ABSTRACT
INTRODUCTION: Oral anticoagulants (OACs) are first-line drugs for stroke prevention in patients with atrial fibrillation (AF). The introduction of new lines of therapy with direct oral anticoagulants (DOACs) has led to a decreased use of vitamin K antagonists (VKAs). Comparative analyses of DOACs in clinical trials are scarce and the comparator has mostly been warfarin. Their impact on health outcomes in observational studies has not always been consistent. The aim of this study is to evaluate the effectiveness and safety of DOACs and VKAs in patients with AF using Real-World Data (RWD). METHODS AND ANALYSIS: Population-based retrospective cohort study using RWD from actual practice. Period: January 2012-December 2020. Inclusion criteria: patients with AF who had not taken OACs in the previous 12 months. Exclusion criteria: <40 years, with severe mitral stenosis, or valvular heart disease or aortic and/or mitral valve procedures. Data source: The Andalusian Population Health Database, Spain. Outcome measures: a) Effectiveness: ischaemic stroke, transient ischaemic attack, systemic and pulmonary embolism, and death; b) Safety: gastrointestinal and intracranial haemorrhaging; Independent variables: age, sex, comorbidities, medication and health resource use, CHA2DS2-VASC, HAS-BLED, and analytical tests. Statistical analysis: crude incidence analysis, survival models, Kaplan-Meier, Cox regression analysis adjusted for possible confounding and paired analysis by propensity score matching.
Subject(s)
Atrial Fibrillation , Brain Ischemia , Stroke , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Atrial Fibrillation/epidemiology , Brain Ischemia/etiology , Retrospective Studies , Stroke/prevention & control , Stroke/complications , Anticoagulants/adverse effects , Administration, OralABSTRACT
Objetivos. El objetivo fue evaluar la evidencia disponible sobre la validez, precisión diagnóstica y utilidad clínica del test multidiana de ADN en heces (Cologuard(TM)) en el cribado de cáncer colorrectal (CCR). Material y métodos. Se realizó una revisión sistemática consultando MedLine, EMBASE y Web of Science hasta julio de 2014. Se seleccionaron estudios de pruebas diagnósticas que evaluaran el test en adultos asintomáticos sometidos a cribado de CCR. La calidad y el riesgo de sesgo se evaluaron mediante la herramienta Quality Assessment of Diagnostic Accuracy Studies. El nivel de evidencia se definió según The National Institute for Healthand Clinical Excellence. Se realizó una síntesis cualitativa. Resultados. Se identificaron 299 referencias bibliográficas, incluyéndose un informe de síntesis y cinco estudios de pruebas diagnósticas, tres de ellos con diseño caso-control en fase II de Sackett y de moderada calidad, y dos con diseño prospectivo en fase III de Sacket y de alta calidad. La sensibilidad para detectar CCR fue superior al 90%, pero solo del 40% para la detección de adenoma avanzado. El test proporcionó evidencia diagnóstica concluyente para descartar CCR (cociente de probabilidad negativo, CPN: 0,02-0,09), aunque no fue útil para descartar adenoma avanzado (CPN: 0,5-0,7). Conclusiones. El test Cologuard(TM) es una prueba de cribado válida para descartar lesiones cancerosas, resultando subóptima para descartar lesiones precancerosas. No hay evidencia sobre resultados en términos de mortalidad o supervivencia, ni sobre coste-efectividad (AU)
Objectives. The aim of this study was to assess the available evidence on the validity, diagnostic accuracy and clinical utility of the multitarget DNA test in faeces (Cologuard(TM)) for screening for colorectal cancer (CRC). Material and methods. A systematic review was performed by consulting MedLine, EMBASE and Web of Science to July 2014. Studies on diagnostic tests were selected that evaluated the test in asymptomatic adults who underwent CRC screening. The quality and risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. The level of evidence was defined according to the National Institute for Health and Clinical Excellence. A qualitative synthesis was conducted. Results. A total of 299 literature references were identified, including 1 synthesis report and 5 diagnostic test studies. Three of the 5 studies had a case-control design in Sackett phase II and were of moderate quality, and 2 had a prospective design in Sacket phase III and were of high quality. The sensitivity for detecting CRC was greater than 90%, but only 40% for detecting advanced adenomas. The test provided conclusive diagnostic evidence to rule out CRC (negative likelihood ratio, LR-: 0.02-0.09), although it was not useful for ruling out advanced adenoma (LR-: 0.5-0.7). Conclusions. The Cologuard(TM) test is a valid screening test for ruling out cancerous lesions but is suboptimal for ruling out precancerous lesions. There is no evidence in terms of mortality, survival or cost-effectiveness (AU)
Subject(s)
Female , Humans , Male , Reproducibility of Results/methods , Reproducibility of Results/standards , Reproducibility of Results/trends , Genetic Testing/methods , Genetic Testing/trends , Genetic Testing , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/genetics , DNA Mutational Analysis/methods , Genetic Testing/statistics & numerical data , Genetic Testing/standards , Mass Screening/methods , Feces , Prospective Studies , Suppression, Genetic/genetics , DNA Mutational Analysis/standards , DNA Mutational Analysis , BiasABSTRACT
OBJECTIVES: The aim of this study was to assess the available evidence on the validity, diagnostic accuracy and clinical utility of the multitarget DNA test in faeces (Cologuard™) for screening for colorectal cancer (CRC). MATERIAL AND METHODS: A systematic review was performed by consulting MedLine, EMBASE and Web of Science to July 2014. Studies on diagnostic tests were selected that evaluated the test in asymptomatic adults who underwent CRC screening. The quality and risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. The level of evidence was defined according to the National Institute for Health and Clinical Excellence. A qualitative synthesis was conducted. RESULTS: A total of 299 literature references were identified, including 1 synthesis report and 5 diagnostic test studies. Three of the 5 studies had a case-control design in Sackett phase II and were of moderate quality, and 2 had a prospective design in Sacket phase III and were of high quality. The sensitivity for detecting CRC was greater than 90%, but only 40% for detecting advanced adenomas. The test provided conclusive diagnostic evidence to rule out CRC (negative likelihood ratio, LR-: 0.02-0.09), although it was not useful for ruling out advanced adenoma (LR-: 0.5-0.7). CONCLUSIONS: The Cologuard™ test is a valid screening test for ruling out cancerous lesions but is suboptimal for ruling out precancerous lesions. There is no evidence in terms of mortality, survival or cost-effectiveness.
ABSTRACT
Objetivo. Estimar y comparar la validez diagnóstica de la tomosíntesis y la mamografía digital para cribar y diagnosticar el cáncer de mama. Material y métodos. Realizamos una revisión sistemática consultando MedLine, EMBASE y Web of Science en el periodo de junio de 2010 a febrero de 2013. Los términos de búsqueda fueron: cáncer de mama, cribado, tomosíntesis, mamografía, sensibilidad y especificidad. Se incluyeron estudios de pruebas diagnósticas y revisiones sistemáticas. Dos investigadores hicieron la selección y evaluación. Usamos QUADAS 2 para valorar el riesgo de sesgo y los criterios NICE para el nivel de evidencia. Se hizo una síntesis narrativa. Resultados. De los 151 estudios originales identificados se seleccionaron 11 que incluyeron 2.475 mujeres. Su calidad fue baja, con riesgo de sesgo de selección y seguimiento, y limitaciones para aplicar sus resultados. Su nivel de evidencia no fue superior a II. La sensibilidad de la tomosíntesis osciló entre el 69 y el 100% y la especificidad entre el 54 y el 100%. El cociente de probabilidad negativo fue bueno, lo que la convertiría en una prueba de confirmación diagnóstica. La tomosíntesis con una proyección no fue superior a la mamografía digital con 2, y con 2 proyecciones los resultados no fueron concluyentes. Conclusiones. Los resultados de la validez diagnóstica de la tomosíntesis en el diagnóstico del cáncer de mama no fueron concluyentes, y no los hubo para usarla en el cribado (AU)
Objective. To estimate and compare the diagnostic validity of tomosynthesis and digital mammography for screening and diagnosing breast cancer. Material and methods. We systematically searched MedLine, EMBASE, and Web of Science for the terms breast cancer, screening, tomosynthesis, mammography, sensitivity, and specificity in publications in the period comprising June 2010 through February 2013. We included studies on diagnostic tests and systematic reviews. Two reviewers selected and evaluated the articles. We used QUADAS 2 to evaluate the risk of bias and the NICE criteria to determine the level of evidence. We compiled a narrative synthesis. Results. Of the 151 original studies identified, we selected 11 that included a total of 2475 women. The overall quality was low, with a risk of bias and follow-up and limitations regarding the applicability of the results. The level of evidence was not greater than level II. The sensitivity of tomosynthesis ranged from 69% to 100% and the specificity ranged from 54% to 100%. The negative likelihood ratio was good, and this makes tomosynthesis useful as a test to confirm a diagnosis. One-view tomosynthesis was no better than two-view digital mammography, and the evidence for the superiority of two-view tomosynthesis was inconclusive. Conclusions. The results for the diagnostic validity of tomosynthesis in the diagnosis of breast cancer were inconclusive and there were no results for its use in screening (AU)
Subject(s)
Adult , Female , Humans , Middle Aged , Breast Neoplasms , Mammography/instrumentation , Mammography/methods , Echocardiography, Three-Dimensional/instrumentation , Echocardiography, Three-Dimensional , Imaging, Three-Dimensional/instrumentation , Imaging, Three-Dimensional/methods , Imaging, Three-Dimensional , Mass Screening/methods , Sensitivity and Specificity , Bias , Selection BiasABSTRACT
OBJECTIVE: To estimate and compare the diagnostic validity of tomosynthesis and digital mammography for screening and diagnosing breast cancer. MATERIAL AND METHODS: We systematically searched MedLine, EMBASE, and Web of Science for the terms breast cancer, screening, tomosynthesis, mammography, sensitivity, and specificity in publications in the period comprising June 2010 through February 2013. We included studies on diagnostic tests and systematic reviews. Two reviewers selected and evaluated the articles. We used QUADAS 2 to evaluate the risk of bias and the NICE criteria to determine the level of evidence. We compiled a narrative synthesis. RESULTS: Of the 151 original studies identified, we selected 11 that included a total of 2475 women. The overall quality was low, with a risk of bias and follow-up and limitations regarding the applicability of the results. The level of evidence was not greater than level II. The sensitivity of tomosynthesis ranged from 69% to 100% and the specificity ranged from 54% to 100%. The negative likelihood ratio was good, and this makes tomosynthesis useful as a test to confirm a diagnosis. One-view tomosynthesis was no better than two-view digital mammography, and the evidence for the superiority of two-view tomosynthesis was inconclusive. CONCLUSIONS: The results for the diagnostic validity of tomosynthesis in the diagnosis of breast cancer were inconclusive and there were no results for its use in screening.
