Reporting guidelines and a touch of critical appraisal.

The biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.

Guías para la elaboración de manuscritos y unas pinceladas de lectura crítica / Reporting guidelines and a touch of critical appraisal

El proceso de investigación biomédica debe seguir unos criterios de calidad en su diseño y elaboración que garanticen que los resultados son creíbles y fiables. Una vez finalizado, llega el momento de escribir un artículo para su publicación. Este debe presentar con suficiente detalle, y de forma clara y transparente, toda la información del trabajo de investigación realizado. De esta forma, los lectores, tras una lectura crítica de lo publicado, podrán juzgar la validez y la relevancia del estudio, y si lo consideran, utilizar los hallazgos. Con el objetivo de mejorar la descripción del proceso de investigación para su publicación, se han desarrollado una serie de guías que, de forma sencilla y estructurada, orientan a los autores a la hora de elaborar un manuscrito. Se presentan en forma de lista, diagrama de flujo, o texto estructurado, y son una ayuda inestimable a la hora de escribir un artículo. Este artículo presenta las guías de elaboración de manuscritos de los diseños más habituales, con sus listas de verificación.(AU)

The biomedical research process must follow certain quality criteria in its design and development to ensure that the results are credible and reliable. Once completed, the time comes to write an article for publication. The article must present in sufficient detail, and in a clear and transparent manner, all the information on the research work that has been carried out. In this way, readers, after a critical reading of the published content, will be able to judge the validity and relevance of the study and, if they so wish, make use of the findings. In order to improve the description of the research process for publication, a series of guidelines have been developed which, in a simple and structured way, guide authors in the preparation of a manuscript. They are presented in the form of a list, flowchart, or structured text, and are an invaluable aid when writing an article. This article presents the reporting guidelines for the most common designs along with the corresponding checklists.(AU)

Evidentia praxis: nirsevimab y prevención de bronquiolitis en lactantes nacidos a término / Evidentia praxis: Nirsevimab and bronchiolitis prevention in term-born infants

Analizamos la evidencia publicada sobre la eficacia y seguridad de nirsevimab, un anticuerpo monoclonal, empleado para prevenir las infecciones de vías respiratorias bajas (IVRB) por virus respiratorio sincitial (VRS) en el lactante a término. Encontramos un ensayo clínico aleatorizado controlado con placebo doble ciego que incluyó 3012 lactantes, nacidos a término o pretérmino tardío, menores de un año con un seguimiento de al menos 150 días. La calidad de la evidencia se clasificó como baja para IVRB muy grave y moderada para IVRB que precisara asistencia o ingreso. La evidencia se sustenta sobre un escaso número de eventos (para ingresos hospitalarios sólo 29 casos, para IVRB con atención médica 78), por lo que cualquier estimación debe considerarse imprecisa. La eficacia, estimada como reducción relativa del riesgo (RRR) fue del 76,4% (intervalo de confianza del 95% [IC 95]: 62,3 a 85,2) para IVRB por VRS y del 76,8% (IC 95: 49,4 a 89,4%) para ingreso. No se encontraron diferencias en cuanto a seguridad. Existen dudas sobre la importancia clínica, por los criterios de gravedad empleados, y sobre su impacto, con un número necesario a tratar para evitar una IVRB con ingreso de 63 y que requiera asistencia médica de 24. Por la información disponible parece una intervención segura, de la que no esperamos efectos adversos comunes, pero no podemos descartar efectos de baja frecuencia. Asimismo, esperamos contar pronto con estimaciones más precisas de eficacia y seguridad (AU)

We reviewed the published evidence on the efficacy and safety of nirsevimab, a monoclonal antibody, used to prevent respiratory syncytial virus (RSV) associated lower respiratory tract infections (LRTI) in term infants. We have found a randomized double-blind placebo-controlled clinical trial that included 3012 infants, born at term or late preterm, less than one year of age with a follow-up of at least 150 days. The quality of the evidence was classified as low for very severe LRTI and moderate for LRTI requiring medical care or admission. The evidence is based on a small number of events (only 29 cases for hospital admissions, 78 for IVRB with medical care), so any estimate must be considered imprecise. Efficacy, estimated as relative risk reduction (RRR) was 76.4% (95% confidence interval [95 CI]: 62.3 to 85.2) for RSV associated LRTI that required medical care and 76.8% (CI 95: 49.4 to 89.4%) for hospital admission. No differences were found in terms of safety. There are doubts about the clinical importance, due to the severity criteria used, and about its impact, with a number needed to treat of 63 to avoid a LRTI with hospital admission and of 24 to avoid LRTI requiring medical care. Based on the available information, it seems a safe intervention, from which we do not expect common adverse effects, but we cannot rule out low-frequency effects. We also expect to have more precise estimates of efficacy and safety soon. (AU)

COVID-19 en pediatría: valoración crítica de la evidencia / COVID-19: Critical appraisal of the evidence

Presentamos el resumen de un documento de valoración crítica de la evidencia disponible sobre la COVID-19, elaborado con formato de guía de práctica clínica siguiendo la metodología GRADE. El documento trata de dar respuestas a una serie de preguntas clínicas estructuradas, con definición explícita de la población, intervención/exposición, comparación y resultado, y una jerarquización de la importancia clínica de las medidas de efecto valoradas. Realizamos revisiones sistemáticas de la literatura para responder a las preguntas, agrupadas en 6 capítulos: epidemiología, clínica, diagnóstico, tratamiento, prevención y vacunas. Valoramos el riesgo de sesgo de los estudios seleccionados con instrumentos estándar (RoB-2, ROBINS-I, QUADAS y Newcastle-Ottawa). Elaboramos tablas de evidencia y, cuando fue necesario y posible, metaanálisis de las principales medidas de efecto. Seguimos el sistema GRADE para realizar síntesis de la evidencia, con valoración de su calidad y, cuando se consideró apropiado, emitir recomendaciones jerarquizadas en función de la calidad de la evidencia, los valores y preferencias, el balance entre beneficios, riesgos y costes, la equidad y la factibilidad. (AU)

We present the summary of a critical appraisal document of the available evidence on COVID-19, developed with a clinical practice guide format following GRADE methodology. The document tries to provide answers to a series of structured clinical questions, with an explicit definition of the population, intervention/exposure, comparison and outcome, and a rating of the clinical relevance of the outcome measures. We conducted a systematic review of the literature to answer the questions, grouped into six chapters: epidemiology, clinical practice, diagnosis, treatment, prevention, and vaccination. We assessed the risk of bias of the selected studies with standard instruments (RoB-2, ROBINS-I, QUADAS and Newcastle-Ottawa). We constructed evidence tables and, when necessary and possible, meta-analysis of the of the most relevant outcome measures. We followed the GRADE system to synthesize the evidence, assessing its quality, and, when appropriate, giving recommendations, rated according to the quality of the evidence, the values and preferences, the balance between benefits, risks and costs, equity and feasibility. (AU)

COVID-19: Critical appraisal of the evidence.

We present the summary of a critical appraisal document of the available evidence on COVID-19, developed with a clinical practice guide format following GRADE methodology. The document tries to provide answers to a series of structured clinical questions, with an explicit definition of the population, intervention / exposure, comparison and outcome, and a rating of the clinical relevance of the outcome measures. We conducted a systematic review of the literature to answer the questions, grouped into six chapters: epidemiology, clinical practice, diagnosis, treatment, prevention, and vaccination. We assessed the risk of bias of the selected studies with standard instruments (RoB-2, ROBINS-I, QUADAS and Newcastle-Ottawa). We constructed evidence tables and, when necessary and possible, meta-analysis of the of the most relevant outcome measures. We followed the GRADE system to synthesise the evidence, assessing its quality, and, when appropriate, giving recommendations, rated according to the quality of the evidence, the values and preferences, the balance between benefits, risks and costs, equity and feasibility.

[COVID-19: Critical appraisal of the evidence]. / COVID-19 en pediatría: valoración crítica de la evidencia.

We present the summary of a critical appraisal document of the available evidence on COVID-19, developed with a clinical practice guide format following GRADE methodology. The document tries to provide answers to a series of structured clinical questions, with an explicit definition of the population, intervention/exposure, comparison and outcome, and a rating of the clinical relevance of the outcome measures. We conducted a systematic review of the literature to answer the questions, grouped into six chapters: epidemiology, clinical practice, diagnosis, treatment, prevention, and vaccination. We assessed the risk of bias of the selected studies with standard instruments (RoB-2, ROBINS-I, QUADAS and Newcastle-Ottawa). We constructed evidence tables and, when necessary and possible, meta-analysis of the of the most relevant outcome measures. We followed the GRADE system to synthesize the evidence, assessing its quality, and, when appropriate, giving recommendations, rated according to the quality of the evidence, the values and preferences, the balance between benefits, risks and costs, equity and feasibility.

Los disruptores endocrinos no parece que se asocien con el autismo o la discapacidad intelectual / Endocrine disrupting chemicals do not seem to be related with autism spectrum disorder or intellectual disability

CONCLUSIONES DE LOS AUTORES DEL ESTUDIO: los análisis no sugieren una relación entre el autismo o la discapacidad intelectual con ninguno de los 25 compuestos químicos analizados. COMENTARIO DE LOS REVISORES: con este modelo probabilístico bayesiano, los autores reducen, por el momento, la alarma sobre la relación entre los principales disruptores endocrinos y los trastornos del espectro autista o discapacidad intelectual, al no demostrarse la asociación que mostraban estudios previos con análisis "frecuentistas". Es un resultado importante dada la preocupación general sobre los efectos de estos contaminantes universales

AUTHORS' CONCLUSIONS: our mixtures analysis does not suggest an independent relationship of autism spectrum disorder or intellectual disability with any of the 25 chemicals examined together in this mixtures analysis. REVIEWERS' COMMENTARY: with this Bayesian probabilistic model, the authors clear up, at this moment, the uncertainty about the relationship between the main endocrine disruptors and autism spectrum disorders or intellectual disability, as the association shown in previous studies with "frequentist" analyzes is not demonstrated. It is an important result given the general concern about the effects of these universal pollutants

Paediatricians provide higher quality care to children and adolescents in primary care: A systematic review.

AIM: The number of primary care paediatricians is decreasing in Europe without a justifiable reason. We aimed to compare the clinical practice of paediatricians and family doctors attending children and adolescents in primary care. METHODS: MEDLINE, Embase, CENTRAL, TRIP and Google Scholar were searched from December 2008 to February 2018. No language or study design restrictions were applied. Three reviewers assessed eligibility of the studies. Seven pairs of reviewers performed the data extraction and assessed the methodological quality independently. Discrepancies were resolved by consensus. RESULTS: Fifty-four, out of 1150 studies preselected, were included. We found that paediatricians show more appropriate pharmacology prescription patterns for the illness being treated; they achieve higher vaccination rates and have better knowledge of vaccines and fewer doubts about vaccine safety; their knowledge and implementation of different screening tests are better; they prescribe psychoactive drugs more cautiously and more in line with current practice guidelines; their evaluation and treatment of obesity and lipid disorders follow criteria more consistently with current clinical practice guidelines; and they perform fewer diagnostic test, show a more suitable use of the test and request fewer referrals to specialists. CONCLUSION: According to published data, in developed countries, paediatricians provide higher quality care to children than family doctors.

La profilaxis antibiótica es innecesaria para prevenir las cicatrices renales tras infección urinaria en niños sanos / Antibiotic prophylaxis is unnecessary to prevent renal scarring after urinary tract infection in healthy children

Conclusiones de los autores del estudio: la profilaxis antibiótica no está indicada para la prevención de cicatrices renales tras la primera o segunda infección urinaria febril en niños sanos. Comentario de los revisores: la incidencia de cicatrices renales tras una infección urinaria febril en niños sanos es baja, en torno al 6%. No hay diferencias entre el grupo tratado profilácticamente con antibióticos y el grupo control, por lo que la administración de profilaxis antibiótica no está justificada

Authors' conclusions: antibiotic prophylaxis is not indicated for the prevention of renal scarring after a first or second symptomatic or febrile urinary tract infection in otherwise healthy children. Reviewers' commentary: incidence of renal scarring after febrile urinary tract infection in healthy children is low, around 6%. There are not differences between prophylaxis and control groups, so prophylactic antibiotic therapy is not justified