Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

Evaluacion de la adecuación del ingreso y alta hospitalarios en un Área de Urgencias / Evaluation of appropiateness on admission and discharge in an emergency area

OBJETIVO: Valorar la adecuación de ingresos y altas hospitalarias de un área de urgencias analizando su relación con diversas variables. MATERIAL Y MÉTODOS: Se evaluó la adecuación del ingreso y alta, aplicando el Appropriateness Evaluation Protocol (AEP) retrospectivamente a una muestra representativa de pacientes atendidos en urgencias en Junio/1998. RESULTADOS: En las altas, el acuerdo encontrado entre el AEP y el juicio médico fue del 96,43 por ciento. El 2,4 por ciento de las altas fueron inadecuadas. Los pacientes a los que se les solicitó alguna prueba, presentaron una inadecuación significativamente mayor (p=0,01). La inadecuación de solicitud de pruebas complementarias actúa como factor independiente de protección para el ingreso inadecuado. CONCLUSIONES: Los resultados obtenidos son aceptables, si bien, deben realizarse estudios de evaluación para identificar problemas y adoptar las correspondientes estrategias de mejora (AU)