Table 1. Baseline characteristics (a) and resource utilization and outcomes over 2 years (b) by country.
France | Germany | Canada | UK | Ireland | Italy | The Netherlands | Venezuela | All | Difference (P-valuea) | |
---|---|---|---|---|---|---|---|---|---|---|
(a) | ||||||||||
Baseline characteristics (effectiveness analysis set) | ||||||||||
n | 398 | 420 | 188 | 410 | 49 | 365 | 350 | 47 | 2227 | |
Age, year | 77.5 | 76.7 | 79.8 | 77.7 | 72.7 | 75.2 | 77.2 | 73.1 | 76.9 | <0.001 |
Female, % | 61 | 60 | 61 | 60 | 73 | 58 | 63 | 60 | 61 | 0.626 |
Baseline VAS | 56.0 | 52.9 | 47.2 | 55.0 | 64.7 | 65.5 | 50.1 | 48.3 | 55.4 | <0.001 |
Lesion type, % | <0.001 | |||||||||
No | 2 | 3 | 2 | 0 | 4 | 1 | 2 | 2 | 2 | |
Classic | 29 | 19 | 10 | 17 | 55 | 27 | 19 | 38 | 22 | |
Classic and occult | 9 | 16 | 3 | 4 | 4 | 15 | 6 | 6 | 9 | |
Occult | 33 | 49 | 15 | 25 | 14 | 34 | 33 | 17 | 33 | |
Disciform scar | 0 | 1 | 2 | 0 | 8 | 0 | 1 | 0 | 1 | |
Not available | 27 | 12 | 69 | 54 | 14 | 23 | 39 | 36 | 34 | |
Prior disease, % | 92 | 95 | 93 | 92 | 88 | 95 | 92 | 98 | 93 | 0.140 |
Concomitant disease, % | 87 | 90 | 86 | 95 | 92 | 93 | 86 | 74 | 90 | <0.001 |
Health insurance, % | <0.001 | |||||||||
Public | 95 | 82 | 93 | 82 | 2 | 89 | 99 | 4 | 86 | |
Private | 2 | 17 | 1 | 1 | 94 | 0 | 1 | 53 | 7 | |
No insurance | 0 | 1 | 3 | 15 | 4 | 11 | 0 | 28 | 6 | |
Not available | 3 | 0 | 3 | 2 | 0 | 0 | 0 | 15 | 1 | |
Reimbursement type, %b | <0.001 | |||||||||
Individual | 2 | 51 | 2 | 1 | 0 | 26 | 3 | 6 | 15 | |
National standards | 44 | 32 | 92 | 94 | 96 | 73 | 96 | 15 | 69 | |
Separate contract | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | |
Independently | 53 | 3 | 1 | 1 | 0 | 1 | 0 | 4 | 10 | |
Patient | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 23 | 1 | |
Not available | 1 | 7 | 7 | 3 | 0 | 0 | 1 | 51 | 4 | |
(b) | ||||||||||
Resource allocation and outcomes in year 1 (first-year completers) | ||||||||||
n | 340 | 232 | 149 | 396 | 31 | 272 | 258 | 17 | 1695 | |
Overall treatment duration, days | 538.3 | 521.8 | 642.2 | 652.2 | 736.0 | 527.8 | 570.4 | 530.9 | 578.5 | <0.001 |
Ranibizumab injections | 4.6 | 4.8 | 6.8 | 5.9 | 7.4 | 4.0 | 6.8 | 3.4 | 5.4 | <0.001 |
Treatment switch, % | 1 | 14 | 15 | 1 | 6 | 10 | 3 | 41 | 6 | 0.632 |
Ophthalmoscopies | 3.3 | 7.6 | 6.0 | 8.7 | 0.6 | 1.9 | 1.6 | 1.8 | 4.8 | <0.001 |
Optical coherence tomography | 5.7 | 2.9 | 2.8 | 9.3 | 6.2 | 3.3 | 4.1 | 2.5 | 5.2 | <0.001 |
Fluorescein angiography | 1.2 | 1.3 | 0.9 | 0.5 | 1.9 | 2.1 | 0.2 | 0.6 | 1.0 | <0.001 |
ICGA | 0.4 | 0.1 | 0 | 0.1 | 0 | 1.1 | 0 | 0 | 0.3 | <0.001 |
Monitoring visitsc | 3.9 | 3.9 | 1.3 | 4.3 | 1.7 | 5.3 | 2.4 | 4.9 | 3.7 | <0.001 |
Clinic visitsc | 4.9 | 5.1 | 7.7 | 6.2 | 8.1 | 4.2 | 7.1 | 3.8 | 5.8 | <0.001 |
Vision gainer, %d | 17 | 17 | 28 | 30 | 11 | 13 | 31 | 25 | 23 | <0.001 |
Vision maintained, %d | 65 | 66 | 76 | 77 | 71 | 61 | 71 | 58 | 70 | 0.001 |
Resource allocation and outcomes over 2 years (second-year completers) | ||||||||||
N | 240 | 136 | 107 | 350 | 18 | 159 | 163 | 11 | 1184 | |
Overall treatment duration, days | 620.1 | 628.1 | 729.0 | 692.1 | 855.6 | 651.9 | 672.5 | 635.7 | 667.4 | <0.001 |
Ranibizumab injections | 7.4 | 7.2 | 12.1 | 9.5 | 15.6 | 6.2 | 10.9 | 4.2 | 8.9 | <0.001 |
Treatment switch, % | 2 | 15 | 13 | 1 | 11 | 11 | 4 | 64 | 6 | 0.749 |
Ophthalmoscopies | 6.1 | 12.4 | 11.6 | 15.6 | 0.8 | 3.8 | 2.8 | 3.3 | 9.2 | <0.001 |
Optical coherence tomography | 10.9 | 6.3 | 6.1 | 17.5 | 12.1 | 6.8 | 7.9 | 5.2 | 10.9 | <0.001 |
Fluorescein angiography | 1.9 | 2.2 | 1.1 | 0.6 | 3.2 | 3.7 | 0.2 | 1.1 | 1.5 | <0.001 |
ICGA | 0.7 | 0.2 | 0 | 0.1 | 0 | 2.2 | 0 | 0 | 0.5 | <0.001 |
Monitoring visitsc | 7.7 | 7.4 | 3.1 | 9.1 | 2.3 | 10.1 | 4.8 | 10.4 | 7.5 | <0.001 |
Clinic visitsc | 8.1 | 8.1 | 14.6 | 10.2 | 17.3 | 6.7 | 11.7 | 6.1 | 9.8 | <0.001 |
Vision gainer, %d | 21 | 21 | 31 | 28 | 20 | 14 | 33 | 38 | 25 | 0.004 |
Vision maintained, %d | 64 | 57 | 62 | 76 | 67 | 54 | 75 | 50 | 67 | <0.001 |
Abbreviations: ICGA, indocyanine green angiography; VAS, visual acuity score.
Mean unless stated.
P-value was derived from ANOVA test for continuous variables and χ2 test for categorical variables.
Individual: reimbursement granted individually for this patient and treatment occasion; national standards: reimbursement according to national standards; independently: reimbursement granted for patient independently of how often treatment was provided.
Monitoring (diagnostic assessments only) and clinic (scheduled treatment) visits. As this was an observational study, the actual number of treatments may differ to visits that were scheduled as clinic (treatment) visits, and the use of diagnostic tests, such as ophthalmoscopies, may have also occurred during clinic or monitoring visits, accounting for differences in numbers.
Vision gainer (defined as patients who gained ⩾15 letters) and vision maintained (defined as no decline in visual acuity from baseline).