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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

From: Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting

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
  1. aUnderstanding -score of Q201, 202, 205, 209, 210, 211, 212, 213, 301, 304, 305, 306, 307
  2. bRecall- score of Q 203, 204, 206, 207, 208, 302, 303, 308A, 308B, 309C, 310A, 310C, 311A, 312A, 312B