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1.
N Engl J Med ; 384(19): 1789-1799, 2021 05 13.
Artículo en Inglés | MEDLINE | ID: mdl-33979487

RESUMEN

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.).


Asunto(s)
Antibacterianos/uso terapéutico , Ventilación del Oído Medio , Otitis Media/tratamiento farmacológico , Otitis Media/cirugía , Enfermedad Aguda , Antibacterianos/efectos adversos , Preescolar , Farmacorresistencia Bacteriana , Femenino , Humanos , Lactante , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Otitis Media con Derrame , Calidad de Vida , Recurrencia
2.
Pediatr Nephrol ; 35(11): 2113-2120, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32556960

RESUMEN

BACKGROUND: To evaluate the efficacy of adjuvant systemic corticosteroids in reducing kidney scarring. A previous study suggested that use of adjuvant systemic corticosteroids reduces kidney scarring in children radiologically confirmed to have extensive pyelonephritis. Efficacy of corticosteroids for children with febrile urinary tract infection (UTI) has not been studied. METHODS: Children aged 2 months to 6 years with their first febrile UTI were randomized to corticosteroids or placebo for 3 days (both arms received antimicrobial therapy); kidney scarring was assessed using 99mTc-dimercaptosuccinic acid kidney scan 5-24 months after the initial UTI. RESULTS: We randomized 546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned). Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1). CONCLUSION: While children randomized to adjuvant corticosteroids tended to develop fewer kidney scars than children who were randomized to receive placebo, a statistically significant difference was not achieved. However, the study was limited by not reaching its intended sample size. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov , NCT01391793, Registered 7/12/2011 Graphical abstract.


Asunto(s)
Corticoesteroides/administración & dosificación , Glomerulonefritis/prevención & control , Infecciones Urinarias/tratamiento farmacológico , Adyuvantes Farmacéuticos/administración & dosificación , Adyuvantes Farmacéuticos/efectos adversos , Corticoesteroides/efectos adversos , Factores de Edad , Antibacterianos/uso terapéutico , Preescolar , Método Doble Ciego , Femenino , Fiebre , Glomerulonefritis/diagnóstico por imagen , Humanos , Lactante , Masculino
4.
Pediatr Nephrol ; 35(2): 321-329, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31758242

RESUMEN

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.


Asunto(s)
Biomarcadores/sangre , Biomarcadores/orina , Infecciones Urinarias/sangre , Infecciones Urinarias/diagnóstico , Infecciones Urinarias/orina , Niño , Preescolar , Reacciones Falso Positivas , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Sensibilidad y Especificidad , Urinálisis
5.
J Pediatr ; 209: 146-153.e1, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30905425

RESUMEN

OBJECTIVE: To determine whether treatment for urinary tract infections in children could be individualized using biomarkers for acute pyelonephritis. STUDY DESIGN: We enrolled 61 children with febrile urinary tract infections, collected blood and urine samples, and performed a renal scan within 2 weeks of diagnosis to identify those with pyelonephritis. Renal scans were interpreted centrally by 2 experts. We measured inflammatory proteins in blood and urine using LUMINEX or an enzyme-linked immunosorbent assay. We evaluated serum RNA expression using RNA sequencing in a subset of children. Finally, for children with Escherichia coli isolated from urine cultures, we performed a polymerase chain reaction for 4 previously identified virulence genes. RESULTS: Urinary markers that best differentiated pyelonephritis from cystitis included chemokine (C-X-C motif) ligand (CXCL)1, CXCL9, CXCL12, C-C motif chemokine ligand 2, INF γ, and IL-15. Serum procalcitonin was the best serum marker for pyelonephritis. Genes in the interferon-γ pathway were upregulated in serum of children with pyelonephritis. The presence of E coli virulence genes did not correlate with pyelonephritis. CONCLUSIONS: Immune response to pyelonephritis and cystitis differs quantitatively and qualitatively; this may be useful in differentiating these 2 conditions.


Asunto(s)
Infecciones Bacterianas , Cistitis/microbiología , Pielonefritis/microbiología , Infecciones Urinarias , Enfermedad Aguda , Infecciones Bacterianas/sangre , Infecciones Bacterianas/orina , Biomarcadores/análisis , Preescolar , Cistitis/sangre , Cistitis/diagnóstico , Cistitis/orina , Diagnóstico Diferencial , Femenino , Humanos , Lactante , Masculino , Proyectos Piloto , Estudios Prospectivos , Pielonefritis/sangre , Pielonefritis/inducido químicamente , Pielonefritis/orina , Infecciones Urinarias/sangre , Infecciones Urinarias/orina
6.
J Pediatr ; 207: 103-108.e1, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30545562

RESUMEN

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.


Asunto(s)
Evaluación de Resultado en la Atención de Salud/métodos , Sinusitis/fisiopatología , Enfermedad Aguda , Niño , Preescolar , Análisis Factorial , Femenino , Humanos , Evaluación de Resultado en la Atención de Salud/normas , Padres , Estudios Prospectivos , Reproducibilidad de los Resultados
8.
Artículo en Inglés | MEDLINE | ID: mdl-28438923

RESUMEN

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.).


Asunto(s)
Combinación Amoxicilina-Clavulanato de Potasio/uso terapéutico , Antibacterianos/uso terapéutico , Ácido Clavulánico/uso terapéutico , Otitis Media/tratamiento farmacológico , Combinación Amoxicilina-Clavulanato de Potasio/administración & dosificación , Combinación Amoxicilina-Clavulanato de Potasio/efectos adversos , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Ácido Clavulánico/administración & dosificación , Ácido Clavulánico/efectos adversos , Dermatitis/etiología , Diarrea/inducido químicamente , Femenino , Humanos , Lactante , Recién Nacido , Masculino
9.
N Engl J Med ; 375(25): 2446-2456, 2016 12 22.
Artículo en Inglés | MEDLINE | ID: mdl-28002709

RESUMEN

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 .).


Asunto(s)
Combinación Amoxicilina-Clavulanato de Potasio/administración & dosificación , Antiinfecciosos/administración & dosificación , Otitis Media/tratamiento farmacológico , Enfermedad Aguda , Combinación Amoxicilina-Clavulanato de Potasio/efectos adversos , Antiinfecciosos/efectos adversos , Esquema de Medicación , Farmacorresistencia Bacteriana , Femenino , Haemophilus influenzae/aislamiento & purificación , Humanos , Lactante , Masculino , Nasofaringe/microbiología , Pronóstico , Streptococcus pneumoniae/aislamiento & purificación , Insuficiencia del Tratamiento
10.
Pediatrics ; 136(1): e13-21, 2015 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-26055855

RESUMEN

OBJECTIVES: To identify risk factors for recurrent urinary tract infection (UTI) and renal scarring in children who have had 1 or 2 febrile or symptomatic UTIs and received no antimicrobial prophylaxis. METHODS: This 2-year, multisite prospective cohort study included 305 children aged 2 to 71 months with vesicoureteral reflux (VUR) receiving placebo in the RIVUR (Randomized Intervention for Vesicoureteral Reflux) study and 195 children with no VUR observed in the CUTIE (Careful Urinary Tract Infection Evaluation) study. Primary exposure was presence of VUR; secondary exposures included bladder and bowel dysfunction (BBD), age, and race. Outcomes were recurrent febrile or symptomatic urinary tract infection (F/SUTI) and renal scarring. RESULTS: Children with VUR had higher 2-year rates of recurrent F/SUTI (Kaplan-Meier estimate 25.4% compared with 17.3% for VUR and no VUR, respectively). Other factors associated with recurrent F/SUTI included presence of BBD at baseline (adjusted hazard ratio: 2.07 [95% confidence interval (CI): 1.09-3.93]) and presence of renal scarring on the baseline (99m)Tc-labeled dimercaptosuccinic acid scan (adjusted hazard ratio: 2.88 [95% CI: 1.22-6.80]). Children with BBD and any degree of VUR had the highest risk of recurrent F/SUTI (56%). At the end of the 2-year follow-up period, 8 (5.6%) children in the no VUR group and 24 (10.2%) in the VUR group had renal scars, but the difference was not statistically significant (adjusted odds ratio: 2.05 [95% CI: 0.86-4.87]). CONCLUSIONS: VUR and BBD are risk factors for recurrent UTI, especially when they appear in combination. Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD.


Asunto(s)
Antibacterianos/uso terapéutico , Profilaxis Antibiótica/métodos , Cicatriz/epidemiología , Riñón/patología , Medición de Riesgo/métodos , Infecciones Urinarias/epidemiología , Reflujo Vesicoureteral/complicaciones , Preescolar , Cicatriz/etiología , Cicatriz/patología , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Lactante , Masculino , Estudios Prospectivos , Recurrencia , Factores de Riesgo , Estados Unidos/epidemiología , Infecciones Urinarias/complicaciones , Infecciones Urinarias/tratamiento farmacológico , Reflujo Vesicoureteral/diagnóstico
11.
Clin Pediatr (Phila) ; 53(2): 151-7, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24151147

RESUMEN

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.


Asunto(s)
Estudios Multicéntricos como Asunto/métodos , Selección de Paciente , Pediatría , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Niño , Humanos , Desarrollo de Programa , Evaluación de Programas y Proyectos de Salud
12.
Clin Pediatr (Phila) ; 52(12): 1118-21, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24137025

RESUMEN

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.


Asunto(s)
Infecciones por Haemophilus/diagnóstico , Haemophilus influenzae/aislamiento & purificación , Moraxella catarrhalis/aislamiento & purificación , Infecciones por Moraxellaceae/diagnóstico , Nasofaringe/microbiología , Infecciones Neumocócicas/diagnóstico , Sinusitis/diagnóstico , Enfermedad Aguda , Niño , Preescolar , Técnicas de Cultivo , Diagnóstico Diferencial , Femenino , Infecciones por Haemophilus/diagnóstico por imagen , Humanos , Funciones de Verosimilitud , Masculino , Infecciones por Moraxellaceae/diagnóstico por imagen , Infecciones Neumocócicas/diagnóstico por imagen , Valor Predictivo de las Pruebas , Estudios Prospectivos , Radiografía , Sinusitis/diagnóstico por imagen , Sinusitis/microbiología
13.
Pediatr Infect Dis J ; 32(10): 1061-5, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23694838

RESUMEN

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.


Asunto(s)
Infecciones del Sistema Respiratorio/diagnóstico , Sinusitis/diagnóstico , Enfermedad Aguda , Niño , Preescolar , Diagnóstico Diferencial , Femenino , Humanos , Masculino , Estudios Prospectivos , Resultado del Tratamiento
14.
JAMA Pediatr ; 167(6): 561-6, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23546617

RESUMEN

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.


Asunto(s)
Consentimiento Paterno/psicología , Padres/psicología , Ensayos Clínicos Controlados Aleatorios como Asunto/psicología , Negativa a Participar/psicología , Adulto , Altruismo , Antiinfecciosos/uso terapéutico , Ansiedad , Niño , Preescolar , Estudios Transversales , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Lactante , Seguro de Salud , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Prevención Secundaria , Factores Socioeconómicos , Encuestas y Cuestionarios , Confianza , Infecciones Urinarias/prevención & control
16.
N Engl J Med ; 364(2): 105-15, 2011 Jan 13.
Artículo en Inglés | MEDLINE | ID: mdl-21226576

RESUMEN

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.).


Asunto(s)
Combinación Amoxicilina-Clavulanato de Potasio/uso terapéutico , Antibacterianos/uso terapéutico , Otitis Media/tratamiento farmacológico , Enfermedad Aguda , Combinación Amoxicilina-Clavulanato de Potasio/efectos adversos , Antibacterianos/efectos adversos , Diarrea/inducido químicamente , Femenino , Humanos , Lactante , Masculino , Nasofaringe/microbiología , Otitis Media/diagnóstico , Otoscopía , Pronóstico , Recurrencia , Análisis de Regresión , Streptococcus pneumoniae/aislamiento & purificación , Insuficiencia del Tratamiento
17.
Clin Pediatr (Phila) ; 50(2): 114-20, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-21098526

RESUMEN

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.


Asunto(s)
Farmacorresistencia Bacteriana , Otitis Media/microbiología , Infecciones Neumocócicas/prevención & control , Vacunas Neumococicas/inmunología , Streptococcus pneumoniae/clasificación , Streptococcus pneumoniae/aislamiento & purificación , Enfermedad Aguda , Femenino , Humanos , Lactante , Masculino , Nasofaringe/microbiología , Otitis Media/inmunología , Infecciones Neumocócicas/microbiología , Vacunas Neumococicas/administración & dosificación , Serotipificación , Vacunación
18.
J Pain ; 11(12): 1291-4, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-20466597

RESUMEN

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.


Asunto(s)
Conducta del Lactante , Otitis Media/diagnóstico , Dimensión del Dolor/métodos , Dolor/diagnóstico , Padres , Femenino , Humanos , Lactante , Masculino , Otitis Media/complicaciones , Dolor/etiología , Clase Social
19.
Pediatrics ; 124(4): e557-63, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19786423

RESUMEN

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.


Asunto(s)
Faringitis/diagnóstico , Índice de Severidad de la Enfermedad , Infecciones Estreptocócicas/diagnóstico , Streptococcus pyogenes/aislamiento & purificación , Adolescente , Factores de Edad , Antibacterianos/uso terapéutico , Niño , Estudios Transversales , Femenino , Estudios de Seguimiento , Humanos , Masculino , Registros Médicos , Variaciones Dependientes del Observador , Evaluación de Resultado en la Atención de Salud , Dimensión del Dolor , Participación del Paciente , Faringitis/tratamiento farmacológico , Reproducibilidad de los Resultados , Medición de Riesgo , Factores Sexuales , Infecciones Estreptocócicas/tratamiento farmacológico , Encuestas y Cuestionarios
20.
Pediatrics ; 124(4): e714-20, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19786431

RESUMEN

OBJECTIVE: We developed a program for training in the diagnosis of otitis media that included images illustrating various otoscopic findings, mnemonic guides to recollection, and discrimination sessions that included feedback and assessments of diagnostic skills. METHODS: We prepared a computerized, interactive curriculum, Enhancing Proficiency in Otitis Media (ePROM), that was centered around assemblages of clinically diverse, still and video images of tympanic membranes (TMs). To assess curriculum effectiveness, we constructed a test, the Diagnostic Ear Assessment Resource, that consisted of 50 video TM images. We administered the test to 84 residents in pediatrics or family practice who had not been exposed to ePROM and, varying the order in which the images were presented, to another group of 102 residents in the same programs both before and after exposure to ePROM. RESULTS: o Mean proportions of correct diagnoses in the Diagnostic Ear Assessment Resource were larger among residents who had been exposed to ePROM than among residents at comparable levels of training who had not been exposed (67% vs 62%; P = .007). Among residents exposed to ePROM, mean proportions of correct diagnoses were larger after exposure than before (67% vs 55%; P < .001). CONCLUSION: A structured, computerized curriculum to supplement standard clinical training can enhance residents' abilities to interpret still and video images of TMs and may improve their skills in diagnosing otitis media.


Asunto(s)
Competencia Clínica , Instrucción por Computador , Modelos Educacionales , Otitis Media/diagnóstico , Enfermedad Aguda , Adulto , Educación Basada en Competencias , Educación de Postgrado en Medicina/métodos , Hospitales Pediátricos , Humanos , Internado y Residencia , Masculino , Otitis Media con Derrame/diagnóstico , Otoscopía , Pennsylvania , Grabación en Video
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