Intravitreal antivascular endothelial growth factor in diabetic macular oedema: scoping review of clinical practice guidelines recommendations.

BACKGROUND: Diabetic macular oedema (DME) is a worldwide major cause of low vision and blindness. Intravitreal antivascular endothelial growth factor (anti-VEGF) constitutes an effective treatment. Clinical practice guidelines (CPGs) are synthesis documents that seek to improve patient care. OBJECTIVES: To identify CPGs that make anti-VEGF recommendations for DME and to assess their reporting quality and their considerations when making recommendations. ELIGIBILITY CRITERIA: CPGs published between December 2009 and December 2019 that make explicit anti-VEGF recommendations in DME. SOURCES OF EVIDENCE: Sensitive search strategy in Embase, Google Scholar and hand-searching on 165 websites. METHODS: We extracted information from each CPG with a previously piloted sheet. Two independent authors applied theAppraisal of Guidelines, Research and Evaluation tool (AGREE-II) assessment for each CPG. RESULTS: The 21 included CPGs recommend anti-VEGF for DME, but there is a wide variation among the clinical aspects included, such as location of DME, visual acuity required, therapeutical alternatives or discontinuation. Most have a poor quality of reporting based on the AGREE-II tool assessment, especially those developed by ophthalmological societies, those that have an exclusive content about DME, and those where most of their authors disclose conflict of interest (COI) with pharmaceutical industry or where their authors did not report COIs. Pharmaceutical-sponsored CPGs did not use systematic reviews (SRs) to support their recommendations. Very few recommendations consider patient values and preferences, equity, acceptability and feasibility of the intervention. CONCLUSIONS: Most of the CPGs that made recommendations of anti-VEGF for DME have poor quality of reporting, do not use SRs and do not consider patients' values and preferences.

How to interpret diagnostic tests. / Cómo interpretar las pruebas diagnósticas.

Healthcare professionals make decisions in a context of uncertainty. When making a diagnosis, relevant patient characteristics are categorized to fit a particular condition that explains what the patient is experiencing. During the diagnostic process, tools such as the medical interview, physical examination, and other complementary tests support this categorization. These tools, known as diagnostic tests, allow professionals to estimate the probability of the presence or absence of the suspected medical condition. The usefulness of diagnostic tests varies for each clinical condition, and studies of accuracy (sensitivity and specificity) and diagnostic impact (impact on health outcomes) are used to evaluate them. In this article, the general theoretical and practical concepts about diagnostic tests in human beings are addressed, considering their historical background, their relationship with probability theories, and their practical utility with illustrative examples.

En el ámbito de la salud, los profesionales deben tomar decisiones en un marco de incertidumbre. Al realizar un diagnóstico, se categorizan los signos y síntomas, sumados a los hallazgos de exámenes complementarios de una condición clínica particular, implicando la definición de un tratamiento y pronóstico específico. Durante el proceso diagnóstico se utilizan herramientas de la anamnesis, examen físico y exámenes complementarios para apoyar dicha categorización. Estas herramientas, conocidas como pruebas diagnósticas, permiten estimar la probabilidad de la presencia o ausencia de la condición médica sospechada. La utilidad de las pruebas diagnósticas varía para cada condición clínica y se evalúan mediante estudios de exactitud (sensibilidad y especificidad) e impacto diagnóstico (repercusión sobre los desenlaces de salud). En este artículo, se abordan los conceptos teóricos y prácticos generales sobre las pruebas diagnósticas en seres humanos considerando sus antecedentes históricos, su relación con las teorías sobre probabilidades y su utilidad práctica con ejemplos ilustrativos.

Graphical representation of the body of the evidence: the essentials for understanding the evidence gap map approach. / Graficando el cuerpo de la evidencia: lo esencial para comprender el enfoque de los mapas de brecha de evidencia.

The significant increase in scientific evidence production has led to the creation of methods to facilitate evidence review and synthesis. This has turned, this has resulted in the emergence of different designs depending on the reviews objective. Evidence gap maps constitute a novel approach for literature review. They are thematic collections of a broad field of evidence, using a systematic search strategy that identifies gaps in knowledge and engages, early on, the target audience to design a friendly graphic product. Evidence maps are a tool to be considered in the roster of options available for research funders in that they are particularly useful for evidence-based decision-making and evidence-based policy development. The most commonly used formats to display the findings of evidence gap search designs are the bubble plot and the intervention-outcome framework. This article corresponds to the sixth of a series of narrative reviews on general topics of biostatistics and clinical epidemiology. The purpose of this review is to describe the principal features of evidence gap maps, highlighting their main objectives and utility, exploring the most commonly used mapping formats, and comparing this approach with other evidence synthesis designs.

El gran aumento en la producción de evidencia científica ha llevado a la creación de métodos para facilitar su revisión y síntesis, surgiendo distintos diseños según el objetivo principal que se busque cumplir. Los mapas de brecha de evidencia constituyen un enfoque novedoso de revisión de literatura. Corresponden a colecciones temáticas de un amplio campo de evidencia, utilizando una estrategia de búsqueda sistemática que destaca por identificar brechas o lagunas en el cuerpo de la evidencia disponible y por involucrar tempranamente a la audiencia definida como blanco para el diseño de un producto gráfico amigable. Se han establecido como una herramienta a considerar para guiar la agenda y el financiamiento de futuras investigaciones, y como apoyo en la toma de decisiones y en la creación de políticas basadas en evidencia. Los formatos más utilizados para representar sus hallazgos son el gráfico de burbujas y la grilla intervención-desenlace. Este artículo corresponde al sexto de una serie de revisiones narrativas acerca de tópicos generales en bioestadística y epidemiología clínica, y tiene por objetivo describir las características generales de los mapas de brecha de evidencia, destacar sus principales objetivos y utilidades, explorar los formatos de mapeo más utilizados y comparar este enfoque con otras propuestas de síntesis.

The GRADE approach, Part 1: how to assess the certainty of the evidence. / Metodología GRADE, parte 1: cómo evaluar la certeza de la evidencia.

The certainty of the evidence for interventions is the certainty or confidence that the true effect is within a particular range or relative to a threshold. In the new pyramid of evidence, systematic reviews represent the magnifying glass through which this certainty is evaluated. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach arises in response to the existence of multiple evidence classification systems, and it offers a transparent and structured process to develop and present summaries of evidence considering its certainty and, in a second step, the strength of the recommendations that they inform. The GRADE process begins with an explicit question that includes all important and critical outcomes explicitly. The main domains used to assess the certainty of the evidence are risk of bias, inconsistency, indirectness of evidence, imprecision, and publication bias. The factors that can increase the certainty of the evidence are dose-response gradient, large magnitude of an effect, and effect of plausible residual confounding. Finally, the Summary of Findings tables summarize the process in a simplified way and with controlled language. This narrative reviews purpose is to address the GRADE approachs theoretical and practical underlying concepts in a simplified way and with practical examples.

La certeza de la evidencia para las intervenciones es la seguridad o confianza de que el verdadero efecto se encuentra dentro de un rango particular o en relación con un umbral. En la nueva pirámide de la evidencia, las revisiones sistemáticas representan la lupa a través de la cual se evalúa dicha certeza. La metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) surge como respuesta a la existencia de múltiples sistemas de clasificación de la evidencia y ofrece un proceso transparente y estructurado para desarrollar y presentar resúmenes de evidencia considerando la certeza de esta y, en un segundo paso, la fuerza de las recomendaciones que informan. El proceso GRADE comienza con una pregunta explícita, que incluye las especificaciones de todos los desenlaces importantes y críticos. Los principales dominios que se utilizan para valorar la certeza de la evidencia son: 1. El riesgo de sesgo, 2. La inconsistencia, 3. Evidencia indirecta, 4. Imprecisión, y 5. El sesgo de publicación. Los factores que pueden aumentar la certeza de la evidencia son: 1. Gradiente dosis respuesta, 2. Gran magnitud del efecto, 3. Efecto de los potenciales factores de confusión residual. Finalmente, las tablas de resumen de hallazgos (Summary of Findings) sintetizan el proceso de manera simplificada y con un lenguaje controlado. El objetivo general de esta revisión narrativa es abordar los principales conceptos básicos teóricos y prácticos de la metodología GRADE de manera simplificada y con ejemplos prácticos.

Minimal clinically important difference: The basics. / Diferencia mínima clínicamente importante: conceptos básicos.

This article is part of a collaborative methodological series of narrative reviews on biostatistics and clinical epidemiology. This review aims to present basic concepts about the minimal clinically important difference and its use in the field of clinical research and evidence synthesis. The minimal clinically important difference is defined as the smallest difference in score in any domain or outcome of interest that patients can perceive as beneficial. It is a useful concept in several aspects since it links the magnitude of change with treatment decisions in clinical practice and emphasizes the primacy of the patients perception, affected by endless variables such as time, place, and current state of health, all of which can cause significant variability in results.

Este artículo es parte de una serie metodológica colaborativa de revisiones narrativas sobre temáticas de bioestadística y epidemiología clínica. El objetivo de esta revisión es presentar conceptos básicos sobre la diferencia mínima clínicamente importante y su utilización en el ámbito de la investigación clínica y la síntesis de evidencia. La diferencia mínima clínicamente importante se define como la diferencia más pequeña en la puntuación en cualquier dominio o desenlace de interés que los pacientes son capaces de percibir como beneficiosa. Es un concepto útil en varios aspectos, ya que vincula la magnitud del cambio con las decisiones de tratamiento en la práctica clínica y enfatiza la primacía de la percepción del paciente, que es afectada por un sinfín de variables tales como el tiempo, el lugar y el estado actual de salud, que pueden ocasionar gran variabilidad en los resultados.

Guidelines in Low and Middle Income Countries Paper 2: Quality assessment of Chilean guidelines: need for improvement in rigor, applicability, updating, and patients' inclusion.

OBJECTIVES: The Chilean health system mandates providers to ensure assistance under a guaranteed system, the Explicit Guarantees in Healthcare (EGH) program. The Health Ministry has developed clinical practice guidelines (CPGs), but independent assessment of their quality is lacking. STUDY DESIGN AND SETTING: We assessed all CPGs of the EGH program using Appraisal of Guidelines for Research & Evaluation II (AGREE II) tool for appraising quality, validity period, and last update. RESULTS: Eighty-six CPGs were published between 2005 and 2016. Only 15 (17.4%) were updated. The overall mean raw score was 4.18 (±0.98). The scaled scores for each domain were: Scope and objectives 79.7%, Stakeholder involvement 46.2%, Rigor of development 36.3%, Clarity of presentation 82.8%, Applicability 23.5%, and Editorial independence 39.2%. The highest items were: overall objectives described, population described, options for management clearly presented, and key recommendations easily identifiable. The worst evaluated items were: views and preferences of the target population, strengths and limitations of the body of evidence, methods for formulating the recommendations, external review by experts, and description of facilitators and barriers to application. CONCLUSION: Most Chilean CPGs included in the EGH program are outdated and show items that should be improved, mainly through a more rigorous methodology, the inclusion of patients in its development, and appropriate consideration of its applicability.

Corneal endothelial cell loss associated to phacoemulsification and ophthalmologist experience: prospective analysis of individual secondary data. / Pérdida celular endotelial corneal asociada a facoemulsificación y experiencia del oftalmólogo: análisis prospectivo de datos secundarios individuales.

INTRODUCTION: Phacoeresis is the procedure through which the lens is surgically removed to treat cataracts. A corneal endothelial loss is a recognized sequel. Although several factors associated with this harm have been described, the surgeon’s prior experience has been scarcely evaluated. OBJECTIVES: To assess the association between the surgeon’s experience and other variables associated with a corneal endothelial cell loss in the context of phacoeresis. METHODS: Clinical records of 198 patients undergoing cataract operations were prospectively reviewed. The experience of the surgeon and other variables were recorded, including cumulative dissipated energy, viscoelastic type, the use of trypan blue, amount of fluidics, ultrasound time, combined phacoemulsification energy, and pre- and postoperative corneal endothelial cell counts. RESULTS: No differences were observed in the postoperative corneal endothelial cell count between surgeons with more or less than five years of experience. Nevertheless, ophthalmologists with more than five years’ experience used less trypan blue, but more cumulative dissipated energy in each procedure, while less experienced ophthalmologists used less fluidics. CONCLUSIONS: Although there were differences in the surgical management regarding the surgeons’ experience in factors known to influence corneal endothelial cell loss, no differences in endothelial cell loss were observed as an outcome.

INTRODUCCIÓN: La facoéresis es el procedimiento en que se extrae quirúrgicamente el cristalino para tratar las cataratas. La pérdida endotelial corneal es una complicación reconocida. Si bien se han descrito diversos factores asociados a este daño, la experiencia del cirujano ha sido poco explorada. OBJETIVOS: Evaluar la asociación entre la experiencia del cirujano y otras variables asociadas a la pérdida celular endotelial en el contexto de la facoéresis. MÉTODOS: Se analizaron registros clínicos de 198 cirugías de cataratas, evaluando el efecto de la experiencia del cirujano y otras variables asociadas: energía disipada acumulada, tipo de viscoelástico empleado, uso de azul tripán, cantidad de fluídica, tiempo de ultrasonido, energía de facoemulsificación combinada y recuento celular endotelial pre y postoperatorio. RESULTADOS: No se observaron diferencias en el conteo postoperatorio de células endoteliales. Los oftalmólogos con más de cinco años de experiencia presentaron menor uso de azul tripán pero mayor cantidad de energía disipada acumulada en cada procedimiento, mientras que los oftalmólogos con menor experiencia utilizaron mayor cantidad de fluídica. CONCLUSIONES: Aunque hubo diferencias en el manejo de algunos factores influyentes sobre la pérdida endotelial cornal según la experiencia de los oftalmólogos, no se hallaron diferencias en relación a dicha pérdida como resultado final.

Identification and description of controlled clinical trials published in Spanish Ophthalmology Journals.

PURPOSE: Properly conducted controlled clinical trials (CCTs) provide the highest level of evidence for optimising decision-making in healthcare. Electronic search strategies do not exhaustively retrieve them, because of issues related to indexing, exclusion of journals in languages other than English, among others. A handsearch approach is therefore warranted. We aimed to identify all CCTs published in Ophthalmology journals in Spain, to describe their main features, and to submit them to the Cochrane Register of CCTs (CENTRAL). METHODS: After identifying all Spanish Ophthalmology Journals, we conducted a systematic handsearch following Cochrane guidelines. When appropriate, results were compared against electronic searches. A descriptive analysis was completed, including risk of bias assessment. RESULTS: We identified 18 eligible journals; 10 074 original articles, editorials, letters to the editor, abstracts and conference proceedings were assessed via handsearching for inclusion. Of these, 136 were subject to title and abstract screening, after which 102 were classified as CCTs. We identified three articles via electronic searches that had not been detected via handsearch, for a total of 105 CCTs. Among these, the most investigated pathologies were cataracts (32/105; 30.5%) and glaucoma (23/105 21.9%). Regarding risk of bias, 104/105 (99.0%) were deemed as "high risk of bias", mainly due to flaws in sequence generation and allocation concealment. 15/105 (14.3%) mentioned conflicts of interest, half of which had something to declare. No CCT reported adherence to CONSORT. CONCLUSION: Spanish Ophthalmology journals publish a low number of CCTs, with limited methodological quality. Handsearching was more sensitive than the electronic searching. Abbreviations CCT: Controlled clinical trial.

Satisfacción con la atención médica de pacientes hospitalizados en un servicio clínico docente y en uno no docente / Satisfaction of health care in hospitalized patients in a teaching hospital and a non teaching hospital

Introducción: En Chile, una proporción importante de hospitales públicos son docente-asistenciales. El objetivo del presente estudio fue determinar y comparar los niveles de satisfacción con la atención médica entre un centro asistencial docente y uno no docente. Material y método: Estudio de corte transversal. Se aplicó un cuestionario para evaluar satisfacción con la atención médica y grado de aceptación hacia estudiantes de Medicina, a pacientes hospitalizados en servicios de urología del Hospital Dr. Gustavo Fricke (no docente) y Hospital Carlos Van Buren (docente), entre septiembre y noviembre de 2009. Se utilizó razón de validez de contenido (CVR) como criterio de inclusión para los diferentes ítems del cuestionario final, que consideró 14 ítems, además de evaluarse su consistencia interna. Resultados: Fueron encuestados 140 pacientes en total, 70 de cada servicio. No hubo diferencia en la satisfacción por servicio (90 por ciento y 88,6 por ciento). Respecto a las variables demográficas, hubo diferencia en edad, proporción de pensionados, y nivel educacional, por servicios La única variable que mostró asociación con satisfacción fue el sexo, apreciándose en un 95 por ciento de hombres contra un 81,4 por ciento de mujeres (p=0,01). Un 94,3 por ciento de los pacientes aceptó la presencia de los estudiantes en el servicio docente. Discusión: En la muestra estudiada, estar internado en uno u otro centro no afectó la satisfacción de los pacientes. La única variable que se asoció a la satisfacción fue el ser hombre, y la presencia del estudiante fue aceptada por la gran mayoría de pacientes.

Material and method: Cross-sectional study. A survey was carried out to evaluate satisfaction with health care and the level of acceptance of medical students by hospitalized patients in urology services in Gustavo Frike Hospital (non teaching) and Carlos Van Buren (teaching), between September and November of 2009. Content validity ratios (CVR) was used as inclusion criteria for the 14 different items on the questionnaire, and it was evaluated for internal consistency. Results: 140 patients completed the questionnaire, 70 at each hospital. There was no difference in the level of satisfaction between hospitals (90 percent and 88.6 percent). With respect to the demographic variables, between the two hospitals there were differences according to age of patients, proportion of retirees, and level of education. The only variable that was associated with satisfaction was sex, found in 95 percent of men and 81.4 percent of women (p=0.01). 94.3 percent of patients accepted the presence of students at the teaching hospital. Discussion: In this sample, hospitalization in the teaching or the non teaching hospital did not affect patient satisfaction. The only variable that was associated with satisfaction was sex, and the presence of students was accepted by the majority of patients.