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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.
Telemed J E Health ; 30(7): e1927-e1934, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38621152

RESUMEN

Objective: We examined the change in pediatric primary care clinician attitudes and perceptions about telemedicine after one year of telemedicine use. Methods: We administered a survey to pediatric primary care clinicians across 50 primary care practices in Pennsylvania in 2020 and 2021. Surveys were linked using a combination of deterministic and probabilistic matching. We used McNemar's test to compare change in responses from 2020 to 2021. Results: Among pediatric primary care clinicians surveyed in 2020 and 2021 (n = 101), clinicians agreed that telemedicine could always or usually deliver high-quality care for mental health (80% in 2020 and 78% in 2021), care coordination (77% in 2020 and 70% in 2021), acute care (33% in 2020 and 34% in 2021), or preventive care (25% in 2020 and 18% in 2021) and this did not significantly change. Clinician perceptions of usability, while high, declined over time with fewer endorsing ease of use (93% in 2020 and 80% in 2021) and reliability (14% in 2020 and 0% in 2021) over time. Despite this, 62% of clinicians agreed that they were satisfied with their use of telemedicine at both time points. Respondents anticipated positive impact on equity and timeliness of care from telemedicine use but did not anticipate positive impact across child health, health care delivery, or clinician experience. Perceptions across these domains did not change over time. Conclusions: With one year of telemedicine experience, primary care clinicians maintained beliefs that telemedicine could deliver high-quality care for specific clinical needs but had worsening perceptions of usability over time.


Asunto(s)
Actitud del Personal de Salud , Atención Primaria de Salud , Telemedicina , Humanos , Masculino , Pennsylvania , Femenino , Atención Primaria de Salud/organización & administración , Adulto , Pediatría , Persona de Mediana Edad , Encuestas y Cuestionarios
3.
J Pediatr ; 256: 11-17.e2, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36470464

RESUMEN

OBJECTIVE: To evaluate the cost-effectiveness of tympanostomy tube placementvs nonsurgical medical management, with the option of tympanostomy tube placement in the event of treatment failure, in children with recurrent acute otitis media (AOM). STUDY DESIGN: A Markov decision model compared management strategies in children ages 6-35 months, using patient-level data from a recently completed, multicenter, randomized clinical trial of tympanostomy tube placement vs medical management. The model ran over a 2-year time horizon using a societal perspective. Probabilities, including risk of AOM symptoms, were derived from prospectively collected patient diaries. Costs and quality-of-life measures were derived from the literature. We performed one-way and probabilistic sensitivity analyses, and secondary analyses in predetermined low- and high-risk subgroups. The primary outcome was incremental cost per quality-adjusted life-year gained. RESULTS: Tympanostomy tubes cost $989 more per child than medical management. Children managed with tympanostomy tubes gained 0.69 more quality-adjusted life-days than children managed medically, corresponding to $520 855 per quality-adjusted life-year gained. Results were sensitive to the costs of oral antibiotics, missed work, special childcare, the societal cost of antibiotic resistance, and the quality of life associated with AOM. In probabilistic sensitivity analyses, medical management was favored in 66% of model iterations at a willingness-to-pay threshold of $100 000/quality-adjusted life-year. Medical management was preferred in secondary analyses of low- and high-risk subgroups. CONCLUSIONS: For young children with recurrent AOM, the additional cost associated with tympanostomy tube placement outweighs the small improvement in quality of life. Medical management for these children is an economically reasonable strategy. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02567825.


Asunto(s)
Otitis Media , Calidad de Vida , Niño , Humanos , Lactante , Preescolar , Análisis Costo-Beneficio , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/cirugía , Otitis Media/terapia , Otitis Media/diagnóstico , Antibacterianos/uso terapéutico , Ventilación del Oído Medio
4.
BMC Infect Dis ; 23(1): 596, 2023 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-37700242

RESUMEN

Acute otitis media (AOM) is the most common childhood bacterial infectious disease requiring antimicrobial therapy. Most cases of AOM are caused by translocation of Streptococcus pneumoniae or Haemophilus influenzae from the nasopharynx to the middle ear during an upper respiratory tract infection (URI). Ongoing genomic surveillance of these pathogens is important for vaccine design and tracking of emerging variants, as well as for monitoring patterns of antibiotic resistance to inform treatment strategies and stewardship.In this work, we examined the ability of a genomics-based workflow to determine microbiological and clinically relevant information from cultured bacterial isolates obtained from patients with AOM or an URI. We performed whole genome sequencing (WGS) and analysis of 148 bacterial isolates cultured from the nasopharynx (N = 124, 94 AOM and 30 URI) and ear (N = 24, all AOM) of 101 children aged 6-35 months presenting with AOM or an URI. We then performed WGS-based sequence typing and antimicrobial resistance profiling of each strain and compared results to those obtained from traditional microbiological phenotyping.WGS of clinical isolates resulted in 71 S. pneumoniae genomes and 76 H. influenzae genomes. Multilocus sequencing typing (MSLT) identified 33 sequence types for S. pneumoniae and 19 predicted serotypes including the most frequent serotypes 35B and 3. Genome analysis predicted 30% of S. pneumoniae isolates to have complete or intermediate penicillin resistance. AMR predictions for S. pneumoniae isolates had strong agreement with clinical susceptibility testing results for beta-lactam and non beta-lactam antibiotics, with a mean sensitivity of 93% (86-100%) and a mean specificity of 98% (94-100%). MLST identified 29 H. influenzae sequence types. Genome analysis identified beta-lactamase genes in 30% of H. influenzae strains, which was 100% in agreement with clinical beta-lactamase testing. We also identified a divergent highly antibiotic-resistant strain of S. pneumoniae, and found its closest sequenced strains, also isolated from nasopharyngeal samples from over 15 years ago.Ultimately, our work provides the groundwork for clinical WGS-based workflows to aid in detection and analysis of H. influenzae and S. pneumoniae isolates.


Asunto(s)
Gripe Humana , Otitis Media , Infecciones del Sistema Respiratorio , Niño , Humanos , Streptococcus pneumoniae/genética , Antibacterianos/farmacología , Tipificación de Secuencias Multilocus , Farmacorresistencia Bacteriana/genética , Genómica , Haemophilus influenzae/genética , Penicilinas
5.
JAMA ; 330(4): 349-358, 2023 07 25.
Artículo en Inglés | MEDLINE | ID: mdl-37490085

RESUMEN

Importance: The large overlap between symptoms of acute sinusitis and viral upper respiratory tract infection suggests that certain subgroups of children being diagnosed with acute sinusitis, and subsequently treated with antibiotics, derive little benefit from antibiotic use. Objective: To assess if antibiotic therapy could be appropriately withheld in prespecified subgroups. Design, Setting, and Participants: Randomized clinical trial including 515 children aged 2 to 11 years diagnosed with acute sinusitis based on clinical criteria. The trial was conducted between February 2016 and April 2022 at primary care offices affiliated with 6 US institutions and was designed to evaluate whether symptom burden differed in subgroups defined by nasopharyngeal Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis on bacterial culture and by the presence of colored nasal discharge. Interventions: Oral amoxicillin (90 mg/kg/d) and clavulanate (6.4 mg/kg/d) (n = 254) or placebo (n = 256) for 10 days. Main Outcomes and Measures: The primary outcome was symptom burden based on daily symptom scores on a validated scale (range, 0-40) during the 10 days after diagnosis. Secondary outcomes included treatment failure, adverse events including clinically significant diarrhea, and resource use by families. Results: Most of the 510 included children were aged 2 to 5 years (64%), male (54%), White (52%), and not Hispanic (89%). The mean symptom scores were significantly lower in children in the amoxicillin and clavulanate group (9.04 [95% CI, 8.71 to 9.37]) compared with those in the placebo group (10.60 [95% CI, 10.27 to 10.93]) (between-group difference, -1.69 [95% CI, -2.07 to -1.31]). The length of time to symptom resolution was significantly lower for children in the antibiotic group (7.0 days) than in the placebo group (9.0 days) (P = .003). Children without nasopharyngeal pathogens detected did not benefit from antibiotic treatment as much as those with pathogens detected; the between-group difference in mean symptom scores was -0.88 (95% CI, -1.63 to -0.12) in those without pathogens detected compared with -1.95 (95% CI, -2.40 to -1.51) in those with pathogens detected. Efficacy did not differ significantly according to whether colored nasal discharge was present (the between-group difference was -1.62 [95% CI, -2.09 to -1.16] for colored nasal discharge vs -1.70 [95% CI, -2.38 to -1.03] for clear nasal discharge; P = .52 for the interaction between treatment group and the presence of colored nasal discharge). Conclusions: In children with acute sinusitis, antibiotic treatment had minimal benefit for those without nasopharyngeal bacterial pathogens on presentation, and its effects did not depend on the color of nasal discharge. Testing for specific bacteria on presentation may represent a strategy to reduce antibiotic use in this condition. Trial Registration: ClinicalTrials.gov Identifier: NCT02554383.


Asunto(s)
Amoxicilina , Antibacterianos , Ácido Clavulánico , Nasofaringe , Sinusitis , Niño , Humanos , Masculino , Enfermedad Aguda , Amoxicilina/efectos adversos , Amoxicilina/uso terapéutico , Antibacterianos/efectos adversos , Antibacterianos/uso terapéutico , Ácido Clavulánico/efectos adversos , Ácido Clavulánico/uso terapéutico , Resfriado Común/diagnóstico , Sinusitis/diagnóstico , Sinusitis/tratamiento farmacológico , Sinusitis/etiología , Sinusitis/microbiología , Femenino , Preescolar , Nasofaringe/microbiología , Streptococcus pneumoniae/aislamiento & purificación , Haemophilus influenzae/aislamiento & purificación , Moraxella catarrhalis/aislamiento & purificación
6.
BMC Infect Dis ; 21(1): 1071, 2021 Oct 18.
Artículo en Inglés | MEDLINE | ID: mdl-34663212

RESUMEN

BACKGROUND: Antigen testing offers rapid and inexpensive testing for SARS-CoV-2 but concerns regarding performance, especially sensitivity, remain. Limited data exists for use of antigen testing in asymptomatic patients; thus, performance and reliability of antigen testing remains unclear. METHODS: 148 symptomatic and 144 asymptomatic adults were included. A nasal swab was collected for testing by Quidel Sofia SARS IFA (Sofia) as point of care. A nasopharyngeal swab was also collected and transported to the laboratory for testing by Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV RT-PCR (Cepheid). RESULTS: Overall, Sofia had good agreement with Cepheid (> 95%) in adults, however was less sensitive. Sofia had a sensitivity of 87.8% and 33.3% for symptomatic and asymptomatic patients, respectively. Among symptomatic patients, testing > 5 days post symptom onset resulted in lower sensitivity (82%) when compared with testing within 5 days of symptom onset (90%). Of the four Sofia false-negative results in the asymptomatic cohort, 50% went on to develop COVID-19 disease within 5 days of testing. Specificity in both symptomatic and asymptomatic cohorts was 100%. CONCLUSIONS: Sofia has acceptable performance in symptomatic adults when tested < 5 days of symptom onset. Caution should be taken when testing patients with ≥ 5 days of symptoms. The combination of low prevalence and reduced sensitivity results in relatively poor performance of in asymptomatic patients. NAAT-based diagnostic assays should be considered in when antigen testing is unreliable, particularly in symptomatic patients with > 5 days of symptom onset and asymptomatic patients.


Asunto(s)
COVID-19 , SARS-CoV-2 , Adulto , Pruebas Diagnósticas de Rutina , Humanos , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
8.
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
9.
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
10.
J Med Internet Res ; 22(12): e24345, 2020 12 18.
Artículo en Inglés | MEDLINE | ID: mdl-33290244

RESUMEN

BACKGROUND: Telehealth, the delivery of health care through telecommunication technology, has potential to address multiple health system concerns. Despite this potential, only 15% of pediatric primary care clinicians reported using telemedicine as of 2016, with the majority identifying inadequate payment for these services as the largest barrier to their adoption. The COVID-19 pandemic led to rapid changes in payment and regulations surrounding telehealth, enabling its integration into primary care pediatrics. OBJECTIVE: Due to limited use of telemedicine in primary care pediatrics prior to the COVID-19 pandemic, much is unknown about the role of telemedicine in pediatric primary care. To address this gap in knowledge, we examined the association between practice-level telemedicine use within a large pediatric primary care network and practice characteristics, telemedicine visit diagnoses, in-person visit volumes, child-level variations in telemedicine use, and clinician attitudes toward telemedicine. METHODS: We analyzed electronic health record data from 45 primary care practices and administered a clinician survey to practice clinicians. Practices were stratified into tertiles based on rates of telemedicine use (low, intermediate, high) per 1000 patients per week during a two-week period (April 19 to May 2, 2020). By practice tertile, we compared (1) practice characteristics, (2) telemedicine visit diagnoses, (3) rates of in-person visits to the office, urgent care, and the emergency department, (4) child-level variation in telemedicine use, and (5) clinician attitudes toward telemedicine across these practices. RESULTS: Across pediatric primary care practices, telemedicine visit rates ranged from 5 to 23 telemedicine visits per 1000 patients per week. Across all tertiles, the most frequent telemedicine visit diagnoses were mental health (28%-36% of visits) and dermatologic (15%-28%). Compared to low telemedicine use practices, high telemedicine use practices had fewer in-person office visits (10 vs 16 visits per 1000 patients per week, P=.005) but more total encounters overall (in-office and telemedicine: 28 vs 22 visits per 1000 patients per week, P=.006). Telemedicine use varied with child age, race and ethnicity, and recent preventive care; however, no significant interactions existed between these characteristics and practice-level telemedicine use. Finally, clinician attitudes regarding the usability and impact of telemedicine did not vary significantly across tertiles. CONCLUSIONS: Across a network of pediatric practices, we identified significant practice-level variation in telemedicine use, with increased use associated with more varied telemedicine diagnoses, fewer in-person office visits, and increased overall primary care encounter volume. Thus, in the context of the pandemic, when underutilization of primary care was prevalent, higher practice-level telemedicine use supported pediatric primary care encounter volume closer to usual rates. Child-level telemedicine use differed by child age, race and ethnicity, and recent preventive care, building upon prior concerns about differences in access to telemedicine. However, increased practice-level use of telemedicine services was not associated with reduced or increased differences in use, suggesting that further work is needed to promote equitable access to primary care telemedicine.


Asunto(s)
COVID-19/epidemiología , Registros Electrónicos de Salud , Pandemias/estadística & datos numéricos , Pediatría/estadística & datos numéricos , Atención Primaria de Salud/estadística & datos numéricos , Telemedicina/estadística & datos numéricos , Adolescente , Atención Ambulatoria/estadística & datos numéricos , Niño , Preescolar , Atención a la Salud , Etnicidad , Accesibilidad a los Servicios de Salud , Humanos , Lactante , Recién Nacido , Visita a Consultorio Médico , Pandemias/prevención & control , Estudios Retrospectivos
12.
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
13.
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
14.
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
15.
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
16.
N Engl J Med ; 370(25): 2367-76, 2014 06 19.
Artículo en Inglés | MEDLINE | ID: mdl-24795142

RESUMEN

BACKGROUND: Children with febrile urinary tract infection commonly have vesicoureteral reflux. Because trial results have been limited and inconsistent, the use of antimicrobial prophylaxis to prevent recurrences in children with reflux remains controversial. METHODS: In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infection, we evaluated the efficacy of trimethoprim-sulfamethoxazole prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance. RESULTS: Recurrent urinary tract infection developed in 39 of 302 children who received prophylaxis as compared with 72 of 305 children who received placebo (relative risk, 0.55; 95% confidence interval [CI], 0.38 to 0.78). Prophylaxis reduced the risk of recurrences by 50% (hazard ratio, 0.50; 95% CI, 0.34 to 0.74) and was particularly effective in children whose index infection was febrile (hazard ratio, 0.41; 95% CI, 0.26 to 0.64) and in those with baseline bladder and bowel dysfunction (hazard ratio, 0.21; 95% CI, 0.08 to 0.58). The occurrence of renal scarring did not differ significantly between the prophylaxis and placebo groups (11.9% and 10.2%, respectively). Among 87 children with a first recurrence caused by Escherichia coli, the proportion of isolates that were resistant to trimethoprim-sulfamethoxazole was 63% in the prophylaxis group and 19% in the placebo group. CONCLUSIONS: Among children with vesicoureteral reflux after urinary tract infection, antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; RIVUR ClinicalTrials.gov number, NCT00405704.).


Asunto(s)
Antiinfecciosos Urinarios/uso terapéutico , Combinación Trimetoprim y Sulfametoxazol/uso terapéutico , Infecciones Urinarias/prevención & control , Reflujo Vesicoureteral/tratamiento farmacológico , Niño , Preescolar , Método Doble Ciego , Farmacorresistencia Microbiana , Femenino , Fiebre/prevención & control , Humanos , Lactante , Estimación de Kaplan-Meier , Riñón/patología , Masculino , Prevención Secundaria , Reflujo Vesicoureteral/complicaciones
17.
J Pediatr ; 189: 54-60.e3, 2017 10.
Artículo en Inglés | MEDLINE | ID: mdl-28666536

RESUMEN

OBJECTIVE: To assess whether antimicrobial therapy in young children with acute otitis media reduces time to resolution of symptoms, overall symptom burden, and persistence of otoscopic evidence of infection. We used a cost-utility model to evaluate whether immediate antimicrobial treatment seems to be worthwhile, and if so, which antimicrobial agent is most cost effective. STUDY DESIGN: We compared the cost per quality-adjusted life-day of 5 treatment regimens in children younger than 2 years of age with acute otitis media: immediate amoxicillin/clavulanate, immediate amoxicillin, immediate cefdinir, watchful waiting, and delayed prescription (DP) for antibiotic. RESULTS: The 5 treatment regimens, listed in order from least effective to most effective were DP, watchful waiting, immediate cefdinir, immediate amoxicillin, and immediate amoxicillin/clavulanate. Listed in order from least costly to most costly, the regimens were DP, immediate amoxicillin, watchful waiting, immediate amoxicillin/clavulanate, and immediate cefdinir. The incremental cost-utility ratio of immediate amoxicillin compared with DP was $101.07 per quality-adjusted life-day gained. The incremental cost-utility ratio of immediate amoxicillin/clavulanate compared with amoxicillin was $2331.28 per quality-adjusted life-day gained. CONCLUSIONS: In children younger than 2 years of age with acute otitis media and no recent antibiotic exposure, immediate amoxicillin seems to be the most cost-effective initial treatment.


Asunto(s)
Antiinfecciosos/uso terapéutico , Otitis Media/tratamiento farmacológico , Enfermedad Aguda , Antiinfecciosos/economía , Niño , Preescolar , Análisis Costo-Beneficio , Humanos , Lactante , Otitis Media/economía , Resultado del Tratamiento
18.
J Pediatr ; 171: 116-21, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26794472

RESUMEN

OBJECTIVE: To determine which children with urinary tract infection are likely to have pathogens resistant to narrow-spectrum antimicrobials. STUDY DESIGN: Children, 2-71 months of age (n = 769) enrolled in the Randomized Intervention for Children with Vesicoureteral Reflux or Careful Urinary Tract Infection Evaluation studies were included. We used logistic regression models to test the associations between demographic and clinical characteristics and resistance to narrow-spectrum antimicrobials. RESULTS: Of the included patients, 91% were female and 76% had vesicoureteral reflux. The risk of resistance to narrow-spectrum antibiotics in uncircumcised males was approximately 3 times that of females (OR 3.1; 95% CI 1.4-6.7); in children with bladder bowel dysfunction, the risk was 2 times that of children with normal function (OR 2.2; 95% CI 1.2-4.1). Children who had received 1 course of antibiotics during the past 6 months also had higher odds of harboring resistant organisms (OR 1.6; 95% CI 1.1-2.3). Hispanic children had higher odds of harboring pathogens resistant to some narrow-spectrum antimicrobials. CONCLUSIONS: Uncircumcised males, Hispanic children, children with bladder bowel dysfunction, and children who received 1 course of antibiotics in the past 6 months were more likely to have a urinary tract infection caused by pathogens resistant to 1 or more narrow-spectrum antimicrobials.


Asunto(s)
Antiinfecciosos/farmacología , Farmacorresistencia Bacteriana , Infecciones Urinarias/tratamiento farmacológico , Infecciones Urinarias/microbiología , Amoxicilina/farmacología , Cefalosporinas/farmacología , Niño , Preescolar , Escherichia coli , Femenino , Humanos , Lactante , Enfermedades Intestinales/tratamiento farmacológico , Enfermedades Intestinales/epidemiología , Enfermedades Intestinales/microbiología , Masculino , Nitrofurantoína/farmacología , Oportunidad Relativa , Análisis de Regresión , Sulfametoxazol/farmacología , Trimetoprim/farmacología , Infecciones Urinarias/epidemiología , Reflujo Vesicoureteral/tratamiento farmacológico , Reflujo Vesicoureteral/epidemiología , Reflujo Vesicoureteral/microbiología
19.
Pediatr Radiol ; 46(11): 1573-8, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27287454

RESUMEN

BACKGROUND: No studies have examined whether use of sedation during a Tc-99 m dimercaptosuccinic acid (DMSA) renal scan reduces patient discomfort. OBJECTIVE: To compare discomfort level during a DMSA scan to the discomfort level during other frequently performed uroradiologic tests, and to determine whether use of sedation during a DMSA scan modifies the level of discomfort. MATERIALS AND METHODS: We examined the discomfort level in 798 children enrolled in the Randomized Intervention for children with Vesicoureteral Reflux (RIVUR) and Careful Urinary Tract Infection Evaluation (CUTIE) studies by asking parents to rate their child's discomfort level with each procedure on a scale from 0 to 10. We compared discomfort during the DMSA scan and the DMSA image quality between centers in which sedation was used >90% of the time (sedation centers), centers in which sedation was used <10% of the time (non-sedation centers), and centers in which sedation was used on a case-by-case basis (selective centers). RESULTS: Mean discomfort level was highest for voiding cystourethrogram (6.4), followed by DMSA (4.0), followed by ultrasound (2.4; P<0.0001). Mean discomfort level during the DMSA scan was significantly higher at non-sedation centers than at selective centers (P<0.001). No difference was apparent in discomfort level during the DMSA scan between sedation centers and selective centers (P=0.12), or between the sedation centers and non-sedation centers (P=0.80). There were no differences in the proportion with uninterpretable DMSA scans according to sedation use. CONCLUSION: Selective use of sedation in children 12-36 months of age can reduce the discomfort level experienced during a DMSA scan.


Asunto(s)
Sedación Consciente , Reflujo Vesicoureteral/diagnóstico por imagen , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Dimensión del Dolor , Padres/psicología , Radiofármacos , Ácido Dimercaptosuccínico de Tecnecio Tc 99m
20.
Paediatr Child Health ; 21(4): 196-8, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-27429572

RESUMEN

The authors administered a written survey consisting of colour images of 28 tympanic membranes (TM) to four groups of examiners: 86 medical students, 68 paediatric residents, 62 paediatricians and seven expert otoscopists. For each image, examiners were asked to indicate whether redness or bulging of the TM was present and to assign a diagnosis. The odds of diagnosing acute otitis media (AOM) was examined according to perceived redness or bulging of the TM. Medical students and paediatricians attributed approximately equal importance to isolated redness and isolated bulging of the TM. In contrast, experts placed significantly greater importance on isolated bulging of the TM compared with isolated redness of the TM. The authors suggest that training curricula emphasize the strong association between a bulging TM and a diagnosis of AOM, while de-emphasizing the association between TM redness and AOM.


Les auteurs ont demandé à quatre groupes d'examinateurs de remplir un sondage écrit composé d'images couleur de 28 tympans. Ces groupes se composaient de 86 étudiants en médecine, 68 résidents en pédiatrie, 62 pédiatres et sept spécialistes de l'otoscopie. Pour chaque image, ils étaient invités à indiquer s'ils observaient une rougeur ou un bombement du tympan et à poser un diagnostic. Les auteurs ont examiné la possibilité de diagnostiquer une otite moyenne aiguë (OMA) selon la rougeur ou le bombement perçu du tympan. Les étudiants en médecine et les pédiatres attribuaient environ autant d'importance à une douleur isolée qu'à un bombement isolé. En revanche, les spécialistes accordaient beaucoup plus d'importance à un bombement isolé du tympan qu'à une rougeur du tympan. Les auteurs proposent que, dans le cursus d'enseignement, les professeurs soulignent l'association importante entre le bombement du tympan et un diagnostic d'OMA, mais atténuent l'association entre la rougeur du tympan et l'OMA.

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