Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors

Paddock, Katie; Woolfall, Kerry; Frith, Lucy; Watkins, Megan; Gamble, Carrol; Welters, Ingeborg; Young, Bridget

doi:10.1136/bmjopen-2020-048193

Cited by 9 publications

(15 citation statements)

References 32 publications

(30 reference statements)

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“…This study also echoes the previous calls for more detailed guidance in relation to the emerging uncertainties around the operationalising of the MCA in research practice, and for researchers to share their experiences of working with the MCA [ 57 ]. It also supports the calls for RECs to have greater expertise in alternative consent processes, such as those required in emergency and critical care research, and to provide greater guidance on these to researchers [ 47 ]. However, this study extends this lacuna in knowledge to identify which groups would most benefit from more guidance and training and explore what content and format these might take.…”

Section: Discussionmentioning

confidence: 80%

“…The context-specific challenges identified in this study reflect those encountered in numerous previous studies exploring research in settings such as critical care [ 47 , 48 ] and care homes [ 49 ], and the issues surrounding capacity and consent in populations such as those receiving palliative and end of life care [ 50 ], people with aphasia [ 51 ] and people with learning disabilities and/or autism [ 52 ]. Our findings that highlight a universal knowledge deficit are also supported by previous studies which have examined understanding of the legal frameworks governing research involving adults who lack capacity by health and social care professionals [ 26 ], RECs [ 53 ] and researchers [ 54 , 55 ].…”

Section: Discussionmentioning

confidence: 90%

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Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

Shepherd

Hood

Wood

2022

Trials

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Background Trials involving adults who lack capacity to consent encounter a range of ethical and methodological challenges, resulting in these populations frequently being excluded from research. Currently, there is little evidence regarding the nature and extent of these challenges, nor strategies to improve the design and conduct of such trials. This qualitative study explored researchers’ and healthcare professionals’ experiences of the barriers and facilitators to conducting trials involving adults lacking capacity to consent. Methods Semi-structured interviews were conducted remotely with 26 researchers and healthcare professionals with experience in a range of roles, trial populations and settings across the UK. Data were analysed using thematic analysis. Results A number of inter-related barriers and facilitators were identified and mapped against key trial processes including during trial design decisions, navigating ethical approval, assessing capacity, identifying and involving alternative decision-makers and when revisiting consent. Three themes were identified: (1) the perceived and actual complexity of trials involving adults lacking capacity, (2) importance of having access to appropriate support and resources and (3) need for building greater knowledge and expertise to support future trials. Barriers to trials included the complexity of the legal frameworks, the role of gatekeepers, a lack of access to expertise and training, and the resource-intensive nature of these trials. The ability to conduct trials was facilitated by having prior experience with these populations, effective communication between research teams, public involvement contributions, and the availability of additional data to inform the trial. Participants also identified a range of context-specific recruitment issues and highlighted the importance of ‘designing in’ flexibility and the use of adaptive strategies which were especially important for trials during the COVID-19 pandemic. Participants identified a need for better training and support. Conclusions Researchers encountered a number of barriers, including both generic and context or population-specific challenges, which may be reinforced by wider factors such as resource limitations and knowledge deficits. Greater access to expertise and training, and the development of supportive interventions and tailored guidance, is urgently needed in order to build research capacity in this area and facilitate the successful delivery of trials involving this under-served population.

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Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 90%

Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

Shepherd

Hood

Wood

2022

Trials

View full text Add to dashboard Cite

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“…Details of workstream 1 are presented elsewhere. 36 Mixed methods provide more comprehensive knowledge than only using one approach 37 to data-gathering and we anticipated that this would help to increase the study’s impact and utility.…”

Section: Methodsmentioning

confidence: 99%

“…38 Sampling continued until the point of information power was reached. Survey items were informed by findings from a linked qualitative interview study of ICU researchers and patient and public involvement contributors, 36 relevant literature [39][40][41][42] and discussion with our advisory group. The surveys were piloted with patients, relatives, and HCPs across three participating hospitals, and refined in consultation with the wider study team.…”

Section: Open Accessmentioning

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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“…Consenting for 'ongoing' patient participation [4], rather than incurring the delays associated with obtaining informed consent prior to participation, would enable testing of early dosing interventions on clinical outcomes. This is especially relevant given that antimicrobial courses can often be of short duration, as evidenced by the DOLPHIN trial (median duration of therapy: 4 days in MIPD group vs 3.5 in standard dosing group) [1].…”

Section: Early Application Of Dosing Interventionsmentioning

confidence: 99%

Advancing precision-based antimicrobial dosing in critically ill patients

2023

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Treatment of infections among critically ill patients remains problematic, with ongoing challenges in antimicrobial dosing optimisation. Strategies, such as modelinformed precision dosing (MIPD), may be effective solutions but as yet without documented clinical benefit.In a paper published in the December issue of Intensive Care Medicine, Ewoldt and colleagues conducted the DOLPHIN trial to evaluate whether a MIPD intervention (therapeutic drug monitoring [TDM] and use of dosing software) in critically ill patients prescribed beta-lactam antimicrobials and ciprofloxacin decreased length of stay (LOS) in the intensive care unit (ICU) when compared to standard dosing alone [1]. The investigators should be commended for the first ever multicentre trial evaluating the potential benefits of MIPD in critically ill patients. The organisational aspects of conducting a multicentre study with essentially two interventions (TDM and dosing software) are challenging.Included in the primary analysis of the trial were 388 patients (MIPD group; n = 189, standard dosing group; n = 199). Contrary to their hypothesis, the investigators found a similar median LOS among both groups, with the MIPD group having a non-significant increase of 2 days on average compared to the standard dosing group (10 days vs 8 days, respectively). In addition, pharmacodynamic (PD) target attainment in the MIPD group remained low, ranging from 55.6 to 71.4%. Do these recent findings mark the beginning of the end to evaluating MIPD as a clinically relevant dose optimisation strategy in critically ill patients? In our opinion, no. We believe that there were some limitations with the study which should be addressed in future studies that test the benefits associated with precision-based antimicrobial dosing.

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Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors

Cited by 9 publications

References 32 publications

Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

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

Advancing precision-based antimicrobial dosing in critically ill patients

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