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Treatment-resistant symptoms occur in about a third of patients with schizophrenia and are associated with a substantial reduction in their quality of life. The development of new treatment options for clozapine-resistant schizophrenia constitutes a crucial, unmet need in psychiatry. Additionally, an overview of past and possible future research avenues to optimise the early detection, diagnosis, and management of clozapine-resistant schizophrenia is unavailable. In this Health Policy, we discuss the ongoing challenges associated with clozapine-resistant schizophrenia faced by patients and health-care providers worldwide to improve the understanding of this condition. We then revisit several clozapine guidelines, the diagnostic tests and treatment options for clozapine-resistant schizophrenia, and currently applied research approaches in clozapine-resistant schizophrenia. We also suggest methodologies and targets for future research, divided into innovative nosology-oriented field trials (eg, examining dimensional symptom staging), translational approaches (eg, genetics), epidemiological research (eg, real-world studies), and interventional studies (eg, non-traditional trial designs incorporating lived experiences and caregivers' perspectives). Finally, we note that low-income and middle-income countries are under-represented in studies on clozapine-resistant schizophrenia and propose an agenda to guide multinational research on the cause and treatment of clozapine-resistant schizophrenia. We hope that this research agenda will empower better global representation of patients living with clozapine-resistant schizophrenia and ultimately improve their functional outcomes and quality of life., Competing Interests: Declaration of interests JL has received honoraria from Otsuka, Janssen, Lundbeck, and Sumitomo Pharmaceuticals. CUC has been a consultant or advisor to, or has received honoraria from AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Boehringer Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Janssen (Johnson & Johnson), Karuna, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Newron, Noven, Otsuka, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Seqirus, SK Life Science, Sunovion, Sun Pharma, Supernus, Takeda, Teva, and Viatris. He has provided expert testimony for Janssen and Otsuka. He has served on a data safety monitoring board for Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva. He has received grant support from Janssen and Takeda. He has received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Mindpax, LB Pharma, and Quantic. ROC has received research funding (awarded to his institution) from Roche and Alkermes, is a consultant to Saladax Biomedical, and is a speaker for Clinical Care Options. ST has received speaker honoraria from Otsuka, Mochida, Takeda, Meiji, Eisai, Sumitomo, Viatris, and Teijin. JT has participated in research projects funded by grants from Janssen-Cilag and Eli Lilly awarded to his institution. He also reports personal fees from Eli Lilly, Evidera, Janssen-Cilag, Lundbeck, Mediuutiset, Otsuka, Sidera, and Suvovion; and he is a consultant to HLS Therapeutics, Orion, and WebMed Global. AH is co-editor of the German Association for Psychiatry, Psychotherapy and Psychosomatics schizophrenia treatment guidelines and first author of the World Federation of Societies of Biological Psychiatry schizophrenia treatment guidelines. He has been on the advisory boards and has received speaker fees from Janssen, Lundbeck, and Otsuka. EW has been on the advisory boards of Recordati. JMG-D is funded by a grant from Ministerio de Ciencia y Tecnología (Colombia), and has been a consultant for, received honoraria from, or been on the speakers or advisory boards of Janssen, Eurofarma, Servier, Sanofi, Lilly, and Pfizer. DSh is an expert advisor to the National Institute for Health and Care Excellence (NICE) centre for guidelines; the views expressed in this Health Policy are the authors' and not those of NICE. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Treatment-resistant schizophrenia (TRS) is associated with significant impairment of functioning and high treatment costs. Identification of patients at high risk of TRS at the time of their initial diagnosis may significantly improve clinical outcomes and minimise social and functional disability. We aim to develop a prognostic model for predicting the risk of developing TRS in patients with first-episode schizophrenia and to examine its potential utility and acceptability as a clinical decision tool., Methods and Analysis: We will use two well-characterised longitudinal UK-based first-episode psychosis cohorts: Aetiology and Ethnicity in Schizophrenia and Other Psychoses and Genetics and Psychosis for which data have been collected on sociodemographic and clinical characteristics. We will identify candidate predictors for the model based on current literature and stakeholder consultation. Model development will use all data, with the number of candidate predictors restricted according to available sample size and event rate. A model for predicting risk of TRS will be developed based on penalised regression, with missing data handled using multiple imputation. Internal validation will be undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model's performance. The clinical utility of the model in terms of clinically relevant risk thresholds will be evaluated using net benefit and decision curves (comparative to competing strategies). Consultation with patients and clinical stakeholders will determine potential thresholds of risk for treatment decision-making. The acceptability of embedding the model as a clinical tool will be explored using qualitative focus groups with up to 20 clinicians in total from early intervention services. Clinicians will be recruited from services in Stafford and London with the focus groups being held via an online platform., Ethics and Dissemination: The development of the prognostic model will be based on anonymised data from existing cohorts, for which ethical approval is in place. Ethical approval has been obtained from Keele University for the qualitative focus groups within early intervention in psychosis services (ref: MH-210174). Suitable processes are in place to obtain informed consent for National Health Service staff taking part in interviews or focus groups. A study information sheet with cover letter and consent form have been prepared and approved by the local Research Ethics Committee. Findings will be shared through peer-reviewed publications, conference presentations and social media. A lay summary will be published on collaborator websites., Competing Interests: Competing interests: DS is expert advisor to the NICE centre for guidelines. The views expressed are the authors’ and not those of NICE., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: STEPWISE is a theory-informed self-management education programme that was co-produced with service users, healthcare professionals and interventionists to support weight loss for people with schizophrenia. We report the process evaluation to inform understanding about the intervention and its effectiveness in a randomised controlled trial (RCT) that evaluated its efficacy., Methods: Following the UK Medical Research Council (MRC) Guidelines for developing and evaluating complex interventions, we explored implementation quality. We considered causal mechanisms, unanticipated consequences and contextual factors associated with variation in actual and intended outcomes, and integrated treatment fidelity, using the programme theory and a pipeline logic model. We followed a modified version of Linnan and Steckler's framework and single case design. Qualitative data from semi-structured telephone interviews with service-users (n = 24), healthcare professionals delivering the intervention (n = 20) and interventionists (n = 7) were triangulated with quantitative process and RCT outcome data and with observations by interventionists, to examine convergence within logic model components., Results: Training and course materials were available although lacked co-ordination in some trusts. Healthcare professionals gained knowledge and some contemplated changing their practice to reflect the (facilitative) 'style' of delivery. They were often responsible for administrative activities increasing the burden of delivery. Healthcare professionals recognised the need to address antipsychotic-induced weight gain and reported potential value from the intervention (subject to the RCT results). However, some doubted senior management commitment and sustainability post-trial. Service-users found the intervention highly acceptable, especially being in a group of people with similar experiences. Service-users perceived weight loss and lifestyle benefits; however, session attendance varied with 23% (n = 47) attending all group-sessions and 17% (n = 36) attending none. Service-users who lost weight wanted closer monitoring and many healthcare professionals wanted to monitor outcomes (e.g. weight) but it was outside the intervention design. No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention., Conclusions: This process evaluation provides a greater understanding of why STEPWISE was unsuccessful in promoting weight loss during the clinical trial. Further research is required to evaluate whether different levels of contact and objective monitoring can support people with schizophrenia to lose weight., Trial Registration: ISRCTN, ISRCTN19447796. Registered 20 March 2014.

Background: Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia., Method: In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included., Results: Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained., Conclusions: Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Background: Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned., Objectives: To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability., Design: A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost-utility analysis., Setting: Ten community mental health trusts in England., Participants: People with first episode psychosis, schizophrenia or schizoaffective disorder., Interventions: Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information., Main Outcome Measures: The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment., Results: The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval -1.59 to 1.67 kg; p  = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants' behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained., Conclusions: Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia., Trial Registration: Current Controlled Trials ISRCTN19447796., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 65. See the NIHR Journals Library website for further project information., Competing Interests: Richard IG Holt received fees for lecturing, consultancy work and attendance at conferences from the following companies: Boehringer Ingelheim (Ingelheim am Rhein, Germany), Eli Lilly and Company (Indianapolis, IN, USA), Janssen Pharmaceutica (Beerse, Belgium), Lundbeck (Copenhagen, Denmark), Novo Nordisk (Bagsværd, Denmark), Novartis (Basel, Switzerland), Otsuka Pharmaceutical Co., Ltd (Tokyo, Japan), Sanofi-Aventis (Paris, France) and Sunovion Pharmaceuticals, Inc. (Marlborough, MA, USA). Paul French is a member of the National Institute for Health Research (NIHR) Health Technology Assessment Mental, Psychological and Occupational Health funding panel. Melanie J Davies and Kamlesh Khunti are members of a NIHR Clinical Trials Unit. Melanie J Davies reports personal fees from Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Merck Sharp & Dohme (Kenilworth, NJ, USA), Boehringer Ingelheim, AstraZeneca (Cambridge, UK), Janssen Pharmaceutica, Servier Laboratories (Neuilly-sur-Seine, France), Mitsubishi Tanabe Pharma Corporation (Tokyo, Japan) and Takeda Pharmaceuticals International Inc. (Canton of Zürich, Switzerland) and grants from Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim and Janssen Pharmaceutica. Kamlesh Khunti has received fees for consultancy and being a speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Servier Laboratories and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Eli Lilly and Company, Pfizer (New York, NY, USA), Boehringer Ingelheim and Merck Sharp & Dohme. Kamlesh Khunti has also received funds for research and honoraria for speaking at meetings, and has served on advisory boards for Eli Lilly and Company, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. David Shiers is an expert advisor to the National Institute for Health and Care Excellence (NICE) centre for guidelines, a board member of the National Collaborating Centre for Mental Health (NCCMH) and a clinical advisor (on a paid consultancy basis) to the National Clinical Audit of Psychosis (NCAP); any views given in this report are personal and not those of NICE, NCCMH or NCAP. David Shiers reports personal fees from the Wiley-Blackwell publication Promoting Recovery in Early Psychosis, 2010 (ISBN 978-1-4051-4894-8), as he is a joint editor in receipt of royalties. John Pendelbury received personal fees for involvement in the study from a NIHR grant; he reports personal fees from the Greater Manchester Mental Health NHS foundation trust outside the submitted work and has published papers in the area of weight management and physical health related to mental health. Marian E Carey and Yvonne Doherty report being employed by the Leicester Diabetes Centre, an organisation (employer) jointly hosted by a NHS hospital trust and the University of Leicester and which is the holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) suite of programmes, training and intervention fidelity framework that were used in this study. Fiona Gaughran reports personal fees from Otsuka and Lundbeck and personal fees and non-financial support from Sunovion, outside the submitted work, and has a family member with professional links to Eli Lilly and Company and GlaxoSmithKline (Brentford, UK), including shares.

Background: In the UK and other high-income countries, life expectancy in people with schizophrenia is 20% lower than in the general population., Aims: To examine the quality of assessment and treatment of physical health problems in people with schizophrenia. Method Retrospective audit of records of people with schizophrenia or schizoaffective disorder aged ⩾18. We collected data on nine key aspects of physical health for 5091 patients and combined these with a cross-sectional patient survey., Results: Body mass index was recorded in 2599 (51.1%) patients during the previous 12 months and 1102 (21.6%) had evidence of assessment of all nine key measures. Among those with high blood sugar, there was recorded evidence of 53.5% receiving an appropriate intervention. Among those with dyslipidaemia, this was 19.9%. Despite this, most patients reported that they were satisfied with the physical healthcare they received., Conclusions: Assessment and treatment of common physical health problems in people with schizophrenia falls well below acceptable standards. Cooperation and communication between primary and secondary care services needs to improve if premature mortality in this group is to be reduced., (Royal College of Psychiatrists.)

The National Audit of Schizophrenia (NAS) examined the quality of care received in England and Wales. Part of the audit set out to determine whether six prescribing standards, set by the national clinical guidelines for schizophrenia, were being implemented and to prompt improvements in care. Mental Health Trusts and Health Boards provided data obtained from case-notes for adult patients living in the community with schizophrenia or schizoaffective disorder. An audit of practice tool was developed for data collection. Most of the 5055 patients reviewed were receiving pharmacological treatment according to national guidelines. However, 15.9% of the total sample (95%CI: 14.9-16.9) were prescribed two or more antipsychotics concurrently and 10.1% of patients (95%CI: 9.3-10.9) were prescribed medication in excess of recommended limits. Overall 23.7% (95%CI: 22.5-24.8) of patients were receiving clozapine. However, there were many with treatment resistance who had no clear reason documented as to why they had not had a trial of clozapine (430/1073, 40.1%). In conclusion, whilst most people were prescribed medication in accordance with nationally agreed standards, there was considerable variation between service providers. Antipsychotic polypharmacy, high dose prescribing and clozapine underutilisation in treatment resistance were all key concerns which need to be further addressed., (Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.)

Background: People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not known whether diabetes self‐management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co‐existing SMI and diabetes. Aims: To develop a core outcome set (COS) for use in effectiveness trials of diabetes self‐management interventions in adults with both type 2 diabetes and SMI. Methods: The COS was developed in three stages: (i) identification of outcomes from systematic literature review of intervention studies, followed by multi‐stakeholder and service user workshops; (ii) rating of outcomes in a two‐round online Delphi survey; (iii) agreement of final 'core' outcomes through a stakeholder consensus workshop. Results: Seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health‐related quality of life, diabetes self‐management, diabetes‐related distress and medication adherence. Conclusions: This COS is recommended for future trials of effectiveness of diabetes self‐management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy. [ABSTRACT FROM AUTHOR]

Objectives: To test the hypotheses that: (1) Prevalence of periodontal disease would be higher in people with a history of psychosis when compared to the general population and (2) Demographic, life‐style related factors and co‐morbid medical conditions would predict periodontal disease in people experiencing psychosis. Methods: The authors performed cross‐sectional analysis of baseline data from the UK Biobank study (2007–2010), identifying cases with psychosis using clinical diagnosis, antipsychotic medication, and self‐report. Demographic (age, gender, ethnicity, socioeconomic status), lifestyle‐related(BMI, blood pressure, smoking and alcohol intake, physical activity) and physical co‐morbidities (cancer, cardiovascular, respiratory, inflammatory disease and metabolic conditions) were included as potential risk factors for periodontal disease among people with a history of psychosis using logistic regression analyses. The analysis sample included 502,505 participants. Results: Risk of periodontal disease was higher in people with psychosis, regardless of how cases were identified. Patients with a clinical diagnosis had the highest proportion of periodontal disease compared to the general population (21.3% vs. 14.8%, prevalence ratio 1.40, 95% CI: 1.26–1.56). Older and female cases were more likely to experience periodontal disease. Lifestyle factors (smoking) and comorbidities (cardiovascular, cancer or respiratory disease) were associated with periodontal disease among people with a history of psychosis. Conclusions: The findings suggest that periodontal disease is more common in people with a history of psychosis, compared to the general population. Prevention and early diagnosis of periodontal disease should be a priority for oral health promotion programmes, which should also address modifiable risk factors like smoking which also contribute to co‐morbid systemic disease. [ABSTRACT FROM AUTHOR]

Informal caregivers of individuals affected by psychotic disorder can play a key role in the recovery process. However, little research has been conducted on the lived experiences of carers and family members. We conducted a bottom-up (from lived experience to theory) review of first-person accounts, co-written between academics and experts by experience, to identify key experiential themes. First-person accounts of carers, relatives, and individuals with psychosis were screened and discussed in collaborative workshops involving individuals with lived experiences of psychosis, family members, and carers, representing various organizations. The lived experiences of family members and carers were characterized by experiential themes related to dealing with the unexpected news, the search for a reason behind the disorder, living with difficult and negative emotions, dealing with loss, feeling lost in fragmented healthcare systems, feeling invisible and wanting to be active partners in care, struggling to communicate with the affected person, fighting stigma and isolation, dealing with an uncertain future, and learning from one's mistakes and building resilience and hope. Our findings bring forth the voices of relatives and informal carers of people with psychosis, by highlighting some of the common themes of their lived experiences from the time of the initial diagnosis and throughout the different clinical stages of the disorder. Informal carers are key stakeholders who can play a strategic role, and their contributions in the recovery process merit recognition and active support by mental health professionals. [ABSTRACT FROM AUTHOR]

Aim: Early Intervention Psychosis Services (EIPS) for people experiencing First Episode Psychosis (FEP) offer important clinical and non‐clinical benefits over standard care. Similarly, intervention for Clinical High Risk for Psychosis state (CHR‐P) can prevent psychosis, ameliorate symptoms and have non‐clinical benefits. This study aimed to estimate associated local economic benefits of FEP and CHR‐P services compared with standard care. Methods: Across four south London boroughs, proportion of annual number of new cases of FEP and CHR‐P seen by early intervention services was estimated. Economic modelling conducted for England's mental health strategy was applied to estimate local economic impacts of current and improved service provision. Results: Across four London boroughs during 2011/2012, proportion of 15‐34 year olds with FEP seen by EIPS was 100.2% assuming 80/100 000 annual incidence whereas proportion with CHR‐P seen by CHR‐P services was 4.1% assuming 200/100 000 annual incidence. Application of economic modelling suggests that provision of EIPS to reach all new FEP cases each year would free up resources of £13.1m over 10 years including £2.0m to National Health Service (NHS) after the first year. Scaling up to reach all new CHR‐P cases each year would free up resources of £19.7m over 10 years with an estimated 10‐year cost of implementation gap for each 1 year cohort of £18.9m. An earlier related briefing resulted in increased funding for EIPS and new CHR‐P services despite overall cuts to mental health services. Conclusions: Estimation of local economic impacts of FEP and CHR‐P services was associated with improved investment in such services. [ABSTRACT FROM AUTHOR]

People with severe mental illness (SMI) have a reduction in life expectancy of around 15-20 years. A higher prevalence of diabetes and its complications contributes to this health inequality. The risk of diabetes and barriers to managing the condition alongside SMI require more tailored lifestyle interventions, regular monitoring of risk from the onset of psychosis, high-quality antipsychotic prescribing, smoking cessation, support for self-management and collaborative care. Increasing awareness about the particular risks that people with SMI face and the proactive approach that is needed to sufficiently screen and intervene for diabetes may help to ensure that these individuals are better supported. The Lester resource provides practitioners with a useful tool to help facilitate this. [ABSTRACT FROM AUTHOR]

Aims: Ongoing NICE guidance recommends research on the clinical and cost effectiveness of psychological treatment alone, compared to antipsychotic medication and compared to psychological treatment and antipsychotic medication combined. The COMPARE study (Cognitive behaviour therapy or Medication for Psychosis- A Randomised Evaluation) was a pilot trial designed to inform a definitive trial to answer this question. Method: COMPARE was a single-site pilot randomised controlled trial to compare a standardised Cognitive Behaviour Therapy (CBT) intervention to treatment with antipsychotic medication (APs) and a combined treatment (CBT plus APs) in adults with psychosis. Participants were assessed using the Positive and Negative Syndrome Scale (PANSS) and followed up at 6, 12, 24 and 52 weeks. The primary outcomes were recruitment and retention of participants. We surveyed a wider population of staff and service users to further inform feasibility of a definitive trial. Results: We report the characteristics of the recruited sample at baseline (n = 75) and results from surveys. Conclusions: The study recruited to target demonstrating it is feasible to identify and recruit participants to a study of this kind. The survey results also suggest that such trials are feasible. [ABSTRACT FROM AUTHOR]

Background: People with schizophrenia are two to three times more likely to be overweight than the general population. The UK National Institute of Health and Care Excellence (NICE) recommends an annual physical health review with signposting to, or provision of, a lifestyle programme to address weight concerns and obesity. The purpose of this randomised controlled trial is to assess whether a group-based structured education programme can help people with schizophrenia to lose weight. Methods: Design: a randomised controlled trial of a group-based structured education programme. Setting: 10 UK community mental health trusts. Participants: 396 adults with schizophrenia, schizoaffective, or first-episode psychosis who are prescribed antipsychotic medication will be recruited. Participants will be overweight, obese or be concerned about their weight. Intervention: participants will be randomised to either the intervention or treatment as usual (TAU). The intervention arm will receive TAU plus four 2.5-h weekly sessions of theory-based lifestyle structured group education, with maintenance contact every 2 weeks and ‘booster’ sessions every 3 months. All participants will receive standardised written information about healthy eating, physical activity, alcohol and smoking. Outcomes: the primary outcome is weight (kg) change at 1 year post randomisation. Secondary outcomes, which will be assessed at 3 and 12 months, include: the proportion of participants who maintained or reduced their weight; waist circumference; body mass index; objectively measured physical activity (wrist accelerometer); self-reported diet; blood pressure; fasting plasma glucose, lipid profile and HbA1c (baseline and 1 year only); health-related quality of life (EQ-5D- 5L and RAND SF-36); (adapted) brief illness perception questionnaire; the Brief Psychiatric Rating Scale; the Client Service Receipt Inventory; medication use; smoking status; adverse events; depression symptoms (Patient Health Questionnaire-9); use of weight-loss programmes; and session feedback (intervention only). Outcome assessors will be blind to trial group allocation. Qualitative interviews with a subsample of facilitators and invention-arm participants will provide data on intervention feasibility and acceptability. Assessment of intervention fidelity will also be performed. Discussion: The STEPWISE trial will provide evidence for the clinical and cost-effectiveness of a tailored intervention, which, if successful, could be implemented rapidly in the NHS. [ABSTRACT FROM AUTHOR]

Purpose – The purpose of this paper is to improve the quality of monitoring of risk factors that predict the likelihood of people with severe mental illness (SMI) developing cardiovascular disease (CVD), diabetes and obesity, major contributors to poor physical health and risk of premature mortality. Design/methodology/approach – The first phase of the AQuA “Don’t just screen-intervene” initiative supported five specialised community-based Early Intervention for Psychosis services in North West England to assess the effectiveness of monitoring of cardiometabolic risk in their patients using standards derived from the Lester Positive Cardiometabolic Health Resource, a nationally acknowledged framework for people with psychosis receiving antipsychotic medication. The initial findings formed the basis for a quality improvement programme which ran from November 2012 until May 2013. Findings – By the end of a six month quality improvement programme the likelihood of a patient receiving a comprehensive cardiometabolic risk screening (evidenced by recorded measurement of body mass index or waist circumference, blood pressure, blood glucose and lipid profile, assessment of smoking status and enquiry of relevant family history) had increased from 10 to between 63 and 80 per cent. Research limitations/implications – Cardiometabolic risk monitoring from the onset of psychosis and its treatment can be improved utilising quality improvement methodology in real-world specialist mental health services. Earlier identification and treatment of risk factors that predict higher rates of obesity, diabetes and SMI may help people with SMI avoid life-restricting and life-shortening physical disorders. Practical implications – Given the National Audit of Schizophrenia findings of inadequate screening in those with established SMI alongside evidence that CVD risk can emerge early in the course of psychosis, a group of early intervention in psychosis services in North West England decided to examine this aspect of their routine clinical practice. This service evaluation describes the effectiveness of a quality improvement programme based on the Lester Positive Cardiometabolic Health Resource (referred to as Lester resource henceforth) to improve the effectiveness of monitoring of risk factors that predict the likelihood of people experiencing psychosis and schizophrenia developing CVD diabetes and obesity. Social implications – A combination of social disadvantage and unhealthy lifestyles, adverse cardiometabolic impacts of antipsychotic medication and inequitable access to physical healthcare combine to put people with SMI at particular risk from CVD, the single biggest cause of premature death, and much more common than suicide (Brown et al., 2010). Despite higher rates of potentially modifiable CVD risk factors (De Hert et al., 2009) people with SMI appear to be missing out on opportunities to actively prevent conditions like CVD and diabetes compared to the general population. Originality/value – People with SMI such as schizophrenia die 15-20 years earlier on average than the general population. Around 20 per cent of premature deaths can be explained by suicide and injury, but the remainder arise from a variety of natural causes such as CVD, chronic obstructive pulmonary disorder and certain cancers and infections (Nordentoft et al., 2013). The authors worked with five mental health trusts in the North West of England covering a sample of over 500 cases within early intervention services. [ABSTRACT FROM AUTHOR]

Aim: To consider how early intervention in psychosis can support a recovery paradigm. Methods: Significant numbers of those developing a first episode of psychosis are on a path to a persisting and potentially life long condition. Constituting the schizophrenia spectrum disorders, such conditions demand the particular qualities and attitudes inherent within recovery-based practice. This paper explores some of these qualities and attitudes by examining the tension between a traditional ‘clinical’ narrative used by many health providers and a ‘human’ narrative of users of services and their families. Results: We draw out key features and constructs of recovery practice as they relate to the EI paradigm. These include: woodshedding, turning points, discontinuous improvement models, therapeutic optimism, gradualism and narratives of story telling. We also highlight the role of family members and other close supporters and believe their potential contribution requires greater consideration. Conclusions: The early intervention (EI) paradigm can resonate and indeed offer a stronghold for recovery-based practice where traditional mental health services have sometimes struggled. Conversely, failure of caregivers to provide such an approach in the early phase of illness can cause unnecessary and sometimes disastrous consequences. [ABSTRACT FROM AUTHOR]

Background: The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15 to 20 years less than that for the population as a whole. Diabetes contributes significantly to this inequality, being 2 to 3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socioeconomic disadvantage and health care inequality. However, little is known about how these factors may interact to influence the risk of developing diabetes and poor diabetic outcomes, or how the organization and provision of health care may contribute. Objective: This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with SMI. Methods: This study will employ a concurrent mixed methods design combining the interrogation of electronic primary care health records from the Clinical Practice Research Datalink (CPRD GOLD) with qualitative interviews with adults with SMI and diabetes, their relatives and friends, and health care staff. The study has been funded for 2 years, from September 2017 to September 2019, and data collection has recently ended. Results: CPRD and linked health data will be used to explore the association of sociodemographics, illness, and health care–related factors with both the development and outcomes of type 2 diabetes in people with SMI. Experiences of managing the comorbidity and accessing health care will be explored through qualitative interviews using topic guides informed by evidence synthesis and expert consultation. Findings from both datasets will be merged to develop a more comprehensive understanding of diabetes risks, interventions, and outcomes for people with SMI. Findings will be translated into recommendations for interventions and services using co-design workshops. Conclusions: Improving diabetes outcomes for people with SMI is a high-priority area nationally and globally. Understanding how risk factors combine to generate high prevalence of diabetes and poor diabetic outcomes for this population is a necessary first step in developing health care interventions to improve outcomes for people with diabetes and SMI. Trial Registration: ClinicalTrials.gov NCT03534921; https://clinicaltrials.gov/ct2/show/NCT03534921 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]

Physical ill health can restrict and shorten the lives of people with severe mental illnesses such as schizophrenia and bipolar disorder. This article looks at a new initiative by the Royal College of Psychiatrists, in collaboration with the Royal College of Nursing and the Royal College of General Practitioners, to help identify the risk of cardiovascular disorders and type 2 diabetes, and improve treatment. [ABSTRACT FROM AUTHOR]

Recounts the authors' experience with their teenage daughter, Mary, who was diagnosed as having schizophrenia. Account on Mary's decline and rehabilitation; Implications of the case.