Table 2 Characteristics of the included study – prospective informed consent
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 |