A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders.

Background: Treatment of a child who has an anxiety disorder usually begins with the question of which treatment to start first, medication or psychotherapy. Both have strong empirical support, but few studies have compared their effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn't working well-whether to optimize the treatment already begun or to add the other treatment.

Methods: This is a single-blind Sequential Multiple Assignment Randomized Trial (SMART) of 24 weeks duration with two levels of randomization, one in each of two 12-week stages.

Phenotype of 7q11.23 duplication: A family clinical series.

Duplication 7q11.23 syndrome is the reciprocal of Williams-Beuren deletion syndrome. Studies have reported a recognizable phenotype, including autism, intellectual disability, speech, and language delay, social anxiety, and behavioral difficulties in these individuals.

Risk of Herpes Zoster and Disseminated Varicella Zoster in Patients Taking Immunosuppressant Drugs at the Time of Zoster Vaccination.

Objective: To determine the risks associated with zoster vaccine when administered to patients taking immunosuppressant medications.

Patients And Methods: Patients enrolled in 1 of 7 managed care organizations affiliated with the Vaccine Safety Datalink between January 1, 2006, and December 31, 2009, were eligible. The exposure of interest was zoster vaccination in patients with current or remote immunosuppressant drug use.

Inpatient admission for febrile seizure and subsequent outcomes do not differ in children with vaccine-associated versus non-vaccine associated febrile seizures.

Introduction: Recent data suggest that the risk factors for febrile seizure (FS) can differ depending on whether the FS was vaccine-associated (VA) or not. As such, there also may be differences in the risk of inpatient admission and/or the incidence of FS-related subsequent outcomes following the index FS depending on whether it was VA or non-vaccine associated (NVA). This could have useful clinical implications including caregiver education and planning for follow-up care.

Exploring the risk factors for vaccine-associated and non-vaccine associated febrile seizures in a large pediatric cohort.

Introduction: It is not known whether there are underlying physiologic or immunologic differences between febrile seizures (FS) triggered by vaccines versus other causes. Furthermore, while secular and individual-level factors have been associated with FS risk, they are rarely evaluated simultaneously.

Methods: Subjects included members of Kaiser Permanente Southern California aged 6 months to 3 years from July 1, 2003-December 31, 2011.

Safety of the yellow Fever vaccine: a retrospective study.

Background: Yellow fever (YF) vaccine is considered safe; however, severe illness and death following vaccination have been reported.

Methods: Vaccine Safety Datalink (VSD) and US Department of Defense (DoD) data were used to identify adverse reactions following YF vaccination. Within the VSD, YF-vaccine-exposed subjects were compared to age-, site-, and gender-matched unexposed subjects.

Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009-2011.

Background: Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited.

Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years.

Objective: To update the American Academy of Pediatrics clinical practice guideline regarding the diagnosis and management of acute bacterial sinusitis in children and adolescents.

Methods: Analysis of the medical literature published since the last version of the guideline (2001).

Results: The diagnosis of acute bacterial sinusitis is made when a child with an acute upper respiratory tract infection (URI) presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever[temperature ≥39°C/102.

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children.

Although no increased risk was detected for serious adverse events in the prelicensure trials for the 13-valent pneumococcal vaccine, Prevnar 13(®) (PCV13), continued monitoring of rare but serious adverse events is necessary. A surveillance system using cohort study design was set up to monitor safety of PCV13 immediately after it was included in the childhood immunization program in the United States. The exposed population included children of 1 month to 2 years old who received PCV13 from April, 2010 to January, 2012 from the eight managed care organizations participating in the Vaccine Safety Datalink Project in the United States.

Vaccination site and risk of local reactions in children 1 through 6 years of age.

Objective: Our objective was to assess whether the occurrence of medically attended local reactions to intramuscularly administered vaccines varies by injection site (arm versus thigh) in children 1 to 6 years of age.

Methods: This is a retrospective cohort study of children in the Vaccine Safety Datalink population from 2002 to 2009. Site of injection and the outcome of medically attended local reactions were identified from administrative data.

Safety of a tetanus-diphtheria-acellular pertussis vaccine when used off-label in an elderly population.

Background: Published data on the safety of tetanus-diphtheria-acellular pertussis vaccine (Tdap) in persons aged ≥65 years are limited. This study aims to examine a large cohort of Tdap users ≥65 years for evidence of increased risk of adverse events following vaccination.

Methods: A matched cohort study design and a self-controlled case series (SCCS) design were used.

Herpes zoster vaccine and the incidence of recurrent herpes zoster in an immunocompetent elderly population.

Background: The benefit of vaccinating immunocompetent patients who have had shingles has not been examined. The study assessed the association between vaccination and the incidence of herpes zoster recurrence among persons with a recent episode of clinically diagnosed herpes zoster.

Methods: This is a matched cohort study in Kaiser Permanente Southern California.

Safety of zoster vaccine in adults from a large managed-care cohort: a Vaccine Safety Datalink study.

Objectives: The aim of this study was to examine a large cohort of adults who received the zoster vaccine for evidence of an increased risk of prespecified adverse events requiring medical attention.

Design: Two self-comparison approaches, including a case-centred approach and a self-controlled case series (SCCS) analysis were used.

Setting: Eight managed-care organizations participating in the Vaccine Safety Datalink project in the United States.

Paralytic syndromes in children: epidemiology and relationship to vaccination.

Acute flaccid paralysis is a standard outcome for detection of poliomyelitis globally and an ongoing potential vaccine-associated adverse event concern for polio, influenza, and meningococcal vaccines. No systematic population-based data on the epidemiologic and clinical features of this condition, or its potential association with immunization, have been reported from the United States. The present retrospective cohort study of acute flaccid paralysis in the Southern and Northern California Kaiser Permanente Health Care Plans was conducted using computerized diagnosis data and medical record review of potential cases among children aged 1 month to <15 years and diagnosed from January 1, 1992 through December 31, 1998.

Risk factors of herpes zoster among children immunized with varicella vaccine: results from a nested case-control study.

Background: Previous studies of varicella-zoster virus reactivation in children have provided little information on potential risk factors. The aim of this study was to investigate the effects of race, chronic medical conditions and treatments, and recent vaccination, on the risk of herpes zoster (HZ) in children vaccinated with one dose of varicella vaccine.

Methods: Case subjects were identified from a cohort of subjects who were members of the Southern California Kaiser Permanente Health Plan and received primary immunization with a single-antigen live varicella vaccine at age < or = 12 years from 2002 to 2008.

Incidence of herpes zoster among children vaccinated with varicella vaccine in a prepaid health care plan in the United States, 2002-2008.

Background: Herpes zoster (HZ), or shingles, is caused by reactivation of latent varicella-zoster virus after a primary infection with either wild-type or vaccine-type varicella-zoster virus, the latter having been introduced in 1995 for children. Since then, few population-based data about the incidence of childhood HZ are available.

Methods: We identified children aged < or = 12 years who were vaccinated with 1 dose of varicella vaccine between 2002 and 2008 in a prepaid health plan and followed them through their electronic health records for a diagnosis of HZ.

Evaluation of vaccine coverage for low birth weight infants during the first year of life in a large managed care population.

Objective: There are few recent population-based assessments of vaccine coverage in premature infants available. This study assesses and compares age- and dose-specific immunization coverage in children of different birth weight categories during the first year of life.

Methods: We performed a retrospective cohort analysis of computerized vaccination data from a large managed care organization in southern California.

Varicella vaccination and ischemic stroke in children: is there an association?

Background: Ischemic stroke is a known complication of varicella disease. Although there have been case reports of ischemic stroke after varicella vaccination, the existence and magnitude of any vaccine-associated risk has not been determined. OBJECTIVE.

A population-based, postlicensure evaluation of the safety of a combination diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine in a large managed care organization.

Background: Prelicensure studies of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus vaccine suggested that there were higher rates of fever after its administration than when its component antigens were given separately.

Methods: We conducted an open, controlled, cohort study to evaluate selected potential adverse events after receipt of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine in the Southern California Kaiser Permanente Health Care Plan. From April 2003 through June 2005, we identified 61,004 infants who received >or=1 dose of vaccine (120000 total doses).

Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years.

Background: It has been hypothesized that early exposure to thimerosal, a mercury-containing preservative used in vaccines and immune globulin preparations, is associated with neuropsychological deficits in children.

Methods: We enrolled 1047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.