ABSTRACT
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.
Subject(s)
Anti-Asthmatic Agents , Asthma , Humans , Child , Omalizumab/therapeutic use , Cost-Benefit Analysis , Anti-Asthmatic Agents/therapeutic use , Spain , Retrospective Studies , Asthma/therapy , Treatment Outcome , Quality of LifeABSTRACT
BACKGROUND: The evidence-based medicine (EBM) paradigm requires the development of health care professionals' skills in the efficient search of evidence in the literature, and in the application of formal rules to evaluate this evidence. Incorporating this methodology into the decision-making routine of clinical practice will improve the patients' health care, increase patient safety, and optimize resources use. OBJECTIVE: The aim of this study is to develop and evaluate a new tool (KNOWBED system) as a clinical decision support system to support scientific knowledge, enabling health care professionals to quickly carry out decision-making processes based on EBM during their routine clinical practice. METHODS: Two components integrate the KNOWBED system: a web-based knowledge station and a mobile app. A use case (bronchiolitis pathology) was selected to validate the KNOWBED system in the context of the Paediatrics Unit of the Virgen Macarena University Hospital (Seville, Spain). The validation was covered in a 3-month pilot using 2 indicators: usability and efficacy. RESULTS: The KNOWBED system has been designed, developed, and validated to support clinical decision making in mobility based on standards that have been incorporated into the routine clinical practice of health care professionals. Using this tool, health care professionals can consult existing scientific knowledge at the bedside, and access recommendations of clinical protocols established based on EBM. During the pilot project, 15 health care professionals participated and accessed the system for a total of 59 times. CONCLUSIONS: The KNOWBED system is a useful and innovative tool for health care professionals. The usability surveys filled in by the system users highlight that it is easy to access the knowledge base. This paper also sets out some improvements to be made in the future.
ABSTRACT
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.
Subject(s)
Anti-Asthmatic Agents/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Asthma , Omalizumab/therapeutic use , Anti-Asthmatic Agents/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Asthma/drug therapy , Child , Humans , Omalizumab/adverse effects , Retrospective Studies , Treatment OutcomeABSTRACT
No disponible
Subject(s)
Humans , Community-Acquired Infections/drug therapy , Pneumonia/drug therapy , Anti-Bacterial Agents/administration & dosage , Time FactorsABSTRACT
La neumonía adquirida en la comunidad (NAC) es una enfermedad prevalente en la edad pediátrica y que ofrece frecuentemente dudas tanto diagnósticas como terapéuticas. Se ha realizado un consenso entre SEPAR, SENP y SEIP, con las siguientes conclusiones: 1. La etiología depende fundamentalmente de la edad y de otros factores, como estado inmunitario, presencia de enfermedad de base o estado vacunal y no existe un marcador analítico único con una absoluta fiabilidad diagnóstica. 2. Ante la sospecha clínica de neumonía, no es imprescindible la realización de una radiografía de tórax en los niños sanos. La ecografía torácica se va imponiendo como método de seguimiento, e incluso de diagnóstico. 3. El tratamiento antibiótico empírico de elección en las formas típicas es la amoxicilina oral a una dosis de 80mg/kg/ día generalmente durante 7 días, mientras que en las atípicas en mayores de 5 años son los macrólidos. En las formas típicas graves se recomienda la combinación de cefalosporina de 3.a generación y cloxacilina (o clindamicina o vancomicina) por vía intravenosa. 4. En caso de requerir drenaje pleural, se recomienda la inserción ecoguiada de un catéter de pequeño tamaño. La administración intrapleural de fibrinolíticos (urocinasa) reduce la estancia hospitalaria en comparación con el drenaje pleural simple. 5. En el derrame pleural paraneumónico el tratamiento con antibioticoterapia junto con drenaje pleural y fibrinolíticos se asocia con una estancia hospitalaria y una tasa de complicaciones similar al tratamiento antibiótico más videotoracoscopia asistida. 6. Se recomienda la vacunación antineumocócica conjugada sistemática en menores de 5 años, ya que reduce la incidencia de NAC y de hospitalización por esta causa
Community-acquired pneumonia (CAP) is a prevalent disease among children and is frequently associated with both diagnostic and therapeutic uncertainties. Consensus has been reached between SEPAR, SENP and SEIP, and their conclusions are as follows: 1. Etiology depends mainly on age and other factors and no single analytical marker offers absolute diagnostic reliability. 2. In the event of clinical suspicion of pneumonia in a healthy child, chest X-ray is not necessary. Chest ultrasound is increasingly implemented as a follow-up method, and even as a diagnostic method. 3. The empirical antibiotic treatment of choice In typical forms of the disease is oral amoxicillin at a dose of 80mg/kg/day for 7 days, while in atypical presentations in children older than 5 years, macrolides should be selected. In severe typical forms, the combination of 3rd generation cephalosporins and cloxacillin (or clindamycin or vancomycin) administered intravenously is recommended. 4. If pleural drainage is required, ultrasound-guided insertion of a small catheter is recommended. Intrapleural administration of fibrinolytics (urokinase) reduces hospital stay compared to simple pleural drainage. 5. In parapneumonic pleural effusion, antibiotic treatment combined with pleural drainage and fibrinolytics is associated with a similar hospital stay and complication rate as antibiotic treatment plus video-assisted thoracoscopy. 6. Systematic pneumococcal conjugate vaccination is recommended in children under 5 years of age, as it reduces the incidence of CAP and hospitalization for this disease
Subject(s)
Humans , Child , Community-Acquired Infections/diagnosis , Community-Acquired Infections/therapy , Pneumonia/diagnosis , Pneumonia/therapy , Consensus , Community-Acquired Infections/etiology , Pneumonia/etiology , Disease Management , SpainABSTRACT
Community-acquired pneumonia (CAP) is a prevalent disease among children and is frequently associated with both diagnostic and therapeutic uncertainties. Consensus has been reached between SEPAR, SENP and SEIP, and their conclusions are as follows.
Subject(s)
Community-Acquired Infections , Pneumonia , Child , Community-Acquired Infections/diagnosis , Consensus , Humans , Pneumonia/diagnosis , Pyruvates , UncertaintyABSTRACT
Tracheal bronchus (TRB) has been generally considered an anatomical variant of the tracheobronchial tree without a precise pathological effect. Its prevalence is estimated to be between 0.2% to 3% of all children undergoing bronchoscopy and scientific information has been limited to case reports or small case series. Our working hypothesis was that TRB could trigger by itself recurrent or persistent respiratory symptoms. The objective of this retrospective and multicentre study of children with a diagnosis of TRB, coming from the main paediatric pulmonology units of Spain, was to determine the anatomical and clinical characteristics, including comorbidities, of TRB in childhood and their impact in the patients' clinical outcomes. One hundred thirty-three patients from 13 institutions were included in the study. Mean diagnostic age was 3.4 years and flexible bronchoscopy was the initial diagnostic method in 85% of cases. All TRB were located on the right wall of the trachea: 76% in the lower third and 24% in the carina. The most common clinical manifestations were obstructive bronchitis (53.3%) and recurrent pneumonia (46.6%), usually affecting the right upper lobe. Regarding associated anomalies, 33% had tracheomalacia, 32% congenital cardiovascular malformations, 28% gastroesophageal reflux, 22.5% congenital tracheal stenosis, and 8.3% Down syndrome. This series appears to be the most extensive published to date addressing this topic and, according to our data, TRB does not appear to be a mere incidental finding but is more likely linked to a wide range of congenital anomalies and contributes by itself to the recurrent respiratory symptomatology that these children exhibit.
Subject(s)
Bronchi/abnormalities , Trachea/abnormalities , Adolescent , Bronchitis/epidemiology , Bronchoscopy , Cardiovascular Abnormalities/epidemiology , Child , Child, Preschool , Down Syndrome/epidemiology , Female , Gastroesophageal Reflux/epidemiology , Humans , Infant , Male , Pneumonia/epidemiology , Prevalence , Spain/epidemiology , Tracheal Diseases/epidemiologyABSTRACT
No disponible
Subject(s)
Humans , Female , Infant , Community-Acquired Infections/epidemiology , Community-Acquired Infections/prevention & control , Pneumonia/complications , Pneumonia/physiopathology , Stents/trendsABSTRACT
No disponible
