Table 2.
Primary outcomes by DOT strategy
| Variable | No vDOT* (n = 107) mean ± SD | Any vDOT (n = 94) mean ± SD | P value |
|---|---|---|---|
| Treatment adherence | |||
| Adherence 1 (observed), %† | 53.9 ± 25.6 | 68.4 ± 10.6 | <0.001§ |
| Median [IQR] | 64.6 [57.8–68.4] | 69.3 [66.4–71.2] | — |
| Adherence 2 (observed + self-administered),‡ % | 98.7 ± 3.1 | 90.0 ± 9.9 | <0.001§ |
| Median [IQR] | 100.0 [98.4–100.0] | 93.5 [87.8–97.7] | — |
| Adherence 3 (observed + self-administered + rejected videos), %¶ | — | 95.9 ± 5.9 | — |
| Median [IQR] | — | 97.4 [94.6–99.6] | — |
| Number of prescribed doses | 149.1 ± 101.2 | 192.0 ± 69.5 | <0.001§ |
| Median [IQR] | 147 [61–198] | 188 [171–223] | |
| Dose outcomes | |||
| Proportion prescribed doses self-administered, % | 45.2 ± 26.1 | 23.8 ± 11.5 | <0.001§ |
| Proportion prescribed doses ‘missed’, % | 1.3 ± 3.1 | 3.4 ± 5.5 | <0.001§ |
| Video outcomes | |||
| Number of rejected videos | — | 5.7 ± 11.9 | — |
| Median [IQR] | — | 0.0 [0.0–5.0] | — |
| Video length, sec | — | 43.5 ± 39.9 | — |
| Median [IQR] | — | 38.4 [5.4–55.2] | — |
| Video size, mb | — | 9.3 ± 15.2 | — |
| Median [IQR] | — | 6.4 [4.1–8.8] | — |
| Time to video treatment start, weeks | — | 6.9 ± 9.2 | — |
| Median [IQR] | — | 2.2 [1.1–10.0] | — |
*
Patients with no vDOT includes some patients who received exclusively self-administered therapy.
†
Calculated as the observable fraction: doses that were observed/total number of doses.
‡
Calculated based on the assumption that patients take every dose that is not observed (including prescribed, dispensed, self-administered doses such as on weekends and holidays).
§
Statistically significant.
¶
Calculated based on crediting videos that were submitted by rejected videos (such as in cases where the observer could not visualize the pill).
DOT = directly observed therapy; vDOT = video DOT; SD = standard deviation; IQR = interquartile range.