Ownership Beneath: Transparency of Land Ownership in Times of Economic Crime.

This article considers 'ownership beneath' in light of the Economic Crime (Transparency and Enforcement) Act 2022, which has introduced a new Schedule 4A into the Land Registration Act 2002. The legislation, with notable exceptions, requires overseas entities to publicly reveal their beneficial owners, with criminal and land law consequences if transparency requirements are not met. The article explores how ownership beneath operates and can be made more transparent, noting the three different forms of beneficial ownership employed: as control, behind a trust and as a consequence. Emphasising the distinctive nature of beneficial ownership of land, the analysis recommends amending ECTEA 2022 to focus on land ownership, not merely landowning overseas entities, facilitating greater transparency by expanding the definition of registrable beneficial owners, closing the loophole where information is not available and requiring public disclosure of most trust information.

Changes in daily mental health service use and mortality at the commencement and lifting of COVID-19 'lockdown' policy in 10 UK sites: a regression discontinuity in time design.

OBJECTIVES: To investigate changes in daily mental health (MH) service use and mortality in response to the introduction and the lifting of the COVID-19 'lockdown' policy in Spring 2020. DESIGN: A regression discontinuity in time (RDiT) analysis of daily service-level activity. SETTING AND PARTICIPANTS: Mental healthcare data were extracted from 10 UK providers. OUTCOME MEASURES: Daily (weekly for one site) deaths from all causes, referrals and discharges, inpatient care (admissions, discharges, caseloads) and community services (face-to-face (f2f)/non-f2f contacts, caseloads): Adult, older adult and child/adolescent mental health; early intervention in psychosis; home treatment teams and liaison/Accident and Emergency (A&E). Data were extracted from 1 Jan 2019 to 31 May 2020 for all sites, supplemented to 31 July 2020 for four sites. Changes around the commencement and lifting of COVID-19 'lockdown' policy (23 March and 10 May, respectively) were estimated using a RDiT design with a difference-in-difference approach generating incidence rate ratios (IRRs), meta-analysed across sites. RESULTS: Pooled estimates for the lockdown transition showed increased daily deaths (IRR 2.31, 95% CI 1.86 to 2.87), reduced referrals (IRR 0.62, 95% CI 0.55 to 0.70) and reduced inpatient admissions (IRR 0.75, 95% CI 0.67 to 0.83) and caseloads (IRR 0.85, 95% CI 0.79 to 0.91) compared with the pre lockdown period. All community services saw shifts from f2f to non-f2f contacts, but varied in caseload changes. Lift of lockdown was associated with reduced deaths (IRR 0.42, 95% CI 0.27 to 0.66), increased referrals (IRR 1.36, 95% CI 1.15 to 1.60) and increased inpatient admissions (IRR 1.21, 95% CI 1.04 to 1.42) and caseloads (IRR 1.06, 95% CI 1.00 to 1.12) compared with the lockdown period. Site-wide activity, inpatient care and community services did not return to pre lockdown levels after lift of lockdown, while number of deaths did. Between-site heterogeneity most often indicated variation in size rather than direction of effect. CONCLUSIONS: MH service delivery underwent sizeable changes during the first national lockdown, with as-yet unknown and unevaluated consequences.

An intervention to improve the quality of life in children of parents with serious mental illness: the Young SMILES feasibility RCT.

BACKGROUND: Quality of life for children and adolescents living with serious parental mental illness can be impaired, but evidence-based interventions to improve it are scarce. OBJECTIVE: Co-production of a child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES)] to improve the health-related quality of life of children and adolescents living with serious parental mental illness, and evaluating its acceptability and feasibility for delivery in NHS and community settings. DESIGN: Qualitative and co-production methods informed the development of the intervention (Phase I). A feasibility randomised controlled trial was designed to compare Young SMILES with treatment as usual (Phase II). Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents. A mixture of semistructured qualitative interviews and focus group research was used to examine feasibility among Young SMILES facilitators and referrers/non-referrers. SETTING: Randomisation was conducted after baseline measures were collected by the study co-ordinator, ensuring that the blinding of the statistician and research team was maintained to reduce detection bias. PARTICIPANTS: Phase I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors. Phase II: 40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators. INTERVENTION: Young SMILES was delivered at two sites: (1) Warrington, supported by the National Society for the Prevention of Cruelty to Children (NSPCC), and (2) Newcastle, supported by the NHS and Barnardo's. An eight-session weekly group programme was delivered, with four to six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years). At week 4, a five-session parallel weekly programme was offered to the parents/carers. Sessions lasted 2 hours each and focused on improving mental health literacy, child-parent communication and children's problem-solving skills. MAIN OUTCOME MEASURES: Phase ll children and parents completed questionnaires at randomisation and then again at 4 and 6 months post randomisation. Quality of life was self-reported by children and proxy-reported by parents using the Paediatric Quality of Life questionnaire and KIDSCREEN. Semistructured interviews with parents (n = 14) and children (n = 17) who participated in the Young SMILES groups gathered information about their motivation to sign up to the study, their experiences of participating in the group sessions, and their perceived changes in themselves and their family members following intervention. Further interviews with individual referrers (n = 5) gathered information about challenges to recruitment and randomisation. Two focus groups (n = 16) with practitioners who facilitated the intervention explored their views of the format and content of the Young SMILES manual and their suggestions for changes. RESULTS: A total of 35 families were recruited: 20 were randomly allocated to Young SMILES group and 15 to treatment as usual. Of those, 28 families [15/20 (75%) in the intervention group and 13/15 (87%) in the control group] gave follow-up data at the primary end point (4 months post baseline). Participating children had high adherence to the intervention and high completion rates of the questionnaires. Children and adolescents living with their parents, who had serious mental illness, and their parents were mainly very positive and enthusiastic about Young SMILES, both of whom invoked the benefits of peer support and insight into parental difficulties. Although facilitators regarded Young SMILES as a meaningful and distinctive intervention having great potential, referrers identified several barriers to referring families to the study. One harm was reported by a parent, which was dealt with by the research team and the NSPCC in accordance with the standard operating procedures. LIMITATIONS: The findings from our feasibility study are not sufficient to recommend a fully powered trial of Young SMILES in the near future. Although it was feasible to randomise children and adolescents living with serious parental mental illness of different ages to standardised, time-limited groups in both NHS and non-NHS settings, an intervention like Young SMILES is unlikely to address underlying core components of the vulnerability that children and adolescents living with serious parental mental illness express as a population over time. CONCLUSIONS: Young SMILES was widely valued as unique in filling a recognised gap in need. Outcome measures in future studies of interventions for children and adolescents living with serious parental mental illness are more likely to capture change in individual risk factors for reduced quality of life by considering their unmet need, rather than on an aggregate construct of health-related quality of life overall, which may not reflect these young people's needs. FUTURE WORK: A public health approach to intervention might be best. Most children and adolescents living with serious parental mental illness remain well most of the time, so, although their absolute risks are low across outcomes (and most will remain resilient most of the time), consistent population estimates find their relative risk to be high compared with unexposed children. A public health approach to intervention needs to be both tailored to the particular needs of children and adolescents living with serious parental mental illness and agile to these needs so that it can respond to fluctuations over time. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36865046. FUNDING: This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 59. See the NIHR Journals Library website for further project information.

Children and adolescents living with serious parental mental illness are at increased risk of poorer mental, physical and emotional health but few services are available to them. We worked with young people, parents and professionals to co-develop a community-based intervention called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES). This involves eight children's sessions over 8 weeks in two age groups (6­11 and 12­16 years) and five separate parent sessions. Each session includes activities designed to improve understanding of mental illness, communication between children and parents, and problem-solving. To assess the feasibility and how acceptable Young SMILES is to those who received (and delivered) the intervention, we recruited 35 families: 20 were offered Young SMILES and 15 continued to receive their usual care. Children and parents completed questionnaires when they entered the research and then after 4 and 6 months. Children and adolescents living with serious parental mental illness assigned to either Young SMILES or usual-care groups reported that their quality of life, mental health, day-to-day functioning and knowledge of mental illness was similar to that of their population peers. Answers to parental questionnaires suggested that overall our participants' parenting style was positive and their levels of stress were as expected for parents in general. Across questionnaires, parents underestimated their children's quality of life and overestimated their difficulties. Children and adolescents living with serious parental mental illness and parents were mainly very positive and enthusiastic about Young SMILES. They liked getting together to discuss their experiences with others in similar situations, but some parents felt unprepared to do this. Children liked having something that focused on their own needs separately from those of their parents; they liked the fun activities and valued the time away from their parents, but also wanted their parents to have support. Facilitators and referrers saw great value in Young SMILES. The needs of children with mentally ill parents remain unmet in the current system; a future evaluation of Young SMILES needs to reconsider the primary outcome and start with a pilot trial with clear criteria for progression to a full trial.

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol.

BACKGROUND: Children and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wellbeing as well as poorer quality of life than their peers with 'healthy' parents. The needs of COPMI are likely to be significant; however, their prevalence is unknown, although estimates suggest over 60% of adults with a serious mental illness have children. Many receive little or no support and remain 'hidden', stigmatised or do not regard themselves as 'in need'. Recent UK policies have identified supporting COPMI as a key priority, but this alone is insufficient and health-related quality of life has been neglected as an outcome. METHODS/DESIGN: An age-appropriate standardised intervention for COPMI, called Young SMILES, was developed in collaboration with service users, National Health Service (NHS) and non-NHS stakeholders in our previous work. This protocol describes a randomised feasibility trial comparing Young SMILES with usual care, involving 60 families that will be identified through third sector organisations and NHS services, and recruited and randomised on a 1:1 basis to receive Young SMILES or usual care. Outcomes of the feasibility trial are rates of recruitment, follow-up and withdrawals, intervention uptake, and engagement. The optimal child-reported outcomes will also be determined alongside the assessment of resource use. A qualitative evaluation conducted at 3-months will explore the experiences and views of children and young people as well as parents accessing the intervention and the facilitators delivering the intervention. DISCUSSION: This paper details the rationale, design, training and recruitment methods for a feasibility study to inform the design and effective implementation of a larger scale randomised controlled trial of Young SMILES. TRIAL REGISTRATION: ISRCTN36865046 , registered 18 December 2015.

The argument for property rights in body parts: scarcity of resources.

This article attempts to answer two basic questions. First, can body parts be the subject of property rights? This requires us to start with a definition of property rights, and this is set out in the first section. In the second section, it will be argued that rights in relation to body parts can come within this definition of property rights. However, as explained in the third section, the fact that body parts can be the subject of property rights does not mean that they should. To answer the question of whether body parts should be the subject of property rights we need to consider policy arguments. This article will develop an argument in favour of the recognition of property rights in body parts which focuses on the notion of scarcity of resources.

Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).

BACKGROUND: Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. METHODS: At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. RESULTS: Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen-Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t = 4.8, df = 317, p < 0.0001). Therapy worksheets were completed in six of the eight centers, with the key elements of the intervention delivered according to the manual for >95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t = 6.5, df = 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. CONCLUSION: The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST.

The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial.

BACKGROUND: Data from 12-week placebo-controlled trials have led to mounting concerns about increased mortality in patients with Alzheimer's disease (AD) who are prescribed antipsychotics; however, there are no mortality data from long-term placebo-controlled trials. We aimed to assess whether continued treatment with antipsychotics in people with AD is associated with an increased risk of mortality. METHODS: Between October, 2001, and December, 2004, patients with AD who resided in care facilities in the UK were enrolled into a randomised, placebo-controlled, parallel, two-group treatment discontinuation trial. Participants were randomly assigned to continue with their antipsychotic treatment (thioridazine, chlorpromazine, haloperidol, trifluoperazine, or risperidone) for 12 months or to switch their medication to an oral placebo. The primary outcome was mortality at 12 months. An additional follow-up telephone assessment was done to establish whether each participant was still alive 24 months after the enrollment of the last participant (range 24-54 months). Causes of death were obtained from death certificates. Analysis was by intention to treat (ITT) and modified intention to treat (mITT). This trial is registered with the Cochrane Central Registry of Controlled Trials/National Research Register, number ISRCTN33368770. FINDINGS: 165 patients were randomised (83 to continue antipsychotic treatment and 82 to placebo), of whom 128 (78%) started treatment (64 continued with their treatment and 64 received placebo). There was a reduction in survival in the patients who continued to receive antipsychotics compared with those who received placebo. Cumulative probability of survival during the 12 months was 70% (95% CI 58-80%) in the continue treatment group versus 77% (64-85%) in the placebo group for the mITT population. Kaplan-Meier estimates of mortality for the whole study period showed a significantly increased risk of mortality for patients who were allocated to continue antipsychotic treatment compared with those allocated to placebo (mITT log rank p=0.03; ITT p=0.02). The hazard ratio for the mITT group was 0.58 (95% CI 0.35 to 0.95) and 0.58 (0.36 to 0.92) for the ITT population. The more pronounced differences between groups during periods of follow up longer than 12 months were evident at specific timepoints (24-month survival 46%vs 71%; 36-month survival 30%vs 59%). INTERPRETATION: There is an increased long-term risk of mortality in patients with AD who are prescribed antipsychotic medication; these results further highlight the need to seek less harmful alternatives for the long-term treatment of neuropsychiatric symptoms in these patients. FUNDING: UK Alzheimer's Research Trust.

A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial).

BACKGROUND: There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease. DESIGN: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial. SETTING: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom. PARTICIPANTS: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo. INTERVENTIONS: Continue neuroleptic treatment for 12 mo or switch to an identical placebo. OUTCOME MEASURES: Primary outcome was total Severe Impairment Battery (SIB) score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI). RESULTS: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment), of whom 128 (78%) commenced treatment (64 continue/64 placebo). Of those, 26 were lost to follow-up (13 per arm), resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo) -0.4 (95% confidence interval [CI] -6.4 to 5.5), adjusted for baseline value (p = 0.9). For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively) in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment) -2.4 (95% CI -8.2 to 3.5), adjusted for baseline value (p = 0.4). Both results became more pronounced at 12 mo. There was some evidence to suggest that those patients with initial NPI >/= 15 benefited on neuropsychiatric symptoms from continuing treatment. CONCLUSIONS: For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this benefit must be weighed against the side effects of therapy. TRIAL REGISTRATION: Cochrane Central Registry of Controlled Trials/National Research Register (#ISRCTN33368770).

Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial.

OBJECTIVES: To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive performance. DESIGN: Randomised double blind (clinician, patient, outcomes assessor) placebo controlled trial. SETTING: Care facilities in the north east of England. PARTICIPANTS: 93 patients with Alzheimer's disease, dementia, and clinically significant agitation. INTERVENTION: Atypical antipsychotic (quetiapine), cholinesterase inhibitor (rivastigmine), or placebo (double dummy). MAIN OUTCOME MEASURES: Agitation (Cohen-Mansfield agitation inventory) and cognition (severe impairment battery) at baseline and at six weeks and 26 weeks. The primary outcome was agitation inventory at six weeks. RESULTS: 31 patients were randomised to each group, and 80 (86%) started treatment (25 rivastigmine, 26 quetiapine, 29 placebo), of whom 71 (89%) tolerated the maximum protocol dose (22 rivastigmine, 23 quetiapine, 26 placebo). Compared with placebo, neither group showed significant differences in improvement on the agitation inventory either at six weeks or 26 weeks. Fifty six patients scored > 10 on the severe impairment battery at baseline, 46 (82%) of whom were included in the analysis at six week follow up (14 rivastigmine, 14 quetiapine, 18 placebo). For quetiapine the change in severe impairment battery score from baseline was estimated as an average of -14.6 points (95% confidence interval -25.3 to -4.0) lower (that is, worse) than in the placebo group at six weeks (P = 0.009) and -15.4 points (-27.0 to -3.8) lower at 26 weeks (P = 0.01). The corresponding changes with rivastigmine were -3.5 points (-13.1 to 6.2) lower at six weeks (P = 0.5) and -7.5 points (-21.0 to 6.0) lower at 26 weeks (P = 0.3). CONCLUSIONS: Neither quetiapine nor rivastigmine are effective in the treatment of agitation in people with dementia in institutional care. Compared with placebo, quetiapine is associated with significantly greater cognitive decline.