Skip to main content

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