The Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: a Prespecified Analysis of the NUDGE-FLU Trial
Influenza vaccines have been demonstrated to effectively reduce the incidence of influenza infection and potentially associated risks of cardiovascular events in patients with cardiovascular disease (CVD). Despite strong guideline and public health endorsements, global influenza vaccination rates in patients with…
Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial
Influenza vaccination rates remain suboptimal despite effectiveness in preventing influenza infection and related complications. We investigated whether behavioural nudges, delivered via a governmental electronic letter system, would increase influenza vaccination uptake among older adults in Denmark. We did a nationwide,…
Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake (NUDGE-FLU)
NUDGE-FLU was a nationwide, pragmatic, registry-based, cluster-randomized implementation trial during the 2022-23 influenza season in Denmark. NUDGE FLU randomized >960,000 Danish citizens aged 65 years or older to usual care or 9 different behaviorally informed electronic letters (9:1:1:1:1:1:1:1:1:1) promoting influenza…
VSD Infrastructure
We conduct administrative tasks, data management, and contribute to vaccine safety assessments to support the management and development of the ongoing work of the VSD. This includes producing and maintaining a high-quality electronic data infrastructure encompassing health plan members of…
Tuberculosis Epidemiologic Studies Consortium III
This study will identify primary care systems and settings that serve non-U.S.-born persons at risk for latent tuberculosis infection (LTBI) and tuberculosis disease; collect retrospective and prospective electronic medical record data; design and implement clinical care-based interventions to improve performance…
Analysis to evaluate the effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea
The goal of this study is to use electronic medical records from 2016 to 2020 to evaluate the protective effect of MenB-4C vaccine against gonococcal infections among 16- to 23-year-old persons.
COVID-19: Antecedents to Hospitalization and Deterioration
This study will characterize and compare antecedents to hospitalization and in-hospital deterioration among patients with COVID-19 and comparator patients with influenza. We will quantify pre-existing comorbidities, medication adherence, and temporal factors prior to hospitalization with COVID-19 or influenza. We will…
Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
This is a Brighton Collaboration Case Definition of the term "Multisystem Inflammatory Syndrome in Children and Adults (MIS-C/A)" to be utilized in the evaluation of adverse events following immunization. The case definition was developed by topic experts convened by the…
Genome Sequencing Study, Flublock Quadrivalent Vaccine
Study will perform sequencing on 300 specimens from a mixture of Flublok Quadrivalent vaccine recipients, SD-IIV4 recipients, and unvaccinated individuals; and describe the molecular epidemiology of approximately 300 influenza strains causing disease in vaccinated (Flublok Quadrivalent vaccine and SD-IIV4) and…
COVID-19 Infrastructure and Activities Vaccine Safety Datalink Project
This work will support and contribute to the COVID-19 vaccine safety work of the VSD: managing site contributions, and participating on working groups and attending conference calls; providing high-quality electronic data for COVID-19 vaccine safety activities; participation on vaccine safety…
Lubrication Practices and Receptive Anal Sex: Implications for STI Transmission and Prevention
Implications of lubricant use in men having sex with men (MSM) are poorly characterized, particularly associations with sexual behavior and rectal sexually transmitted infection (STI) risk. We sought to clarify covariates associated with lubrication type including differing sexual preferences and…
A Risk Score to Predict Clostridioides difficile Infection
Clostridioides difficile infection (CDI) is a major cause of severe diarrhea. In this retrospective study, we identified CDI risk factors by comparing demographic and clinical characteristics for Kaiser Permanente Northern California members ≥18 years old with and without laboratory-confirmed incident…
The Presentation, Pace, and Profile of Infection and Sepsis Patients Hospitalized Through the Emergency Department: An Exploratory Analysis
To characterize the signs and symptoms of sepsis, compare them with those from simple infection and other emergent conditions and evaluate their association with hospital outcomes. A multicenter, retrospective cohort study of 408,377 patients hospitalized through the emergency department from…
SARS-CoV-2 Serological Antibody Testing for Disease Surveillance and Clinical Use
This study will assess the sero-prevalence and sero-incidence of SARS-CoV-2 infection in Kaiser Permanente Northern California and assess correlates of exposure and immunity among KPNC members.
Individual and Neighborhood Factors Associated with Failure to Vaccinate against Influenza during Pregnancy
Uptake of influenza vaccine among pregnant women remains low. We investigated whether unvaccinated pregnant women were clustered geographically and determined factors associated with failure to vaccinate using spatial and multivariate logistic regression analyses. Pregnant women who were members of Kaiser…
History of Early Childhood Infections and Acute Lymphoblastic Leukemia Risk Among Children in a U.S. Integrated Health Care System
Surrogate measures of infectious exposures have been consistently associated with lower childhood acute lymphoblastic leukemia (ALL) risk. However, recent reports have suggested that physician-diagnosed early-life infections increase ALL risk, thereby raising the possibility that stronger responses to infections might promote…
SARS-CoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics – Eight U.S. Health Care Centers, March 1-May 30, 2020
Pregnant women might be at increased risk for severe coronavirus disease 2019 (COVID-19), possibly related to changes in their immune system and respiratory physiology* (1). Further, adverse birth outcomes, such as preterm delivery and stillbirth, might be more common among…
Association of Mortality and Years of Potential Life Lost With Active Tuberculosis in the United States
Active tuberculosis (TB) disease leads to substantial mortality but is preventable through screening and treatment for latent TB infection. Early mortality after TB diagnosis (≤1 year) is well described, but delayed mortality (>1 year) among patients with active TB is…
Virological Failure and Acquired Genotypic Resistance Associated With Contemporary Antiretroviral Treatment Regimens
There are few descriptions of virologic failure (VF) and acquired drug resistance (HIVDR) in large cohorts initiating contemporary antiretroviral therapy (ART). We studied all persons with HIV (PWH) in a California clinic population initiating ART between 2010 and 2017. VF…
Innovative Methods to Inform Estimates of Vaccine Effectiveness Using Information on the Epidemiology and Incidence of Influenza and Other Acute Respiratory Illnesses
This study will estimate influenza vaccine effectiveness by vaccine type and for different ages by combining data from medical records, vaccine registries, and results of clinician-ordered molecular tests for influenza virus infection at Kaiser Permanente Northern California.
Alcohol and drug use, partner PrEP use and STI prevalence among people with HIV
People with HIV (PWH) have a high burden of bacterial sexually transmitted infections (STIs). We examined the relationship of alcohol and drug use and partner pre-exposure prophylaxis (PrEP) use to STI prevalence in a cohort of PWH with a history…
Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this…
Epidemiology and clinical outcomes of hospitalizations for acute respiratory or febrile illness and laboratory-confirmed influenza among pregnant women during six influenza seasons, 2010-2016
Pregnant women are at increased risk of seasonal influenza hospitalizations, but data about the epidemiology of severe influenza among pregnant women remain largely limited to pandemics. To describe the epidemiology of hospitalizations for acute respiratory infection or febrile illness (ARFI)…
Parental Risk Factors for Fever in their Children 7-10 Days After the First Dose of Measles-Containing Vaccines
We evaluated whether parental clinical conditions were associated with fever after a first dose of measles-containing vaccine (MCV) in the child in a cohort study including 244,125 children born in Kaiser Permanente Northern California between 2009 and 2016 who received…
Maternal infection and antibiotic use in pregnancy and the risk of childhood obesity in offspring: a birth cohort study
The reported association between maternal antibiotic use and childhood obesity, if true, could change obstetric practice. However, it is unclear whether the reported association was due to antibiotics, or underlying infection or both. To examine the independent contributions of maternal…
Trivalent inactivated influenza vaccine (IIV3) during pregnancy and six-month infant development
Despite recommendations by professional organizations that all pregnant women receive inactivated influenza vaccine, safety concerns remain a barrier. Our objective was to assess the effect of trivalent influenza vaccines (IIV3) during pregnancy on parent report 6-month infant development. We conducted…
Survey of influenza vaccine knowledge, attitudes, and beliefs among pregnant women in the 2016-17 season
Influenza vaccination coverage among pregnant women in the United States is suboptimal. We surveyed women who were pregnant during the 2016-17 influenza season to assess knowledge and attitudes regarding influenza vaccination. We identified and sampled pregnant women to include approximately…
Background rates of maternal, fetal, neonatal, and infant outcomes and events of interest to inform maternal immunization clinical trials
GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal vaccine candidate in pregnant women. Robust epidemiological data is needed to support the interpretation of maternal and neonatal outcomes in…
Burden of Active Tuberculosis in an Integrated Health Care System, 1997-2016: Incidence, Mortality, and Excess Health Care Utilization
Active tuberculosis (TB) is preventable. To quantify the potential value of prevention, we assessed active TB burden in a large health system from 1997 to 2016. Compared with a matched non-TB cohort, patients with active TB had higher mortality (8.4%…
Assessing clinical heterogeneity in sepsis through treatment patterns and machine learning
To use unsupervised topic modeling to evaluate heterogeneity in sepsis treatment patterns contained within granular data of electronic health records. A multicenter, retrospective cohort study of 29 253 hospitalized adult sepsis patients between 2010 and 2013 in Northern California. We…
Depletion-of-susceptibles bias in influenza vaccine waning studies: how to ensure robust results
Vaccine effectiveness studies are subject to biases due to depletion-of-persons at risk of infection, or at especially high risk of infection, at different rates from different groups (depletion-of-susceptibles bias), a problem that can also lead to biased estimates of waning…
Cardiac Biomarkers and Risk of Incident Heart Failure in Chronic Kidney Disease: The CRIC (Chronic Renal Insufficiency Cohort) Study
Background Cardiac biomarkers may signal mechanistic pathways involved in heart failure (HF), a leading complication in chronic kidney disease. We tested the associations of NT-proBNP (N-terminal pro-B-type natriuretic peptide), high-sensitivity troponin T (hsTnT), galectin-3, growth differentiation factor-15 (GDF-15), and soluble…
Infection and Fever in Pregnancy and Autism Spectrum Disorders: Findings from the Study to Explore Early Development
Maternal infection and fever during pregnancy have been implicated in the etiology of autism spectrum disorder (ASD); however, studies have not been able to separate the effects of fever itself from the impact of a specific infectious organism on the…
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (CP101) in Subjects with Recurrence of Clostridium difficile Infection
This study evaluates the safety and efficacy in reducing recurrence of Clostridium difficile infection in adults who had a recurrence within 8 weeks of receiving CP101 or placebo in PRISM3. Subjects who are experiencing recurrent Clostridium difficile infection will undergo…
Trichomonas vaginalis infection and prostate-specific antigen concentration: Insights into prostate involvement and prostate disease risk.
BACKGROUND: The protist Trichomonas vaginalis causes a common, sexually transmitted infection and has been proposed to contribute to the development of chronic prostate conditions, including benign prostatic hyperplasia and prostate cancer. However, few studies have investigated the extent to which…
The impact of reactogenicity after the first dose of recombinant zoster vaccine upon the physical functioning and quality of life of older adults: an open phase III trial
Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and…
Incidence of Herpes Zoster Among Children: 2003-2014
After the 1996 introduction of routine varicella vaccination in the United States, most studies evaluating pediatric herpes zoster (HZ) incidence reported lower incidence over time, with varying degrees of decline. Using the combined databases of 6 integrated health care organizations,…
Factors associated with recruitment, surveillance participation, and retention in an observational study of pregnant women and influenza
This report describes the results of recruitment efforts and the subsequent participation of pregnant women in study activities in a 2010-2012 observational study focused on influenza illness and vaccination in California and Oregon, USA. Socio-demographic and health characteristics extracted from…
Intra-season Waning of Influenza Vaccine Effectiveness
In the United States, it is recommended that healthcare providers offer influenza vaccination by October, if possible. However, if the vaccine's effectiveness soon begins to wane, the optimal time for vaccination may be somewhat later. We examined whether the effectiveness…
Influenza Vaccine Effectiveness in Preventing Influenza-associated Hospitalizations During Pregnancy: A Multi-country Retrospective Test Negative Design Study, 2010-2016
To date, no study has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy. The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) consisted of public health or healthcare systems with integrated laboratory, medical, and vaccination records in Australia, Canada…
A Multicenter Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota (CP101) in Subjects with Recurrence of Clostridium Difficile Infection
The objectives of this Phase 2 study are to evaluate the safety and tolerability of CP101 treatment compared to placebo in adults with previously treated, recurrent Clostridium difficile infection, and to evaluate the efficacy of CP101 treatment relative to placebo…
Comparison of msp genotyping and a 24 SNP molecular assay for differentiating Plasmodium falciparum recrudescence from reinfection
Current World Health Organization guidelines for conducting anti-malarial drug efficacy clinical trials recommend genotyping Plasmodium falciparum genes msp1 and msp2 to distinguish recrudescence from reinfection. A more recently developed potential alternative to this method is a molecular genotyping assay based…
A Phase 3 Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 through 49 Years of Age
A phase 3, randomized, double-blind trial will evaluate the safety and immunogenicity of 3 lots of 20-valent Pneumococcal conjugate vaccine in Pneumococcal vaccine–naive adults 18 through 49 years of age. The purpose of this study is to evaluate the safety…
A Phase 3 Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
The primary objective of this study is to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events. Secondary objectives are: 1) To evaluate the anti-pneumococcal polysaccharide serotype-specific Immunoglobulin Geometric Mean Concentrations at…
Similar relative risks of seizures following measles containing vaccination in children born preterm compared to full-term without previous seizures or seizure-related disorders
Febrile seizures are associated with the first dose of measles-containing vaccines and the risk increases with chronologic age during the second year of life. We used the Vaccine Safety Datalink (VSD) to determine if the relative increase in risk of…
Infections in children with autism spectrum disorder: Study to Explore Early Development (SEED)
Immune system abnormalities have been widely reported among children with autism spectrum disorder (ASD), which may increase the risk of childhood infections. The Study to Explore Early Development (SEED) is a multisite case-control study of children aged 30-69 months, born…
Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States
Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in…
Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants
This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate…
Brief Report: Low Rates of Herpesvirus Detection in Blood of Individuals with Autism Spectrum Disorder and Controls
Previous research indicates that infection, especially from viruses in the family Herpesviridae, may play a role in the etiology of some cases of autism spectrum disorder (ASD). Using a case-control design and the polymerase chain reaction with site-specific primers, we…
Antenatal and Intrapartum Risk Factors for Hypoxic-Ischemic Encephalopathy in a US Birth Cohort
To identify risk factors for hypoxic-ischemic encephalopathy (HIE) within a recent US birth cohort. In a retrospective cohort study of 44 572 singleton infants ?36 weeks of gestation born at Kaiser Permanente Northern California in 2008-2015, we identified all infants…
Respiratory Syncytial Virus Hospitalization during Pregnancy in Four High-income Countries, 2010-2016
Few studies have addressed respiratory syncytial virus (RSV) infection during pregnancy. Among 846 pregnant women hospitalized with respiratory illness and tested for RSV, 21 (2%) were RSV positive, of whom 8 (38%) were diagnosed with pneumonia. Despite study limitations, these…
Identifying Pre-Sepsis Opportunities for Early, Targeted Intervention
Early evidence suggests there will be ongoing waves of COVID-19 outbreak that can be mitigated through effective community-level prediction models and intervention. This project will Identify pre-sepsis opportunities for early, targeted intervention to inform community-level mitigation strategies of upcoming COVID19…
Examining Vaccine Effectiveness of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years
This study employs a cluster randomization design to examine the vaccine effectiveness of Flublok relative to that of other flu vaccines used at Kaiser Permanente Northern California over two influenza seasons (2018 to 2019 and 2019 to 2020), in Kaiser…
Shingrix Lead Site Evaluating the Effectiveness of Recombinant Zoster Vaccine
The purpose of this project is, first, to estimate the proportion of the population under study receiving one and two doses of recombinant zoster vaccine (RZV). Second, among live zoster vaccine (ZVL)-naive persons, this study aims to: 1) estimate the…
Prevalence of infant bronchiolitis-coded healthcare encounters attributable to RSV
We sought to determine the proportion of bronchiolitis episodes attributable to respiratory syncytial virus (RSV) among ICD-9 coded infant bronchiolitis episodes which were tested for RSV. Bronchiolitis healthcare encounters were extracted from Kaiser Permanente Northern California databases for years 2006…
Reducing risk of Clostridium difficile infection and overall use of antibiotic in the outpatient treatment of urinary tract infection
Risk of community-acquired Clostridium difficile infection (CA-CDI) following antibiotic treatment specifically for urinary tract infection (UTI) has not been evaluated. We conducted a nested case-control study at Kaiser Permanente Northern California, 2007-2010, to assess antibiotic prescribing and other factors in…
Epidemiology, detection, and management of tuberculosis among end-stage renal disease patients
Tuberculosis (TB) remains an important problem among end-stage renal disease (ESRD) patients. We reviewed the epidemiology of TB and ESRD, investigations of TB exposures in US dialysis facilities, and published guidelines to inform screening and treatment practices among US ESRD…
Safety of repeated doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine in adults and adolescents
In light of waning immunity to pertussis following receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine, maintaining protection may require repeated Tdap vaccination. We evaluated the safety of repeated doses of tetanus-containing vaccine in 68 915 nonpregnant…
Helicobacter pylori Infection Is Associated With Reduced Risk of Barrett’s Esophagus: An Analysis of the Barrett’s and Esophageal Adenocarcinoma Consortium
Epidemiological studies of Helicobacter pylori infection and risk of Barrett's esophagus (BE) have reported conflicting results. We examined the association between H. pylori infection and BE and sought to determine whether the association is mediated by gastroesophageal reflux disease (GERD)…
Effect of Maternal Influenza Vaccination during Pregnancy on Risk of Infant Influenza
This project has three major aims: 1) to examine whether influenza vaccination during pregnancy prevents influenza and other respiratory infections in infants aged 0 to 12 months, with a sub-aim to examine the effect of vaccine timing during pregnancy on…
Statistical Analysis Studies Comparing Flucelvax to Egg-Based Influenza Vaccinations
This study has three primary aims: 1) to estimate the relative vaccine effectiveness of Flucelvax versus inactivated influenza vaccine (IIV) in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against all PCR-confirmed influenza A5; 2) to estimate…
A Continuation of Assessment of the Impact of Prevnar 13 on Invasive Pneumococcal Disease Caused by Vaccine Serotypes of Streptococcus pneumoniae After Introduction Into Routine Pediatric and Adult Use for the Period of May 2015 – April 2020
This project will estimate Prevnar 13 (PCV13) vaccine effectiveness against invasive pneumococcal disease using a test-negative design in the Kaiser Permanente Northern California adult population from September 1, 2014, through December 31, 2017. Positive cases will be defined as patients…
Safety of Direct Acting Antiviral Medications for Hepatitis C
This project will identify all patients who have a laboratory-confirmed diagnosis of Hepatitis C. The intervention group will be those who had a prescription filled for a new antiviral medication after October 10, 2014, and who were naive to treatment…
Safety of Direct-Acting Antiviral Medications for Hepatitis C – DUPLICATED DO NOT ACTIVATE
This project will identify all patients who have a laboratory-confirmed diagnosis of Hepatitis C. The intervention group will be those who had a prescription filled for a new antiviral medication after October 10, 2014, and who were naive to treatment…
Cohort Study in the Kaiser Population to Evaluate the Impact of Shoo the Flu
This project will evaluate the school-based influenza vaccine delivery program Shoo the Flu. The program, implemented by Alameda County, delivered influenza vaccines to all K-5 elementary schools in the Oakland Unified School District from 2014 to 2016. This is a…
Disparities in Initiation of Direct-Acting Antiviral Agents for Hepatitis C Virus Infection in an Insured Population
The cost of direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection may contribute to treatment disparities. However, few data exist on factors associated with DAA initiation. We conducted a retrospective cohort study of HCV-infected Kaiser Permanente Northern California…
The Impact of Acute Organ Dysfunction on Long-Term Survival in Sepsis
To estimate the impact of each of six types of acute organ dysfunction (hepatic, renal, coagulation, neurologic, cardiac, and respiratory) on long-term mortality after surviving sepsis hospitalization. Multicenter, retrospective study. Twenty-one hospitals within an integrated healthcare delivery system in Northern…
Sustained influence of infections on prostate-specific antigen concentration: An analysis of changes over 10 years of follow-up.
BACKGROUND: To extend our previous observation of a short-term rise in prostate-specific antigen (PSA) concentration, a marker of prostate inflammation and cell damage, during and immediately following sexually transmitted and systemic infections, we examined the longer-term influence of these infections,…
Vaccination Patterns in Children After Autism Spectrum Disorder Diagnosis and in Their Younger Siblings
In recent years, rates of vaccination have been declining. Whether this phenomenon disproportionately affects children with autism spectrum disorder (ASD) or their younger siblings is unknown. To investigate if children after receiving an ASD diagnosis obtain their remaining scheduled vaccines…
Mortality Measures to Profile Hospital Performance for Patients With Septic Shock
Sepsis care is becoming a more common target for hospital performance measurement, but few studies have evaluated the acceptability of sepsis or septic shock mortality as a potential performance measure. In the absence of a gold standard to identify septic…
Immunogenicity and safety of the quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in splenectomized or hyposplenic children and adolescents: Results of a phase III, open, non-randomized study
Individuals with functional or anatomic asplenia are at high risk for meningococcal disease. We evaluated the immunogenicity and safety of 1 and 2 doses of the quadrivalent meningococcal serogroups A, C, W, Y tetanus toxoid-conjugate vaccine (MenACWY-TT) in this high-risk…
Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children
Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55 years of age, in 2007 for children 2-10 years of age, and in 2011 for infants/toddlers 9-23 months of age. We conducted two studies at Kaiser Permanente Northern California…
Continuation of Group B Streptococcus Epidemiology Study (Phase II)
Kaiser Permanente Northern California has recently collaborated with Pfizer in identifying invasive and noninvasive group B streptococcus (GBS) disease burden in adults during a seven-year time period spanning 2007 to 2014. In Phase 1 of this research collaboration, comorbid medical…
Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method
The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a…
Healthcare Utilization and Infection in the Week Prior to Sepsis Hospitalization
To quantify healthcare utilization in the week preceding sepsis hospitalization to identify potential opportunities to improve the recognition and treatment of sepsis prior to admission. Retrospective study. Two large integrated healthcare delivery systems in the United States. Hospitalized sepsis patients.…
Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non-Vaccine-Targeted Infections From 24 Through 47 Months of Age
Some parents are concerned that multiple vaccines in early childhood could weaken their child's immune system. Biological data suggest that increased vaccine antigen exposure could increase the risk for infections not targeted by vaccines. To examine estimated cumulative vaccine antigen…
Flexible, Cluster-Based Analysis of the Electronic Medical Record of Sepsis with Composite Mixture Models
The widespread adoption of electronic medical records (EMRs) in healthcare has provided vast new amounts of data for statistical machine learning researchers in their efforts to model and predict patient health status, potentially enabling novel advances in treatment. In the…
Recovery or Disability? Trajectories After Pneumonia: Integrating 12 Months of Frequent Patient-Reported Measures with EMR Data
This is a pilot study to determine the feasibility of conducting a prospective study that aims to characterize longitudinal trajectories among patients with pneumonia. To achieve this goal, we will attempt to enroll 150 pneumonia patients at the time of…
Effectiveness of Respiratory Syncytial Virus Immunoprophylaxis on Bronchiolitis Hospitalizations among High-risk Infants
We sought to determine the real-world effectiveness of respiratory syncytial virus (RSV) immunoprophylaxis in a population-based cohort to inform policy. The study population included infants born 1996-2008 and enrolled in Kaiser Permanente Northern California. During the RSV season (November-March), RSV…
Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study
A live attenuated zoster vaccine was licensed in the United States in 2006 for prevention of shingles in persons aged 60 years or older; the indication was extended in 2011 to cover those aged 50-59 years. We assessed vaccine effectiveness…
The safety of live attenuated influenza vaccine in children and adolescents 2 through 17years of age: A Vaccine Safety Datalink study
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…
Predictors of Pneumococcal Vaccination, Pneumococcal Vaccine Effectiveness, and Trends in Pneumonia
The three objectives of this study are to: 1) Identify and compare the clinical, demographic and neighborhood characteristics associated with receipt of pneumococcal vaccine among persons 65 years of age and older, and among persons 18 to 64 years of…
California Emerging Infections Program
The goal of this project is to determine the age-specific rates of laboratory-confirmed influenza-associated hospitalization among children, and to describe clinical and epidemiologic characteristics of pediatric hospitalized case-patients during the influenza season.
The Timing of Early Antibiotics and Hospital Mortality in Sepsis
Prior sepsis studies evaluating antibiotic timing have shown mixed results. To evaluate the association between antibiotic timing and mortality among patients with sepsis receiving antibiotics within 6 hours of emergency department registration. Retrospective study of 35,000 randomly selected inpatients with…
Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine
Menactra� vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55years of age. The aim of this study was to assess the safety of MenACWY-D administered as part of routine clinical care to patients at Kaiser Permanente…
Serious infections among a large cohort of subjects with systemically treated psoriasis
Biologic therapy is effective for treatment of moderate-to-severe psoriasis but may be associated with an increased risk for serious infection. To estimate the serious infection rate among patients with psoriasis treated with biologic as compared with nonbiologic systemic agents within…
Association of Multiple Primary Skin Cancers With Human Immunodeficiency Virus Infection, CD4 Count, and Viral Load
Persons with human immunodeficiency virus (HIV) have a 2.8-fold higher risk than HIV-uninfected persons of nonmelanoma skin cancer (NMSC), defined as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Individuals with a prior NMSC history are at increased risk…
Prediction of Recurrent Clostridium Difficile Infection Using Comprehensive Electronic Medical Records in an Integrated Healthcare Delivery System
BACKGROUND Predicting recurrent Clostridium difficile infection (rCDI) remains difficult. We employed a retrospective cohort design. Granular electronic medical record (EMR) data had been collected from patients hospitalized at 21 Kaiser Permanente Northern California hospitals. The derivation dataset (2007-2013) included data…
Individual and health system variation in rehospitalizations the year after pneumonia
Little is known about variation in patterns of recovery among patients discharged alive from hospitalizations for pneumonia.The aim of the is observational cohort study was to characterize the variation in patterns of hospital readmission and survival in the year after…
Providers’ Experiences with a Melanoma Web-Based Course: a Discussion on Barriers and Intentions
Primary care visits provide an opportunity for skin examinations with the potential to reduce melanoma mortality. The INFORMED (INternet curriculum FOR Melanoma Early Detection) Group developed a Web-based curriculum to improve primary care providers' (PCPs') skin cancer detection skills. This…
Supplement for Integrating Addiction Research in Health Systems: the Addiction Research Network
This study examines factors influencing performance measures of treatment initiation and engagement for alcohol and drugs across seven health care systems.
A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of a Clostridium Difficile Vaccine in Adults 50 Years of Age and Older
Pfizer’s investigational Clostridium difficile vaccine (PF-06425090) is a prophylactic vaccine that is currently being investigated for the prevention of primary C difficile infection in adults 50 years of age and older.
HPV Vaccine Impact Study
The California Emerging Infections Program will collaborate with the California Department of Health Services to develop a comprehensive plan to conduct systematic population-based cervical intraepithelial neoplasia surveillance and implement a pilot project in Alameda County. This population-based surveillance project aims…
Respiratory Syncytial Virus Infection in Preterm Infants: Six Seasons; Experience in an Integrated Health Care Delivery System
We will study the impact of the change in the American Academy of Pediatrics's palivizumab recommendations in a large cohort of infants (300,000) of all gestations over a 7-year period (2010- 2016). We will quantify and characterize the following over…
HIV Drug Resistance Mutation as Predictors of Clinical Outcome
In collaboration with KPNC clinicians and investigators, Stanford performs research investigations regarding the relationship of HIV resistance, antiretroviral therapy and clinical outcomes, including CD4 and HIV RNA response.
Retrospective Cohort Study of Staphylococcus Aureus Surgical Site Infections in Patients Undergoing Elective Surgical Procedures in Kaiser Permanente Northern California (KPNC) Integrated Health System
This project will expand enrollment in an ongoing Staph vaccine trial. This will descriptive analyses of Staph infections following multiple types of surgeries, and risk factors associated with infection.
Achieving Public Health Impact Through Research (APHIR)
This study will develop a multi-country collaboration to investigate the preventive value of IIV during pregnancy using retrospective cohort and case-control study designs. Specifically, we aim to: 1. Estimate influenza inactivated vaccine (IIV) effectiveness in preventing acute respiratory or febrile…
California Emerging Infections Program Active Bacterial Core Surveillance
This study will determine the age-specific rates of laboratory-confirmed influenza associated hospitalization among children and describe clinical and epidemiologic characteristics of pediatric hospitalized case-patients during the 2003-2004 influenza season.
A Methodology Study to Assess the Logistics of Stool Collection and Shipment in an Elderly Population
The study is non-interventional and consists of data collection on patients receiving treatment as part of their standard medical care for C.Diff.
A Postmarketing Observational Study Estimating the Impact of Prevnar 13 (13vPnC) on Invasive Pneucoccal Disease Caused by Vaccine of Streptococcus pneumoniae After Introduction into Routine Pediatric Use
This study is non-interventional and consists of data collection on patients receiving treatment with the Pfizer product Prevnar (13vPnC) as part of their standard medical care.
Using Comparative Effectiveness Analyses to Optimize Cervical Cancer Screening
The overall goal of this study is to identify optimal cervical cancer screening strategies that minimize associated screening harms, while maximizing benefits. The approach will use decision analytic models and comparative effectiveness analyses to identify novel screening strategies that provide…
Development of Predictive Models for Recurrent Clostridium Difficile Infection (rCDI)
This project will examine predictors of and outcomes after recurrent Clostridium difficile infection in adults. Predictors will include age, sex, diagnoses, severity of illness, hospital length of stay, and antibiotic exposure. Outcomes will include hospital utilization, particularly use of intensive…
Primary Care-Based Interventions to Reduce Alcohol Use among HIV Patients – DUPLICATED DO NOT ACTIVATE
This is a comparative effectiveness study of innovative intervention delivery models to reduce hazardous alcohol use among 400 HIV-infected patients recruited from a large KPNC clinic that has integrated hazardous drinking screening within the electronic medical record. We will compare…
North America AIDS Cohorts Collaboration on Research and Design (NA-ACCORD)
The NA-ACCORD is a consortium of HIV cohorts across U.S. and Canada endeavoring to address major HIV-related clinical and epidemiologic questions that cannot be addressed through smaller studies. Dr. Silverberg is leading the HIV and Cancer research efforts in NA-ACCORD.
California Emerging Infections Program Influenza
To determine the age specific rates of laboratory-confirmed influenza associated hospitalization among children and describe clinical and epidemiologic characteristics of pediatric hospitalized case-patients during the 2003-2004 influenza season.
Surveillance for Clinical Adverse Events Among HIV-infected Patients Enrolled in Kaiser Permanente
This study establishes a surveillance system to monitor the incidence and risk factors for serious potential adverse events to antiretroviral therapy. We will determine the incidence of clinical adverse events among HIV-infected patients including AIDS and non-AIDS defining malignancies, AIDS…
Efficacy of Prophylactic Antibiotics in Simple Knee Arthroscopy
To determine the association between the use of preoperative antibiotics and the risk of postoperative infection after simple knee arthroscopy. The electronic medical records of a large integrated health care organization were used to identify patients who underwent simple knee…
Racial Differences in HIV and HCV Risk Behaviors, Transmission, and Prevention Knowledge among Non-Treatment-Seeking Individuals with Opioid Use Disorder.
In light of New York's recently reinforced strategy to end the AIDS epidemic by expanding testing, treatment, and access to pre-exposure prophylaxis (PrEP), we assessed drug use and sexual risk behaviors, along with HIV/Hepatitis C virus (HCV) transmission and prevention…
Risk of End-Stage Liver Disease in HIV-Viral Hepatitis Coinfected Persons in North America From the Early to Modern Antiretroviral Therapy Eras
Human immunodeficiency virus (HIV)-infected patients coinfected with hepatitis B (HBV) and C (HCV) viruses are at increased risk of end-stage liver disease (ESLD). Whether modern antiretroviral therapy has reduced ESLD risk is unknown. Twelve clinical cohorts in the United States…
Preexposure Prophylaxis and Patient Centeredness: A Call for Holistically Protecting and Promoting the Health of Gay Men
Preexposure prophylaxis has transformed HIV prevention, becoming widespread in communities of gay and bisexual men in the developed world in a short time. There is a broad concern that preexposure prophylaxis will discourage condom use among gay men (i.e., "risk…
Risk of underlying chronic medical conditions for invasive pneumococcal disease in adults
In the United States, the 13-valent pneumococcal conjugate vaccine is recommended in persons ⩾65years of age, and persons ⩽65years of age with immunocompromising (IC) conditions. For invasive pneumococcal disease (IPD) prevention in those ⩽65 with non-IC medical conditions, the 23-valent…
Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies
Vaccines are increasingly targeted toward women of reproductive age, and vaccines to prevent influenza and pertussis are recommended during pregnancy. Prelicensure clinical trials typically have not included pregnant women, and when they are included, trials cannot detect rare events. Thus,…
A nested case-control study of dietary factors and the risk of incident cytological abnormalities of the cervix
Several earlier case-control studies reported inverse associations of cervical squamous intraepithelial lesions (SIL) with high dietary or biomarker levels of carotenoids, folate, and vitamins C and E. However, most studies did not measure the primary causal factor, cancer-associated genital human…
Characteristics of women refusing follow-up for tests or symptoms suggestive of breast cancer
BACKGROUND: Delay in diagnosis of breast cancer can occur at several points on the diagnostic pathway. We examined characteristics of women with breast cancer who before diagnosis actively refused recommended follow-up of tests or symptoms suggestive of breast cancer. METHODS:…
Late-stage breast cancer among women with recent negative screening mammography: do clinical encounters offer opportunity for earlier detection?
BACKGROUND: Opportunities to prevent late-stage breast cancer within the course of usual care are needed. We evaluate whether clinical encounters offer such opportunities. METHODS: Within seven health care plans, we identified 1298 women aged more than 50 years with early…
In-hospital mortality following treatment with red blood cell transfusion or inotropic therapy during early goal-directed therapy for septic shock: a retrospective propensity-adjusted analysis
We sought to investigate whether treatment of subnormal (
Towards Smarter Lumping and Smarter Splitting: Rethinking Strategies for Sepsis and ARDS Clinical Trial Design
Both quality improvement and clinical research efforts over the past few decades have focused on consensus definition of sepsis and acute respiratory distress syndrome (ARDS). Although clinical definitions based on readily available clinical data have advanced recognition and timely use…
Multicenter Implementation of a Treatment Bundle for Sepsis Patients with Intermediate Lactate Values
Treatments for patients with sepsis with intermediate lactate values (?2 and
Response to Therapy in Antiretroviral Therapy-Na Patients with Isolated Nonnucleoside Reverse-Transcriptase Inhibitor-Associated Transmitted Drug Resistance
Nonnucleoside reverse transcriptase inhibitor (NNRTI)-associated transmitted drug resistance (TDR) is the most common type of TDR. Few data guide the selection of antiretroviral therapy (ART) for patients with such resistance. We reviewed treatment outcomes in a cohort of HIV-1-infected patients…
Air Pollution and Pulmonary Tuberculosis: A Nested Case-Control Study among Members of a Northern California Health Plan
Ecologic analyses, case-case comparisons, and animal experiments suggest positive associations between air pollution and tuberculosis. We evaluated this hypothesis in a large sample, which yielded results that are applicable to the general population. We conducted a case-control study nested within…
Aging Population and Future Burden of Pneumococcal Pneumonia in the United States
Pneumococcal pneumonia is concentrated among the elderly. Using a decision analytic model, we projected the future incidence of pneumococcal pneumonia and associated healthcare utilization and costs accounting for an aging U.S. population. Between 2004 and 2040, as the population increases…
Monocyte activation by interferon-alpha is associated with failure to achieve a sustained virologic response after treatment for hepatitis C virus infection
Interferon ? (IFN-?) and ribavirin can induce a sustained virologic response (SVR) in some but not all hepatitis C virus (HCV)-infected patients. The mechanism of effective treatment is unclear. One possibility is that IFN-? differentially improves the functional capacity of…
Use of abacavir and risk of cardiovascular disease among HIV-infected individuals
Evidence is conflicting about the association of abacavir use and cardiovascular disease (CVD) among HIV-infected individuals. Previous studies may have been biased by the preferential initiation or continuation of abacavir in patients with renal dysfunction. We conducted a cohort study…
Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
Septic shock currently refers to a state of acute circulatory failure associated with infection. Emerging biological insights and reported variation in epidemiology challenge the validity of this definition. To develop a new definition and clinical criteria for identifying septic shock…
Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
The Third International Consensus Definitions Task Force defined sepsis as "life-threatening organ dysfunction due to a dysregulated host response to infection." The performance of clinical criteria for this sepsis definition is unknown. To evaluate the validity of clinical criteria to…
Successful Implementation of HIV Preexposure Prophylaxis: Lessons Learned From Three Clinical Settings
The past 3years have marked a transition from research establishing the safety and efficacy of HIV preexposure prophylaxis (PrEP) to questions about how to optimize its implementation. Until recently, PrEP was primarily offered as part of randomized controlled trials or…
Infectious mononucleosis, other infections and prostate-specific antigen concentration as a marker of prostate involvement during infection.
Although Epstein-Barr virus has been detected in prostate tissue, no associations have been observed with prostate cancer in the few studies conducted to date. One possible reason for these null findings may be use of cumulative exposure measures that do…
Voriconazole Exposure and Risk of Cutaneous Squamous Cell Carcinoma, Aspergillus Colonization, Invasive Aspergillosis and Death in Lung Transplant Recipients
Voriconazole is a triazole antifungal used to prevent and treat invasive fungal infections after lung transplantation, but it has been associated with an increased risk of developing cutaneous squamous cell carcinoma (SCC). Despite widespread use, there are no clear guidelines…
Rising Obesity Prevalence and Weight Gain Among Adults Starting Antiretroviral Therapy in the United States and Canada
The proportion of overweight and obese adults in the United States and Canada has increased over the past decade, but temporal trends in body mass index (BMI) and weight gain on antiretroviral therapy (ART) among HIV-infected adults have not been…
Prevalence of non-HIV cancer risk factors in persons living with HIV/AIDS: a meta-analysis
The burden of cancer among persons living with HIV/AIDS (PLWHA) is substantial and increasing. We assessed the prevalence of modifiable cancer risk factors among adult PLWHA in Western high-income countries since 2000. Meta-analysis. We searched PubMed to identify articles published…
Laboratory Measures as Proxies for Primary Care Encounters: Implications for Quantifying Clinical Retention Among HIV-Infected Adults in North America
Because of limitations in the availability of data on primary care encounters, patient retention in human immunodeficiency virus (HIV) care is often estimated using laboratory measurement dates as proxies for clinical encounters, leading to possible outcome misclassification. This study included…
Variation in the Contents of Sepsis Bundles and Quality Measures: A Systematic Review
Sepsis contributes to one in every two to three inpatient hospital deaths. Early recognition and treatment are instrumental in reducing mortality, yet there are substantial quality gaps. Sepsis bundles containing quality metrics are often used in efforts to improve outcomes.…
Polymorphisms In HLA Class II Genes Are Associated With Susceptibility To Staphylococcus aureus Infection In A Caucasian Population
Staphylococcus aureus (S. aureus) can cause life-threatening infections. Human susceptibility to S. aureus infection may be influenced by host genetic variation. A genomewide association study (GWAS) in a large health plan-based cohort included biologic specimens from 4701 culture-confirmed S. aureus…
Cumulative Incidence of Cancer Among Persons With HIV in North America: A Cohort Study
Cancer is increasingly common among persons with HIV. To examine calendar trends in cumulative cancer incidence and hazard rate by HIV status. Cohort study. North American AIDS Cohort Collaboration on Research and Design during 1996 to 2009. 86 620 persons…
Body mass index and early CD4 T-cell recovery among adults initiating antiretroviral therapy in North America, 1998-2010
Adipose tissue affects several aspects of the cellular immune system, but prior epidemiological studies have differed on whether a higher body mass index (BMI) promotes CD4 T-cell recovery on antiretroviral therapy (ART). The objective of this analysis was to assess…
Multiple primary melanomas among 16,570 patients with melanoma diagnosed at Kaiser Permanente Northern California, 1996 to 2011
Published rates of cutaneous multiple primary melanoma (MPM) vary widely. We examined incidence of and risk factors associated with MPMs among Kaiser Permanente Northern California members. We estimated MPM incidence among 16,570 patients with melanoma from 1996 through 2011. We…
Stromal immune infiltration in HIV-related diffuse large B-cell lymphoma is associated with HIV disease history and patient survival
Understanding tumor microenvironment and its impact on prognosis of HIV-related lymphomas may provide insight into novel therapeutic strategies. We characterized the relationship between infiltrating immune cells with tumor characteristics, HIV disease history and survival in 80 patients with HIV-related diffuse…
No New HIV Infections with Increasing Use of HIV Preexposure Prophylaxis in a Clinical Practice Setting
Referrals for and initiation of preexposure prophylaxis (PrEP) for HIV infection increased dramatically in a large clinical practice setting since 2012. Despite high rates of sexually transmitted infections among PrEP users and reported decreases in condom use in a subset,…
Survival Among HIV-Infected and HIV-Uninfected Individuals with Common Non-AIDS-Defining Cancers
Non-AIDS-defining cancers increasingly contribute to mortality among human immunodeficiency virus (HIV)-infected individuals. However, few studies have compared cancer prognosis by HIV status with adjustment for risk factors. We conducted a cohort study of HIV-infected and HIV-uninfected adults in Kaiser Permanente…
Identification of Stevens-Johnson syndrome and toxic epidermal necrolysis in electronic health record databases
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) carry a high mortality risk. While identifying clinical and genetic risk factors for these conditions has been hindered by their rarity, large electronic health databases hold promise for identifying large numbers of…
Differences in Response to Antiretroviral Therapy by Sex and Hepatitis C Infection Status
Hepatitis C virus (HCV) co-infection and biological sex may each affect response to antiretroviral therapy (ART), yet no studies have examined HIV-associated outcomes by both HCV status and sex. We conducted a cohort study of HIV-infected adults initiating ART in…
The Association Between Influenza Vaccination and Other Preventative Health Behaviors in a Cohort of Pregnant Women
Although pregnant women are a high-priority group for seasonal influenza vaccination, vaccination rates in this population remain below target levels. Previous studies have identified sociodemographic predictors of vaccine choice, but relationships between preconception heath behaviors and seasonal influenza vaccination are…
Contribution of Demographic and Behavioral Factors on the Changing Incidence Rates of Oropharyngeal and Oral Cavity Cancers in Northern California
It is unknown to what extent patient demographics, smoking, and alcohol use have contributed to changes in oropharyngeal and oral cavity cancer incidence rates. We performed a cohort study of Kaiser Permanente health plan members, ages 20 to 89, for…
Antiretroviral Therapy Adherence and Use of an Electronic Shared Medical Record Among People Living with HIV
Electronic shared medical records (SMR) are emerging healthcare technologies that allow patients to engage in their healthcare by communicating with providers, refilling prescriptions, scheduling appointments, and viewing portions of medical records. We conducted a pre-post cohort study of HIV-positive adults…
Cigarette smoking and pulmonary tuberculosis in northern California
A positive association between smoking and increased risk of tuberculosis disease is well documented for populations outside the USA. However, it is unclear whether smoking increases risk of tuberculosis in the USA, where both smoking prevalence and disease rates are…
Results of a Pilot Study using Self-Collected Mid-Turbinate Nasal Swabs for Detection of Influenza Virus Infection among Pregnant Women
We evaluated the feasibility of asking pregnant women to self-collect and ship respiratory specimens. In a preliminary laboratory study, we compared the RT-PCR cycle threshold (CT) values of influenza A and B viruses incubated at 4 storage temperatures (from 4…
Declining Relative Risk for Myocardial Infarction Among HIV-Positive Compared With HIV-Negative Individuals With Access to Care
Concerns remain for an increased myocardial infarction (MI) risk among individuals infected with human immunodeficiency virus (HIV). We conducted a cohort study evaluating MI risk from 1996 to 2011 by HIV status. The adjusted MI rate ratio for HIV status…
Family History of Skin Cancer Is Associated With Increased Risk of Cutaneous Squamous Cell Carcinoma
The contribution of family history to cutaneous squamous cell carcinoma (SCC) risk has not been systematically quantified. To examine the association between self-reported family history of skin cancer and SCC risk. Cases (n = 415) with a pathology-verified SCC and…
The Impact of Age on Retention in Care and Viral Suppression
Retention in care is important for all HIV-infected persons and is strongly associated with initiation of antiretroviral therapy and viral suppression. However, it is unclear how retention in care and age interact to affect viral suppression. We evaluated whether the…
End Stage Renal Disease Among HIV-Infected Adults in North America
Human immunodeficiency virus (HIV)-infected adults, particularly those of black race, are at high-risk for end-stage renal disease (ESRD), but contributing factors are evolving. We hypothesized that improvements in HIV treatment have led to declines in risk of ESRD, particularly among…
A comparative study of molecular characteristics of diffuse large B-cell lymphoma from patients with and without human immunodeficiency virus infection
HIV-related diffuse large B-cell lymphoma (DLBCL) may be biologically different from DLBCL in the general population. We compared, by HIV status, the expression and prognostic significance of selected oncogenic markers in DLBCL diagnosed at Kaiser Permanente in California, between 1996…
Geographic Clusters in Underimmunization and Vaccine Refusal
Parental refusal and delay of childhood vaccines has increased in recent years and is believed to cluster in some communities. Such clusters could pose public health risks and barriers to achieving immunization quality benchmarks. Our aims were to (1) describe…
Severity of influenza and non-influenza acute respiratory illness among pregnant women, 2010-12
The objective of the study was to identify characteristics of influenza illness contrasted with noninfluenza acute respiratory illness (ARI) in pregnant women. ARI among pregnant women was identified through daily surveillance during 2 influenza seasons (2010-2012). Within 8 days of…
Cytology and human papillomavirus co-test results preceding incident high-grade cervical intraepithelial neoplasia
High-risk HPV (hrHPV) and cytology co-testing is utilized for primary cervical cancer screening and for enhanced follow-up of women who are hrHPV-positive, cytology negative. However, data are lacking on the utility of this method to detect pre-cancer or cancer in…
Effectiveness of Telaprevir and Boceprevir Triple Therapy for Patients with Hepatitis C Virus Infection in a Large Integrated Care Setting
In 2011, the FDA approved telaprevir (TVR) and boceprevir (BOC) for use with pegylated interferon and ribavirin to treat hepatitis C virus (HCV) genotype 1. We aimed to evaluate the real-world application, tolerability, and effectiveness of TVR- and BOC-based HCV…
Genital herpes and its treatment in relation to preterm delivery
To examine the risks of genital herpes and antiherpes treatment during pregnancy in relation to preterm delivery (PTD), we conducted a multicenter, member-based cohort study within 4 Kaiser Permanente regions: northern and southern California, Colorado, and Georgia. The study included…
Incidence and risk factors of HPV-related and HPV-unrelated Head and Neck Squamous Cell Carcinoma in HIV-infected individuals
To examine the risk and trends of HPV-related and HPV-unrelated Head and Neck Squamous Cell Carcinoma (HNSCC) in HIV-infected individuals and assess whether immunosuppression (measured through CD4 cell count) and other risk factors impact HNSCC risk. Incident HNSCCs at HPV-related…
CD8+ Lymphocyte Intratumoral Infiltration as a Stage-Independent Predictor of Merkel Cell Carcinoma Survival: A Population-Based Study
Intratumoral CD8+ lymphocytes (IT-CD8s) have shown promise as a prognostic indicator for Merkel cell carcinoma (MCC). We tested whether IT-CD8s predict survival among a population-based MCC cohort. One hundred thirty-seven MCC cases that had not previously been analyzed for IT-CD8s…
Integrating database knowledge and epidemiological design to improve the implementation of data mining methods that evaluate vaccine safety in large healthcare databases
Large healthcare databases maintained by health plans have been widely used to conduct customized protocol-based epidemiological safety studies as well as targeted routine sequential monitoring of suspected adverse events for newly licensed vaccines. These databases also offer a rich data…
Sebotropic eruption associated with use of oral kava kava supplement
Supplement use is prevalent, and its use is increasing among older adults. Dermatologists need to be aware of the adverse cutaneous effects that can result from herbal supplement use. A 55-year-old man presented with an eruption in a sebotropic distribution…
HIV infection and incidence of ischemic stroke
To determine the association of HIV infection and immunodeficiency with incidence of ischemic stroke. Cohort study of HIV-positive and matched HIV-negative adult Kaiser Permanente Northern and Southern California (KPNC and KPSC, respectively) members during 1996-2011 (KPNC) or 2000-2011 (KPSC). We…
Prostate Cancer Incidence and Prostate-Specific Antigen Testing Among HIV-Positive and HIV-Negative Men
We investigated whether the reported lower incidence of prostate cancer in HIV-positive men is a result of confounding factors or reduced screening. We conducted a cohort study of 17,424 HIV-positive and 182,799 HIV-negative men enrolled in Kaiser Permanente (KP). Subjects…
Comparing characteristics of melanoma cases arising in health maintenance organizations with state and national registries
Datasets from large health maintenance organizations (HMOs), particularly those with established cancer registries that report to the Surveillance, Epidemiology, and End Results program, are potentially excellent resources for studying melanoma epidemiology and outcomes. However, generalizability of the findings beyond HMO-based…
Hospital readmission and healthcare utilization following sepsis in community settings
Sepsis, the most expensive cause of hospitalization in the United States, is associated with high morbidity and mortality. However, healthcare utilization patterns following sepsis are poorly understood. To identify patient-level factors that contribute to postsepsis mortality and healthcare utilization. A…
Combining Immature and Total Neutrophil Counts to Predict Early Onset Sepsis in Term and Late Preterm Newborns: Use of the I/T2
The absolute neutrophil count and the immature/total neutrophil ratio (I/T) provide information about the risk of early onset sepsis in newborns. However, it is not clear how to combine their potentially overlapping information into a single likelihood ratio. We obtained…
Impact of Vaccination on the Epidemiology of Varicella: 1995-2009
When varicella vaccine was licensed in the United States in 1995, there were concerns that childhood vaccination might increase the number of adolescents susceptible to varicella and shift disease toward older age groups where it can be more severe. We…
Complications of herpes zoster in cancer patients
Cancer patients tend to have a higher incidence of herpes zoster (HZ), but little is known about their risk of HZ complications. We conducted a retrospective study of 424 newly diagnosed hematologic (HM, n = 140) and solid tumor malignancy…
Increased one-year health care utilization in survivors of severe sepsis
Hospitalizations for severe sepsis are common, and a growing number of patients survive to hospital discharge. Nonetheless, little is known about survivors' post-discharge healthcare use. To measure inpatient healthcare use of severe sepsis survivors compared with patients' own presepsis resource…
Effect of Host, Tumor, Diagnostic, and Treatment Variables on Outcomes in a Large Cohort With Merkel Cell Carcinoma
Merkel cell carcinoma (MCC) is a rare, aggressive, neuroendocrine-derived skin cancer with high rates of recurrence and associated mortality. Few published studies have used comprehensive patient data and long-term follow-up to examine factors that predict MCC outcomes. To characterize MCC…
Non-AIDS-Defining Malignancies in the HIV-Infected Population
With the advent of effective combination antiretroviral therapy, HIV infection has been transformed from a fatal disease to a chronic condition. There is renewed clinical interest in long-term morbidities, including malignancies that occur disproportionately within this population. Non-AIDS-defining cancers (NADCs)…
Mortality caused by chronic liver disease among american indians and alaska natives in the United States, 1999-2009
We compared chronic liver disease (CLD) mortality from 1999 to 2009 between American Indians and Alaska Natives (AI/ANs) and Whites in the United States after improving CLD case ascertainment and AI/AN race classification. We defined CLD deaths and causes by…
Safety of influenza vaccination during pregnancy: A review of subsequent maternal obstetric events and findings from two recent cohort studies
Pregnant women and their infants are vulnerable to severe disease and secondary complications from influenza infection. For this reason, annual influenza vaccination is recommended for all pregnant women in the United States. Women frequently cite concerns about vaccine safety as…
Telaprevir or boceprevir triple therapy in patients with chronic hepatitis C and varying severity of cirrhosis
Risks and benefits of protease inhibitor (PI) (telaprevir or boceprevir) triple therapy in hepatitis C virus (HCV)-infected patients with mildly decompensated cirrhosis, including those wait-listed for liver transplantation (LT), are incompletely known. To assess virological responses and safety of PI…
Effectiveness of seasonal trivalent influenza vaccine for preventing influenza virus illness among pregnant women: a population-based case-control study during the 2010-2011 and 2011-2012 influenza seasons
Although vaccination with trivalent inactivated influenza vaccine (TIV) is recommended for all pregnant women, no vaccine effectiveness (VE) studies of TIV in pregnant women have assessed laboratory-confirmed influenza outcomes. We conducted a case-control study over 2 influenza seasons (2010-2011 and…
Immunodeficiency and Risk of Myocardial Infarction Among HIV-Positive Individuals With Access to Care
We sought to clarify the association of HIV infection and immunodeficiency on myocardial infarction (MI) risk. We conducted a cohort study from 1996 to 2009 of HIV-positive (HIV) and demographically matched HIV-negative (HIV) Kaiser Permanente California health plan members. Rate…
Predictive value of prostate-specific antigen for prostate cancer: a nested case-control study in EuroSIDA
Although prostate cancer (PCa) incidence is lower in HIV+ men than in HIV- men, the usefulness of prostate-specific antigen (PSA) screening in this population is not well defined and may have higher false negative rates than in HIV- men. We…
Strong agreement of nationally recommended retention measures from the institute of medicine and department of health and human services
We sought to quantify agreement between Institute of Medicine (IOM) and Department of Health and Human Services (DHHS) retention indicators, which have not been compared in the same population, and assess clinical retention within the largest HIV cohort collaboration in…
Factors contributing to risk for cancer among HIV-infected individuals, and evidence that earlier combination antiretroviral therapy will alter this risk
To critically appraise recent published literature about factors associated with cancer risk likely to be influenced by combination antiretroviral therapy (cART) in HIV-infected individuals, and the potential of earlier cART initiation to reduce this risk. Factors leading to increased risk…
Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system
IMPORTANCE:Health care-associated infections (HAIs) account for a large proportion of the harms caused by health care and are associated with high costs. Better evaluation of the costs of these infections could help providers and payers to justify investing in prevention.OBJECTIVE:To…
Effects on skills and practice from a web-based skin cancer course for primary care providers
Melanoma incidence and mortality is a growing concern. Better recognition and management of skin cancer by primary care providers (PCPs) could help, but studies suggest they would benefit from additional education. Effective educational programs are needed. We developed and conducted…
Trends in annual incidence of methicillin-resistant Staphylococcus aureus (MRSA) infection in HIV-infected and HIV-uninfected patients
We describe trends in incidence rates of methicillin-resistant Staphylococcus aureus (MRSA) in HIV-infected and HIV-uninfected patients enrolled in a large northern California Health Plan, and the ratio of MRSA to methicillin-susceptible S. aureus (MSSA) case counts. Between 1995 and 2010,…
Adherence to Immunoprophylaxis Regimens for Respiratory Syncytial Virus Infection in Insured and Medicaid Populations
Immunoprophylaxis is the only pharmaceutical intervention for mitigating respiratory syncytial virus (RSV) infection. Patient level data on adherence to American Academy of Pediatrics (AAP) immunoprophylaxis recommendations are limited. This study characterizes adherence to AAP guidelines in privately insured and Medicaid…
Automated identification of pneumonia in chest radiograph reports in critically ill patients
Prior studies demonstrate the suitability of natural language processing (NLP) for identifying pneumonia in chest radiograph (CXR) reports, however, few evaluate this approach in intensive care unit (ICU) patients. From a total of 194,615 ICU reports, we empirically developed a…
Missed Office Visits and Risk of Mortality Among HIV-Infected Subjects in a Large Healthcare System in the United States
Linkage and retention in care soon after HIV diagnosis improves clinical outcomes. Conversely, missed visits after diagnosis are associated with increased mortality in the public care setting. We analyzed mortality among newly diagnosed HIV patients >/=18 years old in a…
Persistent recurring wheezing in the fifth year of life after laboratory-confirmed, medically attended respiratory syncytial virus infection in infancy
Respiratory syncytial virus (RSV) infection in infancy is associated with subsequent recurrent wheezing. A retrospective cohort study examined children born at ?32 weeks gestation between 1996-2004. All children were enrolled in an integrated health care delivery system in Northern California…
The effect of hepatitis C treatment response on medical costs: a longitudinal analysis in an integrated care setting
Studies suggest that chronic hepatitis C patients who achieve sustained virologic response (SVR) have lower risks of liver-related morbidity and mortality. Given the substantial costs and complexity of hepatitis C virus (HCV) antiviral treatment, post-treatment benefits are important to understand. …
Predicting risk of cancer during HIV infection: the role of inflammatory and coagulation biomarkers
OBJECTIVE: To investigate the relationship between inflammatory [interleukin-6 (IL-6) and C-reactive protein (CRP)] and coagulation (D-dimer) biomarkers and cancer risk during HIV infection. DESIGN: A prospective cohort. METHODS: HIV-infected patients on continuous antiretroviral therapy (ART) in the control arms of…
Long-term Effectiveness of Varicella Vaccine: A 14-Year, Prospective Cohort Study
BACKGROUND: Varicella vaccine was licensed in the United States in 1995 for individuals >/=12 months of age. A second dose was recommended in the United States in June 2006. Varicella incidence and vaccine effectiveness were assessed in a 14-year prospective…
Aspirin is associated with lower melanoma risk among postmenopausal Caucasian women: The Women’s Health Initiative
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with decreased risk of gastric, colorectal, and breast cancer. However, the impact of NSAIDs on the risk of melanoma has been inconsistent. The authors evaluated the association between NSAID use and cutaneous…
Early-onset sepsis: a predictive model based on maternal risk factors
PURPOSE OF REVIEW: Neonatal early-onset sepsis (EOS) is a very low-incidence, but potentially fatal condition among term and late preterm newborns. EOS algorithms based on risk-factor threshold values result in evaluation and empiric antibiotic treatment of large numbers of uninfected…
Use of web-based shared medical records among patients with HIV
To compare use of 7 shared electronic medical record (SMR) features by adult HIV patients. Observational cohort study of adult HIV-positive patients in the first 36 months following implementation of the SMR at Group Health and Kaiser Permanente Northern California.…
HIV Infection Status, Immunodeficiency, and the Incidence of Non-Melanoma Skin Cancer
Background The incidence of non-melanoma skin cancers (NMSCs), including basal cell (BCC) or squamous cell carcinoma (SCC), is not well documented among HIV-positive (HIV(+)) individuals. Methods We identified 6560 HIV(+) and 36 821 HIV-negative (HIV(-)) non-Hispanic white adults who were…
Sexual transmission of HCV among monogamous heterosexual couples: The HCV partners study
The efficiency of hepatitis C virus (HCV) transmission by sexual activity remains controversial. We conducted a cross-sectional study of HCV-positive subjects and their partners to estimate the risk for HCV infection among monogamous heterosexual couples. A total of 500 anti-HCV-positive,…
Kaiser Permanente Vaccine Study Center: Highlights of 2009-2012
The Kaiser Permanente Vaccine Study Center is a specialized research organization in Oakland, California. They have been an active vaccine research group for many years, and have participated in and led a multitude of vaccine studies. This article will review…
Mycobacterial diseases and antitumour necrosis factor therapy in USA
OBJECTIVE: In North America, tuberculosis and nontuberculous mycobacterial (NTM) disease rates associated with antitumour necrosis factor alpha (anti-TNFalpha) therapy are unknown. METHODS: At Kaiser Permanente Northern California, the authors searched automated pharmacy records to identify inflammatory disease patients who received…
The Epidemiology of Herpes Zoster in Patients with Newly Diagnosed Cancer
BACKGROUND: Given the limited literature, we conducted a study to examine the epidemiology of herpes zoster (HZ) among newly diagnosed cancer patients. METHODS: We identified adult health plan members of Kaiser Permanente Northern California diagnosed with invasive cancer from 2001…
Physical, Social, and Psychological Consequences of Treatment for Hepatitis C : A Community-Based Evaluation of Patient-Reported Outcomes
BACKGROUND: Hepatitis C virus (HCV) antiviral therapy entails a long treatment course, as well as significant side effects that can lead to medication non-adherence and premature termination of treatment. Few large studies have comprehensively examined patient perspectives on the treatment…
Validation of a large Basal cell carcinoma registry
The epidemiological study of basal cell carcinomas (BCCs) is difficult because BCCs lack distinct disease codes and are excluded from most cancer registries. To develop and validate a large BCC registry based on electronically assigned Systematized Nomenclature of Medicine (SNOMED)…
Biologically plausible and evidence-based risk intervals in immunization safety research
In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic…
Developing an Interactive Web-Based Learning Program on Skin Cancer: the Learning Experiences of Clinical Educators
Web-based learning in medical education is rapidly growing. However, there are few firsthand accounts on the rationale for and development of web-based learning programs. We present the experience of clinical educators who developed an interactive online skin cancer detection and…
Neisseria gonorrhea and Chlamydia trachomatis Screening at Intrauterine Device Insertion and Pelvic Inflammatory Disease
OBJECTIVE: To evaluate the relationship between Neisseria gonorrhea and Chlamydia trachomatis screening strategies and risk of pelvic inflammatory disease (PID) after intrauterine device (IUD) insertion. METHODS: We conducted a retrospective cohort study of all IUD insertions at Kaiser Permanente Northern…
Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events, as well as events that are temporally, but not necessarily causally related to vaccine. OBJECTIVE: We sought to determine if…
Exposure to antiretroviral therapy and risk of cancer in HIV-infected persons
OBJECTIVE:: The incidence of certain non-AIDS-defining cancers (NADC) in HIV patients has been reported to have increasedin the combination antiretroviral therapy (ART) era. Studies are needed to directly evaluate the effect of ART use on cancer risk. DESIGN:: We followed…
Vitamin D in cutaneous carcinogenesis: Part II
The role of vitamin D in health maintenance and disease prevention in fields ranging from bone metabolism to cancer is currently under intensive investigation. A number of epidemiologic studies have suggested that vitamin D may have a protective effect on…
Distribution of hepatitis C virus genotypes in a diverse US integrated health care population
Hepatitis C virus (HCV) genotypes influence response to therapy, and recently approved direct-acting antivirals are genotype-specific. Genotype distribution information can help to guide antiviral development and elucidate infection patterns. HCV genotype distributions were studied in a diverse cross-section of patients…
Vitamin D in cutaneous carcinogenesis: Part I
Skin cancer is the most common cancer in the United States. Exposure to ultraviolet radiation is a known risk factor for skin cancer but is also the principal means by which the body obtains vitamin D. Several studies have suggested…
A Large, Population-Based Study of 2009 Pandemic Influenza A Virus Subtype H1N1 Infection Diagnosis During Pregnancy and Outcomes for Mothers and Neonates
BACKGROUND: Pregnant women were at increased risk for serious outcomes of 2009 pandemic influenza A virus subtype H1N1 (influenza A[H1N1]pdm09) infection, but little is known about the overall impact of the pandemic on neonatal and maternal outcomes. METHODS: We identified…
Waning protection after fifth dose of acellular pertussis vaccine in children
BACKGROUND: In the United States, children receive five doses of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine before 7 years of age. The duration of protection after five doses of DTaP is unknown. METHODS: We assessed the risk of pertussis…
The association between sepsis and potential medical injury among hospitalized patients
BACKGROUND: Patient safety remains a national priority, but the role of disease-specific characteristics in safety is not well characterized. METHODS: We identified potentially preventable medical injuries using patient safety indicators (PSIs) and annual data from the Nationwide Inpatient Sample between…
HIV infection, aging, and immune function: implications for cancer risk and prevention
PURPOSE OF REVIEW: Combination antiretroviral therapy (ART) has turned HIV infection into a complex chronic disease. This article documents cancer risk among HIV-infected persons, reviews immune system effects of HIV infection in relation to cancer risk, discusses implications for cancer…
Epstein-Barr virus infection and expression of B-cell oncogenic markers in HIV-related diffuse large B-cell lymphoma
PURPOSE: Epstein-Barr virus (EBV)-mediated lymphomagenesis in the setting of HIV infection has been widely accepted. However, little is known about how EBV impacts prognosis. We investigated the hypothesis that EBV infection is associated with expression of specific B-cell oncogenic markers…
Algorithm to assess causality after individual adverse events following immunizations
Assessing individual reports of adverse events following immunizations (AEFI) can be challenging. Most published reviews are based on expert opinions, but the methods and logic used to arrive at these opinions are neither well described nor understood by many health…
Clinical effectiveness of pneumococcal polysaccharide vaccine in men: California Men’s Health Study
OBJECTIVE: To examine the effectiveness of pneumococcal polysaccharide vaccine (PPV) among approximately 40,000 community-dwelling men aged 45 years and older in the California Men's Health Study (CMHS) cohort. METHODS: All participants completed an extensive questionnaire at baseline (2002-2003) and were…
Immunogenicity and Safety of Two Tetravalent (Measles, Mumps, Rubella, Varicella) Vaccines Co-Administered with Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12 14 Months of Age
BACKGROUND:: This study compared single-dose tetravalent measles, mumps, rubella, varicella (MMRV) vaccine, Priorix-Tetra, stored refrigerated (GSK+4C) or frozen (GSK 20C), with ProQuad (Merck-20C), when co-administered with hepatitis A vaccine (HAV) and 7-valent pneumococcal conjugate vaccine (PCV7). METHODS:: Multicenter, observer-blind Phase…
Assessing the safety of influenza vaccination in specific populations: children and the elderly
Comprehensive monitoring of the safety of influenza vaccines remains a public health priority, particularly as immunization coverage increases across different age groups at the global level. In this review, the authors provide state-of-the-art knowledge on the safety of influenza immunization…
The Effect of HIV Infection, Immunodeficiency and Antiretroviral Therapy on the Risk of Hepatic Dysfunction
BACKGROUND: Limited data exists regarding the effect of chronic HIV infection on the liver. We sought to characterize the hepatic risks of HIV infection, immunodeficiency, and cumulative use of antiretroviral therapy (ART). METHODS: Adult HIV infected and 10:1 age-matched and…
An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women
Our recent experience in a post-licensure safety study of autoimmune conditions following the quadrivalent human papillomavirus vaccine in 189,629 girls and young women ages 9-26 years led us to question the adequacy of the exclusion of Day 0 events to…
Frequency, duration and predictors of bronchiolitis episodes of care among infants [greater than or equal to]32 weeks gestation in a large integrated healthcare system: a retrospective cohort study
BACKGROUND: Bronchiolitis is common in the first two years of life and is the most frequent cause of hospitalization in this age group. No previous studies have used an episode-of-care analysis to describe the frequency, duration, and predictors of bronchiolitis…
Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers
BACKGROUND: Invasive meningococcal disease can have devastating outcomes, especially in high-risk groups such as infants. As infants are recommended to receive multiple vaccines during a single office visit, this phase 3 study assessed the safety and immune response to MenACWY-CRM…
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
An increased risk of Guillain-Barre 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…
Trends and Characteristics of Culture-Confirmed Staphylococcus aureus Infections in a Large U.S. Integrated Health Care Organization
Infections due to Staphylococcus aureus present a significant health problem in the United States. Between 1990 and 2005, there was a dramatic increase in community-associated methicillin-resistant S. aureus (MRSA), but recent reports suggest that MRSA may be declining. We retrospectively…
Determination of Optimized Multidisciplinary Care Team for Maximal Antiretroviral Therapy Adherence
OBJECTIVE: We seek to determine the optimized multidisciplinary care team (MDCT) composition for antiretroviral therapy (ART) adherence. METHODS: We analyzed all new regimen starts (n = 10,801; 7071 ART naive, 3730 ART experienced) among HIV-positive patients in Kaiser Permanente California…
Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: A randomized, controlled, open-label, multicenter study
BACKGROUND: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. METHODS: A randomized, controlled, open-label, 4-armed, multicenter study…
Immunization and Bell’s Palsy in Children: A Case-Centered Analysis
Bell's palsy (BP) is an acute and idiopathic paralysis of the facial nerve, with an estimated incidence ranging from 11.5 per 100,000 person-years to 53.3 per 100,000 person-years in different populations. BP has been reported following immunization with inactivated trivalent…
Measles-Containing Vaccines and Febrile Seizures in Children Age 4 to 6 Years
BACKGROUND: In the United States, children receive 2 doses of measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), the first between ages 1 to 2 years and the second between ages 4 to 6 years. Among 1- to 2-year-olds, the risk…
Risk of Anal Cancer in HIV-Infected and HIV-Uninfected Individuals in North America
BACKGROUND: Anal cancer is one of the most common cancers affecting individuals infected with human immunodeficiency virus (HIV), although few have evaluated rates separately for men who have sex with men (MSM), other men, and women. There are also conflicting…
Recurrent Guillain-Barre Syndrome Following Vaccination
BACKGROUND: Guillain-Barre syndrome (GBS) is an acute polyradiculopathy, thought to be autoimmune, which has been reported following vaccinations. The Advisory Committee on Immunization Practices recommends not administering influenza vaccine to individuals who have had a history of GBS within 6…
Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants
CONTEXT: Current rotavirus vaccines were not associated with intussusception in large prelicensure trials. However, recent postlicensure data from international settings suggest the possibility of a low-level elevated risk, primarily in the first week after the first vaccine dose. OBJECTIVE: To…
An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children
BACKGROUND: In the US, it is recommended that 4-6 year old children receive diphtheria-tetanus-acellular pertussis (DTaP), inactivated poliovirus (IPV), measles-mumps-rubella (MMR), varicella (V), and influenza vaccines. Data relating to the concomitant administration of combination DTaP-IPV vaccine (Kinrix; GlaxoSmithKline Biologicals) and…
Lack of association between childhood immunizations and encephalitis in California, 1998-2008
OBJECTIVE: A number of new and combination vaccines have been introduced for children in the past two decades. Encephalitis cases occurring within defined time windows following administration of pertussis- or measles-containing vaccines are eligible for compensation by the Vaccine Injury…
Effect of Sexually Transmitted Infections, Lifetime Sexual Partner Count, and Recreational Drug Use on Lower Urinary Tract Symptoms in Men Who Have Sex With Men
OBJECTIVE: To investigate the relationship of lower urinary tract symptoms (LUTS) to urinary tract infection, prostatitis, sexually transmitted infection, lifetime sexual partner count, and recreational drug use in a population of men who have sex with men. LUTS in men…
Predictors of recruited melanoma families into a behavioral intervention project
BACKGROUND: Examination of families represents an important priority in health research. In this paper we report on individual and family-level factors associated with enrollment in a cancer prevention research project. We approached families affected by melanoma for possible participation in…
Prescription Long-term Opioid Use in HIV-infected Patients
OBJECTIVES: To examine changes the in use of prescription opioids for the management of chronic noncancer pain in human immunodeficiency virus (HIV)-infected patients and to identify patient characteristics associated with long-term use. METHODS: Long-term prescription opioid use (ie, 120+ days…
Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-Conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants
BACKGROUND: In phase II studies, MenACWY-CRM elicited robust immunologic responses in young infants. We now present results from our pivotal phase III infant immunogenicity/safety study. METHODS: In this open-label phase III study, we randomized full-term 2-month-old infants to 4 doses…
Influence of provider experience on antiretroviral adherence and viral suppression
BACKGROUND AND AIM: Early in the combination antiretroviral therapy (cART) era, provider experience (as measured by panel size) was associated with improved outcomes. We explored that association and other characteristics of provider experience. METHODS: We performed a retrospective cohort analysis…
Epidemiologic and Clinical Features of Bell’s Palsy among Children in Northern California
BACKGROUND: Bell's palsy (BP) is an acute, idiopathic, and usually unilateral paralysis of the facial nerve. Large population-based studies of BP among children are lacking. We determined epidemiologic and clinical features of BP among children enrolled in a large integrated…
HIV Infection, Immunodeficiency, Viral Replication, and the Risk of Cancer
BACKGROUND: Few studies have compared cancer risk between HIV-infected individuals and a demographically similar HIV-uninfected internal comparison group, adjusting for cancer risk factors.METHODS: We followed 20,775 HIV-infected and 215,158 HIV-uninfected individuals enrolled in Kaiser Permanente (KP) California for incident cancer…
Estimating the probability of neonatal early-onset infection on the basis of maternal risk factors
OBJECTIVE: To develop a quantitative model to estimate the probability of neonatal early-onset bacterial infection on the basis of maternal intrapartum risk factors. METHODS: This was a nested case-control study of infants born at >/=34 weeks' gestation at 14 California…
Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination
BACKGROUND: Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-2010…
Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink
BACKGROUND: In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9-26 year-old female vaccine recipients between August 2006 and October 2009. METHODS: Sequential analyses were conducted weekly to detect…
Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009
BACKGROUND: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). METHODS: Cases were referred by practitioners, health departments,…
Risk factors for tuberculosis after highly active antiretroviral therapy initiation in the United States and Canada: implications for tuberculosis screening
BACKGROUND: Screening for tuberculosis prior to highly active antiretroviral therapy (HAART) initiation is not routinely performed in low-incidence settings. Identifying factors associated with developing tuberculosis after HAART initiation could focus screening efforts. METHODS: Sixteen cohorts in the United States and…
Missing data on the estimation of the prevalence of accumulated human immunodeficiency virus drug resistance in patients treated with antiretroviral drugs in north america
Determination of the prevalence of accumulated antiretroviral drug resistance among persons infected with human immunodeficiency virus (HIV) is complicated by the lack of routine measurement in clinical care. By using data from 8 clinic-based cohorts from the North American AIDS…
HMG-CoA reductase inhibitors (statins) use and risk of non-Hodgkin lymphoma in HIV-positive persons
OBJECTIVE: Experimental studies suggested that HMG-CoA reductase inhibitors ('statins') may have antilymphoma properties. We investigated whether statin use is associated with reduced risk of non-Hodgkin lymphoma (NHL) in HIV-positive persons. DESIGN: A nested case-control study was conducted among HIV-positive members…
Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among persons 15-59 years of age
BACKGROUND: Associations between vaccinations, particularly hepatitis B, and onset of rheumatoid arthritis (RA) have been reported, but examined in few large-scale studies. METHOD: Onset of RA cases and dates of vaccination against hepatitis B, tetanus, and influenza were identified in…
Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine When Coadministered With Diphtheria-tetanus-acellular Pertussis and Haemophilus influenzae Type B Vaccines in Children 15 Months of Age
BACKGROUND: This study (NCT00197236) evaluated the safety and immunogenicity of a hepatitis A virus (HAV) vaccine when coadministered with diphtheria-tetanus-acellular pertussis (DTaP) and Haemophilus influenzae type b (Hib) vaccines in children 15 months of age. METHODS: This was an open-labeled,…
Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the vaccine safety datalink
OBJECTIVES: 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…
Sexual dysfunction; HIV; and AIDS in men who have sex with men
HIV infection is associated with sexual dysfunction. Using validated instruments; we investigated the relationship between HIV/AIDS and sexual function in a contemporary cohort of men who have sex with men (MSM). An anonymous Internet-based survey was disseminated to MSM via…
The Pregnancy and Influenza Project: design of an observational case-cohort study to evaluate influenza burden and vaccine effectiveness among pregnant women and their infants
The US Centers for Disease Control and Prevention is conducting an observational study of 300-500 women infected with influenza during pregnancy. Women are being recruited from members of the Kaiser Permanente health plan in 2 metropolitan areas before and during…
Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information
OBJECTIVES: To determine if giving vaccine-information materials before the 2-month vaccination visit to mothers with concerns about vaccine safety positively changed their attitudes and beliefs about vaccine safety. METHODS: Mothers who indicated concerns about infant vaccinations were recruited from 2…
The Vaccine Safety Datalink: a model for monitoring immunization safety
The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8 managed care organizations (MCOs) in the United States. Established in 1990 to conduct postmarketing evaluations of vaccine safety, the project…
Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network
The Clinical Immunization Safety Assessment (CISA) Network is a collaboration between the Centers for Disease Control and Prevention (CDC) and 6 academic medical centers to provide support for immunization safety assessment and research. The CISA Network was established by the…
Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project
OBJECTIVE: To describe the Vaccine Safety Datalink (VSD) project's experience with population-based, active surveillance for vaccine safety and draw lessons that may be useful for similar efforts. PATIENTS AND METHODS: The VSD comprises a population of 9.2 million people annually…
Evaluation of immunization rates and safety among children with inborn errors of metabolism
BACKGROUND: Children with inherited metabolic disorders are a potential high-risk group for vaccine-preventable diseases, yet information regarding immunization rates and vaccine safety within this population is limited. METHODS: Using Northern California Kaiser Permanente's electronic medical record, we identified children with…
Clinical implications of the nelfinavir-proton pump inhibitor drug interaction in patients with human immunodeficiency virus
STUDY OBJECTIVE: To determine if the concomitant use of nelfinavir and proton pump inhibitors (PPIs) in patients with human immunodeficiency virus (HIV) infection results in the loss of virologic control. DESIGN: Retrospective cohort study. DATA SOURCE: Pharmacy, laboratory, and administrative…
Timely detection of localized excess influenza activity in Northern California across patient care, prescription, and laboratory data
Timely detection of clusters of localized influenza activity in excess of background seasonal levels could improve situational awareness for public health officials and health systems. However, no single data type may capture influenza activity with optimal sensitivity, specificity, and timeliness,…
Vaccine safety in special populations
Studies evaluating the safety of vaccines routinely administered to a population of healthy infants and children may not provide adequate reassurance for members of special populations such as premature infants and children with chronic conditions. However, evaluating the safety of…
Enhanced Liver Fibrosis (ELF) test accurately identifies liver fibrosis in patients with chronic hepatitis C
Assessment of liver fibrosis is important in determining prognosis and evaluating interventions. Due to limitations of accuracy and patient hazard of liver biopsy, non-invasive methods have been sought to provide information on liver fibrosis, including the European liver fibrosis (ELF)…
Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age
BACKGROUND: Routine administration of quadrivalent meningococcal conjugate vaccine to adolescents and certain high risk groups is recommended in the United States and Canada. We compared the immunogenicity and safety of an investigational quadrivalent meningococcal vaccine conjugated to CRM-197 (MenACWY-CRM) with…
Interpreting complete blood counts soon after birth in newborns at risk for sepsis
BACKGROUND: A complete blood count (CBC) with white blood cell differential is commonly ordered to evaluate newborns at risk for sepsis. OBJECTIVES: To quantify how well components of the CBC predict sepsis in the first 72 hours after birth. METHODS:…
Recurrent wheezing in the third year of life among children born at 32 weeks’ gestation or later: relationship to laboratory-confirmed, medically attended infection with respiratory syncytial virus during the first year of life
OBJECTIVE: To quantify the relationship between recurrent wheezing (RW) in the third year of life and respiratory syncytial virus (RSV) infection, prematurity, and neonatal oxygen exposure. DESIGN: Retrospective cohort study linking inpatient, outpatient, and laboratory databases for cohort assembly and…
Vaccine effectiveness against laboratory-confirmed influenza in infants: A matched case control study
Influenza is a common and potentially serious infection in infants. Previous studies of influenza vaccine in this age group have reported widely varying estimates of vaccine effectiveness, and few have used laboratory confirmation of influenza diagnoses. We evaluated the effectiveness…
Risk of fever and sepsis evaluations after routine immunizations in the neonatal intensive care unit
OBJECTIVE: Premature infants can experience cardiorespiratory events such as apnea after immunization in the neonatal intensive care unit (NICU). These changes in clinical status may precipitate sepsis evaluations. This study evaluated whether sepsis evaluations are increased after immunizations in the…
Lack of association between acellular pertussis vaccine and seizures in early childhood
OBJECTIVES: Receipt of diphtheria-tetanus-whole-cell pertussis vaccine (diphtheria-tetanus toxoids-pertussis [DTP]) is associated with seizures. Limited population-based studies have been conducted on the risk for seizures after receipt of diphtheria-tetanus-acellular pertussis vaccine (diphtheria-tetanus-acellular pertussis [DTaP]). METHODS: We conducted a retrospective study from…
Survival of non-Hodgkin lymphoma patients with and without HIV infection in the era of combined antiretroviral therapy
OBJECTIVE: To investigate the survival outcomes for non-Hodgkin lymphoma (NHL) in HIV-infected vs. uninfected patients from the same integrated healthcare system, and to identify prognostic factors for HIV-related NHL in the era of combined antiretroviral therapy. DESIGN: A cohort study.…
Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures
OBJECTIVE: In February 2008, we alerted the Advisory Committee on Immunization Practices to preliminary evidence of a twofold increased risk of febrile seizures after the combination measles-mumps-rubella-varicella (MMRV) vaccine when compared with separate measles-mumps-rubella (MMR) and varicella vaccines. Now with…
Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization
BACKGROUND: Prelicensure clinical studies may not include sufficient numbers of subjects to assess the potential for rare postvaccination adverse events. The aim of this postlicensure study (NCT00297856) was to evaluate uncommon outcomes following vaccination with a tetanus, reduced-antigen-content diphtheria, and…
An update on the use of Atripla in the treatment of HIV in the United States
Atripla((R)) (Gilead Sciences Inc, Foster City, CA, USA and Bristol-Myers Squibb, New York City, NY, USA) is a coformulated single pill composed of efavirenz, emtricitabine, and tenofovir disoproxil, intended as a once-daily potent combination antiretroviral therapeutic agent. Its efficacy is…
Late presentation for human immunodeficiency virus care in the United States and Canada
BACKGROUND. Initiatives to improve early detection and access to human immunodeficiency virus (HIV) services have increased over time. We assessed the immune status of patients at initial presentation for HIV care from 1997 to 2007 in 13 US and Canadian…
Effect of once-daily FDC treatment era on initiation of cART
OBJECTIVES: Combination antiretroviral therapy (cART) is associated with increased survival among HIV-infected persons. Yet, no research to date has examined whether introduction of once-daily fixed-dosed combinations (FDC) affects the likelihood of cART initiation. We aimed to determine whether implementation of…
Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies
Safety monitoring following new vaccine introduction includes assessment of potential new onset autoimmune diseases (AID). As knowledge regarding AID background rates is limited, we evaluated the incidence of 11 AID in Northern California Kaiser Permanente. AID cases were identified using…
Preterm infants’ T cell responses to inactivated poliovirus vaccine
BACKGROUND: The antigen-specific T cell responses of preterm infants to immunization are not well understood. The aim of the present study was to compare the T cell responses of preterm infants after inactivated poliovirus vaccination with those of term infants.…
Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age
Meningococcal disease incidence is highest in infants, but a significant burden of disease also occurs in children. In this Phase II, single-centre US study, 619 healthy children (2-10 years of age) received one dose of an investigational quadrivalent meningococcal CRM(197)-conjugated…
Prostatitis, sexually transmitted diseases, and prostate cancer: the California Men’s Health Study
BACKGROUND: Prostatitis and sexually transmitted diseases (STDs) have been positively associated with prostate cancer in previous case-control studies. However, results from recent prospective studies have been inconclusive. METHODOGY/PRINCIPAL FINDINGS: We investigated the association between prostatitis, STDs, and prostate cancer among…
Impact of tenofovir on renal function in HIV-infected, antiretroviral-naive patients
OBJECTIVE: To better characterize the long-term effects of tenofovir on renal function in a large managed care organization. METHODS: We performed a retrospective cohort analysis in Kaiser Permanente for years 2002 to 2005 comparing renal function among antiretroviral naive patients…
Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine
BACKGROUND: A pentavalent, bovine-derived rotavirus vaccine (RotaTeq, Merck) was licensed in 2006 for use in infants. A previously licensed rotavirus vaccine was withdrawn due to elevated risk of intussusception. We prospectively evaluated the risk of intussusception and other pre-specified adverse…
CD4 count at presentation for HIV care in the United States and Canada: Are those over 50 years more likely to have a delayed presentation?
ABSTRACT: We assessed CD4 count at initial presentation for HIV care among >/=50-year-olds from 1997-2007 in 13 US and Canadian clinical cohorts and compared to /=50-years-old increased from 17% to 27% (p-value < 0.01). The median CD4 count among >/=50…
Identification of patients with nonmelanoma skin cancer using health maintenance organization claims data
Cancer registries usually exclude nonmelanoma skin cancers (NMSC), despite the large population affected. Health maintenance organization (HMO) and health system administrative databases could be used as sampling frames for ascertaining NMSC. NMSC patients diagnosed between January 1, 1988, and December…
Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California
BACKGROUND: Syphilis rates are rising in California, but the impact of HIV infection on syphilis infection remains uncertain. We describe differences between HIV-infected and HIV-uninfected patients diagnosed with syphilis within Kaiser Permanente Northern California. METHODS: We performed retrospective analyses of…
Trends in multidrug treatment failure and subsequent mortality among antiretroviral therapy-experienced patients with HIV infection in North America
BACKGROUND: Although combination antiretroviral therapy continues to evolve, with potentially more effective options emerging each year, the ability of therapy to prevent multiple regimen failure and mortality in clinical practice remains poorly defined. METHODS: Sixteen cohorts representing over 60 sites…
HIV infection and the risk of cancers with and without a known infectious cause
OBJECTIVE: To evaluate the risk of cancers with and without a known infectious cause in HIV-infected persons. DESIGN: Retrospective cohort study. METHODS: Adult HIV-infected and matched HIV-uninfected members of Kaiser Permanente followed between 1996 and 2007 for incident AIDS-defining cancers…
Prevalence and predictors of hepatic steatosis in adults with newly diagnosed chronic liver disease due to hepatitis C
Obesity appears to be a risk factor for hepatic steatosis, which has been implicated in the development of hepatic fibrosis in patients with hepatitis C virus infection. We conducted the current study to examine whether obesity is associated with hepatic…
Race/ethnicity and risk of AIDS and death among HIV-infected patients with access to care
BACKGROUND: Prior studies evaluating racial/ethnic differences in responses to antiretroviral therapy (ART) among HIV-infected patients have not adequately accounted for many potential confounders, and few have included Hispanic patients. OBJECTIVE: To identify racial/ethnic differences in ART adherence, and risk of…
Influenza vaccination and mortality: differentiating vaccine effects from bias
It is widely believed that influenza (flu) vaccination of the elderly reduces all-cause mortality, yet randomized trials for assessing vaccine effectiveness are not feasible and the observational research has been controversial. Efforts to differentiate vaccine effectiveness from selection bias have…
Predictive value of HIV-1 genotypic resistance test interpretation algorithms
BACKGROUND: Interpreting human immunodeficiency virus type 1 (HIV-1) genotypic drug-resistance test results is challenging for clinicians treating HIV-1-infected patients. Multiple drug-resistance interpretation algorithms have been developed, but their predictive value has rarely been evaluated using contemporary clinical data sets. METHODS:…
Virologic outcomes of changing enfuvirtide to raltegravir in HIV-1 patients well controlled on an enfuvirtide based regimen: 24-week results of the CHEER study
OBJECTIVES: To determine the safety and efficacy of changing enfuvirtide to raltegravir in HIV-1-infected patients with HIV-1 RNA below the level of quantification for at least 6 months on an enfuvirtide-containing antiretroviral regimen. DESIGN: Prospective, nonrandomized, historical control study. METHODS:…
Response to newly prescribed lipid-lowering therapy in patients with and without HIV infection
BACKGROUND: Antiretroviral agents, particularly protease inhibitors (PIs), may adversely affect lipid levels in patients with HIV infection. However, it is not known whether HIV-associated dyslipidemia is more difficult to treat. OBJECTIVE: To compare the effectiveness and safety of lipid-lowering therapy…
Smoking enhances risk for new external genital warts in men
Repeat episodes of HPV-related external genital warts reflect recurring or new infections. No study before has been sufficiently powered to delineate how tobacco use, prior history of EGWs and HIV infection affect the risk for new EGWs. Behavioral, laboratory and…
Do antiretrovirals reduce the risk of non-AIDS-defining malignancies?
PURPOSE OF REVIEW: There is an increasing burden of non-AIDS-defining malignancies (NADMs) in the antiretroviral therapy (ART) era. The recent literature is reviewed with respect to NADM risk, ART use, and immune function. RECENT FINDINGS: Recent studies have increasingly focused…
Efficacy and safety of ritonavir-boosted and unboosted atazanavir among antiretroviral-naive patients
PURPOSE: Evaluate responses and safety of ritonavir-boosted atazanavir ('boosted atazanavir') compared to unboosted atazanavir among antiretroviral-naive patients in the clinical managed care setting. METHOD: Observational cohort analysis of atazanavir use (comparing ritonavir-boosted to non-boosted) at Kaiser Permanente and Group Health…
The epidemiology of newly diagnosed chronic liver disease in gastroenterology practices in the United States: results from population-based surveillance
OBJECTIVES: Chronic liver disease (CLD) is an important cause of morbidity and mortality, but the epidemiology is not well described. We conducted prospective population-based surveillance to estimate newly diagnosed CLD incidence, characterize etiology distribution, and determine disease stage. METHODS: We…
Limitations of conventionally derived chronic liver disease mortality rates: Results of a comprehensive assessment
Standard death certificate-based methods for ascertaining deaths due to chronic liver disease (CLD), such as the U.S. vital statistics approach, rely on a limited set of diagnostic codes to define CLD. These codes do not include viral hepatitis or consider…
Influence of prior antiretroviral experience on adherence and responses to new highly active antiretroviral therapy regimens
The impact of prior antiretroviral experience on adherence and clinical outcomes in patients initiating a new highly active antiretroviral therapy (HAART) regimen is not well defined. We performed an observational cohort analysis of antiretroviral-experienced or -naive HIV-infected patients prescribed a…
Risk adjusting community-acquired pneumonia hospital outcomes using automated databases
OBJECTIVE: To describe the development and assessment of the Abbreviated Fine Severity Score (AFSS), a simplified version of the Pneumonia Severity Index (PSI) suitable for providing risk-adjusted reports to clinicians caring for patients hospitalized with community-acquired pneumonia. STUDY DESIGN: Retrospective…
Incidence of hepatocellular carcinoma among individuals with hepatitis B virus infection identified using an automated data algorithm
The purpose of this study was to develop an algorithm for identifying patients with chronic hepatitis B virus (HBV) using automated data sources from two US health systems and evaluate the algorithm's performance by quantifying the incidence of hepatocellular carcinoma…
Case-control study of antibiotic use and subsequent Clostridium difficile-associated diarrhea in hospitalized patients
OBJECTIVE: To determine which antibiotics increase or decrease the risk of Clostridium difficile-associated diarrhea (CDAD). DESIGN: Retrospective case-control study. SETTING: Nonprofit, integrated healthcare delivery system in Northern California. PATIENTS: Study participants included patients with cases of hospital-acquired CDAD that occurred…
Ensuring access to treatment for HIV infection
The recent recommendations of the Centers for Disease Control and Prevention for opt-out testing are intended to address the evolving human immunodeficiency virus (HIV) epidemic in the United States by bringing more HIV-infected individuals into medical care. This is an…
Mammographic density in a multiethnic cohort
OBJECTIVES: To compare mammographic density among premenopausal and early perimenopausal women from four racial/ethnic groups and to examine density and acculturation among Japanese and Chinese women. DESIGN: The study included 391 white, 60 African American, 171 Japanese, and 179 Chinese…
AIDS-defining and non-AIDS-defining malignancies: cancer occurrence in the antiretroviral therapy era
PURPOSE OF REVIEW: Effective antiretroviral therapy use has resulted in a large number of older individuals living with HIV. Recent literature is reviewed with respect to the incidence and risk factors for cancer in HIV patients. RECENT FINDINGS: Previous studies…
Incidence of non-Hodgkin’s lymphoma among individuals with chronic hepatitis B virus infection
Although hepatitis C virus (HCV) infection has been shown to be associated with development of non-Hodgkin's lymphoma (NHL), few studies have investigated the association between chronic HBV infection and NHL. The purpose of this study was to compare the incidence…
Effect of clinical pharmacists on utilization of and clinical response to antiretroviral therapy
OBJECTIVE: To determine the association of clinical pharmacists with health outcomes and utilization measures among HIV-infected patients. METHODS: Observational study of 1571 HIV-infected patients prescribed their initial highly active antiretroviral therapy (HAART) regimen in clinics with and without a clinical…
Older age and the response to and tolerability of antiretroviral therapy
BACKGROUND: The unique health needs of a growing older adult population infected with human immunodeficiency virus (HIV) require study, especially in terms of the response to and tolerability of highly active antiretroviral therapy (HAART). METHODS: Changes in HIV clinical markers…
Cost-effectiveness of pneumococcal conjugate vaccine: evidence from the first 5 years of use in the United States incorporating herd effects
BACKGROUND: Pneumococcal conjugate vaccine (PCV) has been in routine use in the United States for 5 years. Prior U.S. cost-effectiveness analyses have not taken into account the effect of the vaccine on nonvaccinated persons. METHODS: We revised a previously published…
Serological detection of human papillomavirus type 16 infection in human immunodeficiency virus (HIV)-positive and high-risk HIV-negative women
Serial measurement of antibodies has not been used to provide evidence of active viral replication of human papillomavirus (HPV). Serum specimens from sequential study visits contributed by 642 human immunodeficiency virus (HIV)-positive and 116 HIV-negative participants enrolled in the Women's…
A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients
INTRODUCTION: The Oncotype DX assay was recently reported to predict risk for distant recurrence among a clinical trial population of tamoxifen-treated patients with lymph node-negative, estrogen receptor (ER)-positive breast cancer. To confirm and extend these findings, we evaluated the performance…
Hospital-level rates of fluoroquinolone use and the risk of hospital-acquired infection with ciprofloxacin-nonsusceptible Pseudomonas aeruginosa
BACKGROUND: In recent years, Pseudomonas aeruginosa has become increasingly resistant to fluoroquinolones, and fluoroquinolone use in the United States has also increased. Our objective was to determine whether higher hospital-level rates of use of ciprofloxacin, levofloxacin, and moxifloxacin antimicrobials were…
HIV-1 Protease and reverse-transcriptase mutations: correlations with antiretroviral therapy in subtype B isolates and implications for drug-resistance surveillance
Background. It is important, for drug-resistance surveillance, to identify human immunodeficiency virus type 1 (HIV-1) strains that have undergone antiretroviral drug selection.Methods. We compared the prevalence of protease and reverse-transcriptase (RT) mutations in HIV-1 sequences from persons with and without…
Life After Cancer Epidemiology (LACE) Study: a cohort of early stage breast cancer survivors (United States)
The Life After Cancer Epidemiology (LACE) Study, a cohort of 2321 early stage breast cancer survivors, was established in 2000 to examine how modifiable behavioral risk factors affect quality of life and long-term survival. Women were recruited primarily from the…
History of chickenpox and shingles and prevalence of antibodies to varicella-zoster virus and three other herpes viruses among adults with glioma and controls
Whether viruses or immunologic factors might cause or prevent human brain cancer is of interest. Statistically significant inverse associations of adult glioma with history of chickenpox and immunoglobulin G antibodies to varicella-zoster virus have been reported. The authors evaluate associations…
What have we learned from observational studies on neonatal sepsis?
OBJECTIVE: To assess how observational studies on neonatal sepsis can help define the knowledge base required for neonatal randomized, clinical trials. DESIGN: Methodologic review of past observational studies and critical reviews. RESULTS: Observational studies on neonatal sepsis have suffered from…
Cervical cancer in women with comprehensive health care access: attributable factors in the screening process
BACKGROUND: Invasive cervical cancer is highly preventable, yet it continues to occur, even among women who have access to cancer screening and treatment services. To reduce cervical cancer among such women, reasons for its occurrence must be better understood. We…
Racial and ethnic distribution of nonalcoholic fatty liver in persons with newly diagnosed chronic liver disease
We performed a cross-sectional study of newly diagnosed cases of nonalcoholic fatty liver disease (NAFLD) identified between December 1998 and December 2000 in the Chronic Liver Disease Surveillance Study. We compared the demographic and clinical features of NAFLD in a…
Reason for late-stage breast cancer: absence of screening or detection, or breakdown in follow-up?
BACKGROUND: Mammography screening increases the detection of early-stage breast cancers. Therefore, implementing screening should reduce the percentage of women who are diagnosed with late-stage disease. However, despite high national mammography screening rates, late-stage breast cancers still occur, possibly because of…
Processes of care in cervical and breast cancer screening and follow-up–the importance of communication
BACKGROUND: Given limited research, we investigated patient reports of processes of care related to screening follow-up, timing of result notification, communication issues, and adherence following an abnormal mammogram or Pap test. METHODS: Women age 50 and over with an abnormal…
Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente
OBJECTIVE: To assess the direct and indirect effects of the introduction of routine use of pneumococcal conjugate vaccine in infants and toddlers at risk for invasive disease caused by vaccine serotypes and nonvaccine serotypes in vaccinated children and unvaccinated children…
A prospective study of Chlamydia pneumoniae infection and risk of MS in two US cohorts
BACKGROUND: Chlamydia pneumoniae (Cpn) has been proposed as a possible etiologic agent in multiple sclerosis (MS). However, previous studies were cross-sectional and could not assess whether Cpn infection preceded the onset of MS. METHODS: The authors conducted a prospective nested…
Comparison between prototype hybrid capture 3 and hybrid capture 2 human papillomavirus DNA assays for detection of high-grade cervical intraepithelial neoplasia and cancer
We compared the performance of a prototype version of the Hybrid Capture 3 (HC3) human papillomavirus (HPV) DNA assay to the current generation Hybrid Capture 2 (HC2) assay, both of which target 13 oncogenic HPV types, for the detection of…
Impact of the pneumococcal conjugate vaccine on otitis media
CONTEXT: The heptavalent pneumococcal conjugate vaccine (PCV) is recommended for infants to protect against invasive disease, but its impact on otitis might also have public health importance. OBJECTIVE: To examine the impact of PCV on the incidence of otitis media,…
Healthcare utilization by women in a comprehensive managed care population subsequent to diagnosis of a sexually transmitted disease
BACKGROUND: Healthcare utilization (HCU) following a sexually transmitted disease (STD) diagnosis is poorly characterized. GOAL: The goal was to quantify HCU for new/recurrent STDs and other relevant Ob-Gyn and mental health problems in the 18 months subsequent to an STD…
Lack of association between receipt of conjugate haemophilus influenzae type B vaccine (HbOC) in infancy and risk of type 1 (juvenile onset) diabetes: long term follow-up of the HbOC efficacy trial cohort
We evaluated the effect of infant vaccination with HbOC Haemophilus influenzae type b (Hib) conjugate vaccine on the risk of onset of type 1 juvenile diabetes later in life by examining data from a large controlled prospective Phase III clinical…
CagA status of Helicobacter pylori infection and p53 gene mutations in gastric adenocarcinoma
Infection with Helicobacter pylori (H. pylori) increases stomach cancer risk. Helicobacter pylori strains with the cag pathogenicity island (PAI) induce more severe inflammation in the gastric epithelium and are more strongly associated with stomach cancer risk than strains lacking the…
Sexual behavior, human papillomavirus type 16 (HPV 16) infection, and HPV 16 seropositivity
BACKGROUND: Sexual behaviors have been linked to seropositivity for human papillomavirus (HPV) but not with the magnitude of the seroreactivity. GOALS: The objective of this analysis was to examine the association of sexual behavior, cervical HPV 16 DNA positivity at…
Use of a Staphylococcus aureus conjugate vaccine in patients receiving hemodialysis
BACKGROUND: In patients with decreased resistance to infection, Staphylococcus aureus is a major cause of bacteremia and its complications. The capsular polysaccharides are essential for the pathogenesis of and immunity to S. aureus infection and are targets for vaccines. METHODS:…
Atypical glandular cells of undetermined significance (AGUS): Interobserver reproducibility in cervical smears and corresponding thin-layer preparations
Five panelists independently reviewed 135 consecutive conventional cervical smears (CPs) originally classified as atypical glandular cells of undetermined significance (AGUS). A thin-layer slide (TP), prepared from the residual material, also was reviewed in each case. All patients underwent colposcopy that…
A community-based collaboration to assess and improve medical insurance status and access to health care of Latino children
OBJECTIVES: Despite eligibility for subsidized insurance, low-income Latino children are at high risk of being medically uninsured. The authors sought to understand and improve access to medical insurance for Latino children living in a California community of predominantly low-income immigrant…
A prospective study of human papillomavirus (HPV) type 16 DNA detection by polymerase chain reaction and its association with acquisition and persistence of other HPV types
Human papillomavirus (HPV)-16 causes about half the cases of cervical cancer worldwide and is the focus of HPV vaccine development efforts. Systematic data are lacking as to whether the prevention of HPV-16 could affect the equilibrium of infection with other…
Effect of physician and patient gender concordance on patient satisfaction and preventive care practices
OBJECTIVE: To explore the role of the gender of the patient and the gender of the physician in explaining differences in patient satisfaction and patient-reported primary care practice. DESIGN: Crosssectional mailed survey [response rate of 71%]. SETTING: A large group-model…
Neonatal sepsis workups in infants >/=2000 grams at birth: A population-based study
BACKGROUND: Few data are available on the outcome of neonatal sepsis evaluations in an era when intrapartum antibiotic therapy is common. METHODS: We identified all newborns weighing >/=2000 g at birth who were ever evaluated for suspected bacterial infection at…
Seroreactivity to human papillomavirus types 16, 18, 31, and 45 virus-like particles in a case-control study of cervical squamous intraepithelial lesions
Serum IgG antibodies to human papillomavirus (HPV) types 16, 18, 31, and 45 virus-like particles were measured in a nested case-control study of cervical squamous intraepithelial lesions. HPV-16 seroreactivity was strongly associated with HPV-16 DNA detection (odds ratio, 9.0; 95%…
Rehospitalization for respiratory syncytial virus among premature infants
OBJECTIVES: New interventions to prevent respiratory syncytial virus (RSV) have recently become available. Clinical decisions about the use of these interventions require a better understanding of the incidence of and risk factors for RSV. We sought to characterize the epidemiology…
Cost-effectiveness of respiratory syncytial virus prophylaxis among preterm infants
OBJECTIVES: To evaluate the costs and benefits of two new agents, respiratory syncytial virus immune globulin (RSVIG) and palivizumab, to prevent respiratory syncytial virus (RSV) infection among premature infants discharged from the neonatal intensive care unit (NICU) before the start…
Identifying women with cervical neoplasia: using human papillomavirus DNA testing for equivocal Papanicolaou results
CONTEXT: A Papanicolaou (Pap) test result of atypical squamous cells of undetermined significance (ASCUS) presents a clinical challenge. Only 5% to 10% of women with ASCUS harbor serious cervical disease, but more than one third of the high-grade squamous intraepithelial…
Preventing neonatal group B streptococcal disease: cost-effectiveness in a health maintenance organization and the impact of delayed hospital discharge for newborns who received intrapartum antibiotics
OBJECTIVES: To estimate the cost and health benefits of implementing a risk factor-based prevention strategy for early-onset neonatal group B streptococcal (GBS) disease, using baseline assumptions and costs from a health maintenance organization. With the risk factor-based strategy, intrapartum antibiotics…
The neonatal ‘sepsis work-up’: personal reflections on the development of an evidence-based approach toward newborn infections in a managed care organization
'Rule out sepsis' may be the most common discharge diagnosis among infants admitted to the neonatal intensive care unit. Although the frequency of sepsis, meningitis, and other confirmed bacterial infections has remained constant (between 1 and 5/1000 live births) for…
Cohort study of serum total cholesterol and in-hospital incidence of infectious diseases
A multiethnic cohort of adult members of the Kaiser Permanente Medical Care Program (55300 men and 65271 women) was followed for 15 years (1979-93) to assess the association between total cholesterol and risk of infections (other than respiratory and HIV)…
Where’s the high-grade cervical neoplasia? The importance of minimally abnormal Papanicolaou diagnoses
OBJECTIVE: To characterize the relative contributions of the different abnormal Papanicolaou smear cytologic diagnoses in the Bethesda System to the subsequent histologic diagnosis of high-grade cervical neoplasia. METHODS: A total of 46,009 nonpregnant female members of the Kaiser Permanente Health…
The rarity of cryptococcosis in Northern California: the 10-year experience of a large defined population
The incidence of clinically manifest cryptococcosis was determined among over one million subscribers to the Kaiser-Permanente Medical Care Program in Northern California during the 10-year period 1971-1980. A total of 10 persons developed the disease, of whom two had no…