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As part of the ‘Suicidality: Treatment Occurring in Paediatrics (STOP)’ study, we developed and performed psychometric validation of an electronic-clinical-outcome-assessment (eCOA), which included a patient-reported-outcome (ePRO), an observer-rated-outcome (eObsRO) for parents/carers and a clinician-reported-outcome (eClinRO) that allows identification and monitoring of medication-related suicidality (MRS) in adolescents.
STOP: Prospective study: A two phase validation study to assess the impact of medication on suicidal ideations.
Six participating countries: Netherlands, UK, Germany, France, Spain and Italy that were part of the Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 261411.
Cohort 1 consisted of 41 adolescent-completions, 50 parent-completions and 56 clinician-completions. Cohort 2 consisted of 244 adolescent-completions, 198 parent-completions and 240 clinician-completions from across the six countries. The scale was administered only to participants who have screened positive for the STOP-Suicidality Assessment Scale (STOP-SAS).
A total of 24 items for the development of the STOP-Medication Suicidality Side Effects Scale (STOP-MS3) were identified and three versions (for patients, parents and clinicians) of the STOP-MS3 were developed and validated in two separate study cohorts comprising of adolescents, their parents and clinicians. Cronbach’s α coefficients were above 0.85 for all domains. The inter-rater reliability of the STOP-MS3 was good and significant for the adolescent (ePRO), clinician (eClinRO) (r=0.613), parent (eObsRO) versions of the scale (r=0.394) and parent and clinician (r=0.347). Exploratory factor analysis identified a 3-factor model across 24 items for the adolescent and parent version of the scale: (1) Emotional Dysregulation, (2) Somatic Dysregulation and (3) Behavioural Dysregulation. For the clinician version, a 4-factor model defined the scale structure: (1) Somatic Dysregulation, (2) Emotional Dysregulation, (3) Behavioural Dysregulation and (4) Mood Dysregulation.
These findings suggest that the STOP-MS3 scale, a web-based eCOA, allows identification and monitoring of MRS in the adolescent population and shows good reliability and validity.
To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.
A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.
Three inner-city UK National Health Service hospitals in London.
Pregnant women with gestational diabetes treated with medication.
2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.
Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.
Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.
Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.
It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.
Sr. Director: El Reglamento Sanitario Internacional (2005) exponía que las amenazas para la salud pública internacional en el siglo XXI se centraban en 7 campos: enfermedades epidemiógenas, enfermedades transmitidas por los alimentos, brotes accidentales, brotes intencionados, accidentes por sustancias químicas tóxicas, accidentes radio nucleares y desastres ambientales [Fragmento de texto].
Introducción: El asma, enfermedad crónica infantil más frecuente, está aumentando probablemente en relación a la exposición a factores ambientales. Estos están asociados a la aparición de asma y como desencadenante de síntomas. La literatura al respecto es controvertida. El objetivo de este trabajo es comprobar la posible influencia de la exposición a animales y/o humo de tabaco en el domicilio sobre el grado de control de la enfermedad y el número de exacerbaciones en población pediátrica asmática. Metodología: Estudio observacional realizado en población pediátrica que acudía a consulta de Neumología Pediátrica del hospital de referencia diagnosticados de asma y que tuviera pautado tratamiento inhalado. Como variable dependiente se consideró el número de exacerbaciones y como variables independientes se incluyeron sociodemográficas, variables asociadas a factores ambientales, así como a la técnica de inhalación. Resultados: Participaron 204 familias (66,7% niños). El 70,6% no tenían animales y el 78% no eran fumadores. La media de las exacerbaciones durante el periodo a estudio fue de 1,62. Un 84,8% de los/las pacientes presentan un buen control de la enfermedad. Discusión: Se encuentra relación entre el tener o no animales en casa y/o estar expuestos al tabaco y el grado de control de la enfermedad y número de exacerbaciones, confirmando lo descrito por varios autores. Es importante realizar una intervención individual donde se evalúen los factores que afectan a niños asmáticos y tratar los que sean modificables: manejo guiado de síntomas y tratamiento de exacerbaciones, consejo antitabaco, fomento actividad física… para mejorar su calidad de vida.
ABSTRACT
Introduction: Asthma, the most common chronic disease in childhood, is probably increasing in relation to exposure to environmental factors. These are associated with the onset of asthma and as a trigger for symptoms. The evidence on this is controversial. The objective of this study is to verify the possible influence of exposure to animals and/or tobacco smoke at home on the degree of control of the disease and the number of exacerbations in the paediatric asthmatic population. Methodology: Observational study carried out in a paediatric population that were attended at the paediatric pulmonology consultation of the reference hospital diagnosed with asthma and who had scheduled inhaled treatment. The number of exacerbations was considered as a dependent variable, and sociodemographic variables, variables associated with environmental factors, as well as the inhalation technique were included as independent variables. Results: 204 families participated (66,7% boys). 70,6% did no have animals and 78% were not smokers. The mean number of exacerbations during the study period was 1,62. 84,4% of the patients have good control of the disease. Discussion: A relationship was found between having or not having animals at home and/or being exposed to tobacco smoke and the degree of control of the disease and the number of exacerbations, confirming what has been described by several authors. It is important to carry out an individual intervention where the factors that affect asthmatic children are evaluated and treat those that are modifiable: guided management of symptoms and treatment of exacerbations, anti-smoking advice, physical activity promotion … to improve their quality of life.
Objetivo principal: Evaluar si el uso de catéter venoso central (CVC) impregnado en antimicrobiano es útil para la reducción de la bacteriemia relacionada con el catéter en pacientes ingresados en la Unidad de Cuidados Intensivos (UCI), e identificar el antimicrobiano más efectivo. Metodología: Se realizó una revisión sistemática en Bases Datos (CINAHL, PUBMED, CUIDEN, EMBASE, LILACS y SCIELO). Incluidos artículos de 2009 a 2017, inglés y español, que fuesen ensayos clínicos aleatorizados e incluyeran pacientes de UCI con CVC impregnado comparado con CVC convencional. Se evaluó la calidad metodológica de los artículos mediante la herramienta CASPE. Resultados principales: De los 8 estudios, 4 mostraron significancia en cuanto al uso de CVC impregnados para la reducción de infecciones relacionadas con el catéter. Dentro de los antimicrobianos usados, la minociclina-rifampicina muestra la mayor efectividad. Conclusión principal: El uso de CVC impregnado, puede ser efectivo en la reducción de infecciones en UCI. Dentro de las limitaciones de este tipo de catéter, a mayor número de luces y tiempo de mantenimiento de CVC, menor efectividad antimicrobiana.
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