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BACKGROUND: Cervical cancer is the fourth most common cancer in women, with an estimated 342,000 deaths worldwide in 2020. Current standard of care in the UK for locally advanced cervical cancer is concurrent chemoradiotherapy with weekly cisplatin, yet 5-year overall survival rates are only 65% with a distant relapse rate of 50%. Inhibitors of Apoptosis Proteins (IAPs) are often overexpressed in cancer cells and associated with tumour progression and resistance to treatment. Tolinapant, developed by Astex Pharmaceuticals, is an IAP antagonist with an additional mechanism of action via down-regulation of NF-kB, an important regulator in cervical cancer. Preclinical studies performed using tolinapant in combination with cisplatin and radiotherapy showed inhibition of tumour growth and enhanced survival. There is therefore a strong rationale to combine tolinapant with chemoradiotherapy (CRT). METHODS: CRAIN is a phase Ib open-label, dose escalation study to characterise the safety, tolerability and initial evidence for clinical activity of tolinapant when administered in combination with cisplatin based CRT. Up to 42 patients with newly diagnosed cervix cancer will be recruited from six UK secondary care sites. The number of participants and the duration of the trial will depend on toxicities observed and dose escalation decisions, utilising a TiTE-CRM statistical design. Treatment will constist of standard of care CRT with 45 Gy external beam radiotherapy given in 25 daily fractions over 5 weeks with weekly cisplatin 40mg/m2. This is followed by brachytherapy for which common schedules will be 28 Gy in 4 fractions high-dose-rate or 34 Gy in 2 fractions pulsed-dose-rate. Tolinapant will be administered in fixed dose capsules taken orally daily for seven consecutive days as an outpatient on alternate weeks (weeks 1, 3, 5) during chemoradiation. Dose levels for tolinapant which will be assessed are: 60 mg; 90 mg (starting level); 120 mg; 150 mg; 180 mg. Escalation will be guided by emerging safety data and decisions by the Safety Review Committee. DISCUSSION: If this trial determines a recommended phase II dose and shows tolinapant to be safe and effective in combination with CRT, it would warrant future phase trials. Ultimately, we hope to provide a synergistic treatment option for these patients to improve outcome. TRIAL REGISTRATIONS: EudraCT Number: 2021-006555-34 (issued 30th November 2021); ISRCTN18574865 (registered 30th August 2022).
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Quimiorradioterapia , Neoplasias do Colo do Útero , Adulto , Feminino , Humanos , Quimiorradioterapia/métodos , Cisplatino/administração & dosagem , Cisplatino/uso terapêutico , Reino Unido , Neoplasias do Colo do Útero/terapia , Neoplasias do Colo do Útero/tratamento farmacológico , Neoplasias do Colo do Útero/patologia , Ensaios Clínicos Fase I como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Acute Day Units (ADUs) provide intensive, non-residential, short-term treatment for adults in mental health crisis. They currently exist in approximately 30% of health localities in England, but there is little research into their functioning or effectiveness, and how this form of crisis care is experienced by service users. This qualitative study explores the views and experiences of stakeholders who use and work in ADUs. METHODS: We conducted 36 semi-structured interviews with service users, staff and carers at four ADUs in England. Data were analysed using thematic analysis. Peer researchers collected data and contributed to analysis, and a Lived Experience Advisory Panel (LEAP) provided perspectives across the whole project. RESULTS: Both service users and staff provided generally positive accounts of using or working in ADUs. Valued features were structured programmes that provide routine, meaningful group activities, and opportunities for peer contact and emotional, practical and peer support, within an environment that felt safe. Aspects of ADU care were often described as enabling personal and social connections that contribute to shifting from crisis to recovery. ADUs were compared favourably to other forms of home- and hospital-based acute care, particularly in providing more therapeutic input and social contact. Some service users and staff thought ADU lengths of stay should be extended slightly, and staff described some ADUs being under-utilised or poorly-understood by referrers in local acute care systems. CONCLUSIONS: Multi-site qualitative data suggests that ADUs provide a distinctive and valued contribution to acute care systems, and can avoid known problems associated with other forms of acute care, such as low user satisfaction, stressful ward environments, and little therapeutic input or positive peer contact. Findings suggest there may be grounds for recommending further development and more widespread implementation of ADUs to increase choice and effective support within local acute care systems.
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Transtornos Mentais , Serviços de Saúde Mental , Adulto , Cuidadores , Inglaterra , Humanos , Transtornos Mentais/terapia , Saúde Mental , Pesquisa QualitativaRESUMO
The specialist voluntary sector plays a crucial role in supporting survivors of sexual violence. However, in England, short-term funding underpins the sector's financial stability. This article examines sector leaders' ways of coping, resisting and being affected by funding practices. Using the concept of edgework, we show how funding and commissioning dynamics push individuals to the edge of service sustainability, job satisfaction, and emotional well-being. We examine how these edges are "worked," for example, by circumventing and remolding the edge. We offer an original way to theorize participants, make visible the emotional toll of service precarity and offer suggestions for support.
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Background: We explored the feasibility of a large-scale UK ambulance services trial of optimal defibrillation shock energy for out-of-hospital cardiac arrest. The primary objective of this feasibility study was to establish the number of eligible patients and the number recruited. Secondary outcomes were adherence to allocated treatment and data completeness. Methods: We conducted a three-arm parallel group cluster randomised controlled feasibility study in a single ambulance service in southern England. Adult patients in out-of-hospital cardiac arrest treated for a shockable rhythm were included. Zoll X series defibrillators (clusters) were randomised to deliver 120-150-200 J, 150-200-200 J, or 200-200-200 J shock strategies. Results: Between March 2022 and February 2023, we randomised 38 eligible patients (120-150-200 J (n = 12), 150-200-200 J (n = 10), 200-200-200 J (n = 16)) to the study. The recruitment rate per cluster was 0.07 per month. The median patient age was 71 years (IQR 59-81 years); 79% were male. Twenty-eight cardiac arrests (74%) occurred in a private residence, 29 (76%) were witnessed and 32 (84%) patients received bystander CPR. Treatment adherence was 93% and completeness of clinical and electrical outcomes was 86%. At 30 days, 3/36 (8.3%) patients survived; we were unable to collect survival outcomes for two patients. Defibrillation data collection became difficult when defibrillators became separated from their allocated vehicles. Conclusion: We have demonstrated the feasibility of a cluster randomised controlled trial of optimal shock energy for defibrillation in a UK ambulance service. We have identified possible solutions to issues relating to trial design.
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Background: UK COVID-19 vaccination policy has evolved to offering COVID-19 booster doses to individuals at increased risk of severe Illness from COVID-19. Building on our analyses of vaccine effectiveness of first, second and initial booster doses, we aimed to identify individuals at increased risk of severe outcomes (i.e., COVID-19 related hospitalisation or death) post the autumn 2022 booster dose. Methods: We undertook a national population-based cohort analysis across all four UK nations through linked primary care, vaccination, hospitalisation and mortality data. We included individuals who received autumn 2022 booster doses of BNT162b2 (Comirnaty) or mRNA-1273 (Spikevax) during the period September 1, 2022 to December 31, 2022 to investigate the risk of severe COVID-19 outcomes. Cox proportional hazard models were used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CIs) for the association between demographic and clinical factors and severe COVID-19 outcomes after the autumn booster dose. Analyses were adjusted for age, sex, body mass index (BMI), deprivation, urban/rural areas and comorbidities. Stratified analyses were conducted by vaccine type. We then conducted a fixed-effect meta-analysis to combine results across the four UK nations. Findings: Between September 1, 2022 and December 31, 2022, 7,451,890 individuals ≥18 years received an autumn booster dose. 3500 had severe COVID-19 outcomes (2.9 events per 1000 person-years). Being male (male vs female, aHR 1.41 (1.32-1.51)), older adults (≥80 years vs 18-49 years; 10.43 (8.06-13.50)), underweight (BMI <18.5 vs BMI 25.0-29.9; 2.94 (2.51-3.44)), those with comorbidities (≥5 comorbidities vs none; 9.45 (8.15-10.96)) had a higher risk of COVID-19 hospitalisation or death after the autumn booster dose. Those with a larger household size (≥11 people within household vs 2 people; 1.56 (1.23-1.98)) and from more deprived areas (most deprived vs least deprived quintile; 1.35 (1.21-1.51)) had modestly higher risks. We also observed at least a two-fold increase in risk for those with various chronic neurological conditions, including Down's syndrome, immunodeficiency, chronic kidney disease, cancer, chronic respiratory disease, or cardiovascular disease. Interpretation: Males, older individuals, underweight individuals, those with an increasing number of comorbidities, from a larger household or more deprived areas, and those with specific underlying health conditions remained at increased risk of COVID-19 hospitalisation and death after the autumn 2022 vaccine booster dose. There is now a need to focus on these risk groups for investigating immunogenicity and efficacy of further booster doses or therapeutics. Funding: National Core Studies-Immunity, UK Research and Innovation (Medical Research Council and Economic and Social Research Council), Health Data Research UK, the Scottish Government, and the University of Edinburgh.
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BACKGROUND: A small amount of evidence suggests that nasal sprays, or physical activity and stress management, could shorten the duration of respiratory infections. This study aimed to assess the effect of nasal sprays or a behavioural intervention promoting physical activity and stress management on respiratory illnesses, compared with usual care. METHODS: This randomised, controlled, open-label, parallel-group trial was done at 332 general practitioner practices in the UK. Eligible adults (aged ≥18 years) had at least one comorbidity or risk factor increasing their risk of adverse outcomes due to respiratory illness (eg, immune compromise due to serious illness or medication; heart disease; asthma or lung disease; diabetes; mild hepatic impairment; stroke or severe neurological problem; obesity [BMI ≥30 kg/m2]; or age ≥65 years) or at least three self-reported respiratory tract infections in a normal year (ie, any year before the COVID-19 pandemic). Participants were randomly assigned (1:1:1:1) using a computerised system to: usual care (brief advice about managing illness); gel-based spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); saline spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); or a brief behavioural intervention in which participants were given access to a website promoting physical activity and stress management. The study was partially masked: neither investigators nor medical staff were aware of treatment allocation, and investigators who did the statistical analysis were unaware of treatment allocation. The sprays were relabelled to maintain participant masking. Outcomes were assessed using data from participants' completed monthly surveys and a survey at 6 months. The primary outcome was total number of days of illness due to self-reported respiratory tract illnesses (coughs, colds, sore throat, sinus or ear infections, influenza, or COVID-19) in the previous 6 months, assessed in the modified intention-to-treat population, which included all randomly assigned participants who had primary outcome data available. Key secondary outcomes were possible harms, including headache or facial pain, and antibiotic use, assessed in all randomly assigned participants. This trial was registered with ISRCTN, 17936080, and is closed to recruitment. FINDINGS: Between Dec 12, 2020, and April 7, 2023, of 19 475 individuals screened for eligibility, 13 799 participants were randomly assigned to usual care (n=3451), gel-based nasal spray (n=3448), saline nasal spray (n=3450), or the digital intervention promoting physical activity and stress management (n=3450). 11 612 participants had complete data for the primary outcome and were included in the primary outcome analysis (usual care group, n=2983; gel-based spray group, n=2935; saline spray group, n=2967; behavioural website group, n=2727). Compared with participants in the usual care group, who had a mean of 8·2 (SD 16·1) days of illness, the number of days of illness was significantly lower in the gel-based spray group (mean 6·5 days [SD 12·8]; adjusted incidence rate ratio [IRR] 0·82 [99% CI 0·76-0·90]; p<0·0001) and the saline spray group (6·4 days [12·4]; 0·81 [0·74-0·88]; p<0·0001), but not in the group allocated to the behavioural website (7·4 days [14·7]; 0·97 [0·89-1·06]; p=0·46). The most common adverse event was headache or sinus pain in the gel-based group: 123 (4·8%) of 2556 participants in the usual care group; 199 (7·8%) of 2498 participants in the gel-based group (risk ratio 1·61 [95% CI 1·30-1·99]; p<0·0001); 101 (4·5%) of 2377 participants in the saline group (0·81 [0·63-1·05]; p=0·11); and 101 (4·5%) of 2091 participants in the behavioural intervention group (0·95 [0·74-1·22]; p=0·69). Compared with usual care, antibiotic use was lower for all interventions: IRR 0·65 (95% CI 0·50-0·84; p=0·001) for the gel-based spray group; 0·69 (0·45-0·88; p=0·003) for the saline spray group; and 0·74 (0·57-0·94; p=0·02) for the behavioural website group. INTERPRETATION: Advice to use either nasal spray reduced illness duration and both sprays and the behavioural website reduced antibiotic use. Future research should aim to address the impact of the widespread implementation of these simple interventions. FUNDING: National Institute for Health and Care Research.
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COVID-19 , Sprays Nasais , Atenção Primária à Saúde , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , COVID-19/complicações , Adulto , Idoso , Infecções Respiratórias/terapia , SARS-CoV-2 , Reino Unido , Terapia Comportamental/métodos , Exercício Físico , Estresse Psicológico/terapiaRESUMO
INTRODUCTION: Breast cancer is the most commonly diagnosed cancer in Australian women. Given the diverse geography and populations within Australia, the ability to offer a telemedicine-supported breast screening and assessment service may increase access. The aim of this study was to assess clinical outcomes of a telemedicine-based remote radiology assessment service delivery model for detecting breast cancer in regional Australian women compared to the traditional radiologist onsite model. METHODS: This study was a pre-post intervention study using de-identified administrative data. Data were collected from seven sites across three health jurisdictions within Australia. There were a total of 21,117 assessment visits, with 10,508 (49.8%) pre- and 10,609 (50.2%) post-remote model implementation. Of the 10,609 post-remote model visits, 3,904 (36.8%) were under the remote model. The main outcome was cancer detection, split into any cancer, any invasive cancer or any small invasive cancer. Timeliness of assessment was also examined. RESULTS: After adjusting for multiple factors, there were no statistically significant differences in cancer detection rates between the remote and onsite models (adjusted odds ratio (AOR) = 1.02, 95% CI 0.86-1.19, n.s.). Implementing the remote assessment model had statistically significant positive effects on the timeliness of assessment (AOR = 0.68, 95% CI 0.59-0.77, p < 0.001). DISCUSSION: This study found the remote model delivers safe and high-quality assessment services, with equivalent rates of cancer detection and improved timeliness of assessment when compared to the traditional onsite model. Careful monitoring and ongoing evaluation of any health-service model is important for ongoing safety, efficiency and acceptability.
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Neoplasias da Mama , Serviços de Saúde Rural , Telemedicina , Humanos , Feminino , Austrália , Acessibilidade aos Serviços de Saúde , Neoplasias da Mama/diagnóstico por imagemRESUMO
OBJECTIVE: This study investigated perspectives of healthcare professionals (HCPs) on the feasibility of giving additional support to patients after cancer is not found following urgent referral. We sought to understand key facilitators or barriers to offering such support. METHODS: A convenience sample of primary and secondary care healthcare professionals (n = 36) participated in semi-structured interviews. Interviews were transcribed verbatim and analysed using Framework Analysis, inductively and deductively, guided by the Theoretical Domains Framework. RESULTS: HCPs indicated that support should be offered if proven to be efficacious. It needs to avoid potential negative consequences such as patient anxiety and information overload. HCPs were more hesitant about whether support could feasibly be offered, due to resource restrictions and perceived remit of the urgent pathway for suspected cancer. CONCLUSION: HCP support after discharge from urgent cancer referral pathways needs to be resource efficient, developed in collaboration with patients and should have proven efficacy. Development of brief interventions for delivery by a range of staff, and use of technology could mitigate barriers to implementation. PRACTICE IMPLICATIONS: Changes to discharge procedures to provide information, endorsement or direction to services could offer much needed support. Additional support would need to overcome logistical challenges and address limited capacity.
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Detecção Precoce de Câncer , Neoplasias , Humanos , Estudos de Viabilidade , Pesquisa Qualitativa , Pessoal de Saúde , Neoplasias/diagnóstico , Neoplasias/prevenção & controle , Encaminhamento e ConsultaRESUMO
INTRODUCTION: Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices. OBJECTIVE: To better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency. DESIGN: Multicentre, observational cohort study. SETTING: Secondary care acute hospitals in South Wales, UK. PATIENTS: We plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration. PRIMARY OUTCOME: Presence of lower extremity DVT. SECONDARY OUTCOMES: Symptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration. ANALYSIS: The study statistical analysis plan will document analysis, methodology and procedures. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)-the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
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Hospitais para Doentes Terminais , Neoplasias , Tromboembolia Venosa , Humanos , Adolescente , Cuidados Paliativos , Anticoagulantes , Pacientes Internados , Estudos Observacionais como AssuntoRESUMO
BACKGROUND: The COVID-19 pandemic has directly and indirectly had an impact on health service provision owing to surges and sustained pressures on the system. The effects of these pressures on the management of long-term or chronic conditions are not fully understood. AIM: To explore the effects of COVID-19 on the recorded incidence of 17 long-term conditions. DESIGN AND SETTING: This was an observational retrospective population data linkage study on the population of Wales using primary and secondary care data within the Secure Anonymised Information Linkage (SAIL) Databank. METHOD: Monthly rates of new diagnosis between 2000 and 2021 are presented for each long-term condition. Incidence rates post-2020 were compared with expected rates predicted using time series modelling of pre-2020 trends. The proportion of annual incidence is presented by sociodemographic factors: age, sex, social deprivation, ethnicity, frailty, and learning disability. RESULTS: A total of 5 476 012 diagnoses from 2 257 992 individuals are included. Incidence rates from 2020 to 2021 were lower than mean expected rates across all conditions. The largest relative deficit in incidence was in chronic obstructive pulmonary disease corresponding to 343 (95% confidence interval = 230 to 456) undiagnosed patients per 100 000 population, followed by depression, type 2 diabetes, hypertension, anxiety disorders, and asthma. A GP practice of 10 000 patients might have over 400 undiagnosed long-term conditions. No notable differences between sociodemographic profiles of post- and pre-2020 incidences were observed. CONCLUSION: There is a potential backlog of undiagnosed patients with multiple long-term conditions. Resources are required to tackle anticipated workload as part of COVID-19 recovery, particularly in primary care.
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COVID-19 , Diabetes Mellitus Tipo 2 , Humanos , País de Gales/epidemiologia , COVID-19/epidemiologia , Incidência , Estudos Retrospectivos , Pandemias , Atenção Secundária à Saúde , Armazenamento e Recuperação da InformaçãoRESUMO
INTRODUCTION: The impact of long COVID on health-related quality of-life (HRQoL) and productivity is not currently known. It is important to understand who is worst affected by long COVID and the cost to the National Health Service (NHS) and society, so that strategies like booster vaccines can be prioritised to the right people. OpenPROMPT aims to understand the impact of long COVID on HRQoL in adults attending English primary care. METHODS AND ANALYSIS: We will ask people to participate in this cohort study through a smartphone app (Airmid), and completing a series of questionnaires held within the app. Questionnaires will ask about HRQoL, productivity and symptoms of long COVID. Participants will be asked to fill in the questionnaires once a month, for 90 days. Questionnaire responses will be linked, where possible, to participants' existing health records from primary care, secondary care, and COVID testing and vaccination data. Analysis will take place using the OpenSAFELY data platform and will estimate the impact of long COVID on HRQoL, productivity and cost to the NHS. ETHICS AND DISSEMINATION: The Proportionate Review Sub-Committee of the South Central-Berkshire B Research Ethics Committee has reviewed and approved the study and have agreed that we can ask people to take part (22/SC/0198). Our results will provide information to support long-term care, and make recommendations for prevention of long COVID in the future. TRIAL REGISTRATION NUMBER: NCT05552612.
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COVID-19 , Aplicativos Móveis , Adulto , Humanos , Big Data , Estudos de Coortes , COVID-19/prevenção & controle , Teste para COVID-19 , Medidas de Resultados Relatados pelo Paciente , Síndrome de COVID-19 Pós-Aguda , Smartphone , Medicina EstatalRESUMO
OBJECTIVES: Nasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people's perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use. DESIGN: Qualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at 'first signs' of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis. SETTING: Primary care, UK. PARTICIPANTS: 407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections. RESULTS: Both studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic. CONCLUSIONS: People who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.
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COVID-19 , Infecções Respiratórias , Humanos , Sprays Nasais , Pandemias/prevenção & controle , Atenção Primária à Saúde , Pesquisa Qualitativa , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/prevenção & controleRESUMO
BACKGROUND: In the UK, acute mental healthcare is provided by in-patient wards and crisis resolution teams. Readmission to acute care following discharge is common. Acute day units (ADUs) are also provided in some areas. AIMS: To assess predictors of readmission to acute mental healthcare following discharge in England, including availability of ADUs. METHOD: We enrolled a national cohort of adults discharged from acute mental healthcare in the English National Health Service (NHS) between 2013 and 2015, determined the risk of readmission to either in-patient or crisis teams, and used multivariable, multilevel logistic models to evaluate predictors of readmission. RESULTS: Of a total of 231 998 eligible individuals discharged from acute mental healthcare, 49 547 (21.4%) were readmitted within 6 months, with a median time to readmission of 34 days (interquartile range 10-88 days). Most variation in readmission (98%) was attributable to individual patient-level rather than provider (trust)-level effects (2.0%). Risk of readmission was not associated with local availability of ADUs (adjusted odds ratio 0.96, 95% CI 0.80-1.15). Statistically significant elevated risks were identified for participants who were female, older, single, from Black or mixed ethnic groups, or from more deprived areas. Clinical predictors included shorter index admission, psychosis and being an in-patient at baseline. CONCLUSIONS: Relapse and readmission to acute mental healthcare are common following discharge and occur early. Readmission was not influenced significantly by trust-level variables including availability of ADUs. More support for relapse prevention and symptom management may be required following discharge from acute mental healthcare.
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BACKGROUND: For people in mental health crisis, acute day units (ADUs) provide daily structured sessions and peer support in non-residential settings, often as an addition or alternative to crisis resolution teams (CRTs). There is little recent evidence about outcomes for those using ADUs, particularly compared with those receiving CRT care alone. AIMS: We aimed to investigate readmission rates, satisfaction and well-being outcomes for people using ADUs and CRTs. METHOD: We conducted a cohort study comparing readmission to acute mental healthcare during a 6-month period for ADU and CRT participants. Secondary outcomes included satisfaction (Client Satisfaction Questionnaire), well-being (Short Warwick-Edinburgh Mental Well-being Scale) and depression (Center for Epidemiologic Studies Depression Scale). RESULTS: We recruited 744 participants (ADU: n = 431, 58%; CRT: n = 312, 42%) across four National Health Service trusts/health regions. There was no statistically significant overall difference in readmissions: 21% of ADU participants and 23% of CRT participants were readmitted over 6 months (adjusted hazard ratio 0.78, 95% CI 0.54-1.14). However, readmission results varied substantially by setting. At follow-up, ADU participants had significantly higher Client Satisfaction Questionnaire scores (2.5, 95% CI 1.4-3.5, P < 0.001) and well-being scores (1.3, 95% CI 0.4-2.1, P = 0.004), and lower depression scores (-1.7, 95% CI -2.7 to -0.8, P < 0.001), than CRT participants. CONCLUSIONS: Patients who accessed ADUs demonstrated better outcomes for satisfaction, well-being and depression, and no significant differences in risk of readmission, compared with those who only used CRTs. Given the positive outcomes for patients, and the fact that ADUs are inconsistently provided in the National Health Service, their value and place in the acute care pathway needs further consideration and research.
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BACKGROUND: Working in good jobs is associated with good health. High unemployment rates are reported in those disabled with musculoskeletal pain. Supported employment interventions work well for helping people with mental health difficulties to gain and retain employment. With adaptation, these may be useful for people with chronic pain. We aimed to develop and explore the feasibility of delivering such an adapted intervention. METHODS: We developed an intervention and recruited unemployed people with chronic pain from NHS pain clinics and employment services. We trained case managers to assess participants and match them to six-week work placements in the Midlands and provide ongoing support to them and their managers. Participants attended a two-day work preparation session prior to placement. Outcome measures included quality of life at baseline, six- weeks, 14-weeks, and six-months, and return to work at 14-weeks and six-months. We held focus groups or interviews with stakeholders to examine acceptability and experiences of the intervention. RESULTS: We developed an intervention consisting of work preparation sessions, work experience placements, and individualised employment support. We enrolled 31 people; 27 attended work preparation sessions, and 15 attended placements. Four of our participants started jobs during the study period. We are aware of two others starting jobs shortly after cessation of follow-up. We experienced challenges to recruitment in one area where we had many and diverse placement opportunities and good recruitment in another area where we had a smaller range of placement opportunities. All stakeholders found the intervention acceptable, and it was valued by those given a placement. While there was some disappointment among those not placed, this group still valued the work preparation sessions. CONCLUSIONS: The developed intervention was acceptable to participants and partners. Trialling the developed intervention could be feasible with attention to three main processes. To ensure advanced availability of a sufficiently wide range of work placements in each area, multiple partners would be needed. Multiple recruitment sites and focus on employment services will yield better recruitment rates than reliance on NHS pain clinics. Maintaining an adequate follow-up response rate will likely require additional approaches with more than the usual effort.
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INTRODUCTION: The voluntary sector provides a range of specialist services to survivors of sexual violence, many of which have evolved from grass roots organisations responding to unmet local needs. However, the evidence base is poor in terms of what services are provided to which groups of survivors, how voluntary sector specialist (VSS) services are organised and delivered and how they are commissioned. This will be the first national study on the role of the voluntary sector in supporting survivors in England. METHODS AND ANALYSIS: This study uses an explanatory sequential naturalistic mixed-methods design with two stages. For stage 1, two national surveys of providers' and commissioners' views on designing and delivering VSS services will facilitate detailed mapping of service provision and commissioning in order to create a taxonomy of VSS services. Variations in the national picture will then be explored in stage 2 through four in-depth, qualitative case studies using the critical incident technique to explain the observed variations and understand the key contextual factors which influence service provision. Drawing on theory about the distinctive service contribution of the voluntary sector, survivors will be involved as co-researchers and will play a central role in data collection and interpretation. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of Birmingham research ethics committee for stage 1 of the project. In line with the sequential and co-produced study design, further applications for ethical review will be made in due course. Dissemination activities will include case study and end-of-project workshops; good practice guides; a policy briefing; project report; bitesize findings; webinars; academic articles and conference presentations. The project will generate evidence about what survivors want from and value about services and new understanding about how VSS services should be commissioned and provided to support survivors to thrive in the long term.