Table 4.
Assessment of challenges by participantsa
| Challenge | Participants from countries with CED programmes for medical devices (Belgium, Englandb, Franceb, Germany, Netherlands, Spain, Switzerland) | Participants from countries without CED programmes for medical devices (Bulgaria, Hungary, Ireland, Italyb, Poland, Portugal, Scotland, Slovakia) | |||||
|---|---|---|---|---|---|---|---|
| n | Mean (SD) | Median (IQR) | n | Mean (SD) | Median (IQR) | ||
| 1 | Deciding which medical devices are candidates for CED schemes | 9 | 2.5 (1.17) | 2 (2.25) | 9 | 3.78 (1.48) | 4 (2.5) |
| 2 | Obtaining stakeholder agreement on the scheme | 9 | 2.17 (1.46) | 2 (2.75) | 8 | 2.75 (1.83) | 2.5 (3.5) |
| 3 | Securing funding for the scheme | 9 | 0.89 (1.05) | 1 (1.50) | 8 | 3 (1.69) | 3 (3.5) |
| 4 | Determining the appropriate study design for data collection | 9 | 2.39 (1.45) | 2 (2.75) | 9 | 3.33 (1.32) | 4 (2) |
| 5 | Determining the relevant outcome measure(s) on which data are collected | 9 | 2.61 (1.27) | 2 (2.50) | 9 | 2.78 (1.72) | 2 (3.5) |
| 6 | Dealing with data collection and monitoring | 8 | 2.13 (1.64) | 2.5 (3.5) | 9 | 3.78 (1.2) | 4 (2.5) |
| 7 | Dealing with data analysis | 9 | 1.61 (1.22) | 1.5 (2.5) | 8 | 3 (1.51) | 3.5 (2.75) |
| 8 | Ex-ante definition of decision rule, based on possible outcomes of the scheme | 3 | 3 (1) | 3 (2) | 8 | 3.75 (1.58) | 4.5 (2.75) |
| 9 | Reaching an agreement on price, reimbursement or use of the device at the end of the scheme | 5 | 2.1 (2.13) | 2 (4.25) | 7 | 3.57 (1.27) | 4 (3) |
| 10 | Withdrawing a device from the market when evidence indicates the device is not (cost-) effective | 6 | 3 (0.89) | 3 (2) | 8 | 4.5 (1.07) | 5 (0.75) |
| 11 | Obtaining agreements about the duration of the scheme and the stopping rule | 9 | 1.94 (1.13) | 2 (1.25) | 8 | 1.75 (1.49) | 1.5 (2.75) |
| 12 | Adapting the scheme to account for product modifications or a learning curve | 8 | 1.44 (1.45) | 1.5 (2.38) | 8 | 3.25 (1.49) | 3.5 (2.75) |
| 13 | Dealing with the market entry of similar devices | 9 | 1.83 (1.73) | 1 (2.75) | 8 | 2.25 (1.67) | 2 (3) |
aAssessed on a six-point Likert scale (ranging from 0 “not a challenge” to 5 “a major challenge”)
bTwo participants scored the challenges for this country