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1.
J Asthma ; : 1-10, 2020 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-32160068

RESUMO

Objective: Pathways are succinct, operational versions of evidence-based guidelines. Studies have demonstrated pathways improve quality of care for children hospitalized with asthma, but we have limited information on other key factors to guide hospital leaders and clinicians in pathway implementation efforts. Our objective was to evaluate the adoption, implementation, and reach of inpatient pediatric asthma pathways.Methods: This was a mixed-methods study of hospitals participating in a national collaborative to implement pathways. Data sources included electronic surveys of implementation leaders and staff, field observations, and chart review of children ages 2-17 years admitted with a primary diagnosis of asthma. Outcomes included adoption by hospitals, pathway implementation factors, and reach of pathways to children hospitalized with asthma. Quantitative data were analyzed using descriptive statistics and multivariable regression. Qualitative data were analyzed using thematic content analysis.Results: Eighty-five hospitals enrolled; 68 (80%) adopted/completed the collaborative. These 68 hospitals implemented pathways with overall high fidelity, implementing a median of 5 of 5 core pathway components (Interquartile Range [IQR] 4-5) in a median of 5 months (IQR 3-9). Implementation teams reported a median time cost of 78 h (IQR: 40-120) for implementation. Implementation leaders reported the values of pathway implementation included improvements in care, enhanced interdisciplinary collaboration, and access to educational resources. Leaders reported barriers in modifying electronic health records (EHRs), and only 63% of children had electronic pathway orders placed.Conclusions: Hospitals implemented pathways with high fidelity. Barriers in modifying EHRs may have limited the reach of pathways to children hospitalized with asthma.

3.
J Allergy Clin Immunol ; 145(2): 528-536.e1, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31145939

RESUMO

BACKGROUND: The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT) pregnancy registry was a prospective observational study established in 2006 to evaluate perinatal outcomes in pregnant women exposed to omalizumab and their infants. OBJECTIVE: This analysis compares EXPECT outcomes with those from a disease-matched population of pregnant women not treated with omalizumab. Data from a substudy of platelet counts among newborns are also presented. METHODS: The EXPECT study enrolled 250 women with asthma exposed to omalizumab during pregnancy. The disease-matched external comparator cohort of women with moderate-to-severe asthma (n = 1153), termed the Quebec External Comparator Cohort (QECC), was created by using data from health care databases in Quebec, Canada. Outcome estimates were age adjusted based on the maternal age distribution of the EXPECT study. RESULTS: Among singleton infants in the EXPECT study, the prevalence of major congenital anomalies was 8.1%, which was similar to the 8.9% seen in the QECC. In the EXPECT study 99.1% of pregnancies resulted in live births, which was similar to 99.3% in the QECC. Premature birth was identified in 15.0% of EXPECT infants and 11.3% in the QECC. Small for gestational age was identified in 9.7% of EXPECT infants and 15.8% in the QECC. CONCLUSION: There was no evidence of an increased risk of major congenital anomalies among pregnant women exposed to omalizumab compared with a disease-matched unexposed cohort. Given the observational nature of this registry, however, an absence of increased risk with omalizumab cannot be definitively established.

4.
J Asthma ; 57(2): 205-216, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30657001

RESUMO

Objective: To evaluate the extent of documentation of asthma control and severity and associated characteristics among pediatric asthma patients in office-based settings. Methods: This cross-sectional study utilized data from the 2012-2015 National Ambulatory Medical Care Survey (NAMCS). Patients aged 6-17 years with a diagnosis of asthma were included. Weighted descriptive analysis examined the extent of documentation and uncontrolled asthma; while logistic regression evaluated associated characteristics. Results: Overall, there were 2.47 million (95% confidence interval, 95% CI: 2.04-2.90) average annual visits with asthma as a primary diagnosis. Asthma control and severity was documented in only 36.1% and 33.8% of the visits, respectively. An established patient (odds ratio, OR = 3.81), Hispanic ethnicity (OR = 2.10), chronic sinusitis (OR = 5.59), and visits in the Northeast (OR = 2.12) and Midwest (OR = 2.25) regions had higher odds of documented asthma control status, whereas undocumented asthma severity (OR = 0.02), and visits in spring (OR = 0.34), had lower odds. Osteopathic doctors (OR = 0.18), visits in the Northeast region (OR = 0.23), chronic sinusitis (OR = 0.08), and undocumented asthma control status (OR = 0.03) had lower odds of documented asthma severity, whereas visits in spring (OR = 3.88) and autumn (OR = 3.32) had higher odds. Moderate/severe persistent asthma (OR = 15.35) had higher odds of uncontrolled asthma (as compared to intermittent asthma), while visits in the summer (OR = 0.14) had lower odds. Conclusion: The findings of this study suggest a critical need to increase the documentation of asthma severity and control to improve quality of asthma care in children.

7.
J Allergy Clin Immunol ; 144(6): 1524-1533, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31520679

RESUMO

BACKGROUND: Minority groups of African descent experience disproportionately greater asthma morbidity compared with other racial groups, suggesting that genetic variation from a common ancestry could influence exacerbation risk. OBJECTIVE: We evaluated clinical trial measures in the context of self-reported race and genetic ancestry to identify risk factors for asthma exacerbations. METHODS: One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n = 760). RESULTS: Twenty-four percent of 1840 subjects self-identified as black. Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects. In the combined multiethnic cohort, neither race (P = .30) nor percentage of genetic African ancestry as a continuous variable associated with exacerbation risk (adjusted rate ratio [RR], 1.26 [95% CI, 0.94-1.70; P = .13]; RR per 1-SD change [32% ancestry], 0.97 [95% CI, 0.78-1.19; P = .74]). However, in 161 black subjects with genetic data, those with African ancestry greater than the median (≥82%) had a significantly greater risk of exacerbation (RR, 3.06 [95% CI, 1.09-8.6; P = .03]). CONCLUSION: Black subjects have unique risk factors for asthma exacerbations, of which global African genetic ancestry had the strongest effect.

8.
N Engl J Med ; 381(13): 1227-1239, 2019 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-31553835

RESUMO

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.).


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Afro-Americanos , Asma/tratamento farmacológico , Broncodilatadores/administração & dosagem , Fluticasona/administração & dosagem , Glucocorticoides/administração & dosagem , Xinafoato de Salmeterol/administração & dosagem , Administração por Inalação , Adolescente , Adulto , Criança , Pré-Escolar , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Masculino , Estudos Prospectivos
9.
Pediatrics ; 144(4)2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31554667

RESUMO

BACKGROUND AND OBJECTIVES: Asthma is responsible for ∼1.7 million emergency department (ED) visits annually in the United States. Studies in adults have shown that anxiety and depression are associated with increased asthma-related ED use. Our objective was to assess this association in pediatric patients with asthma. METHODS: We identified patients aged 6 to 21 years with asthma in the Massachusetts All-Payer Claims Database for 2014 to 2015 using International Classification of Diseases, Ninth and 10th Revision codes. We examined the association between the presence of anxiety, depression, or comorbid anxiety and depression and the rate of asthma-related ED visits per 100 child-years using bivariate and multivariable analyses with negative binomial regression. RESULTS: Of 65 342 patients with asthma, 24.7% had a diagnosis of anxiety, depression, or both (11.2% anxiety only, 5.8% depression only, and 7.7% both). The overall rate of asthma-related ED use was 17.1 ED visits per 100 child-years (95% confidence interval [CI]: 16.7-17.5). Controlling for age, sex, insurance type, and other chronic illness, patients with anxiety had a rate of 18.9 (95% CI: 17.0-20.8) ED visits per 100 child-years, patients with depression had a rate of 21.7 (95% CI: 18.3-25.0), and patients with both depression and anxiety had a rate of 27.6 (95% CI: 24.8-30.3). These rates were higher than those of patients who had no diagnosis of anxiety or depression (15.5 visits per 100 child-years; 95% CI: 14.5-16.4; P < .001). CONCLUSIONS: Children with asthma and anxiety or depression alone, or comorbid anxiety and depression, have higher rates of asthma-related ED use compared with those without either diagnosis.


Assuntos
Ansiedade/epidemiologia , Asma/epidemiologia , Depressão/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Adolescente , Algoritmos , Criança , Comorbidade , Intervalos de Confiança , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Cobertura do Seguro/estatística & dados numéricos , Masculino , Massachusetts/epidemiologia , Prevalência , Análise de Regressão , Adulto Jovem
11.
J Am Soc Nephrol ; 30(8): 1505-1513, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31320460

RESUMO

BACKGROUND: Study findings suggest that initiating dialysis at a higher eGFR level in adults with ESRD does not improve survival. It is less clear whether starting dialysis at a higher eGFR is associated with a survival benefit in children with CKD. METHODS: To investigate this issue, we performed a retrospective cohort study of pediatric patients aged 1-18 years who, according to the US Renal Data System, started dialysis between 1995 and 2015. The primary predictor was eGFR at the time of dialysis initiation, categorized as higher (eGFR>10 ml/min per 1.73 m2) versus lower eGFR (eGFR≤10 ml/min per 1.73 m2). RESULTS: Of 15,170 children, 4327 (29%) had a higher eGFR (median eGFR, 12.8 ml/min per 1.73 m2) at dialysis initiation. Compared with children with a lower eGFR (median eGFR, 6.5 ml/min per 1.73 m2), those with a higher eGFR at dialysis initiation were more often white, girls, underweight or obese, and more likely to have GN as the cause of ESRD. The risk of death was 1.36 times higher (95% confidence interval, 1.24 to 1.50) among children with a higher (versus lower) eGFR at dialysis initiation. The association between timing of dialysis and survival differed by treatment modality-hemodialysis versus peritoneal dialysis (P<0.001 for interaction)-and was stronger among children initially treated with hemodialysis (hazard ratio, 1.56, 95% confidence interval, 1.39 to 1.75; versus hazard ratio, 1.07, 95% confidence interval, 0.91 to 1.25; respectively). CONCLUSIONS: In children with ESRD, a higher eGFR at dialysis initiation is associated with lower survival, particularly among children whose initial treatment modality is hemodialysis.

12.
Breastfeed Med ; 14(8): 533-537, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31314569

RESUMO

Objective: Early exposure to formula can interfere with successful long-term breastfeeding. The objective of this study was to determine whether limiting the volume of formula used in the first month attenuates formula's detrimental impact on long-term breastfeeding success. Materials and Methods: Using detailed data on dietary intake from a randomized clinical trial, we conducted a secondary analysis of the association between volume of formula received in the first month and breastfeeding cessation before 6 and 12 months of age. We used descriptive statistics and multivariable logistic regression, respectively, to explore this association without and with adjustment for demographic and clinical predictors of infant feeding. Results: Among 199 breastfeeding infants, 80 (40%) received formula daily at 1 month of age, and breastfeeding cessation before 6 and 12 months of age was higher for these infants (46% and 67%) than for those breastfed exclusively (6% and 27%) (p < 0.0005 for each). The risk of cessation did not differ between those who received ≤4 fl oz daily in the first month (11%) and those who did not receive formula in the first month (6%) (p = 0.42). Adjusting for gestational age, race/ethnicity, income, and intention to breastfeed exclusively, the odds ratio for the outcome of cessation before 6 months was 1.15 (95% confidence interval = 0.20-6.67) for infants who received ≤4 fl oz daily compared with those who breastfed exclusively. Conclusion: Limiting formula volumes to ≤4 fl oz daily may attenuate the deleterious association between early formula use and subsequent successful breastfeeding.

13.
Nat Microbiol ; 4(11): 1851-1861, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31332384

RESUMO

Neonates at risk of childhood atopy and asthma exhibit perturbation of the gut microbiome, metabolic dysfunction and increased concentrations of 12,13-diHOME in their faeces. However, the mechanism, source and contribution of this lipid to allergic inflammation remain unknown. Here, we show that intra-abdominal treatment of mice with 12,13-diHOME increased pulmonary inflammation and decreased the number of regulatory T (Treg) cells in the lungs. Treatment of human dendritic cells with 12,13-diHOME altered expression of PPARγ-regulated genes and reduced anti-inflammatory cytokine secretion and the number of Treg cells in vitro. Shotgun metagenomic sequencing of neonatal faeces indicated that bacterial epoxide hydrolase (EH) genes are more abundant in the gut microbiome of neonates who develop atopy and/or asthma during childhood. Three of these bacterial EH genes (3EH) specifically produce 12,13-diHOME, and treatment of mice with bacterial strains expressing 3EH caused a decrease in the number of lung Treg cells in an allergen challenge model. In two small birth cohorts, an increase in the copy number of 3EH or the concentration of 12,13-diHOME in the faeces of neonates was found to be associated with an increased probability of developing atopy, eczema or asthma during childhood. Our data indicate that elevated 12,13-diHOME concentrations impede immune tolerance and may be produced by bacterial EHs in the neonatal gut, offering a mechanistic link between perturbation of the gut microbiome during early life and atopy and asthma during childhood.


Assuntos
Asma/imunologia , Bactérias/classificação , Epóxido Hidrolases/genética , Fezes/química , Ácidos Linoleicos/análise , Animais , Bactérias/enzimologia , Bactérias/genética , Fenômenos Fisiológicos Bacterianos , Proteínas de Bactérias/genética , Modelos Animais de Doenças , Feminino , Microbioma Gastrointestinal , Humanos , Tolerância Imunológica , Recém-Nascido , Masculino , Camundongos , Linfócitos T Reguladores/metabolismo
14.
Public Health Nutr ; 22(15): 2856-2867, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31303190

RESUMO

OBJECTIVE: To evaluate whether a multipronged pilot intervention promoting healthier beverage consumption improved at-home beverage consumption and weight status among young children. DESIGN: In this exploratory pilot study, we randomly assigned four childcare centres to a control (delayed-intervention) condition or a 12-week intervention that promoted consumption of healthier beverages (water, unsweetened low- or non-fat milk) and discouraged consumption of less-healthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk). The multipronged intervention was delivered via childcare centres; simultaneously targeted children, parents and childcare staff; and included environmental changes, policies and education. Outcomes were measured at baseline and immediately post-intervention and included children's (n 154) at-home beverage consumption (assessed via parental report) and overweight/obese status (assessed via objectively measured height and weight). We estimated intervention impact using difference-in-differences models controlling for children's demographics and classroom. SETTING: Two northern California cities, USA, 2013-2014. PARTICIPANTS: Children aged 2-5 years and their parents. RESULTS: Relative to control group children, intervention group children reduced their consumption of less-healthy beverages from baseline to follow-up by 5·9 ounces/d (95 % CI -11·2, -0·6) (-174·5 ml/d; 95 % CI -331·2, -17·7) and increased their consumption of healthier beverages by 3·5 ounces/d (95 % CI -2·6, 9·5) (103·5 ml/d; 95 % CI -76·9, 280·9). Children's likelihood of being overweight decreased by 3 percentage points (pp) in the intervention group and increased by 3 pp in the control group (difference-in-differences: -6 pp; 95 % CI -15, 3). CONCLUSIONS: Our exploratory pilot study suggests that interventions focused comprehensively on encouraging healthier beverage consumption could improve children's beverage intake and weight. Findings should be confirmed in longer, larger studies.

15.
Headache ; 59(7): 988-1001, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31222745

RESUMO

BACKGROUND: Infant colic, or excessive crying in an otherwise healthy infant, is common, although the cause(s) are not known. This study aimed to determine whether parental migraine is associated with infant colic. METHODS: This was a cross-sectional online survey study of biological parents of 4-8 week olds in the United States during February and March 2017 and October 2017-April 2018. Parents self-reported information about their and their infant's health using validated instruments wherever possible. Parents were recruited using social media advertisements and completed the survey online. Migraine was identified with a validated screener using modified International Classification of Headache Disorders 3rd edition criteria. Parental depression and anxiety were screened with the Patient Health Questionnaire-2 (PHQ-2) and Generalized Anxiety Disorder Scale-2 (GAD-2). Parental seasonal allergies and asthma were assessed by self-report. Infant colic was determined based on parental response to the question, "Has your baby cried for at least 3 hours on at least 3 days in the last week?" RESULTS: A total of 1,715 surveys were completed over 2 recruitment periods; 1,419 formed the analysis set. Eight hundred twenty-seven were completed by biological mothers and 592 by biological fathers. Mean (SD) maternal age: 28.9 (5.1) years; 33.5% had migraine/probable migraine. Maternal migraine was associated with increased odds of infant colic: OR 1.7 (1.3-2.4). Among mothers with migraine, headache frequency ≥15 days/month was associated with higher risk of infant colic (OR 2.5 (1.2-5.3)); and anxiety was borderline associated (OR 1.7 (1.0-2.9)). Mean (SD) paternal age was 31.6 (4.5) years; 20.8% had migraine/probable migraine. Paternal migraine was not associated with infant colic: OR 1.0 (0.7-1.5). Fathers with depression (OR 2.4 (1.4-4.3)) or anxiety (OR 1.7 (1.1-2.7)) were more likely to have a baby with colic but having a girl infant was protective: (OR 0.7 (0.5-0.97)). CONCLUSIONS: Mothers with migraine are more likely to have a baby with colic, while fathers with migraine are not. Further research is needed to determine the mechanisms underlying these findings. In the meantime, clinicians may wish to counsel parents with a maternal history of migraine about the increased possibility of having a colicky infant and provide resources and education about infant crying.

16.
JAMA Pediatr ; 173(8): 729-735, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31157878

RESUMO

Importance: Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants. Objective: To determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months. Design, Setting, and Participants: This randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016. Interventions: Early Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention. Main Outcomes and Measures: The study's primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey. Results: Eighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%]; P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P = .049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, -12%; 95% CI, -26% to 3%; P = .12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, -18%; 95% CI, -34% to -3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group. Conclusions and Relevance: In this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation. Trial Registration: ClinicalTrials.gov identifier: NCT02313181.

17.
Glob Pediatr Health ; 6: 2333794X19847026, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31106244

RESUMO

National guidelines recommend that providers counsel all patients with sickle cell anemia about hydroxyurea (HU) therapy and screen children with sickle cell anemia annually for the risk of stroke with transcranial Doppler (TCD). We surveyed a national convenience sample of sickle cell disease clinicians to assess factors associated with low adherence. Adherence was 46% for TCD screening. Low adherence was associated with a lack of outcome expectancy (eg, a belief that there would be poor patient follow-up to TCD testing; P < .05). Adherence was 72% for HU counseling. Practice barriers (eg, lack of support staff or time) and a lack of agreement with HU recommendations were associated with low adherence (P < .05). This study demonstrates that different types of strategies are needed to improve TCD screening (to address follow-up and access to testing) versus HU counseling (to address physician agreement and practice barriers).

18.
N Engl J Med ; 380(21): 2009-2019, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31112384

RESUMO

BACKGROUND: In many patients with mild, persistent asthma, the percentage of eosinophils in sputum is less than 2% (low eosinophil level). The appropriate treatment for these patients is unknown. METHODS: In this 42-week, double-blind, crossover trial, we assigned 295 patients who were at least 12 years of age and who had mild, persistent asthma to receive mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist), or placebo. The patients were categorized according to the sputum eosinophil level (<2% or ≥2%). The primary outcome was the response to mometasone as compared with placebo and to tiotropium as compared with placebo among patients with a low sputum eosinophil level who had a prespecified differential response to one of the trial agents. The response was determined according to a hierarchical composite outcome that incorporated treatment failure, asthma control days, and the forced expiratory volume in 1 second; a two-sided P value of less than 0.025 denoted statistical significance. A secondary outcome was a comparison of results in patients with a high sputum eosinophil level and those with a low level. RESULTS: A total of 73% of the patients had a low eosinophil level; of these patients, 59% had a differential response to a trial agent. However, there was no significant difference in the response to mometasone or tiotropium, as compared with placebo. Among the patients with a low eosinophil level who had a differential treatment response, 57% (95% confidence interval [CI], 48 to 66) had a better response to mometasone, and 43% (95% CI, 34 to 52) had a better response to placebo (P = 0.14). In contrast 60% (95% CI, 51 to 68) had a better response to tiotropium, whereas 40% (95% CI, 32 to 49) had a better response to placebo (P = 0.029). Among patients with a high eosinophil level, the response to mometasone was significantly better than the response to placebo (74% vs. 26%) but the response to tiotropium was not (57% vs. 43%). CONCLUSIONS: The majority of patients with mild, persistent asthma had a low sputum eosinophil level and had no significant difference in their response to either mometasone or tiotropium as compared with placebo. These data provide equipoise for a clinically directive trial to compare an inhaled glucocorticoid with other treatments in patients with a low eosinophil level. (Funded by the National Heart, Lung, and Blood Institute; SIENA ClinicalTrials.gov number, NCT02066298.).


Assuntos
Asma/tratamento farmacológico , Broncodilatadores/uso terapêutico , Eosinófilos , Glucocorticoides/uso terapêutico , Furoato de Mometasona/uso terapêutico , Escarro/imunologia , Brometo de Tiotrópio/uso terapêutico , Administração por Inalação , Adolescente , Adulto , Asma/imunologia , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Contagem de Leucócitos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Adulto Jovem
19.
J Asthma ; : 1-11, 2019 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-31020879

RESUMO

OBJECTIVE: Clinical pathways (operational versions of practice guidelines) can improve guideline adherence and quality of care for children hospitalized with asthma. However, there is limited guidance on how to implement pathways successfully. Our objective was to identify potential best practices in pathway implementation. METHODS: In a previous observational study, we identified higher and lower performing children's hospitals based on hospital-level changes in asthma patient length of stay after implementation of a pathway. In this qualitative study, we conducted semi-structured interviews with a purposive sample of healthcare providers involved in pathway implementation at these hospitals. We used constant comparative methods to develop a conceptual model of potential best practices in implementation. RESULTS: Healthcare providers (n = 24) from 6 higher performing and 2 lower performing hospitals were interviewed about pathway implementation. We identified several practices that addressed barriers and promoted successful pathway implementation: (1) utilizing quality improvement (QI) methodology and a data-driven approach helped overcome inertia of current practice; (2) getting teams to commit to shared goals around asthma care helped overcome disagreements in the implementation process; (3) integrating pathways into the electronic medical record decreased some burdens of implementation; (4) leveraging multidisciplinary teams by developing protocols for nurses and/or respiratory therapists to titrate medications reduced variability in provider practice; and (5) engaging hospital leaders with pathway implementation teams helped secure crucial resources. CONCLUSIONS: We identified several potential best practices to support pathway implementation. Hospitals implementing pathways should consider applying these strategies to better ensure success in improving quality of asthma care for children.

20.
JAMA Dermatol ; 155(5): 556-563, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30892577

RESUMO

Importance: The well-being and development of children is strongly influenced by parents' physical and psychosocial health. Data from small, clinic-based studies suggest that sleep loss may be common in parents of children with atopic dermatitis (AD), but longitudinal population-based studies are lacking. Objectives: To compare sleep disturbances over time between mothers of children with and without AD and to determine whether these disturbances are associated with the child's disease severity and the child's sleep disturbances. Design, Setting, and Participants: In the ongoing Avon Longitudinal Study of Parents and Children, all pregnant women residing in Avon, United Kingdom, with an expected delivery date between April 1, 1991, and December 31, 1992, were recruited. Analyses for this study, a secondary analysis of this cohort, were performed from September 2017 to September 2018. Mother-child pairs were followed up with a time-varying measure of child AD activity and severity and self-reported maternal sleep measures repeated at multiple time points between child ages 6 months and 11 years. Main Outcomes and Measures: Time-varying binary measures of maternal sleep duration (<6 vs ≥6 hours per night), difficulty falling asleep, early morning awakening, subjectively insufficient sleep, and daytime exhaustion. Results: The study followed up 13 988 mother-child pairs from birth for a median duration of 11 (interquartile range, 7-11) years. Among the cohort, 11 585 of 13 972 mothers (82.9%) were aged 21 to 34 years and 12 001 of 12 324 (97.4%) were of white race/ethnicity; 7220 of 13 978 children (51.7%) were male. Sleep duration (adjusted odds ratio [AOR], 1.09; 95% CI, 0.90-1.32) and early morning awakenings (AOR, 1.16; 95% CI, 0.93-1.46) were similar between mothers of children with and without AD. In contrast, mothers of children with AD were more likely to report difficulty falling asleep (AOR, 1.36; 95% CI, 1.01-1.83), subjectively insufficient sleep (AOR, 1.43; 95% CI, 1.24-1.66), and daytime exhaustion (AOR, 1.41; 95% CI, 1.12-1.78) independent of the child's comorbid asthma and/or allergic rhinitis. For all measures, worse child AD severity was associated with worse maternal sleep outcomes. The magnitude and significance of the associations were largely unchanged after adjustment for child sleep disturbances. Conclusions and Relevance: Mothers of children with AD reported difficulty falling asleep, subjectively insufficient sleep, and daytime exhaustion throughout the first 11 years of childhood. However, child sleep disturbances did not fully explain maternal sleep disturbances, and future research should investigate other mechanisms. In caring for children with AD, clinicians should consider maternal sleep disturbances and caregiver fatigue.


Assuntos
Dermatite Atópica/psicologia , Mães/psicologia , Transtornos do Sono-Vigília/epidemiologia , Adulto , Criança , Pré-Escolar , Estudos de Coortes , Dermatite Atópica/patologia , Feminino , Humanos , Lactente , Recém-Nascido , Estudos Longitudinais , Masculino , Índice de Gravidade de Doença , Reino Unido , Adulto Jovem
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