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OBJECTIVES. Children POPULATION AND SETTING. We evaluated 125 928 children 6 months through 8 years of age who were enrolled in health maintenance organizations in the United States participating in the Vaccine Safety Datalink project and who received their first dose of trivalent inactivated influenza vaccine in the 2001-2002, 2002-2003, or 2003-2004 influenza seasons. RESULTS. Compliance with the 2 dose recommendations varied by age group and influenza season. Among children 6 to 23 months of age, the proportion of first-vaccinated children who received a second vaccination was 44% in 2001-2002, 54% in 2002-2003, and 29% in 2003-2004. Among children 2 to 8 years of age, the corresponding proportions were 15%, 24%, and 12%, respectively. In all seasons, compliance with the second vaccination was highest in children first vaccinated by mid-November. CONCLUSIONS. The majority of children who received their first dose of trivalent inactivated influenza vaccine did not complete the 2-dose series. The recently expanded recommendation for universal vaccination of children 6 to 59 months of age and their household contacts will substantially increase the number of children targeted for a first influenza vaccination. Noncompliance with the 2-dose trivalent inactivated influenza vaccine series may be associated with suboptimal protection against infection, which may impact the magnitude of the direct and indirect benefits achieved by the vaccination program. Key Words influenza, influenza vaccine Abbreviations TIV--trivalent inactivated influenza vaccine HAI--hemagglutination-inhibition HMO--health maintenance organization, CHILDREN Children who have not been exposed previously to influenza viruses, either as a consequence of vaccination or natural infection, do not respond optimally to a single dose of trivalent [...]

A study was conducted to screen for medically attended events in the clinic, emergency department or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. It is found that in the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine.

Objectives. To evaluate compliance with national immunization guidelines among a large cohort of children cared for at health maintenance organizations (HMOs) and to examine effects on immunization status. Methods. A cohort study of 176 134 children born between January 1, 1994, and December 31, 1997, and monitored from birth to the second birthday was performed. Subjects belonged to the Vaccine Safety Datalink Project, a study of children enrolled in 1 of 4 HMOs. Children were continuously enrolled in a HMO for the first 2 years of life. Prevailing recommendations regarding optimal ages of immunization and intervals between doses were applied to define appropriate immunization timing and immunization status. Noncompliance was defined as having a missing or late immunization or an immunization error. Immunization errors included invalid immunizations (too early to be acceptable), extra immunizations (superfluous immunizations or make-up immunizations for invalid immunizations), and missed opportunities resulting in late or missing immunizations. Results. Although 75.4% of children in these HMOs were up to date for all immunizations at 2 years, only 35.6% of children were fully compliant with recommended immunization practices. Less than 8% of children received all immunizations in accordance with strict interpretation of recommended guidelines. Fifty-one percent of children had at least 1 immunization error by age 2 years; 29.7% had a missed opportunity with subsequent late or missing immunization, 20.4% had an invalid immunization, and 11.6% had an extra immunization. Common reasons for noncompliance included missed opportunities for the fourth Haemophilus influenzae type b vaccine (14.6%), invalid fourth diphtheria-tetanus-pertussis/acellular pertussis immunizations (11.0%), and superfluous polio immunizations (9.8%). Conclusions. Approximately 35.6% of children were compliant with prevailing childhood immunization recommendations from 1996 to 1999. Efforts to improve compliance with guidelines are recommended, to optimize childhood infectious disease prevention. Pediatrics 2005; 115:461-467; compliance, immunization, guidelines, health maintenance organization., ABBREVIATIONS. HMO, health maintenance organization; Hib, Haemophilus influenzae type b; DTP, diphtheria-tetanus-pertussis; DTaP, diphtheria-tetanus-acellular pertussis; HBV, hepatitis B virus; IPV, inactivated polio vaccine; OPV, oral polio vaccine; MMR, measles-mumps-rubella; VSD, [...]

Objective. To investigate trends over time in polio extraimmunization among children in 4 large health maintenance organizations and to study the association with recent changes in polio immunization policy. Methods. Using 176 169 children who were born after 1994 and enrolled for their first 2 years of life, we assessed rates and trends of polio extraimmunization in the Vaccine Safety Datalink project. We used logistic regression to test the association of extraimmunization with different polio immunization schedules and with sociodemographic characteristics and used Poisson regression to test changes in rates over time. Results. Overall, 10.5% were extraimmunized for poliovirus; children on the all inactivated polio virus or sequential schedule were one half as likely as those on the all oral polio virus schedule to be extraimmunized by 2 years of age. There was a significant decrease in extraimmunization over time, with < 5% of children born at the end of 1997 being extraimmunized, compared with > 15% at the beginning of 1994. Conclusions. Poliovirus extraimmunization rates have fallen dramatically in association with the changeover to the all inactivated polio virus schedule. Pediatrics 2003;111:296-301; extraimmunization, polio vaccine., ABBREVIATIONS. OPV, oral polio virus; IPV, inactivated polio virus; DTP, diphtheria and tetanus toxoids and whole-cell pertussis; DTaP, diphtheria and tetanus toxoids and acellular pertussis; Hib, Haemophilus influenzae type b; [...]

The DTP and MMR vaccines may cause fever and a seizure in children a few days after vaccination, but this side effect will not last and does not produce long-term neurological disability. This was the conclusion of a study of 679,942 children vaccinated at four large HMOs.

Antibiotic therapy for the common cold may contribute greatly to unnecessary overuse of antibiotics. Viral rhinosinusitis describes the nasal congestion, sneezing, and coughing typically observed in children with the common cold. There is no evidence that antibiotic treatment changes the course of the illness or reduces the risk of bacterial complications. Thick, opaque, or discolored nasal discharge should be recognized as part of the natural course of the viral disease, and not as an indication of bacterial infection, unless persisting for greater than 10 to 14 days., Most children will suffer between 3 and 8 colds per year, and over half of patients seen for the common cold are given an antimicrobial prescription. Unnecessary antimicrobial therapy can be avoided by recognizing the signs and symptoms that are part of the usual course of these diseases. Controlled trials of antimicrobial treatment of the common cold are reviewed. These trials consistently fail to show that treatment changes the course or outcome. Furthermore, antimicrobial therapy for patients with viral rhinosinusitis is not an effective way to prevent bacterial complications. Mucopurulent rhinitis (thick, opaque, or discolored nasal discharge) frequently accompanies the common cold and is part of the natural course of viral rhinosinusitis. It is not an indication for antimicrobial treatment unless it persists without improvement for [is greater than]10 to 14 days. Pediatrics 1998;101:181-184; common cold, upper respiratory tract infection, mucopurulent rhinitis, diagnosis, antimicrobial therapy., ABBREVIATION. URI, upper respiratory tract infection. PRINCIPLES 1. Antimicrobial agents should not be given for the common cold. 2. Mucopurulent rhinitis (thick, opaque, or discolored nasal discharge) frequently accompanies the [...]

Prolonged cough illness or bronchitis in children may not warrant the use of antibiotics in most cases. Most cough illnesses in children are caused by viral infection, and there is no evidence that antibiotic treatment is effective in preventing bacterial complications. Children older than 5 years of age with prolonged cough, or those with chronic lung disease, may benefit from treatment directed at specifically indicated infections. Markedly prolonged coughs, lasting 4 to 8 weeks, should be investigated for treatable causes, including non-infectious sources., Millions of courses of antibiotics are prescribed for children with acute cough illness each year, despite evidence from randomized, placebo-controlled trials that such treatment is not effective. Evidence that children with cough for [is less than or equal to] 10 days should not be treated with antimicrobial agents is presented. Older children with prolonged cough or those with underlying lung disease may benefit from antimicrobial treatment directed specifically at B pertussis, M pneumoniae, C pneumoniae, P aeruginosa, or other specific infections. None of the routinely prescribed cephalosporin or amino penicillin antimicrobials would be effective for these organisms. Noninfectious diagnosis should be sought in children with markedly prolonged cough. Pediatrics 1998; 101:178-181; bronchitis, cough, diagnosis, antimicrobial therapy, antimicrobial resistance, pediatrics., ABBREVIATION. NP, nasopharyngeal. PRINCIPLES 1. Regardless of duration, nonspecific cough illness/bronchitis in children rarely warrants antimicrobial treatment. 2. Antimicrobial treatment for prolonged cough ([is greater than] 10 days) may be [...]

Because pharyngitis, or sore throat, is most often caused by viral infection, withholding antibiotic treatment until laboratory tests confirm the presence of group A streptococcus may reduce the overuse of antibiotics. Sore throat is a common complaint in the pediatric population, and is not reliably diagnosed by physical examination. Documented streptococcal infection should be treated with penicillin to avoid complications of rheumatic fever, but most episodes of pharyngitis do not require antibiotic therapy. Beginning therapy pending culture results is not recommended., Accurate diagnosis of group A streptococcal pharyngitis and appropriate antimicrobial therapy are important, particularly to prevent nonsuppurative sequelae such as rheumatic fever. Most episodes of sore throat, however, are caused by viral agents. Clinical findings cannot reliably differentiate streptococcal from viral pharyngitis and most physicians tend to overestimate the probability of a streptococcal infection based on history and physical examination alone. Therefore, diagnosis should be based on results of a throat culture or an antigen-detection test with throat culture backup. Presumptively starting therapy pending results of a culture is discouraged because treatment often continues despite a negative test result. Other bacterial causes of pharyngitis are uncommon and often can be diagnosed based on nonpharyngeal findings. Penicillin remains the drug of choice for streptococcal pharyngitis because of its effectiveness, relatively narrow spectrum, and low cost. No group A streptococci are resistant to [Beta]-lactam antibiotics. High rates of resistance to macrolides has been documented in several areas; in Finland, decreased national rates of macrolide use led to a decline in the proportion of macrolide-resistant group A streptococci. Pediatrics 1998;101:171-174; group A Streptococcus, pharyngitis, diagnosis, antimicrobial therapy., PRINCIPLES 1. Diagnosis of group A streptococcal pharyngitis should be made based on results of appropriate laboratory tests in conjunction with clinical and epidemiologic findings. 2. Antimicrobial therapy should not [...]

Because antibiotics are more frequently prescribed for otitis media than any other condition in the US, eliminating unnecessary treatment may profoundly reduce antibiotic use. Ear infections can be classified as episodes of acute otitis media (AOM), requiring antibiotic treatment, or otitis media with effusion (OME), with medication not indicated if persisting less than three months. The diagnosis of AOM must include documented evidence of fluid in the middle ear as well as symptoms of local or systemic illness. OME is the presence of fluid in the middle ear with no acute symptoms., Otitis media is the leading indication for outpatient antimicrobial use in the United States. Overdiagnosis of and unnecessary prescribing for this condition has contributed to the spread of antimicrobial resistance. A critical step in reducing unnecessary prescribing is to identify the subset of patients who are unlikely to benefit from antibiotics. Conscientiously distinguishing acute otitis media (AOM) from otitis media with effusion (OME), and deferring antibiotics for OME will accomplish this goal, and will avoid up to 8 million unnecessary courses of antibiotics annually. Criteria for defining these conditions are presented, as well as the evidence supporting deferring antibiotic treatment. Discussions of shortened courses of antibiotics for AOM and restricted indications for antimicrobial prophylaxis are also presented. Pediatrics 1998;101:165-171; antimicrobial resistance, antimicrobial use, otitis media, upper respiratory infection, antimicrobial therapy, pediatrics, acute otitis media, otitis media with effusion, prophylaxis., ABBREVIATION. AHCPR, Agency for Health Care Policy and Research. PRINCIPLES 1. Episodes of otitis media should be classified as acute otitis media (AOM) or otitis media with effusion (OME). 2. [...]

Distinguishing bacterial sinusitis from that caused by viral infection is critical to avoid the unnecessary use of antibiotics. Clinical diagnosis should be made on the basis of symptoms persisting for greater than 10 to 14 days, or severe symptoms including fever and facial pain and swelling. Abnormal radiographic imaging, or X-rays, cannot distinguish between viral, bacterial, or allergic causes for sinus inflammation, and should be interpreted with caution. Narrow-spectrum antibiotic therapy, when indicated, should be limited to 7 days after symptoms improve., Establishing an accurate diagnosis of bacterial sinusitis is challenging but critical, because viral rhinosinusitis is at least 20 to 200 times more common than bacterial infection of the sinuses. Strict criteria for clinical diagnosis that require either prolonged and persistent symptoms or an acute severe presentation are supported with published evidence. Radiographic imaging of the sinuses should be used only in very selected circumstances. A majority of patients with the common cold will meet radiographic criteria for sinusitis early in the course of their illness. For patients meeting these strict criteria, an appropriate narrow-spectrum antimicrobial agent will be of modest benefit compared with symptomatic treatment alone. Pediatrics 1998;101:174-177; sinusitis, diagnosis, antimicrobial therapy, mucopurulent rhinitis, antimicrobial resistance, pediatrics., ABBREVIATIONS. URI, upper respiratory tract illness; CT, computed tomography. PRINCIPLES 1. Clinical diagnosis of bacterial sinusitis requires the following: prolonged nonspecific upper respiratory signs and symptoms (ie, rhinosinusitis and cough [...]

Data collected by the Vaccine Safety Datalink Project appears to be consistent with known vaccine safety characteristics and may prove useful for monitoring and studying vaccine safety. This database links vaccine data on over 500,000 children at four health maintenance organizations. Three years of data collection has shown that a measles-mumps-rubella vaccine triples the seizure risk eight to 14 days after vaccination and a diphtheria-tetanus-pertussis vaccine doubles the seizure risk on the day of vaccination. There appears to be no increased seizure risk associated with the influenza type b vaccine., Objective. To fill the large "gaps and limitations" in current scientific knowledge of rare vaccine adverse events identified in recent reviews of the Institute of Medicine. Methods. Computerized information on immunization, medical outcomes, and potential confounders on more than 500 000 children 0 to 6 years of age is linked annually at several health maintenance organizations to create a large cohort for multiple epidemiologic studies of vaccine safety. Results. Analysis of 3 years of follow-up data shows that 549 488 doses of diphtheria-tetanus-pertussis (DTP) and 310 618 doses of measles-mumps-rubella (MMR) vaccines have been administered to children in the study cohort. Analyses for associations between vaccines and 34 medical outcomes are underway. Screening of automated data shows that seizures are associated with receipt of DTP on the same day (relative risk [RR], 2.1; 95% confidence interval [CI], 1.1 to 4.0) and 8 to 14 days after receipt of MMR (RR, 3.0; 95% CI, 2.1 to 4.2). The diversity of vaccination exposures in this large cohort permits us to show that an apparent association of seizures 8 to 14 days after Haemophilus influenzae type b vaccine (RR, 1.6; 95% CI, 1.2 to 2.1) was attributable to confounding by simultaneous MMR vaccination; the association disappears with appropriate adjustment (RR, 1.0; 95% CI, 0.7 to 1.4). Conclusion. Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines. The diversity in vaccine administration schedules permits potential disentangling of effects of simultaneous and combined vaccinations. The project provides a model of public health-managed care collaborations in addition to an excellent :infrastructure for safety and other studies of vaccines. Pediatrics 1997;99:765-773; vaccines, immunization, adverse reactions, databases, record linkage, vaccine safety., ABBREVIATIONS. VAERS, Vaccine Adverse Event Reporting System; IOM, Institute of Medicine; CDC, Centers for Disease Control and Prevention; LLDB, large linked database; VSD, Vaccine Safety Datalink; HMO, health maintenance organization; [...]

Context. In 1995, [is greater than] 5 million episodes of acute otitis media (AOM) accounted for $3 billion in health care expenditures. Objectives. To synthesize the literature on the natural history of AOM, the effectiveness of antibiotic treatment in uncomplicated AOM, and the relative effectiveness of specific antibiotic regimens. Data Sources. Seven electronic databases for articles published between 1966 and March 1999 and reference lists in proceedings, published articles, reports, and guidelines. Study Selection. Two physicians independently assessed each article. Studies addressing AOM in children 4 weeks to 18 years old were included; those addressing children with immunodeficiencies or craniofacial abnormalities were excluded. Randomized, controlled trials (RCTs) were used to assess antibiotic effectiveness, and RCTs and cohort studies were used to assess the natural history of AOM. Among the 3491 citations identified, 80 (2.3%) met our inclusion criteria. Data Extraction. Two physicians independently abstracted data and assessed the quality of studies using a validated scale for RCTs and 8 quality components for cohort studies. Data Synthesis. Random-effects estimates of pooled absolute rate differences of outcomes were derived, and heterogeneity of both the rates and rate differences was assessed. Children with AOM not treated with antibiotics experienced a 1- to 7-day clinical failure rate of 19% (95% confidence interval: 0.10-0.28) and few suppurative complications. When patients were treated with amoxicillin, the 2- to 7-day clinical failure rate was reduced to 7%, a 12% (95% confidence interval: 0.04-0.20) reduction. Adverse effects, primarily gastrointestinal, were more common among children on cefixime than among those on ampicillin or amoxicillin. They were also more common among children on amoxicillin-clavulanate than among those on azithromycin. Conclusions. The majority of uncomplicated cases of AOM resolve spontaneously without apparent suppurative complications. Ampicillin or amoxicillin confers a limited therapeutic benefit. There is no evidence to support any particular antibiotic regimens as more effective at relieving symptoms. Certain antibiotics are more likely than others to cause diarrhea and other adverse events. Pediatrics 2001;108:239-247; otitis media, children, antibiotics., ABBREVIATIONS. AOM, acute otitis media; NAMCS, National Ambulatory Medical Care Surveys; RCT, randomized, controlled trial; CI, confidence interval. The incidence of acute otitis media (AOM), one of the most common [...]

Objectives. To report research gaps and priorities of future research identified during an evidence assessment process on the management of acute otitis media (AOM). Methods. A conceptual framework for management of AOM was developed to guide the evidence assessment. An 11-member technical expert panel guided the selection of key questions, prioritization of influencing factors, development of scope, definition of AOM, and search strategy through polling processes and conference calls. Quality of clinical trials was evaluated using established scales. Outcome measures were abstracted from each study. Results. A total of 3461 titles and abstracts were screened, and 760 full-length articles were reviewed. Of the 760 articles, 80 studies addressed the key questions. In defining AOM, 42 (52.5%) of the 80 studies included the middle-ear effusion component, only 2 (2.5%) included the rapid onset component, and 26 (32.5%) included the signs/symptoms of inflammation component. None of the 80 studies used all 3 components. Of the 74 controlled trials, 39 (53%) were of acceptable quality (Jadad score of 3 or higher). The technical experts did not agree in the ranking of the importance of the 41 influencing factors (Kendall&apos;s coefficient of concordance was 0.0022). Another poll also indicated diverse opinions of the experts on the importance of 7 key questions derived from the conceptual framework (Kendall coefficient of concordance is 0.21). Furthermore, our review found that the type and definition of outcome measure varied. Conclusions. Despite the large body of literature on AOM, its quality is uneven and its findings are not generalizable. Future research should try to answer all key questions and investigate all risk factors in well-designed, scientific studies. Pediatrics 2001;108:248-254; otitis media, children, future research., ABBREVIATIONS. AOM, acute otitis media; MEE, middle-ear effusion. The treatment of acute otitis media (AOM) requires the understanding and completion of several clinical processes before a successful outcome can be [...]