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OBJECTIVE: While diet plays a key role in chronic kidney disease (CKD) management, the potential for diet to impact CKD prevention in the general population is less clear. Using a priori knowledge, we derived disease-related dietary patterns (DPs) through reduced rank regression (RRR) and investigated associations with kidney function, separately focusing on generally healthy individuals and those with self-reported kidney diseases, hypertension, or diabetes mellitus. METHODS: Eight thousand six hundred eighty-six participants from the population-based Cooperative Health Research in South Tyrol study were split into a group free of kidney disease, hypertension and diabetes (n = 6,133) and a group with any of the 3 conditions (n = 2,553). Diet was assessed through the self-administered Global Allergy and Asthma Network of Excellence food frequency questionnaire and DPs were derived through RRR selecting food frequency questionnaire-derived sodium, potassium, phosphorus, and protein intake as mediators. Outcomes were creatinine-based estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, CKD and microalbuminuria. Multiple linear and logistic models were used to assess associations between RRR-based DPs and kidney outcomes separately in the 2 analytic groups. RESULTS: We identified 3 DPs, where high adherence reflected high levels of all nutrients (DP1), high potassium-phosphorus and low protein-sodium levels (DP2), and low potassium-sodium and high protein-phosphorus levels (DP3), respectively. We observed heterogeneous associations with kidney outcomes, varying by analytic group and sex. Kidney outcomes were much more strongly associated with DPs than with single nutrients. CONCLUSION: RRR is a feasible approach to estimate disease-related DPs and explore the combined effects of nutrients on kidney health. Heterogeneous associations across kidney outcomes suggest possible specificity to kidney function or damage. In individuals reporting kidney disease, hypertension or diabetes, specific dietary habits were associated with better kidney health, indicating that disease-specific dietary interventions can be effective for disease control.
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BACKGROUND: Monovalent varicella vaccines have been available in the Veneto Region of Italy since 2004. In 2006, a single vaccine dose was added to the immunisation calendar for children aged 14 months. ProQuad®, a quadrivalent measles-mumps-rubella-varicella vaccine, was introduced in May 2007 and used, among other varicella vaccines, until October 2008. This study aimed to evaluate the effectiveness of a single dose of ProQuad, and the population impact of a vaccination program (VP) against varicella of any severity in children who received a first dose of ProQuad at 14 months of age in the Veneto Region, METHODS: All children born in 2006/2007, i.e., eligible for varicella vaccination after ProQuad was introduced, were retrospectively followed through individual-level data linkage between the Pedianet database (varicella cases) and the Regional Immunization Database (vaccination status). The direct effectiveness of ProQuad was estimated as the incidence rate of varicella in ProQuad-vaccinated children aged < 6 years compared to children with no varicella vaccination from the same birth cohort. The impact of the VP on varicella was measured by comparing children eligible for the VP to an unvaccinated historical cohort from 1997/1998. The vaccine impact measures were: total effect (the combined effect of ProQuad vaccination and being covered by the Veneto VP); indirect effect (the effect of the VP on unvaccinated individuals); and overall effect (the effect of the VP on varicella in the entire population of the Veneto Region, regardless of their vaccination status). RESULTS: The adjusted direct effectiveness of ProQuad was 94%. The vaccine impact measures total, indirect, and overall effect were 97%, 43%, and 90%, respectively. CONCLUSIONS: These are the first results on the effectiveness and impact of ProQuad against varicella; data confirmed its high effectiveness, based on immunological correlates for protection. Direct effectiveness is our only ProQuad-specific measure; all impact measures refer at least partially to the VP and should be interpreted in the context of high vaccine coverage and the use of various varicella vaccines in this region. The Veneto Region offered a unique opportunity for this study due to an individual data linkage between Pedianet and the Regional Immunization database.
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Vacina contra Varicela/imunologia , Varicela/epidemiologia , Vacina contra Sarampo-Caxumba-Rubéola/imunologia , Adolescente , Varicela/diagnóstico , Criança , Pré-Escolar , Estudos de Coortes , Bases de Dados Factuais , Feminino , Humanos , Programas de Imunização , Lactente , Recém-Nascido , Itália/epidemiologia , Masculino , Sistema de Registros , Estudos Retrospectivos , Resultado do Tratamento , Vacinas Combinadas/imunologiaRESUMO
BACKGROUND: Epstein-Barr Virus (EBV) is involved in a wide range of malignancies, particularly in immunocompromised subjects. In Africa, EBV primary infection occurs during early childhood, but little is known about the EBV load in Human Immunodeficiency Virus type 1 (HIV-1)-infected children. METHODS: Blood samples from 213 HIV-1-infected children, 140 of whom were receiving antiretroviral therapy (ART), were collected at the Nsambya Hospital in Kampala, Uganda, and obtained for dried blood spot analysis. Nucleic acids were extracted and analyzed for quantification of EBV types 1 and 2; 16S ribosomal DNA (rDNA), a marker of microbial translocation; and HIV-1 RNA. RESULTS: Ninety-two of 140 children (66%) receiving ART and 57 of 73 ART-naive children (78%) had detectable EBV DNA levels. Coinfection with both EBV types was less frequent in ART-treated children than in ART-naive children (odds ratio, 0.54 [95% confidence interval {CI}, .30-.98]; P = .042). Mean EBV DNA levels (±standard deviation) were lower in the former (3.99 ± 0.59 vs 4.22 ± 0.54 log10 copies/mL; P = .006) and tended to be inversely associated with ART duration. EBV DNA levels were higher in children with an HIV-1 RNA load of > 3 log10 copies/mL of blood (regression coefficient, 0.32 [95% CI, .05-.59]; P = .020) and correlated with circulating 16S rDNA levels (rs = 0.25 [95% CI, .02-.46]; P = .031). CONCLUSIONS: These findings suggest that ART, by limiting HIV-1 replication, microbial translocation, and related immune activation, prevents superinfection with both EBV types and keeps EBV viremia down, thus potentially reducing the risk of EBV-associated lymphomas.
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Infecções por Vírus Epstein-Barr/virologia , Infecções por HIV/complicações , HIV-1/isolamento & purificação , Herpesvirus Humano 4/isolamento & purificação , Carga Viral , Adolescente , Fármacos Anti-HIV/uso terapêutico , Criança , Pré-Escolar , DNA Viral/isolamento & purificação , Feminino , Infecções por HIV/sangue , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Humanos , Lactente , MasculinoRESUMO
Correlations between clinical/immunological treatment failure and viral load (VL) detected by dried blood spot (DBS) sampling were explored in HIV-1-infected children in Uganda. Of 104 children on combined antiretroviral treatment (cART), 12.5% experienced clinical and/or immunological failure, while 28.8%, 44.2%, and 26.9% had VLs of <1,000, 1,000 to 5,000, and >5,000 copies/ml, respectively. Clinical/immunological failure poorly predicted virological failure.
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Sangue/virologia , Dessecação/métodos , Infecções por HIV/virologia , HIV-1/isolamento & purificação , Manejo de Espécimes/métodos , Carga Viral/métodos , Antirretrovirais/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/imunologia , Humanos , Masculino , Sensibilidade e Especificidade , Falha de Tratamento , UgandaRESUMO
To characterize COVID-19 epidemiology, numerous population-based studies have been undertaken to model the risk of SARS-CoV-2 infection. Less is known about what may drive the probability to undergo testing. Understanding how much testing is driven by contextual or individual conditions is important to delineate the role of individual behavior and to shape public health interventions and resource allocation. In the Val Venosta/Vinschgau district (South Tyrol, Italy), we conducted a population-representative longitudinal study on 697 individuals susceptible to first infection who completed 4,512 repeated online questionnaires at four-week intervals between September 2020 and May 2021. Mixed-effects logistic regression models were fitted to investigate associations of self-reported SARS-CoV-2 testing with individual characteristics (social, demographic, and biological) and contextual determinants. Testing was associated with month of reporting, reflecting the timing of both the pandemic intensity and public health interventions, COVID-19-related symptoms (odds ratio, OR:8.26; 95% confidence interval, CI:6.04-11.31), contacts with infected individuals within home (OR:7.47, 95%CI:3.81-14.62) or outside home (OR:9.87, 95%CI:5.78-16.85), and being retired (OR:0.50, 95%CI:0.34-0.73). Symptoms and next within- and outside-home contacts were the leading determinants of swab testing predisposition in the most acute phase of the pandemics. Testing was not associated with age, sex, education, comorbidities, or lifestyle factors. In the study area, contextual determinants reflecting the course of the pandemic were predominant compared to individual sociodemographic characteristics in explaining the SARS-CoV-2 probability of testing. Decision makers should evaluate whether the intended target groups were correctly prioritized by the testing campaign.
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COVID-19 , Humanos , COVID-19/diagnóstico , COVID-19/epidemiologia , SARS-CoV-2 , Teste para COVID-19 , População Rural , Estudos LongitudinaisRESUMO
OBJECTIVES: The continuous monitoring of SARS-CoV-2 infection waves and the emergence of novel pathogens pose a challenge for effective public health surveillance strategies based on diagnostics. Longitudinal population representative studies on incident events and symptoms of SARS-CoV-2 infection are scarce. We aimed at describing the evolution of the COVID-19 pandemic during 2020 and 2021 through regular monitoring of self-reported symptoms in an Alpine community sample. DESIGN: To this purpose, we designed a longitudinal population representative study, the Cooperative Health Research in South Tyrol COVID-19 study. PARTICIPANTS AND OUTCOME MEASURES: A sample of 845 participants was retrospectively investigated for active and past infections with swab and blood tests, by August 2020, allowing adjusted cumulative incidence estimation. Of them, 700 participants without previous infection or vaccination were followed up monthly until July 2021 for first-time infection and symptom self-reporting: COVID-19 anamnesis, social contacts, lifestyle and sociodemographic data were assessed remotely through digital questionnaires. Temporal symptom trajectories and infection rates were modelled through longitudinal clustering and dynamic correlation analysis. Negative binomial regression and random forest analysis assessed the relative importance of symptoms. RESULTS: At baseline, the cumulative incidence of SARS-CoV-2 infection was 1.10% (95% CI 0.51%, 2.10%). Symptom trajectories mimicked both self-reported and confirmed cases of incident infections. Cluster analysis identified two groups of high-frequency and low-frequency symptoms. Symptoms like fever and loss of smell fell in the low-frequency cluster. Symptoms most discriminative of test positivity (loss of smell, fatigue and joint-muscle aches) confirmed prior evidence. CONCLUSIONS: Regular symptom tracking from population representative samples is an effective screening tool auxiliary to laboratory diagnostics for novel pathogens at critical times, as manifested in this study of COVID-19 patterns. Integrated surveillance systems might benefit from more direct involvement of citizens' active symptom tracking.
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Anosmia , COVID-19 , Humanos , COVID-19/diagnóstico , COVID-19/epidemiologia , Estudos Longitudinais , Pandemias , Estudos Retrospectivos , SARS-CoV-2RESUMO
BACKGROUND: The Russian Federation has the largest paediatric hepatitis C virus (HCV) disease burden in the World Health Organization European region with an estimated 118,000 children living with HCV viraemia. Direct-acting antivirals (DAAs) have been available for adults in Russia since 2015 and approved for treatment of adolescents aged ≥12 years since 2019. We evaluated DAA availability and uptake for HCV treatment of children and adolescents and clinical practices on diagnosis and management of paediatric HCV in Russia. METHODS: A survey was distributed to regional ministries of health in 85 administrative regions during September 2020. The survey consisted of 22 items collecting data on: type of facility, aggregate patient characteristics, HCV testing practices for children and pregnant women and HCV management and treatment practices for children. RESULTS: Survey responses were received from 37 of the 85 regions in Russia (response rate 44%). 2159 children and adolescents with chronic HCV were in follow-up; 1089 (50%) were female. Of 2080 children with available data on age-groups, 134 (6%) were <3 years, 336 (16%) 3-<6 years, 718 (35%) 6-<12 years and 892 (43%) 12-<18 years. 134 (15%) of 892 adolescents ≥12 years received DAAs, 96 (72%) glecaprevir/pibrentasvir, 26 (19%) sofosbuvir, 8 (6%) daclatasvir and 4 (3%) sofosbuvir/ledipasvir. CONCLUSIONS: This study provides a baseline of DAA uptake in early stages of rollout for children and adolescents. The use of DAAs for treatment of adolescents in Russia presents a unique opportunity for HCV micro-elimination in this population.
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INTRODUCTION AND OBJECTIVE: Community-acquired pneumonia (CAP) is one of the most common reasons of prescribing antibiotics for children, often with overuse of broad-spectrum antibiotics. The aim of this study is to describe the antibiotic prescriptions for Italian children with CAP, at the primary care level. STUDY DESIGN: Retrospective cohort study conducted among children 3 months-14 years of age with CAP, enrolled in Pedianet (http://www.pedianet.it) from January 1, 2009 to December 31, 2018. Antibiotic treatment was defined as narrow-spectrum (NS-ABT) if amoxicillin and broad-spectrum (BS-ABT) if amoxicillin/clavulanic acid, cephalosporins or any combination. Crude and adjusted logistic regressions for the odds of receiving NS-ABT were conducted (all episodes of CAP and per patient). A P value <0.05 was considered statistically significant. RESULTS: Among 9691 CAP, 7260 episodes from 6409 children followed by 147 pediatricians were analyzed. The 16.7% of CAP [1216/7260, 95% confidence interval (CI): 15.9%-17.6%] received an NS-ABT while 53.3% (3863/7260, 95% CI: 52%-54.4%) received BS-ABTs and 30% (2181/7260, 95% CI: 28.9%-31.1%) macrolides. Within 10 years, a slight but increasing trend of NS-ABT prescription was observed (P < 0.001). Factors independently associated with reduced odds of receiving an NS-ABT compared with BS-ABT including macrolides were being older than 5 years [odds ratio (OR) 0.45, 95% CI: 0.39-0.52], living in Central/Southern Italy (OR 0.13, 95% CI: 0.10-0.16) and being exposed to ABT 3 months before (OR 0.61, 95% CI: 0.53-0.70). These findings were confirmed comparing NS-ABT versus BS-ABT excluding macrolides (n = 5079) and when the analysis was limited to index CAP. CONCLUSION: Our findings report a very limited prescription of narrow-spectrum antibiotics for Italian children with CAP.
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Antibacterianos/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Infecções Comunitárias Adquiridas/epidemiologia , Pneumonia Bacteriana/tratamento farmacológico , Pneumonia Bacteriana/epidemiologia , Criança , Pré-Escolar , Feminino , Humanos , Itália/epidemiologia , Masculino , Estudos RetrospectivosRESUMO
INTRODUCTION: Acute otitis media (AOM) is the most common childhood disease leading to antibiotic use. More than 80% of children under three years of age experience at least one episode, and about one-third of these report significant recurrence of episodes. In recent years, several studies reported that normal nasopharyngeal flora inhibits growth of common otopathogens, suggesting that maintenance of an "adequate" nasopharyngeal flora might prevent occurrence of upper respiratory tract infections, including AOM. This study aims to determine whether five-month treatment with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray prevents recurrence of AOM and prescription of antibiotics in children with diagnosis of recurrent AOM. METHODS: Observational prospective cohort study including children aged 1-6 years with diagnosis of recurrent AOM registered with 31 Italian family pediatricians. 81 children were enrolled in the study from September 2016 to the end of the five therapeutic cycles of the Streptococcus salivarius 24SMB and Streptococcus oralis 89a supplied 7 days each month for 5 consecutive months. For each treated child, one untreated control was randomly selected, 1:1 matched for gender, age, and follow-up. RESULTS: 158 children (79 treated and 70 untreated) were included into the analysis (mean age, 3.9 years; 47% female). Univariate analysis showed a statistically significant 34% (95% CI 1%-56%) reduction in number of AOM episodes in treated children compared with those not treated. Significantly fewer antibiotics were dispensed among treated children (24%, 95% CI 1%-41%). CONCLUSIONS: Our findings suggest that intermittent treatment of children with diagnosis of recurrent AOM with nasal spray containing Streptococcus salivarius 24SMB and Streptococcus oralis 89a for a period of five months might be effective in preventing antibiotic use associated with recurrent episodes of AOM. Additional larger studies to address this important clinical problem are recommended.
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Terapia Biológica/métodos , Otite Média/prevenção & controle , Prevenção Secundária/métodos , Streptococcus oralis , Streptococcus salivarius , Doença Aguda , Antibacterianos , Criança , Pré-Escolar , Doença Crônica , Feminino , Humanos , Lactente , Masculino , Sprays Nasais , Nasofaringe/microbiologia , Otite Média/tratamento farmacológico , Estudos Prospectivos , RecidivaRESUMO
BACKGROUND: Data on Candida bloodstream infections in pediatric patients in Europe are limited. We performed a retrospective multicenter European study of the epidemiology and outcome of neonatal and pediatric candidemia. MATERIAL AND METHODS: All first positive blood cultures from patients ≤ 18 years of age with candidemia were registered. Patients' demographic and clinical characteristics and causative Candida species were collected and analyzed. Regression analysis was used to identify factors independently associated with mortality. RESULTS: One thousand three hundred ninety-five episodes of candidemia (57.8% male) were reported from 23 hospitals in 10 European countries. Of the 1395 episodes, 36.4% occurred in neonates (≤ 44 weeks postmenstrual age), 13.8% in infants (> 44 weeks postmenstrual age to 1 year) and 49.8% in children and adolescents. Candida albicans (52.5%) and Candida parapsilosis (28%) were the predominant species. A higher proportion of candidemia caused by C. albicans was observed among neonatal patients (60.2%) with highest rates of C. parapsilosis seen among infants (42%). Children admitted to hematology-oncology wards presented the highest rates of non-albicans Candida species. Candidemia because of C. albicans was more frequent than non-albicans Candida in Northern versus Southern Europe (odds ratio, 2.3; 95% confidence interval, 1.8-2.9; P < 0.001). The all-cause mortality at 30 days was 14.4%. All-cause mortality was higher among patients admitted to the neonatal or pediatric intensive care units than other wards. Over time, no significant changes in species distribution were observed. CONCLUSIONS: This first multicenter European study shows unique characteristics of the epidemiology of pediatric candidemia. The insights obtained from this study will be useful to guide clinical management and antifungal stewardship.
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Candidemia/epidemiologia , Candidemia/etiologia , Adolescente , Fatores Etários , Candida/isolamento & purificação , Candidemia/diagnóstico , Criança , Pré-Escolar , Infecção Hospitalar , Suscetibilidade a Doenças , Europa (Continente)/epidemiologia , Feminino , Hospitalização , Humanos , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Pediátrica , Masculino , Avaliação de Resultados da Assistência ao Paciente , Prognóstico , Vigilância em Saúde Pública , Estudos Retrospectivos , Medição de Risco , Fatores de RiscoRESUMO
Smoking cessation is essential after the diagnosis of cancer to improve clinical outcomes. The purpose of this chapter is to provide a systematic review of research on smoking cessation in the context of cancer care with an emphasis on nursing contributions to the field. Data sources included research reports of smoking cessation interventions conducted in people with cancer. Nineteen primary studies were reviewed. High intensity interventions, targeting multiple behaviors, and/or using a multicomponent intervention that included pharmacotherapy, behavioral counseling, and social support were characteristics of the most successful treatments for tobacco dependence. The majority of interventions were conducted in adults with smoking-related malignancies during acute phases of illness. The most striking finding was that more than one half of the studies tested the efficacy of nurse-delivered interventions. Conceptual and methodological issues that can be improved in future studies include: using theoretical frameworks to specify how the intervention will affect outcomes, ensuring adequate sample sizes, using biochemical verification to monitor smoking outcomes, and using standardized outcome measures of abstinence. Although effective interventions are available for healthy populations, further research is needed to determine if tailored cessation interventions are needed for patients with cancer. To provide optimal quality care it is imperative that delivery of evidence-based smoking cessation interventions be integrated into the cancer treatment trajectory. Multiple barriers, including patient and nurse attitudes toward smoking and lack of knowledge related to tobacco treatment, prevent translating evidence-based tobacco dependence treatment into clinical practice. Further nursing research is needed to address these barriers.
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Neoplasias/enfermagem , Abandono do Hábito de Fumar/métodos , Humanos , Pesquisa em Enfermagem , Enfermagem Oncológica , Projetos de Pesquisa , Abandono do Hábito de Fumar/psicologiaRESUMO
AIMS: Women with pre-existing diabetes should plan for optimal care of the disease before, during and after pregnancy. The aim of this study was to assess the quality of diabetes mellitus monitoring and care before, during and after pregnancy in a large cohort of women. METHODS: 1913 diabetic women resident in the Lombardy Region (Italy) who experienced at least a birth between 2011 and 2015 and exhibited signs of diabetes ≥2â¯years before delivery were identified using the healthcare utilization database. Antidiabetic care was defined via outpatient examinations (i.e., assessments of glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine, and dilated eye exams) and use of antidiabetic drugs. Differences in adherence to recommendations before, during and after pregnancy were assessed by the non-parametric McNemar's test among the whole cohort and among the subgroup with type 1 diabetes. RESULTS: Adherence to recommendations was very poor before pregnancy, ranging from 13% to 42% for dilated eye and serum creatinine exam, respectively. During pregnancy, a significant portion of women increased adherence to all recommendations (e.g., glycated haemoglobin from 20% to 47%, p-valueâ¯<â¯0.001), with the exception of lipid profile control. After pregnancy, adherence dropped to pre-pregnancy levels. A similar trend was observed in the use of antidiabetic drugs. Although women with type 1 diabetes showed better adherence across all periods, the same patterns emerged. CONCLUSIONS: Besides an improvement in the indicators of clinical adherence during pregnancy, the management of diabetes among pregnant women remains sub-optimal both before and after the birth.
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Biomarcadores/sangue , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Cooperação do Paciente/estatística & dados numéricos , Gravidez em Diabéticas/sangue , Adolescente , Adulto , Estudos de Coortes , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/prevenção & controle , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/prevenção & controle , Feminino , Humanos , Hipoglicemiantes , Itália/epidemiologia , Pessoa de Meia-Idade , Gravidez , Gravidez em Diabéticas/epidemiologia , Gravidez em Diabéticas/prevenção & controle , Prognóstico , Adulto JovemRESUMO
Purpose: This study aims to determine the effectiveness of an Antimicrobial Stewardship Program based on a Clinical Pathway (CP) to improve appropriateness in perioperative antibiotic prophylaxis (PAP). Materials and methods: This pre-post quasi-experimental study was conducted in a 12 month period (six months before and six months after CP implementation), in a tertiary Pediatric Surgical Centre. All patients from 1 month to 15 years of age receiving one or more surgical procedures were eligible for inclusion. PAP was defined appropriate according to clinical practice guidelines. Results: Seven hundred sixty-six children were included in the study, 394 in pre-intervention and 372 in post-intervention. After CP implementation, there was an increase in appropriate PAP administration, as well as in the selection of the appropriate antibiotic for prophylaxis, both for monotherapy (p = 0.02) and combination therapy (p = 0.004). Even the duration of prophylaxis decreased during the post-intervention period, with an increase of correct PAP discontinuation from 45.1 to 66.7% (p < 0.001). Despite the greater use of narrow-spectrum antibiotic for fewer days, there was no increase in treatment failures (10/394 (2.5%) pre vs 7/372 (1.9%) post, p = 0.54). Conclusions: CPs can be a useful tool to improve the choice of antibiotic and the duration of PAP in pediatric patients.
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Antibacterianos/administração & dosagem , Infecções Bacterianas/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Adolescente , Antibioticoprofilaxia/métodos , Gestão de Antimicrobianos/métodos , Criança , Pré-Escolar , Procedimentos Clínicos , Feminino , Humanos , Lactente , Masculino , Pediatria/estatística & dados numéricos , Período PerioperatórioRESUMO
INTRODUCTION: Gabapentin is currently used 'off-label' in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking. OBJECTIVES: The GABA-1 trial aims to compare the efficacy and safety of gabapentin liquid formulation relative to tramadol and to explore the pharmacokinetics of both drugs in the treatment of chronic, neuropathic or mixed pain in the paediatric population. METHODS AND ANALYSIS: The trial is a multicentre, double-blind, double-dummy, randomised, active-controlled, non-inferiority trial. Participants aged from 3 months to <18 years of age with moderate to severe (≥4/10 in age-appropriate pain scales) chronic neuropathic or mixed pain will be recruited in 14 clinical sites in eight European countries. A total of 94 subjects will be randomised to receive gabapentin and tramadol placebo or tramadol and gabapentin placebo throughout 16-19 weeks (including 3 weeks of titration [optimisation period], 12 weeks of treatment at a stable dose [maintenance period] and 1-4 weeks of tapering [discontinuation period]). The primary objective is to assess the efficacy of gabapentin relative to tramadol for the treatment of moderate to severe chronic neuropathic or mixed pain by comparing the difference in average pain scores (assessed by age-appropriate pain scales) between intervention arms after 15 weeks of treatment. Secondary objectives include the assessment of the safety, quality of life and global satisfaction with treatment and the description of the pharmacokinetic-pharmacodynamic relationship of gabapentin liquid formulation and tramadol oral drops to validate the recommended paediatric doses. Only rescue pain medication by paracetamol and/or ibuprofen is allowed during the trial. ETHICS AND DISSEMINATION: Ethic approval was obtained in the eight participating countries. Results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. TRIAL REGISTRATION NUMBERS: 2014-004851-30 and NCT02722603. TRIAL STATUS: Ongoing research study, currently recruiting.
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Analgésicos Opioides/uso terapêutico , Analgésicos/uso terapêutico , Dor Crônica/tratamento farmacológico , Gabapentina/uso terapêutico , Neuralgia/tratamento farmacológico , Tramadol/uso terapêutico , Adolescente , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Lactente , MasculinoRESUMO
BACKGROUND: Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults. Although pediatric pain specialists have extensive experience with gabapentin for the treatment of neuropathic pain, its use is off-label. Its efficacy and safety in this context have never been shown. The aim of this trial is to compare gabapentin with placebo as add-on to morphine for the treatment of severe chronic mixed or neuropathic pain in children. This trial is part of the European Union Seventh Framework Programme project Gabapentin in Paediatric Pain (GAPP) to develop a pediatric use marketing authorization for a new gabapentin suspension. METHODS/DESIGN: The GAPP-2 study is a randomized, double-blind, placebo-controlled, multicenter superiority phase II study in children with severe chronic neuropathic or mixed pain. Its primary objective is to evaluate the efficacy of a gabapentin liquid formulation as adjunctive therapy to morphine. Sixty-six eligible children 3 months to 18 years of age with severe pain (pain scores ≥ 7), stratified in three age groups, will be randomized to receive gabapentin (to an accumulating dose of 45 to 63 mg/kg/day, dependent on age) or placebo, both in addition to morphine, for 12 weeks. Randomization will be preceded by a short washout period, and treatment will be initiated by a titration period of 3 weeks. After the treatment period, medication will be tapered during 4 weeks. The primary endpoint is the average pain scores in the two treatment groups (average of two measures each day for 3 days before the end-of-study visit [V10] assessed by age-appropriate pain scales (Face, Legs, Activity, Cry, Consolability scale; Faces Pain Scale-Revised; Numeric Rating Scale). Secondary outcomes include percentage responders to treatment (subjects with 30% reduction in pain scale), number of episodes of breakthrough pain, number of rescue interventions, number of pain-free days, participant dropouts, quality of life (Pediatric Quality of Life Inventory), and acceptability of treatment. Outcomes will be measured at the end-of-study visit after 12 weeks of treatment at the optimal gabapentin dose. Groups will be compared on an intention-to-treat basis. DISCUSSION: We hope to provide evidence that the combination of morphine and gabapentin will provide better analgesia than morphine alone and will be safe. We also aim to obtain confirmation of the recommended pediatric dose. TRIAL REGISTRATION: EudractCT, 2014-004897-40 . Registered on 7 September 2017. ClinicalTrials.gov, NCT03275012 . Registered on 7 September 2017.
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Analgésicos Opioides/administração & dosagem , Analgésicos/administração & dosagem , Analgésicos/farmacocinética , Dor Crônica/tratamento farmacológico , Gabapentina/administração & dosagem , Gabapentina/farmacocinética , Morfina/administração & dosagem , Neuralgia/tratamento farmacológico , Manejo da Dor/métodos , Administração Oral , Adolescente , Fatores Etários , Analgésicos/efeitos adversos , Analgésicos Opioides/efeitos adversos , Criança , Pré-Escolar , Dor Crônica/diagnóstico , Dor Crônica/fisiopatologia , Ensaios Clínicos Fase II como Assunto , Método Duplo-Cego , Quimioterapia Combinada , Estudos de Equivalência como Asunto , Feminino , Gabapentina/efeitos adversos , Humanos , Lactente , Masculino , Morfina/efeitos adversos , Estudos Multicêntricos como Assunto , Países Baixos , Neuralgia/diagnóstico , Neuralgia/fisiopatologia , Manejo da Dor/efeitos adversos , Medição da Dor , Soluções Farmacêuticas , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
Following publication of the original article [1], we have been notified that the tagging of one of the author names was done incorrectly in the XML version of the paper. Original and corrected tagging can be seen below.
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BACKGROUND: Concerns regarding vaccine safety are increasing along with lack of compliance to vaccination schedules. This study aimed to assess vaccination-related risks and the impact of a Special Immunization Service (SIS) at the Pediatric Emergency Department (PED) of Padua on vaccination compliance among participants. MATERIALS AND METHODS: This retrospective cohort study included all children attending the SIS from January 1st 2002 to December 31st 2015. The Service is divided into a clinic (SIS-C) where all referred children undergo a pre-vaccination visit and an area within the Pediatric Emergency Department (SIS-PED) where children are vaccinated if indicated. During each SIS-C visit, age, gender, admission criteria and scheduled vaccinations were recorded, with any vaccine-related adverse events captured during SIS-PED visits. Follow-up was conducted to evaluate vaccination plan completion. RESULTS: 359 children received 560 vaccine administrations (41.3% MMR/MMRV, 17.5% hexavalent) at the SIS during the 14 year study. Admission criteria were adverse events after previous vaccination (immediate, IgE/not IgE mediated, and late) in 27.2% of cases, non-anaphylactic allergies (mostly egg allergy) in 42.7% and anaphylaxis in 10.3%. After vaccination, 15/560 (2.7%) mild adverse events were observed. 96.3% of children vaccinated at least once at the SIS-PED and available for follow-up completed their vaccination plan, in contrast to 55.5% of children referred to the SIS-C who were not vaccinated in SIS-PED. CONCLUSIONS: For children referred to SIS-C and available for follow-up, vaccination in SIS-PED was associated with more frequent completion of vaccination plans, indicating a benefit of the service to vaccine coverage. The low number and mild severity of adverse events reported after vaccination of high-risk children in SIS-PED attest to the safety of the service.
Assuntos
Controle de Doenças Transmissíveis , Imunização , Vigilância em Saúde Pública , Vacinação , Adolescente , Criança , Pré-Escolar , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/organização & administração , Feminino , Seguimentos , Humanos , Programas de Imunização/métodos , Programas de Imunização/organização & administração , Lactente , Recém-Nascido , Itália/epidemiologia , Masculino , Cobertura Vacinal , Vacinas/administração & dosagem , Vacinas/efeitos adversosRESUMO
BACKGROUND: Although Italian pediatric antimicrobial prescription rates are among the highest in Europe, little action has been taken to improve the appropriateness of antimicrobial prescriptions. The primary aim of this study was to assess changes in antibiotic prescription before and after acute otitis media (AOM) and group A streptococcus (GAS) pharyngitis Clinical Pathway (CP) implementation; secondary aims were to compare treatment failures and to assess change in the total antibiotics costs before and after CP implementation. METHODS: Pre-post quasi-experimental study comparing the 6-month period before CP implementation (baseline period: October 15, 2014, through April 15, 2015) to the 6 months after intervention (postintervention: October 15, 2015, through April 15, 2016). RESULTS: Two hundred ninety-five pre- and 278 postintervention emergency department visits were associated with AOM. After CP implementation, there was an increase in "wait and see" approach and a decrease in overall prescription of broad-spectrum antibiotics from 53.2% to 32.4% (P < 0.001). One hundred fifty-one pre- and 166 postimplementation clinic visits were associated with GAS pharyngitis, with a decrease in broad-spectrum prescription after CP implementation (46.4% vs. 6.6%; P < 0.001). For both conditions, no difference was found in treatment failure, and total antibiotics cost was significantly reduced after CP implementation, with a decrease especially in broad-spectrum antibiotics costs. CONCLUSIONS: A reduction in broad-spectrum antibiotic prescriptions and a reduction in the total cost of antibiotics for AOM and GAS pharyngitis along with an increase in "wait and see" prescribing for AOM indicate effectiveness of CP for antimicrobial stewardship in this setting.
Assuntos
Antibacterianos/uso terapêutico , Procedimentos Clínicos , Prescrições de Medicamentos/estatística & dados numéricos , Otite Média/tratamento farmacológico , Faringite/tratamento farmacológico , Falha de Tratamento , Doença Aguda , Adolescente , Antibacterianos/economia , Gestão de Antimicrobianos/economia , Criança , Pré-Escolar , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Lactente , Itália , Masculino , Otite Média/microbiologia , Faringite/microbiologia , Padrões de Prática Médica/estatística & dados numéricos , Streptococcus pyogenes/efeitos dos fármacosRESUMO
BACKGROUND: Italian pediatric antimicrobial prescription rates are among the highest in Europe. As a first step in an Antimicrobial Stewardship Program, we implemented a Clinical Pathway (CP) for Community Acquired Pneumonia with the aim of decreasing overall prescription of antibiotics, especially broad-spectrum. MATERIALS AND METHODS: The CP was implemented on 10/01/2015. We collected antibiotic prescribing and outcomes data from children aged 3 months-15 years diagnosed with CAP from 10/15/2014 to 04/15/2015 (pre-intervention period) and from 10/15/2015 to 04/15/2016 (post-intervention period). We assessed antibiotic prescription differences pre- and post-CP, including rates, breadth of spectrum, and duration of therapy. We also compared length of hospital stay for inpatients and treatment failure for inpatients and outpatients. Chi-square and Fisher's exact test were used to compare categorical variables and Wilcoxon rank sum test was used to compare quantitative outcomes. RESULTS: 120 pre- and 86 post-intervention clinic visits were identified with a diagnosis of CAP. In outpatients, we observed a decrease in broad-spectrum regimens (50% pre-CP vs. 26.8% post-CP, p = 0.02), in particular macrolides, and an increase in narrow-spectrum (amoxicillin) post-CP. Post-CP children received fewer antibiotic courses (median DOT from 10 pre-CP to 8 post-CP, p<0.0001) for fewer days (median LOT from 10 pre-CP to 8 post-CP, p<0.0001) than their pre-CP counterparts. Physicians prescribed narrow-spectrum monotherapy more frequently than broad-spectrum combination therapy (DOT/LOT ratio 1.157 pre-CP vs. 1.065 post-CP). No difference in treatment failure was reported before and after implementation (2.3% pre-CP vs. 11.8% post-CP, p = 0.29). Among inpatients we also noted a decrease in broad-spectrum regimens (100% pre-CP vs. 66.7% post-CP, p = 0.02) and the introduction of narrow-spectrum regimens (0% pre-CP vs. 33.3% post-CP, p = 0.02) post-CP. Hospitalized patients received fewer antibiotic courses post-CP (median DOT from 18.5 pre-CP to 10 post-CP, p = 0.004), while there was no statistical difference in length of therapy (median LOT from 11 pre-CP to 10 post-CP, p = 0.06). Days of broad spectrum therapy were notably lower post-CP (median bsDOT from 17 pre-CP to 4.5 post-CP, p <0.0001). No difference in treatment failure was reported before and after CP implementation (16.7% pre-CP vs. 15.4% post-CP, p = 1). CONCLUSIONS: Introduction of a CP for CAP in a Pediatric Emergency Department led to reduction of broad-spectrum antibiotic prescriptions, of combination therapy and of duration of treatment both for outpatients and inpatients.
Assuntos
Antibacterianos/uso terapêutico , Infecções Comunitárias Adquiridas/tratamento farmacológico , Procedimentos Clínicos/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Pneumonia/tratamento farmacológico , Adolescente , Criança , Pré-Escolar , Humanos , Lactente , Pacientes Internados/estatística & dados numéricos , Tempo de Internação , Pacientes Ambulatoriais/estatística & dados numéricos , Falha de TratamentoRESUMO
BACKGROUND: Intensified tuberculosis (TB) case finding and isoniazid preventive therapy (IPT) are strongly recommended for children who are HIV infected. Data are needed to assess the feasibility of the WHO 2011 intensified tuberculosis case finding/IPT clinical algorithm. METHODS: Children who are HIV infected and attending Nsambya Home Care at Nsambya Hospital, Uganda, were screened for TB following WHO recommendations. IPT was given for 6 months after excluding TB. Factors associated with time to IPT initiation were investigated by multivariate Cox proportional hazard regression. Health care workers were interviewed on reasons for delay in IPT initiation. RESULTS: Among the 899 (49% male) children with HIV, 529 (58.8%) were screened for TB from January 2011 to February 2013. Children with active TB were 36/529 (6.8%), 24 (4.5%) were lost to follow-ups and 280 (52.9%) started IPT, 86/280 (30.7%) within 3 months of TB screening and 194/280 (69.3%) thereafter. Among the 529 children screened for TB, longer time to IPT initiation was independently associated with cough at TB screening (hazard ratio 0.62, P = 0.02, 95% confidence interval: 0.41 to 0.94). Four children (1% of those starting treatments) interrupted IPT because of a 5-fold increase in liver function measurements. In the survey, Health care workers reported poor adherence to antiretroviral therapy, poor attendance to periodic HIV follow-ups, and pill burden as the 3 main reasons to delay IPT. CONCLUSION: In resource-constrained settings, considerable delays in IPT initiation may occur, particularly in children with HIV who are presenting with cough at TB screening. The good safety profile of isoniazid in antiretroviral-therapy-experienced children provides further support to IPT implementation in this population.