Table 2 Description of methodological characteristics of the highest level of evidence studies considered for assessment of implantable medical devices (one study analysed per opinion)
Overall N (%) | Sufficient Expected Benefit (EB*) | Insufficient EB | |||||
|---|---|---|---|---|---|---|---|
IEB* I | IEB II | IEB III | IEB IV | IEB V | |||
Number of centres † | |||||||
Single centre | 12 (19.7) | 0 | 0 | 1 | 2 | 4 | 5 |
National multicentre | 16 (26.2) | 0 | 1 | 0 | 4 | 8 | 3 |
International multicentre | 12 (19.7) | 1 | 0 | 2 | 3 | 1 | 5 |
Not known | 21 (34.4) | 0 | 2 | 1 | 5 | 9 | 4 |
Design | |||||||
Meta-analysis of RCTs‡ | 5 (6.9) | 0 | 5 | 0 | 0 | 0 | 0 |
RCTs | 25 (34.7) | 1 | 3 | 3 | 7 | 7 | 4 |
Comparative non-randomised study | 4 (5.6) | 0 | 0 | 0 | 0 | 1 | 3 |
Non-comparative study | 34 (47.2) | 0 | 0 | 1 | 8 | 15 | 10 |
Retrospective case series | 5 (14.7) | 0 | 0 | 0 | 0 | 2 | 3 |
Prospective cohort | 21 (61.8) | 0 | 0 | 1 | 5 | 9 | 6 |
Observational registry | 6 (17.6) | 0 | 0 | 0 | 2 | 3 | 1 |
Meta-analysis of non comparative study | 2 (5.9) | 0 | 0 | 0 | 1 | 1 | 0 |
Systematic literature review | 4 (5.6) | 0 | 0 | 1 | 0 | 1 | 2 |
Number of patients § | |||||||
(median (range)) | 127.5 (8-18 023) | 40 (.) | 530 (22-18 023) | 568.5 (8-1 065) | 67 (15-859) | 198 (29-8 318) | 62 (19-280) |
Output || | |||||||
Significant result | 21 (70.0) | 1 | 8 | 2 | 3 | 4 | 3 |
Insignificant result | 9 (30.0) | 0 | 0 | 1 | 1 | 4 | 3 |
Total | 72 (100.0) | 1 | 8 | 5 | 15 | 24 | 19 |