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Questionnaire items (in order of appearance) and respective percentage of answers obtained |
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| Total (N = 214) |
Acute coronary syndrome subgroup (n = 158)* |
Acute stroke subgroup (n = 54)* |
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|
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| What was the scope of the trial information and how was it delivered to trial participants?** |
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| all-embracing information, verbal + written*** |
53.3% |
47.5% |
70.4% |
| abbreviated information, verbal and written |
38.8% |
41.8% |
29.6% |
| all-embracing verbal + abbreviated written information*** |
15.0% |
14.6% |
13.0% |
| abbreviated verbal + all-embracing written information*** |
10.7% |
12.0% |
7.4% |
| abbreviated verbal information only |
4.2% |
4.4% |
3.7% |
| proxy consent (by guardianship court) only |
0.0% |
0.0% |
0.0% |
|
|
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| Did you additionally seek consent of participants' relative(s), if available? |
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| yes, always |
18.3% |
9.5% |
44.4% |
| yes, sometimes |
43.7% |
41.4% |
48.1% |
| rarely or exceptionally |
25.3% |
32.5% |
5.6% |
| never |
12.7% |
16.6% |
1.9% |
|
|
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| Following enrolment, did you inform participants' relative(s), if available, about their trial participation? |
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| yes, always |
54.2% |
43.0% |
87.0% |
| yes, sometimes |
33.7% |
41.8% |
11.1% |
| rarely or exceptionally |
9.8% |
12.7% |
1.9% |
| never |
2.3% |
2.5% |
0.0% |
|
|
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| Did the involvement of a participant's relative(s) influence the time necessary to obtain informed consent? |
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| yes, delayed |
55.6% |
55.1% |
57.4% |
| yes, shortened |
6.6% |
6.3% |
7.4% |
| no influence |
29.4% |
27.8% |
35.2% |
| not applicable (no involvement) |
8.4% |
10.8% |
0.0% |
|
|
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| How do patients react to a trial proposal in an emergency condition? |
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| positively/somewhat positively |
65.7% |
61.1% |
77.8% |
| equal proportions for positive and negative responses |
29.1% |
33.8% |
16.7% |
| negatively/somewhat negatively |
1.0% |
1.3% |
0.0% |
| uncertain |
4.2% |
3.8% |
5.5% |
|
|
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| Is an emergency (conscious) patient able to understand the nature of the trial and consciously decide whether or not to participate? |
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| always/most often |
32.3% |
31.7% |
33.3% |
| some patients are able |
46.7% |
43.0% |
59.3% |
| no or few patients are able |
17.3% |
20.9% |
5.6% |
| uncertain |
3.7% |
4.4% |
1.8% |
|
|
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| How much of the verbal information received by the patient is really understood? |
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| all/almost all |
32.9% |
33.8% |
31.5% |
| some |
58.2% |
58.6% |
55.5% |
| almost none |
1.9% |
2.5% |
0.0% |
| uncertain |
7.0% |
5.1% |
13.0% |
|
|
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| How much of the written trial information does an emergency patient actually read? |
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| all/almost all |
14.5% |
13.3% |
18.5% |
| some |
62.1% |
62.0% |
61.1% |
| almost none |
19.2% |
21.5% |
13.0% |
| uncertain |
4.2% |
3.2% |
7.4% |
|
|
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| The amount of information supposed to be given to patient was, in general: |
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| too comprehensive |
80.4% |
85.4% |
64.8% |
| adequate in regard to the patient's condition |
17.7% |
13.3% |
31.5% |
| too brief |
0.0% |
0.0% |
0.0% |
| uncertain |
1.9% |
1.3% |
3.7% |
|
|
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| How does a trial proposal to an emergency patient affect their trust in the physician? |
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| increases trust |
26.3% |
27.4% |
24.1% |
| neither increases nor decreases trust |
48.3% |
49.0% |
46.3% |
| decreases trust |
9.9% |
10.2% |
9.2% |
| uncertain |
15.5% |
13.4% |
20.4% |
|
|
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| Does informing a participant's relative(s) about their trial participation make sense at all? |
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| yes |
68.1% |
63.3% |
83.0% |
| no |
12.7% |
14.6% |
5.7% |
| uncertain |
19.2% |
22.1% |
11.3% |
|
|
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| Which of the following models of informed consent in emergency settings would be the best? |
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| all-embracing information (like non-emergency trials), verbal and written*** |
14.0% |
11.4% |
22.2% |
| abbreviated information, verbal and written + abbreviated consent form, with obligatory all-embracing written consent to continue the trial once the participant's status has sufficiently improved (ICH GCP-based)*** |
78.0% |
81.7% |
66.7% |
| abbreviated oral information + only verbal consent, with obligatory all-embracing written consent to continue the trial once the participant's status has sufficiently improved (currently unrealistic under national regulations)*** |
7.5% |
6.3% |
11.1% |
| other model |
0.5% |
0.6% |
0.0% |
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* two respondents declaring experience with both acute coronary syndrome and stroke trials were not taken into account for subgroup analysis ** multiple choice possible; all other items were single choice *** embracing all aspects required by Good Clinical Practice (GCP) and law for a regular trial | |||
Iwanowski et al. Trials 2008 9:45 doi:10.1186/1745-6215-9-45 |
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