Table 2.
Protocol Level Noncompliance Rates by Location, Size, and Category by Time
| Noncompliance events/participants at risk (unique protocols) |
Median within protocol change in rates [Q1-Q3] |
p- value |
|||
|---|---|---|---|---|---|
| Pre-Lockdown N = 35 |
Post-Lockdown N = 35 |
||||
| Location | Onsite | 76/10,284 (33) | 234/10,862 (33) | 0.001 [−0.051-0.090] | 0.54 |
| Size | Small | 67/10,284 (24) | 90/10,862 (24) | −0.015 [−0.091-0.096] | 0.76 |
| Large | 15/10,284 (11) | 151/10,862 (11) | 0.001 [−0.001-0.016] | 0.15 | |
| Category | Natural history | 29/10,284 (18) | 155/10,862 (18) | 0.001 [−0.003-0.016] | 0.34 |
| Clinical trial | 53/10,284 (17) | 86/10,862 (17) | −0.032 [−0.174-0.124] | 0.86 | |
The number of noncompliance events, participants at risk, and unique protocols by time, median change in rate of noncompliance per participant by location, size, and category at the protocol level for 35 protocols. N indicates the number of protocols. P-values are for the median, within protocol change using the Wilcoxon Signed-Rank test.
Q1 = first quartile; Q3 = third quartile.