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1.
Acad Pediatr ; 24(4): 669-676, 2024.
Article En | MEDLINE | ID: mdl-38246348

OBJECTIVE: To examine the association between adverse childhood experiences (ACEs) and related events and asthma symptom burden in children. METHODS: This is a cross-sectional study of baseline data from 147 participants with asthma from a cohort of children enrolled in the Pediatric ACEs Screening and Resiliency Study. Participants completed the PEdiatric ACEs and Related Life Events Screener (PEARLS) tool, a 17-item questionnaire, capturing 3 domains of childhood adversity-child maltreatment, household challenges, and social context. Asthma symptom burden was assessed using the International Study of Asthma and Allergies in Childhood core questionnaire, which asks participants to identify the presence and frequency of severe wheezing that limits speech, wheezing with exercise, nocturnal wheezing, and nocturnal cough in the last 12 months. Using multivariable logistical regression models, we examined the relationship between reported PEARLS and asthma symptoms. RESULTS: Of children with asthma, 86% reported at least 1 adversity, with 48% reporting 4 or more. The odds of severe wheeze limiting speech increased by 19% with each additional reported adversity captured by the PEARLS tool (95% confidence intervals (CI) 1.01-1.41). Increasing PEARLS scores were also associated with 16% increased odds of reporting wheeze with exercise (95% CI 1.03-1.31). Wheezing with exercise was associated with the household challenges domain (odds ratio (OR) 1.34; 95% CI 1.05-1.72), while severe wheeze limiting speech was associated with the social context domain (OR 1.75; 95%CI 1.02-3.02). CONCLUSIONS: Childhood adversities are associated with increased asthma symptom burden, suggesting the tool may be helpful in identifying children at risk for poorly controlled asthma.


Adverse Childhood Experiences , Asthma , Respiratory Sounds , Humans , Asthma/epidemiology , Female , Male , Child , Cross-Sectional Studies , Adverse Childhood Experiences/statistics & numerical data , Logistic Models , Adolescent , Surveys and Questionnaires , Child Abuse/statistics & numerical data , Cough/epidemiology , Cough/etiology , Child, Preschool , Multivariate Analysis
2.
BMC Pediatr ; 23(1): 367, 2023 07 17.
Article En | MEDLINE | ID: mdl-37461038

BACKGROUND: Research examining the connections between individual adverse childhood experiences (ACEs) and how groupings of interrelated adversities are linked with subsequent health is scarce, limiting our understanding of risk during a period of rapid expansion of ACE screening in clinical practice. The study objective was to conduct a psychometric analysis to derive latent domains of ACEs and related life events and assess the association between each domain and health outcome. METHODS: Participants (3 months-11 years) were recruited from the University of California San Francisco Benioff's Children Hospital Oakland Primary Care Clinic. Children were screened with the Pediatric ACEs and Related Life Events Screener (PEARLS) (n = 340), which assessed 17 total ACEs and related life events, including forms of abuse, household challenges, and social risks. Domains were constructed using confirmatory factor analysis and associations between the three identified domains and 14 health outcomes were assessed using multivariable linear and logistic regression models. RESULTS: Three PEARLS domains were identified: Maltreatment (ω = 0.73, ɑ=0.87), Household Challenges (ω = 0.70, ɑ=0.82), and Social Context (ω = 0.55, ɑ=0.70). Measurement invariance was supported across both gender and screening format. All domains were associated with poorer general and behavioral health and stomachaches. Maltreatment and Social Context were additionally associated with eczema while only Social Context was associated with increased odds of reporting headaches and somatic symptoms. CONCLUSION: In an underserved, urban west-coast pediatric population, the PEARLS found three adversity domains of Maltreatment, Household Challenges, and Social Context that all had an independent statistically significant association with poorer child health. The results provide a timely and more nuanced representation of risk that can inform clinical practice and policy using more targeted resources and interventions.

3.
PLoS One ; 17(12): e0273491, 2022.
Article En | MEDLINE | ID: mdl-36520927

BACKGROUND: While there is growing support for screening for Adverse Childhood Experiences (ACEs), rigorous evidence on the efficacy and preference of screening methods is needed. OBJECTIVE: To examine caregiver: (1) rates of disclosure of their child's exposure to ACEs using item-level response (each item can be endorsed) versus aggregate-level response (only total score reported) screening format, (2) associations between family demographic factors and disclosure by screening format, and (3) emotional reaction and experience of screening formats in a diverse, low-income pediatric population. METHODS: Caregiver participants (n = 367) were randomized to complete the Pediatric ACEs and Related Life Events Screener (PEARLS) tool, in an aggregate-level response vs item-level response format from 2016-2019. Select caregivers (n = 182) participated in debriefing interviews. T-test and chi-square analyses in 2019 compared PEARLS disclosure rates and reactions between the screening modalities. Regression models explored interactions with child characteristics. Thematic analysis of interview notes captured caregiver screening experience. RESULTS: PEARLS disclosure rates were significantly higher in the aggregate-level response compared to the item-level response screening arm (p <0.05). This difference was accentuated for children identified as black and/or male (p <0.05). Caregiver reactions to PEARLS screening were rarely negative in either screening format. Qualitative data demonstrated strong caregiver preference for the item-level response format; additional themes include provider relationship, fear with disclosure, and screening outcome expectations. CONCLUSION: While caregivers reported a preference for the item-level response format, the aggregate-level response screening format elicited higher disclosures rates particularly for children who are black or ma. TRIAL REGISTRATION: Clinical trial registry: NCT04182906.


Adverse Childhood Experiences , Pediatrics , Child , Humans , Male , Caregivers/psychology , Disclosure
4.
Child Abuse Negl ; 108: 104685, 2020 10.
Article En | MEDLINE | ID: mdl-32898839

BACKGROUND: Adverse Childhood Experiences (ACEs) are associated with behavioral, mental, and clinical outcomes in children. Tools that are easy to incorporate into pediatric practice, effectively screen for adversities, and identify children at high risk for poor outcomes are lacking. OBJECTIVE: To examine the relationship between caregiver-reported child ACEs and related life events with health outcomes. PARTICIPANTS AND SETTING: Participants (0-11 years) were recruited from the University of California San Francisco Benioff's Children Hospital Oakland Primary Care Clinic. There were 367 participants randomized. METHODS: Participants were randomized 1:1:1 to item-level (item response), aggregate-level (total number of exposures), or no screening for ACEs (control arm) with the PEdiatric ACEs and Related Life Event Screener (PEARLS). We assessed 10 ACE categories capturing abuse, neglect, and household challenges, as well as 7 additional categories. Multivariable regression models were conducted. RESULTS: Participants reported a median of 2 (IQR 1-5) adversities with 76 % (n = 279) reporting at least one adversity; participants in the aggregate-level screening arm, on average, disclosed 1 additional adversity compared to item-level screening (p = 0.01). Higher PEARLS scores were associated with poorer perceived child general health (adjusted B = -0.94, 95 %CI: -1.26, -0.62) and Global Executive Functioning (adjusted B = 1.99, 95 %CI: 1.51, 2.46), and greater odds of stomachaches (aOR 1.14; 95 %CI: 1.04-1.25) and asthma (aOR 1.08; 95 %CI 1.00, 1.17). Associations did not differ by screening arm. CONCLUSION: In a high-risk pediatric population, ACEs and other childhood adversities remain an independent predictor of poor health. Increased efforts to screen and address early-life adversity are necessary.


Adverse Childhood Experiences/psychology , Safety-net Providers/methods , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Risk Factors
5.
N Engl J Med ; 381(13): 1227-1239, 2019 09 26.
Article En | MEDLINE | ID: mdl-31553835

BACKGROUND: Morbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately controlled asthma benefit more from addition of a long-acting beta-agonist (LABA) than from increased glucocorticoids; however, these data may not be informative for treatment in black patients. METHODS: We conducted two prospective, randomized, double-blind trials: one involving children and the other involving adolescents and adults. In both trials, the patients had at least one grandparent who identified as black and had asthma that was inadequately controlled with low-dose inhaled glucocorticoids. We compared combinations of therapy, which included the addition of a LABA (salmeterol) to an inhaled glucocorticoid (fluticasone propionate), a step-up to double to quintuple the dose of fluticasone, or both. The treatments were compared with the use of a composite measure that evaluated asthma exacerbations, asthma-control days, and lung function; data were stratified according to genotypic African ancestry. RESULTS: When quintupling the dose of fluticasone (to 250 µg twice a day) was compared with adding salmeterol (50 µg twice a day) and doubling the fluticasone (to 100 µg twice a day), a superior response occurred in 46% of the children with quintupling the fluticasone and in 46% of the children with doubling the fluticasone and adding salmeterol (P = 0.99). In contrast, more adolescents and adults had a superior response to added salmeterol than to an increase in fluticasone (salmeterol-low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003]; salmeterol-medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). Neither the degree of African ancestry nor baseline biomarkers predicted a superior response to specific treatments. The increased dose of inhaled glucocorticoids was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years of age. CONCLUSIONS: In contrast to black adolescents and adults, almost half the black children with poorly controlled asthma had a superior response to an increase in the dose of an inhaled glucocorticoid and almost half had a superior response to the addition of a LABA. (Funded by the National Heart, Lung, and Blood Institute; BARD ClinicalTrials.gov number, NCT01967173.).


Adrenergic beta-2 Receptor Agonists/administration & dosage , Asthma/drug therapy , Black or African American , Bronchodilator Agents/administration & dosage , Fluticasone/administration & dosage , Glucocorticoids/administration & dosage , Salmeterol Xinafoate/administration & dosage , Administration, Inhalation , Adolescent , Adult , Child , Child, Preschool , Cross-Over Studies , Dose-Response Relationship, Drug , Double-Blind Method , Drug Combinations , Female , Humans , Male , Prospective Studies
7.
PLoS One ; 13(12): e0208088, 2018.
Article En | MEDLINE | ID: mdl-30540843

Adverse Childhood Experiences (ACEs) are associated with poor health outcomes, underlining the significance of early identification and intervention. Currently, there is no validated tool to screen for ACEs exposure in childhood. To fill this gap, we designed and implemented a pediatric ACEs questionnaire in an urban pediatric Primary Care Clinic. Questionnaire items were selected and modified based on literature review of existing childhood adversity tools. Children twelve years and under were screened via caregiver report, using the developed instrument. Cognitive interviews were conducted with caregivers, health providers, and clinic staff to assess item interpretation, clarity, and English/Spanish language equivalency. Using a rapid cycle assessment, information gained from the interviews were used to iteratively change the instrument. Additional questions assessed acceptability of screening within primary care and preferences around administration. Twenty-eight (28) caregivers were administered the questionnaire. Cognitive interviews conducted among caregivers and among 16 health providers and clinic staff resulted in the changes in wording and addition of examples in the items to increase face validity. In the final instrument, no new items were added; however, two items were merged and one item was split into three separate items. While there was a high level of acceptability of the overall questionnaire, some caregivers reported discomfort with the sexual abuse, separation from caregiver, and community violence items. Preference for methods of administration were split between tablet and paper formats. The final Pediatric ACE and other Determinants of Health Questionnaire is a 17-item instrument with high face validity and acceptability for use within primary care settings. Further evaluation on the reliability and construct validity of the instrument is being conducted prior to wide implementation in pediatric practice.


Adverse Childhood Experiences/statistics & numerical data , Patient-Centered Care/organization & administration , Social Determinants of Health/statistics & numerical data , Surveys and Questionnaires , Adult , Caregivers , Child , Child, Preschool , Female , Health Plan Implementation , Humans , Male , Middle Aged , Patient-Centered Care/statistics & numerical data , Pilot Projects , Reproducibility of Results , Urban Health Services/organization & administration , Urban Health Services/statistics & numerical data
8.
N Engl J Med ; 378(10): 891-901, 2018 Mar 08.
Article En | MEDLINE | ID: mdl-29504498

BACKGROUND: Asthma exacerbations occur frequently despite the regular use of asthma-controller therapies, such as inhaled glucocorticoids. Clinicians commonly increase the doses of inhaled glucocorticoids at early signs of loss of asthma control. However, data on the safety and efficacy of this strategy in children are limited. METHODS: We studied 254 children, 5 to 11 years of age, who had mild-to-moderate persistent asthma and had had at least one asthma exacerbation treated with systemic glucocorticoids in the previous year. Children were treated for 48 weeks with maintenance low-dose inhaled glucocorticoids (fluticasone propionate at a dose of 44 µg per inhalation, two inhalations twice daily) and were randomly assigned to either continue the same dose (low-dose group) or use a quintupled dose (high-dose group; fluticasone at a dose of 220 µg per inhalation, two inhalations twice daily) for 7 days at the early signs of loss of asthma control ("yellow zone"). Treatment was provided in a double-blind fashion. The primary outcome was the rate of severe asthma exacerbations treated with systemic glucocorticoids. RESULTS: The rate of severe asthma exacerbations treated with systemic glucocorticoids did not differ significantly between groups (0.48 exacerbations per year in the high-dose group and 0.37 exacerbations per year in the low-dose group; relative rate, 1.3; 95% confidence interval, 0.8 to 2.1; P=0.30). The time to the first exacerbation, the rate of treatment failure, symptom scores, and albuterol use during yellow-zone episodes did not differ significantly between groups. The total glucocorticoid exposure was 16% higher in the high-dose group than in the low-dose group. The difference in linear growth between the high-dose group and the low-dose group was -0.23 cm per year (P=0.06). CONCLUSIONS: In children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth. (Funded by the National Heart, Lung, and Blood Institute; STICS ClinicalTrials.gov number, NCT02066129 .).


Anti-Asthmatic Agents/administration & dosage , Asthma/prevention & control , Fluticasone/administration & dosage , Administration, Inhalation , Albuterol/administration & dosage , Anti-Asthmatic Agents/adverse effects , Child , Child, Preschool , Dose-Response Relationship, Drug , Double-Blind Method , Female , Fluticasone/adverse effects , Growth/drug effects , Humans , Male , Peak Expiratory Flow Rate
9.
J Allergy Clin Immunol ; 138(6): 1608-1618.e12, 2016 12.
Article En | MEDLINE | ID: mdl-27777180

BACKGROUND: Phenotypic presentations in young children with asthma are varied and might contribute to differential responses to asthma controller medications. METHODS: The Individualized Therapy for Asthma in Toddlers study was a multicenter, randomized, double-blind, double-dummy clinical trial in children aged 12 to 59 months (n = 300) with asthma necessitating treatment with daily controller (Step 2) therapy. Participants completed a 2- to 8-week run-in period followed by 3 crossover periods with daily inhaled corticosteroids (ICSs), daily leukotriene receptor antagonists, and as-needed ICS treatment coadministered with albuterol. The primary outcome was differential response to asthma medication based on a composite measure of asthma control. The primary analysis involved 2 stages: determination of differential response and assessment of whether 3 prespecified features (aeroallergen sensitization, previous exacerbations, and sex) predicted a differential response. RESULTS: Seventy-four percent (170/230) of children with analyzable data had a differential response to the 3 treatment strategies. Within differential responders, the probability of best response was highest for a daily ICS and was predicted by aeroallergen sensitization but not exacerbation history or sex. The probability of best response to daily ICS was further increased in children with both aeroallergen sensitization and blood eosinophil counts of 300/µL or greater. In these children daily ICS use was associated with more asthma control days and fewer exacerbations compared with the other treatments. CONCLUSIONS: In young children with asthma necessitating Step 2 treatment, phenotyping with aeroallergen sensitization and blood eosinophil counts is useful for guiding treatment selection and identifies children with a high exacerbation probability for whom treatment with a daily ICS is beneficial despite possible risks of growth suppression.


Adrenal Cortex Hormones/therapeutic use , Asthma/drug therapy , Leukotriene Antagonists/therapeutic use , Administration, Inhalation , Albuterol/therapeutic use , Child, Preschool , Female , Follow-Up Studies , Humans , Infant , Male , Precision Medicine , Recurrence , Treatment Outcome , United States
10.
N Engl J Med ; 375(7): 619-30, 2016 Aug 18.
Article En | MEDLINE | ID: mdl-27532828

BACKGROUND: Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS: In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS: Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS: Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).


Acetaminophen/adverse effects , Asthma/chemically induced , Ibuprofen/adverse effects , Acetaminophen/therapeutic use , Asthma/epidemiology , Child, Preschool , Double-Blind Method , Female , Fever/drug therapy , Humans , Ibuprofen/therapeutic use , Incidence , Infant , Kaplan-Meier Estimate , Male , Pain/drug therapy , Prospective Studies
11.
JAMA ; 314(19): 2034-2044, 2015 Nov 17.
Article En | MEDLINE | ID: mdl-26575060

IMPORTANCE: Many preschool children develop recurrent, severe episodes of lower respiratory tract illness (LRTI). Although viral infections are often present, bacteria may also contribute to illness pathogenesis. Strategies that effectively attenuate such episodes are needed. OBJECTIVE: To evaluate if early administration of azithromycin, started prior to the onset of severe LRTI symptoms, in preschool children with recurrent severe LRTIs can prevent the progression of these episodes. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled, parallel-group trial conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by December 2014. Participants were 607 children aged 12 through 71 months with histories of recurrent, severe LRTIs and minimal day-to-day impairment. INTERVENTION: Participants were randomly assigned to receive azithromycin (12 mg/kg/d for 5 days; n = 307) or matching placebo (n = 300), started early during each predefined RTI (child's signs or symptoms prior to development of LRTI), based on individualized action plans, over a 12- through 18-month period. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the number of RTIs not progressing to a severe LRTI, measured at the level of the RTI, that would in clinical practice trigger the prescription of oral corticosteroids. Presence of azithromycin-resistant organisms in oropharyngeal samples, along with adverse events, were among the secondary outcome measures. RESULTS: A total of 937 treated RTIs (azithromycin group, 473; placebo group, 464) were experienced by 443 children (azithromycin group, 223; placebo group, 220), including 92 severe LRTIs (azithromycin group, 35; placebo group, 57). Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0.64 [95% CI, 0.41-0.98], P = .04; absolute risk for first RTI: 0.05 for azithromycin, 0.08 for placebo; risk difference, 0.03 [95% CI, 0.00-0.06]). Induction of azithromycin-resistant organisms and adverse events were infrequently observed. CONCLUSIONS AND RELEVANCE: Among young children with histories of recurrent severe LRTIs, the use of azithromycin early during an apparent RTI compared with placebo reduced the likelihood of severe LRTI. More information is needed on the development of antibiotic-resistant pathogens with this strategy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01272635.


Anti-Bacterial Agents/administration & dosage , Azithromycin/administration & dosage , Respiratory Tract Infections/prevention & control , Secondary Prevention/methods , Child, Preschool , Disease Progression , Double-Blind Method , Drug Administration Schedule , Drug Resistance, Bacterial , Female , Humans , Infant , Male , Recurrence , Respiratory Tract Infections/microbiology , Respiratory Tract Infections/virology
12.
J Urban Health ; 88 Suppl 1: 49-60, 2011 Feb.
Article En | MEDLINE | ID: mdl-21337051

Emergency care and hospitalizations account for 36% of asthma-related medical expenses for children. National asthma guidelines emphasize the need for asthma self-management education at multiple points of care, including the hospital, to help prevent acute exacerbations. The integration of a bedside asthma education program into discharge planning at a busy urban children's hospital aimed to reduce repeat emergency department (ED) visits and hospitalizations by educating the community's highest-risk children and their families about asthma. A trained respiratory professional provided 45 minutes of individualized bedside education to families at the hospital and one follow-up support phone call within 3 weeks after discharge. Children receiving the intervention were matched to a control group of children not receiving the intervention by age and 2 markers of past utilization using data obtained from hospital records. Repeat ED utilization was analyzed using a Cox proportional hazards model controlling for sex, residence, race or ethnicity, and year. Compared to 698 matched controls, no significant improvement was observed in the 698 intervention participants or any subgroups followed for 12 months after the intervention.


Asthma/therapy , Caregivers/education , Patient Education as Topic/methods , Self Care/standards , Adolescent , California , Child , Child, Preschool , Emergency Service, Hospital , Female , Hospitals, Pediatric , Hospitals, Urban , Humans , Infant , Male , Patient Discharge/standards , Patient Education as Topic/standards , Patient Readmission/statistics & numerical data , Proportional Hazards Models , Self Care/methods
13.
J Urban Health ; 88 Suppl 1: 130-43, 2011 Feb.
Article En | MEDLINE | ID: mdl-21337059

Community-based coalitions are commonly formed to plan and to carry out public health interventions. The literature includes evaluations of coalition structure, composition, and functioning; evaluations of community-level changes achieved through coalition activities; and the association between coalition characteristics and various indicators of success. Little information is available on the comparative advantage or "added value" of conducting public health interventions through coalitions as opposed to less structured collaborative mechanisms. This paper describes a qualitative, iterative process carried out with site representatives of the Controlling Asthma in American Cities Project (CAACP) to identify outcomes directly attributable to coalitions. The process yielded 2 complementary sets of results. The first were criteria that articulated and limited the concept of "added value of coalitions". The criteria included consensus definitions, an organizing figure, a logic model, and inclusion/exclusion criteria. The second set of results identified site-specific activities that met the definitional criteria and were, by agreement, examples of CAACP coalitions' added value. Beyond the specific findings relevant to the added value of coalitions in this project, the use of a social ecological model to identify the components of added value and the placement of those components within a logic model specific to coalitions should provide useful tools for those planning and assessing coalition-based projects.


Asthma/prevention & control , Community Health Planning/methods , Health Care Coalitions , Urban Health , Asthma/therapy , Centers for Disease Control and Prevention, U.S. , Humans , Logistic Models , Models, Organizational , Program Evaluation/methods , Qualitative Research , United States
14.
Telemed J E Health ; 10 Suppl 2: S-6-14, 2004.
Article En | MEDLINE | ID: mdl-23570208

Asthma prevalence is increasing among poor and minority children. We examined the effectiveness of a novel interactive device programmed for self-management of pediatric asthma in reducing asthma control problems and hospitalizations. A randomized controlled trial (66 children in the intervention group and 68 in the control group) was conducted at home and in an outpatient hospital clinic with 8-16-year-old inner-city children with physician-diagnosed asthma. During a 12-week period, children in the experimental group received an asthma self-management and education program, the Health Buddy (Health Hero Network), designed to enable them to monitor their symptoms and transmit this information to a case manager through a secure website. Control group participants used an asthma diary. After adjusting for baseline asthma control problems, asthma severity, and seasonality, children randomized to automated self-management had a significantly lower mean number of asthma control problems at 6 weeks (2.0, SD = 1.6) as compared to children assigned to the asthma diary (2.7, SD = 1.6) (p = 0.03). By 12 weeks, after adjusting for time and the other covariates, asthma control problems dropped markedly in both groups, and did not differ by intervention modality (p = .07). The intervention modality was not a significant predictor of hospitalization. Educational interventions that encourage children's active involvement in their own care and symptom monitoring would help children increase their control of asthma problems. Compared to the asthma diary, the automated self-management had a significant short-term impact on asthma control problems. Its initial effectiveness and more consistent use suggest that remote monitoring may be successfully used in short-term interventions and in settings where staffing for case management is weak.


Asthma/drug therapy , Hospitalization/trends , Urban Population , Adolescent , Asthma/complications , California , Child , Female , Humans , Male , Medical Records , Self Care , User-Computer Interface
15.
Pediatrics ; 112(1 Pt 1): 66-73, 2003 Jul.
Article En | MEDLINE | ID: mdl-12837869

OBJECTIVE: Heptavalent pneumococcal conjugate vaccine (PCV) has been shown to be safe and effective in healthy infants and children. However, little is known about its use in children who have human immunodeficiency virus (HIV) infection and are known to be at increased risk of developing pneumococcal infections. This study was conducted to evaluate the safety and immunogenicity of heptavalent PCV in infants with HIV infection. METHODS: The Pediatric AIDS Clinical Trials Group Study 292 Team randomized infants with HIV infection 2:1 to receive heptavalent PCV or placebo in a double-blinded manner. Infants were vaccinated with 3 doses at 2-month intervals, starting at ages 56 to 180 days. A booster dose was given at 15 months of age. Immunogenicity was evaluated after the third dose of vaccine, before and after the booster dose, and at 24 months of age. RESULTS: Thirty infants with HIV infection received PCV, and 15 received placebo. No differences in baseline characteristics were found across arms. Five severe acute reactions were experienced by 4 subjects: 3 in the PCV arm and 1 in the placebo arm; all occurred among subjects with symptomatic disease at study entry. No differences were found in the 2 arms with respect to the number or timing of new diagnoses through 24 months of age, including diagnoses of otitis media. However, when symptomatic subjects were examined separately, the first new diagnosis occurred more rapidly among PCV recipients. Three deaths, all judged to be unrelated to study vaccine, occurred during follow-up: 2 in the PCV arm and 1 in the placebo arm. The primary immunogenicity measures were based on composites of 4-fold changes in serotype-specific immunoglobulin G titers from preimmunization levels. We found a highly significant difference between the vaccine and placebo arms, with the PCV arm showing higher rates of response. Asymptomatic and symptomatic subjects who received PCV had similar immunologic responses for all serotypes. CONCLUSIONS: This study demonstrates that heptavalent PCV was well tolerated and not associated with vaccine-associated adverse reactions. Most important, this vaccine was immunogenic in the infant with HIV infection. However, additional studies of this vaccine (or others) must pay special attention to patients with symptomatic HIV disease, as they seem to be at higher risk for adverse events to any antigen.


HIV Infections/immunology , HIV-1 , Meningococcal Vaccines/immunology , Pneumococcal Vaccines/immunology , Antibodies, Bacterial/biosynthesis , Antibodies, Bacterial/blood , Antiretroviral Therapy, Highly Active , Double-Blind Method , Female , Follow-Up Studies , HIV Infections/drug therapy , Heptavalent Pneumococcal Conjugate Vaccine , Humans , Immunization, Secondary , Immunocompetence , Immunoglobulin G/biosynthesis , Immunoglobulin G/blood , Infant , Male , Meningococcal Vaccines/adverse effects , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/adverse effects , Risk , Safety , Streptococcus pneumoniae/classification , Streptococcus pneumoniae/immunology , Vaccination
16.
Arch Pediatr Adolesc Med ; 156(2): 114-20, 2002 Feb.
Article En | MEDLINE | ID: mdl-11814370

BACKGROUND: Asthma is an important cause of morbidity, absence from school, and use of health services among children. Computer-based educational programs can be designed to enhance children's self-management skills and to reduce adverse outcomes. OBJECTIVE: To assess the effectiveness of an interactive device programmed for the management of pediatric asthma. DESIGN: A randomized controlled trial (66 participants were in the intervention group and 68 were in the control group). SETTING: Interventions conducted at home and in an outpatient hospital clinic. PARTICIPANTS: Inner-city children aged 8 to 16 years diagnosed as having asthma by a physician. INTERVENTION: An asthma self-management and education program, the Health Buddy, designed to enable children to assess and monitor their asthma symptoms and quality of life and to transmit this information to health care providers (physicians, nurses, or other case managers) through a secure Web site. Control group participants used an asthma diary. MAIN OUTCOME MEASURES: Any limitation in activity was the primary outcome. Secondary outcomes included perceived asthma symptoms, absence from school, any peak flow reading in the yellow or red zone, and use of health services. RESULTS: After adjusting for covariates, the odds of having any limitation in activity during the 90-day trial were significantly (P =.03) lower for children randomized to the Health Buddy. The intervention group also was significantly (P =.01) less likely to report peak flow readings in the yellow or red zone or to make urgent calls to the hospital (P =.05). Self-care behaviors, which were important correlates of asthma outcomes, also improved far more for the intervention group. CONCLUSION: Compared with the asthma diary, monitoring asthma symptoms and functional status with the Health Buddy increases self-management skills and improves asthma outcomes.


Asthma/therapy , Health Behavior , Patient Compliance , Self Care/methods , Adolescent , California , Child , Computers , Female , Humans , Male , Patient Education as Topic , Urban Population
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