Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Shepherd, Victoria; Wood, Fiona; Griffith, Richard; Sheehan, Mark; Hood, Kerenza

doi:10.21203/rs.2.16645/v1

Cited by 3 publications

(4 citation statements)

References 43 publications

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“…30,44 In critical care populations where there are complex barriers to informed consent, patient decision aids may be appropriate to enhance understanding, 45 and support surrogate decision-makers. 46 Adopting strategies to build trust and develop rapport with gatekeepers, 43 and understanding clinician reluctance to enrol patients into trials, 24 may improve recruitment. Opposition to coenrolment requires further evaluation to determine impact on trial validity.…”

Section: Practical Implicationsmentioning

confidence: 99%

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

2021

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Background: Critical care trials are limited by problems with participant recruitment, and little is known about the most effective ways to enhance trial participation. Despite clinical research improving in the past decades within intensive care, participant recruitment remains a challenge. Not all eligible patients are identified, and opportunities for enrolment into clinical trials are often missed. Interventions to facilitate recruitment need to be identified to improve trial conduct in the critical care environment. Therefore, we aimed to establish the effectiveness of recruitment strategies in critical care trials in order to inform future research practice. Methods: Databases including MEDLINE, Embase, CINAHL and PsycINFO were searched for English language papers from inception to February 2020. The objectives were to: (1) establish the effectiveness of recruitment strategies and (2) recommend how effective recruitment strategies can inform research practice. Two reviewers independently assessed papers for inclusion and critically appraised the quality of the studies. Discrepancies were discussed within the research team. Relevant data were extracted and thematically coded into five overarching themes using a narrative synthesis approach. The review was prospectively registered on PROSPERO (CRD42019160519). Results: The search resulted in 2509 initially identified articles, with 15 that met the inclusion criteria. Articles reported a combination of quantitative, mixed methods and qualitative studies and a range of low-, moderate- and high-quality studies. Although, in-keeping with narrative synthesis approaches, none were excluded based on methodological quality. Five themes were identified relating to: patient eligibility identification, who provides information and seeks consent, resource limitations, research culture or environment and the consent model used. The relative success of recruitment strategies was dependent upon the experience and availability of the staff involved in the approach, trial design, the application of the strategy to the specific intensive care environment, the acceptability of the recruitment and consent models used, and the efficiency of the recruitment procedures. Opportunities for consent were missed in a proportion of eligible patients in most studies, suggesting that clinicians may avoid recruiting more complex patients or in more complex situations and that further development of strategies is needed. Conclusion: More effective recruitment strategies are required to enhance recruitment and the representativeness of the patient sample obtained in critical care trials, in order to expand the evidence base for treatments in this field. Greater focus is needed on assessing the performance of different recruitment strategies within different types of studies and critical care research environments. Future research should explore key stakeholders’ experiences of, and attitudes towards, recruitment and establish the most important and feasible modifiable barriers to recruitment.

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Section: Practical Implicationsmentioning

confidence: 99%

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

2021

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“…There is growing evidence of the effectiveness of DAs in improving both the quality of the decision-making process and decision quality for healthcare decisions [10] and more recently clinical trial participation decisions [8]. A novel decision support intervention has now been developed which aims to improve proxy decisions about research on behalf of adults who lack capacity to consent [11]. In order to establish the effectiveness of any such interventions, RCTs or other well-designed studies will be needed [5].…”

Section: Decision Aids For Trial Participation Decisionsmentioning

confidence: 99%

Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

Shepherd

Wood

Robling

et al. 2021

Preprint

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BackgroundTrials involving adults who lack capacity to provide consent for themselves rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Following decades of innovations to improve informed consent in trials, the first interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measurement in the evaluation of these novel interventions will impede comparisons between their effectiveness. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation on behalf of adults who lack capacity to consent.MethodsWe used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.ResultsA total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items. Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group. We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.ConclusionsThe study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. Further work is required to identify appropriate measures and timing of outcome measurement. Enhancing the quality of proxy decisions will help improve trial participation decisions for these vulnerable groups. Trial registration: The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

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“…Despite the additional complexity of proxy decisions about participation made on behalf of an adult who lacks capacity, and how the person's preferences and wishes can best be respected, there has been little research in this area. Our research has identified the emotional and decisional burdens experienced by proxies making decisions about research [31], and developed the first intervention to support family members acting as proxies [24]. However, more research is needed to explore the experiences and support needs of family members and others acting as proxies (e.g.…”

Section: Challenges Of Proxy Decision Makingmentioning

confidence: 99%

“…However, this issue is more complex than might be first thought. The recruitment of adults with impaired capacity is situated within a complex system of factors [24], and the differences between legal jurisdictions and how different types of research are governed within these jurisdictions adds further complexities [2]. Research governance and funder oversight that focuses on ensuring that appropriate eligibility criteria are used will not be effective in increasing inclusivity in trials for adults who lack capacity unless the wider barriers to inclusion are recognised and addressed.…”

Section: Introductionmentioning

confidence: 99%

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

Shepherd

2020

Trials

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Background: There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide informed consent are frequently excluded from trials. Addressing the under-representation of groups such as those with impaired capacity to consent is essential to develop effective interventions and provide these groups with the opportunity to benefit from evidence-based care. While the spotlight has been on ensuring only appropriate and justifiable exclusion criteria are used in trials, barriers to the inclusion of adults lacking capacity are multifactorial and complex, and addressing their under-representation will require more than merely widening eligibility criteria. This commentary draws on the literature exploring the inclusion of adults lacking the capacity to consent in research and a number of recent studies to describe the methodological, structural, and systemic factors that have been identified. Main text: A number of potentially modifiable factors contributing to the under-representation of adults lacking the capacity to consent in trials have been identified. In addition to restrictive eligibility criteria, methodological issues include developing appropriate interventions and outcome measures for populations with impaired capacity. Structurally determined factors include the resource-intensive nature of these trials, the requirement for more appropriate research infrastructure, and a lack of interventions to inform and support proxy decision-makers. Systemic factors include the complexities of the legal frameworks, the challenges of ethical review processes, and paternalistic attitudes towards protecting adults with incapacity from the perceived harms of research.

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Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Cited by 3 publications

References 43 publications

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

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