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.

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.).

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 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.

Are nasopharyngeal cultures useful in diagnosis of acute bacterial sinusitis in children?

The diagnosis of acute bacterial sinusitis can be challenging because symptoms of acute sinusitis and an upper respiratory tract infection (URI) overlap. A rapid test, if accurate in differentiating sinusitis from URI, could be helpful in the diagnostic process. We examined the utility of nasopharyngeal cultures in identifying the subgroup of children with a clinical diagnosis of acute sinusitis who are least likely to benefit from antimicrobial therapy (those with completely normal sinus radiographs). Nasopharyngeal swabs were collected from 204 children meeting a priori clinical criteria for acute sinusitis. All children had sinus X-rays at the time of diagnosis. To determine if negative nasopharyngeal culture results could reliably identify the subgroup of children with normal radiographs, we calculated negative predictive values and negative likelihood ratios. Absence of pathogens in the nasopharynx was not helpful in identifying this low-risk subgroup.

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.

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

IMPORTANCE: A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. OBJECTIVE: To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. DESIGN: Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. SETTING: Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. PARTICIPANTS: Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. MAIN OUTCOMES AND MEASURES: A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND RELEVANCE Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision, and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty. Consideration of the factors included in the conceptual model should enhance the quality of the informed consent process and improve participation in pediatric clinical trials.

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.).

Pneumococcal resistance and serotype 19A in Pittsburgh-area children with acute otitis media before and after introduction of 7-valent pneumococcal polysaccharide vaccine.

METHODS: Before and after introduction of pneumococcal conjugate vaccine (PCV7), the authors obtained nasopharyngeal (NP) specimens from 3 groups of children aged 6 to 23 months with acute otitis media (AOM): group 1 (pre-PCV7), group 2 (early post-PCV7), and group 3 (late post-PCV7). RESULTS: Of the Streptococcus pneumoniae isolates, the proportion that were vaccine serotypes (VTs) declined progressively (60.4% vs 48.6% vs 5.2% in groups 1, 2, and 3, respectively; P < .001). Concurrently, increases occurred in the proportion of penicillin-nonsusceptible isolates (minimum inhibitory concentration >0.1 µg/mL; 26.7% vs 37.8% vs. 38.5%; P = .12); the proportion of isolates that were serotype 19A (4.0% vs 0% vs 25.9%; P < .001); and the proportion of 19A isolates that were penicillin-nonsusceptible (0% in group 1, 68.6% in group 3; P = .004). CONCLUSION: Shifts in pneumococcal serotype distribution and increases in penicillin nonsusceptibility among pneumococcal isolates from children with AOM underscore the need for continuing bacteriological surveillance for future vaccine development.

How do parents of preverbal children with acute otitis media determine how much ear pain their child is having?

UNLABELLED: The objective of this study was to determine how parents of preverbal children determine whether their child is having otalgia. We constructed 8 cases describing a 1-year-old child with acute otitis media (AOM) using various combinations of the following 6 observable symptoms: fussiness, ear tugging, eating less, fever, sleeping difficulty, and playing less. Parents of children with a history of AOM presenting for well or sick appointments to an ambulatory clinic were asked to assign a pain level to each case on a visual analog scale. Sixty-nine parents participated in the study. Each of the 6 behaviors was associated with increased pain levels (P < .0001). Ear tugging and fussiness had the highest impact on the assigned pain levels. Higher level of parental education and private insurance were associated with higher reported pain levels (P = .007 and P = .001, respectively). Because interpretation of symptoms appears to be influenced by socioeconomic status, we question the utility of using an overall pain score from a 1-item parent scale as an outcome measure in clinical trials that include preverbal children. PERSPECTIVE: Parents of preverbal children with acute otitis media use observable behaviors to determine their child's pain level. Interpretation of symptoms, however, appears to be influenced by socioeconomic status. Thus, we question the utility of using a 1-item parental pain scale in clinical trials that include preverbal children.

Development of a patient-reported outcome measure for children with streptococcal pharyngitis.

OBJECTIVE: The objective of this study was to develop a patient-reported outcome measure (Strep-PRO) for assessing symptoms of group A Streptococcus (GAS) pharyngitis from the child's point of view and to present preliminary data on its internal reliability, construct validity, and responsiveness. METHODS: We selected 8 symptoms for inclusion in the Strep-PRO. We used the Strep-PRO to assess improvement in children who were aged 5 to 15 years and had confirmed GAS pharyngitis. Children completed the scale at study visits and as a diary at home. To evaluate internal reliability, we examined correlations between the items on the scale. To evaluate construct validity, we examined the correlation at entry between Strep-PRO scores and scores on other, previously validated measures of pain and functional status. To evaluate responsiveness, we examined the change in score from enrollment to follow-up. The correlation between the Strep-PRO score and parental assessment of symptoms was also evaluated. RESULTS: A total of 131 children were enrolled; 113 returned completed diaries. The internal reliability of the scale was high. The magnitude of correlations between Strep-PRO scores and other measures of pain and functional status ranged from 0.39 to 0.63. The responsiveness of the Strep-PRO was very good. The overall level of agreement between child Strep-PRO scores and parental assessment of symptoms was 0.57. CONCLUSIONS: The scale seems to measure effectively both pain and overall functional status in children with GAS pharyngitis. These data support the use of Strep-PRO as a measure of outcome in future clinical trials.

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.

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.

Beliefs and attitudes about influenza immunization among parents of children with chronic medical conditions over a two-year period.

Influenza vaccination is recommended for children with chronic medical conditions yet is infrequently performed. The reasons for low influenza vaccination rates in this group have not been well studied. We assessed and compared parents of children with chronic medical conditions regarding their beliefs and attitudes about influenza vaccination in 2003 and 2004. Parents of 2- to 13-year-old children with chronic medical conditions from health centers in low-income urban neighborhoods completed a 19-question survey, mailed following the 2002-2003 and 2003-2004 influenza seasons. Parent-reported influenza vaccination rate declined from 2003 (44%) to 2004 (25%). The most important factors related to influenza vaccination status were perceived doctor's recommendation (odds ratio [OR] = 6.0, 95% confidence interval [CI] = 3.7-9.7), parents' belief that the child should be vaccinated (OR = 5.4, 95%CI = 3.3-8.8), relatives' belief that the child should be vaccinated (OR = 1.7, 95%CI = 1.1-2.7), easy access to the doctor's office for a flu shot (OR = 2.4, 95%CI = 1.4-4.2), and receipt of a reminder from the doctor's office (OR = 1.7, 95%CI = 1.1-2.6). In 2004 compared with 2003, fewer parents reported getting a reminder, and fewer believed that their child's doctor recommended flu vaccine. Doctors' recommendation that children with chronic medical conditions should receive an annual influenza vaccine and vaccine availability are important factors that resulted in a higher likelihood of influenza vaccination. Our findings that fewer parents reported receiving reminders and that fewer children were vaccinated in 2004 suggest that sustained improvements in vaccination rates may require continual changes in the format and delivery method of vaccination reminders from physicians.