Table 2.
Primary Outcomes by DOT Strategy
| Variable | In-Person DOT | vDOT | P |
|---|---|---|---|
| Adherence,a median (IQR), % | 98 (90–100) | 94 (88–98) | .17 |
| Observable fraction,b median (IQR), % | 66 (62–72) | 72 (67–92) | .03 |
| No. (%) of patients with observable fraction greater than a target 80% | 4 (15) | 10 (36) | .01 |
| DOT schedule among active TB patients (n = 25),c % | |||
| 3x/wk DOT | 6 (24) | 4 (16) | .32 |
| 5x/wk DOT | 25 (100) | 19 (76) | .01 |
| 7x/wk DOT | 0 (100) | 2 (8) | .16 |
| Treatment length, wk | .01 | ||
| Mean ± SD | 12.22 ± 6.5 | 19.2 ± 9.7 | |
| Range | 0–26 | 5–37 | |
| No. of rejected videos | |||
| Mean (SD) | 1.8 (2.4) | ||
| Range | 0–11 | ||
| Unexpected video submission | |||
| Mean (SD) | 2.7 (5.3) | ||
| Range | 0–20 | ||
| Patients reporting ≥1 side effects via mobile platform,d % | 46 | ||
| Video length, median (IQR), sec | 48 (29–63) | ||
| Video size, median (IQR), mb | 4.8 (1.4–5.8) | ||
Abbreviations: DOT, directly observed therapy; IQR, interquartile range; TB, tuberculosis; vDOT, video directly observed therapy.
Only participants treated for active TB included (n = 25).
aPercentage of “expected” DOT doses (in-person or video) completed, excluding self-administered doses (ie, weekends or clinic holidays). An additional, less stringent analysis was also conducted wherein “completed” vDOT was loosely defined to include both verified and rejected miDOT videos: in-person 98% (90%–100%) vs vDOT 96% (89%–100%), P = .37.
bPercentage of total planned doses (inclusive of weekend/holiday self-administered) that were observed (in-person or video). For vDOT, “observation” was loosely defined to include all forms of uploaded miDOT videos (verified, rejected, unexpected), though only 1 video was counted for a given dosing day. An additional, stricter analysis was also conducted wherein, for vDOT, “observation” referred only to verified videos: in-person 66% (62%–71%) vs vDOT 70% (63%–90%), P = .22.
cTotal number of regimens exceeds sample size (n = 25, active TB only) as some participants had >1 dosing frequency during their therapy.
dThe miDOT video system prompts patients to indicate side effects prior to video submission using checkboxes on the mobile app, with positives resulting in an automatic provider alert. The most common symptom reported was abdominal pain, followed by weakness. Other reported side effects included nausea/vomiting, rash, sores on lips/mouth, joint pain, yellowish skin or eyes, and other. Of note, some patients digitally captured side effects during the video recordings (eg, rash).