Table 5.
Secondary endpoints of the Monitoring Substudy
| On-site | No on-site | OR (95% CI)a | p-valuea | |
|---|---|---|---|---|
| No. sites | 99 | 97 | ||
| No. participants | 2107 | 2264 | ||
| Pct. lost to follow-upb | 7.1 | 8.6 | 0.8 (0.5, 1.1) | 0.19 |
| - withdrawal due to site closure | 0.4 | 1.1 | ||
| - withdrawal of consent | 2.3 | 2.4 | ||
| - no data for 10 months | 4.4 | 5.0 | ||
| No. follow-up visits expectedc | 30237 | 32585 | ||
| Pct. of visits missed | 8.6 | 7.8 | ||
| No. follow-up visits attended | 27629 | 30035 | ||
| Pct. forms submitted > 2 weeks after visit | 29.2 | 23.0 | ||
| Pct. forms with query upon submission | 38.7 | 31.2 | ||
| Pct. forms clean > 2 weeks | 20.9 | 15.7 | ||
| Pct. forms with missing required data | 8.4 | 5.9 |
a
Logistic regression fixed effects hierarchical model comparing the on-site group to the no on-site group
b
No data in 10 months or withdrawal from START after the opening of the monitoring substudy
c
Baseline and START follow-up visits that took place or whose visit window closed between 1 Sep 2011 and 31 Dec 2016