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Table 2 Characteristics of the included study – prospective informed consent

From: Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Reference Country Clinical context Study design Study aim Scenario: real or hypothetical Study sample
Respondents Direct experience of clinical context or condition Direct experience of consent model
Potential research participants
Qualitative or mixed methods studies
1. Agard 2001 Sweden Acute myocardial infarction Mixed methods Investigate patient experience of consent process Studies of early phase of treatment for myocardial infarction 31 trial participants Yes Yes
2. Blixen 2005a USA Stroke Qualitative (interview) Evaluate preferences or values Hypothetical study – emergency stroke research 12 stroke patients Yes No
3. Gammelgaard 2004a Denmark Acute myocardial infarction Qualitative (interviews) Investigate patient experience of consent process Clinical trial comparing intervention (primary angioplasty) with medical strategy (fibrinolysis) 32 trial candidates (23 participants, 9 who did not consent) Yes Yes
4. Mangset 2008 Norway Stroke Qualitative (interviews) Investigate patient experience of consent process Clinical trial evaluating thrombolytic drug treatment for stroke 11 trial participants Yes Yes
Survey studies
5. Chenaud 2009a Switzerland ICU Survey (Self-administered) To evaluate preferences Hypothetical scenarios of ICU research 67 patients; 52 relatives from recent ICU admission Yes No
6. Gammelgaard 2014b Denmark Acute myocardial infarction Survey (Self-administered) Investigate experience of consent process Clinical trial comparing intervention (primary angioplasty) with medical strategy (fibrinolysis) 181 trial candidates (103 participants, 78 who did not consent) Yes Yes
7. Gigon 2013 Switzerland ICU Survey (self-administered) Evaluate choice Hypothetical scenarios of ICU research 185 patients, 125 relatives following ICU discharge Yes No
8. Paradis 2010 USA ED research Survey (interview) Investigate perspectives on consent process 10 studies involving cardiac conditions 150 study participants Yes Yes
9. Schats 2003a Netherlands Stroke Survey (interview) Post-trial evaluation. Two clinical trials that evaluated interventions for subarachnoid haemorrhage 49 patients; 47 relatives (trial participants) Yes Yes
10. Williams 2003 Australia, New Zealand Acute myocardial infarction Survey (interview) Evaluation of consent for trial Clinical trial of two antithrombin therapies for acute myocardial infarction 399 trial candidates Yes No
11. Yuval 2000 Israel Acute myocardial infarction Survey (Self-administered) Post-trial evaluation Large trial evaluating therapies for acute myocardial infarction 129 trial participants Yes Yes
Clinical, research staff and regulators
Qualitative or mixed methods studies
12. Chamberlain 2009b USA Paediatrics –status epilepticus Qualitative (focus groups) Evaluation during trial Pharmacokinetic study evaluating lorazapam for status epilepticus 18 research staff Yes Yes
  1. acompares different consent models
  2. bpaediatrics