Validez clínica de la prueba genética Cologuard(TM) para el cribado de cáncer colorrectal: revisión sistemática / A systematic review of the clinical validity of the Cologuard(TM) genetic test for screening colorectal cancer

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)

Uso adecuado de la prótesis invertida de hombro mediante aplicación del método RAND/UCLA / Appropriateness of the indication for reverse shoulder replacement using the RAND/UCLA method

Objetivo: En las series de casos publicadas sobre artropatía del manguito rotador, tratadas con prótesis invertida de hombro, se analizan factores asociados que pueden influir en su evolución como dolor, edad, calidad ósea o limitación articular. En ningún trabajo se plantea una posible actitud de decisión médica partiendo de estas variables. El objetivo del presente estudio fue desarrollar criterios de uso adecuado de la prótesis invertida de hombro en pacientes con artropatía del manguito rotador a través de escenarios creados con dichas variables. Material y método: Se aplicó el método RAND/ UCLA para combinar la evidencia científica disponible con el juicio de 12 expertos en la materia. Los expertos expresaron su opinión de forma cuantitativa sobre cada situación clínica. Se calificaron como adecuadas, cuando los beneficios superaban con margen a los riesgos o consecuencias negativas, o inadecuadas, si los riesgos superaban a los beneficios. Resultados: El panel de expertos, tras dos rondas de puntuación, encontró que de 192 situaciones clínicas planteadas, 22 (11,4%) fueron consideradas adecuadas, 47 (24,5%) dudosas y 123 (64,1%) inadecuadas. El grado de desacuerdo bajó respecto al obtenido en la primera ronda, calificando con desacuerdo 5 indicaciones (2,6%), indeterminadas 82 (42,7%) y con acuerdo 105 (54,7%). Conclusiones: Los panelistas consideraron adecuadas aquellas indicaciones definidas por dolor severo y limitación funcional importante, combinada con lesión del manguito rotador no reparable y edad mayor a 65 años. Otras variables como la calidad ósea, la existencia de un defecto glenoideo o la reparabilidad de la lesión del manguito, podrían afectar la decisión

Purpose: The case series studies performed on rotator cuff arthropathy treated with reverse shoulder replacement (RSR) examine factors influencing the outcome, such as pain, age, bone quality or limited joint mobility. However, none of these studies examine how these variables influence the treatment choice. The aim of this study is to develop appropriateness criteria for the use of RSR in patients with rotator cuff tear arthropathy (RCTA) according to a variety of cases including the variables mentioned above. Material and methods: We applied the RAND/ UCLA appropriateness method to combine the available scientific evidence with the judgment of 12 experts in RCTA. Indication for RSR was considered appropriate when the benefits outweighed the associated risks or complications, and inappropriate when the risks outweighed the benefits. Results: After two rating rounds, the panel of experts found that out of the 192 cases analyzed, 22 (11.4%) were considered appropriate, 47 (24.5%) were uncertain and 123 (64.1%) were considered inappropriate. The level of disagreement was lower in the second rating round: there was agreement on 5 indications (2.6%), indeterminate on 82 (42.7%) and disagreement on 105 cases (54.7%). Conclusion: The experts agreed that appropriateness criteria for indication of reverse shoulder replacement were acute pain and severe functional limitation combined with irreparable rotator cuff dysfunction and older than 65 years. Other variables such as bone quality, the presence of a glenoid defect or the reparability of the cuff failure might affect the treatment choice

A systematic review of the clinical validity of the Cologuard™ genetic test for screening colorectal cancer.

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.