Synthesis of qualitative research studies regarding the factors surrounding UK critical care trial infrastructure

Pattison, Natalie; Arulkumaran, Nishkantha; O’Gara, Geraldine; Connolly, Bronwen; Humphreys, Sally; Walsh, Tim; Hopkins, Philip; Dark, Paul

doi:10.1136/bmjopen-2019-030815

Cited by 7 publications

(11 citation statements)

References 26 publications

(35 reference statements)

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“…Most studies on barriers to recruitment originate from the USA, and many are specific to cancer research [ 11 , 12 ]. Examples exist of research exploring barriers and solutions to participation in other areas, for instance older people, those from ethnic minorities and those in acute or critical care [ 13 – 17 ]. Different areas of research have different barriers in engagement to overcome; hence, a tailored approach is required.…”

Section: Discussion and Future Directionsmentioning

confidence: 99%

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

Witham

Anderson

Carroll

et al. 2020

Trials

141

132

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Background: Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of under-served groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of under-served groups in clinical trials. Methods: The project comprised three main strands: (1) a targeted scoping review of literature to identify previous work characterising under-served groups and barriers to inclusion, (2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice and (3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans and a strategic roadmap for future development work in this area. Results: 'Under-served groups' was identified and agreed by the stakeholder group as the preferred term. Threequarters of stakeholders felt that a clear definition of under-served groups did not currently exist; definition was challenging and context-specific, but exemplar groups (e.g. those with language barriers or mental illness) were identified as under-served. Barriers to successful inclusion of under-served groups could be clustered into communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with under-served groups, developing training resources to improve design and delivery of trials for under-served groups, developing infrastructure and systems to support this work and working with funders, regulators and other stakeholders to remove barriers to inclusion.

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Section: Discussion and Future Directionsmentioning

confidence: 99%

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

Witham

Anderson

Carroll

et al. 2020

Trials

141

132

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“…The importance of bedside nurses in facilitating recruitment has been documented elsewhere. 10 53 54 Other studies have emphasised the role clinical teamscan play in this. 10 Our findings demonstrate how different team members can inform and facilitate consent and recruitment, and help patients/relatives to feel supported.…”

Section: Discussionmentioning

confidence: 99%

Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study

et al. 2022

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ObjectivesObtaining informed consent from patients in intensive care units (ICUs) prior to enrolment in a study is practically and ethically complex. Decisions about the participation of critically ill patients in research often involve substitute decision makers (SDMs), such as a patient’s relatives or doctors. We explored the perspectives of different stakeholder groups towards these consent procedures.Design and methodsMixed-methods study comprising surveys completed by ICU patients, their relatives and healthcare practitioners in 14 English ICUs, followed by qualitative interviews with a subset of survey participants. Empirical bioethics informed the analysis and synthesis of the data. Survey data were analysed using descriptive statistics of Likert responses, and analysis of interview data was informed by thematic reflective approaches.ResultsAnalysis included 1409 survey responses (ICU patients n=333, relatives n=488, healthcare practitioners n=588) and 60 interviews (ICU patients n=13, relatives n=30, healthcare practitioners n=17). Most agreed with relatives acting as SDMs based on the perception that relatives often know the patient well enough to reflect their views. While the practice of doctors serving as SDMs was supported by most survey respondents, a quarter (25%) disagreed. Views were more positive at interview and shifted markedly depending on particularities of the study. Participants also wanted reassurance that patient care was prioritised over research recruitment. Findings lend support for adaptations to consent procedures, including collaborative decision-making to correct misunderstandings of the implications of research for that patient. This empirical evidence is used to develop good practice guidance that is to be published separately.ConclusionsParticipants largely supported existing consent procedures, but their perspectives on these consent procedures depended on their perceptions of what the research involved and the safeguards in place. Findings point to the importance of explaining clearly what safeguards are in place to protect the patient.

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“…Most studies on barriers to recruitment originate from the USA, and many are speci c to cancer research [11,12]. Examples exist of research exploring barriers and solutions to participation in other areas, for instance older people, those from ethnic minorities, and those in acute or critical care [13][14][15][16][17]. Different areas of research have different barriers in engagement to overcome, hence a tailored approach is required.…”

Section: Discussion and Future Directionsmentioning

confidence: 99%

Developing a roadmap to improve trial delivery for underserved groups: results from a UK multi-stakeholder process

Witham

Anderson

Carroll

et al. 2020

Preprint

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Background Participants in clinical research studies often do not reflect the populations for which healthcare interventions are needed or will be used. Enhancing representation of underserved groups in clinical research is important to ensure that research findings are widely applicable. We describe a multicomponent workstream project to improve representation of underserved groups in clinical trials. Methods The project comprised three main strands: 1) a targeted scoping review of literature to identify previous work characterising underserved groups and barriers to inclusion; 2) surveys of professional stakeholders and participant representative groups involved in research delivery to refine these initial findings and identify examples of innovation and good practice; 3) a series of workshops bringing together key stakeholders from funding, design, delivery and participant groups to reach consensus on definitions, barriers and a strategic roadmap for future work. The work was commissioned by the UK National Institute for Health Research Clinical Research Network. Output from these strands was integrated by a steering committee to generate a series of goals, workstream plans, and a strategic roadmap for future development work in this area. Results ‘Underserved groups’ was identified and agreed by the stakeholder group as the preferred term. Three-quarters of stakeholders felt that a clear definition of underserved groups did not currently exist; definition was challenging and context-specific but exemplar groups (e.g. those with language barriers or mental illness) were identified as underserved. Barriers to successful inclusion of underserved groups could be clustered into: communication between research teams and participant groups; how trials are designed and delivered, differing agendas of research teams and participant groups; and lack of trust in the research process. Four key goals for future work were identified: building long-term relationships with underserved groups; developing training resources to improve design and delivery of trials for underserved groups; developing infrastructure and systems to support this work, and working with funders, regulators and other stakeholders to remove barriers to inclusion. Conclusions The work of the INCLUDE group over the next 12 months will build on these findings by generating resources customised for different underserved groups to improve the representativeness of trial populations.

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Synthesis of qualitative research studies regarding the factors surrounding UK critical care trial infrastructure

Cited by 7 publications

References 26 publications

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process

Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study

Developing a roadmap to improve trial delivery for underserved groups: results from a UK multi-stakeholder process

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