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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)

From: Medical device assessment: scientific evidence examined by the French national agency for health – a descriptive study

  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
  1. * EB: expected benefit; IEB: improvement in expected benefit.
  2. Non-applicable for 11 studies (meta-analysis and systematic literature reviews).
  3. RCTs: randomised controlled trials.
  4. § Non-applicable for systematic literature reviews.
  5. || For comparative studies and meta-analyses of RCTs only; for 4 the information is missing.