Table 3.
Comprehension and Feeling Well Informed at Enrollment
| Form A (n=55) |
Form B (n=56) |
Comparison P value |
||
|---|---|---|---|---|
| Mean (median) | ||||
| Understanding Score; number correct out of 8 multiple choice questions | 6.5 (7) | 6.5 (7) | 0.79 | |
| Assessment of Understanding Quiz: number correct out of 21 true or false statements | 20.4 (21) | 20.1 (20) | 0.13 | |
| Survey Item # | Answer | percentage | ||
| Item #2 | 0.03(*) | |||
| How well informed do you feel right now about this study? | No answer | 0 | 1.8 | 0.50 |
| 1-Not informed at all | 0 | 1.8 | 0.50 | |
| 2-Slightly informed | 0 | 0 | ||
| 3-moderately well informed | 14.5 | 1.8 | 0.02 (*) | |
| 4-very well informed | 85.5 | 94.6 | 0.12 | |
| Item #13 | 0.01(*) | |||
| How well did the research staff (doctors, nurse, others) explain the medical research study to you? | 1-Very well | 89.1 | 100 | 0.01 |
| 2-Fairly well | 10.9 | 0 | 0.01 | |
| 3-Not very well | 0 | 0 | ||
| 4-No one explained the study | 0 | 0 | ||
| 5-I don’t remember | 0 | 0 | ||
| Item #17 | 0.11 | |||
| In this study who will get the [inactivated flu] vaccine? | 1-Everybody in the study | 58.2 | 67.9 | 0.33 |
| 2-Half of those who join | 30.9 | 14.3 | 0.04(*) | |
| 3-Only people assigned to Group 1 | 7.3 | 16.1 | 0.24 | |
| 4-I was not given that information | 3.6 | 1.8 | 0.62 | |
Asterisk (*) indicates statistically significant difference between consent form groups.
Note that not all questions related to understanding are shown in this table.