Table 1.
Distribution of studies of selected device categories between the EU member states
| EU member states | Total number of studies | Number of studies that included PRO measures | Proportion of studies included PROM (%) | ||
|---|---|---|---|---|---|
| United Kingdom | 186 | (18%) | 121 | (24%) | 65 |
| Germany | 178 | (17%) | 92 | (18%) | 52 |
| France | 108 | (10%) | 42 | (10%) | 39 |
| Italy | 98 | (9.5%) | 16 | (3%) | 16 |
| Spain | 79 | (7.7%) | 39 | (8%) | 49 |
| The Netherlands | 65 | (6.3%) | 28 | (5%) | 43 |
| Belgium | 57 | (5.5%) | 28 | (5%) | 49 |
| Austria | 56 | (5.5%) | 13 | (2.5%) | 23 |
| Denmark | 54 | (5.2%) | 27 | (5%) | 50 |
| Sweden | 52 | (5%) | 27 | (5%) | 52 |
| Switzerland | 52 | (5%) | 13 | (2.5%) | 25 |
| Norway | 28 | (2.7%) | 25 | (5%) | 89 |
| Poland | 23 | (2.2% | 9 | (2%) | 39 |
| Finland | 18 | (1.7%) | 5 | (1%) | 28 |
| Hungary | 18 | (1.7%) | 4 | (0.8%) | 22 |
| Czech Republic | 14 | (1.4%) | 5 | (1%) | 36 |
| Portugal | 14 | (1.4%) | 5 | (1%) | 36 |
| Slovakia | 7 | (0.7%) | 4 | (0.8%) | 57 |
| Greece | 4 | (0.4%) | 3 | (0.6%) | 75 |
| Ireland | 4 | (0.4%) | 2 | (0.4%) | 50 |
| Latvia | 4 | (0.4%) | 0 | (0%) | 0 |
| Romania | 4 | (0.4%) | 3 | (0.6%) | 75 |
| Lithuania | 3 | (0.3%) | 0 | (0%) | 0 |
| Croatia | 1 | (0.1%) | 1 | (0.2%) | 100 |
| Estonia | 1 | (0.1%) | 0 | (0%) | 0 |
| Slovenia | 1 | (0.1%) | 1 | (0.2%) | 100 |
Concerning the CEE region, 27 (35%) device studies included some kind of PROMs. Most of the device studies are organized in Poland and in Hungary, respectively. There is no data on device related clinical studies from Bulgaria. CEE region implies Poland, Czech Republic, Slovakia, Hungary, Slovenia, Croatia, Romania, Bulgaria and the Baltic states