WP1 Real-world evidence for economic evaluation of medical devices: methodological challenges and applications

WP1 is led by Erasmus University Rotterdam, and its overall aim is to explore existing real world evidence (RWD) for medical device and their use for economic evaluation and provide methodological guidelines to include this sources in cost and outcome analysis.

• » To provide a comprehensive assessment of possible sources of real world evidence or medical devices in EU countries (e.g. registries, administrative data);
• » To develop a methodological checklist to inform data collection on the costs and outcome of medical devices in real world settings;
• » To develop a questionnaire to solicit expert opinion on learning curves in a structured way.
• » To propose methodologies to analyse cost and outcome data of medical devices derived from real world evidence sources.

• » A comprehensive assessment of existing sources of real world evidence for cost and outcome analysis of medical devices in Europe (i.e. registries, administrative data, observational studies) will be provided.
• » Methodological guidelines for integrating existing data sources of real world evidence will be developed to inform data collection on the real world costs and outcome of medical devices in real world settings