'ThinkCancer!' - Randomised feasibility trial of a novel practice-based early cancer diagnosis intervention.

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.

RCT-based Social Return on Investment (SROI) of a Home Exercise Program for People With Early Dementia Comparing In-Person and Blended Delivery Before and During the COVID-19 Pandemic.

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.

Health economic evaluations of preventative care for perinatal anxiety and associated disorders: a rapid review.

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.

The Diagnostic Pathway Experiences of People Living with Rare Dementia and Their Family Caregivers: A Cross-Sectional Mixed Methods Study Using Qualitative and Economic Analyses.

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.

Development of a value-based scoring system for the MobQoL-7D: a novel tool for measuring quality-adjusted life years in the context of mobility impairment.

PURPOSE: To create a preference-based value set scoring system for the MobQoL-7D outcome measure, and to examine differences in the health state preferences of the general population and individuals with impaired mobility. METHODS AND MATERIALS: A preference elicitation study was undertaken to ascribe utility weights to all health states (i.e., all unique combination of answers) described by the MobQoL-7D. The elicitation exercise was developed using the Online Elicitation of Personal Utility Functions (OPUF) tool. Two UK sample groups were recruited; firstly a representative general population sample (N = 504), secondly a balanced sample of individuals with impaired mobility (N = 368). Distinct preference-based value sets were developed for each sample. Differences in dimension ranking, weighting, and overall utility values were assessed. RESULTS: The general population sample considered most health states, especially the more severe states, to be worse than the mobility impaired sample comparatively. Statistically significant differences between the samples were observed in four of the seven MobQoL-7D dimensions. CONCLUSIONS: This study is the first to provide preference-based value sets for the MobQoL-7D, ready for use in economic evaluations, QALY calculation, and other clinical or research applications. The study demonstrates how the general public and individuals with impaired mobility value health states differently.

The MobQoL-7D offers a concise and valid tool for rehabilitation professionals to measure and monitor quality of life and quality-adjusted life years (QALYs) in the context of mobility impairment.The MobQoL-7D value set calculator allows summary utility scores and QALYs to be calculated using MobQoL-7D outcome data; the first of its kind.The general public and individuals with impaired mobility value health states differently, which could impact cost-per QALY calculations and subsequent service commissioning and funding decisions.

Cost-effectiveness of High-Intensity Interval Training (HIIT) vs Moderate Intensity Steady-State (MISS) Training in UK Cardiac Rehabilitation.

OBJECTIVE: To perform a cost-effectiveness analysis of high-intensity interval training (HIIT) compared with moderate intensity steady-state (MISS) training in people with coronary artery disease (CAD) attending cardiac rehabilitation (CR). DESIGN: Secondary cost-effectiveness analysis of a prospective, assessor-blind, parallel group, multi-center RCT. SETTING: Six outpatient National Health Service cardiac rehabilitation centers in England and Wales, UK. PARTICIPANTS: 382 participants with CAD (N=382). INTERVENTIONS: Participants were randomized to twice-weekly usual care (n=195) or HIIT (n=187) for 8 weeks. Usual care was moderate intensity continuous exercise (60%-80% maximum capacity, MISS), while HIIT consisted of 10 × 1-minute intervals of vigorous exercise (>85% maximum capacity) interspersed with 1-minute periods of recovery. MAIN OUTCOME MEASURES: We conducted a cost-effectiveness analysis of the HIIT or MISS UK trial. Health related quality of life was measured with the EQ-5D-5L to estimate quality-adjusted life years (QALYs). Costs were estimated with health service resource use and intervention delivery costs. Cost-utility analysis measured the incremental cost-effectiveness ratio (ICER). Bootstrapping assessed the probability of HIIT being cost-effective according to the UK National Institute for Health and Care Excellence (NICE) threshold value (£20,000 per QALY). Missing data were imputed. Uncertainty was estimated using probabilistic sensitivity analysis. Assumptions were tested using univariate/1-way sensitivity analysis. RESULTS: 124 (HIIT, n=59; MISS, n=65) participants completed questionnaires at baseline, 8 weeks, and 12 months. Mean combined health care use and delivery cost was £676 per participant for HIIT, and £653 for MISS. QALY changes were 0.003 and -0.013, respectively. For complete cases, the ICER was £1448 per QALY for HIIT compared with MISS. At a willingness-to-pay threshold of £20,000 per QALY, the probability of HIIT being cost-effective was 96% (95% CI, 0.90 to 0.95). CONCLUSION: For people with CAD attending CR, HIIT was cost-effective compared with MISS. These findings are important to policy makers, commissioners, and service providers across the health care sector.

Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: The ASCOT study.

BACKGROUND/AIMS: To investigate the clinical effectiveness of adjunctive triamcinolone acetonide (TA) given at the time of vitreoretinal surgery following open globe trauma (OGT). METHODS: A phase 3, multicentre, double-masked randomised controlled trial of patients undergoing vitrectomy following OGT comparing adjunctive TA (intravitreal and subtenons) against standard care (2014-2020). The primary outcome was the proportion of patients with at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement in corrected visual acuity (VA) at 6 months. Secondary outcomes included: change in ETDRS, retinal detachment (RD) secondary to PVR, retinal reattachment, macular reattachment, tractional RD, number of operations, hypotony, elevated intraocular pressure and quality of life. RESULTS: 280 patients were randomised over 75 months, of which 259 completed the study. 46.9% (n=61/130) of patients in the treatment group had a 10-letter improvement in VA compared with 43.4% (n=56/129) of the control group (difference 3.5% (95% CI -8.6% to 15.6%), OR=1.03 (95% CI 0.61 to 1.75), p=0.908)). Secondary outcome measures also failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal and macular reattachment, outcomes were worse in the treatment group compared with controls, respectively, 51.6% (n=65/126) vs 64.2% (n=79/123), OR=0.59 (95% CI 0.36 to 0.99), and 54.0% (n=68/126) vs 66.7% (n=82/123), OR=0.59 (95% CI 0.35 to 0.98), for TA vs control. CONCLUSION: The use of combined intraocular and sub-Tenons capsule TA is not recommended as an adjunct to vitrectomy surgery following OGT. TRIAL REGISTRATION NUMBER: NCT02873026.

Uptake of diabetes follow-up checks by minority community groups: a rapid review of the evidence for the CYMELL study.

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.

"Better Living with Non-memory-led Dementia": protocol for a feasibility randomised controlled trial of a web-based caregiver educational programme.

BACKGROUND: Non-memory-led dementias such as posterior cortical atrophy (PCA), primary progressive aphasia (PPA) and behavioural variant frontotemporal dementia (bvFTD) are low prevalent and often affect individuals under the age of 65. Tailored educational and support resources for caregivers of people living with these dementia phenotypes are scarce and unevenly distributed geographically. Web-based educational programmes are emerging as promising alternatives to improve caregiver self-efficacy and well-being. Here, we present the protocol of a study aiming to assess the feasibility of a co-produced online educational programme for caregivers of people living PCA, PPA and bvFTD: the Better Living with Non-memory-led Dementia programme. METHODS: A randomised controlled feasibility trial will be conducted on a sample of 30 caregivers of people living with PCA, PPA and bvFTD. Participants will be recruited among members of the support organisation Rare Dementia Support (based at UCL in the UK). The intervention group will be given access to an 8-week co-produced web-based educational programme consisting of 6 modules addressing education about PCA, PPA and bvFTD and support strategies for the person with dementia and for the caregiver. The control group will receive treatment as usual (TAU). Feasibility will be measured through feasibility of recruitment, clinical measurement tools and acceptability. Clinical measures will be used to assess preliminary efficacy and data on completion rates, missing data and variability used to decide on measures to be included in a full-scale trial. Allocation ratio will be 2:1 (intervention:control) stratified by diagnosis. Feasibility of recruitment and acceptability will be assessed. Clinical measures will be administered at baseline and 8-week and 3-month post-randomisation. The control group will be offered access to the intervention at the completion of data collection. Participants will be unblinded, and all measures will be self-reported online. DISCUSSION: Online-delivered educational programmes show potential for improving care competency of caregivers and may contribute to overcoming geographical inequalities in local provision of support services. This pilot study will inform a fully powered international trial to determine the effectiveness of Better Living with Non-memory-led Dementia. TRIAL REGISTRATION: This trial has been registered prospectively on the Clinical Trials Registry on 1st September 2022, registration number NCT05525377.

A randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery for open globe trauma - the ASCOT study.

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.

Prospects and Aspirations for Workforce Training and Education in Social Prescribing.

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.

Single-centre, single-blinded, randomised, parallel group, feasibility study protocol investigating if mandibular advancement device treatment for obstructive sleep apnoea can reduce nocturnal gastro-oesophageal reflux (MAD-Reflux trial).

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.

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial.

OBJECTIVE: To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. DESIGN: Randomised controlled trial. SETTING: Participants' homes and communities at five sites in the United Kingdom. PARTICIPANTS: 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers. INTERVENTION: The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dementia specific, rehabilitation programme focusing on strength, balance, physical activity, and performance of activities of daily living, which was tailored and progressive and addressed risk and the psychological needs of people with dementia. Up to 50 therapy sessions were provided over 12 months. The control group received usual care plus a falls risk assessment. Procedures were adapted during the covid-19 pandemic. MAIN OUTCOME MEASURES: The primary outcome was score on the carer (informant) reported disability assessment for dementia scale 12 months after randomisation. Secondary outcomes were self-reported activities of daily living, physical activity, quality of life, balance, functional mobility, fear of falling, frailty, cognition, mood, carer strain, service use at 12 months, and falls between months 4 and 15. RESULTS: 365 patient participants were randomised, 183 to intervention and 182 to control. The median age of participants was 80 years (range 65-95), median Montreal cognitive assessment score was 20 out of 30 (range 13-26), and 58% (n=210) were men. Intervention participants received a median of 31 therapy sessions (interquartile range 22-40) and reported completing a mean 121 minutes of PrAISED exercise each week. Primary outcome data were available for 149 intervention and 141 control participants. Scores on the disability assessment for dementia scale did not differ between groups: adjusted mean difference -1.3, 95% confidence interval -5.2 to 2.6; Cohen's d effect size -0.06, 95% confidence interval -0.26 to 0.15; P=0.51). Upper 95% confidence intervals excluded small to moderate effects on any of the range of outcome measures. Between months 4 and 15 the intervention group experienced 79 falls and the control group 200 falls (adjusted incidence rate ratio 0.78, 95% confidence interval 0.5 to 1.3; P=0.3). CONCLUSION: The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, or quality of life; reduce falls; or improve any other secondary health status outcomes, despite good uptake. Future research should consider alternative approaches to maintaining ability and wellbeing in people with dementia. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15320670.

Social Return on Investment of Nature-Based Activities for Adults with Mental Wellbeing Challenges.

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.

Social Return on Investment of Social Prescribing via a Diabetes Technician for Preventing Type 2 Diabetes Progression.

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.

Prevention of Poor Physical and Mental Health through the Green Social Prescribing Opening Doors to the Outdoors Programme: A Social Return on Investment Analysis.

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.

What makes for effectiveness when starting early - Learning from an integrated school-based violence and abuse prevention programme for children under 12.

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.

Prevention of postpartum haemorrhage: Economic evaluation of the novel butterfly device in a UK setting.

OBJECTIVES: To explore the cost-effectiveness of a novel PPH device as compared with usual care. DESIGN: A decision analytical model was used to explore the cost-effectiveness of the PPH Butterfly device compared with usual care. This was part of a United Kingdom, UK, clinical trial ISRCTN15452399 using a matched historical cohort who had standard PPH management without the use of the PPH Butterfly device. The economic evaluation was conducted from a UK National Health Service (NHS) perspective. SETTING: Liverpool Women's Hospital, UK. PARTICIPANTS: 57 women with 113 matched controls. INTERVENTION: The PPH Butterfly is a novel device that has been invented and developed in the UK to facilitate bimanual compression of the uterus in the treatment of PPH. MAIN OUTCOME MEASURES: Main outcome measures included healthcare costs, blood loss, and maternal morbidity events. RESULTS: Mean treatment costs in the Butterfly cohort were £3,459.66 as compared with standard care £3,223.93. Treatment with the Butterfly device resulted in decreased total blood loss in comparison with standard care. The Butterfly device had an incremental cost-effectiveness ratio of £3,795.78 per PPH progression avoided (defined as ≤ 1000 ml additional blood loss from device insertion point). If the NHS is prepared to pay £8,500 per PPH progression avoided, then the Butterfly device is cost-effective with a probability of 87 percent. In the PPH Butterfly treatment arm there were 9% fewer cases of massive obstetric haemorrhage (severe PPH of more than 2000mls or more than 4 units of blood transfusion required) recorded as compared with the standard care historical cohort. As a low-cost device, the PPH Butterfly device is cost-effective but can be cost-saving to the NHS. CONCLUSION: The PPH pathway can result in high-cost resource use such as blood transfusion or high dependence unit hospital stays. The Butterfly device is a relative low-cost device in a UK NHS setting with a high probability of being cost-effective. The National Institute for Health and Care Excellence (NICE) can use this evidence in considering the adoption of innovative technologies such as the Butterfly device in the NHS. Extrapolation on an international scale to lower and middle-income countries could prevent mortality associated with PPH.

High-intensity interval training in cardiac rehabilitation: a multi-centre randomized controlled trial.

BACKGROUND: There is a lack of international consensus regarding the prescription of high-intensity interval training (HIIT) for people with coronary artery disease (CAD) attending cardiac rehabilitation (CR). AIMS: To assess the clinical effectiveness and safety of low-volume HIIT compared with moderate-intensity steady-state (MISS) exercise training for people with CAD. METHODS AND RESULTS: We conducted a multi-centre RCT, recruiting 382 patients from 6 outpatient CR centres. Participants were randomized to twice-weekly HIIT (n = 187) or MISS (n = 195) for 8 weeks. HIIT consisted of 10 × 1 min intervals of vigorous exercise (>85% maximum capacity) interspersed with 1 min periods of recovery. MISS was 20-40 min of moderate-intensity continuous exercise (60-80% maximum capacity). The primary outcome was the change in cardiorespiratory fitness [peak oxygen uptake (VO2 peak)] at 8 week follow-up. Secondary outcomes included cardiovascular disease risk markers, cardiac structure and function, adverse events, and health-related quality of life. At 8 weeks, VO2peak improved more with HIIT (2.37 mL.kg-1.min-1; SD, 3.11) compared with MISS (1.32 mL.kg-1.min-1; SD, 2.66). After adjusting for age, sex, and study site, the difference between arms was 1.04 mL.kg-1.min-1 (95% CI, 0.38 to 1.69; P = 0.002). Only one serious adverse event was possibly related to HIIT. CONCLUSIONS: In stable CAD, low-volume HIIT improved cardiorespiratory fitness more than MISS by a clinically meaningful margin. Low-volume HIIT is a safe, well-tolerated, and clinically effective intervention that produces short-term improvement in cardiorespiratory fitness. It should be considered by all CR programmes as an adjunct or alternative to MISS. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02784873. https://clinicaltrials.gov/ct2/show/NCT02784873.

Cardiac rehabilitation exercise training can improve cardiorespiratory fitness and quality of life for people with coronary artery disease, but sometimes, it is not effective. The intensity of the exercise training may be important. We conducted a randomized controlled trial to test if moderate-intensity exercise or high-intensity exercise was better.High-intensity interval training was more effective than moderate-intensity exercise training for improving cardiorespiratory fitness in people with coronary artery disease attending cardiac rehabilitation.High-intensity interval training was safe and well tolerated.

A mixed method, phase 2 clinical evaluation of a novel device to treat postpartum haemorrhage.

BACKGROUND: We evaluated the safety, efficacy, and acceptability of a new device designed to facilitate uterine compression in women with postpartum haemorrhage (PPH). METHODS: A prospective, phase two clinical device trial with concurrent qualitative study, conducted in a UK consultant obstetric unit. The device was used in addition to standard care in women unresponsive to initial oxytocin therapy. The primary effectiveness outcome was additional blood loss of over 1000mls, whilst safety was assessed through adverse events. Interviews assessed device feasibility and acceptability, and were analysed using framework analysis. RESULTS: We recruited 57 women with clinical PPH after vaginal birth; 67% were primiparous and 47% had undergone operative birth. All but two (96%) had atony as a cause of the haemorrhage; in addition, 30% also had bleeding from lacerations and 11% had retained tissue. After device use, only one woman had additional blood loss over 1000mls, although 3 women (7%) needed a Bakri balloon and 14% received a blood transfusion. All but one clinician felt that the device was easy to use. Clinicians stated that the device assisted management in 85% of cases. All 56 women who responded stated that if they bled in a future birth they would want the device to be used again. There were no serious adverse events related to the device. However, 3 events were judged as 'possibly' being caused by the device - 2 minor vaginal grazes and one postnatal episiotomy infection and breakdown. Lax vaginal tissue complicated the use of the device in three women. In 47 interviews, participants, birth partners, clinician users and attending midwives viewed the device positively. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding. CONCLUSIONS: The PPH Butterfly may provide a rapid, acceptable and effective treatment for postpartum haemorrhage. Clinical Trial Registration prospective with ISRCTN15452399 11/09/2017 (www.isrctn.com/ISRCTN15452399).