| Δ1 (baseline to 6-month follow-up) | Δ2 (6-month follow-up to 9-month follow-up) | ||||||
---|---|---|---|---|---|---|---|---|
Intervention group (IG) (n = 252) | Control group (CG) (n = 250) | Total (N = 502) | Proportion difference IG vs. CG (95% CI) | Intervention group (IG) (n = 252) | Control group (CG) (n = 250) | Total (N = 502) | Proportion difference IG vs. CG (95% CI) | |
API | ||||||||
 Addition | 160 (63%) | 153 (61%) | 313 (62%) | 0.02 (−0.07;0.11) P = 0.661 | 93 (37%) | 88 (35%) | 181 (36%) | 0.02 (− 0.07;0.11) P = 0.761 |
 Discontinuation | 176 (70%) | 161 (64%) | 337 (67%) | 0.05 (− 0.03;0.14) P = 0.229 | 119 (47%) | 129 (52%) | 248 (49%) | −0.04 (− 0.14;0.05) P = 0.373 |
 Intraclass substitution | 23 (9%) | 18 (7%) | 41 (8.2%) | 0.02 (− 0.03;0.07) P = 0.532 | 14 (6%) | 7 (3%) | 21 (4%) | 0.03 (− 0.01;0.07), P = 0.187 |
 Restart of previously discontinued drugs | – | – | – | n.a. | 51/176 (29%) | 53/161 (30%) | 104/337 (31%) | − 0.01 (− 0.08;0.07), P = 0.876 |
Strength of the API | ||||||||
 Increase | 46 (18%) | 36 (14%) | 82 (16%) | 0.04 (− 0.03;0.11) P = 0.295 | 45 (18%) | 35 (14%) | 80 (16%) | 0.04 (−0.03;0.11), P = 0.29 |
 Decrease | 44 (17%) | 49 (20%) | 93 (19%) | −0.02 (− 0.09;0.05), P = 0.616 | 31 (12%) | 37 (15%) | 70 (14%) | − 0.02 (− 0.09;0.04), P = 0.492 |
Dosage | ||||||||
 Daily dosage increase | 91 (36%) | 80 (32%) | 171 (34%) | 0.04 (− 0.05;0.13), P = 0.38 | 67 (27%) | 61 (24%) | 128 (26%) | 0.02 (−0.06;0.1), P = 0.646 |
 Daily dosage decrease | 106 (42%) | 79 (32%) | 185 (37%) | 0.1 (0.02;0.19), P = 0.019* | 72 (29%) | 58 (23%) | 130 (26%) | 0.05 (− 0.03;0.13), P = 0.203 |
 Application interval shortened | 55 (22%) | 42 (17%) | 97 (19%) | 0.05 (− 0.02;0.12), P = 0.189 | 32 (13%) | 20 (8%) | 52 (10%) | 0.05 (− 0.01;0.1), P = 0.114 |
 Application interval prolonged | 48 (19%) | 35 (14%) | 83 (17%) | 0.05 (− 0.02;0.12), P = 0.161 | 28 (11%) | 26 (10%) | 54 (11%) | 0.01 (−0.05;0.07), P = 0.91 |
 Change in application time point | 145 (58%) | 155 (62%) | 300 (60%) | − 0.04 (− 0.13;0.05), P = 0.353 | 98 (39%) | 118 (47%) | 216 (45%) | − 0.08 (− 0.17;0.01), P = 0.073 |
 Pill splitting started | 43 (17%) | 35 (14%) | 78 (16%) | 0.03 (−0.04;0.1), P = 0.41 | 23 (9%) | 19 (8%) | 42 (8%) | 0.02 (− 0.04;0.07), P = 0.648 |
 Pill splitting stopped | 30 (12%) | 35 (14%) | 65 (13%) | −0.02 (− 0.08;0.04), P = 0.571 | 13 (5%) | 18 (7%) | 31 (6%) | − 0.02 (− 0.07;0.03), P = 0.445 |
Administration method | ||||||||
 Change in administration method | 47 (19%) | 32 (13%) | 79 (16%) | 0.06 (− 0.01;0.13), P = 0.093 | 37 (15%) | 42 (17%) | 79 (16%) | −0.02 (− 0.09;0.05), P = 0.597 |