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 | ||||||||
13. Ali 2006 | UK | Stroke | Mixed methods | Inform clinical trial design. | Proposed trial evaluates the effect of routine oxygen supplementation after acute stroke | 49 stroke patients, 24 carers | Yes | No |
14. Blixen 2005a | USA | Stroke | Qualitative (interview) | Evaluate preferences or values | Hypothetical study – emergency stroke research | 12 stroke patients | Yes | No |
15. Koops 2002 | UK | Stroke | Mixed methods | Inform study design. | Proposed study evaluates thrombolysis for acute ischaemic stroke | 54 stroke patients and carers | Yes | No |
Survey studies | ||||||||
16. Barrett 2012 | Canada | ICU | Survey (interview) | Evaluate attitude or opinion | Hypothetical scenarios of ICU research | 136 surrogate decision makers of critically ill patients (adults and children) | Yes | No |
17. Biros 2009a | USA | Status seizure – | Survey (self-administered) | Part of a public consultation prior to trial initiation. | Proposed trial evaluates pre-hospital intervention for status seizures | 1901 community members | No | Some |
18. Chenaud 2009a | Switzerland | ICU | Survey (Self-administered) | Evaluate preferences | Hypothetical scenarios of ICU research | 67 patients; 52 relatives from recent ICU admission | Yes | No |
19. Clark 2013 | UK | Neurosurgery | Survey (Self-administered) | Part of a public consultation prior to trial initiation. | Proposed study evaluates surgical techniques | 171 patients and carers in neuro-surgical clinic | No | No |
20. Gigon 2013 | Switzerland | ICU | Survey (self-administered) | Evaluate choice | Hypothetical scenarios of ICU research | 185 patients, 125 relatives following ICU discharge | Yes | No |
21. Kamarainen 2012c | Finland | Cardiac arrest | Survey (Self-administered) | Post-trial evaluation. | Trial evaluated pre-hospital intervention for cardiac arrest | 11 patient; 17 consent providers; 13 physicians (trial participants) | Yes | Yes |
22. Perner 2010 | Denmark | ICU | Survey (self-administered) | Assess attitudes | Hypothetical trials and new medications | 42 next-of-kin of unconscious ICU patients | Yes | No |
23. Scales 2009a | Canada | Critical illness | Survey (interview) | Survey preferences | Hypothetical study scenarios of research during critical illness | 240 survivors of critical illness | Yes | No |
24. Schats 2003a | Netherlands | Stroke | Survey (interview) | Post-trial evaluation. | Two trials that evaluated interventions for subarachnoid haemorrhage | 49 patients; 47 relatives (trial participants) | Yes | Yes |
25. Stephenson 2007 | Australia | Emergency care | Survey (self-administered) | Attitudes survey | Hypothetical scenarios of critical care research | 185 patients | Possible | No |
Clinical, research staff or regulators | ||||||||
Survey studies | ||||||||
26. Burns 2013 | Canada | Pandemic research | Survey (self-administered) | Evaluate experiences, beliefs and practices | Hypothetical -pandemic research | 168 administrative and clinical staff involved in H1N1 pandemic research | Yes | Yes |
27. Cook 2008c | Canada, Australia, New Zealand | Critical illness | Survey (self-administered) | Evaluate experience, beliefs, and practices | Hypothetical – enrolment of critically ill children and adults | 284 clinicians caring for critically ill patients | Yes | Yes |
28. Duffett 2011a | Canada | Critical care research | Survey (self-administered) | Evaluate attitudes and beliefs | Hypothetical scenario of double-blind, placebo-controlled, RCT evaluating single dose of medication perceived by REB as minimal risk | 98 ICU researchers; 52 members of hospital research ethics boards. | Yes | Possible |
29. Kompanje 2005a | Netherlands | Traumatic brain injury | Survey (self-administered) | Evaluate opinions | Hypothetical -clinical emergency care | 79 neuro-trauma clinical staff across 19 European countries | Yes | Possible |