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Table 1 Questionnaire items (in order of appearance) and respective percentage of answers obtained

From: Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

 

Total (N = 214)

Acute coronary syndrome subgroup (n = 158)*

Acute stroke subgroup (n = 54)*

What was the scope of the trial information and how was it delivered to trial participants?**

   

   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%

Did you additionally seek consent of participants' relative(s), if available?

   

   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%

Following enrolment, did you inform participants' relative(s), if available, about their trial participation?

   

   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%

Did the involvement of a participant's relative(s) influence the time necessary to obtain informed consent?

   

   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%

How do patients react to a trial proposal in an emergency condition?

   

   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%

Is an emergency (conscious) patient able to understand the nature of the trial and consciously decide whether or not to participate?

   

   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%

How much of the verbal information received by the patient is really understood?

   

   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%

How much of the written trial information does an emergency patient actually read?

   

   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%

The amount of information supposed to be given to patient was, in general:

   

   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%

How does a trial proposal to an emergency patient affect their trust in the physician?

   

   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%

Does informing a participant's relative(s) about their trial participation make sense at all?

   

   yes

68.1%

63.3%

83.0%

   no

12.7%

14.6%

5.7%

   uncertain

19.2%

22.1%

11.3%

Which of the following models of informed consent in emergency settings would be the best?

   

   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%

  1. * two respondents declaring experience with both acute coronary syndrome and stroke trials were not taken into account for subgroup analysis
  2. ** multiple choice possible; all other items were single choice
  3. *** embracing all aspects required by Good Clinical Practice (GCP) and law for a regular trial