Cost-effectiveness of omalizumab for the treatment of severe pediatric allergic asthma-Results of a real-life study in Spain.

BACKGROUND: Severe pediatric allergic asthma (SPAA) induces a huge economic burden in terms of direct, indirect, and intangible costs. The use of omalizumab for the treatment of these patients has produced a significant improvement in several clinical outcomes, but at the same time, the cost for the management of the disease has also increased. The aim of this report was to evaluate whether the use of omalizumab is cost-effective. METHODS: A sample of 426 children with SPAA from the ANCHORS (Asthma iN CHildren: Omalizumab in Real-life in Spain) study was used to calculate the incremental cost-effectiveness ratio (ICER) for the avoidance of moderate-to-severe exacerbations (MSE) and also for the improvement in childhood Asthma Control Test (c-ACT) or the Asthma Control Questionnaire (ACQ5). We retrospectively collected data on health encounters and drug consumption before and up to 6 years after the beginning of the treatment with omalizumab. RESULTS: The ICER per avoided MSE was €2107 after 1 year, and it consistently decreased to €656 in those followed up to 6 years. Similarly, the ICER for the minimally important difference in control tests showed a decrease from €2059 to €380 per each 0.5 points of improvement in ACQ5 and from €3141 to €2322 per each 3 points improvement in c-ACT, at years 1 and 6, respectively. CONCLUSION: The use of OMZ is a cost-effective option for most children with uncontrolled SPAA, especially those who have frequent exacerbations; the costs are progressively reduced in successive years of treatment.

Maternal smoking during pregnancy and asthma during the first year of life: a comparative study between smokers and nonsmoker mothers.

BACKGROUND: We investigated the relationship between maternal smoking in pregnancy and health care problems in the offspring during the first year of life, particularly asthma. MATERIAL AND METHODS: A cohort of 648 consecutive infants born at term and alive at Hospital de Sagunto (Valencia, Spain) over one year period was followed for 12 months. Clinical data of the infants were prospectively collected from the database of ambulatory medical records (ABUCASIS) of the Valencia health system. RESULTS: Smoking during pregnancy was recorded in 164 (25.3%) mothers. During the first year of life, asthma was diagnosed in 101 infants, with an incidence of 15.7%. The diagnoses of asthma (25.6% vs. 12.3%; P < 0.0001) and bronchiolitis (44.5% vs. 28.6%; P = 0.0002) during the first year of life were more common among infants in the smoking group. The probability of developing asthma during the first year of life was two-fold higher for the male gender and 2.5 times higher when mothers smoked while pregnant. Up to 52% of asthma cases could have been avoided in infants born to smoking mothers if they did not smoke during pregnancy. Infants in the smoking group showed a lower weight and length at birth than infants in the nonsmoking group differences almost disappeared at 6 months and 12 months. CONCLUSION: Asthma during the first year of life showed a clear relationship with maternal smoking in pregnancy. Pregnant women should be advised of the significant perinatal risk for respiratory diseases associated with tobacco use.

Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma.

BACKGROUND: Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date. METHODS: ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients < 18 years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of the annual number of moderate-to-severe exacerbations compared with the baseline period. RESULTS: Of the 484 patients included, 101 (20.9%) reached 6 years of treatment. The mean ± standard deviation number of exacerbations decreased during the first year of treatment (7.9 ± 6.6 to 1.1 ± 2.0, P < .001) and remained likewise for up to 6 years. The other clinical parameters assessed also improved significantly during the first year and stabilized or continued to improve thereafter. The percentage of patients experiencing adverse events was consistently low, and the main reason for discontinuation was good disease evolution. CONCLUSION: In this large, long-term, observational study, moderate-to-severe exacerbations decreased significantly from the first year of treatment with omalizumab. The beneficial effect was maintained in the long term, along with a good safety profile. Our results position omalizumab as an effective long-term treatment in pediatric patients with severe persistent allergic asthma.

[Use of hypotonic fluids in the prescription of maintenance intravenous fluid therapy]. / Uso de sueros hipotónicos en la prescripción de la fluidoterapia intravenosa de mantenimiento.

INTRODUCTION: Isotonic fluids, in most cases, are the safest way to dispense fluids intravenously. The aim of this study was to determine the prescription of maintenance intravenous fluids and to study possible associated factors. MATERIAL AND METHOD: A descriptive, cross-sectional, multi-centre study was performed. A questionnaire was sent nationwide to several healthcare providers via an on-line survey, sent by email through different Medical Scientific Societies, and the Official Spanish Medical Association, between December 2016 and December 2017. RESULTS: A total of 487 questionnaires were received, of which 456 were submitted by paediatricians. More than one quarter (28.95%) (95% CI; 24.77-33.13) of the paediatricians usually dispense hypotonic fluids and 81.14% (95% CI; 77.54-84.74) prescribe infusion rates based on the Holliday and Segar protocol. The general profile of paediatricians who prescribe hypotonic fluids intravenously in Spain are medical residents, paediatricians working in paediatric non-intensive care units, in private hospitals, and those who recognise that no consensus exists among their direct work colleagues regarding this subject. CONCLUSIONS: More than twenty-five per cent of all paediatricians in our country continue to use hypotonic fluids as maintenance intravenous fluid therapy. There might be several potential factors associated to this. These kind of studies provide evidence of the great difficulties in transferring scientific knowledge to clinical practice.

[Multimodal implementation of clinical practice guidelines on bronchiolitis: ending the overuse of diagnostic resources]. / Implementación multimodal de una guía de práctica clínica en bronquiolitis: acabando con el uso excesivo de recursos diagnósticos.

INTRODUCTION: Clinical Practice Guidelines have been shown to be valuable tools for guiding medical decisions. However, their mere publication has not reduced the variability of practice in terms of the way acute bronchiolitis is managed. METHOD: A before-and-after study design was used to analyse the effectiveness of a method of disseminating diagnostic recommendations among physicians regarding the management of infants, hospitalised due to bronchiolitis. Patients with comorbidities, ex-premature patients, and patients transferred to other hospitals were excluded. The diagnostic resources studied were: chest X-ray, full blood count, C-reactive protein, blood culture, venous blood gas, and determination of the respiratory syncytial virus. Eleven epidemic periods were analysed. RESULTS: A total of 259 patients were studied including 98 in the pre-intervention group (2006-2010), and 131 in the post-intervention group (2011-2017). The intervention took place in October of 2010 and 2011. A comparison of the two periods showed that the use of chest X-rays dropped from 73.5% to 16% (p<.01), full blood counts from 51% to 21.4% (p<.01), C-reactive protein from 48% to 22.1% (p<.01), and blood cultures from 23.5% to 7.6% (p<.01). Length of stay dropped by 0.6 (SD: 1) days and there were no differences in re-admission rates. CONCLUSIONS: The organised and systematised dissemination, using a multimodal method, of the diagnostic recommendations contained in the clinical practice guidelines on bronchiolitis, is capable of transforming the clinical practice by reducing the use of diagnostic resources, without an increase in the re-admission rate.

[Influence of the month of birth on the demand for healthcare to treat attention deficit hyperactivity disorder. Results of a retrospective study conducted in a neuropaediatric clinic]. / Influencia del mes de nacimiento en la demanda asistencial por trastorno por deficit de atencion/hiperactividad. Resultados de un estudio retrospectivo realizado en una consulta de neuropediatria.

INTRODUCTION: There is an increase in the child neurology attention and, specially in attention deficit hyperactivity disorder (ADHD). It's been proposed that the birth date affects the diagnosis of ADHD, so the youngest children more susceptible of being diagnosed. AIMS: To analyse if there is a relationship between the birth date and the suspicion of ADHD, and to investigate the health demand of child neurology and its evolution regarding diagnostic categories. PATIENTS AND METHODS: Retrospective study of patients been attended in a child neurology clinic between 1992 and 2012. Different diagnostic groups were compared considering epidemiologic variables and trimester and semester of birth to determine whether exists a seasonal pattern. RESULTS: 3469 patients were included, 58.5% were male with a median age of 6 years old. The first reason of consultation was the headache, and the ADHD has experienced an increase of 350% in the last 10 years of the study. 61.6% of patients with ADHD suspicion were born in the second semester of the year. The difference was higher for girls. This pattern was not observed in other neurologic diseases when a comparative analysis was done. CONCLUSIONS: There is an increase of child neurologic demand within the last years, mainly of ADHD patients. Children born in the last semester of the year have a higher risk of being sent to a neurology clinic for evaluation.

TITLE: Influencia del mes de nacimiento en la demanda asistencial por trastorno por deficit de atencion/hiperactividad. Resultados de un estudio retrospectivo realizado en una consulta de neuropediatria.Introduccion. Las consultas de neuropediatria se han incrementado en los ultimos años, especialmente por trastorno por deficit de atencion/hiperactividad (TDAH). Se postula que los niños mas jovenes del curso tienen mas riesgo de ser diagnosticados de TDAH. Objetivos. Analizar la demanda asistencial de neuropediatria, comparar su evolucion por grupos diagnosticos y determinar si existe una relacion entre la fecha de nacimiento de los pacientes y la sospecha de TDAH. Pacientes y metodos. Estudio retrospectivo de los pacientes remitidos a neuropediatria entre 1992 y 2012. Se compararon las distintas categorias diagnosticas segun variables epidemiologicas y se exploro si existia un factor relativo a la edad. Resultados. Se incluyeron 3.469 pacientes, un 58,5% varones, con una mediana de edad de 6 años. El principal motivo de consulta fue la cefalea, y todos los grupos diagnosticos sufrieron un incremento de las consultas. El TDAH experimento un aumento del 350% en los ultimos 10 años. El 61,6% de los niños con sospecha de TDAH nacio en el segundo semestre del año, y la diferencia es mas notable en las niñas. Se objetiva un incremento de sospecha de TDAH en los niños nacidos antes de la fecha de corte del curso escolar que no aparece en ninguna de las otras patologias en el analisis comparativo. Conclusiones. Existe un incremento de la demanda asistencial de neuropediatria en los ultimos años, principalmente por TDAH. Los niños nacidos el ultimo semestre del año tienen un riesgo mayor de ser remitidos por sospecha de esta enfermedad.