Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.

BACKGROUND: Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media. METHODS: We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period. RESULTS: In our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial. CONCLUSIONS: Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).

Biomarkers that differentiate false positive urinalyses from true urinary tract infection.

BACKGROUND: The specificity of the leukocyte esterase test (87%) is suboptimal. The objective of this study was to identify more specific screening tests that could reduce the number of children who unnecessarily receive antimicrobials to treat a presumed urinary tract infection (UTI). METHODS: Prospective cross-sectional study to compare inflammatory proteins in blood and urine samples collected at the time of a presumptive diagnosis of UTI. We also evaluated serum RNA expression in a subset. RESULTS: We enrolled 200 children; of these, 89 were later demonstrated not to have a UTI based on the results of the urine culture obtained. Urinary proteins that best discriminated between children with UTI and no UTI were involved in T cell response proliferation (IL-9, IL-2), chemoattractants (CXCL12, CXCL1, CXCL8), the cytokine/interferon pathway (IL-13, IL-2, INFγ), or involved in innate immunity (NGAL). The predictive power (as measured by the area under the curve) of a combination of four urinary markers (IL-2, IL-9, IL-8, and NGAL) was 0.94. Genes in the pathways related to inflammation were also upregulated in serum of children with UTI. CONCLUSIONS: Urinary proteins involved in the inflammatory response may be useful in identifying children with false positive results with current screening tests for UTI; this may reduce unnecessary treatment.

Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children.

BACKGROUND: Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media. METHODS: We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms. RESULTS: Children who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P=0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P=0.001). The percentage of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment was lower in the 5-day group than in the 10-day group (181 of 227 children [80%] vs. 211 of 233 [91%], P=0.003). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001). CONCLUSIONS: Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).

Development and Modification of an Outcome Measure to Follow Symptoms of Children with Sinusitis.

OBJECTIVE: To develop a parent-reported Pediatric Rhinosinusitis Symptom Scale (PRSS) that could be used to monitor symptoms of young children with acute sinusitis in response to therapy. STUDY DESIGN: We developed an 8-item symptom severity scale and evaluated its internal reliability, construct validity, and responsiveness in children 2-12 years of age with acute sinusitis. Parents of 258 children with acute sinusitis completed the PRSS at the time of diagnosis, as a diary at home, and at the follow-up visit at days 10-12. Based on psychometric results and additional parent feedback, we revised the scale. We evaluated the revised version in 185 children with acute sinusitis. RESULTS: Correlations between the scale and reference measures on the day of enrollment were in the expected direction and of the expected magnitude. PRSS scores at the time of presentation correlated with radiographic findings (P < .001), functional status (P < .001), and parental assessment of overall symptom severity (P < .001). Responsiveness (standardized response mean) and test-retest reliability of the revised scale were good (2.17 and 0.75, respectively). CONCLUSIONS: We have developed an outcome measure to track the symptoms of acute sinusitis. Data presented here support the use of the PRSS as a measure of change in symptom burden in clinical trials of children with acute sinusitis.

Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media.

Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6.4 mg clavulanate/kg of body weight/day commonly causes diarrhea. We examined whether an A/C formulation containing lower concentrations of clavulanate would result in less diarrhea while maintaining plasma levels of amoxicillin and clavulanate adequate to eradicate middle-ear pathogens and to achieve clinical success. We conducted an open-label study in children with AOM who were 6 to 23 months of age. In phase 1, we treated 40 children with a reduced-clavulanate A/C formulation providing 90 mg amoxicillin/3.2 mg clavulanate/kg/day for 10 days. In phase 2, we treated 72 children with the same formulation at a dosage of 80 mg amoxicillin/2.85 mg clavulanate/kg/day for 10 days. We compared the rates of protocol-defined diarrhea (PDD), diaper dermatitis, and AOM clinical response in these children with rates we had reported in children who received the standard A/C regimen, and we obtained plasma levels of amoxicillin and clavulanate at various time points. Outcomes in phase 1 children and in children who had received the standard regimen did not differ significantly. Rates of PDD in children receiving phase 2 and standard regimens were 17% and 26%, respectively (P = 0.10). The corresponding rates of diaper dermatitis were 21% and 33% (P = 0.04) and of AOM treatment failure were 12% and 16% (P = 0.44). Symptomatic responses did not differ significantly between regimens; both gave clavulanate levels sufficient to inhibit ß-lactamase activity. In young children with AOM, clavulanate dosages lower than those currently used may be associated with fewer side effects without reducing clinical efficacy. (This study has been registered at ClinicalTrials.gov under registration no. NCT02630992.).

Treatment of acute otitis media in children under 2 years of age.

BACKGROUND: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. METHODS: We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure. RESULTS: Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. CONCLUSIONS: Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).

Development and preliminary evaluation of a parent-reported outcome instrument for clinical trials in acute otitis media.

BACKGROUND: Acute otitis media (AOM) is the most common childhood diagnosis, leading to prescription of an antibiotic in the United States. Although antibiotics are used in children with AOM, in part, to shorten the duration of symptoms, no instruments have been developed to track early changes in symptoms from the parent's point of view. The goal of the present study was to develop and evaluate a parent-reported symptom scale for children with AOM (AOM-SOS) for use as an outcome measure in AOM treatment trials. METHODS: From a pool of 28 potential symptoms, we selected 7 on the basis of parent questionnaire, expert interviews, and review of the literature for inclusion in the AOM-SOS. We administered the AOM-SOS to a primary-care sample of children aged 6-25 months enrolled in a study of nasopharyngeal bacterial colonization. Children were seen for well visits, illness visits, and AOM follow-up visits. At each visit, parents completed the AOM-SOS and their children were examined by trained otoscopists. As part of the evaluation of the AOM-SOS, we examined the association between each item on the questionnaire and the clinical diagnosis of AOM while adjusting for the presence of upper respiratory tract infection. To assess responsiveness, we examined the change in AOM-SOS scores in patients with AOM who were seen for follow-up within 3 weeks of diagnosis. RESULTS: We evaluated 264 children (mean age, 12.5 months at entry) at a total of 642 visits. We diagnosed AOM at 24% of the visits. Each item on the questionnaire was significantly associated with the clinical diagnosis of AOM (P < 0.001 for each), before and after adjusting for the presence or absence of upper respiratory infection. The mean AOM-SOS score at visits when AOM was diagnosed was 3.71, compared with 0.96 at visits when AOM was not diagnosed (P < 0.001). Internal reliability of the scale as measured by Cronbach's alpha was 0.84. AOM-SOS scores in children with AOM who were otoscopically improved decreased by an average of 2.81 points (standardized response mean = 0.73). CONCLUSIONS: We have developed a short symptom scale for children with AOM. This study provides preliminary data on the performance of the AOM-SOS in a primary care sample of children.

Responsiveness and construct validity of a symptom scale for acute otitis media.

BACKGROUND: Because resolution of symptoms is a primary goal of antimicrobial therapy in children with acute otitis media (AOM), measurement of symptoms in studies of antimicrobial effectiveness in such children is important. We have developed a scale for measuring symptoms of AOM in young children (AOM-SOS), and we present data on its construct validity and responsiveness. METHODS: We followed children 3 months to 3 years of age with AOM, who were receiving antimicrobial treatment, using the AOM-SOS scale. The scale was administered at the enrollment visit, as a twice-a-day diary measure, and at the follow-up visit (days 5-7). To evaluate construct validity, we examined the correlation, at entry, between AOM-SOS scores and scores on other measures of pain and functional status. To evaluate the scale's responsiveness, we examined the change in scale scores from entry to follow-up. We also examined the levels of agreement between the scale scores and overall assessments of the children by parents. RESULTS: We enrolled 70 children (mean age 12.5 months) of whom 57 returned for follow-up. The magnitude of the correlations between the AOM-SOS scale scores and other measures of pain and functional status ranged from 0.56 to 0.84. The responsiveness of the AOM-SOS, as measured by the standardized response mean was 1.20. CONCLUSIONS: These data support the validity and responsiveness of the AOM-SOS; the scale seems to measure effectively both pain and overall functional status in young children with AOM. Changes in score over the first few days of illness were substantial and generally matched the assessments both of parents and of clinicians. The AOM-SOS promises to be useful as an outcome measure in clinical studies of AOM.

Imaging studies after a first febrile urinary tract infection in young children.

BACKGROUND: Guidelines from the American Academy of Pediatrics recommend obtaining a voiding cystourethrogram and a renal ultrasonogram for young children after a first urinary tract infection; renal scanning with technetium-99m-labeled dimercaptosuccinic acid has also been endorsed by other authorities. We investigated whether imaging studies altered management or improved outcomes in young children with a first febrile urinary tract infection. METHODS: In a prospective trial involving 309 children (1 to 24 months old), an ultrasonogram and an initial renal scan were obtained within 72 hours after diagnosis, contrast voiding cystourethrography was performed one month later, and renal scanning was repeated six months later. RESULTS: The ultrasonographic results were normal in 88 percent of the children (272 of 309); the identified abnormalities did not modify management. Acute pyelonephritis was diagnosed in 61 percent of the children (190 of 309). Thirty-nine percent of the children who underwent cystourethrography (117 of 302) had vesicoureteral reflux; 96 percent of these children (112 of 117) had grade I, II, or III vesicoureteral reflux. Repeated scans were obtained for 89 percent of the children (275 of 309); renal scarring was noted in 9.5 percent of these children (26 of 275). CONCLUSIONS: An ultrasonogram performed at the time of acute illness is of limited value. A voiding cystourethrogram for the identification of reflux is useful only if antimicrobial prophylaxis is effective in reducing reinfections and renal scarring. Renal scans obtained at presentation identify children with acute pyelonephritis, and scans obtained six months later identify those with renal scarring. The routine performance of urinalysis, urine culture, or both during subsequent febrile illnesses in all children with a previous febrile urinary tract infection will probably obviate the need to obtain either early or late scans.

Changes in parents' perceptions of infant influenza vaccination over two years.

BACKGROUND: Inner-city health centers serving large proportions of low-income and minority children participated in a study to introduce influenza vaccination among healthy infants in 2002-2003 and 2003-2004. METHODS: Following the 2002-2003 and 2003-2004 influenza vaccination seasons, a short, low-literacy level survey was mailed to parents of vaccine-eligible children. Factors related to vaccination status were determined using Chi-squared and logistic regression procedures. In 2003, 436 of 1000 surveys were returned and in 2004, 274 of 583 surveys were returned. RESULTS: Influenza vaccination rate by parental report was 56% in 2003 and 45% in 2004. The most important factors related to immunization were doctor's recommendation (OR = 10.5, 95% CI: 6.2-17.7; P < 0.001), receiving a reminder (OR = 1.6, 95% CI: 1.01-2.6; P = 0.047) and parental belief that the child should be vaccinated (OR = 7.1, 95% CI: 4.3-11.6; P < 0.001). From 2003-2004, nonphysician social influences to have infants vaccinated against influenza increased overall, and perceived positive consequences of vaccination increased among parents of vaccinated children. CONCLUSIONS: Social support for influenza vaccination of healthy infants increased over the two years of the encouragement period, suggesting that information regarding this vaccine was reaching the general public. The most important facilitators of influenza immunization were physician recommendation, parental support and reminders. This suggests that reminders from physicians should specifically state that the doctor recommends influenza vaccine and address common misperceptions about influenza vaccine. These findings may have broader applications as the age groups for whom influenza vaccination is recommended continue to expand.

Parental perspectives on influenza vaccination of children with chronic medical conditions.

BACKGROUND: Minorities and those living in the inner city have a higher respiratory disease burden than other groups. Yet, influenza vaccination rates among all children with chronic medical conditions remain low. METHODS: Parents of 2-13-year-old children with high-risk medical conditions from health centers in low-income urban neighborhoods completed a mailed survey. Immunization status from medical records was used to calculate validity measures. Survey data are presented for those whose vaccination status was concordant between parental report and the medical record (n=183). RESULTS: Parent-reported influenza vaccination versus medical record review showed 84.9% sensitivity, 68.7% specificity, 49.1% positive predictive value and 92.7% negative predictive value, with a kappa of 0.43. Vaccination rate was 30.6%. Medical record-verified influenza vaccination was associated with parental beliefs that the doctor recommends a flu shot (OR, 40.9; 95% Cl, 9.0-184.9) and that relatives recommend a flu shot (OR, 4.3; 95% Cl, 1.7-10.5), and was less likely if the parent believed that the child will get the flu if a household member is infected (OR, 0.2; 95% Cl, 0.1-0.6). CONCLUSIONS: The message that influenza vaccination is important to protect children with chronic medical conditions may be relayed through physician recommendation or a relative's suggestion and may be more effective if it addresses vaccine efficacy issues.

Penicillin susceptibility of pneumococcal isolates causing acute otitis media in children: seasonal variation.

BACKGROUND: During the past decade, the prevalence of nonsusceptible Streptococcus pneumoniae strains that cause acute otitis media (AOM) has increased to approximately 30%, and the proportion of fully resistant strains has also increased. The purpose of this study was to determine whether seasonal variation in resistance exists among pneumococcal isolates from children with AOM. METHODS: Between 1991 and 2003, children 2 months-8 years of age diagnosed with AOM according to stringent criteria underwent tympanocentesis in various clinical trials. RESULTS: Cultures from 567 of 794 tympanocenteses (71.4%) performed between 1991 and 2003 yielded AOM pathogens. During 1991-1995, only 1 of 43 S. pneumoniae isolates recovered (2%) was nonsusceptible to penicillin. The present analysis focuses on the 691 cultures obtained during 1996-2003; of these, 491 (71.1%) yielded AOM pathogens, of which 165 (33.6%) were S. pneumoniae. Of the pneumococcal isolates, 52 (31.5%) were nonsusceptible to penicillin. The proportion of nonsusceptible strains of S. pneumoniae increased over time: 0 of 3 (0%) in 1996; 2 of 11 (18%) in 1997; 14 of 40 (35%) in 1998; 3 of 34 (9%) in 1999; 11 of 25 (44%) in 2000; 11 of 22 (50%) in 2001; 4 of 18 (22%) in 2002; and 7 of 12 (58%) in 2003 (Cochran Armitage trend test, P = 0.03). AOM caused by nonsusceptible S. pneumoniae was more likely to occur as the winter progressed (P = 0.03); a similar trend was noted for the proportion of nonsusceptible strains that were fully resistant. CONCLUSIONS: In children with AOM, an increase in the proportion of episodes caused by nonsusceptible S. pneumoniae as the winter months progress may serve as a potential factor in guiding antimicrobial therapy for such children.

Parental perspectives on influenza immunization of children aged 6 to 23 months.

BACKGROUND: For the first time, in 2002, the Advisory Committee on Immunization Practices encouraged the vaccination of healthy children 6 to 23 months against influenza, whenever feasible. Participating inner-city health centers designed interventions to introduce influenza vaccination among this group of children. The study was designed to assess parents' attitudes toward the vaccine. METHODS: Following the 2002-2003 influenza vaccination season, parents were surveyed to identify barriers to and facilitators of influenza vaccination. A low-literacy level, 19-question survey was mailed to parents in three waves, 4 weeks apart. A subset of children had medical record data available to confirm vaccination status. Measures of validity were calculated. This paper focused only on the children whose parent-reported vaccination status was concordant with that reported in medical records (n = 193). Associations of responses to vaccination status were calculated in 2004, using chi-square and logistic regression procedures. RESULTS: Sensitivity was 85.7% and specificity was 66% (kappa = 0.50), assessing the ability of parents to recall receipt or nonreceipt of influenza vaccine. The most important factors related to immunization of healthy infants were perceived doctor's recommendation (odds ratio [OR] = 5.5; 95% confidence interval [CI] = 2.4-12.3; p < 0.001) and belief that getting an influenza shot is a smart idea (OR = 3.5; 95% CI = 1.3-8.9; p < 0.01) for those with medical record-confirmed vaccination status. CONCLUSIONS: A clear message that the doctor recommends influenza vaccination for a child is an important factor for ensuring vaccination, and may foster the idea that vaccination is "smart."

Tailored interventions to introduce influenza vaccination among 6- to 23-month-old children at inner-city health centers.

BACKGROUND: Because of high rates of hospitalization for influenza infections among very young children (< 2 years), the Advisory Committee on Immunization Practices initiated a new policy in 2002 that encouraged vaccination of healthy children aged 6 to 23 months against influenza. OBJECTIVE: To evaluate the effectiveness of implementing tailored interventions to introduce influenza vaccination of children 6 to 23 months of age in inner-city practices. STUDY DESIGN: A before-after trial with historical and concurrent controls was conducted in 6 health centers in low-income urban locations. METHODS: Intervention sites were selected, and interventions (directed at 1534 patients who were 6 to 23 months old) were implemented from a menu of strategies. Vaccination rates were measured from medical record reviews. Focus groups of nursing staffs provided evaluative information on strategies. RESULTS: Influenza vaccination rates improved significantly at the intervention health centers compared with the control center. Preintervention (2001-2002) rates ranged from 0% to 7.6%, and intervention (2002-2003) rates ranged from 15.2% to 49.2% (P < .001). The number of interventions ranged from 6 to 11. Sites that used more interventions (odds ratio, 1.24; 95% confidence interval, 1.15-1.34) and had staff support of the vaccination effort (odds ratio, 1.91; 95% confidence interval, 1.40-2.60) had higher vaccination rates. CONCLUSIONS: Tailored interventions resulted in successful introduction of influenza vaccination of 6- to 23-month-old children in inner-city health centers. More strategies and enthusiastic staff support may result in higher vaccination rates.

Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial.

CONTEXT: Acute otitis media (AOM) frequently complicates influenza infection. Previous studies have found influenza vaccine effective in reducing the occurrence of AOM in children mainly older than 2 years. OBJECTIVE: To evaluate the effectiveness of inactivated influenza vaccine in preventing AOM in children aged 6 to 24 months. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled trial of 786 children aged 6 to 24 months enrolled at Children's Hospital of Pittsburgh before the 1999-2000 (411 children) and 2000-2001 (375 children) respiratory seasons (defined as December 1 through March 31 of the respective following year). Children received influenza vaccine or placebo in a 2:1 ratio. The first cohort was observed for 1 year and the second cohort until the end of the ensuing respiratory season. INTERVENTION: Two doses (0.25 mL each) of inactivated trivalent subvirion influenza vaccine or placebo were administered intramuscularly approximately 4 weeks apart. MAIN OUTCOME MEASURES: Proportion of children who developed AOM, monthly occurrence rate of AOM, estimated proportion of time with middle ear effusion, and utilization of selected health care and related resources. RESULTS: Of the 66 children in the vaccine group from whom serum samples were collected, seroconversion against strains in the vaccine formulations developed in 88.6% to 96.8%, depending on the specific strain. The efficacy of the vaccine against culture-confirmed influenza was 66% (95% confidence interval [CI], 34%-82%) in 1999-2000 and -7% (95% CI, -247% to 67%) in 2000-2001; however, influenza attack rates differed between these 2 periods (in the placebo group, 15.9% and 3.3%, respectively). Compared with placebo, influenza vaccine did not reduce the proportion of children who had at least 1 episode of AOM during the respiratory season (in the first cohort: vaccine, 49.2% vs placebo, 52.2%; P =.56 ]; in the second cohort: vaccine, 55.8% vs placebo, 48.3%; P =.17). The vaccine also did not reduce the monthly rate of AOM; the estimated proportion of time with middle ear effusion; or the utilization of selected health care and related resources. There were also no differences between the vaccine and placebo groups regarding any of these outcomes during peak influenza periods. The vaccines administered to both cohorts of children were well tolerated. CONCLUSION: Administration of inactivated trivalent influenza vaccine to children aged 6 to 24 months did not reduce their burden of AOM or their utilization of selected health care and related resources.

Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial.

OBJECTIVES: Our primary objective was to develop and evaluate an intervention to increase recruitment in a multicenter pediatric randomized clinical trial (RCT). Our secondary objective was to assess the impact beyond 120 days. METHODS: The study was conducted at 17 academic centers participating in a pediatric RCT. The intervention consisted of utilizing a recruitment assessment tool at a site visit or teleconference with key site personnel. RESULTS: We found a significant increase in the number of individuals enrolled for all 17 sites at 120 days postintervention (mean = 1.12 per site; median = 1 per site; 95% confidence interval = 1-2; P = .04). No significant differences were apparent beyond the first 120 days postintervention. CONCLUSIONS: Successful recruitment in RCTs is essential to the quality, generalizability, and cost-effectiveness of clinical research. Implementation of this recruitment intervention may effectively increase recruitment in RCTs. Beyond the first 120 days postintervention, repeated interventions may be required. What is new? Despite general and pediatric-specific challenges to recruitment in RCTs, a paucity of evidence exists on effective recruitment strategies or assessment tools to reliably enhance recruitment. We developed a recruitment intervention for use in RCTs that enables clinical researchers to enhance recruitment.

Signs and symptoms that differentiate acute sinusitis from viral upper respiratory tract infection.

OBJECTIVE: Differentiating acute bacterial sinusitis from viral upper respiratory tract infection (URI) is challenging; 20% to 40% of children diagnosed with acute sinusitis based on clinical criteria likely have an uncomplicated URI. The objective of this study was to determine which signs and symptoms could be used to identify the subgroup of children who meet current clinical criteria for sinusitis but who nevertheless have a viral URI. METHODS: We obtained sinus radiographs in consecutive children meeting a priori clinical criteria for acute sinusitis. We considered the subgroup of children with completely normal sinus radiographs to have an uncomplicated URI despite meeting the clinical diagnostic criteria for sinusitis. We examined the utility of signs and symptoms in identifying children with URI. RESULTS: Of 258 children enrolled, 54 (20.9%) children had completely normal radiographs. The absence of green nasal discharge, the absence of disturbed sleep and mild symptoms were associated with a diagnosis of URI. No physical exam findings were particularly helpful in distinguishing between children with normal versus abnormal radiographs. CONCLUSIONS: Among children meeting current criteria for the diagnosis of acute sinusitis, those with mild symptoms are significantly more likely to have a URI than those with severe symptoms. In addition to assessing overall severity of symptoms, practitioners should ask about sleep disturbance and green nasal discharge when assessing children with suspected sinusitis; their absence favors a diagnosis of URI.