL OF PREVENTIVE MEDICINE
2013; 45 (1): 91-97
Determining the baseline mortality rate in a vaccinated population is necessary to be able to identify any unusual increases in deaths following vaccine administration. Background rates are particularly useful during mass immunization campaigns and in the evaluation of new vaccines.Provide background mortality rates and describe causes of death following vaccination in the Vaccine Safety Datalink (VSD).Analyses were conducted in 2012. Mortality rates were calculated at 0-1 day, 0-7 days, 0-30 days, and 0-60 days following vaccination for deaths occurring between January 1, 2005, and December 31, 2008. Analyses were stratified by age and gender. Causes of death were examined, and findings were compared to National Center for Health Statistics (NCHS) data.Among 13,033,274 vaccinated people, 15,455 deaths occurred between 0 and 60 days following vaccination. The mortality rate within 60 days of a vaccination visit was 442.5 deaths per 100,000 person-years. Rates were highest in the group aged ≥85 years, and increased from the 0-1-day to the 0-60-day interval following vaccination. Eleven of the 15 leading causes of death in the VSD and NCHS overlap in both systems, and the top four causes of death were the same in both systems.VSD mortality rates demonstrate a healthy vaccinee effect, with rates lowest in the days immediately following vaccination, most apparent in the older age groups. The VSD mortality rate is lower than that in the general U.S. population, and the causes of death are similar.
View details for DOI 10.1016/j.amepre.2013.02.020
View details for Web of Science ID 000320827500011
View details for PubMedID 23790993
Guillain-Barre Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009-2011
2013; 8 (6)
Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited.We identified patients enrolled in health plans participating in the Vaccine Safety Datalink and diagnosed with GBS from July 2009 through June 2011. Medical records of GBS cases with 2009-10 MIV, 2010-11 trivalent inactivated influenza vaccine (TIV), and/or a medically-attended respiratory or gastrointestinal infection in the 1 through 141 days prior to GBS diagnosis were reviewed and classified according to Brighton Collaboration criteria for diagnostic certainty. Using a case-centered design, logistic regression models adjusted for patient-level time-varying sources of confounding, including seasonal vaccinations and infections in GBS cases and population-level controls.Eighteen confirmed GBS cases received vaccination in the 6 weeks preceding onset, among 1.27 million 2009-10 MIV recipients and 2.80 million 2010-11 TIV recipients. Forty-four confirmed GBS cases had infection in the 6 weeks preceding onset, among 3.77 million patients diagnosed with medically-attended infection. The observed-versus-expected odds that 2009-10 MIV/2010-11 TIV was received in the 6 weeks preceding GBS onset was odds ratio = 1.54, 95% confidence interval (CI), 0.59-3.99; risk difference = 0.93 per million doses, 95% CI, -0.71-5.16. The association between GBS and medically-attended infection was: odds ratio = 7.73, 95% CI, 3.60-16.61; risk difference = 11.62 per million infected patients, 95% CI, 4.49-26.94. These findings were consistent in sensitivity analyses using alternative infection definitions and risk intervals for prior vaccination shorter than 6 weeks.After adjusting for antecedent infections, we found no evidence for an elevated GBS risk following 2009-10 MIV/2010-11 TIV influenza vaccines. However, the association between GBS and antecedent infection was strongly elevated.
View details for DOI 10.1371/journal.pone.0067185
View details for Web of Science ID 000321424400082
View details for PubMedID 23840621
View details for PubMedCentralID PMC3694016
Population genomics of post-vaccine changes in pneumococcal epidemiology
2013; 45 (6): 656-?
Whole-genome sequencing of 616 asymptomatically carried Streptococcus pneumoniae isolates was used to study the impact of the 7-valent pneumococcal conjugate vaccine. Comparison of closely related isolates showed the role of transformation in facilitating capsule switching to non-vaccine serotypes and the emergence of drug resistance. However, such recombination was found to occur at significantly different rates across the species, and the evolution of the population was primarily driven by changes in the frequency of distinct genotypes extant before the introduction of the vaccine. These alterations resulted in little overall effect on accessory genome composition at the population level, contrasting with the decrease in pneumococcal disease rates after the vaccine's introduction.
View details for DOI 10.1038/ng.2625
View details for Web of Science ID 000319563900013
View details for PubMedID 23644493
View details for PubMedCentralID PMC3725542
Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 20072010
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
2013; 22 (4): 335-344
An association between the influenza antiviral medication oseltamivir and neuropsychiatric events has been suggested by post-marketing case reports in Japan. This possible association was not supported by cohort studies in the U.S. conducted prior to the 2009 influenza A (H1N1) pandemic, when usage rates were comparatively low. We assessed oseltamivir safety before and during the pandemic using biologically plausible risk intervals, particularly focusing on psychiatric events.Outpatients with influenza episodes from January 2007 through June 2010 were identified using diagnosis codes and positive tests at eight health care systems (sites) in the Vaccine Safety Datalink Project. Oseltamivir-treated and untreated patients were matched according to calendar week, age, sex, site, and propensity for treatment. Within this matched cohort, conditional logistic regression models were used to estimate the risk of four neuropsychiatric and five other adverse events (AEs) during pre-specified risk intervals.Among 27,684 matched pairs, no associations were identified between oseltamivir treatment and any pre-defined AE. The absolute risks of incident psychiatric events in the 1-7 day risk interval were 0.126% for oseltamivir-treated and 0.105% for untreated patients (odds ratio = 1.21, 95% confidence interval [CI]: 0.74, 1.97; risk difference = 0.022%, 95% CI: -0.035%, 0.078%); the most common diagnosis was unspecified anxiety state. Results were similar for 1-14 and 1-2 day risk intervals and for pediatric/adolescent subgroups.Consistent with prior U.S. cohort studies, no evidence was identified for an increased risk of neuropsychiatric or other AEs following oseltamivir treatment. Safety should be prospectively monitored to inform antiviral medication usage recommendations.
View details for DOI 10.1002/pds.3363
View details for Web of Science ID 000317009200001
View details for PubMedID 23129321
A Population-Based Cohort Study of Undervaccination in 8 Managed Care Organizations Across the United States
2013; 167 (3): 274-281
OBJECTIVES To examine patterns and trends of undervaccination in children aged 2 to 24 months and to compare health care utilization rates between undervaccinated and age-appropriately vaccinated children. DESIGN Retrospective matched cohort study. SETTING Eight managed care organizations of the Vaccine Safety Datalink. PARTICIPANTS Children born between 2004 and 2008. MAIN EXPOSURE Immunization records were used to calculate the average number of days undervaccinated. Two matched cohorts were created: 1 with children who were undervaccinated for any reason and 1 with children who were undervaccinated because of parental choice. For both cohorts, undervaccinated children were matched to age-appropriately vaccinated children by birth date, managed care organization, and sex. MAIN OUTCOME MEASURES Rates of undervaccination, specific patterns of undervaccination, and health care utilization rates. RESULTS Of 323 247 children born between 2004 and 2008, 48.7% were undervaccinated for at least 1 day before age 24 months. The prevalence of undervaccination and specific patterns of undervaccination increased over time (P < .001). In a matched cohort analysis, undervaccinated children had lower outpatient visit rates compared with children who were age-appropriately vaccinated (incidence rate ratio [IRR], 0.89; 95% CI, 0.89- 0.90). In contrast, undervaccinated children had increased inpatient admission rates compared with age-appropriately vaccinated children (IRR, 1.21; 95% CI, 1.18-1.23). In a second matched cohort analysis, children who were undervaccinated because of parental choice had lower rates of outpatient visits (IRR, 0.94; 95% CI, 0.93-0.95) and emergency department encounters (IRR, 0.91; 95% CI, 0.88-0.94) than age-appropriately vaccinated children. CONCLUSIONS Undervaccination appears to be an increasing trend. Undervaccinated children appear to have different health care utilization patterns compared with age-appropriately vaccinated children.
View details for DOI 10.1001/jamapediatrics.2013.502
View details for Web of Science ID 000316799500010
View details for PubMedID 23338829
Accuracy of Hospital Administrative Data in Reporting Central Line-Associated Bloodstream Infections in Newborns
2013; 131: S75-S80
Central line-associated bloodstream infections (CLABSIs) are a significant source of morbidity and mortality in the NICU. In 2010, Medicaid was mandated not to pay hospitals for treatment of CLABSI; however, the source of CLABSI data for this policy was not specified. Our objective was to evaluate the accuracy of hospital administrative data compared with CLABSI confirmed by an infection control service.We evaluated hospital administrative and infection control data for newborns admitted consecutively from January 1, 2008, to December 31, 2010. Clinical and demographic data were collected through chart review. We compared cases of CLABSI identified by administrative data (International Classification of Diseases, Ninth Revision, Clinical Modification 999.31) with infection control data that use national criteria from the Centers for Disease Control and Prevention as the gold standard. To ascertain the nature possible deficiencies in the administrative data, each patient's medical record was searched to determine if clinical phrases that commonly refer to CLABSI appeared.Of 2920 infants admitted to the NICU during our study period, 52 were identified as having a CLABSI: 42 by infection control data only, 7 through hospital administrative data only, and 3 appearing in both. Against the gold standard, hospital administrative data were 6.7% sensitive and 99.7% specific, with a positive predictive value of 30.0% and a negative predictive value of 98.6%. Only 48% of medical records indicated a CLABSI.Our findings from a major children's hospital NICU indicate that International Classification of Diseases, Ninth Revision, Clinical Modification code 993.31 is presently not accurate and cannot be used reliably to compare CLABSI rates in NICUs.
View details for DOI 10.1542/peds.2012-1427i
View details for Web of Science ID 000317269700008
View details for PubMedID 23457153
Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women
OBSTETRICS AND GYNECOLOGY
2013; 121 (3): 519-525
To estimate the risks for medically attended events occurring within 42 days of receiving trivalent inactivated influenza vaccine and to evaluate specific risks of first-trimester vaccination.This retrospective observational cohort study compared rates of medically attended adverse events in trivalent inactivated influenza-vaccinated and unvaccinated pregnant women in the Vaccine Safety Datalink. Using a Poisson distribution and log link, we calculated maternal adjusted incident rate ratios for composite safety outcomes for the full cohort and the subset vaccinated during the first trimester.The cohort included 75,906 vaccinated (28.4% in the first trimester) and 147,992 unvaccinated women matched by age, site, and pregnancy start date. In the first 3 days after vaccination, trivalent inactivated influenza vaccine was not associated with increased risk of specified medically attended events, including allergic reactions, cellulitis, and seizures (full cohort adjusted incident rate ratio 1.12, 95% confidence interval [CI] 0.81-1.55; P=.48; first-trimester adjusted incident rate ratio .97, 95% CI 0.53-1.78; P=.93). In the first 42 days, no incident cases of Guillain-Barré syndrome, optic neuritis, transverse myelitis, or Bells palsy were identified. Trivalent inactivated influenza vaccine was not associated with thrombocytopenia (full cohort adjusted incident rate ratio 0.90, 95% CI 0.68--1.19; P=.45; first-trimester adjusted incident rate ratio 0.56, 95% CI 0.22-1.39; P=.21) or an acute neurologic event (full cohort adjusted incident rate ratio 0.92, 95% CI 0.54-1.6; P=.75; first-trimester adjusted incident rate ratio 1.05, 95% CI 0.46-2.38; P=.91).Receipt of trivalent inactivated influenza vaccine during pregnancy was not associated with increased risk of adverse events in the 42 days after vaccination, supporting its safety for the mother.
View details for DOI 10.1097/AOG.0b013e3182831b83
View details for Web of Science ID 000316607600005
View details for PubMedID 23635613
The impact of RSV, adenovirus, influenza, and parainfluenza infection in pediatric patients receiving stem cell transplant, solid organ transplant, or cancer chemotherapy
2013; 17 (2): 133-143
RVIs are a significant cause of morbidity and mortality in immunocompromised children. We analyzed the characteristics and outcomes of infection by four respiratory viruses (RSV, adenovirus, influenza, and parainfluenza) treated at a pediatric tertiary care hospital in a retrospective cohort of patients who had received cancer chemotherapy, hematopoietic stem cell, or SOT. A total of 208 infections were studied among 166 unique patients over a time period of 1993-2006 for transplant recipients, and 2000-2005 for patients with cancer. RSV was the most common respiratory virus identified. There were 17 (10% of all patients) deaths overall, of which 12 were at least partly attributed to the presence of a RVI. In multivariate models, LRT symptoms in the absence of upper respiratory symptoms on presentation (OR 10.2 [2.3, 45.7], p = 0.002) and adenoviral infection (OR 3.7 [1.1, 12.6], p = 0.034) were significantly associated with poor outcome, defined as death or disability related to RVI. All of the deaths occurred in patients who had received either solid organ or HSCT. There were no infections resulting in death or disability in the cancer chemotherapy group.
View details for DOI 10.1111/petr.12022
View details for Web of Science ID 000315467000014
View details for PubMedID 23228170
- Nonpayment for Preventable Infections in U.S. Hospitals Reply NEW ENGLAND JOURNAL OF MEDICINE 2013; 368 (2): 191-192
Including catheter-associated urinary tract infections in the 2008 CMS payment policy: a qualitative analysis.
2013; 33 (1): 15-23
The study presented in this article addresses the impact of the 2008 nonpayment policy of the Centers for Medicare and Medicaid Services (CMS) on catheter-associated urinary tract infections (CAUTIs) from the perspective of infection preventionists. With rich qualitative data, it sheds light on the day-to-day impact of this recent health policy on CAUTI prevention.
View details for PubMedID 23556374
View details for PubMedCentralID PMC3998716
Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
2012; 55 (10): 1279-1282
The guideline is intended for use by healthcare providers who care for adult and pediatric patients with group A streptococcal pharyngitis. The guideline updates the 2002 Infectious Diseases Society of America guideline and discusses diagnosis and management, and recommendations are provided regarding antibiotic choices and dosing. Penicillin or amoxicillin remain the treatments of choice, and recommendations are made for the penicillin-allergic patient, which now include clindamycin.
View details for DOI 10.1093/cid/cis847
View details for PubMedID 23091044
Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance
2012; 31 (11): 2518-2527
In response to the 2009 H1N1 pandemic and subsequent vaccination program, the Department of Health and Human Services and collaborators developed the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program as a demonstration project to detect rare adverse events rapidly. The program monitored three million people who had received the H1N1 vaccine by linking data from large private health plans and from public immunization registries that had originally not been designed to share data, and on a larger scale than had been previously attempted. The program generated safety data in two weeks rather than three to six monty 10ths-the standard time frame achievable using health plan data. PRISM substantially contributed to the understanding of the safety of H1N1 vaccines. Its use in the case of H1N1 highlights the necessity of proactive planning, scalable infrastructure, and public-private partnerships in tracking adverse events after vaccination in epidemics. It also illustrates how data could be integrated to produce policy-relevant information for other medical products.
View details for DOI 10.1377/hlthaff.2012.0104
View details for Web of Science ID 000311026900020
View details for PubMedID 23129683
Effect of Nonpayment for Preventable Infections in US Hospitals
NEW ENGLAND JOURNAL OF MEDICINE
2012; 367 (15): 1428-1437
In October 2008, the Centers for Medicare and Medicaid Services (CMS) discontinued additional payments for certain hospital-acquired conditions that were deemed preventable. The effect of this policy on rates of health care-associated infections is unknown.Using a quasi-experimental design with interrupted time series with comparison series, we examined changes in trends of two health care-associated infections that were targeted by the CMS policy (central catheter-associated bloodstream infections and catheter-associated urinary tract infections) as compared with an outcome that was not targeted by the policy (ventilator-associated pneumonia). Hospitals participating in the National Healthcare Safety Network and reporting data on at least one health care-associated infection before the onset of the policy were eligible to participate. Data from January 2006 through March 2011 were included. We used regression models to measure the effect of the policy on changes in infection rates, adjusting for baseline trends.A total of 398 hospitals or health systems contributed 14,817 to 28,339 hospital unit-months, depending on the type of infection. We observed decreasing secular trends for both targeted and nontargeted infections long before the policy was implemented. There were no significant changes in quarterly rates of central catheter-associated bloodstream infections (incidence-rate ratio in the postimplementation vs. preimplementation period, 1.00; P=0.97), catheter-associated urinary tract infections (incidence-rate ratio, 1.03; P=0.08), or ventilator-associated pneumonia (incidence-rate ratio, 0.99; P=0.52) after the policy implementation. Our findings did not differ for hospitals in states without mandatory reporting, nor did it differ according to the quartile of percentage of Medicare admissions or hospital size, type of ownership, or teaching status.We found no evidence that the 2008 CMS policy to reduce payments for central catheter-associated bloodstream infections and catheter-associated urinary tract infections had any measurable effect on infection rates in U.S. hospitals. (Funded by the Agency for Healthcare Research and Quality.).
View details for DOI 10.1056/NEJMsa1202419
View details for Web of Science ID 000309652700009
View details for PubMedID 23050526
Trends in Antibiotic Use in Massachusetts Children, 2000-2009
2012; 130 (1): 15-22
Antibiotic use rates have declined dramatically since the 1990s. We aimed to determine if, when, and at what level the decline in antibiotic-dispensing rates ended and which diagnoses contributed to the trends.Antibiotic dispensings and diagnoses were obtained from 2 health insurers for 3- to <72-month-olds in 16 Massachusetts communities from 2000 to 2009. Population-based antibiotic-dispensing rates per person-year (p-y) were determined according to year (September-August) for 3 age groups. Fit statistics were used to identify the most likely year for a change in trend. Rates for the first and last years were compared according to antibiotic category and associated diagnosis.From 2000-2001 to 2008-2009, the antibiotic-dispensing rate for 3- to <24-month-olds decreased 24% (2.3-1.8 antibiotic dispensings per p-y); for 24- to <48-month-olds, it decreased 18% (1.6-1.3 antibiotic dispensings per p-y); and for 48- to <72-month-olds, it decreased 20% (1.4-1.1 antibiotic dispensings per p-y). For 3- to <48-month-olds, rates declined until 2004-2005 and remained stable thereafter; the downward trend for 48- to <72-month-olds ended earlier in 2001-2002. Among 3- to <24-month-olds, first-line penicillin use declined 26%. For otitis media, the dispensing rate decreased 14% and the diagnosis rate declined 9%, whereas the treatment fraction was stable at 63%.The downward trend in antibiotic dispensings to young children in these communities ended by 2004-2005. This trend was driven by a declining otitis media diagnosis rate. Continued monitoring of population-based dispensing rates will support efforts to avoid returning to previous levels of antibiotic overuse.
View details for DOI 10.1542/peds.2011-3137
View details for Web of Science ID 000305905900038
View details for PubMedID 22732172
View details for PubMedCentralID PMC3382917
Risk of Confirmed Guillain-Barre Syndrome Following Receipt of Monovalent Inactivated Influenza A (H1N1) and Seasonal Influenza Vaccines in the Vaccine Safety Datalink Project, 2009-2010
AMERICAN JOURNAL OF EPIDEMIOLOGY
2012; 175 (11): 1100-1109
An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.
View details for DOI 10.1093/aje/kws195
View details for Web of Science ID 000305082300002
View details for PubMedID 22582210
Surveillance for Adverse Events Following Receipt of Pandemic 2009 H1N1 Vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) System, 2009-2010
AMERICAN JOURNAL OF EPIDEMIOLOGY
2012; 175 (11): 1120-1128
The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system is a cohort-based active surveillance network initiated by the US Department of Health and Human Services to supplement preexisting and other vaccine safety monitoring systems in tracking the safety of monovalent pandemic 2009 H1N1 influenza vaccine in the United States during 2009-2010. PRISM investigators conducted retrospective analysis to determine whether 2009 H1N1 vaccination was associated with increased risk of any of 14 prespecified outcomes. Five health insurance and associated companies with 38 million members and 9 state/city immunization registries contributed records on more than 2.6 million doses of 2009 H1N1 vaccine. Data on outcomes came from insurance claims. Complementary designs (self-controlled risk interval, case-centered, and current-vs.-historical comparison) were used to optimize control for confounding and statistical power. The self-controlled risk interval analysis of chart-confirmed Guillain-Barré syndrome found an elevated but not statistically significant incidence rate ratio following receipt of inactivated 2009 H1N1 vaccine (incidence rate ratio = 2.50, 95% confidence interval: 0.42, 15.0) and no cases following live attenuated 2009 H1N1 vaccine. The study did not control for infection prior to Guillain-Barré syndrome, which may have been a confounder. The risks of other health outcomes of interest were generally not significantly elevated after 2009 H1N1 vaccination.
View details for DOI 10.1093/aje/kws197
View details for Web of Science ID 000305082300004
View details for PubMedID 22582207
Perceived impact of the Medicare policy to adjust payment for health care-associated infections
AMERICAN JOURNAL OF INFECTION CONTROL
2012; 40 (4): 314-319
In 2008, the Centers for Medicare and Medicaid Services (CMS) ceased additional payment for hospitalizations resulting in complications deemed preventable, including several health care-associated infections. We sought to understand the impact of the CMS payment policy on infection prevention efforts.A national survey of infection preventionists from a random sample of US hospitals was conducted in December 2010.Eighty-one percent reported increased attention to HAIs targeted by the CMS policy, whereas one-third reported spending less time on nontargeted HAIs. Only 15% reported increased funding for infection control as a result of the CMS policy, whereas most reported stable (77%) funding. Respondents reported faster removal of urinary (71%) and central venous (50%) catheters as a result of the CMS policy, whereas routine urine and blood cultures on admission occurred infrequently (27% and 13%, respectively). Resource shifting (ie, less time spent on nontargeted HAIs) occurred more commonly in large hospitals (odds ratio, 2.3; 95% confidence interval: 1.0-5.1; P = .038) but less often in hospitals where front-line staff were receptive to changes in clinical processes (odds ratio, 0.5; 95% confidence interval: 0.3-0.8; P = .005).Infection preventionists reported greater hospital attention to preventing targeted HAIs as a result of the CMS nonpayment policy. Whether the increased focus and greater engagement in HAI prevention practices has led to better patient outcomes is unclear.
View details for DOI 10.1016/j.ajic.2011.11.003
View details for Web of Science ID 000303418400008
View details for PubMedID 22541855
View details for PubMedCentralID PMC3998719
Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011
2012; 30 (11): 2024-2031
In fall 2010 in the southern hemisphere, an increased risk of febrile seizures was noted in young children in Australia in the 24 h after receipt of trivalent inactivated influenza vaccine (TIV) manufactured by CSL Biotherapies. Although the CSL TIV vaccine was not recommended for use in young children in the US, during the 2010-2011 influenza season near real-time surveillance was conducted for febrile seizures in the 0-1 days following first dose TIV in a cohort of 206,174 vaccinated children ages 6 through 59 months in the Vaccine Safety Datalink Project. On a weekly basis, surveillance was conducted with the primary approach of a self-controlled risk interval design and the secondary approach of a current vs. historical vaccinee design. Sequential statistical methods were employed to account for repeated analyses of accumulating data. Signals for seizures based on computerized data were identified in mid November 2010 using a current vs. historical design and in late December 2010 using a self-controlled risk interval design. Further signal evaluation was conducted with chart-confirmed febrile seizure cases using only data from the primary approach (i.e. self-controlled risk interval design). The magnitude of the incidence rate ratio and risk difference comparing risk of seizures in the 0-1 days vs. 14-20 days following TIV differed by receipt of concomitant 13-valent pneumococcal conjugate vaccine (PCV13). Among children 6-59 months of age, the incidence rate ratio (IRR) for TIV adjusted for concomitant PCV13 was 2.4 (95% CI 1.2, 4.7) while the IRR for PCV13 adjusted for concomitant TIV was 2.5 (95% CI 1.3, 4.7). The IRR for concomitant TIV and PCV13 was 5.9 (95% CI 3.1, 11.3). Risk difference estimates varied by age due to the varying baseline risk for seizures in young children, with the highest estimates occurring at 16 months (12.5 per 100,000 doses for TIV without concomitant PCV13, 13.7 per 100,000 doses for PCV13 without concomitant TIV, and 44.9 per 100,000 doses for concomitant TIV and PCV13) and the lowest estimates occurring at 59 months (1.1 per 100,000 doses for TIV without concomitant PCV13, 1.2 per 100,000 doses for PCV13 without concomitant TIV, and 4.0 per 100,000 doses for concomitant TIV and PCV13). Incidence rate ratio and risk difference estimates were lower for children receiving TIV without concomitant PCV13 or PCV13 without concomitant TIV. Because of the importance of preventing influenza and pneumococcal infections and associated complications, our findings should be placed in a benefit-risk framework to ensure that population health benefits are maximized.
View details for DOI 10.1016/j.vaccine.2012.01.027
View details for Web of Science ID 000302662800016
View details for PubMedID 22361304
Pneumococcal Carriage and Antibiotic Resistance in Young Children Before 13-valent Conjugate Vaccine
PEDIATRIC INFECTIOUS DISEASE JOURNAL
2012; 31 (3): 249-254
We sought to measure trends in Streptococcus pneumoniae carriage and antibiotic resistance in young children in Massachusetts communities after widespread adoption of heptavalent 7-valent pneumococcal conjugate vaccine (PCV7) and before the introduction of the 13-valent PCV (PCV13).We conducted a cross-sectional study including collection of questionnaire data and nasopharyngeal specimens among children aged <7 years in primary care practices from 8 Massachusetts communities during the winter season of 2008-2009 and compared with similar studies performed in 2001, 2003-2004, and 2006-2007. Antimicrobial susceptibility testing and serotyping were performed on pneumococcal isolates, and risk factors for colonization in recent seasons (2006-2007 and 2008-2009) were evaluated.We collected nasopharyngeal specimens from 1011 children, 290 (29%) of whom were colonized with pneumococcus. Non-PCV7 serotypes accounted for 98% of pneumococcal isolates, most commonly 19A (14%), 6C (11%), and 15B/C (11%). In 2008-2009, newly targeted PCV13 serotypes accounted for 20% of carriage isolates and 41% of penicillin-nonsusceptible S. pneumoniae. In multivariate models, younger age, child care, young siblings, and upper respiratory illness remained predictors of pneumococcal carriage, despite near-complete serotype replacement. Only young age and child care were significantly associated with penicillin-nonsusceptible S. pneumoniae carriage.Serotype replacement post-PCV7 is essentially complete and has been sustained in young children, with the relatively virulent 19A being the most common serotype. Predictors of carriage remained similar despite serotype replacement. PCV13 may reduce 19A and decrease antibiotic-resistant strains, but monitoring for new serotype replacement is warranted.
View details for DOI 10.1097/INF.0b013e31824214ac
View details for Web of Science ID 000300706700010
View details for PubMedID 22173142
View details for PubMedCentralID PMC3288953
The Medicare Policy of Payment Adjustment for Health Care-Associated Infections: Perspectives on Potential Unintended Consequences
MEDICAL CARE RESEARCH AND REVIEW
2012; 69 (1): 45-61
In 2008, the Centers for Medicare & Medicaid Services introduced a new policy to adjust payment to hospitals for health care-associated infections (HAIs) not present on admission. Interviews with 36 hospital infection preventionists across the United States explored the perspectives of these key stakeholders on the potential unintended consequences of the current policy. Responses were analyzed using an iterative coding process where themes were developed from the data. Participants' descriptions of unintended impacts of the policy centered around three themes. Results suggest the policy has focused more attention on targeted HAIs and has affected hospital staff; relatively fewer systems changes have ensued. Some consequences of the policy, such as infection preventionists having less time to devote to HAIs other than those in the policy or having less time to implement prevention activities, may have undesirable effects on HAI rates if hospitals do not recognize and react to potential time and resource gaps.
View details for DOI 10.1177/1077558711413606
View details for Web of Science ID 000300442500002
View details for PubMedID 21810797
View details for PubMedCentralID PMC3998710
Guillain-Barre Syndrome Incidence in a Large United States Cohort (2000-2009)
2012; 39 (2): 109-115
We describe the incidence of Guillain-Barré syndrome (GBS) in a large United States cohort.Between 2000 and 2009, we identified visits with an ICD-9 code for GBS (357.0) from all persons with continuous enrollment for at least 1 year. The primary case definition was restricted to emergency department and inpatient visits. We calculated age-standardized rates and used multivariate Poisson regression to assess variation in rates by sex, age, season and year of diagnosis. We tabulated descriptive characteristics and the positive predictive value (PPV) for a subset of the visits with available medical record review.1,619 visits with the GBS ICD-9 code were identified from 50,290,898 person-years of observation. After considering the PPV (55%) for record-reviewed visits, the age-standardized incidence rate was approximately 1.72/100,000 person-years. The rate was 40% higher for males and increased by 50% for every 10-year increase in age. The rate was 15% higher in winter and spring compared with summer. Rates were higher in more recent years.GBS rates are higher in males and increase considerably with age. The potential reasons for differences in rates by season and the increased rates in more recent years should be further investigated.
View details for DOI 10.1159/000339248
View details for Web of Science ID 000308731000006
View details for PubMedID 22846726
Financing and systems barriers to seasonal influenza vaccine delivery in community settings
2011; 29 (52): 9632-9639
Recommendations for annual seasonal influenza vaccination have expanded to now include >300 million children and adults each year. Community settings have become increasingly important venues for influenza vaccination. We sought to identify barriers to and solutions for expanding influenza vaccination in community settings.Semi-structured telephone interviews were conducted from 01/09 to 06/10 with a range of stakeholders involved in influenza vaccination, including health plans, medical services firms, retail based clinics, pharmacies, schools, and state and local public health immunization programs. Participants (n=65) were asked about barriers and feasible solutions to influenza vaccine delivery to children and adults in community settings. Key themes were identified through iterative coding using a grounded theory approach.Stakeholders identified specific financial barriers to influenza vaccine delivery in 3 major areas: purchase and distribution, delivery, and reimbursement. Limited purchasing power, the uncertain nature of public demand, and unpredictable timing of influenza vaccine supply were important barriers to enhance delivery in community settings. Barriers to delivery included complexities in running off-site clinics, especially in school settings, the need to manage publicly vs. privately purchased vaccines separately, and state-to-state variability in requirements for credentialing, physician oversight, and reporting. Reimbursement barriers included a protracted credentialing process, the need to determine insurance eligibility at point-of-service, and lack of a billing infrastructure in off-site clinics. Opportunities to mitigate financial barriers to influenza vaccine delivery in community settings focused on coordination across providers and the role of public health as a "trusted broker" to overcome existing challenges.Financial and systems barriers hamper the optimal use of community settings to effectively deliver influenza vaccines. Public health partners at the federal, state, and local levels are well-positioned to facilitate the engagement of all stakeholders in this important and complex vaccine delivery system.
View details for DOI 10.1016/j.vaccine.2011.10.041
View details for Web of Science ID 000298623000014
View details for PubMedID 22036886
Clonal replacement among 19A Streptococcus pneumoniae in Massachusetts, prior to 13 valent conjugate vaccination
2011; 29 (48): 8877-8881
As part of an ongoing study of the response of the Streptococcus pneumoniae population to conjugate vaccination, we applied multi-locus sequence typing (MLST) to 291 isolates sampled from nasopharyngeal carriage in Massachusetts children. We found 94 distinct sequence types (STs), including 19 that had not been previously recorded, and a xpt allele containing a large insertion. Comparison with a similar sample collected in 2007 revealed no significant overall difference in the ST composition (p=0.51) suggesting that the population has reached a new equilibrium following the introduction of 7 valent vaccination in 2000. Within serotypes, a large and statistically significant increase (p=0.014 Fisher's Exact test) was noted in the prevalence of the major multiresistant clone ST 320, which is apparently outcompeting ST 199 among serotype 19A strains. This sample will be used as a baseline to study the future evolution of the pneumococcal population in Massachusetts following introduction of vaccines with higher valency.
View details for DOI 10.1016/j.vaccine.2011.09.075
View details for Web of Science ID 000297601200015
View details for PubMedID 21964059
View details for PubMedCentralID PMC3221484
Making the CMS Payment Policy for Healthcare-Associated Infections Work: Organizational Factors That Matter
JOURNAL OF HEALTHCARE MANAGEMENT
2011; 56 (5): 319-335
Healthcare-associated infections (HAIs) are among the most common adverse events in hospitals, and the morbidity and mortality associated with them are significant. In 2008, the Centers for Medicare and Medicaid Services (CMS) implemented a new financial policy that no longer provides payment to hospitals for services related to certain infections not present on admission and deemed preventable. At present, little is known about how this policy is being implemented in hospital settings. One key goal of the policy is for it to serve as a quality improvement driver within hospitals, providing the rationale and motivation for hospitals to engage in greater infection-related surveillance and prevention activities. This article examines the role organizational factors, such as leadership and culture, play in the effectiveness of the CMS policy as a quality improvement (QI) driver within hospital settings. Between late 2009 and early 2010, interviews were conducted with 36 infection preventionists working at a national sample of 36 hospitals. We found preliminary evidence that hospital executive behavior, a proactive infection control (IC) culture, and clinical staff engagement played a favorable role in enhancing the recognition, acceptance, and significance of the CMS policy as a QI driver within hospitals. We also found several other contextual factors that may impede the degree to which the above factors facilitate links between the CMS policy and hospital QI activities.
View details for Web of Science ID 000295067100007
View details for PubMedID 21991680
View details for PubMedCentralID PMC3998712
H1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink Project
AMERICAN JOURNAL OF PREVENTIVE MEDICINE
2011; 41 (2): 121-128
The emergence of pandemic H1N1 influenza virus in early 2009 prompted the rapid licensure and use of H1N1 monovalent inactivated (MIV) and live, attenuated (LAMV) vaccines separate from seasonal trivalent inactivated (TIV) and live, attenuated (LAIV) influenza vaccines. A robust influenza immunization program in the U.S. requires ongoing monitoring of potential adverse events associated with vaccination.To prospectively conduct safety monitoring of H1N1 and seasonal influenza vaccines during the 2009-2010 season.The Vaccine Safety Datalink (VSD) Project monitors ∼9.2 million members in eight U.S. medical care organizations. Electronic data on vaccines and pre-specified adverse events were updated and analyzed weekly for signal detection from November 2009 to April 2010 using either a self-controlled design or a current versus historical comparison. Statistical signals were further evaluated using alternative approaches to identify temporal clusters and to control for time-varying confounders.As of May 1, 2010, a total of 1,345,663 MIV, 267,715 LAMV, 2,741,150 TIV, and 157,838 LAIV doses were administered in VSD. No significant associations were noted during sequential analyses for Guillain-Barré syndrome, most other neurologic outcomes, and allergic and cardiac events. For MIV, a statistical signal was observed for Bell's palsy for adults aged ≥25 years on March 31, 2010, using the self-controlled approach. Subsequent analyses revealed no significant temporal cluster. Case-centered logistic regression adjusting for seasonality demonstrated an OR for Bell's palsy of 1.26 (95% CI=0.97, 1.63).No major safety problems following H1N1 or seasonal influenza vaccines were detected in the 2009-2010 season in weekly sequential analyses. Seasonality likely contributed to the Bell's palsy signal following MIV. Prospective safety monitoring followed by rigorous signal refinement is critical to inform decision-making by regulatory and public health agencies.
View details for DOI 10.1016/j.amepre.2011.04.004
View details for Web of Science ID 000292958900002
View details for PubMedID 21767718
Safety of Trivalent Inactivated Influenza Vaccine in Children Aged 24 to 59 Months in the Vaccine Safety Datalink
ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE
2011; 165 (8): 749-755
To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate the risk of medically attended events (MAEs) in a subcohort of children who had multiple annual doses of TIV over their lifetimes.Self-controlled screening study.Seven US managed care organizations from October 1, 2002, to March 31, 2006.Children aged 24 to 59 months who received at least 1 TIV dose (66 283 children and 91 692 TIV doses).Vaccination with TIV.Medically attended events in inpatient and emergency department settings in one of the following risk windows: 0 to 2, 1 to 14, or 1 to 42 days after vaccination. All MAEs that met the screening criteria of incidence rate ratios (IRRs) exceeding 1.0 and P ≤ .05 or IRRs exceeding 2.0 and P < .20 underwent medical record review. A secondary analysis examined the risk of MAEs in children who had multiple annual lifetime TIV doses.Nine diagnoses met the screening criteria. After medical record review, gastrointestinal tract symptoms (IRR, 1.18; 95% confidence interval [CI], 1.10-1.25), gastrointestinal tract disorders (7.70; 1.11-53.52), and fever (1.71; 1.64-1.80) remained significantly associated with vaccination. None of the events seemed to be serious, and none had complications. In the secondary analysis, there was an apparent dose response for vaccine and allergic reactions in the 1- to 3-day risk window.There was no evidence of serious MAEs following vaccination with TIV among children aged 24 to 59 months. Further studies are warranted to evaluate the risk of MAEs in children with multiple lifetime TIV doses.
View details for Web of Science ID 000293342900010
View details for PubMedID 21810637
Epidemiology and Risk Factors for Clostridium difficile Infection in Children
PEDIATRIC INFECTIOUS DISEASE JOURNAL
2011; 30 (7): 580-584
Pediatric Clostridium difficile infection (CDI)-related hospitalizations are increasing. We sought to describe the epidemiology of pediatric CDI at a quaternary care hospital.Nested case-control study within a cohort of children <18 years tested for C. difficile between January and August 2008. The study included patients who were ≥ 1 year with a positive test and diarrhea; those without diarrhea (ie, presumed colonization) were excluded. Two unmatched controls per case were randomly selected from patients ≥ 1 year with a negative test. Potential predictors of CDI included age, gender, comorbidities, prior hospitalization, receipt of C. difficile-active antibiotics in the prior 24 hours, and recent (≤ 4 weeks) exposure to antibiotics or acid-blocking medications. Multivariate logistic regression models were created to identify independent predictors of CDI.Of 1891 tests performed, 263 (14%) were positive in 181 children. Ninety-five patients ≥ 1 year with CDI were compared with 238 controls. In multivariate analyses, predictors of CDI included solid organ transplant (odds ratio [OR], 8.09; 95% confidence interval [CI], 2.10-31.12), lack of prior hospitalization (OR, 8.43; 95% CI, 4.39-16.20), presence of gastrostomy or jejunostomy (G or J) tube (OR, 3.32; 95% CI 1.71-6.42), and receipt of fluoroquinolones (OR, 17.04; 95% CI, 5.86-49.54) or nonquinolone antibiotics (OR, 2.23; 95% CI, 1.18-4.20) in the past 4 weeks. Receipt of C. difficile-active antibiotics within 24 hours before testing was associated with a lower odds of CDI (OR, 0.22; 95% CI, 0.09-0.58).Recent antibiotic exposure and certain comorbid conditions (solid organ transplant, presence of a gastrostomy or jejunostomy tube) were associated with CDI. Diagnostic testing has less utility in patients being treated with C. difficile-active antibiotics.
View details for DOI 10.1097/INF.0b013e31820bfb29
View details for Web of Science ID 000291675100012
View details for PubMedID 21233782
Near real-time vaccine safety surveillance with partially accrued data
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
2011; 20 (6): 583-590
The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered during a short period, such as influenza vaccines, timeliness can be improved by undertaking analyses while risk windows following vaccination are ongoing and by accommodating predictable and unpredictable data accrual delays. We describe practical solutions to these challenges, which were adopted by the VSD Project during pandemic and seasonal influenza vaccine safety surveillance in 2009/2010.Adjustments were made to two sequential analytic approaches. The Poisson-based approach compared the number of pre-defined adverse events observed following vaccination with the number expected using historical data. The expected number was adjusted for the proportion of the risk window elapsed and the proportion of inpatient data estimated to have accrued. The binomial-based approach used a self-controlled design, comparing the observed numbers of events in risk versus comparison windows. Events were included in analysis only if they occurred during a week that had already passed for both windows.Analyzing data before risk windows fully elapsed improved the timeliness of safety surveillance. Adjustments for data accrual lags were tailored to each data source and avoided biasing analyses away from detecting a potential safety problem, particularly early during surveillance.The timeliness of vaccine and drug safety surveillance can be improved by properly accounting for partially elapsed windows and data accrual delays.
View details for DOI 10.1002/pds.2133
View details for Web of Science ID 000292601300004
View details for PubMedID 21538670
Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program
2011; 127: S78-S86
The effort to vaccinate the US population against the 2009 H1N1 influenza virus hinged, in part, on public confidence in vaccine safety. Early in the vaccine program, >20% of parents reported that they would not vaccinate their children. Concerns about the safety of the vaccines were reported by many parents as a factor that contributed to their intention to forgo vaccination (see www.hsph.harvard.edu/news/press-releases/2009-releases/survey-40-adults-absolutely-certain-h1n1-vaccine.html and www.med.umich.edu/mott/npch/reports/h1n1.htm). The safety profiles of 2009 H1N1 monovalent influenza vaccines were anticipated to be (and have been) similar to those of seasonal influenza vaccines, for which an excellent safety profile has been demonstrated. Here we describe steps taken by the US government to (1) assess the key federal systems in place before 2009 for monitoring the safety of vaccines and (2) integrate and upgrade those systems for optimal vaccine-safety monitoring during the 2009 H1N1 monovalent influenza vaccination program. These efforts improved monitoring of 2009 H1N1 vaccine safety, hold promise for enhancing future national monitoring of vaccine safety, and may ultimately help improve public confidence in vaccines.
View details for DOI 10.1542/peds.2010-1722L
View details for Web of Science ID 000296918100012
View details for PubMedID 21502251
Financing vaccines for adolescents: a position paper of the society for adolescent health and medicine.
journal of adolescent health
2011; 48 (3): 320-321
An increasing number of vaccines are now recommended for adolescents. These vaccines may greatly improve the health of adolescents and their communities. However, adolescent vaccine coverage rates lag behind those for infants and behind goals set by Healthy People 2010 . Financial constraints have been reported to be a significant obstacle to immunizing adolescents and young adults . At the Society for Adolescent Health and Medicine, we believe that to achieve increased vaccine coverage in this age group, financial barriers to immunization must be removed.
View details for DOI 10.1016/j.jadohealth.2010.12.025
View details for PubMedID 21338909
Serotype specific invasive capacity and persistent reduction in invasive pneumococcal disease
2010; 29 (2): 283-288
Defining the propensity of Streptococcus pneumoniae (SP) serotypes to invade sterile body sites following nasopharyngeal (NP) acquisition has the potential to inform about how much invasive pneumococcal disease (IPD) may occur in a typical population with a given distribution of carriage serotypes. Data from enhanced surveillance for IPD in Massachusetts children ≤7 years in 2003/04, 2006/07 and 2008/09 seasons and surveillance of SP NP carriage during the corresponding respiratory seasons in 16 Massachusetts communities in 2003/04 and 8 of the 16 communities in both 2006/07 and 2008/09 were used to compute a serotype specific "invasive capacity (IC)" by dividing the incidence of IPD due to serotype x by the carriage prevalence of that same serotype in children of the same age. A total of 206 IPD and 806 NP isolates of SP were collected during the study period. An approximate 50-fold variation in the point estimates between the serotypes having the highest (18C, 33F, 7F, 19A, 3 and 22F) and lowest (6C, 23A, 35F, 11A, 35B, 19F, 15A, and 15BC) IC was observed. Point estimates of IC for most of the common serotypes currently colonizing children in Massachusetts were low and likely explain the continued reduction in IPD from the pre-PCV era in the absence of specific protection against these serotypes. Invasive capacity differs among serotypes and as new pneumococcal conjugate vaccines are introduced, ongoing surveillance will be essential to monitor whether serotypes with high invasive capacity emerge (e.g. 33F, 22F) as successful colonizers resulting in increased IPD incidence due to replacement serotypes.
View details for DOI 10.1016/j.vaccine.2010.10.032
View details for Web of Science ID 000287057300017
View details for PubMedID 21029807
View details for PubMedCentralID PMC3139683
Physicians' opinions about critical attributes of a potential group A streptococcal vaccine
2010; 28 (44): 7155-7160
A group A streptococcal (GAS) vaccine, while not currently available, offers the possibility of a more effective approach; however, barriers to its implementation are likely to exist. The objectives of this study were to describe the attitudes of physicians about the importance of preventing GAS-associated conditions and to identify potential barriers to vaccine implementation. Surveys were sent to randomly selected physicians from the AAP and the AAFP. The GAS conditions believed by respondents to be most important to prevent among pediatric patients were ARF (31%) followed by STSS (24%) and pharyngitis (20%). Pediatricians and family physicians identified similar factors that would encourage routine use of a GAS vaccine. Less than half of pediatricians and only a third of family physicians would recommend a GAS vaccine if it could not be given concurrently with other immunizations or if there were strong parental resistance to the vaccine. This descriptive study provides important information about the anticipated use of a GAS vaccine by primary care physicians in the United States.
View details for DOI 10.1016/j.vaccine.2010.08.071
View details for Web of Science ID 000283980400004
View details for PubMedID 20817014
Higher Prevalence of Pharyngeal than Nasal Staphylococcus aureus Carriage in Pediatric Intensive Care Units
JOURNAL OF CLINICAL MICROBIOLOGY
2010; 48 (8): 2957-2959
Sensitive detection of Staphylococcus aureus colonization is important for epidemiologic studies, infection control, and decolonization measures. We examined the sensitivity of nasal and pharyngeal sampling for S. aureus colonization in 331 children admitted to intensive care units. Pharyngeal screening was more sensitive than nasal screening (92.6% versus 63.1%, P < 0.0001).
View details for DOI 10.1128/JCM.00547-10
View details for Web of Science ID 000280550500048
View details for PubMedID 20573867
Re-emergence of the type 1 pilus among Streptococcus pneumoniae isolates in Massachusetts, USA
2010; 28 (30): 4842-4846
Pneumococcal type 1 pilus proteins have been proposed as potential vaccine candidates. Following conjugate pneumococcal vaccination, the prevalence of the pneumococcal type 1 pilus declined dramatically, a decline associated with the elimination of vaccine-type (VT) strains. Here we show that between 2004 and 2007, there has been a significant increase in pilus prevalence, now exceeding rates from the pre-conjugate vaccine era. This increase is primarily due to non-VT strains. These emerging piliated non-VT strains are mostly novel clones, with some exceptions. The rise in pilus type 1 frequency across multiple distinct genetic backgrounds suggests that the pilus may confer an intrinsic advantage.
View details for DOI 10.1016/j.vaccine.2010.04.042
View details for Web of Science ID 000280345700023
View details for PubMedID 20434550
View details for PubMedCentralID PMC2897942
Outpatient urticaria diagnosis codes have limited predictive value for same-day influenza vaccine adverse event detection
JOURNAL OF CLINICAL EPIDEMIOLOGY
2010; 63 (4): 407-411
To assess the predictive value of claims-based outpatient urticaria diagnosis codes to identify potential vaccine-related adverse events (AEs) when recorded on the same day as influenza vaccination.Health plan members with outpatient claims for influenza vaccination and urticaria on the same day between October 1, 2002, and December 31, 2007, were eligible for inclusion. Electronic medical records (EMRs) for 50 eligible patients with the most recent visits of interest occurring at a large group practice were sampled for review.EMRs were available and reviewed for 42 of 50 patients. An influenza vaccination was confirmed in all reviewed medical charts. Urticaria occurring on the day of influenza vaccination was confirmed for 40% of participants (17/42); 3 confirmed urticaria diagnoses were potential AEs and 14 urticaria events occurred before vaccination. Among those with unconfirmed diagnoses, 17 had no evidence of urticaria on physical examination on the day of interest (4 had evidence of a nonurticarial rash and 13 had no evidence of rash on examination) and 8 had insufficient information to make a clinical determination.Outpatient diagnosis codes for urticaria found in health insurance claims data are limited in their predictive value to identify same-day vaccine AEs.
View details for DOI 10.1016/j.jclinepi.2009.08.002
View details for Web of Science ID 000275588900009
View details for PubMedID 19889513
Preferences for health outcomes associated with Group A Streptococcal disease and vaccination
HEALTH AND QUALITY OF LIFE OUTCOMES
A 26-valent Group A Streptococcus (GAS) vaccine candidate has been developed that may provide protection against pharyngitis, invasive disease and rheumatic fever. However, recommendations for the use of a new vaccine must be informed by a range of considerations, including parents' preferences for different relevant health outcomes. Our objectives were to: (1) describe parent preferences for GAS disease and vaccination using willingness-to-pay (WTP) and time trade-off (TTO) methods; and (2) understand how parents' implied WTP for a quality-adjusted life year (QALY) gained might vary depending on the particular health outcome considered (e.g. averted GAS disease vs. vaccine adverse events).Telephone interviews were conducted with parents of children diagnosed with GAS pharyngitis at 2 pediatric practice sites in the Boston metropolitan area. WTP and TTO (trading parental longevity for child's health) questions for 2 vaccine and 4 disease-associated health states were asked using a randomly selected opening bid, followed by a 2nd bid and a final open-ended question about the amount willing to pay or trade. Descriptive analyses included medians and interquartile ranges for WTP and TTO estimates. The Wilcoxon signed-rank test was used to assess differences in WTP/QALY values for vaccine adverse events vs. disease states.Of 119 respondents, 100 (84%) and 96 (81%) provided a complete set of responses for WTP and TTO questions, respectively. The median WTP and discounted (at 3% per year) TTO values to avoid each health state were as follows: local reaction, $30, 0.12 days; systemic reaction, $50, 0.22 days; impetigo, $75, 1.25 days; strep throat, $75, 2.5 days; septic arthritis, $1,000, 6.6 days; and toxic shock syndrome, $3,000, 31.0 days. The median WTP/QALY was significantly higher for vaccine adverse events (approximately $60,000/QALY) compared to disease states ($18,000 to $36,000/QALY).Parents strongly prefer to prevent GAS disease in children compared to vaccine adverse events. However, implied WTP/QALY ratios were higher for the prevention of vaccine adverse events. Regret for errors of commission vs. omission may differ and should be considered by vaccine policymakers.
View details for DOI 10.1186/1477-7525-8-28
View details for Web of Science ID 000276380200001
View details for PubMedID 20226042
View details for PubMedCentralID PMC2848145
TEST CHARACTERISTICS OF COMMERCIAL INFLUENZA ASSAYS FOR DETECTING PANDEMIC INFLUENZA A (H1N1) IN CHILDREN
PEDIATRIC INFECTIOUS DISEASE JOURNAL
2010; 29 (3): 261-262
We assessed the test characteristics of 2 influenza antigen tests, a rapid immunoassay and a direct fluorescence antibody (DFA) assay, in detecting pandemic influenza A (H1N1) in children up to 18 years of age, using polymerase chain reaction as the standard. The sensitivities of BinaxNOW (59.6%) and direct fluorescence antibody (57.3%) were similar. The specificity of each test was >99%.
View details for DOI 10.1097/INF.0b013e3181be9f9c
View details for Web of Science ID 000275136000014
View details for PubMedID 19935118
Near Real-Time Surveillance for Influenza Vaccine Safety: Proof-of-Concept in the Vaccine Safety Datalink Project
AMERICAN JOURNAL OF EPIDEMIOLOGY
2010; 171 (2): 177-188
The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06-2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillain-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety.
View details for DOI 10.1093/aje/kwp345
View details for Web of Science ID 000273224700005
View details for PubMedID 19965887
View details for PubMedCentralID PMC2878099
Active Influenza Vaccine Safety Surveillance Potential Within a Healthcare Claims Environment
2009; 47 (12): 1251-1257
Rapid safety assessment of novel vaccines, especially those targeted against pandemic influenza, is a public health priority.Assess the feasibility of using healthcare claims data to rapidly detect influenza vaccine adverse events using sequential analytic methods.Retrospective pilot study simulating prospective surveillance using 6 cumulative monthly administrative claims data extracts. The first included encounters occurring in October; each subsequent extract included an additional month of encounters. Ten adverse events were evaluated, comparing postvaccination rates during the 2006-2007 influenza season to those expected based on rates observed in the prior season.Members of a large, multistate health insurer who had a claim for influenza vaccination during the 2005-2006 or 2006-2007 influenza seasons.The completeness of monthly claims extracts.Most vaccinations and outcomes were identified early in the 2006-2007 season; about 50% of vaccinations and short latency events were identified in the second monthly data extract, which would typically become available by mid-December, and 80% of vaccinations and events were identified in the third extract. With respect to overall claims lag, approximately 90% of vaccinations and events were identified within 1 to 2 months after vaccination, regardless of vaccination month.This study suggests that administrative claims data might contribute to same season influenza vaccine safety surveillance in large, defined populations, especially during a threat of pandemic influenza. Based on our previous work, we believe this method could be applied to multiple health plans' data to monitor a large portion of the US population.
View details for Web of Science ID 000272488100009
View details for PubMedID 19786905
Uptake of meningococcal conjugate vaccine among adolescents in large managed care organizations, United States, 2005: Demand, supply and seasonality
BMC INFECTIOUS DISEASES
In February 2005, the US Advisory Committee on Immunization Practices recommended the new meningococcal conjugate vaccine (MCV4) for routine use among 11- to 12-year-olds (at the preadolescent health-care visit), 14- to 15-year-olds (before high-school entry), and groups at increased risk. Vaccine distribution started in March; however, in July, the manufacturer reported inability to meet demand and widespread MCV4 shortages were reported. Our objectives were to determine early uptake patterns among target (11-12 and 14-15 year olds) and non-target (13- plus 16-year-olds) age groups. A post hoc analysis was conducted to compare seasonal uptake patterns of MCV4 with polysaccharide meningococcal (MPSV4) and tetanus diphtheria (Td) vaccines.We analyzed data for adolescents 11-16 years from five managed care organizations participating in the Vaccine Safety Datalink (VSD). For MCV4, we estimated monthly and cumulative coverage during 2005 and calculated risk ratios. For MPSV4 and Td, we combined 2003 and 2004 data and compared their seasonal uptake patterns with MCV4.Coverage for MCV4 during 2005 among the 623,889 11-16 years olds was 10%. Coverage for 11-12 and 14-15 year olds was 12% and 11%, respectively, compared with 8% for 13- plus 16-year-olds (p < 0.001). Of the 64,272 MCV4 doses administered from March-December 2005, 73% were administered June-August. Fifty-nine percent of all MPSV4 doses and 38% of all Td doses were administered during June-August.A surge in vaccine uptake between June and August was observed among adolescents for MCV4, MPSV4 and Td vaccines. The increase in summer-time vaccinations and vaccination of non-targeted adolescents coupled with supply limitations likely contributed to the reported shortages of MCV4 in 2005.
View details for DOI 10.1186/1471-2334-9-175
View details for Web of Science ID 000272386900001
View details for PubMedID 19887009
View details for PubMedCentralID PMC2781813
- Infection prevention and control in health-care facilities in which hematopoietic cell transplant recipients are treated BONE MARROW TRANSPLANTATION 2009; 44 (8): 495-507
- Safe living after hematopoietic cell transplantation BONE MARROW TRANSPLANTATION 2009; 44 (8): 509-519
Epidemiology and risk factors for Staphylococcus aureus colonization in children in the post-PCV7 era
BMC INFECTIOUS DISEASES
The incidence of community-associated methicillin-resistant Staphylococcus aureus (MRSA) has risen dramatically in the U.S., particularly among children. Although Streptococcus pneumoniae colonization has been inversely associated with S. aureus colonization in unvaccinated children, this and other risk factors for S. aureus carriage have not been assessed following widespread use of the heptavalent pneumococcal conjugate vaccine (PCV7). Our objectives were to (1) determine the prevalence of S. aureus and MRSA colonization in young children in the context of widespread use of PCV7; and (2) examine risk factors for S. aureus colonization in the post-PCV7 era, including the absence of vaccine-type S. pneumoniae colonization.Swabs of the anterior nares (S. aureus) were obtained from children enrolled in an ongoing study of nasopharyngeal pneumococcal colonization of healthy children in 8 Massachusetts communities. Children 3 months to <7 years of age seen for well child or sick visits in primary care offices from 11/03-4/04 and 10/06-4/07 were enrolled. S. aureus was identified and antibiotic susceptibility testing was performed. Epidemiologic risk factors for S. aureus colonization were collected from parent surveys and chart reviews, along with data on pneumococcal colonization. Multivariate mixed model analyses were performed to identify factors associated with S. aureus colonization.Among 1,968 children, the mean age (SD) was 2.7 (1.8) years, 32% received an antibiotic in the past 2 months, 2% were colonized with PCV7 strains and 24% were colonized with non-PCV7 strains. The prevalence of S. aureus colonization remained stable between 2003-04 and 2006-07 (14.6% vs. 14.1%), while MRSA colonization remained low (0.2% vs. 0.9%, p = 0.09). Although absence of pneumococcal colonization was not significantly associated with S. aureus colonization, age (6-11 mo vs. > or =5 yrs, OR 0.39 [95% CI 0.24-0.64]; 1-1.99 yrs vs. > or =5 yrs, OR 0.35 [0.23-0.54]; 2-2.99 yrs vs. > or =5 yrs, OR 0.45 [0.28-0.73]; 3-3.99 yrs vs. > or =5 yrs, OR 0.53 [0.33-0.86]) and recent antibiotic use were significant predictors in multivariate models.In Massachusetts, S. aureus and MRSA colonization remained stable from 2003-04 to 2006-07 among children <7 years despite widespread use of pneumococcal conjugate vaccine. S. aureus nasal colonization varies by age and is inversely correlated with recent antibiotic use.
View details for DOI 10.1186/1471-2334-9-110
View details for Web of Science ID 000268570600001
View details for PubMedID 19594890
Continued Impact of Pneumococcal Conjugate Vaccine on Carriage in Young Children
2009; 124 (1): E1-E11
The goals were to assess serial changes in Streptococcus pneumoniae serotypes and antibiotic resistance in young children and to evaluate whether risk factors for carriage have been altered by heptavalent pneumococcal conjugate vaccine (PCV7).Nasopharyngeal specimens and questionnaire/medical record data were obtained from children 3 months to <7 years of age in primary care practices in 16 Massachusetts communities during the winter seasons of 2000-2001 and 2003-2004 and in 8 communities in 2006-2007. Antimicrobial susceptibility testing and serotyping were performed with S pneumoniae isolates.We collected 678, 988, and 972 specimens during the sampling periods in 2000-2001, 2003-2004, and 2006-2007, respectively. Carriage of non-PCV7 serotypes increased from 15% to 19% and 29% (P < .001), with vaccine serotypes decreasing to 3% of carried serotypes in 2006-2007. The relative contribution of several non-PCV7 serotypes, including 19A, 35B, and 23A, increased across sampling periods. By 2007, commonly carried serotypes included 19A (16%), 6A (12%), 15B/C (11%), 35B (9%), and 11A (8%), and high-prevalence serotypes seemed to have greater proportions of penicillin nonsusceptibility. In multivariate models, common predictors of pneumococcal carriage, such as child care attendance, upper respiratory tract infection, and the presence of young siblings, persisted.The virtual disappearance of vaccine serotypes in S pneumoniae carriage has occurred in young children, with rapid replacement with penicillin-nonsusceptible nonvaccine serotypes, particularly 19A and 35B. Except for the age group at highest risk, previous predictors of carriage, such as child care attendance and the presence of young siblings, have not been changed by the vaccine.
View details for DOI 10.1542/peds.2008-3099
View details for Web of Science ID 000267448100057
View details for PubMedID 19564254
View details for PubMedCentralID PMC2782668
Financial Barriers to Implementing Combination Vaccines: Perspectives From Pediatricians and Policy Makers
2009; 48 (5): 539-547
To describe the factors that affect the use of new combination vaccines, the authors conducted qualitative interviews with pediatricians (n = 7), state immunization program managers (n = 7), and health insurance plan representatives (n = 6 plans). Respondents from each group identified reduction in pain and potentially increased immunization coverage as key benefits of new combination vaccines. For several pediatricians, low reimbursement for cost of vaccine doses and potential loss of fees for vaccine administration were barriers to using combination vaccines. For most state immunization programs, the higher cost of combination vaccines relative to separate vaccines was an important consideration but not a barrier to adoption. Most insurers were not aware of the financial issues for providers, but some had changed or were willing to change reimbursement to support the use of new combination vaccines. Financial issues for pediatric practices that purchase and provide vaccines for children may be an important barrier to offering combination vaccines.
View details for DOI 10.1177/0009922808330773
View details for Web of Science ID 000265954800012
View details for PubMedID 19318705
- Vaccine Financing in the United States An Emerging Crisis ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE 2009; 163 (5): 485-487
Adverse Events After Administration of Tetanus-Diphtheria-Acellular Pertussis Vaccine to Healthcare Workers
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
2009; 30 (4): 389-391
Healthcare workers who received the tetanus-diphtheria-acellular pertussis (Tdap) vaccine were surveyed about adverse events. Local adverse events were more common among women and among those who received the Tdap vaccine less than 5 years after they had received the tetanus-diphtheria vaccine. Systemic adverse events were more common among healthcare workers aged less than 30 years. These findings provide guidance for counseling of healthcare workers who receive Tdap vaccine.
View details for DOI 10.1086/596201
View details for Web of Science ID 000263897700014
View details for PubMedID 19239376
Influenza Vaccination in Adolescents With High-Risk Conditions
2008; 122 (5): 920-928
We assessed influenza vaccination rates from 1992 to 2002, individual continuity of vaccination, and missed opportunities for vaccination in adolescents with high-risk conditions.We performed a retrospective observational study of 18 703 adolescents with high-risk conditions who were enrolled in a large health maintenance organization and received care at a multisite practice for >or=1 influenza season and the preceding year, between 1992 and 2002, was performed. Subjects were identified as having a high-risk condition if they had >or=1 visit with an associated International Classification of Diseases, Ninth Revision, Clinical Modification code during the season or previous year. Influenza vaccination rates were compared by season in logistic regression analyses, using generalized estimating equations for repeated measurements of subjects enrolled for multiple seasons. Vaccination continuity was measured for adolescents who were enrolled for 4 consecutive seasons (1999-2002) as the number of seasons during which vaccine was received. Missed opportunities were defined as visits during the first 4 months of influenza season at which an unvaccinated adolescent did not receive vaccine.For adolescents with high-risk conditions, influenza vaccination rates varied from 8.3% to 15.4%. Rates improved significantly from 1992 to 1993, from 8.3% to 12.8%, and again in 2001, reaching 15.4%. Only 11.1% of those enrolled continuously from 1999 to 2002 received vaccine during all 4 seasons. According to season from 1992 to 2002, 45.7% to 53.6% of unvaccinated subjects had >or=1 missed opportunity.Influenza vaccination rates in adolescents with high-risk conditions improved from 1992 to 2002 but were still low in recent years. Individual vaccination continuity was poor. Numerous opportunities already exist for improving coverage.
View details for DOI 10.1542/peds.2007-3032
View details for Web of Science ID 000260542500002
View details for PubMedID 18977969
Adolescent immunizations: Missed opportunities for prevention
2008; 122 (4): 711-717
The goals were (1) to describe immunization rates for tetanus-diphtheria, hepatitis B, and measles-mumps-rubella vaccines among 13-year-old adolescents; (2) to identify missed opportunities for tetanus-diphtheria immunization among adolescents 11 to 17 years of age; and (3) to evaluate the association between preventive care use and tetanus-diphtheria immunization.Adolescents born between January 1, 1986, and December 31, 1991, and enrolled in Harvard Pilgrim Health Care and Harvard Vanguard Medical Associates for >or=1 year in 1997-2004 were included. Immunization rates for tetanus-diphtheria, hepatitis B, and measles-mumps-rubella were assessed at 13 years of age. Missed opportunities for tetanus-diphtheria immunization within 14 days after a health care visit were measured. Multivariate models were used to determine predictors of timeliness of tetanus-diphtheria vaccination, particularly the use of preventive care services. RESULTS. A total of 23,987 eligible adolescents were enrolled in Harvard Pilgrim Health Care and Harvard Vanguard Medical Associates between 1997 and 2004. Among 13-year-old adolescents in the most recent birth cohort, 84%, 74%, and 67% were up to date for tetanus-diphtheria, hepatitis B, and measles-mumps-rubella, respectively. When the analysis was limited to those with >or=1 vaccine received before 2 years of age (a proxy measure for complete records), 92%, 82%, and 85% were up to date for tetanus-diphtheria, hepatitis B, and measles-mumps-rubella, respectively. Missed opportunities for tetanus-diphtheria immunization occurred at 84% of all health care visits. Adolescents who did not seek preventive care were less likely to receive tetanus-diphtheria in a timely manner.Adolescent immunization rates lag far behind childhood rates, and missed opportunities are common. Additional strategies are needed to increase the use of preventive services among adolescents and to enable providers to vaccinate adolescents at every opportunity.
View details for DOI 10.1542/peds.2007-2857
View details for Web of Science ID 000259812600003
View details for PubMedID 18829792
Cost-effectiveness of adult pertussis vaccination in Germany
2008; 26 (29-30): 3673-3679
The incidence of pertussis in adults is high despite good childhood vaccination coverage. An adult formulation of an acellular pertussis vaccine is licensed and available for use in Germany.To evaluate the potential health benefits, risks, costs and cost-effectiveness of routine pertussis vaccination programs for German adults.A Markov model was used to simulate health states and immunity levels associated with pertussis disease and vaccination. The following strategies were evaluated: (1) no adult pertussis vaccination, (2) one-time adult vaccination at 20-64 years, and (3) adult vaccination with decennial boosters. Our main outcome measures were costs (2006 Euros), cases prevented, incremental cost per case prevented and incremental cost per quality-adjusted life year (QALY) saved. We performed sensitivity analyses for key assumptions in the model including disease incidence, vaccine cost, vaccine efficacy, disease costs and frequency of adverse events. Future costs and benefits were discounted at 3%.At a disease incidence of 165 per 100,000, the one-time adult vaccination strategy would prevent 498,000 cases, and the decennial adult vaccination strategy would prevent 1 million cases. Approximately 31 million adults ( approximately 62% of the cohort) would be vaccinated with a one-time adult vaccination strategy for a total program cost of 366 million Euros, while a decennial vaccination strategy would cost 687 million Euros. The one-time adult vaccination strategy resulted in CE ratios of 5800 Euros per QALY saved, or 160 Euros per pertussis case prevented. The decennial booster strategy cost 7200 Euros per QALY saved, or 200 Euros per case prevented. The results were most sensitive to assumptions about disease incidence and vaccine cost.Routine vaccination of German adults aged 20-64 years with Tdap is cost-effective.
View details for DOI 10.1016/j.vaccine.2008.04.068
View details for Web of Science ID 000257649000017
View details for PubMedID 18538901
Tetanus-diphtheria-acellular pertussis vaccination of adults in the USA
EXPERT REVIEW OF VACCINES
2008; 7 (5): 621-634
Pertussis is an important cause of morbidity and mortality, and its incidence has been increasing in adolescents and adults over the past two decades. Waning immunity in adolescents and adults may be partially responsible. Adults can suffer significant illness from pertussis and its complications, such as pneumonia, rib fractures and syncope. Moreover, adults serve as a source of disease for infants, who are more vulnerable to severe complications and even death. The economic burden of pertussis is substantial, in terms of both medical and nonmedical costs. Fortunately, the burden of pertussis disease can now be safely and effectively reduced by vaccinating adults with tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Further research is needed to elucidate the role of vaccination in pregnant women and those over 65 years of age, and also to determine whether further booster doses of Tdap are needed.
View details for DOI 10.1586/147605126.96.36.1991
View details for Web of Science ID 000257617400015
View details for PubMedID 18564017
Pertussis vaccination for health care workers
CLINICAL MICROBIOLOGY REVIEWS
2008; 21 (3): 426-434
Pertussis, an acute respiratory infection caused by Bordetella pertussis, classically manifests as a protracted cough illness. The incidence of pertussis in the United States has been increasing in recent years. Immunity wanes after childhood vaccination, leaving adolescents and adults susceptible to infection. The transmission of pertussis in health care settings has important medical and economic consequences. Acellular pertussis booster vaccines are now available for use and have been recommended for all adolescents and adults. These vaccines are safe, immunogenic, and effective. Health care workers are a priority group for vaccination because of their increased risk of acquiring infection and the potential to transmit pertussis to high-risk patients. Health care worker vaccination programs are likely to be cost-effective, but further research is needed to determine the acceptability of pertussis vaccines among health care workers, the duration of immunity after booster doses, and the impact of vaccination on the management of pertussis exposures in health care settings.
View details for DOI 10.1128/CMR.00003-08
View details for Web of Science ID 000258667400002
View details for PubMedID 18625679
View details for PubMedCentralID PMC2493083
Burden and economic cost of group A streptococcal pharyngitis
2008; 121 (2): 229-234
Our aim was to describe the morbidity, medical costs, and nonmedical costs associated with group A streptococcal pharyngitis in school-aged children.Our study population included parents of children diagnosed as having group A streptococcal pharyngitis at 2 pediatric practice sites in the Boston, Massachusetts, metropolitan area. Telephone interviews were conducted with parents of eligible children, who were asked questions about health care utilization, medications, and time missed from work or school, for calculation of medical and nonmedical costs associated with illness.One hundred thirty-five parents completed interviews between October 2005 and January 2006. Older children were significantly more likely to present with headache, compared with those < or = 5 years of age. No significant differences between older and younger children were found for rates of sore throat, fever, abdominal pain/nausea/vomiting, or rash. Children missed a mean of 1.9 days (range: 0-7 days) of school/day care, and 42% of parents missed a mean of 1.8 days of work. A second parent or caregiver also missed a mean of 1.5 days in 14% of families. The total societal cost per case of group A streptococcal pharyngitis was $205 (medical: $118; nonmedical: $87).The societal cost of group A streptococcal pharyngitis is substantial, with almost one half being attributable to nonmedical costs. Through extrapolation from this experience, the total cost of group A streptococcal pharyngitis among children in the United States ranges from $224 to $539 million per year.
View details for DOI 10.1542/peds.2007-0484
View details for Web of Science ID 000252877600001
View details for PubMedID 18245412
Projected cost-effectiveness of new vaccines for adolescents in the United States
2008; 121: S63-S78
Economic assessments that guide policy making on immunizations are becoming increasingly important in light of new and anticipated vaccines for adolescents. However, important considerations that limit the utility of these assessments, such as the diversity of approaches used, are often overlooked and should be better understood.Our goal was to examine economic studies of adolescent vaccines and compare cost-effectiveness outcomes among studies on a particular vaccine, across adolescent vaccines, and between new adolescent vaccines versus vaccines that are recommended for young children.A systematic review of economic studies on immunizations for adolescents was conducted. Studies were identified by searching the Medline, Embase, and EconLit databases. Each study was reviewed for appropriateness of model design, baseline setup, sensitivity analyses, and input variables (ie, epidemiologic, clinical, cost, and quality-of-life impact). For comparison, the cost-effectiveness outcomes reported in key studies on vaccines for younger children were selected.Vaccines for healthy adolescents were consistently found to be more costly than the health care or societal cost savings they produced and, in general, were less cost-effective than vaccines for younger children. Among the new vaccines, pertussis and human papillomavirus vaccines were more cost-effective than meningococcal vaccines. Including herd-immunity benefits in studies significantly improved the cost-effectiveness estimates for new vaccines. Differences in measurements or assumptions limited further comparisons.Although using the new adolescent vaccines is unlikely to be cost-saving, vaccination programs will result in sizable health benefits.
View details for DOI 10.1542/peds.2007-1115H
View details for Web of Science ID 000253781900008
View details for PubMedID 18174323
Gaps in vaccine financing for underinsured children in the United States
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2007; 298 (6): 638-643
The number of new vaccines recommended for children and adolescents has nearly doubled during the past 5 years, and the cost of fully vaccinating a child has increased dramatically in the past decade. Anecdotal reports from state policy makers and clinicians suggest that new gaps have arisen in financial coverage of vaccines for children who are underinsured (ie, have private insurance that does not cover all recommended vaccines). In 2000, approximately 14% of children were underinsured for vaccines in the United States.To describe variation among states in the provision of new vaccines to underinsured children and to identify barriers to state purchase and distribution of new vaccines.A 2-phase mixed-methods study of state immunization program managers in the United States. The first phase included 1-hour qualitative telephone interviews conducted from November to December 2005 with 9 program managers chosen to represent different state vaccine financing policies. The second phase incorporated findings from phase 1 to develop a national telephone and paper-based survey of state immunization program managers that was conducted from January to June 2006.Percentage of states in which underinsured children are unable to receive publicly purchased vaccines in the private or public sectors.Immunization program managers from 48 states (96%) participated in the study. Underinsured children were not eligible to receive publicly purchased meningococcal conjugate or pneumococcal conjugate vaccines in the private sector in 70% and 50% of states, respectively, or in the public sector in 40% and 17% of states, respectively. Due to limited financing for new vaccines, 10 states changed their policies for provision of publicly purchased vaccines between 2004 and early 2006 to restrict access to selected new vaccines for underinsured children. The most commonly cited barriers to implementation in underinsured children were lack of sufficient federal and state funding to purchase vaccines.The current vaccine financing system has resulted in gaps for underinsured children in the United States, many of whom are now unable to receive publicly purchased vaccines in either the private or public sectors. Additional strategies are needed to ensure financial coverage for all vaccines, particularly new vaccines, among this vulnerable population.
View details for Web of Science ID 000248574800024
View details for PubMedID 17684186
- Varicella vaccination in adults: Is it cost-effective? Editorial commentary CLINICAL INFECTIOUS DISEASES 2007; 44 (8): 1049-1050
Cost effectiveness of pertussis vaccination in adults
AMERICAN JOURNAL OF PREVENTIVE MEDICINE
2007; 32 (3): 186-193
Prior economic analyses have reached disparate conclusions about whether vaccinating adults against pertussis would be cost effective. Newly available data on pertussis incidence were used to evaluate the cost effectiveness of one-time adult vaccination and adult vaccination with decennial boosters.A Markov model was used to calculate the health benefits, risks, costs, and cost effectiveness of the following strategies: (1) no adult pertussis vaccination, (2) one-time adult vaccination at 20-64 years, and (3) adult vaccination with decennial boosters. The impact of the severity of pertussis illness, vaccine adverse events, and herd immunity on model outcomes were also examined.At a disease incidence of 360 per 100,000, the one-time adult vaccination strategy would prevent 2.8 million cases, and the decennial vaccination strategy would prevent 8.3 million cases. As disease incidence varied from 10 to 500 per 100,000, the one-time adult vaccination strategy was projected to prevent 79,000 to 3.8 million adult pertussis cases, while the decennial vaccination program would prevent 239,000 to 11.4 million cases. A one-time adult vaccination strategy would result in 106 million people vaccinated, or approximately 64% of the adult cohort, for a total program cost of $2.1 billion, while a decennial vaccination strategy would cost $6.7 billion. The one-time and decennial booster vaccination strategies result in cost-effectiveness ratios of <$50,000 per quality-adjusted life year saved if disease incidence in adults were greater than 120 cases per 100,000 population.Routine vaccination of adults aged 20 to 64 years with combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis is cost effective if pertussis incidence in this age group is greater than 120 per 100,000 population.
View details for DOI 10.1016/j.amepre.2006.10.016
View details for Web of Science ID 000244730000002
View details for PubMedID 17296470
Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel.
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports
2006; 55 (RR-17): 1-37
On June 10, 2005, a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) formulated for use in adults and adolescents was licensed in the United States for persons aged 11-64 years (ADACEL, manufactured by sanofi pasteur, Toronto, Ontario, Canada). Prelicensure studies demonstrated safety and efficacy, inferred through immunogenicity, against tetanus, diphtheria, and pertussis when Tdap was administered as a single booster dose to adults. To reduce pertussis morbidity among adults and maintain the standard of care for tetanus and diphtheria prevention and to reduce the transmission of pertussis to infants and in health-care settings, the Advisory Committee on Immunization Practices (ACIP) recommends that: 1) adults aged 19-64 years should receive a single dose of Tdap to replace tetanus and diphtheria toxoids vaccine (Td) for booster immunization against tetanus, diphtheria, and pertussis if they received their last dose of Td >or=10 years earlier and they have not previously received Tdap; 2) intervals shorter than 10 years since the last Td may be used for booster protection against pertussis; 3) adults who have or who anticipate having close contact with an infant aged <12 months (e.g., parents, grandparents aged <65 years, child-care providers, and health-care personnel) should receive a single dose of Tdap to reduce the risk for transmitting pertussis. An interval as short as 2 years from the last Td is suggested; shorter intervals can be used. When possible, women should receive Tdap before becoming pregnant. Women who have not previously received Tdap should receive a dose of Tdap in the immediate postpartum period; 4) health-care personnel who work in hospitals or ambulatory care settings and have direct patient contact should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap. An interval as short as 2 years from the last dose of Td is recommended; shorter intervals may be used. These recommendations for use of Tdap in health-care personnel are supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC). This statement 1) reviews pertussis, tetanus and diphtheria vaccination policy in the United States; 2) describes the clinical features and epidemiology of pertussis among adults; 3) summarizes the immunogenicity, efficacy, and safety data of Tdap; and 4) presents recommendations for the use of Tdap among adults aged 19-64 years.
View details for PubMedID 17167397
- Changing epidemiology of acute rheumatic fever in the United States CLINICAL INFECTIOUS DISEASES 2006; 42 (4): 448-450
Quality of life for children and adolescents: Impact of HIV infection and antiretroviral treatment
2006; 117 (2): 273-283
HIV/AIDS mortality rates in the United States are declining; pediatric HIV has become a chronic disease, with quality of life (QoL) outcomes assuming greater importance.To compare QoL among HIV-infected and uninfected children and to assess the impact of different antiretroviral regimens on QoL among HIV-infected children.Perinatally exposed, HIV-infected (N = 1847) and uninfected (N = 712) children and adolescents were studied. Among infected children, 1283 were available for the antiretroviral regimen analysis. QoL domain scores were assessed for subjects 6 months to 4 years, 5 to 11 years, and 12 to 21 years of age, and the impact of infection status and alternative treatment regimens on QoL domains was evaluated.HIV infection was associated with significantly worse mean adjusted scores for functional status among children 6 months to 4 years of age and health perceptions, physical resilience, physical functioning, and social/role functioning among those 5 to 11 years of age. However, uninfected children 5 to 11 years of age reported significantly worse psychological functioning. HIV-infected children (5-11 years of age) and adolescents (12-21 years of age) receiving no antiretroviral treatment had worse health perceptions. Adolescents receiving no antiretroviral agents also had worse symptoms. When antiretroviral regimens were compared, adolescents receiving protease inhibitor plus nonnucleoside reverse transcriptase inhibitor-containing therapy had worse symptoms, compared with those receiving protease inhibitor-containing therapy; otherwise, no significant differences were found.Generally parents of HIV-infected children 6 months to 4 years and 5 to 11 years of age generally reported lower mean QoL scores than did parents of uninfected children, although worse psychological functioning was reported for uninfected children. HIV-infected adolescents not receiving antiretroviral treatment had worse health perceptions and symptoms. We found no consistent QoL differences among children receiving different antiretroviral regimens.
View details for DOI 10.1542/peds.2005-0323
View details for Web of Science ID 000235491100002
View details for PubMedID 16452344
Antibiotic treatment of children with sore throat
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2005; 294 (18): 2315-2322
Of children with sore throat, 15% to 36% have pharyngitis caused by group A beta-hemolytic streptococci (GABHS). Performance of a GABHS test prior to antibiotic prescribing is recommended for children with sore throat. Penicillin, amoxicillin, erythromycin, and first-generation cephalosporins are the recommended antibiotics for treatment of sore throat due to GABHS.To measure rates of antibiotic prescribing and GABHS testing and to evaluate the association between testing and antibiotic treatment for children with sore throat.Analysis of visits by children aged 3 to 17 years with sore throat to office-based physicians, hospital outpatient departments, and emergency departments in the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey, 1995 to 2003 (N = 4158) and of a subset of visits with GABHS testing data (n = 2797).National rates of antibiotic prescribing, prescribing of antibiotics recommended and not recommended for GABHS, and GABHS testing.Physicians prescribed antibiotics in 53% (95% confidence interval [CI], 49%-56%) of an estimated 7.3 million annual visits for sore throat and nonrecommended antibiotics to 27% (95% CI, 24%-31%) of children who received an antibiotic. Antibiotic prescribing decreased from 66% of visits in 1995 to 54% of visits in 2003 (P = .01 for trend). This decrease was attributable to a decrease in the prescribing of recommended antibiotics (49% to 38%; P = .002). Physicians performed a GABHS test in 53% (95% CI, 48%-57%) of visits and in 51% (95% CI, 45%-57%) of visits at which an antibiotic was prescribed. GABHS testing was not associated with a lower antibiotic prescribing rate overall (48% tested vs 51% not tested; P = .40), but testing was associated with a lower antibiotic prescribing rate for children with diagnosis codes for pharyngitis, tonsillitis, and streptococcal sore throat (57% tested vs 73% not tested; P<.001).Physicians prescribed antibiotics to 53% of children with sore throat, in excess of the maximum expected prevalence of GABHS. Although there was a decrease in the proportion of children receiving antibiotics between 1995 and 2003, this was due to decreased prescribing of agents recommended for GABHS. Although GABHS testing was associated with a lower rate of antibiotic prescribing for children with diagnosis codes of pharyngitis, tonsillitis, and streptococcal sore throat, GABHS testing was underused.
View details for Web of Science ID 000233089700023
View details for PubMedID 16278359
Randomized, controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home
2005; 116 (3): 587-594
Good hand hygiene may reduce the spread of infections in families with children who are in out-of-home child care. Alcohol-based hand sanitizers rapidly kill viruses that are commonly associated with respiratory and gastrointestinal (GI) infections. The objective of this study was to determine whether a multifactorial campaign centered on increasing alcohol-based hand sanitizer use and hand-hygiene education reduces illness transmission in the home.A cluster randomized, controlled trial was conducted of homes of 292 families with children who were enrolled in out-of-home child care in 26 child care centers. Eligible families had > or =1 child who was 6 months to 5 years of age and in child care for > or =10 hours/week. Intervention families received a supply of hand sanitizer and biweekly hand-hygiene educational materials for 5 months; control families received only materials promoting good nutrition. Primary caregivers were phoned biweekly and reported respiratory and GI illnesses in family members. Respiratory and GI-illness-transmission rates (measured as secondary illnesses per susceptible person-month) were compared between groups, adjusting for demographic variables, hand-hygiene practices, and previous experience using hand sanitizers.Baseline demographics were similar in the 2 groups. A total of 1802 respiratory illnesses occurred during the study; 443 (25%) were secondary illnesses. A total of 252 GI illnesses occurred during the study; 28 (11%) were secondary illnesses. The secondary GI-illness rate was significantly lower in intervention families compared with control families (incidence rate ratio [IRR]: 0.41; 95% confidence interval [CI]: 0.19-0.90). The overall rate of secondary respiratory illness was not significantly different between groups (IRR: 0.97; 95% CI: 0.72-1.30). However, families with higher sanitizer usage had a marginally lower secondary respiratory illness rate than those with less usage (IRR: 0.81; 95% CI: 0.65-1.09).A multifactorial intervention emphasizing alcohol-based hand sanitizer use in the home reduced transmission of GI illnesses within families with children in child care. Hand sanitizers and multifaceted educational messages may have a role in improving hand-hygiene practices within the home setting.
View details for DOI 10.1542/peds.2005-0199
View details for Web of Science ID 000231576600029
View details for PubMedID 16140697
Pertussis in adolescents and adults: Should we vaccinate?
2005; 115 (6): 1675-1684
The incidence of reported pertussis among adolescents, adults, and young infants has increased sharply over the past decade. Combined acellular pertussis vaccines for adolescents and adults are available in Canada, Australia, and Germany and may soon be considered for use in the United States.To evaluate the potential health benefits, risks, and costs of a national pertussis vaccination program for adolescents and/or adults.The projected health states and immunity levels associated with pertussis disease and vaccination were simulated with a Markov model. The following strategies were examined from the health care payer and societal perspectives: (1) no vaccination; (2) 1-time adolescent vaccination; (3) 1-time adult vaccination; (4) adult vaccination with boosters; (5) adolescent and adult vaccination with boosters; and (6) postpartum vaccination. Data on disease incidence, costs, outcomes, vaccine efficacy, and adverse events were based on published studies, recent unpublished clinical trials, and expert panel input.Cases prevented, adverse events, costs (in 2004 US dollars), cost per case prevented, and cost per quality-adjusted life-year (QALY) saved.One-time adolescent vaccination would prevent 30800 cases of pertussis (36% of projected cases) and would result in 91000 vaccine adverse events (67% local reactions). If pertussis vaccination cost $15 and vaccine coverage was 76%, then 1-time adolescent vaccination would cost $1100 per case prevented (or $1200 per case prevented) or $20000 per QALY (or $23000 per QALY) saved, from the societal (or health care payer) perspective. With a threshold of $50000 per QALY saved, the adolescent and adult vaccination with boosters strategy became potentially cost-effective from the societal perspective only if 2 conditions were met simultaneously, ie, (1) the disease incidence for adolescents and adults was > or =6 times higher than base-case assumptions and (2) the cost of vaccination was less than $10. Adult vaccination strategies were more costly and less effective than adolescent vaccination strategies. The results were sensitive to assumptions about disease incidence, vaccine efficacy, frequency of vaccine adverse events, and vaccine costs.Routine pertussis vaccination of adolescents results in net health benefits and may be relatively cost-effective.
View details for DOI 10.1542/peds.2004-2509
View details for Web of Science ID 000229504800029
View details for PubMedID 15930232
Illness transmission in the home: A possible role for alcohol-based hand gels
2005; 115 (4): 852-860
The widespread use of child care has altered the epidemiology of respiratory and gastrointestinal (GI) infection in the community. Our primary objective was to measure transmission of respiratory and GI illnesses among families with children enrolled in child care. We also sought to examine potential predictors of reduced illness transmission in the home in a secondary analysis.We performed an observational, prospective cohort study to determine transmission rates for respiratory and GI illnesses within families with at least 1 child between 6 months and 5 years of age enrolled in child care. A survey about family beliefs and practices was mailed at the beginning of the study. Symptom diaries were provided for families to record the timing and duration of respiratory and GI illnesses. To ensure the accuracy of symptom diaries, biweekly telephone calls were performed to review illnesses recorded by participants. Families with > or =4 weeks of data recorded were included in the analysis. Families were recruited from 5 pediatric practices in the metropolitan Boston area. Of 261 families who agreed to participate in the study, 208 were available for analysis. Secondary transmission rates for respiratory and GI illnesses were measured as illnesses per susceptible person-month.We observed 1545 respiratory and 360 GI illnesses in 208 families from November 2000 to May 2001. Of these, 1099 (71%) respiratory and 297 (83%) GI illnesses were considered primary illnesses introduced into the home. The secondary transmission rates for respiratory and GI illnesses were 0.63 and 0.35 illnesses per susceptible person-month, respectively. Only two thirds of respondents correctly believed that contact transmission was important in the spread of colds, and fewer than half believed that it was important in the spread of stomach flus. Twenty-two percent of respondents reported use of alcohol-based hand gels all, most, or some of the time; 33% reported always washing their hands after blowing or wiping a nose. In multivariate models, use of alcohol-based hand gels had a protective effect against respiratory illness transmission in the home.In homes with young children enrolled in child care, illness transmission to family members occurs frequently. Alcohol-based hand gel use was associated with reduced respiratory illness transmission in the home.
View details for DOI 10.1542/peds.2004-0856
View details for PubMedID 15805355
Health-state valuations for pertussis: methods for valuing short-term health states.
Health and quality of life outcomes
2005; 3: 17-?
The incidence of reported adolescent and adult pertussis continues to rise in the United States. Acellular pertussis vaccines for adolescents and adults have been developed and may be available soon for use in the U.S. Our objectives were: (1) to describe patient valuations of pertussis disease and vaccination; and (2) to compare valuations for short-term and long-term health states associated with pertussis.We conducted telephone surveys with 515 adult patients and parents of adolescent patients with pertussis in Massachusetts to determine valuations of pertussis-related health states for disease and vaccination using time trade-off (TTO) and contingent valuation (CV) techniques. Respondents were randomized to complete either a short-term or long-term TTO exercise. Discrimination between health states for each valuation technique was assessed using Tukey's method, and valuations for short-term vs. long-term health states were compared using the Wilcoxon rank-sum test.Three hundred three (59%) and 309 (60%) respondents completed and understood the TTO and CV exercises, respectively. Overall, respondents gave lower valuations (lower TTO and higher CV values) to avoid a given state for adolescent/adult disease compared to vaccine adverse events. Infant complications due to pertussis were considered worse than adolescent/adult disease, regardless of the method of valuation. The short-term TTO resulted in lower mean valuations and larger mean differences between health states than the long-term TTO exercise.Pertussis was considered worse than adverse events due to vaccination. Short-term health-state valuation is better able to discriminate among health states, which is useful for cost-utility analysis.
View details for PubMedID 15780145
Societal costs and morbidity of pertussis in adolescents and adults
CLINICAL INFECTIOUS DISEASES
2004; 39 (11): 1572-1580
Since the 1980s, the reported incidence of pertussis among adolescents and adults has been steadily increasing. To understand whether the benefits of an acellular pertussis vaccine formulated for adolescents and adults might offset its costs, policy makers will need information about morbidity and societal (medical and nonmedical) costs of pertussis.Adolescents (age, 10-17 years) and adults (age, >or=18 years) with confirmed pertussis illness were identified by the Massachusetts enhanced pertussis surveillance system. We evaluated medical costs in a cohort of patients who had confirmed pertussis during the period of January 1998 through December 2000; nonmedical costs, by means of prospective interviews, in a cohort of patients who had confirmed pertussis during the period of December 2001 through January 2003; and morbidity in both cohorts. Our main outcome measures were mean costs per case, in 2002 US dollars.In the analysis of medical costs, 1679 adolescents and 936 adults were found to have mean costs of 242 dollars and 326 dollars, respectively (P<.05). In interviews with 314 adolescents and 203 adults, adults had significantly higher nonmedical costs (447 dollars) than those of adolescents (155 dollars). A total of 83% of adolescents missed a mean of 5.5 days from school (range, 0.4-32 days), and 61% of adults missed a mean of 9.8 days from work (range, 0.1-180 days) because of pertussis. Thirty-eight percent of adolescents and 61% of adults were still coughing at the time of the interview, which occurred an average of 106 days and 94 days, respectively, after cough onset.Pertussis causes significant morbidity in and costs for adolescents and adults, with time losses comprising the largest proportion of the cost. Societal costs should be considered when making decisions about potential vaccine use in the future.
View details for Web of Science ID 000227492100002
View details for PubMedID 15578353
Child care center policies and practices for management of ill children
2004; 4 (5): 455-460
The objectives of this study were to 1) describe child care staff knowledge and beliefs regarding upper respiratory tract infections and antibiotic indications and 2) evaluate child care staff reported reasons for a) exclusion from child care, b) referral to a health care provider, and c) recommending antibiotics for an ill child.A longitudinal study based in randomly selected child care centers in Massachusetts. Staff completed a survey to assess knowledge regarding common infections. For six weeks, staff completed a record of absences each day, describing the reason for an absence, and advice given to the parents regarding exclusion, referral to a health care provider, and obtaining antibiotics. Exclusions for the specific illness/symptom were defined as appropriate or inappropriate based on national guidelines.A large proportion of child care staff incorrectly believed that antibiotics are indicated for bronchitis (80.5%) and green rhinorrhea (80.5%) in children. For 82.2% of absences, the circumstances or reasons for the absence were discussed with a child care staff member. Of 538 absences due to illness that child care staff discussed with parents, there were 45 inappropriate exclusions (8.4% of illnesses discussed), 91 appropriate exclusions (16.9% of illnesses discussed), and 402 cases (74.7%) in which no recommendation for exclusion was made.Misconceptions regarding the need for antibiotics for URIs are common among child care staff. However, day care staff do not pressure parents to seek medical attention or antibiotics.
View details for Web of Science ID 000224035900011
View details for PubMedID 15369413
Acute care and antibiotic seeking for upper respiratory tract infections for children in day care - Parental knowledge and day care center policies
ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE
2003; 157 (4): 369-374
Children who attend day care are high consumers of antibiotics. Studies suggest that physicians prescribe unnecessary antibiotics for upper respiratory tract infections (URIs) for children who attend day care on the basis of perceived pressure from parents and/or day care centers.To determine both parental and day care-level predictors of acute care and antibiotic seeking for children who attend day care.We conducted a day care center-based cross-sectional survey of parents and day care center staff. Two hundred eleven parents of children attending 36 day care centers in Massachusetts completed a survey. Day care center staff completed a separate survey addressing their day care center's policies for ill children.Few parents reported day care staff pressure to seek care from a physician (3.9%) or antibiotics (1.9%). In multivariate models, higher parental knowledge about URIs was related to decreased acute care seeking for 3 upper respiratory symptoms (clear rhinorrhea, green rhinorrhea, and cough) in the absence of fever (odds ratios and 95% confidence intervals: 0.45 [0.31-0.65], 0.66 [0.52-0.85], and 0.57 [0.45-0.72], respectively). Parent-reported acute care seeking was not related to a day care center's polices for exclusion or physician clearance for these illnesses. Similar results were also found for the parental belief that antibiotics expedite return to day care for these symptoms.Although it has been suggested that inappropriate day care center policies for exclusion motivate parental acute care and antibiotic seeking, this study suggests that parental knowledge is a more important predictor of these reported behaviors than are day care center policies.
View details for Web of Science ID 000182096100012
View details for PubMedID 12695233
Misconceptions about colds and predictors of health service utilization
2003; 111 (2): 231-236
Colds accounted for 1.6 million emergency department (ED) visits and 25 million ambulatory visits by children and adults in 1998. Although most colds are caused by viruses and do not require medical intervention, many families seek health care for the treatment of colds. Parental misconceptions about the cause and appropriate treatment of colds may contribute to unnecessary health service utilization. The objective of this study was to determine predictors of reported ED use and ambulatory care use for colds among families with young children.This study was an observational, prospective cohort study to determine attack rates for respiratory illnesses within families that have at least 1 child who is 6 months to 5 years of age and enrolled in out-of-home child care. Families were randomly selected from 5 pediatric practices in Massachusetts and were considered eligible when the child was enrolled in child care with at least 5 other children for >or=10 hours per week. Enrolled families were asked to complete a survey that assessed knowledge about colds, antibiotic indications, and frequency of health service utilization. Predictors of self-reported use of health care services were assessed in multivariate logistic regression models.Of the 261 families enrolled in the study, 197 families (75%) returned completed surveys. Although 93% of parents understood that viruses caused colds, 66% of parents also believed that colds were caused by bacteria. Fifty-three percent believed that antibiotics were needed to treat colds. Parents reported that they would visit the ED (23%) or their doctor's office (60%) when their child had a cold. Predictors of ED use on multivariate analysis included Medicaid insurance (odds ratio [OR]: 17.6 [2.2-139.3]), history of wheezing (OR: 18.3 [4.4-75.8]), and belief that antibiotics treat colds (OR: 4.2 [1.4-12.9]). Predictors of ambulatory care use included parent younger than 30 years (OR: 10.0 [1.6-64.3]), history of wheezing (OR: 5.6 [1.1-29.7]), and belief that antibiotics treat colds (OR: 3.8 [1.7-8.5]).Misconceptions about the appropriate treatment of colds are predictive of increased health service utilization. Targeted educational interventions for families may reduce inappropriate antibiotic-seeking behavior and unnecessary health service utilization for colds.
View details for Web of Science ID 000180709100017
View details for PubMedID 12563044
Management of febrile children in the age of the conjugate pneumococcal vaccine: A cost-effectiveness analysis
2001; 108 (4): 835-844
The optimal practice management of highly febrile 3- to 36-month-old children without a focal source has been controversial. The recent release of a conjugate pneumococcal vaccine may reduce the rate of occult bacteremia and alter the utility of empiric testing and treatment. The objective of this study was to determine the cost-effectiveness of 6 different management strategies of febrile 3- to 36-month-old children at current and declining rates of occult pneumococcal bacteremia.A cost-effectiveness (CE) analysis was performed to compare the strategies of "no work-up," "clinical judgment," "blood culture," "blood culture + treatment," "complete blood count (CBC) + selective blood culture and treatment," and "CBC and blood culture + selective treatment." A hypothetical cohort of 100 000 children who were 3 to 36 months of age and had a fever of >/=39 degrees C and no source of infection was modeled for each strategy. Our main outcome measures were cases of meningitis prevented, life-years saved compared with "no work-up," total cost (1999 dollars), and incremental CE ratios.When compared with "no work-up," the strategy of "CBC + selective blood culture and treatment" using a white blood cell (WBC) cutoff of 15 x 10(9)/L prevents 48 cases of meningitis, saves 86 life-years per 100 000 patients, and is less costly at the current rate of bacteremia (1.5%). Using the strategy of "CBC + selective blood culture and treatment" with a lower WBC cutoff of 10 x 10(9)/L costs an additional $72 300 per life-year saved. If the rate of bacteremia declines to 0.5%, then the incremental CE ratio of "clinical judgment" compared with "no work-up" is $38 000 per life-year saved; however, strategies that include empiric testing or treatment result in CE ratios greater than $300 000 per life-year saved."CBC + selective blood culture and treatment" using a WBC cutoff of 15 x 10(9)/L is cost-effective at the current rate of pneumococcal bacteremia. If the rate of occult bacteremia falls below 0.5% with widespread use of the conjugate pneumococcal vaccine, then strategies that use empiric testing and treatment should be eliminated.
View details for Web of Science ID 000171319600022
View details for PubMedID 11581433
Risk of bacteremia for febrile young children in the post-Haemophilus influenzae type b era
ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE
1998; 152 (7): 624-628
To determine the risk for bacteremia, in the post-Haemophilus influenzae type b era, in a prospective cohort of well-appearing febrile children 3 to 36 months of age with no obvious source of infection; and to compare the predictive abilities of objective criteria in identification of children with occult pneumococcal bacteremia from those at risk.All children seen from 1993 through 1996, 3 to 36 months of age with a temperature of 39.0 degrees C or higher, no identified source of infection (except otitis media), and discharged to home were considered to be at risk for occult bacteremia and included in the study.Urban pediatric emergency department.Of 199868 patient visits to the emergency department, 1911 children were considered to be at risk for occult bacteremia. Blood cultures were obtained from 9465 (79%). A total of 149 blood cultures contained pathogenic organisms, indicating a rate of occult bacteremia of 1.57% (95% confidence intervals: 1.32%-1.83%). White blood cell count and absolute neutrophil count were the best predictors for occult pneumococcal bacteremia. Using a white blood cell count cutoff value of 15 cells x 10(9)/L (sensitivity, 86%; specificity, 77%; and positive predictive value, 5.1%) would result in the treatment of approximately 19 nonbacteremic children for each bacteremic child treated.The prevalence of occult bacteremia in children 3 to 36 months old with temperatures of 39.0 degrees C or higher and no obvious source of infection is 1.6%. The white blood cell and absolute neutrophil counts are the most accurate predictors of occult pneumococcal bacteremia and when available should be used if presumptive antibiotic therapy is being considered.
View details for Web of Science ID 000074610000002
View details for PubMedID 9667531