Informed consent process components | Quality of IC (Mean %) | Â | ||
---|---|---|---|---|
Intervention (n = 114) | Control (n = 85) | Mean difference (95 % CI) | P value | |
There was sufficient time for consent discussion. [Agree] | 93.9 | 82.4 | 11.5 (2.7, 20.3) | 0.010 |
Agreed to participate in this study voluntarily and with full understanding. [Agree] | 100 | 87.1 | 12.9 (6.7, 19.2) | <0.001 |
Enrolment decision made mainly by me the respondent. [Agree] | 99.1 | 92.9 | 6.2 (1.0, 11.3) | 0.019 |
Discussed about the research with other patients or participants. [Agree] | 91.2 | 17.6 | 8.9 (0.5, 18.2) | 0.062 |
Consent form read or explained carefully. [Agree] | 82.5 | 81.2 | 1.3 (-9.7 , 12.2) | 0.818 |
Consent form was important source of information. [Agree] | 92.1 | 88.2 | 3.9 (-4.5 , 12.2) | 0.361 |
Consent form was easy to understand. [Agree] | 97.4 | 90.6 | 6.8 (0.4, 13.2) | 0.039 |
Consent form was important to the decision. [Agree] | 95.6 | 95.3 | 0.3 (-5.6, 6.2) | 0.915 |
Pressure from provider to sign/agree consent form. [Disagree] | 95.6 | 76.5 | 19.1 (10.1, 28.2) | <0.001 |
Sufficient opportunity to ask questions. [Agree] | 95.6 | 67.1 | 28.6 (18.8, 38.3) | <0.001 |
Questions answered thoroughly by the consent provider. [Agree] | 99.1 | 74.1 | 25.0 (16.6, 33.4) | <0.001 |
Satisfied with informed consent process. [Agree] | 99.1 | 81.2 | 17.9 (10.4, 25.5) | <0.001 |
Decision to participate was easy or very easy. [Agree] | 99.1 | 87.1 | 12.1 (5.5, 18.6) | <0.001 |
Mean score of Quality of informed consent | 89.06 | 78.53 | 10.5 (6.8, 14.2) | <0.001 |