Tipping point analysis for the between-arm correlation in an arm-based evidence synthesis.

Systematic reviews and meta-analyses are essential tools in contemporary evidence-based medicine, synthesizing evidence from various sources to better inform clinical decision-making. However, the conclusions from different meta-analyses on the same topic can be discrepant, which has raised concerns about their reliability. One reason is that the result of a meta-analysis is sensitive to factors such as study inclusion/exclusion criteria and model assumptions. The arm-based meta-analysis model is growing in importance due to its advantage of including single-arm studies and historical controls with estimation efficiency and its flexibility in drawing conclusions with both marginal and conditional effect measures. Despite its benefits, the inference may heavily depend on the heterogeneity parameters that reflect design and model assumptions. This article aims to evaluate the robustness of meta-analyses using the arm-based model within a Bayesian framework. Specifically, we develop a tipping point analysis of the between-arm correlation parameter to assess the robustness of meta-analysis results. Additionally, we introduce some visualization tools to intuitively display its impact on meta-analysis results. We demonstrate the application of these tools in three real-world meta-analyses, one of which includes single-arm studies.

Revisiting Level of Evidence Ratings in Plastic Surgery: A Call to Action.

BACKGROUND: Evidence-based medicine underpins medical and surgical practice, with level of evidence (LOE) being a key aspect that allows clinicians and researchers to better discriminate the methodological context by which studies are conducted and appropriately interpret their conclusions, and more specifically the strength of their recommendations. OBJECTIVES: The aim of this study was to reassess the LOE of articles published in plastic surgery journals. METHODS: To assess the overall LOE of publications from January 1 to December 31, 2021, a review of the following plastic surgery journals was performed: Aesthetic Surgery Journal (ASJ), Annals of Plastic Surgery (Annals), Journal of Plastic Reconstructive and Aesthetic Surgery (JRPAS), Plastic and Reconstructive Surgery (PRS), and Plastic and Reconstructive Surgery Global Open (PRS GO). RESULTS: Of 3698 PUBMED articles, 1649 original articles and systematic reviews were analyzed. The average LOE for each journal was: ASJ 3.02 ± 0.94, Annals 3.49 ± 0.62, JPRAS 3.33 ± 0.77, PRS 2.91 ± 0.77, and PRS GO 3.45 ± 0.70. The collective average LOE was 3.28 ± 0.78. Only 4.4% were LOE 1 and 7.3% were LOE 2. Compared to past studies, PRS showed a significant LOE improvement (P = .0254), while ASJ and JPRAS saw nonsignificant changes; Annals experienced a significant decrease (P = .0092). CONCLUSIONS: ASJ and PRS showed the highest LOE among the journals analyzed. Despite this, low LOE studies remain prevalent in plastic surgery. This paper serves as a call to action for both researchers and academic journals to elevate the standard, offering several strategies to help improve the LOE in plastic surgery.

Publication Bias in Upper Gastrointestinal Oncology Clinical Trials.

PURPOSE: Evidence-based medicine requires evaluation of the medical literature to guide clinical reasoning and treatment recommendations. The presence of publication bias towards exclusion of non-statistically significant clinical trials may be leading to an incomplete evaluation of the literature and cause potentially incomplete guidance for patients. We aimed to compare publication rates and impact of publications of positive and negative outcome clinical trials. METHODS: We queried the US National Library of Medicine Clinical Trials database identifying clinical trials with reported results on the topics of pancreatic, liver, and gastric cancer. A "positive" trial was defined as having a statistically significant difference between the treatment arms, while a "negative" did not. Data collected included termination cause, intervention, funding type, publication rates, and journal characteristics. RESULTS: In total, 535 clinical trials were examined, across all pathologies clinical trials with significant findings for the primary outcome were published at a higher rate (99%) compared to those with non-significant findings (77%) (p < 0.01). Significantly, more studies with significant findings reached at least 80% of their estimated enrollment goal versus non-significant studies, 72% and 53% respectively (p < 0.01). Three of four metrics for impact of publication showed no difference between significant and non-significant studies once they reached publication. CONCLUSION: These findings suggest that clinical trials of three of the most common upper gastrointestinal malignancies have a publication bias towards studies with significant primary outcome findings. This study has implications to the way evidence-based medicine is practiced as the medical literature appears to be failing to capture important data for consideration of clinical decision making.

Adrenalina y vasopresina para la parada cardiaca / Adrenaline and vasopressin for cardiac arrest

No disponible

Systematic review protocol: following PRISMA guide from Cochrane to generate evidence as treatment effect of pharmaceutical care for hypertension in primary care

Pharmaceutical care (PC) is in the implementation process in Brazil and Latin America. Synthesis of evidence has been requested for monitoring and evaluating the process regarding the treatment effect. The objective is to build and disseminate a systematic review protocol to make a standard for updating results from pharmaceutical care for hypertension and for other diseases. This is a protocol for systematic review studies regarding a real example of a protocol reasoned in pharmaceutical care for hypertension in primary care. This protocol was delineated grounded in the Cochrane Handbook. Descriptors and words were defined using MeSH (Medical Subject Headings), DeCS (Descriptors in Health Sciences) and Emtree thesaurus, and the search was performed in English, Spanish and Portuguese, without filters, up to March, 27th, 2017. The results were structured in the PRISMA flowchart. Results found from all databases were: the Cochrane Library (n= 202); PubMed (n= 2608); LILACs (n= 909); Embase (n= 1653); Scopus (n=1298); IPA (n=967); and Web of Sciences (n=435). From these, 1688 were duplicate articles. The content of this paper can aid the constant monitoring of pharmaceutical care implementation and contribute to the improvement of the quality and evidence levels of published studies.

Actitudes hacia la estadística en residentes de medicina que cursan un posgrado de investigación / Attitudes toward statistics in medicine residents studying a research postgraduate degree

Introducción: La bioestadística es fundamental en la medicina basada en la evidencia y, por ello, para que los nuevos médicos adquieran habilidades clave en su carrera. Objetivos: Documentar las actitudes hacia la estadística y explorar sus determinantes en los estudiantes de posgrado de medicina. Sujetos y métodos: Estudio observacional, transversal y analítico en médicos residentes que cursaban estudios de posgrado en investigación en la Universidad de Zaragoza y respondieron a la versión en castellano del Survey of Attitudes Toward Statistics-28 (SATS-28). Resultados: Respondió el 93,2% (n = 41) de los asistentes. La puntuación media del SATS-28 fue de 4,43 ± 0,72. Las puntuaciones en las subescalas indicaron que los estudiantes conciben la estadística como muy útil pero difícil. La regresión múltiple mostró que las mujeres tenían mejor actitud hacia la estadística, obteniendo puntuaciones totales 0,5 puntos más altas que los hombres (p = 0,046). Conclusiones: Los residentes de medicina tienen una buena actitud hacia la estadística, aunque se necesita más investigación centrada en los cambios en la metodología de enseñanza, desde el comienzo del grado, para mejorar la percepción sobre su dificultad

Introduction: Biostatistics is core in evidence-based medicine and thus for novel doctors to acquire key skills in their future career. Aims: To document attitudes towards statistics and to explore its determinants in postgraduate medical students. Subjects and methods: Observational, cross-sectional and analytical study in resident doctors who were pursuing a postgraduate degree in research at the University of Zaragoza who responded to the Spanish version of the Survey of Attitudes Toward Statistics-28 (SATS-28). Results: The 93.2% (n = 41) of attendees responded. SATS-28 average score was 4.43 ± 0.72. The scores on the sub-scales indicated that students conceive Statistics as very useful but difficult. Multiple regression showed that women had better attitudes towards statistics, obtaining a total score 0.5 points higher than men (p = 0.046). Conclusions: Medicine residents have good attitude towards statistics, although more research focused on changes in teaching methodology is needed, even since the beginning of the degree, to improve the perception about its difficulty

Diez años de experiencia con el primer biosimilar autorizado de hormona del crecimiento recombinante humana en la práctica clínica habitual / Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice

INTRODUCCIÓN: La hormona de crecimiento humana recombinante biosimilar (rhGH) fue el primer medicamento autorizado por la Agencia Europea del Medicamento (EMA), en el año 2006, por la vía de registro biosimilar. Se aprobó su uso para el tratamiento del déficit de hormona de crecimiento, trastorno de crecimiento asociado al síndrome de Turner, trastorno de crecimiento asociado a insuficiencia renal crónica, síndrome de Prader-Willi, trastorno de crecimiento en niños/adolescentes nacidos pequeños para su edad gestacional y como terapia de sustitución en adultos con deficiencia pronunciada de hormona de crecimiento. MATERIALES Y MÉTODOS: Esta revisión se centra en las evidencias científicas publicadas en los últimos 10 años, incluyendo los ensayos clínicos utilizados para conseguir la aprobación por parte de la EMA y los estudios más relevantes que evalúan el medicamento en la práctica clínica habitual. RESULTADOS: La equivalencia entre este biosimilar de rhGH y su producto de referencia ha sido demostrada en los ensayos clínicos publicados por Romer et al. y López-Siguero et al. Asimismo, los estudios del fármaco realizados en condiciones de práctica clínica habitual confirman su eficacia y seguridad a largo plazo, así como la ausencia de impacto clínico al cambiar el producto original por el biosimilar. CONCLUSIÓN: Desde su aprobación, el número de pacientes que reciben esta medicación ha experimentado un continuo crecimiento. Los datos preliminares del estudio postautorización PATRO indican que la eficacia y seguridad del fármaco se correlaciona con la obtenida en los ensayos clínicos. No obstante, aún queda pendiente evaluar los resultados definitivos del estudio que aportarán información adicional sobre la eficacia y seguridad del fármaco a largo plazo

INTRODUCTION: Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. MATERIALS AND METHODS: This review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. RESULTS: The equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. CONCLUSION: The number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug

Top 5.000 en el blog «Pediatría basada en pruebas» y el interés de la «blogmetría» / Top 5000 in the blog «Pediatría basada en pruebas» and the interest about «blogmetrics»

El blog «Pediatría basada en pruebas» es una fuente de información y formación contrastada tras 8 años de existencia en el entorno de la blogosfera pediátrica española y la web social. En este artículo se analizan las 2.486 entradas publicadas en este blog durante el periodo de revisión (desde agosto de 2008 hasta julio de 2016), con un estudio pormenorizado de los 59 posts que han recibido más de 5.000 visitas. Desde el punto de vista cuantitativo, se confirma la vida propia de un blog a lo largo del tiempo respecto a un estudio previo realizado en 2012. Las tres entradas más visitadas en estos 8 años son: «Por una sanidad Google Style», con 71.418 visitas (fecha de publicación: 08/04/13), «Cine y Pediatría (210): El milagro de Carintia, el milagro de cada día en una guardia», con 27.361 visitas (fecha de publicación: 18/01/14), y «Que no. Que la leche no produce mocos», con 19.850 visitas (fecha de publicación: 21/07/11). Desde el punto de vista cualitativo, los temas que más interesan a los lectores del blog «Pediatría basada en pruebas» se concentran en seis grupos bien consolidados en ese top 5.000: 19 posts como secciones ya establecidas del blog (principalmente Cine y Pediatría); 11 posts como Temas sociales (tabaquismo, accidentes, inmigración, acoso escolar, etc.); 9 posts como Polémicas (temas de especial debate social y/o médico, como el aborto, grupos antivacunas, mala praxis sanitaria, etc.); 7 posts como Enfermedades infecciosas (gripe, meningitis, sepsis, sarampión, varicela, vacunas, etc.), 7 posts como Perineonatología (temas de la gestación y del recién nacido) y 6 posts como Guías e informes de sociedades científicas. La mejor forma posible de mejorar en un blog es conocer la dinámica de nuestros lectores (desde los ámbitos cuantitativo y cualitativo) y la webmetría es una buena herramienta para ello. El análisis de los resultados permite mejorar la transmisión de formación e información a nuestros colegas de profesión, a los pacientes y sus familias y a la sociedad en general (AU)

The blog «Pediatría basada en pruebas» is a source of proven information and training after 8 years around the Spanish pediatric blogosphere and the social web. In this article, 2,486 public entries in this blog from August 2008 to July 2016 are analyzed, with a detailed study of the 59 posts with more than 5,000 visits. From the quantitative point of view, the life of a blog and changes are confirmed over time. The three most visited post over this 8 years are: «Por una sanidad Google Style», 71,418 visits (publication date: 08/04/13); «Cine y pediatría (210): El milagro de Carintia, el milagro de cada día en una guardia», 27,361 visits (publication date: 18/01/14); and «Que no. Que la leche no produce mocos», 19,850 visits (publication date: 21/07/11). From the qualitative point of view, the subjects that interest the most to the readers of «Pediatría basada en pruebas» blog gather around six groups, consolidate in this top 5,000: 19 posts as established sections in the blog (mainly Cinema and pediatrics); 11 posts as Social subjects (smoking, injuries, immigration, bulling, etc.); 9 posts as Controversies (subjects of special social and/or healthcare debate, such as abortion, anti-vaccination groups, medical malpractice, etc.); 7 posts as Infectious diseases (flu, meningitis, septicemia, measles, chickenpox, vaccinations, etc.); 7 posts as Perineonatology (pregnancy and newborn subjects), and 6 posts a Guidelines and reports of scientific societies. The initial best possible way of improve in a blog is to know our readers’ dynamics (from both areas, quantitative and qualitative) and webmetrics is a good tool. And with these results of the blog to build the information and training in the best possible way to our colleagues, patients and families, and to society in general (AU)

Hierarchy of evidence referring to the central nervous system in a high-impact radiation oncology journal: a 10-year assessment. Descriptive critical appraisal study / Hierarquia de evidência referindo-se ao sistema nervoso central em um jornal de radioterapia de alto impacto: uma avaliação de 10 anos. Estudo descritivo de avaliação crítica

CONTEXT AND OBJECTIVE: To the best of our knowledge, there has been no systematic assessment of the classification of scientific production within the scope of radiation oncology relating to central nervous system tumors. The aim of this study was to systematically assess the status of evidence relating to the central nervous system and to evaluate the geographic origins and major content of these published data.DESIGN AND SETTING: Descriptive critical appraisal study conducted at a private hospital in São Paulo, Brazil.METHODS: We evaluated all of the central nervous system studies published in the journal Radiotherapy & Oncology between 2003 and 2012. The studies identified were classified according to their methodological design and level of evidence. Information regarding the geographical location of the study, the institutions and authors involved in the publication, main condition or disease investigated and time of publication was also obtained.RESULTS: We identified 3,004 studies published over the 10-year period. Of these, 125 (4.2%) were considered eligible, and 66% of them were case series. Systematic reviews and randomized clinical trials accounted for approximately 10% of all the published papers. We observed an increase in high-quality evidence and a decrease in low-quality published papers over this period (P = 0.036). The inter-rater reliability demonstrated significant agreement between observers in terms of the level of evidence.CONCLUSIONS: Increases in high-level evidence and in the total number of central nervous system papers were clearly demonstrated, although the overall number of such studies remained relatively small.

CONTEXTO E OBJETIVO: Até onde sabemos, não há avaliação sistemática da classificação da produção científica no âmbito da radioterapia de tumores de sistema nervoso central. O objetivo deste estudo foi avaliar sistematicamente o estado das evidências relativas ao sistema nervoso central e avaliar origem geográfica e a temática envolvida nestas publicações.TIPO DE ESTUDO E LOCAL: Estudo descritivo de avaliação crítica, realizado em um hospital privado em São Paulo, Brasil.MÉTODOS: Foram avaliados todos os estudos publicados em sistema nervoso central na revista Radiotherapy & Oncology, entre 2003 e 2012. Os estudos identificados foram classificados de acordo com o desenho metodológico e nível de evidência. Informações sobre a localização geográfica do estudo, instituições e os autores envolvidos nas publicações, a principal condição ou doença estudada e o período de publicação também foram obtidos.RESULTADOS: Foram identificados 3.004 estudos publicados no período de 10 anos. Destes, 125 (4,2%) foram considerados como elegíveis, e 66% destes eram séries de casos. As revisões sistemáticas e ensaios clínicos randomizados foram responsáveis por cerca de 10% de todas as publicações. Observou-se um aumento das evidências de alta qualidade e uma diminuição das publicações de baixa qualidade durante o período (P = 0,036). A confiabilidade entre avaliadores demonstrou concordância significativa para níveis de evidência.CONCLUSÕES: Um aumento nas evidências de alto nível, assim como no número absoluto de artigos em sistema nervoso central foi claramente demonstrado, apesar de o número global ser ainda relativamente pequeno.

Improving Indicators in a Brazilian Hospital Through Quality-Improvement Programs Based on STS Database Reports

ABSTRACT OBJECTIVE: To report the initial changes after quality-improvement programs based on STS-database in a Brazilian hospital. METHODS: Since 2011 a Brazilian hospital has joined STS-Database and in 2012 multifaceted actions based on STS reports were implemented aiming reductions in the time of mechanical ventilation and in the intensive care stay and also improvements in evidence-based perioperative therapies among patients who underwent coronary artery bypass graft surgeries. RESULTS: All the 947 patients submitted to coronary artery bypass graft surgeries from July 2011 to June 2014 were analyzed and there was an improvement in all the three target endpoints after the implementation of the quality-improvement program but the reduction in time on mechanical ventilation was not statistically significant after adjusting for prognostic characteristics. CONCLUSION: The initial experience with STS registry in a Brazilian hospital was associated with improvement in most of targeted quality-indicators.

Acupuntura y moxibustión para embarazadas con presentación no cefálica. Estrategias de intervención y revisión de la literatura / Acupuncture and moxibustion for pregnant women with non-cephalic presentation. Intervention strategies and literature review

Objetivo: Realizar una evaluación de la evidencia científica publicada y explorar las estrategias e intervenciones más adecuadas en la presentación no cefálica con acupuntura o moxibustión. Método: Búsqueda bibliográfica realizada entre los años 2003 y 2018 con las palabras clave «acupuntura», «moxibustión», «presentación de nalgas» y «presentación no cefálica» en las bases de datos PubMed, Cinahl, WoS, Medline y CENTRAL. Resultados: Finalmente se seleccionaron 15 artículos que cumplían con los criterios de inclusión. La moxibustión es eficaz para conseguir la versión a cefálica en las embarazadas con feto en presentación no cefálica en el tercer trimestre de gestación. Los países asiáticos son los que obtienen resultados con mayor éxito (96,7%), respecto a los países occidentales (53,6-75,4%). Discusión: La revisión de la bibliografía nos ofrece una buena evidencia científica en relación con la efectividad de la moxibustión en el punto de acupuntura V67, en la versión del feto a una presentación cefálica. En la gran mayoría de los estudios se ha observado una mejora en la versión del feto en los grupos que aplicaron la técnica de moxibustión en V67 respecto al grupo control, en que no se había aplicado la técnica. Conclusión: En la actualidad, el uso de la moxibustión para la versión cefálica de una presentación no cefálica es un procedimiento de interés tanto para los profesionales sanitarios como para las gestantes, ya que es una técnica efectiva, segura y de fácil aplicación

Objective: To carry out an evaluation of the published scientific evidence and to explore the most appropriate strategies and interventions in the non-cephalic presentation with acupuncture or moxibustion. Method: Bibliographic search was carried out between 2003 and 2018 with the keywords «acupuncture», «moxibustion», «breech presentation», «non-cephalic presentation», in the databases PubMed, Cinahl, WoS, Medline and CENTRAL. Results: Finally, 15 articles were selected that met the inclusion criteria. Moxibustion is effective to achieve the cephalic version in pregnant women with a fetus in non-cephalic presentation in the third trimester of pregnancy. The Asian countries have the most successful results (96.7%) in relation to those in the West (between 53.6 and 75.4%). Discussion: The review of the literature offers us good scientific evidence regarding the effectiveness of moxibustion in V67, in the fetus version of a cephalic presentation. In the vast majority of studies, an improvement in the version of the fetus was observed in the groups that applied the moxibustion technique in V67 in relation to the control group, which had not applied the technique. Conclusion: At present, the use of moxibustion for the cephalic version of a non-cephalic presentation is a procedure of interest for health workers and pregnant women, since it is an effective, safe and easy to apply technique whenever it is indicated

Rationale and design for a cluster randomized quality improvement trial to increase the uptake of evidence based therapies for patients at high cardiovascular risk: The bridge cardiovascular prevention trial

BACKGROUND: Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes. OBJECTIVES: The main objectives are to evaluate the impact of a multifaceted educational intervention on adherence to local guidelines for the prescription of statins, antiplatelets and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers for high cardiovascular risk patients, as well as on the incidence of major cardiovascular events. DESIGN: We designed a pragmatic two arm cluster randomized trial involving 40 clusters. Clusters are randomized to receive a multifaceted quality improvement intervention or to routine practice (control). The multifaceted intervention includes: reminders, care algorithms, training of a case manager, audit and feedback reports, and distribution of educational materials to health care providers. The primary endpoint is the adherence to combined evidence-based therapies (statins, antiplatelet therapy and angiotensin converting enzyme inhibitors or angiotensin receptor blockers) at 12 months after the intervention period in patients without contra-indications for these medications. All analyses follow the intention-to-treat principle and take the cluster design into account using linear mixed logistic regression modeling. SUMMARY: If proven effective, this multifaceted intervention would have wide utility as a means of promoting optimal usage of evidence-based interventions for the management of high cardiovascular risk patients. (AU)

Bloqueo dual del sistema renina-angiotensina frente a la monoterapia: revisión sistemática y metaanálisis acumulativo de ensayos clínicos y estudios observacionales / Risks of dual blockade of the renin-angiotensin system compared with, mnotherapy: a systematic review and cumulative meta-analysis of randomized trials and observational studies

Fundamentos: Trabajos previos han sugerido que el bloqueo dual con inhibidores del sistema renina-angiotensina (SRA) estaría asociado a un incremento de efectos adversos comparado con la monoterapia. Se reexamina la seguridad del doble bloqueo del SRA, especialmente en pacientes de riesgo y se explora la estabilidad de la evidencia acumulada a lo largo de los años. Método: Revisión sistemática con metaanálisis de efectos aleatorios. Se revisaron 15 metaanálisis publicados anteriormente como punto de partida. Se realizó una búsqueda en PubMed/Medline de estudios observacionales y de ensayos clínicos controlados recientes. Las variables dependientes estudiadas fueron: mortalidad (general y cardiovascular), hiperpotasemia, hipotensión, insuficiencia renal, accidente cerebrovascular y la retirada del tratamiento por efectos adversos. Se calcularon los riesgos relativos (RR) y su intervalo de confianza (IC95%) Resultados: El bloqueo dual del SRA no se asoció con una reducción del RR de la mortalidad general (RR:1,00; IC95%: 0,96-1,05; 21 estudios), ni de la mortalidad cardiovascular (RR:1,01; 0,94-1,09; 13 estudios) ni del riesgo de accidente cerebrovascular (RR:1,02; 0,94-1,11; 11 estudios) en comparación con la monoterapia. El bloqueo dual se asoció a un riesgo aumentado de hiperpotasemia (RR:1,58; 1,37-1,81; 34 estudios), hipotensión (RR:1,66; 1,41-1,95; 25 estudios), daño renal (1,52; 1,28-1,81; 29 estudios) y retirada del tratamiento por efectos adversos (RR:1,26; 1,22-1,30; 37 estudios). Los resultados fueron consistentes en las cohortes de pacientes con diabetes mellitus, enfermedad renal o insuficiencia cardiaca. Conclusiones: El bloqueo dual del SRA vs monoterapia incrementa los riesgos de hiperpotasemia, hipotensión, insuficiencia renal e interrupción del tratamiento por efectos adversos. Además no ofrece beneficios adicionales por reducción de la mortalidad general, mortalidad cardiovascular o accidente cerebrovascular. Estos hallazgos son consistentes a lo largo del tiempo (AU)

Background: Previous work has suggested that dual blockade using inhibitors of the renin-angiotensin system (RAS) would be associated with an increase in side effects compared to monotherapy. We reexamined the safety of dual RAS blockade, especially in patients at risk, and explored the stability of the evidence accumulated over the years. Method: Systematic review with random-effects meta-analyses. We reviewed 15 previously published meta-analyses as the starting point. PubMed/Medline was searched for recent evidence from both observational and randomized controlled trials. Outcomes measures were: mortality (overall and cardiovascular), hyperkalemia, hypotension, renal failure, stroke, and treatment withdrawal due to adverse effects. We calculated relative risks (RR) and confidence intervals (95% CI) Results:Dual RAS blockade was not associated with reduced relative risk (RR) overall mortality (RR:1.00, 0.96-1.05; 21 studies), cardiovascular mortality (RR:1.01, 0.94-1.09; 13 studies) or stroke (RR:1.02; 0.94-1.11; 11 studies) compared to monotherapy. Dual blockade was associated with an increased risk of hyperkalemia (RR:1.58, 1.37-1.81; 34 studies), hypotension (RR:1.66; 1.41-1.95; 25 studies), renal failure (RR:1.52;1.28-1.81; 29 studies) and treatment discontinuation due to adverse events (RR:1.26;1.22-1.30; 37 studies). These results were consistent in cohorts of patients with diabetes mellitus, kidney disease or heart failure. Conclusions: Dual RAS blockade increased (vs monotherapy) the risks of hyperkalemia, hypotension, renal failure and treatment discontinuation. Dual RAS blockade did not offer additional benefit in reducing overall mortality, cardiovascular mortality or stroke. These findings are consistent over time (AU)

Validating assessments: introduction to the special section / Evaluaciones de validez: introducción a la Sección Especial

BACKGROUND: Validation is the process of providing evidence that tests and questionnaires are adequately and appropriately fulfilling the purposes for which they are developed. In this special issue, experts from several countries describe specific approaches to test validation and provide examples of their approach. These approaches and examples illustrate the validation framework implied by the Standards for Educational and Psychological Testing. METHOD: We describe the Standards' approach for building a validity argument based on validity evidence based on test content, response processes, internal structure, relations to other variables, and testing consequences. RESULTS: The five articles provide comprehensive examples of gathering data regarding these five sources of evidence and how they contribute to the validation of the use of test scores for particular purposes. CONCLUSIONS: These five articles provide concrete examples of how the five sources of validity evidence suggested by the Standards can be used to develop a sound validity argument to support the use of a test for its intended purposes

ANTECEDENTES: la validación es el proceso de aportar evidencias de que las evaluaciones mediante tests y cuestionarios cumplen adecuada y apropiadamente los objetivos para los que se elaboran. En este número especial expertos de varios países describen enfoques específicos para la validación y aportan ejemplos. Estos enfoques y ejemplos ilustran el marco de validación implicado por los Standards for Educational and Psychological Testing. MÉTODO: describimos la aproximación de los Standards para elaborar un argumento de validez a partir de evidencias de validez basadas en el contenido del test, los procesos de respuesta, la estructura interna, las relaciones con otras variables y las consecuencias del uso del test. RESULTADOS: los cinco artículos aportan ejemplos comprehensivos de obtención de datos en relación con las cinco fuentes de evidencia, y de cómo contribuyen a la validación del uso de las puntuaciones en el test para objetivos específicos. CONCLUSIONES: los cinco artículos aportan ejemplos concretos de cómo las cinco fuentes de evidencias de validez sugeridas por los Standards pueden utilizarse para elaborar un sólido argumento de validez que apoye el uso de test para sus objetivos previstos

Desarrollo de una hoja excel para metaanálisis de comparaciones indirectas y mixtas / Development of an excel spreadsheet for meta analysis of indirect and mixed treatment comparisons

En investigación clínica, el metaanálisis ha servido generalmente para evaluar la eficacia y la seguridad de un tratamiento a través de la comparación con un único comparador. Las comparaciones indirectas, a través del método de Bucher, permiten combinar datos procedentes de estudios primarios de una forma sencilla cuando la información para las comparaciones directas es limitada o inexistente. Las comparaciones mixtas permiten combinar las estimaciones procedentes de comparaciones directas e indirectas, aumentando el poder estadístico. En la actualidad, es necesario el desarrollo de aplicaciones informáticas para el cálculo de metaanálisis de comparaciones indirectas y mixtas. Por este motivo, se ha desarrollado una hoja de cálculo con Microsoft Office Excel para el cálculo de comparaciones indirectas y mixtas, de uso sencillo para investigadores clínicos interesados en revisiones sistemáticas con metaanálisis, pero no familiarizados con el uso de paquetes estadísticos más avanzados. La utilización de esta hoja de cálculo para las comparaciones indirectas y mixtas puede ser de gran utilidad en epidemiología clínica, con el fin de extender el conocimiento proporcionado por el metaanálisis tradicional cuando la evidencia de las comparaciones directas es limitada o inexistente (AU)

Metaanalyses in clinical research usually aimed to evaluate treatment efficacy and safety in direct comparison with a unique comparator. Indirect comparisons, using the Bucher’s method, can summarize primary data when information from direct comparisons is limited or nonexistent. Mixed comparisons allow combining estimates from direct and indirect comparisons, increasing statistical power. There is a need for simple applications for metaanalysis of indirect and mixed comparisons. These can easily be conducted using a Microsoft Office Excel spreadsheet.We developed a spreadsheet for indirect and mixed effects comparisons of friendly use for clinical researchers interested in systematic reviews, but nonfamiliarized with the use of more advanced statistical packages. The use of the proposed Excel spreadsheet for indirect and mixed comparisons can be of great use in clinical epidemiology to extend the knowledge provided by traditional metaanalysis when evidence from direct comparisons is limited or nonexistent (AU)

Neuroticismo y trastorno por estrés postraumático: un estudio metaanalítico / Neuroticism and post traumatic stress disorder: a metaanalytic study

Fundamentos: Existen resultados contradictorios sobre el papel del neuroticismo como factor de riesgo del trastorno por estrés postraumático (TEPT). Los objetivos de este estudio fueron estimar la magnitud y dirección de la asociación entre neuroticismo y TEPT así como analizar la influencia de diferentes variables moderadoras sobre el tamaño del efecto. Métodos: Se realizó una revisión sistemática y un metaanálisis. La búsqueda de estudios se efectuó en Medline, IME, PsycINFO, Trip Databse y Google Scholar, siendo el límite temporal hasta octubre de 2012. También se hizo una búsqueda manual y se contactó con los autores principales. Criterios de inclusión: (a) estudios empíricos que analizaran la asociación entre neuroticismo y TEPT mediante escalas validadas o criterios diagnósticos (DSM, CIE); (b) en sujetos expuestos a un evento traumático y (c) escritos en inglés o español. Dos evaluadores independientes realizaron la selección y codificaron los datos siguiendo el protocolo previamente elaborado. Se aplicó el modelo de efectos aleatorios para obtener el tamaño del efecto medio y explorar variables moderadoras. Resultados: De 96 artículos elegibles, 34 cumplieron los criterios de inclusión (9.941 participantes). El tamaño del efecto medio fue r+=0,371 (IC95%: 0,3270,414). Se descartó que hubiera sesgo de publicación. Se construyó un modelo predictivo con tres variables (reporte de la etnia, edad y tipo de muestra: comunitaria o clínica). Conclusión: El neuroticismo puede considerarse un factor de riesgo para el TEPT en personas que han estado expuestas a un evento traumático. Estos hallazgos son importantes para la elaboración de actuaciones preventivas y de intervención (AU)

Background: There are conflicting results on the role of neuroticism as a risk factor for posttraumatic stress disorder (PTSD). The objectives of this study were to estimate the magnitude and direction of the association between neuroticism and PTSD, and to analyze the influence of different moderator variables on effect size. Methods: A systematic review and a metaanalysis were carried out. The search for studies was conducted in Medline, IME, PsycINFO, Trip Database, and Google Scholar, until October 2012.Ahand search was also carried out and main researchers were contacted. Inclusion criteria: (a) empirical studies of the association between neuroticism and PTSD using validated scales or diagnostic criteria (DSM, ICD), (b) in participants exposed to a traumatic event and (c) written in English or Spanish. Two independent evaluators performed the selection and extracted the data following a previously developed protocol. The randomeffects model was applied to obtain the mean effect size and to explore moderators. Results: Out of 96 potential articles, 34 fulfilled the inclusion criteria (9,941 participants). The mean effect size was r+ = 0.371 (95%CI: 0.327 and 0.414). Publication bias was discarded as a threat.Apredictive model was elaborated with three variables (reporting of ethnicity, age, and type of sample). Conclusion: Neuroticism can be considered as a risk factor for PTSD in people who have been exposed to a traumatic event. These findings are relevant for developing preventive interventions and treatments (AU)

Validity evidence based on test content / Evidencia de validez basada en el contenido del test

BACKGROUND: Validity evidence based on test content is one of the five forms of validity evidence stipulated in the Standards for Educational and Psychological Testing developed by the American Educational Research Association, American Psychological Association, and National Council on Measurement in Education. In this paper, we describe the logic and theory underlying such evidence and describe traditional and modern methods for gathering and analyzing content validity data. METHOD: A comprehensive review of the literature and of the aforementioned Standards is presented. RESULTS: For educational tests and other assessments targeting knowledge and skill possessed by examinees, validity evidence based on test content is necessary for building a validity argument to support the use of a test for a particular purpose. CONCLUSIONS: By following the methods described in this article, practitioners have a wide arsenal of tools available for determining how well the content of an assessment is congruent with and appropriate for the specific testing purposes

ANTECEDENTES: la evidencia de validez basada en el contenido del test es una de las cinco formas de evidencias de validez estipuladas en los Standards for Educational and Psychological Testing de la American Educational Research Association. En este artículo describimos la lógica y teoría que subyace a tal fuente de evidencia, junto a métodos tradicionales y modernos para obtener y analizar los datos de validez de contenido. MÉTODO: una revisión comprehensiva de la bibliografía y de los mencionados Standards. RESULTADOS: para los tests educativos y otras evaluaciones de los conocimientos y habilidades que poseen los examinados, la evidencia de validez basada en el contenido del test es necesaria para elaborar un argumento de validez que apoye el uso de un test para un objetivo particular. CONCLUSIONES: siguiendo los métodos descritos en este artículo, los profesionales tienen un amplio arsenal de herramientas disponibles para determinar en qué medida el contenido de una evaluación es congruente y apropiado para los objetivos específicos de la evaluación

Modelos de colaboración entre atención primaria y salud mental en la asistencia sanitaria a las personas con depresión: resultados principales y retos metodológicos de una meta-revisión sistemática / Models for primary care and mental health collaboration in the care of people with depression: main results and methodological challenges of a systematic overview

Fundamentos: Las carencias en la colaboración entre Atención Primaria (AP) y Salud Mental (SM) constituyen un problema relevante en la atención a los pacientes con depresión. Resulta necesario analizar y evaluar los modelos de colaboración existentes para valorar su aplicabilidad en el sistema de salud español. El objetivo del presente estudio es conocer las principales características de los distintos modelos de colaboración AP-SM en la atención a los pacientes diagnosticados de depresión y la calidad de la evidencia científica acerca de su efectividad. Métodos: Meta-revisión sistemática de los estudios secundarios publicados entre 2001 y 2010 en MEDLINE, PsycINFO, Embase, LILACS, IBECS, IME y la Biblioteca Cochrane. Las revisiones se evaluaron mediante la herramienta AMSTAR. Se realizó una síntesis aproximativa de la calidad de las evidencias encontradas. Resultados: Se evaluaron 69 estudios. La variabilidad según contextos y las carencias metodológicas condicionan que la calidad de las evidencias sea en general baja o dudosa. Las estrategias más efectivas integran intervenciones de responsabilización en el seguimiento de los pacientes, rediseños en la gestión, e información y comunicación compartidas. Las meta-revisiones de estudios secundarios sobre modelos colaborativos favorecen la accesibilidad a las evidencias publicadas, pero conllevan importantes retos metodológicos. Conclusiones: La calidad de la evidencia sobre la efectividad de los modelos de colaboración AP-SM durante la atención sanitaria a las personas con depresión es predominantemente baja o dudosa y su significado y aplicabilidad son menores cuanto más se simplifica el análisis de sus componentes, procesos y circunstancias de implementación (AU)

Background: Weaknesses in the collaboration between Primary Care (PC) and Mental Health (MH) are a relevant problem in the care of depressed patients. It is necessary to analyse and appraise the existing models of collaboration to assess their applicability to the Spanish Health System. The aim of this study is to know the main characteristics of the different models of collaboration between PC and MH in the care of patients with depression and the quality of their effectiveness evidence. Methods: Systematic overview of secondary studies published from 2001 to 2010 in MEDLINE, PsycINFO, Embase, LILACS, IBECS, IME and The Cochrane Library. Assessment of reviews applying the AMSTAR tool. Approximative synthesis of the quality of evidences. Results: A total of 69 studies were assessed. Quality of evidences is generally low or inconclusive due to the great variability among contexts and the methodological weaknesses. The most effective strategies integrate interventions for assigning responsibility for patient follow-up, redesigning management and communication/information sharing. Overviews of secondary studies on collaborative models facilitate access to published evidence, but entail important methodological challenges. Conclusion: The quality of evidences on effectiveness of PC-MH collaboration models in depression care is mainly low or inconclusive, and the more simplified are the analysis of components, processes and implementation conditions, the less meaningful and applicable they are (AU)