Randomized controlled trials (RCTs) are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. The low external validity of RCTs and the general shortage of clinical evidence available to support the use of many medical devices have emphasized the necessity for exploring the use of real-world data (RWD) as a complementary source to RCTs data for establishing a more robust evidence base on the effectiveness of medical devices. The aim of the present project is to assess in a comprehensive way the existing sources of real world data on medical devices in Europe.

The guidelines to the mapping exercise have been outlined in a research protocol. First, all national relevant sources (e.g. website of Ministry of Health, national institutions, research bodies) are screened, both in local language and English. Second, we perform a systematic search on PubMed using a set of key words for each case study, adapted to each country setting. Finally, we seek advice from key actors in the field of the device and clinical conditions, such as manufacturers or clinicians.

Information on existing sources of RWD for each case studies are provided in a template including details on the key features of the source (e.g. data producer, data collection period, sample size, study design, geographical coverage) and the main content of the dataset, distinguishing socio-demographic information, clinical and epidemiological data, data on resource use and health outcomes. The data mapping includes all countries of the project participants, i.e. Italy, UK, Netherlands, Switzerland, Germany, Hungary, and we enlarge the scope of our mapping including other countries: Spain, France, Denmark, Finland, Sweden, Poland and Hungary as well as international databases at pan-EU level. The number of available sources of RWD and their quality vary depending on case study and across countries. For example, in the case of orthopaedics, many countries have a national registry and administrative data, such as hospital discharge, contain useful information, although not as detailed. When a registry is not available, it is often the case that more observational studies are available; this occurs for example in France.

In this work we shows the importance of RWE and map in an accurate and comprehensive way which source of RWD are currently available and to what extent they are known and used in medical, epidemiological and economic research.