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BACKGROUND: UK cancer deaths remain high; primary care is key for earlier cancer diagnosis as half of avoidable delays occur here. Improvement is possible through lower referral thresholds, better guideline adherence, and better safety netting systems. Few interventions target whole practice teams. We developed a novel whole practice team intervention to address this. AIM: To test the feasibility and acceptability of a novel, complex behavioural intervention 'ThinkCancer!' for assessment in a subsequent Phase III trial. DESIGN & SETTING: Pragmatic, superiority pilot RCT with an embedded process evaluation and feasibility economic analysis in Welsh general practices. METHOD: Clinical outcome data were collected from practices (the unit of randomisation). Practice characteristics and cancer safety netting systems were assessed. Individual practice staff completed evaluation and feedback forms, and qualitative interviews. The intervention was adapted and refined. RESULTS: Trial recruitment and workshop deliveries took place between March 2020 to May 2021. Trial progression criteria for recruitment, intervention fidelity and routine data collection were met. Staff-level fidelity, retention and individual level data collection processes were reviewed and amended. Interviews highlighted positive participant views on all aspects of the intervention. All practices set out to liberalise referral thresholds appropriately, implement guidelines, and address safety netting plans in detail. CONCLUSION: 'ThinkCancer!' appears feasible and acceptable; the new iteration of the workshops was completed, and the Phase III trial has been funded to assess the effectiveness and cost effectiveness of this novel professional behaviour change intervention. Delivery at scale to multiple practices will likely improve fidelity and reach.
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Regular exercise and community engagement may slow the rate of function loss for people with dementia. However, the evidence is uncertain regarding the cost-effectiveness and social return on investment (SROI) of home exercise with community referral for people with dementia. This study aimed to compare the social value generated from the in-person PrAISED program delivered before March 2020 with a blended PrAISED program delivered after March 2020. SROI methodology compared in-person and blended delivery formats of a home exercise program. Stakeholders were identified, a logic model was developed, outcomes were evidenced and valued, costs were calculated, and SROI ratios were estimated. Five relevant and material outcomes were identified: 3 outcomes for patient participants (fear of falling, health-related quality of life, and social connection); 1 outcome for carer participants (carer strain), and 1 outcome for the National Health Service (NHS) (health service resource use). Data were collected at baseline and at 12-month follow-up. The in-person PrAISED program generated SROI ratios ranging from £0.58 to £2.33 for every £1 invested. In-person PrAISED patient participants gained social value from improved health-related quality of life, social connection, and less fear of falling. In-person PrAISED carer participants acquired social value from less carer strain. The NHS gained benefit from less health care service resource use. However, the blended PrAISED program generated lower SROI ratios ranging from a negative ratio to £0.08:£1. Compared with the blended program, the PrAISED in-person program generated higher SROI ratios for people with early dementia. An in-person PrAISED intervention with community referral is likely to provide better value for money than a blended one with limited community referral, despite the greater costs of the former.Trial registration: ISRCTN Registry ISRCTN15320670.
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COVID-19 , Análise Custo-Benefício , Demência , Qualidade de Vida , Humanos , Demência/economia , SARS-CoV-2 , Terapia por Exercício/economia , Terapia por Exercício/métodos , Serviços de Assistência Domiciliar/economia , Masculino , Feminino , Idoso , Cuidadores/psicologia , Medicina EstatalRESUMO
OBJECTIVES: Perinatal mental health problems affect one in five women and cost the UK £8.1 billion for every year of births, with 72% of this cost due to the long-term impact on the child. We conducted a rapid review of health economic evaluations of preventative care for perinatal anxiety and associated disorders. DESIGN: This study adopted a rapid review approach, using principles of the standard systematic review process to generate quality evidence. This methodology features a systematic database search, Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram, screening of evidence, data extraction, critical appraisal and narrative synthesis. DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Applied Social Sciences Index and Abstracts, PsycINFO and MEDLINE. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies that evaluated the costs and cost-effectiveness of preventative care for perinatal anxiety and associated disorders carried out within the National Health Service and similar healthcare systems. DATA EXTRACTION AND SYNTHESIS: A minimum of two independent reviewers used standardised methods to search, screen, critically appraise and synthesise included studies. RESULTS: The results indicate a lack of economic evaluation specifically for perinatal anxiety, with most studies focusing on postnatal depression (PND). Interventions to prevent postnatal mental health problems are cost-effective. Modelling studies have also been conducted, which suggest that treating PND with counselling would be cost-effective. CONCLUSION: The costs of not intervening in maternal mental health outweigh the costs of preventative interventions. Preventative measures such as screening and counselling for maternal mental health are shown to be cost-effective interventions to improve outcomes for women and children. PROSPERO REGISTRATION NUMBER: CRD42022347859.
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Análise Custo-Benefício , Humanos , Feminino , Gravidez , Ansiedade/prevenção & controle , Complicações na Gravidez/prevenção & controle , Complicações na Gravidez/economia , Depressão Pós-Parto/prevenção & controle , Depressão Pós-Parto/economia , Transtornos de Ansiedade/prevenção & controle , Transtornos de Ansiedade/economia , Reino Unido , Assistência Perinatal/economia , Assistência Perinatal/métodosRESUMO
The pathways for receiving a diagnosis of a rare type of dementia are poorly understood. Diagnostic challenges decrease access to relevant health promotion activities and post-diagnostic support. This study was focused on pathways experienced by people affected by rare dementia in Wales, United Kingdom (UK), considering the practical, emotional, and economic consequences. Semi-structured interviews were completed with 10 people affected by rare dementia across Wales, UK (nine family caregivers and one person living with rare dementia). The interview data were subject to a thematic analysis and a bottom-up costing approach was used to cost the pathway journeys. Five transitional points occurred across the diagnostic pathway (initial contact, initial referral, further referrals-provider, further referrals-private, and diagnosis) alongside two further themes (i.e., involved in the diagnostic process and disputes between stakeholders). The timeliness of the diagnosis was perceived to often be subject to 'luck', with access to private healthcare a personal finance option to expedite the process. Higher economic costs were observed when, in retrospect, inappropriate referrals were made, or multiple referrals were required. The confusion and disputes relating to individual diagnostic pathways led to further emotional burdens, suggesting that higher economic costs and emotional consequences are interlinked. Clearer diagnostic pathways for rare dementia may prevent unnecessary service contacts, waiting times, and associated distress. Prioritising appropriate and timely service contacts leads to diagnosis and support to families and enables people to increase control over their health. Appropriate diagnostic pathways may be less costly and reduce costs for families.
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Cuidadores , Demência , Humanos , Cuidadores/psicologia , Demência/diagnóstico , Demência/psicologia , Estudos Transversais , Atenção à Saúde , Reino Unido , Pesquisa QualitativaRESUMO
BACKGROUND: Type 2 diabetes is a public health priority for the UK. A growing body of evidence has indicated ethnic and socioeconomic disparities in rates of diabetes prevalence and complications. Attendance at diabetes follow-up checks is key to ensuring complications are identified and managed at an early stage. The aim of this rapid review was to identify and summarise evidence of ways to improve diabetes management in ethnic minority groups. METHODS: In this rapid review, we searched PubMed, PsycInfo, and CINAHL for studies published in English between Jan 1, 2000, and Jan 31, 2023. Studies were included if the population was from ethnic minority groups and if the intervention was community-based and aimed to improve diabetes self-care. The comparisons were persuasion and behaviour change, and the outcomes were improved diabetes self-management including, glycaemic control, attending eye tests, kidney, and foot screening follow-up checks. This study is registered with PROSPERO 2023, CRD42023399283. FINDINGS: Nine studies were included, from Mexico (n=1), USA (n=7), and UK (n=1). Most studies reported on community engagement (n=8), and one focussed on peer support and diabetes self-management. Peer support and diabetes self-management education were found to significantly improve diabetes control in a Mayan community (n=29) in Mexico (p<0·0001) and in the Korean American (n=105), African American (n=107), and Latino American (n=56) communities in the USA. Another study showed that women from the Pakistani community in England also benefitted from a culturally appropriate and socially supportive environment when learning about diabetes self-management. Diabetic eye screening rates could be increased through education but not through incentive payments. INTERPRETATION: Culturally competent health-care policies and programmes have been shown to increase diabetes self-management including uptake of diabetes screening for people with diabetes from ethnic minority communities to avoid potential harmful and life limiting conditions. A strength of this review is that robust, recent, and relevant papers regarding self-management of diabetes were included. The main limitations were that none of the nine studies included any cost analyses, and only one UK-based study was included, indicating that further research is required to fill the evidence gap. FUNDING: Research for Patient and Public Benefit (RfPPB), Health and Care Research Wales.
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Diabetes Mellitus Tipo 2 , Grupos Minoritários , Humanos , Feminino , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Etnicidade , Seguimentos , Comportamentos Relacionados com a SaúdeRESUMO
Background: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Proliferative vitreoretinopathy is the most common cause of retinal detachment and visual loss in eyes with open globe trauma. There is evidence from experimental studies and pilot clinical trials that the use of adjunctive steroid medication triamcinolone acetonide can reduce the incidence of proliferative vitreoretinopathy and improve outcomes of surgery for open globe trauma. Objective: The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study aimed to investigate the clinical effectiveness of adjunctive triamcinolone acetonide given at the time of vitreoretinal surgery for open globe trauma. Design: A phase 3 multicentre double-masked randomised controlled trial randomising patients undergoing vitrectomy following open globe trauma to either adjunctive triamcinolone acetonide or standard care. Setting: Hospital vitreoretinal surgical services dealing with open globe trauma. Participants: Patients undergoing vitrectomy surgery who had sustained open globe trauma. Interventions: Triamcinolone acetonide 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml sub-Tenon's or standard vitreoretinal surgery and postoperative care. Main outcome measures: The primary outcome was the proportion of patients with at least 10 letters of improvement in corrected visual acuity at six months. Secondary outcomes included retinal detachment secondary to proliferative vitreoretinopathy, retinal reattachment, macula reattachment, tractional retinal detachment, number of operations, hypotony, elevated intraocular pressure and quality of life. Health-related quality of life was assessed using the EuroQol Five Domain and Visual Function Questionnaire 25 questionnaires. Results: A total of 280 patients were randomised; 129 were analysed from the control group and 130 from the treatment group. The treatment group appeared, by chance, to have more severe pathology on presentation. The primary outcome (improvement in visual acuity) and principal secondary outcome (change in visual acuity) did not demonstrate any treatment benefit for triamcinolone acetonide. The proportion of patients with improvement in visual acuity was 47% for triamcinolone acetonide and 43% for standard care (odds ratio 1.03, 95% confidence interval 0.61 to 1.75, p = 0.908); the baseline adjusted mean difference in the six-month change in visual acuity was -2.65 (95% confidence interval -9.22 to 3.92, p = 0.430) for triamcinolone acetonide relative to control. Similarly, the secondary outcome measures failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal reattachment and stable macular retinal reattachment, outcomes for the treatment group were significantly worse for triamcinolone acetonide at the 5% level (respectively, odds ratio 0.59, 95% confidence interval 0.36 to 0.99, p = 0.044 and odds ratio 0.59, 95% confidence interval 0.35 to 0.98, p = 0.041) compared with control in favour of control. The cost of the intervention was £132 per patient. Health economics outcome measures (Early Treatment Diabetic Retinopathy Study, Visual Function Questionnaire 25 and EuroQol Five Dimensions) did not demonstrate any significant difference in quality-adjusted life-years. Conclusions: The use of combined intraocular and sub-Tenon's capsule triamcinolone acetonide is not recommended as an adjunct to vitrectomy surgery for intraocular trauma. Secondary outcome measures are suggestive of a negative effect of the adjunct, although the treatment group appeared to have more severe pathology on presentation. Future work: The use of alternative adjunctive medications in cases undergoing surgery for open globe trauma should be investigated. Refinement of clinical grading and case selection will enable better trail design for future studies. Trial registration: This trial is registered as ISRCTN 30012492, EudraCT number 2014-002193-37, REC 14/LNO/1428, IRAS 156358, Local R&D registration CHAD 1031. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (12/35/64) and will be published in full in Health Technology Assessment; Vol. 27, No. 12. See the NIHR Journals Library website for further project information.
Despite advances in surgical techniques, eye trauma remains a leading cause of blindness and visual impairment. The main cause of trauma is a scarring process within the eye proliferative vitreoretinopathy. There is good evidence from laboratory work and small-scale clinical studies that the addition of a steroid medication, triamcinolone acetonide, given in and around the eye at the time of surgery for eye trauma, can reduce the incidence of proliferative vitreoretinopathy scarring and improve the outcomes of surgery. The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study was a multicentre clinical trial designed to test the use of triamcinolone acetonide as an addition to surgery to improve outcomes in eyes with 'open globe' penetrating injuries. A total of 280 patients were recruited and randomised to receive standard surgery or surgery with the additional steroid (triamcinolone acetonide). No benefit was found from the addition of the steroid medication. The addition of steroid medication was not good value for money. Secondary outcome measures suggested that triamcinolone acetonide may have had a negative effect on outcomes, although this may have been due to the presence of more severe cases amongst the patients allocated to receive the additional steroid (triamcinolone acetonide). The use of adjunctive triamcinolone acetonide in eye trauma cases undergoing surgery is therefore not recommended. Future studies with different additional medications and/or more targeted case selection are indicated to improve outcomes for eyes experiencing penetrating trauma.
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Descolamento Retiniano , Cirurgia Vitreorretiniana , Vitreorretinopatia Proliferativa , Humanos , Triancinolona Acetonida/uso terapêutico , Glucocorticoides/uso terapêutico , Descolamento Retiniano/cirurgia , Descolamento Retiniano/complicações , Vitreorretinopatia Proliferativa/tratamento farmacológico , Vitreorretinopatia Proliferativa/cirurgia , Vitreorretinopatia Proliferativa/etiologia , Cirurgia Vitreorretiniana/efeitos adversos , Qualidade de VidaRESUMO
INTRODUCTION: Just under half of patients with obstructive sleep apnoea (OSA) also have gastro-oesophageal reflux disease (GORD). These conditions appear to be inter-related and continual positive airway pressure (CPAP) therapy, the gold standard treatment for OSA to prevent airway collapse, has been shown to reduce GORD. As the impact of mandibular advancement devices, a second-line therapy for OSA, on GORD has yet to be investigated, a feasibility study is needed prior to a definitive trial. METHODS: This will be a single-centre, single-blinded, tertiary-care based, interdisciplinary, parallel randomised controlled study. Potential OSA participants presenting to the sleep department will be pre-screened for GORD using validated questionnaires, consented and invited to receive simultaneous home sleep and oesophageal pH monitoring. Those with confirmed OSA and GORD (n=44) will be randomly allocated to receive either CPAP (n=22) or MAD therapy (n=22). Following successful titration and 3 weeks customisation period, participants will repeat the simultaneous sleep and oesophageal pH monitoring while wearing the device. The number of patients screened for recruitment, drop-out rates, patient feedback of the study protocol, costs of interventions and clinical information to inform a definitive study design will be investigated. ETHICS AND DISSEMINATION: Health Research Authority approval has been obtained from the Nottingham 2 Research Ethics Committee, ref:22/EM/0157 and the trial has been registered on ISRCTN (https://doi.org/10.1186/ISRCTN16013232). Definitive findings about the feasibility of doing 24 hour pH oesophageal monitoring while doing a home sleep study will be disseminated via clinical and research networks facilitating valuable insights into the simultaneous management of both conditions. TRIAL REGISTRATION NUMBER: ISRCTN Reg No: 16013232.
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Refluxo Gastroesofágico , Apneia Obstrutiva do Sono , Humanos , Estudos de Viabilidade , Placas Oclusais , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/terapia , Apneia Obstrutiva do Sono/terapia , Sono , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: A social prescribing (SP) link worker (LW) is responsible for enabling and supporting individuals, by assessing their personal goals and co-producing solutions to make use of appropriate local non-clinical resources or interventions. As an emerging new role, LWs are not regulated by professional bodies associated with SP. Therefore, currently there is no standardised training for LWs who are from varied backgrounds. As such, LWs have varying knowledge about how to deal with individuals with complex needs, which can impact on their decision-making capabilities to seek solutions and navigate complex systems. The purpose of the research was to explore LWs' level of education, past and current training requirements as well as elicit how much LWs were willing to pay (WTP) to access and undertake training to improve their skill set. METHODS: A rigorous mixed method research design was employed which included semi-structured interviews with key stakeholders and quantitative questionnaires including contingent valuation (CV) questions to a population of LWs across Wales from March to June 2020. Qualitative interviews with key stakeholders who commission and deliver social prescribing interventions employing LWs identified perceived link worker qualities and requirements for LW roles. Purposive sampling was used to identify and select individuals that have experience in managing LWs. Due to the COVID-19 pandemic, interviews were carried out exclusively online. LWs self-selected to complete the online questionnaires. Questionnaires gathered data on LW qualifications and demographic information with the CV questions gathering data on the value LW placed on accessing training in SP. Thematic narrative analysis was applied to interpret the data from the semi-structured interviews. Descriptive frequency analysis was conducted on the quantitative data generated from the online questionnaire. FINDINGS: SP coordinators (n = 6) reported that 'personal skills' are the most essential skills required by LWs in SP intervention. Training is available for LWs; however, the training undertaken varies depending on the type of intervention delivered, with 70% of LWs previously undertaking training to facilitate their development as an LW. The results from the contingent valuation questionnaire (n = 54) indicated that 100% of the respondents would avail of training. LWs were asked how much they were willing to pay as a single payment for professional training; on average, LWs were WTP GBP 58 from their personal funds to access training and the associated benefits to enhance their skills and knowledge. INTERPRETATION: The semi-structured interviews conducted with the key SP stakeholders yielded rich information and novel insight into LW training. External funding for the salary of the LW is an obstacle for LW development through training. In addition, the questionnaire results regarding stated preference techniques demonstrate that LWs place value on their professional development and would be willing to spend their own money on training to improve their knowledge and skills.
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COVID-19 , Pandemias , Humanos , Escolaridade , Confiabilidade dos Dados , Recursos HumanosRESUMO
Increased time spent in nature can enhance physical health and mental wellbeing. The UK Government's '25 Year Environment Plan' recommends extending the health benefits of contact with nature to a wider group of people, including those with mental health challenges. This study investigated whether nature-based interventions (NBIs) for people with mild mental health challenges could generate a positive social return on investment (SROI). Between May 2017 and January 2019, 120 participants at six outdoor sites in Wales participated in a 6 to 12-week NBI, which consisted of a weekly 2- to 4-h session. Quantitative data were collected from baseline and follow-up questionnaires identifying participant demographics and measuring mental wellbeing, physical activity, self-efficacy, and social trust. Wellbeing valuation generated a range of social value ratios by applying the Housing Association Charitable Trust (HACT) Social Value Calculator (SVC 4.0) and HACT Mental Health Social Value Calculator (MHSVC 1.0). Seventy-four participants (62%) completed follow-up questionnaires at 6 months. SROI ratios were calculated using the SVC for physical activity, self-efficacy, and social trust. The MHSVC generated social value ratios for mental wellbeing. The base case results revealed a positive social value ratio for participants, ranging from British Pound Sterling (GBP) 2.57 to GBP 4.67 for every GBP 1 invested, indicating favourable outcomes in terms of value generated.
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In Wales, the prevalence of Type 2 Diabetes Mellitus (T2DM) has increased from 7.3% in 2016 to 8% in 2020, creating a major concern for the National Health Service (NHS). Social prescribing (SP) has been found to decrease T2DM prevalence and improve wellbeing. The MY LIFE programme, a scheme evaluated between June 2021 and February 2022 in the Conwy West Primary Care Cluster, aimed to prevent T2DM by referring prediabetic patients with a BMI of ≥30 to a diabetes technician (DT), who then signposted patients to community-based SP programmes, such as the National Exercise Referral Scheme (NERS), KindEating, and Slimming World. Although some patients engaged with SP, others chose to connect only with the DT. A Social Return on Investment (SROI) analysis was conducted to evaluate those patients who engaged with the DT plus SP, and those who connected solely with the DT. Relevant participant outcomes included 'mental wellbeing' and 'good overall health', which were measured at baseline (n = 54) and at the eight-week follow-up (n = 24). The estimated social value for every GBP 1 invested for participants who engaged with the 'DT only' ranged from GBP 4.67 to 4.70. The social value for participants who engaged with the 'DT plus SP programme' ranged from GBP 4.23 to 5.07. The results indicated that most of the social value generated was associated with connecting with the DT.
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Diabetes Mellitus Tipo 2 , Estado Pré-Diabético , Humanos , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/prevenção & controle , Medicina Estatal , Exercício Físico , País de GalesRESUMO
There is growing interest in green social prescribing and connecting with nature-based activities to promote social cohesion along with improving levels of health, wealth and well-being. The Outdoor Partnership is a third sector organisation based in North Wales offering nature based social prescribing interventions. Individuals experiencing poor mental health and wellbeing are referred from GPs, community mental health services, and third sector organisations to the 'Opening the Doors to the Outdoors' (ODO) programme which is a 12-week outdoor walking and climbing green prescribing intervention. The purpose of the ODO programme is to provide a supportive environment to increase levels of physical activity among participants leading to improvements in overall health and mental wellbeing while promoting socialisation among peers. In this evaluation of a preventative green social prescribing intervention, a mixed method social return on investment (SROI) approach used quantitative and qualitative data from ODO participants. Data collection took place from April 2022-November 2022. Mental wellbeing data was collected at baseline and at 12 weeks using the Short Warwick Edinburgh Mental Wellbeing Scale, a social trust question, an overall health question, and the International Physical Activity Questionnaire- short form. Baseline and follow-up data was available for 52 ODO participants. Results indicate that for every £1 invested in the ODO programme, social values ranging from £4.90 to £5.36 were generated.
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Exercício Físico , Saúde Mental , Humanos , País de GalesRESUMO
BACKGROUND: Integrated programmes addressing varying forms of violence and abuse are increasingly delivered to children under 12 but uncertainty remains about what should be delivered to whom, when and in what dose. OBJECTIVE: To examine the impact of Speak Out Stay Safe (SOSS) - an integrated prevention programme for children under 12 - and whether impact varied by age, gender and context. PARTICIPANTS AND SETTING: A representative UK sample of primary schools in receipt of SOSS was matched with comparison schools not receiving SOSS. At 6 months follow-up, 1553 children from 36 schools completed the survey. METHODS: The matched control study incorporated economic and process evaluations. Survey measures included: children's knowledge and understanding of different forms of violence and abuse, readiness to seek help, knowledge of sexual abuse, perceptions of school culture and health and wellbeing. Perceptions of children, teachers, and facilitators were captured. RESULTS: At 6 months, children aged 9-10 who received SOSS retained their improved knowledge of neglect and their ability to identify a trusted adult who they would tell about violence or abuse. Children aged 6-7 receiving a shorter version of the programme were less likely to benefit and boys made fewer gains than girls. SOSS improved the knowledge of children with low knowledge of abuse. School culture was closely associated with programme impact. CONCLUSION: School-based prevention programmes deliver benefits at low cost but should acknowledge and engage with the specific school context to achieve school readiness and embed programme messages.
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Maus-Tratos Infantis , Instituições Acadêmicas , Masculino , Feminino , Criança , Humanos , Maus-Tratos Infantis/prevenção & controle , Violência/prevenção & controle , Serviços de Saúde EscolarRESUMO
BACKGROUND: UK cancer survival rates are much lower compared with other high-income countries. In primary care, there are opportunities for GPs and other healthcare professionals to act more quickly in response to presented symptoms that might represent cancer. ThinkCancer! is a complex behaviour change intervention aimed at primary care practice teams to improve the timely diagnosis of cancer. AIM: To explore the costs of delivering the ThinkCancer! intervention to expedite cancer diagnosis in primary care. DESIGN & SETTING: Feasibility economic analysis using a micro-costing approach, which was undertaken in 19 general practices in Wales, UK. METHOD: From an NHS perspective, micro-costing methodology was used to determine whether it was feasible to gather sufficient economic data to cost the ThinkCancer! INTERVENTION: Owing to the COVID-19 pandemic, ThinkCancer! was mainly delivered remotely online in a digital format. Budget impact analysis (BIA) and sensitivity analysis were conducted to explore the costs of face-to-face delivery of the ThinkCancer! intervention as intended pre-COVID-19. RESULTS: The total costs of delivering the ThinkCancer! intervention across 19 general practices in Wales was £25 030, with an average cost per practice of £1317 (standard deviation [SD]: 578.2). Findings from the BIA indicated a total cost of £34 630 for face-to-face delivery. CONCLUSION: Data collection methods were successful in gathering sufficient health economics data to cost the ThinkCancer! INTERVENTION: Results of this feasibility study will be used to inform a future definitive economic evaluation alongside a pragmatic randomised controlled trial (RCT).
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INTRODUCTION: In the UK, National Health Service (NHS) guidelines recommend that informal carers of people living with dementia should be offered training to help them develop care skills and manage their own physical and mental health. The WHO recommends access to affordable, proven, well-designed, online technologies for education, skills training and support for dementia carers. In response to these recommendations, this multisite randomised controlled trial (RCT) is the first study in the UK to evaluate the clinical and cost-effectiveness of an online support programme developed by the WHO called 'iSupport for dementia carers'. METHODS AND ANALYSIS: 350 informal carers (age 18+ years) living in Britain who self-identify as experiencing stress and depression will be recruited. They will be randomised to receive 'iSupport', or standardised information about caring for someone with dementia (control-comparison). Data will be collected via videoconferencing (eg, Zoom) or telephone interview at baseline, 3 months and 6 months. Intention-to-treat analysis will ascertain effectiveness in the primary outcomes (distress and depression) and combined cost, and quality-adjusted life-year data will be used to assess cost-effectiveness compared with usual care from a public sector and wider societal perspective. A mixed-methods process evaluation with a subgroup of carers in the intervention (~N=50) will explore the barriers and facilitators to implementing 'iSupport'. A non-randomised feasibility study will adapt 'iSupport' for young carers (n=38 participants, age 11-17 years). ETHICS AND DISSEMINATION: The research plan was scrutinised by National Institute for Health Research reviewers ahead of funding being awarded. Ethical approval was granted by Bangor University's School of Health and Medical Sciences Academic Ethics Committee, reference number 2021-16915. Dissemination plans include delivering events for stakeholders, social media, a project website, developing policy briefings, presenting at conferences and producing articles for open access publications. TRIAL REGISTRATION NUMBER: ISRCTN17420703.
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Demência , Telemedicina , Adolescente , Cuidadores/psicologia , Criança , Análise Custo-Benefício , Estudos de Viabilidade , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
The COVID-19 pandemic contributed to longer waiting lists for people seeking to access mental health services. The NHS Five Year Forward View encourages the development of empowerment-based social prescribing interventions to supplement existing mental health programmes. Based in South Wales, EmotionMind Dynamic (EMD) is a lifestyle coaching programme that supports individuals suffering from anxiety or depression. In this evaluation of lifestyle coaching, a mixed-method social return on investment (SROI) methodology was used to value quantitative and qualitative data from face-to-face and online participants. Data collection took place between June 2021 and January 2022. Participants included both self-referred clients and those referred from health services. Mental wellbeing data were collected at baseline and at the end of the programme using the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) and the General Self-Efficacy Scale (GSES). Baseline and follow-up data were available for 15 face-to-face participants and 17 online clients. Wellbeing valuation quantified and valued outcomes from participants. Results indicated that for every GBP 1 invested, lifestyle coaching generated social values ranging from GBP 4.12-GBP 7.08 for face-to-face clients compared with GBP 2.37-GBP 3.35 for online participants. Overall, lifestyle coaching generated positive social value ratios for both face-to-face and online clients.
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COVID-19 , Tutoria , COVID-19/epidemiologia , Humanos , Investimentos em Saúde , Saúde Mental , Pandemias/prevenção & controleRESUMO
BACKGROUND: People living with rarer dementias face considerable difficulty accessing tailored information, advice, and peer and professional support. Web-based meeting platforms offer a critical opportunity to connect with others through shared lived experiences, even if they are geographically dispersed, particularly during the COVID-19 pandemic. OBJECTIVE: We aim to develop facilitated videoconferencing support groups (VSGs) tailored to people living with or caring for someone with familial or sporadic frontotemporal dementia or young-onset Alzheimer disease, primary progressive aphasia, posterior cortical atrophy, or Lewy body dementia. This paper describes the development, coproduction, field testing, and evaluation plan for these groups. METHODS: We describe a 3-phase approach to development. First, information and knowledge were gathered as part of a coproduction process with members of the Rare Dementia Support service. This information, together with literature searches and consultation with experts by experience, clinicians, and academics, shaped the design of the VSGs and session themes. Second, field testing involved 154 Rare Dementia Support members (people living with dementia and carers) participating in 2 rounds of facilitated sessions across 7 themes (health and social care professionals, advance care planning, independence and identity, grief and loss, empowering your identity, couples, and hope and dementia). Third, a detailed evaluation plan for future rounds of VSGs was developed. RESULTS: The development of the small groups program yielded content and structure for 9 themed VSGs (the 7 piloted themes plus a later stages program and creativity club for implementation in rounds 3 and beyond) to be delivered over 4 to 8 sessions. The evaluation plan incorporated a range of quantitative (attendance, demographics, and geography; pre-post well-being ratings and surveys; psycholinguistic analysis of conversation; facial emotion recognition; facilitator ratings; and economic analysis of program delivery) and qualitative (content and thematic analysis) approaches. Pilot data from round 2 groups on the pre-post 3-word surveys indicated an increase in the emotional valence of words selected after the sessions. CONCLUSIONS: The involvement of people with lived experience of a rare dementia was critical to the design, development, and delivery of the small virtual support group program, and evaluation of this program will yield convergent data about the impact of tailored support delivered to geographically dispersed communities. This is the first study to design and plan an evaluation of VSGs specifically for people affected by rare dementias, including both people living with a rare dementia and their carers, and the outcome of the evaluation will be hugely beneficial in shaping specific and targeted support, which is often lacking in this population. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35376.
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BACKGROUND: Reducing bullying is a public health priority. KiVa, a school-based anti-bullying programme, is effective in reducing bullying in Finland and requires rigorous testing in other countries, including the UK. This trial aims to test the effectiveness and cost-effectiveness of KiVa in reducing child reported bullying in UK schools compared to usual practice. The trial is currently on-going. Recruitment commenced in October 2019, however due to COVID-19 pandemic and resulting school closures was re-started in October 2020. METHODS: Design: Two-arm pragmatic multicentre cluster randomised controlled trial with an embedded process and cost-effectiveness evaluation. PARTICIPANTS: 116 primary schools from four areas; North Wales, West Midlands, South East and South West England. Outcomes will be assessed at student level (ages 7-11 years; n = approximately 13,000 students). INTERVENTION: KiVa is a whole school programme with universal actions that places a strong emphasis on changing bystander behaviour alongside indicated actions that provide consistent strategies for dealing with incidents of bullying. KiVa will be implemented over one academic year. COMPARATOR: Usual practice. PRIMARY OUTCOME: Student-level bullying-victimisation assessed through self-report using the extensively used and validated Olweus Bully/Victim questionnaire at baseline and 12-month follow-up. SECONDARY OUTCOMES: student-level bullying-perpetration; student mental health and emotional well-being; student level of, and roles in, bullying; school related well-being; school attendance and academic attainment; and teachers' self-efficacy in dealing with bullying, mental well-being, and burnout. SAMPLE SIZE: 116 schools (58 per arm) with an assumed ICC of 0.02 will provide 90% power to identify a relative reduction of 22% with a 5% significance level. RANDOMISATION: recruited schools will be randomised on 1:1 basis stratified by Key-Stage 2 size and free school meal status. Process evaluation: assess implementation fidelity, identify influences on KiVa implementation, and examine intervention mechanisms. Economic evaluation: Self-reported victimisation, Child Health Utility 9D, Client Service Receipt Inventory, frequency of services used, and intervention costs. The health economic analysis will be conducted from a schools and societal perspective. DISCUSSION: This two-arm pragmatic multicentre cluster randomised controlled trial will evaluate the KiVa anti-bullying intervention to generate evidence of the effectiveness, cost-effectiveness and scalability of the programme in the UK. Our integrated process evaluation will assess implementation fidelity, identify influences on KiVa implementation across England and Wales and examine intervention mechanisms. The integrated health economic analysis will be conducted from a schools and societal perspective. Our trial will also provide evidence regarding the programme impact on inequalities by testing whether KiVa is effective across the socio-economic gradient. TRIAL REGISTRATION: Trials ISRCTN 12300853 Date assigned 11/02/2020.
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Bullying , COVID-19 , Bullying/prevenção & controle , Bullying/psicologia , Criança , Análise Custo-Benefício , Humanos , Estudos Multicêntricos como Assunto , Pandemias , Ensaios Clínicos Controlados Aleatórios como Assunto , Instituições Acadêmicas , Reino UnidoRESUMO
Research on quality adjusted life year (QALY) has been underway for just over 50 years, which seems like a suitable milestone to review its history. The purpose of this study is to provide a historical overview of why the QALY was developed, the key theoretical work undertaken by Torrance, Bush and Fanshel and how two seminal papers shaped its subsequent development. Moving the QALY forward - there are several historical and reflective exercises. The historical interplay between politics, policy and the challenges facing the National Health Service (NHS) in formulating the QALY concept in the UK has been explored in some depth already, whilst the conceptualization and development of the methodological framework is relatively underexplored. We address this gap by viewing the QALY through the lens of the methodological debates, reflecting upon two key papers underpinning the QALY methodology and how these methods have been developed over time. In part the changes in technology e.g. Google Scholar, and the availability of tools to search for early uses of the QALY allow us to better understand the historical context in which the theoretical development of the QALY has taken place. Here we celebrate two seminal papers that shaped early QALY development. The first section provides a history of these papers, summaries their contributions and explores the uptake of these papers over time. The second section reviews the methodological debates that have surrounded the QALY over the last 50 years and looks at how the QALY has moved to address these challenges. The third section presents the voices of diverse commentators representing the field of health economics who have contributed to the subsequent development of the QALY in both theoretical and empirical capacities and captures their thoughts about future research and policy use of QALYS.
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Medicina Estatal , Análise Custo-Benefício , Humanos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: Previous evidence suggests home-based dialysis to be more cost-effective than unit-based or hospital-based dialysis. However, previous analyses to quantify the costs of different dialysis modalities have used varied perspectives, different methods, and required assumptions due to lack of available data. The National Institute for Health and Care Excellence reports uncertainty about the differences in costs between home-based and unit-based dialysis. This uncertainty limits the ability of policy makers to make recommendations based on cost effectiveness, which also impacts on the ability of budget holders to model the impact of any service redesign and to understand which therapies deliver better value. The aim of our study was to use a combination of top-down and bottom-up costing methods to determine the direct medical costs of different dialysis modalities in one UK nation (Wales) from the perspective of the National Health Service (NHS). METHODS: Detailed hybrid top-down and bottom-up micro-costing methods were applied to estimate the direct medical costs of dialysis modalities across Wales. Micro-costing data was obtained from commissioners of the service and from interviews with renal consultants, nurses, accountants, managers and allied health professionals. Top-down costing information was obtained from the Welsh Renal Clinical Network (who commission renal services across Wales) and the Welsh Ambulance Service Trust. RESULTS: The annual direct cost per patient for home-based modalities was £16,395 for continuous ambulatory peritoneal dialysis (CAPD), £20,295 for automated peritoneal dialysis (APD) and £23,403 for home-based haemodialysis (HHD). The annual cost per patient for unit-based modalities depended on whether or not patients required ambulance transport. Excluding transport, the cost of dialysis was £19,990 for satellite units run in partnership with independent sector providers and £23,737 for hospital units managed and staffed by the NHS. When ambulance transport was included, the respective costs were £28,931 and £32,678, respectively. CONCLUSION: Our study is the most comprehensive analysis of the costs of dialysis undertaken thus far in the United Kingdom and clearly demonstrate that CAPD is less costly than other dialysis modalities. When ambulance transport costs are included, other home therapies (APD and HHD) are also less costly than unit-based dialysis. This detailed analysis of the components that contribute to dialysis costs will help inform future cost-effectiveness studies, inform healthcare policy and drive service redesign.
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Diálise Peritoneal , Diálise Renal , Humanos , Diálise Renal/métodos , Diálise Peritoneal/métodos , Medicina Estatal , Custos de Cuidados de Saúde , Análise Custo-Benefício , Reino UnidoRESUMO
BACKGROUND: The head and neck cancer (HNC) Patient Concerns Inventory (PCI) is a condition-specific prompt list that allows patients to raise concerns to cancer consultants that otherwise might be overlooked. OBJECTIVE: This is the first economic evaluation of the PCI in patients with HNC investigating the costs and effects to the health service of not prioritising certain treatment pathways in addition to the primary cancer pathway. Additional costs can be accrued due to delayed referral to other appropriate services, e.g. hospital dentist. Economic evidence could influence future policy direction in this area globally. METHODS: Alongside a 3-year clustered randomised controlled trial, an economic evaluation was undertaken with Client Service Receipt Inventory data collected at three different time points (baseline and 6 and 12 months post-baseline). Patients were identified by a multidisciplinary team at the trial clinics. This economic analysis compared the PCI intervention versus the non-PCI treatment pathway. A deterministic and probabilistic sensitivity analysis was conducted to investigate the cost per quality-adjusted life-year (QALY) gain of the PCI versus non-PCI intervention treatment pathways. Qualitative data were also collected from seven consultants to triangulate findings from the economic evaluation. RESULTS: The analysis used data from 191 patients (66% of the full trial sample). The PCI inventory was low cost, at just over £13 per participant. The PCI intervention was cost effective and also cost saving, with an incremental cost difference of £295.91 over the 12-month follow-up period. The QALY values were higher in the PCI intervention strategy, with a value of 0.79, whereas the non-PCI group had a value of 0.76, thus the PCI intervention was dominant. The sensitivity analysis showed that, at a willingness-to-pay threshold of £20,000 per QALY gained, the probability of being cost effective was 0.85 (95% confidence interval [CI] 0.80-0.83). Qualitative results showed that consultants using the PCI reported an enhanced awareness of patients' overall post-treatment needs. DISCUSSION: The PCI provided an effective means to conduct clinical consultations by avoiding unnecessary healthcare costs and focussing on aspects of care most important to patients. The cost per QALY gain was within the National Institute for Health and Care Excellence guideline threshold. The economic evaluation showed that the PCI intervention strategy was dominant and therefore cost saving to the national health service (NHS) and was more effective in terms of treatment. CONCLUSION: The PCI appears to be a low-cost intervention that generates a cost-effective benefit to patients from a NHS perspective if rolled out as part of routine care. Qualitative evidence has shown that the use of the PCI is supported by consultants in routine practice. TRIAL REGISTRATION: Clinical Trials Identifier: NCT03086629.