How to deal with the consent of adults with cognitive impairment involved in European geriatric living labs?

Background Living labs are realistic environments designed to create links between technology developers and end-users (i.e. mostly older adults). Research in LLH (Living labs in health) covers a wide range of studies from non-interventional studies to CT (clinical trials) and should involve patients with neurocognitive disorders. However, the ethical issues raised by the design, development, and implementation of research and development projects in LLH have been the subject of only little interest thus far. Objective Our aim was to determine a pragmatic, ethical and regulatory correct approach to seek the informed consent of patients with neurocognitive disorders according to the different types of studies carried out in European LLH, with a focus on the French context. Methods A narrative review of regulatory texts and clinical articles was conducted, and a pragmatic procedure to determine the decision-making capacity of older adults in LLH was proposed. Results Individuals must be adequately informed and freely agree to participate in CT. The capacity to consent should be assessed in CT including cognitively impaired older adults. We propose the following steps: first to assess for delirium using the 4 ‘A’s Test (4AT) or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM), second to search for medical history of major neurocognitive disorder, and third to assess the decision capacity using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). Conclusions Including individuals with neurocognitive disorders in research implies using an efficient and pragmatic strategy to inform participants and obtain their consent. The tool we offer here may be useful in the routine operation of LLH but can also be extended to all CT with this population.

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)

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)

Capacity to consent to admission of patients detained under Section 5(2) of the Mental Health Act

Background: Little is known regarding capacity to agree to admission of informal patients later detained under Section 5(2) of the UK Mental Health Act.<br/> Aim: To evaluate how frequently such capacity is assessed and to discover associations related to length of time from admission until imposition of Section 5(2).<br/> Method: Patients detained under Section 5(2) on acute inpatient general adult and old age psychiatric wards in one UK location between June 2016 and March 2018 were identified. Their admission records were scrutinized.<br/> Results: Capacity was assessed in 97 of 124 patients. Fewer assessments were performed immediately prior to admission, especially upon patients admitted from residential settings. On admission, medical staff assessed for capacity less than non-medics, but found an individual lacked capacity more frequently. Time until detention was less upon a first admission, in absence of pre-admission capacity assessment, when medical staff assessed, or when any inpatient clinician detected incapacity.<br/> Conclusion: Routine capacity assessment immediately prior to and at psychiatric admission should be formalized and offers potential to reduce use of Section 5(2), unlawful detention and negative sequalae.

A Local Authority v JB [2020] EWCA Civ 735; [2019] EWCOP 39

In Re JB, a local authority, concerned with the risk the respondent posed to vulnerable women, successfully appealed against an order made in the Court of Protection that declared JB, an autistic man with impaired cognition, possessed capacity to consent to sexual relations. In this recent decision, the Court of Appeal has arguably reset the last 15 years of jurisprudence concerning P’s capacity to make decisions in regard to sexual relations. Previous case law focused on P’s ability to consent to such relations, and whether P understood the information relevant to that decision. Notwithstanding the abundance of legal authority, including the recent appellate judgments of Hayden J in London Borough of Tower Hamlets v NB and AU (consent to sex) [2019] EWCOP 27. and B v A Local Authority [2019] EWCA Civ 913. there was a lacuna in the existing law in relation to what information was relevant for the purposes of assessing the issue of capacity to consent to sexual relations. Judges have traditionally adopted a protectionist stance in understanding “the information relevant to the decision” under s3(1) of the Mental Capacity Act 2005 (MCA), with an emphasis on whether P understood the risks of pregnancy and sexually transmitted diseases. However, the Court of Appeal in Re JB has broadened its interpretation of ‘relevant’ information to also include the ability to understand the importance of a partner’s consent to such relations. This is a welcome change to previous courts’ interpretations of the ‘nature’ of the sexual act, moving from an approach focused on the physical sexual mechanics to one which views the nature of sex as a mutually consensual engagement. However, a fundamental shift in how we view such cases is likely to have far-reaching consequences, particularly for local authorities and professionals seeking guidance in relation to their care planning.

Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis

ABSTRACT Objectives: To perform a meta-analysis of clinical studies on the differences in treatment or research decision-making capacity among patients with Mild Cognitive Impairment (MCI), Alzheimer’s disease (AD), and healthy comparisons (HCs). Design: A systematic search was conducted on Medline/Pubmed, CINAHL, PsycINFO, Web of Science, and Scopus. Standardized mean differences and random-effects model were used in all cases. Setting: The United States, France, Japan, and China. Participants: Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included. Measurements: The studies we included in the analysis assessed decisional capacity to consent by the MacArthur Competence Assessment Tool for Treatment (MAcCAT-T), MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), Capacity to Consent to Treatment Instrument (CCTI), and University of California Brief Assessment of Capacity to Consent (UBACC). Results: We identified 109 potentially eligible studies from 1672 records, and 7 papers were included in the meta-analysis. The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the HCs group in terms of Understanding (SMD = −1.04, 95% CI: −1.31 to −0.77, P < 0.001; I2 = 52%, P = 0.07), Appreciation (SMD = −0.51, 95% CI: −0.66 to −0.36, P < 0.001; I2 = 0%, P = 0.97), and Reasoning (SMD = −0.62, 95% CI: −0.77, −0.47, P < 0.001; I2=0%, P =0.46). MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P = 0.01, I2 = 78%, P = 0.00001) compared to patients affected by AD. Conclusions: Patients affected by MCI are at higher risk of impaired capacity to consent to treatment and research compared to HCs, despite being at lower risk compared to patients affected by AD. Clinicians and researchers need to carefully evaluate decisional capacity in MCI patients providing informed consent.

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

Background Informed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of lay advisors and relevant stakeholders. Results Previous research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and utilises a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid to ensure that it would be acceptable for use. Conclusions Frameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.