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.

Oral health status and coverage of oral health care: A five-country comparison.

Oral health has received increased attention in health services research and policy. This study aims to assess oral health outcomes and public coverage of oral health services in Belgium, Denmark, Germany, the Netherlands, and Spain. Various indicators were used to compare oral health outcomes concerning the most common disorders by age group. Coverage of oral health services was analyzed according to the dimensions of the WHO Universal Coverage Cube. The results showed major differences in the coverage of services for the adult population: coverage was most comprehensive in Germany, followed by Belgium and Denmark. In Spain and the Netherlands, public coverage was limited. Except in Spain, coverage of oral health services for children was high, although with some differences between countries. Regarding oral health outcomes measured by the T-Health index, no country showed outstanding results across all age groups. While Denmark, the Netherlands, and Spain performed above average among 5- to 7-year-olds, Denmark and Germany performed above average among 12- to 14-year-olds, the Netherlands, Spain, and Belgium among 35- to 44-year-olds, and Belgium and the Netherlands among 65- to 74-year-olds. The selection of countries of this study was limited due to the availability and quality of oral health data demonstrating the urgent need for the European member states to establish corresponding databases.