Characteristics | Range | Total number (%) | Number of trials |
---|---|---|---|
Sample size, n | 16–2922 | 8763 | 26 |
Self-monitoring, n | 4553 (51.9) | ||
PSM | 14–579 | 2619 (57.5) | 20* |
PST | 14–1465 | 1934 (42.5) | 9* |
Standard care, n | 4199 (47.9) | ||
AC clinic | 17–1457 | 2669 (63.6) | 15 |
GP/physician | 26–576 | 1143 (27.2) | 6 |
AC clinic or GP/physician | 49 to103 | 387 (9.2) | 5 |
Study duration, months | 3.5–57† | ||
<12 | 16–320 | 2186 (25) | 17 |
≥12 | 28–2922 | 6577 (75) | 9 |
Age, years | 1–91 | ||
Mean age groups, years | |||
Mean age ≤18 | 1–19 | 28 (<1) | 1 |
Mean age >18 to <50 | 22–71 | 100 (∼1) | 1 |
Mean age ≥50 to <70 | 16–91 | 8289 (94.6) | 21 |
Mean age ≥70 | 65–91 | 85 (∼1) | 1 |
Clinical indication, n | |||
AF | 85–202 | 287 (3) | 2 |
AHV | 58–1155 | 2434 (28) | 6 |
Mixed indication | 16–2922 | 6042 (69) | 18 |
POC devices, n | |||
CoaguChek | 28–1155 | 5479 (62.5) | 22 |
ProTime | 140–2922 | 3062 (35.0) | 2 |
INRatio2 | – | 0 | 0 |
CoaguChek+INRatio2 | 16–206 | 222 (2.5) | 2 |
Outcomes, n | |||
Thromboembolic events | 49–2922 | 8394 (95.8) | 21 |
Bleeding events | 49–2922 | 8394 (95.8) | 21 |
Mortality | 49–2922 | 6537 (74.6) | 13 |
Time in therapeutic range | 28–2922 | 6245 (71.3) | 18 |
INR values in range | 49–1155 | 4472 (51) | 12 |
*For conversion of study duration reported in week, 4 weeks was considered equivalent to 1 month.
†Three of the 26 trials reported both PSM and PST arms.62–64
PSM, patient self-management; PST, patient self-testing; AC, anticoagulation; GP, general practitioner; AF, atrial fibrillation; AHF, artificial heart valves; POC, point-of-care; INR, international normalised ratio.