GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.

OBJECTIVES: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA). STUDY DESIGN AND SETTING: We present an overview of the GRADE approach and guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. Part 1 of the two parts in this 21st guidance article about how to apply GRADE focuses on understanding study design issues in test accuracy, provide an overview of the domains, and describe risk of bias and indirectness specifically. RESULTS: Supplemented by practical examples, we describe how raters of the evidence using GRADE can evaluate study designs focusing on tests and how they apply the GRADE domains risk of bias and indirectness to a body of evidence of TA studies. CONCLUSION: Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews and World Health Organization and other guidelines dealing with in TA studies helped refining our approach. The resulting guidance will help applying GRADE successfully for questions and recommendations focusing on tests.

GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables.

OBJECTIVES: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can rate the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA) on the domains imprecision, inconsistency, publication bias, and other domains. It also provides guidance for how to present synthesized information in evidence profiles and summary of findings tables. STUDY DESIGN AND SETTING: We present guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. RESULTS: Supplemented by practical examples, we describe how raters of the evidence can apply the GRADE domains inconsistency, imprecision, and publication bias to a body of evidence of TA studies. CONCLUSION: Using GRADE in Cochrane and other reviews as well as World Health Organization and other guidelines helped refining the GRADE approach for rating the certainty of a body of evidence from TA studies. Although several of the GRADE domains (e.g., imprecision and magnitude of the association) require further methodological research to help operationalize them, judgments need to be made on the basis of what is known so far.

Clinical practice guideline. Integral Care Guidelines for the prevention, early detection and treatment of pregnancy, childbirth and puerperium complications: Section on toxoplasmosis in pregnancy / Guia de atencion integral para la prevencion, deteccion temprana y tratamiento de las complicaciones del embarazo: Sección de Toxoplasmosis

Como parte de la Guia de atencion integral para la prevencion, deteccion temprana y tratamiento de las complicaciones del embarazo, desarrollada y financiada por el Departamento de Ciencia, Tecnologia e Innovacion, Colciencias, y el Ministerio de Salud y Proteccion Social de Colombia, se seleccionó a la infeccion por Toxoplasma para el desarrollo de recomendaciones para su prevencion, diagnostico y tratamiento. La infeccion por Toxoplasma gondii (T. gondii) durante el embarazo puede resultar en graves complicaciones para el feto y dejar importantes secuelas al recien nacido. Se realizo una guia basada en la mejor evidencia disponible en la literatura cientifica, con especial pertinencia a la informacion colombiana. Un consenso de expertos en parasitologia, ginecologia, neonatologia e infectologia, tanto de adultos como pediatrica, desarrollo las recomendaciones. Se propone que las recomendaciones de esta guia de atencion integral sean utilizadas por los profesionales de salud de los programas de atencion del embarazo del pais con el fin de disminuir la morbilidad y mortalidad atribuible a esta enfermedad. Se formulan recomendaciones especificas para el diagnostico desde el primer trimestre, consejos de prevencion en las mujeres no infectadas, identificacion de la infeccion del feto o del recien nacido y recomendaciones de tratamiento en estos escenarios.

Toxoplasma infection, an aspect included in the Integral Care Guidelines for prevention, early detection and treatment of complications during pregnancy developed and sponsored by the Department of Science, Technology and Innovation, Colciencias and the Ministry of Health and Social Protection; was selected to develop recommendations that may contribute to its prevention diagnostic and treatment. Guidelines were developed through systematic review of literature, two panels of evaluation, gradation of evidence: SIGN (Scottish Intercollegiate Guidelines Network), discussion panel with users and patients, external evaluation and socioeconomical evaluation of the impact of recommendations. The Toxoplasma gondii infection that occurs during pregnancy may cause serious complications for the fetus and important sequelae for the newborn. A clinical guideline based on the best available scientific evidence, with emphasis on Colombian references, was performed. Experts in parasitology, neonatology and infectious diseases (adult and pediatric) developed the recommendations. It is suggested that the recommendations included in this guideline be followed by healthcare professionals in pregnancy care programs nationwide, with the purpose of lowering the morbidity and mortality related to this disease. Specific recommendations for diagnosis during the first trimester of the pregnancy, recommendations for prevention in noninfected women, identification of fetal or newborn infection and recommendations for treatment in those given cases are included.