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Table 5 Mean informed consent comprehension score (CS) of participants, 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) Control (N = 85) Mean difference (95 % CI) P value
201 This health related study is a form of a researcha. [True] 44.7 30.6 14.1 (0.5 , 27.8 ) 0.043
202 Obligation to participate in this medical researcha. [False] 19.3 8.2 11.1 (1.2 , 21.0) 0.029
203 Told who is funding this researcha. [True] 46.5 34.1 12.4 (1.5 , 26.2 ) 0.080
204 Told the total number of people that participate in this researcha. [False] 57.9 44.7 13.2 (0.9, 27.3) 0.066
205 Except study team no one will be allowed to see my health informationa. [True] 65.8 81.2 15.4 (27.9, 2.9) 0.016
206 I will be told test results from this researchb. [False] 76.3 15.3 61.0 (49.7, 72.3) <0.0001
207 Treated for the infection tested by this researchb. [False] 63.2 11.8 51.4 (39.4, 63.4) <0.0001
208 I have been told contact person addressa. [True] 71.9 41.2 30.8 (17.5, 44.0) <0.0001
209 I will get a special care in my regular ANC follow upb. [False] 64.0 55.3 8.7 (5.1, 22.6) 0.215
210 My participation in the study can be stopped at any timea. [True] 81.6 20.0 61.6 (5.0, 72.8) <0.0001
211 I will be asked for costs related to my participation in this studya. [False] 80.7 50.6 30.1 (17.5, 42.7) <0.0001
212 I will be paid or got any incentive for participating in this studya. [False] 95.6 42.4 53.3 (43.1, 63.4) <0.0001
213 The sample taken in this study can be used for other purposea. [False] 87.7 49.4 38.3 (26.6, 50.0) <0.0001
301 Selection to participate in this studya. [A] 99.1 78.8 20.3 (12.5, 28.1) <0.0001
302 When to visit a doctor to avoid cervical cancerb. [B] 67.5 51.8 15.8 (2.1, 29.5) 0.024
303 Who analyze and discuss test resultsb. [A] 95.6 51.8 43.3 (33.6, 54.1) <0.0001
304 At what time can leave the study?a [A] 64.0 12.9 51.1 (39.0, 63.1) <0.0001
305 Agreed or signed to participate in this research meana. [C] 87.7 61.2 26.5 (15.1, 38.0) <0.0001
306 Can stop participation after you signed to participate?a [A] 73.3 21.2 52.5 (40.4, 64.6) <0.0001
307 Any difference made to regular ante natal care if not participate?a [B] 85.1 81.2 3.9 (6.6 , 14.5) 0.466
308 The main purpose(s) of the study?c
To know more about cancer disease in Ethiopia [A]
67.5 56.5 11.1 (2.6 , 24.7) 0.111
To introduce vaccine to benefit future generation of girls [B] 91.2 47.1 44.2 (33.1, 55.3) <0.0001
309 The main benefit(s) taking part in this research?c
Future generation of girls but not me will benefit. [C]
69.3 36.5 32.8 (19.5, 46.2) <0.0001
310 Procedure(s) asked to take part in?c
Giving a small amount blood for test [A]
96.5 65.9 30.6 (21.0, 40.3) <0.0001
Giving vaginal secretion for test [C] 91.2 56.5 34.8 (23.7, 45.8) <0.0001
311 Task(s) asked to complete?c
Attend appointment [A]
98.2 83.5 14.7 (7.3, 22.2) <0.0001
312 Side effect(s) that might occur during blood drawing for test?c
Pain or bruising on the vein [A]
57.0 41.2 15.8 (1.8, 29.9) 0.027
Bleeding at the site of the needle [B] 47.4 34.1 13.3 (0.6 , 27.1 ) 0.061
Over all C-Score 73.1 45.2 27.9 (23.96, 31.87) <0.0001
  1. a Generic test item- These test items appear on each version of MICCA
  2. b Trial specific test item- These test items do not appear on every version of the MICCA. They are generated based on responses to BIQ
  3. c Trial specific test items appear on each version of the MICCA. The response option for each of these test items are generated based on response to BIQ