Antipsychotic dose reduction and discontinuation versus maintenance treatment in people with schizophrenia and other recurrent psychotic disorders in England (the RADAR trial): an open, parallel-group, randomised controlled trial.

BACKGROUND: Maintenance antipsychotic medication is recommended for people with schizophrenia or recurrent psychosis, but the adverse effects are burdensome, and evidence on long-term outcomes is sparse. We aimed to assess the benefits and harms of a gradual process of antipsychotic reduction compared with maintenance treatment. Our hypothesis was that antipsychotic reduction would improve social functioning with a short-term increase in relapse. METHODS: RADAR was an open, parallel-group, randomised trial done in 19 National Health Service Trusts in England. Participants were aged 18 years and older, had a diagnosis of recurrent, non-affective psychotic disorder, and were prescribed an antipsychotic. Exclusion criteria included people who had a mental health crisis or hospital admission in the past month, were considered to pose a serious risk to themselves or others by a treating clinician, or were mandated to take antipsychotic medication under the Mental Health Act. Through an independent, internet-based system, participants were randomly assigned (1:1) to gradual, flexible antipsychotic reduction, overseen by treating clinicians, or to maintenance. Participants and clinicians were aware of treatment allocations, but assessors were masked to them. Follow-up was for 2 years. Social functioning, assessed by the Social Functioning Scale, was the primary outcome. The principal secondary outcome was severe relapse, defined as requiring admission to hospital. Analysis was done blind to group identity using intention-to-treat data. The trial is completed and has been registered with ISRCTN registry (ISRCTN90298520) and with ClinicalTrials.gov (NCT03559426). FINDINGS: 4157 people were screened, of whom 253 were randomly allocated, including 168 (66%) men, 82 (32%) women, and 3 (1%) transgender people, with a mean age of 46 years (SD 12, range 22-79). 171 (67%) participants were White, 52 (21%) were Black, 16 (6%) were Asian, and 12 (5%) were of other ethnicity. The median dose reduction at any point during the trial was 67% in the reduction group and zero in the maintenance group; at 24 months it was 33% versus zero. At the 24-month follow-up, we assessed 90 of 126 people assigned to the antipsychotic dose reduction group and 94 of 127 assigned to the maintenance group, finding no difference in the Social Functioning Scale (ß 0·19, 95% CI -1·94 to 2·33; p=0·86). There were 93 serious adverse events in the reduction group affecting 49 individuals, mainly comprising admission for a mental health relapse, and 64 in the maintenance group, relating to 29 individuals. INTERPRETATION: At 2-year follow-up, a gradual, supported process of antipsychotic dose reduction had no effect on social functioning. Our data can help to inform decisions about the use of long-term antipsychotic medication. FUNDING: National Institute for Health Research.

A rapid mixed-methods evaluation of remote home monitoring models during the COVID-19 pandemic in England.

Background: Remote home monitoring services were developed and implemented for patients with COVID-19 during the pandemic. Patients monitored blood oxygen saturation and other readings (e.g. temperature) at home and were escalated as necessary. Objective: To evaluate effectiveness, costs, implementation, and staff and patient experiences (including disparities and mode) of COVID-19 remote home monitoring services in England during the COVID-19 pandemic (waves 1 and 2). Methods: A rapid mixed-methods evaluation, conducted in two phases. Phase 1 (July-August 2020) comprised a rapid systematic review, implementation and economic analysis study (in eight sites). Phase 2 (January-June 2021) comprised a large-scale, multisite, mixed-methods study of effectiveness, costs, implementation and patient/staff experience, using national data sets, surveys (28 sites) and interviews (17 sites). Results: Phase 1 Findings from the review and empirical study indicated that these services have been implemented worldwide and vary substantially. Empirical findings highlighted that communication, appropriate information and multiple modes of monitoring facilitated implementation; barriers included unclear referral processes, workforce availability and lack of administrative support. Phase 2 We received surveys from 292 staff (39% response rate) and 1069 patients/carers (18% response rate). We conducted interviews with 58 staff, 62 patients/carers and 5 national leads. Despite national roll-out, enrolment to services was lower than expected (average enrolment across 37 clinical commissioning groups judged to have completed data was 8.7%). There was large variability in implementation of services, influenced by patient (e.g. local population needs), workforce (e.g. workload), organisational (e.g. collaboration) and resource (e.g. software) factors. We found that for every 10% increase in enrolment to the programme, mortality was reduced by 2% (95% confidence interval: 4% reduction to 1% increase), admissions increased by 3% (-1% to 7%), in-hospital mortality fell by 3% (-8% to 3%) and lengths of stay increased by 1.8% (-1.2% to 4.9%). None of these results are statistically significant. We found slightly longer hospital lengths of stay associated with virtual ward services (adjusted incidence rate ratio 1.05, 95% confidence interval 1.01 to 1.09), and no statistically significant impact on subsequent COVID-19 readmissions (adjusted odds ratio 0.95, 95% confidence interval 0.89 to 1.02). Low patient enrolment rates and incomplete data may have affected chances of detecting possible impact. The mean running cost per patient varied for different types of service and mode; and was driven by the number and grade of staff. Staff, patients and carers generally reported positive experiences of services. Services were easy to deliver but staff needed additional training. Staff knowledge/confidence, NHS resources/workload, dynamics between multidisciplinary team members and patients' engagement with the service (e.g. using the oximeter to record and submit readings) influenced delivery. Patients and carers felt services and human contact received reassured them and were easy to engage with. Engagement was conditional on patient, support, resource and service factors. Many sites designed services to suit the needs of their local population. Despite adaptations, disparities were reported across some patient groups. For example, older adults and patients from ethnic minorities reported more difficulties engaging with the service. Tech-enabled models helped to manage large patient groups but did not completely replace phone calls. Limitations: Limitations included data completeness, inability to link data on service use to outcomes at a patient level, low survey response rates and under-representation of some patient groups. Future work: Further research should consider the long-term impact and cost-effectiveness of these services and the appropriateness of different models for different groups of patients. Conclusions: We were not able to find quantitative evidence that COVID-19 remote home monitoring services have been effective. However, low enrolment rates, incomplete data and varied implementation reduced our chances of detecting any impact that may have existed. While services were viewed positively by staff and patients, barriers to implementation, delivery and engagement should be considered. Study registration: This study is registered with the ISRCTN (14962466). Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (RSET: 16/138/17; BRACE: 16/138/31) and NHSEI and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 13. See the NIHR Journals Library website for further project information. The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Care Research or the Department of Health and Social Care.

COVID-19 patients can experience very low oxygen levels, without feeling breathless. Patients may not realise there is a problem until they become extremely unwell, risking being admitted to hospital too late. To address this, COVID-19 remote home monitoring services were developed and later rolled out across England. Patients monitored oxygen levels at home using an 'oximeter' (a small device which clips on to your finger) and sent these readings to providers via phone or technology (e.g. an app). Patients could access further care if needed. We did not know whether these services worked, or what people felt about them. • How services were set up and used in England. • Whether services work (e.g. by reducing deaths and length of hospital stay). • How much they cost. • What patients, carers and staff think about these services (including differences between groups and telephone vs. technology). We looked at available existing evidence and collected data from eight services operating in the first wave of the pandemic. During the second wave of the pandemic, we used data available at a national level and conducted surveys (28 sites) and interviews (17 sites) with staff, patients and individuals involved in developing/leading services nationally. These services have been used worldwide, but they vary considerably. We found many things that help these services to be used (e.g. good communication) but also things that get in the way (e.g. unclear referrals). Our findings did not show that services reduce deaths or time in hospital. But these findings are limited by a lack of data. Staff and patients liked these services, but we found some barriers to delivering and using the service. Some groups found services harder to use (e.g. older patients, those with disabilities and ethnic minorities). Using technology helped with large patient groups, but it did not completely replace phone calls. Better information is needed to know whether these services work. Staff and patients liked these services. However, improvements may make them easier to deliver and use (e.g. further staff training and giving additional support to patients who need it).

Patient and staff experiences of using technology-enabled and analogue models of remote home monitoring for COVID-19 in England: A mixed-method evaluation.

OBJECTIVE: To evaluate patient and staff experiences of using technology-enabled ('tech-enabled') and analogue remote home monitoring models for COVID-19, implemented in England during the pandemic. METHODS: Twenty-eight sites were selected for diversity in a range of criteria (e.g. pre-hospital or early discharge service, mode of patient data submission). Between February and May 2021, we conducted quantitative surveys with patients, carers and staff delivering the service, and interviewed patients, carers, and staff from 17 of the 28 services. Quantitative data were analysed using descriptive statistics and both univariate and multivariate analyses. Qualitative data were interpreted using thematic analysis. RESULTS: Twenty-one sites adopted mixed models whereby patients could submit their symptoms using either tech-enabled (app, weblink, or automated phone calls) or analogue (phone calls with a health professional) options; seven sites offered analogue-only data submission (phone calls or face-to-face visits with a health professional). Sixty-two patients and carers were interviewed, and 1069 survey responses were received (18 % response rate). Fifty-eight staff were interviewed, and 292 survey responses were received (39 % response rate). Patients who used tech-enabled modes tended to be younger (p = 0.005), have a higher level of education (p = 0.011), and more likely to identify as White British (p = 0.043). Most patients found relaying symptoms easy, regardless of modality, though many received assistance from family or friends. Staff considered the adoption of mixed delivery models beneficial, enabling them to manage large patient numbers and contact patients for further assessment as needed; however, they suggested improvements to the functionality of systems to better fit clinical and operational needs. Human contact was important in all remote home monitoring options. CONCLUSIONS: Organisations implementing tech-enabled remote home monitoring at scale should consider adopting mixed models which can accommodate patients with different needs; focus on the usability and interoperability of tech-enabled platforms; and encourage digital inclusivity for patients.

Staff experiences of training and delivery of remote home monitoring services for patients diagnosed with COVID-19 in England: A mixed-methods study.

OBJECTIVES: Remote home monitoring services for patients at risk of rapid deterioration introduced during the COVID-19 pandemic had important implications for the health workforce. This study explored the nature of 'work' that health care staff in England undertook to manage patients with COVID-19 remotely, how they were supported to deliver these new services, and the factors that influenced delivery of COVID-19 remote home monitoring services for staff. METHODS: We conducted a rapid mixed-methods evaluation of COVID-19 remote home monitoring services during November 2020 to July 2021 using a cross-sectional survey of a purposive sample of staff involved in delivering the service (clinical leads, frontline delivery staff and those involved in data collection and management) from 28 sites across England. We also conducted interviews with 58 staff in a subsample of 17 sites. Data collection and analysis were carried out in parallel. We used thematic analysis to analyse qualitative data while quantitative survey data were analysed using descriptive statistics. RESULTS: A total of 292 staff responded to the surveys (39% response rate). We found that prior experience of remote monitoring had some, albeit limited benefit for delivering similar services for patients diagnosed with COVID-19. Staff received a range of locally specific training and clinical oversight along with bespoke materials and resources. Staff reported feeling uncertain about using their own judgement and being reliant on seeking clinical oversight. The experience of transitioning from face-to-face to remote service delivery led some frontline delivery staff to reconsider their professional role, as well as their beliefs around their own capabilities. There was a general perception of staff being able to adapt, acquire new skills and knowledge and they demonstrated a commitment to continuity of care for patients, although there were reports of struggling with the increased accountability and responsibility attached to their adapted roles at times. CONCLUSIONS: Remote home monitoring models can play an important role in managing a large number of patients for COVID-19 and possibly a range of other conditions. Successful delivery of such service models depends on staff competency and the nature of training received to facilitate effective care and patient engagement.

Recruitment to a trial of antipsychotic reduction: impact of an acceptability study.

OBJECTIVES: Pre-trial acceptability studies may boost recruitment, especially in trials comparing distinctly different interventions. We evaluated the impact of an acceptability study on recruitment to a randomised trial of antipsychotic reduction versus maintenance treatment and explored demographic and clinical predictors of subsequent enrolment. METHODS: Participants with a diagnosis of a schizophrenia spectrum disorder who were taking antipsychotic medication were interviewed about their views of taking part in a future trial. RESULTS: In a sample of 210 participants, 151 (71.9%) expressed an interest in taking part in the future trial, 16 (7.6%) said they might be interested, and 43 (20.5%) said they were not. Altruistic reasons were most commonly given for wanting to take part, and concern about randomisation for not wanting to. Ultimately 57 people enrolled in the trial (27.1% of the original sample). Eighty-five people who initially expressed an interest did not enrol due to declining or not being eligible (for clinical reasons). Women and people from a white ethnic background were more likely to enrol in the trial, but no illness or treatment-related characteristics were associated with enrolment. CONCLUSION: An acceptability study can be a useful tool for recruitment to challenging trials, but it may over-estimate recruitment.

Undertaking rapid evaluations during the COVID-19 pandemic: Lessons from evaluating COVID-19 remote home monitoring services in England.

Introduction: Rapid evaluations can offer evidence on innovations in health and social care that can be used to inform fast-moving policy and practise, and support their scale-up according to previous research. However, there are few comprehensive accounts of how to plan and conduct large-scale rapid evaluations, ensure scientific rigour, and achieve stakeholder engagement within compressed timeframes. Methods: Using a case study of a national mixed-methods rapid evaluation of COVID-19 remote home monitoring services in England, conducted during the COVID-19 pandemic, this manuscript examines the process of conducting a large-scale rapid evaluation from design to dissemination and impact, and reflects on the key lessons for conducting future large-scale rapid evaluations. In this manuscript, we describe each stage of the rapid evaluation: convening the team (study team and external collaborators), design and planning (scoping, designing protocols, study set up), data collection and analysis, and dissemination. Results: We reflect on why certain decisions were made and highlight facilitators and challenges. The manuscript concludes with 12 key lessons for conducting large-scale mixed-methods rapid evaluations of healthcare services. We propose that rapid study teams need to: (1) find ways of quickly building trust with external stakeholders, including evidence-users; (2) consider the needs of the rapid evaluation and resources needed; (3) use scoping to ensure the study is highly focused; (4) carefully consider what cannot be completed within a designated timeframe; (5) use structured processes to ensure consistency and rigour; (6) be flexible and responsive to changing needs and circumstances; (7) consider the risks associated with new data collection approaches of quantitative data (and their usability); (8) consider whether it is possible to use aggregated quantitative data, and what that would mean when presenting results, (9) consider using structured processes & layered analysis approaches to rapidly synthesise qualitative findings, (10) consider the balance between speed and the size and skills of the team, (11) ensure all team members know roles and responsibilities and can communicate quickly and clearly; and (12) consider how best to share findings, in discussion with evidence-users, for rapid understanding and use. Conclusion: These 12 lessons can be used to inform the development and conduct of future rapid evaluations in a range of contexts and settings.

Patients' experiences of, and engagement with, remote home monitoring services for COVID-19 patients: A rapid mixed-methods study.

INTRODUCTION: Remote home monitoring models were implemented during the COVID-19 pandemic to shorten hospital length of stay, reduce unnecessary hospital admission, readmission and infection and appropriately escalate care. Within these models, patients are asked to take and record readings and escalate care if advised. There is limited evidence on how patients and carers experience these services. This study aimed to evaluate patient experiences of, and engagement with, remote home monitoring models for COVID-19. METHODS: A rapid mixed-methods study was carried out in England (conducted from March to June 2021). We remotely conducted a cross-sectional survey and semi-structured interviews with patients and carers. Interview findings were summarized using rapid assessment procedures sheets and data were grouped into themes (using thematic analysis). Survey data were analysed using descriptive statistics. RESULTS: We received 1069 surveys (18% response rate) and conducted interviews with patients (n = 59) or their carers (n = 3). 'Care' relied on support from staff members and family/friends. Patients and carers reported positive experiences and felt that the service and human contact reassured them and was easy to engage with. Yet, some patients and carers identified problems with engagement (e.g., hesitancy to self-escalate care). Engagement was influenced by patient factors such as health and knowledge, support from family/friends and staff, availability and ease of use of informational and material resources (e.g., equipment) and service factors. CONCLUSION: Remote home monitoring models place responsibility on patients to self-manage symptoms in partnership with staff; yet, many patients required support and preferred human contact (especially for identifying problems). Caring burden and experiences of those living alone and barriers to engagement should be considered when designing and implementing remote home monitoring services. PATIENT OR PUBLIC CONTRIBUTION: The study team met with service users and public members of the evaluation teams throughout the project in a series of workshops. Workshops informed study design, data collection tools and data interpretation and were conducted to also discuss study dissemination. Public patient involvement (PPI) members helped to pilot patient surveys and interview guides with the research team. Some members of the public also piloted the patient survey. Members of the PPI group were given the opportunity to comment on the manuscript, and the manuscript was amended accordingly.

The impact of post-hospital remote monitoring of COVID-19 patients using pulse oximetry: A national observational study using hospital activity data.

Background: There was a national roll out of 'COVID Virtual Wards' (CVW) during England's second COVID-19 wave (Autumn 2020 - Spring 2021). These services used remote pulse oximetry monitoring for COVID-19 patients following discharge from hospital. A key aim was to enable rapid detection of patient deterioration. It was anticipated that the services would support early discharge, reducing pressure on beds. This study is an evaluation of the impact of the CVW services on hospital activity. Methods: Using retrospective patient-level hospital admissions data, we built multivariate models to analyze the relationship between the implementation of CVW services and hospital activity outcomes: length of COVID-19 related stays and subsequent COVID-19 readmissions within 28 days. We used data from more than 98% of recorded COVID-19 hospital stays in England, where the patient was discharged alive between mid-August 2020 and late February 2021. Findings: We found a longer length of stay for COVID-19 patients discharged from hospitals where a CVW was available, when compared to patients discharged from hospitals where there was no CVW (adjusted IRR 1·05, 95% CI 1·01 to 1·09). We found no evidence of a relationship between the availability of CVW and subsequent rates of readmission for COVID-19 (adjusted OR 0.97, 95% CI 0.91 to 1·03). Interpretation: We found no evidence of early discharges or changes in readmissions associated with the roll out of COVID Virtual Wards across England. Our analysis made pragmatic use of national-scale hospital data, but it is possible that a lack of specific data (for example, on which patients were enrolled and on potentially important confounders) may have meant that true impacts, especially at a local level, were not ultimately discernible. It is important that future research is able to make use of better quality - preferably linked - data, from multiple sites. Funding: This is independent research funded by the National Institute for Health Research, Health Services & Delivery Research program (RSET Project no. 16/138/17; BRACE Project no. 16/138/31) and NHSE&I. NJF is an NIHR Senior Investigator.

A qualitative exploration of family members' perspectives on reducing and discontinuing antipsychotic medication.

BACKGROUND: Antipsychotics are routinely prescribed to people diagnosed with schizophrenia or psychosis on a long-term basis. Considerable literature explores service users' opinions and experiences of antipsychotics, but studies investigating family members' views are lacking. AIMS: To explore family members' perspectives on antipsychotics, particularly their views on long-term use, reduction and discontinuation of antipsychotics. METHODS: Semi-structured interviews were conducted with 11 family members of people experiencing psychosis. Participants were recruited through community support groups and mental health teams. Interviews were analysed thematically. RESULTS: The majority of family members valued antipsychotic medication primarily in supporting what they saw as a fragile stability in the person they cared for. Their views of medication were ambivalent, combining concerns about adverse effects with a belief in the importance of medication due to fears of relapse. They described a need for constant vigilance in relation to medication to ensure it was taken consistently, and often found changes, particularly reduction in medication difficult to contemplate. CONCLUSIONS: Findings highlight that family members' attitudes to medication sometimes conflict with those of the people they care for, impacting on their health and the caring relationship. Family members may need more support and could be usefully involved in medication decision-making.

An analysis of views about supported reduction or discontinuation of antipsychotic treatment among people with schizophrenia and other psychotic disorders.

BACKGROUND: Antipsychotic medication can reduce psychotic symptoms and risk of relapse in people with schizophrenia and related disorders, but it is not always effective and adverse effects can be significant. We know little of patients' views about continuing or discontinuing antipsychotic treatment. AIMS: To explore the views of people with schizophrenia and other psychotic disorders about continuing their antipsychotic medication or attempting to reduce or discontinue this medication with clinical support. METHODS: We collected quantitative and qualitative data by conducting semi-structured interviews in London, UK. Factors predicting a desire to discontinue medication were explored. Content analysis of qualitative data was undertaken. RESULTS: We interviewed 269 participants. 33% (95% CI, 27 to 39%) were content with taking long-term antipsychotic medication. Others reported they took it reluctantly (19%), accepted it on a temporary basis (24%) or actively disliked it (18%). 31% (95% CI, 25 to 37%) said they would like to try to stop medication with professional support, and 45% (95% CI, 39 to 51%) wanted the opportunity to reduce medication. People who wanted to discontinue had more negative attitudes towards the medication but were otherwise similar to other participants. Wanting to stop or reduce medication was motivated mainly by adverse effects and health concerns. Professional support was identified as potentially helpful to achieve reduction. CONCLUSIONS: This large study reveals that patients are commonly unhappy about the idea of taking antipsychotics on a continuing or life-long basis. Professional support for people who want to try to reduce or stop medication is valued.

The impact of remote home monitoring of people with COVID-19 using pulse oximetry: A national population and observational study.

BACKGROUND: Remote home monitoring of people testing positive for COVID-19 using pulse oximetry was implemented across England during the Winter of 2020/21 to identify falling blood oxygen saturation levels at an early stage. This was hypothesised to enable earlier hospital admission, reduce the need for intensive care and improve survival. This study is an evaluation of the clinical effectiveness of the pre-hospital monitoring programme, COVID oximetry @home (CO@h). METHODS: The setting was all Clinical Commissioning Group (CCG) areas in England where there were complete data on the number of people enrolled onto the programme between 2nd November 2020 and 21st February 2021. We analysed relationships at a geographical area level between the extent to which people aged 65 or over were enrolled onto the programme and outcomes over the period between November 2020 to February 2021. FINDINGS: For every 10% increase in coverage of the programme, mortality was reduced by 2% (95% confidence interval:4% reduction to 1% increase), admissions increased by 3% (-1% to 7%), in-hospital mortality fell by 3% (-8% to 3%) and lengths of stay increased by 1·8% (-1·2% to 4·9%). None of these results are statistically significant, although the confidence interval indicates that any adverse effect on mortality would be small, but a mortality reduction of up to 4% may have resulted from the programme. INTERPRETATION: There are several possible explanations for our findings. One is that CO@h did not have the hypothesised impact. Another is that the low rates of enrolment and incomplete data in many areas reduced the chances of detecting any impact that may have existed. Also, CO@h has been implemented in many different ways across the country and these may have had varying levels of effect. FUNDING: This is independent research funded by the National Institute for Health Research, Health Services & Delivery Research programme (RSET Project no. 16/138/17; BRACE Project no. 16/138/31) and NHSEI. NJF is an NIHR Senior Investigator.

A systematic review of social functioning outcome measures in schizophrenia with a focus on suitability for intervention research.

Social functioning is an important part of recovery and a key treatment target in clinical research in schizophrenia. Evaluating and comparing interventions is challenged by the choice of many measures which focus on different aspects of functioning, with little to guide selection. This results in difficulties comparing outcomes of treatment where studies have used different measures. To improve the measurement of social functioning in intervention research, we aimed to provide practical information on suitability of measures. We conducted a systematic review of measures developed or psychometrically evaluated since 2007, and assessed and discussed the structure, content, quality, and the use of the measures in intervention research. Thirty-two measures of social functioning and 22 validation papers were identified. Measures included structured questionnaires, semi-structured interviews, and assessment of performance on specific tasks. The content of measures was organised into eight categories, which are in order of frequency with which they were covered by measures: activities of daily living, productive activity, relationships, leisure activities, cognition, anti-social behaviour, psychosis symptoms and self-esteem and empowerment. In terms of quality, most measures were rated as moderate, with the Personal and Social Performance Scale gaining the highest rating. However, there was little data on responsiveness of measures, or how they compare to objective or 'real-world' indicators of functioning. The Social Functioning Scale and Personal and Social Performance Scale have been most frequently used in intervention studies to date. Future research should aim to provide further data on psychometric properties relevant to intervention research.

A systematic review of the effects of psychiatric medications on social cognition.

INTRODUCTION: Social cognition is an important area of mental functioning relevant to psychiatric disorders and social functioning, that may be affected by psychiatric drug treatments. The aim of this review was to investigate the effects of medications with sedative properties, on social cognition. METHOD: This systematic review included experimental and neuroimaging studies investigating drug effects on social cognition. Data quality was assessed using a modified Downs and Black checklist (Trac et al. CMAJ 188: E120-E129, 2016). The review used narrative synthesis to analyse the data. RESULTS: 40 papers were identified for inclusion, 11 papers investigating benzodiazepine effects, and 29 investigating antipsychotic effects, on social cognition. Narrative synthesis showed that diazepam impairs healthy volunteer's emotion recognition, with supporting neuroimaging studies showing benzodiazepines attenuate amygdala activity. Studies of antipsychotic effects on social cognition gave variable results. However, many of these studies were in patients already taking medication, and potential practice effects were identified due to short-term follow-ups. CONCLUSION: Healthy volunteer studies suggest that diazepam reduces emotional processing ability. The effects of benzodiazepines on other aspects of social cognition, as well as the effects of antipsychotics, remain unclear. Interpretations of the papers in this review were limited by variability in measures, small sample sizes, and lack of randomisation. More robust studies are necessary to evaluate the impact of these medications on social cognition.

Community Occupational Therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID]) study: A single-blind, randomised controlled trial.

BACKGROUND: We aimed to estimate the clinical effectiveness of Community Occupational Therapy for people with dementia and family carers-UK version (Community Occupational Therapy in Dementia-UK version [COTiD-UK]) relative to treatment as usual (TAU). We hypothesised that COTiD-UK would improve the ability of people with dementia to perform activities of daily living (ADL), and family carers' sense of competence, compared with TAU. METHODS AND FINDINGS: The study design was a multicentre, 2-arm, parallel-group, assessor-masked, individually randomised controlled trial (RCT) with internal pilot. It was conducted in 15 sites across England from September 2014 to January 2018. People with a diagnosis of mild to moderate dementia living in their own home were recruited in pairs with a family carer who provided domestic or personal support for at least 4 hours per week. Pairs were randomised to either receive COTiD-UK, which comprised 10 hours of occupational therapy delivered over 10 weeks in the person with dementia's home or TAU, which comprised the usual local service provision that may or may not include standard occupational therapy. The primary outcome was the Bristol Activities of Daily Living Scale (BADLS) score at 26 weeks. Secondary outcomes for the person with dementia included the following: the BADLS scores at 52 and 78 weeks, cognition, quality of life, and mood; and for the family carer: sense of competence and mood; plus the number of social contacts and leisure activities for both partners. Participants were analysed by treatment allocated. A total of 468 pairs were recruited: people with dementia ranged from 55 to 97 years with a mean age of 78.6 and family carers ranged from 29 to 94 with a mean of 69.1 years. Of the people with dementia, 74.8% were married and 19.2% lived alone. Of the family carers, 72.6% were spouses, and 22.2% were adult children. On randomisation, 249 pairs were assigned to COTiD-UK (62% people with dementia and 23% carers were male) and 219 to TAU (52% people with dementia and 32% carers were male). At the 26 weeks follow-up, data were available for 364 pairs (77.8%). The BADLS score at 26 weeks did not differ significantly between groups (adjusted mean difference estimate 0.35, 95% CI -0.81 to 1.51; p = 0.55). Secondary outcomes did not differ between the groups. In total, 91% of the activity-based goals set by the pairs taking part in the COTiD-UK intervention were fully or partially achieved by the final COTiD-UK session. Study limitations include the following: Intervention fidelity was moderate but varied across and within sites, and the reliance on primarily proxy data focused on measuring the level of functional or cognitive impairment which may not truly reflect the actual performance and views of the person living with dementia. CONCLUSIONS: Providing community occupational therapy as delivered in this study did not improve ADL performance, cognition, quality of life, or mood in people with dementia nor sense of competence or mood in family carers. Future research should consider measuring person-centred outcomes that are more meaningful and closely aligned to participants' priorities, such as goal achievement or the quantity and quality of activity engagement and participation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10748953.

Psychosocial interventions for people with schizophrenia or psychosis on minimal or no antipsychotic medication: A systematic review.

Antipsychotics are the first-line treatment for people with schizophrenia or psychosis. There is evidence that they can reduce the symptoms of psychosis and risk of relapse. However many people do not respond to these drugs, or experience adverse effects and stop taking them. In the UK, clinical guidelines have stressed the need for research into psychosocial interventions without antipsychotics. This systematic review examines the effects of psychosocial interventions for people with schizophrenia or psychosis who are on no/minimal antipsychotics. Databases were searched for empirical studies investigating a psychosocial intervention in people with a schizophrenia spectrum disorder who were not taking antipsychotics or had received an antipsychotic minimisation strategy. We identified nine interventions tested in 17 studies (N = 2250), including eight randomised controlled trials. Outcomes were generally equal to or in a small number of cases better than the control group (antipsychotics/treatment as usual) for Cognitive Behavioural Therapy (CBT), Need Adapted Treatment and Soteria. The remaining interventions provided some encouraging, but overall inconsistent findings and were Psychosocial Outpatient Treatment, Open Dialogue, Psychosocial Inpatient Treatment, Psychoanalysis/Psychodynamic Psychotherapy, Major Role Therapy, and Milieu Treatment. Study quality was generally low with little recent research. In conclusion, nine psychosocial interventions have been studied for patients on no/minimal antipsychotics. The majority of studies reported outcomes for the intervention which were the same as the control group, however, study quality was problematic. Given the adverse effects of antipsychotics and that many people do not want to take them, high quality trials of psychosocial treatments for people on minimal/no antipsychotics are needed.

Definitions of relapse in trials comparing antipsychotic maintenance with discontinuation or reduction for schizophrenia spectrum disorders: A systematic review.

INTRODUCTION: Avoidance of relapse is the main aim of long-term antipsychotic treatment in schizophrenia, yet how 'relapse' is defined in trials is not well-known. METHODS: We conducted a systematic review of definitions of relapse in trials of continuous antipsychotic treatment compared with discontinuation, intermittent treatment or dose reduction for people with schizophrenia spectrum disorders. Trials were identified from previous Cochrane reviews and a new search. The quality of relapse definitions was rated in terms of reliability and clinical relevance and associations between quality of definitions and trial characteristics and outcome were explored. RESULTS: We identified 82 reports of 81 trials which employed 54 different definitions of relapse. There were 33 definitions in the 35 trials published since 1990, with recent trials employing complex definitions often involving alternative criteria. Only ten primary definitions of relapse required the presence of psychotic symptoms in all cases, and only three specified this in combination with a measure of overall severity or functional decline. Only two definitions specified a duration longer than two days. Relapse definitions were rated as showing good reliability in 37 trials, but only seven showed good clinical relevance. Six trials with definitions that were both reliable and clinically relevant were slightly longer, but did not differ from remaining trials in other characteristics or overall or relative risk of relapse. CONCLUSIONS: Antipsychotic trials define relapse in numerous different ways, and few definitions consistently reflect suggested indications of a clinically significant relapse.

Experiences of taking neuroleptic medication and impacts on symptoms, sense of self and agency: a systematic review and thematic synthesis of qualitative data.

PURPOSE: Neuroleptic (antipsychotic) drugs reduce psychotic symptoms, but how they achieve these effects and how the drugs' effects are experienced by people who take them are less well understood. The present study describes a synthesis of qualitative data about mental and behavioural alterations associated with taking neuroleptics and how these interact with symptoms of psychosis and people's sense of self and agency. METHODS: Nine databases were searched to identify qualitative literature concerning experiences of taking neuroleptic medication. A thematic synthesis was conducted. RESULTS: Neuroleptics were commonly experienced as producing a distinctive state of lethargy, cognitive slowing, emotional blunting and reduced motivation, which impaired functioning but also had beneficial effects on symptoms of psychosis and some other symptoms (e.g. insomnia). For some people, symptom reduction helped restore a sense of normality and autonomy, but others experienced a loss of important aspects of their personality. Across studies, many people adopted a passive stance towards long-term medication, expressing a sense of resignation, endurance or loss of autonomy. CONCLUSIONS: Neuroleptic drugs modify cognition, emotions and motivation. These effects may be associated with reducing the intensity and impact of symptoms, but also affect people's sense of self and agency. Understanding how the effects of neuroleptics are experienced by those who take them is important in developing a more collaborative approach to drug treatment in psychosis and schizophrenia.

Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction).

INTRODUCTION: Antipsychotic medication is effective in reducing acute symptoms of psychosis, but it has a range of potentially serious and debilitating adverse effects and is often disliked by patients. It is therefore essential it is only used when benefits outweigh harms. Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes. METHODS AND ANALYSIS: This is a multicentre, randomised controlled trial involving people with schizophrenia and related disorders who have had more than one episode. Participants are randomised to have a clinically-supervised, gradual reduction of antipsychotic medication, leading to discontinuation when possible, or to continue with maintenance treatment. Blinded follow-up assessments are conducted at 6, 12 and 24 months and the primary outcome is social functioning, measured by the Social Functioning Scale at 24 months. A minimum of 134 evaluable participants provides 90% power to detect a five-point difference, and 206 to detect a four-point difference. Secondary outcomes include severe relapse (admission to hospital) and the study is also intended to detect a minimum 10% difference in severe relapse, which requires 402 participants, assuming a 15% loss to follow-up. Other secondary outcomes include all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures. Enrolment started in 2016. The trial is scheduled to finish in June 2022. ETHICS AND DISSEMINATION: Ethical approval was initially obtained on 27 October 2016 (UK Research Ethics Committee reference 16/LO/1507). Results will be published in peer-reviewed journals and disseminated to the public. TRIAL REGISTRATION NUMBER: ISRCTN90298520. EudraCT: 2016-000709-36. Pre-results.

Factors related to sense of competence in family caregivers of people living with dementia in the community: a narrative synthesis.

ABSTRACTObjectives:Sense of competence defines a caregiver's feeling of being capable to manage the caregiving task and is an important clinical concept in the caregiving literature. The aim of this review was to identify the factors, both positive and negative, associated with a caregiver's perception of their sense of competence. DESIGN: A systematic review of the literature was conducted, retrieving both quantitative and qualitative papers from databases PsycINFO, CINAHL, EMBASE, and Medline. A quality assessment was conducted using the STROBE and CASP checklists, and the quality rating informed the inclusion of papers ensuring the evidence was robust. Narrative synthesis was employed to synthesize the findings and to generate an updated conceptual model of sense of competence. RESULTS: Seventeen papers were included in the review, all of which were moderate to high quality. These included 13 quantitative, three mixed-methods and one qualitative study. Factors associated with sense of competence included: behavioral and psychological symptoms of dementia (BPSD), caregiver depression, gratitude, and the ability to find meaning in caregiving. CONCLUSIONS: The results of this review demonstrate that both positive and negative aspects of caring are associated with caregiver sense of competence. Positive and negative aspects of caregiving act in tandem to influence caregiver perception of their competence. The proposed model of sense of competence aims to guide future research and clinical interventions aimed at improving this domain but requires further testing, as due to the observational nature of the include papers, the direction of causality could not be inferred.