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Table 2 Table of Included studies

From: Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes

Study author and year

Country

Clinical context

Study design

Study aims

Scenario: real or hypothetical

Participant characteristics

Quality appraisal

Armstrong, S. et al. (2019) [24]

UK

Ambulance trials

Qualitative study

Understand the views of and experiences of expert informants

Real experiences and views of researchers regarding pre-hospital ambulance research

Academic researchers: n = 11

Clinical researchers: n = 3

High

Beshansky, J. R. et al. (2014) [25]

USA

Acute myocardial infarction

Quantitative descriptive study

Evaluate the utility of telephone survey data done as part of the EFIC process

As part of the IMMEDIATE trial investigating pharmacological myocardial metabolic support for acute myocardial infarction

Community members surveyed: n = 2079

Patients eligible for the study: n = 828

High

Booth, M. G. et al. (2005) [26]

UK

Cardiac arrest and severe trauma

Quantitative descriptive study

Assess public perception and attitudes

Two hypothetical scenarios of ICU research

Patients: n = 361

Low

Brown, P. et al. (2020) [27]

UK

Emergency department research

Qualitative descriptive study

Explore the experience of research nurses

Real experiences of healthcare professionals in ICU and emergency unit research

Research nurses: n = 10

High

Buckley, J. M. et al. (2016) [28]

UK

Emergency department research

Qualitative study

Investigate patients’ feelings

Hypothetical scenario of emergency research

Inpatients: n = 17

High

Burns, K. E. A. et al. (2011) [29]

Canada

Emergency department research

Quantitative descriptive study

Assess the general public’s attitudes

Three hypothetical scenarios of emergency research

Members of the public: n = 221

Low

Campwala, I. et al. (2020) [30]

USA

Haemorrhagic shock

Quantitative descriptive study

Learn about the experience of patients and surrogates and their general opinions

As part of the PAMPer study investigating pre-hospital plasma for haemorrhagic shock

Respondents in total: n = 93

Moderate

Cook, D. J. et al. (2008) [31]

Canada

Australia

NZ

Emergency department research

Quantitative descriptive study

Understand the experiences, beliefs, and practices of professionals involved in critical care research

Experiences of healthcare professionals and researchers in ICU and emergency unit research

Respondents (physicians, research coordinators, or others): n = 284

High

de Tonnerre, E. J. et al. (2020) [32]

Australia

Emergency department research

Quantitative descriptive study

Determine patients' perceptions

Real experiences and views of patients in emergency research

Suitable patients participated: n = 315/360

Moderate

Dickert, N. W. et al. (2017) [33]

USA

Acute myocardial infarction

Quantitative descriptive study

Explore views of patients

Hypothetical acute myocardial infarction study types

Patients with AMI: n = 30

Moderate

Dickert, N. W. et al. (2019) [34]

USA

Acute myocardial infarction and stroke

Quantitative descriptive study

Study experiences of patients

Real experiences of ICU patients in previous acute myocardial infarction/stroke research

Respondents by referred patients: n = 176/540

Patients: n = 107

Patient surrogates: n = 69

Moderate

Do Amaral Pfeilsticker, F. J. et al. (2020) [35]

Brazil

ICU research

Quantitative descriptive study

Address the willingness of patients to be enrolled in a scientific study as volunteers

Hypothetical ICU study

Pairs of ICU patients and their respective legal representatives: n = 208

Low

Furyk, J. et al. (2018) [21]

Australia

Emergency department research

Quantitative descriptive study

Give voice to the general public’s views of prospective and retrospective (deferred) consent

Hypothetical emergency research

Public responses: n = 1217

Moderate

Gigon, F. et al. (2013) [36]

Switzerland

ICU research

Quantitative descriptive study

Investigate the preferences of both patients and relatives

Two hypothetical ICU studies

Eligible patient responses: n = 185/472

Patient accompanied with relative: n = 125

Patient unaccompanied: n = 60

Moderate

Gobat, N. et al. (2019) [37]

Belgium, Spain, Poland, Ireland, the UK, Canada, Australia, New Zealand

Emergency department research

Quantitative descriptive study

Understand public views

Hypothetical scenarios of emergency research during an influenza pandemic

Members of the public: n = 6804

Moderate

Honarmand et al. (2018) [38]

Canada

ICU research

Prospective observational study

Describe the feasibility of the deferred consent model in a low-risk study

As part of the PRO-TROPICS trials

Critically ill patients in the ICU: n = 266/280

High

Houghton, G. et al. (2018) [39]

UK

Post-partum haemorrhage

Qualitative study

Investigate participants’ views

Clinical trial investigating the effect of tranexamic acid versus placebo for post-partum haemorrhage

Participants: n = 15

Consented while PPH was ongoing: n = 8

Consent was waived: n = 7

High

Kamarainen, A. et al. (2012) [40]

Finland

Cardiac arrest

Quantitative descriptive study

Survey the attitudes and experiences of surviving cardiac arrest victims, legal representatives, consent providers, and emergency physicians

As part of the pre-hospital index study investigating therapeutic hypothermia after cardiac arrest

Patients: n = 11/12

Consent providers: n = 17/25

Physicians: n = 13/13

High

Kleindorfer, D. et al. (2011) [41]

USA

Stroke

Quantitative descriptive study

Explore stroke survivors’ opinions

Hypothetical scenarios of stroke research

Ischaemic stroke patients (or proxies): n = 194/329

Moderate

Manda-Taylor, L. et al. (2019) [42]

Malawi

Emergency department research

Qualitative study

Examine the acceptability of deferred consent for research studies

Real experiences and views towards emergency department research

REC (research ethics committee) members: n = 5

Health care providers: n = 6

Local community members (one focus group): n = 12

High

Perner, A. et al. (2010) [43]

Denmark

ICU

Quantitative descriptive study

Survey attitudes amongst relatives of unconscious adult patients

Hypothetical ICU drug trial

Relatives of unconscious ICU patients: n = 42

High

Potter, J. E. et al. (2013) [44]

Australia

ICU

Quantitative descriptive study

Determine the opinion of participants

As part of the NICE-SUGAR study comparing blood glucose targets in ICU patients

Participants of the NICE-SUGAR study: n = 210

High

Scales, D. C. et al. (2009) [45]

Canada

ICU

Quantitative descriptive study

Determine patients’ preferences for different consent frameworks

Hypothetical study—randomised placebo-controlled trial of low-risk

Capable and consenting survivors of critical illness: n = 240

Moderate

Scicluna, V. M. et al. (2019) [46]

USA

AMI and stroke

Qualitative study

Explore the experiences of participants

Real experiences and attitudes of ICU patients towards their involvement in trials

Interviews: n = 27

Acute MI patients: n = 12

Stroke patients: n = 2

Surrogates for stroke patients: n = 13

High

Scicluna, V. M. et al. (2020) [47]

USA

Emergency department research

Quantitative descriptive study

Explore attitudes in patients

As part of the ESETT trial—comparing anticonvulsant therapies in status epilepticus

Participants: n = 317

Adult patients: n = 48

Surrogates for paediatric patients: n = 151

Surrogates for adult patients: n = 118

Moderate

Shamy, M. C. F. et al. (2019) [48]

Canada and Europe

ICU

Quantitative descriptive study

Investigate the knowledge and opinions of patients

As part of the ESCAPE trial—evaluating standard care plus thrombectomy in acute ischaemic stroke

Patients/authorised third parties who completed baseline survey: n = 33/56

Patients/authorised third parties who completed the 90-day follow-up survey: n = 27/56

Moderate

Terry, M. A. et al. (2017) [49]

USA

ICU

Prospective cohort study

Determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal-risk study

As part of the microbiome study with added hypothetical scenarios

ICU patients: n = 135/157

Moderate