Table 6 Comparison of percentage of participants giving correct responses to the main consent components in the intervention and standard group, WukiroKilte-Awulaelo and Hintal-wajiratworedas(districts), Tigray region, Northern Ethiopia, July 2013
Consent component | Mean % CS Intervention N = 114) | Mean % CS Control (N = 85) | Mean difference (95 % CI) | P |
|---|---|---|---|---|
Disease information [Q302] | 67.54 | 51.77 | 15.8 (2.1, 29.5) | 2.4 |
Information about the study[Q201, 203, 204, 208] | 55.26 | 37.64 | 17.6 (9.46, 25.76) | <0.001 |
Aim /purpose of the study[Q308A, 308B] | 79.38 | 51.76 | 27.62 (19.53, 35.70) | <0.001 |
Selection criteria [Q301] | 99.12 | 78.82 | 20.30 (12.50, 28.10) | <0.001 |
Procedure of sample collection [Q310A, 310C] | 93.86 | 61.18 | 32.68 (25.21, 40.86) | <0.001 |
Tasks to be performed by participants [Q311A] | 98.25 | 83.53 | 14.70 (7.30, 22.20) | <0.001 |
Risk of the study/ side effect of sample collection [Q312A, 312B] | 52.19 | 37.65 | 14.55 (4.05, 25.04) | 0.007 |
Benefit of the study [Q206, 207,209, 309C] | 68.20 | 29.71 | 38.50 (29.38, 47.61) | <0.001 |
Confidentiality [Q205, 213] | 76.75 | 65.29 | 11.46 (2.21, 20.71) | 0.015 |
Participant right [Q202, 210, 212, 304, 305, 306] | 70.32 | 27.64 | 42.67 (36.35, 48.99) | <0.001 |
Summary comprehension score | ||||
aUnderstanding | 73.01 | 45.61 | 27.40 (22.60, 32.19) | <0.001 |
bRecall | 73.16 | 44.78 | 28.37 (23.34, 33.40) | <0.001 |
Over all C- score | 73.09 | 45.17 | 27.92 (23.97, 31.87) | <0.001 |