From: Patients’ beliefs regarding informed consent for low-risk pragmatic trials
Overall (n = 338) n (%) | Drug RCT, % | Dose-Timing RCT, % | ||||
---|---|---|---|---|---|---|
Written consent vs General Notification (n = 85) | Written Consent vs Verbal Consent (n = 85) | Written consent vs General Notification (n = 85) | Written Consent vs Verbal Consent (n = 83) | |||
Age | ||||||
18/44 y | 50 | (14.8) | 18.8 | 8.2 | 12.9 | 19.3 |
45/64 y | 169 | (50.0) | 50.6 | 55.3 | 48.2 | 45.8 |
≧65 y | 119 | (35.2) | 30.6 | 36.5 | 38.8 | 34.9 |
p = 0.377 | ||||||
Sex | ||||||
Male | 201 | (59.5) | 58.8 | 63.5 | 61.2 | 54.2 |
Female | 137 | (40.5) | 41.2 | 36.5 | 38.8 | 45.8 |
p = 0.648 | ||||||
Geographical area | ||||||
North | 48 | (14.2) | 9.4 | 15.3 | 14.1 | 18.1 |
Northeast | 60 | (17.8) | 21.2 | 16.5 | 11.8 | 21.7 |
East | 46 | (13.6) | 12.9 | 14.1 | 15.3 | 12.0 |
Central-West | 94 | (27.8) | 34.1 | 27.1 | 29.4 | 20.5 |
South | 65 | (19.2) | 15.3 | 21.2 | 21.2 | 19.3 |
Islands | 25 | (7.4) | 7.1 | 5.9 | 8.2 | 8.4 |
p = 0.808 | ||||||
Marital status | ||||||
Never married | 31 | (9.2) | 11.8 | 5.9 | 7.1 | 12.0 |
Married or living with partner | 251 | (74.3) | 74.1 | 77.6 | 77.6 | 67.5 |
Other | 56 | (16.6) | 14.1 | 16.5 | 15.3 | 20.5 |
p = 0.579 | ||||||
Annual Household income | ||||||
< 12.600 € | 65 | (19.2) | 22.3 | 15.3 | 20.1 | 19.3 |
12.600 - 25.000€ | 90 | (26.6) | 31.8 | 27.1 | 29.4 | 18.1 |
25.001 – 38.000€ | 56 | (16.6) | 10.6 | 18.8 | 18.8 | 18.1 |
> 38.000€ | 53 | (15.7) | 14.1 | 17.6 | 14.1 | 16.8 |
No answer | 74 | (21.9) | 21.2 | 21.2 | 17.6 | 27.7 |
p = 0.654 | ||||||
Employment status | ||||||
Employed | 106 | (31.4) | 31.8 | 36.4 | 24.7 | 32.5 |
Unemployed or other | 111 | (32.8) | 34.1 | 22.4 | 43.5 | 31.4 |
Retired | 121 | (35.8) | 34.1 | 41.2 | 31.8 | 36.1 |
p = 0.174 | ||||||
Education | ||||||
Primary school | 77 | (22.8) | 23.5 | 21.2 | 21.2 | 25.3 |
Secondary education | 105 | (31.1) | 31.8 | 24.7 | 36.5 | 31.3 |
High school | 101 | (29.9) | 28.2 | 32.9 | 31.8 | 26.5 |
College and postgraduate | 55 | (16.3) | 16.5 | 21.2 | 10.6 | 16.9 |
p = 0.731 | ||||||
Religious attendance | ||||||
Regularly | 59 | (17.5) | 18.8 | 17.6 | 14.1 | 19.3 |
Rarely | 59 | (17.5) | 23.5 | 16.5 | 16.5 | 13.3 |
Never | 177 | (52.4) | 44.7 | 57.6 | 55.3 | 51.8 |
No answer | 43 | (12.7) | 12.9 | 8.2 | 14.1 | 15.7 |
p = 0.625 | ||||||
Ideology | ||||||
1 -2 Left | 63 | (18.6) | 17.6 | 20.0 | 14.1 | 22.8 |
3 | 67 | (19.8) | 21.3 | 20.0 | 17.7 | 20.5 |
4 Moderate | 105 | (31.1) | 29.4 | 37.6 | 34.1 | 22.9 |
5-6-7 Right | 57 | (16.9) | 14.1 | 15.3 | 17.6 | 20.5 |
No answer | 46 | (13.6) | 17.6 | 7.1 | 16.5 | 13.3 |
p = 0.541 | ||||||
RCT: Randomized, controlled trial. |