Table 2.
Use of mobile outcome assessments in RCTs
| Primary endpoint (n = 10) |
Co-primary endpoint (n = 5) |
Secondary endpoint (n = 9) |
Exploratory endpoint(n = 3) |
Other (n = 2) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n (%) | Ref. | n (%) | Ref. | n (%) | Ref. | n (%) | Ref. | n (%) | Ref. | |
| Therapeutic area | ||||||||||
| Cardiology | 1 (10) | 19 | 1 (20) | 17 | 2 (22) | 19, 25 | 0 (0) | - | 0 (0) | - |
| Diabetes | 3 (30) | 11, 24, 26 | 2 (40) | 12, 28 | 3 (33) | 11, 26, 28 | 0 (0) | - | 1 (50) | 26 |
| Sleep | 0 (0) | - | 1 (20) | 21 | 2 (22) | 15, 20 | 0 (0) | - | 0 (0) | - |
| Neurology | 1 (10) | 13 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |
| Reproductive and | 2 (20) | 8, 10 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |
| peripartum health Orthopedics | 1 (10) | 22 | 0 (0) | - | 1 (11) | 22 | 0 (0) | - | 0 (0) | - |
| Pediatrics | 0 (0) | - | 0 (0) | - | 0 (0) | - | 1 (33) | 9 | 0 (0) | - |
| Arthritis | 0 (0) | - | 0 (0) | - | 1 (11) | 16 | 0 (0) | - | 0 (0) | - |
| Cancer | 0 (0) | - | 1 (20) | 23 | 0 (0) | - | 2 (66) | 14, 18 | 1 (50) | 14 |
| Gastroenterology | 1 (10) | 29 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |
| Nutrition | 1 (10) | 27 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |
| Mobile outcome category | ||||||||||
| Performance outcome | 6 (60) | 8, 10, 13, 19, 22, 27 | 3 (60) | 17, 21, 23 | 6 (67) | 15, 16, 19, 20, 22, 25 | 3 (100) | 9, 14, 18 | 1 (50) | 14 |
| Biomarkers | 4 (40) | 11, 24, 26, 29 | 2 (40) | 12, 28 | 3 (33) | 11, 26, 28 | 0 (0) | 1 (50) | 26 | |
| Device | ||||||||||
| Wearable inertial sensor/accelerometer | 5 (50) | 8, 19, 22, 24, 27 | 4 (80) | 12, 17, 21, 23 | 6 (67) | 15, 16, 19, 20, 22, 25 | 3 (100) | 9, 14, | 1 (50) | 14 |
| Biosensor | 4 (40) | 11, 24, 26, 29 | 2 (40) | 12, 28 | 3 (33) | 11, 26, 28 | 0 (0) | 18 | 1 (50) | 26 |
| Continuous glucose monitor | 3 (30) | 11, 24, 26 | 2 (40) | 12, 28 | 3 (33) | 11, 26, 28 | 0 (0) | - | 1 (50) | 26 |
| Ingestible pH monitor | 1 (10) | 29 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |
| Pressure sensor and instrumented walkways | 1 (10) | 13 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |
| Medication adherence monitor | 1 (10) | 10 | 0 (0) | - | 0 (0) | - | 0 (0) | - | 0 (0) | - |