Loneliness in Pregnancy and Parenthood: Impacts, Outcomes, and Costs.

Background: Becoming a parent has been highlighted as a period associated with increased risks for loneliness, with around one-third of parents reporting feeling lonely often or always. However, as most understanding of loneliness is based on elderly or student cohorts, further insights into the costs of parental loneliness is needed. Method: We conducted a literature review of impacts of loneliness in pregnancy and parenthood and present a synthesis of the health, social, societal, and economic costs. We draw on evidence about impacts and costs of loneliness in other cohorts to help provide a wider context to understand the impacts and costs and how parental loneliness differs from other populations. Results: Similar to literature with elderly cohorts, parental loneliness has impacts on health and wellbeing, such as depression in new parents and increased general practitioner (GP) visits in pregnancy. But also has intergenerational impacts via its association with poor mental health and social competence and increased respiratory tract infections in the child. Physical health impacts widely associated with loneliness in other cohorts have yet to be examined in parents. Loneliness in parents is likely to result in social withdrawal further isolating parents and wider societal and economic costs relating to absence from employment and informal caring roles. Conclusion: Parental loneliness has the potential for negative and pervasive impacts. As parental loneliness has wide ranging and intergenerational impacts it is important that a multi-sectoral perspective is used when examining its costs.

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.

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.

Cost of health inequality to the NHS in Wales.

Background: Forty years from the seminal work of Welsh GP Julian Tudor Hart on the Inverse Care Law, inequalities in health and healthcare remain deeply embedded in Wales. There is a wider gap (over 17 years) in healthy life expectancy between people living in the most and least deprived neighborhoods in Wales. This health inequality is reflected in additional healthcare use. In this study we estimate the cost of inequality associated with this additional healthcare use to the publicly funded National Health Service (NHS) in Wales. Methods: We retrieved administrative data on all NHS inpatient admissions, outpatient and accident and emergency attendances in Wales between April 2018 and March 2019 from Digital Health and Care Wales (DHCW). Hospital service use data were translated to costs using Healthcare Resource Group (HRG) and health service specific unit cost data and linked with area level mid-year population and deprivation indices in order to calculate the healthcare costs associated with socioeconomics deprivation. Results: Inequality in healthcare use between people from more and less deprived neighborhoods was associated with an additional cost of £322 million per year to the NHS in Wales, accounting for 8.7% of total NHS hospital expenditure in the country. Emergency inpatient admissions made up by far the largest component of this additional cost contributing £247.4 million, 77% of the total. There are also substantial costs of inequality for A&E attendances and outpatient visits, though not maternity services. Elective admissions overall have a negative cost of inequality, since among men aged 50-75 and women aged 60-70, elective utilization is actually negatively associated with deprivation. Conclusion: There are wide inequalities in health and healthcare use between people living in more deprived neighborhoods and those living in less deprived neighborhoods in Wales. Tackling health inequality through a combination of health promotion and early intervention policies targeted toward deprived communities could yield substantial improvement in health and wellbeing, as well as savings for the Welsh NHS through reduced use of emergency hospital care.

The UK stand together trial: protocol for a multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of KiVa to reduce bullying in primary schools.

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.

CHoosing Active Role Models to INspire Girls (CHARMING): protocol for a cluster randomised feasibility trial of a school-based, community-linked programme to increase physical activity levels in 9-10-year-old girls.

BACKGROUND: In the UK, there is evidence that girls' physical activity tends to decline to a greater extent than boys as they enter adolescence. 'Role models' could play a vital role in inspiring girls to become or remain physically active. The CHARMING Programme is a primary school-based community linked role-model programme, co-developed in 2016, with children, parents, schools and wider stakeholders. It involves different types of physical activity delivered for 1-h each week by a community provider and peer role models (e.g. older girls from secondary schools) joining in with the sessions. The programme ultimately aims to increase and sustain physical activity levels among 9-10-year-old girls. This study aims to assess the feasibility and acceptability of the CHARMING Programme and of evaluating it using a randomised trial. METHODS: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation and health economic evaluation. Approximately 90 Year 5 (i.e. 9-10-year-old) girls will be recruited across six primary schools in Mid-South Wales. Participating schools will be allocated to the programme: control on a 2:1 basis; four intervention schools will run the CHARMING Programme and two will continue with usual practice. A survey and accelerometer will be administered at baseline and repeated at 12 months. Interviews and focus groups will be conducted post-intervention delivery. The primary aim is to assess feasibility of a future randomised trial via the recruitment of schools, participants and role models; randomisation; retention; reach; data collection completion rates; programme adherence; and programme fidelity, views on intervention acceptability and programme barriers and facilitators. Secondary aims are to evaluate established physical activity outcome measures for children plus additional health economic outcomes for inclusion in a future full-scale trial. DISCUSSION: The results of this study will inform decisions on whether and how to proceed to a full-scale evaluation of the effectiveness and cost-effectiveness of the CHARMING Programme to improve or sustain physical activity. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN36223327. Registered March 29, 2021.

Current costs of dialysis modalities: A comprehensive analysis within the United Kingdom.

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.

Assessing the efficacy of coproduction to better understand the barriers to achieving sustainability in NHS chronic kidney services and create alternate pathways.

CONTEXT: Too many people living with chronic kidney disease are opting for and starting on hospital-based dialysis compared to a home-based kidney replacement therapy. Dialysis services are becoming financially unsustainable. OBJECTIVE: This study aimed to assess the efficacy of coproductive research in chronic kidney disease service improvement to achieve greater sustainability. DESIGN: A 2-year coproductive service improvement study was conducted with multiple stakeholders with the specific intention of maximizing engagement with the national health kidney services, patients and public. SETTING AND PARTICIPANTS: A national health kidney service (3 health boards, 18 dialysis units), patients and families (n = 50), multidisciplinary teams including doctors, nurses, psychologists, social workers, and so forth (n = 68), kidney charities, independent dialysis service providers and wider social services were part of this study. FINDINGS: Coproductive research identified underutilized resources (e.g., patients on home dialysis and social services) and their potential, highlighted unmet social care needs for patients and families and informed service redesign. Education packages were reimagined to support the home dialysis agenda including opportunities for wider service input. The impacts of one size fits all approaches to dialysis on specialist workforce skills were made clearer and also professional, patient and public perceptions of key sustainability policies. DISCUSSION AND CONCLUSIONS: Patient and key stakeholders mapped out new ways to link services to create more sustainable models of kidney health and social care. Maintaining principles of knowledge coproduction could help achieve financial sustainability and move towards more prudent adult chronic kidney disease services. PATIENT OR PUBLIC CONTRIBUTION: Involved in developing research questions, study design, management and conduct, interpretation of evidence and dissemination.

Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture: fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III).

INTRODUCTION: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care. METHODS AND ANALYSIS: Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme. ETHICS AND DISSEMINATION: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN28376407; Pre-results registered on 23 November 2018.

Which factors determine treatment choices in patients with advanced kidney failure? a protocol for a co-productive, mixed methods study.

INTRODUCTION: Kidney disease is common, affecting up to 1 in 10 of the adult population, and the numbers are expected to rise over the next decade. There are three main treatments that are available to patients with kidney disease: transplantation, dialysis and supportive care without dialysis. Dialysis can occur in a dialysis unit or in a person's home, but unit-based dialysis remains the most common initial treatment for patients in Wales. This is a cause for concern as most studies suggest that it is associated with the lowest quality of life and the highest mortality, and is a more expensive treatment option.This study aims to identify the factors that lead to patients choosing unit-based haemodialysis rather than home-based dialysis with a view to informing future changes in patient education and service commissioning in Wales. A secondary aim is to determine if the co-production of research leads to more sustainable services. METHODS AND ANALYSIS: This mixed-method study taking place between October 2018 and September 2020 will use a sequential explanatory design whereby the descriptive quantitative cross-sectional analysis of linked health and administrative data sets inform qualitative data collection from patients, carers and health and care professionals. Qualitative findings will be used to interpret or explain quantitative descriptive results. Additional strands to the study include a review of materials and education provided to patients and an economic review of treatment modalities. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from Health and Care Research Wales Research Ethics Committee #5. As a co-productive study involving patients, clinicians, third sector partners and academics, findings from this study will be shared on a continual basis. Study results will be published in peer-reviewed journals and presented at national and international conferences.

Micro-costing and a cost-consequence analysis of the 'Girls Active' programme: A cluster randomised controlled trial.

Physical inactivity has been identified as a leading risk factor for premature mortality globally, and adolescents, in particular, have low physical activity levels. Schools have been identified as a setting to tackle physical inactivity. Economic evidence of school-based physical activity programmes is limited, and the costs of these programmes are not always collected in full. This paper describes a micro-costing and cost-consequence analysis of the 'Girls Active' secondary school-based programme as part of a cluster randomised controlled trial (RCT). Micro-costing and cost-consequence analyses were conducted using bespoke cost diaries and questionnaires to collect programme delivery information. Outcomes for the cost-consequence analysis included health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the 'Girls Active' programme. Overall, 1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427) was used for the cost-consequence analysis. The micro-costing analysis demonstrated that, depending upon how the programme was delivered, 'Girls Active' costs ranged from £1,054 (£2 per pupil, per school year) to £3,489 (£7 per pupil, per school year). The least costly option was to absorb 'Girls Active' strictly within curriculum hours. The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes. This paper provides recommendations for those gathering cost and service use data in school settings to supplement validated and objective measures, furthering economic research in this field. Trial registration: -ISRCTN, ISRCTN10688342.

General medical services by non-medical health professionals: a systematic quantitative review of economic evaluations in primary care.

BACKGROUND: Previous systematic reviews have found that nurses and pharmacists can provide equivalent, or higher, quality of care for some tasks performed by GPs in primary care. There is a lack of economic evidence for this substitution. AIM: To explore the costs and outcomes of role substitution between GPs and nurses, pharmacists, and allied health professionals in primary care. DESIGN AND SETTING: A systematic review of economic evaluations exploring role substitution of allied health professionals in primary care was conducted. Role substitution was defined as 'the substitution of work that was previously completed by a GP in the past and is now completed by a nurse or allied health professional'. METHOD: The following databases were searched: Ovid MEDLINE, CINAHL, Cochrane Library, National Institute for Health and Care Excellence (NICE), and the Centre for Reviews and Dissemination. The review followed guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). RESULTS: Six economic evaluations were identified. There was some limited evidence that nurse-led care for common minor health problems was cost-effective compared with GP care, and that nurse-led interventions for chronic fatigue syndrome and pharmacy-led services for the medicines management of coronary heart disease and chronic pain were not. In South Korea, community health practitioners delivered primary care services for half the cost of physicians. The review did not identify studies for other allied health professionals such as physiotherapists and occupational therapists. CONCLUSION: There is limited economic evidence for role substitution in primary care; more economic evaluations are needed.

Acceptability and Feasibility of Implementing Accelorometry-Based Activity Monitors and a Linked Web Portal in an Exercise Referral Scheme: Feasibility Randomized Controlled Trial.

BACKGROUND: Exercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services. OBJECTIVE: To determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial. METHODS: We conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2. RESULTS: Participants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future. CONCLUSIONS: To our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met. TRIAL REGISTRATION: ISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652.

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

BACKGROUND: Health economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants' recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases.The aim was to test methods for obtaining these data and compare with those data collected using the CSRI, within a feasibility study of an enhanced rehabilitation intervention following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation: FEMuR). METHODS: Primary care activity including prescribing data was obtained from the Secure Anonymised Information Linkage (SAIL) Databank and secondary care activity (Emergency Department attendances, out-patient visits and in-patient days) directly from Betsi Cadwaladr University Health Board (BCUHB), North Wales, UK. These data were compared with patient responses from the CSRI using descriptive statistics and the intraclass correlation coefficient (ICC). RESULTS: It was possible to compare health service resource use data for 49 out of 61 participants in the FEMuR study. For emergency department (ED) attendances, records matched in 23 (47%) cases, 21 (43%) over-reported on electronic records compared with CSRI and five participants (10%) under-reported, with an overall ICC of 0.42. For out-patient episodes, records matched in only six cases, 28 participants over-reported on electronic records compared with CSRI and 15 (12%) under-reported, with an overall ICC of only 0.27. For in-patient days, records matched exactly in only five cases (10%), but if an error margin of 7 days was allowed, then agreement rose to 39 (66%) cases, and the overall ICC for all data was 0.88.It was only possible to compare prescribing data for 12 participants. For prescribing data, the SAIL data reported 117 out of 118 items (99%) and the CSRI only 89 (79%) items. CONCLUSIONS: The use of routinely collected data has the potential to improve the efficiency of trials and other studies. Although the methodology to make the data available has been demonstrated, the data obtained was incomplete and the validity of using this method remains to be demonstrated. TRIAL REGISTRATION: Trial registration: ISRCTN22464643 Registered 21 July 2014.

Preferences of older patients regarding hip fracture rehabilitation service configuration: A feasibility discrete choice experiment.

OBJECTIVE: As part of a wider feasibility study, the feasibility of gaining older patients' views for hip fracture rehabilitation services was tested using a discrete choice experiment in a UK context. DESIGN: Discrete choice experiment is a method used for eliciting individuals' preferences about goods and services. SUBJECTS/PATIENTS: The discrete choice experiment was administered to 41 participants who had experienced hip fracture (mean age 79.3 years; standard deviation (SD) 7.5 years), recruited from a larger feasibility study exploring a new multidisciplinary rehabilitation for hip fracture. METHODS: Attributes and levels for this discrete choice experiment were identified from a systematic review and focus groups. The questionnaire was administered at the 3-month follow-up. RESULTS: Participants indicated a significant preference for a fully-qualified physiotherapist or occupational therapist to deliver the rehabilitation sessions (ß = 0·605, 95% confidence interval (95% CI) 0.462-0.879), and for their rehabilitation session to last less than 90 min (ß = -0.192, 95% CI -0.381 to -0.051). CONCLUSION: The design of the discrete choice experiment using attributes associated with service configuration could have the potential to inform service implementation, and assist rehabilitation service design that incorporates the preferences of patients.

Effectiveness of the 'Girls Active' school-based physical activity programme: A cluster randomised controlled trial.

BACKGROUND: Globally, adolescent girls' physical activity (PA) levels are low. The 'Girls Active' secondary school-based programme, developed by the Youth Sport Trust, aims to increase PA in adolescent girls. This paper explores the effectiveness of the 'Girls Active' school-based PA programme. METHODS: A random sample of girls aged 11-14 from 20 secondary schools (Midlands, UK) participated in a two-arm cluster randomised controlled trial. Ten schools received Girls Active and 10 continued with usual practice. Measurements were taken at baseline, seven- and 14-month follow-up. PRIMARY OUTCOME: wrist-worn accelerometer measured moderate- to vigorous-intensity PA (MVPA). SECONDARY OUTCOMES: overall PA, light PA, sedentary time, body composition, and psychosocial outcomes. Generalised estimating equations, adjusted for school cluster and potential confounders, were used and A priori subgroup analysis was undertaken. Micro-costing and cost-consequence analyses were conducted using bespoke collection methods on programme delivery information. Outcomes for the cost-consequence analysis were health related quality of life measured by the Child Health Utility-9D and service use. RESULTS: Overall, 1752 pupils participated, 1211 (69.1%) provided valid 14-month accelerometer data. No difference in MVPA (mins/day; 95% confidence intervals) was found at 14 months (1.7; -0.8 to 4.3), there was at seven months (2.4; 0.1 to 4.7). Subgroup analyses showed significant intervention effects on 14-month in larger schools (3.9; 1.39 to 6.09) and in White Europeans (3.1; 0.60 to 6.02) and in early maturers (5.1; 1.69 to 8.48) at seven months. The control group did better in smaller schools at 14-months (-4.38; -7.34 to -1.41). Significant group differences were found in 14-month identified motivation (-0.09; -0.18 to -0.01) and at seven months in: overall PA (1.39 mg/day; 0.1 to 2.2), after-school sedentary time (-4.7; -8.9 to -0.6), whole day (5.7; 1.0 to 10.5) and school day (4.5; 0.25 to 8.75) light PA, self-esteem. Small, statistically significant, differences in some psychosocial variables favoured control schools. Micro-costing demonstrated that delivering the programme resulted in a range of time and financial costs at each school. Cost-consequence analysis demonstrated no effect of the programme for health related quality of life or service use. CONCLUSIONS: Compared with usual practice, 'Girls Active' did not affect 14-month MVPA. TRIAL REGISTRATION: ISRCTN10688342.

Protocol for a feasibility randomised controlled trial of the use of Physical ACtivity monitors in an Exercise Referral Setting: the PACERS study.

BACKGROUND: Exercise referral schemes are recommended by the National Institute for Clinical Excellence (NICE) for physical activity promotion among inactive patients with health conditions or risk factors. Whilst there is evidence for the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, evidence of long-term effects is limited. Techniques such as goal setting, self-monitoring and personalised feedback may support motivation for physical activity. Technologies such as activity monitoring devices provide an opportunity to enhance delivery of motivational techniques. This paper describes the PACERS study protocol, which aims to assess the feasibility and acceptability of implementing an activity monitor within the existing Welsh National Exercise Referral Scheme (NERS) and proposed evaluation methodology for a full-scale randomised controlled trial. METHODS/DESIGN: The PACERS study consists of a pilot randomised controlled trial, process evaluation and exploratory economic analyses. Participants will be recruited from the generic pathway of the Welsh NERS and will be randomly assigned to receive the intervention or usual practice. Usual practice is a 16-week structured exercise programme; the intervention consists of an accelerometry-based activity monitor (MyWellnessKey) and an associated web platform (MyWellnessCloud). The primary outcomes are predefined progression criteria assessing the acceptability and feasibility of the intervention and feasibility of the proposed evaluation methodology. Postal questionnaires will be completed at baseline (time 0: T0), 16 weeks after T0 (T1) and 12 months after T0 (T2). Routinely collected data will also be accessed at the same time points. A sub-sample of intervention participants and exercise referral staff will be interviewed following initiation of intervention delivery and at the end of the study. DISCUSSION: The PACERS study seeks to assess the feasibility of adding a novel motivational component to an existing effective intervention in order to enhance effects on physical activity and support longer-term maintenance. The study will provide insight into the acceptability of activity-monitoring technologies to an exercise referral population and delivery staff. Data from this study will be used to determine whether and how to proceed to a full-scale trial of effectiveness of the intervention, including any necessary refinements to intervention implementation or the proposed evaluation methodology. TRIAL REGISTRATION: ISRCTN85785652.

Development of an evidence-based complex intervention for community rehabilitation of patients with hip fracture using realist review, survey and focus groups.

OBJECTIVES: To develop an evidence and theory-based complex intervention for improving outcomes in elderly patients following hip fracture. DESIGN: Complex-intervention development (Medical Research Council (MRC) framework phase I) using realist literature review, surveys and focus groups of patients and rehabilitation teams. SETTING: North Wales. PARTICIPANTS: Surveys of therapy managers (n=13), community and hospital-based physiotherapists (n=129) and occupational therapists (n=68) throughout the UK. Focus groups with patients (n=13), their carers (n=4) and members of the multidisciplinary rehabilitation teams in North Wales (n=13). RESULTS: The realist review provided understanding of how rehabilitation interventions work in the real-world context and three programme theories were developed: improving patient engagement by tailoring the intervention to individual needs; reducing fear of falling and improving self-efficacy to exercise and perform activities of daily living; and coordination of rehabilitation delivery. The survey provided context about usual rehabilitation practice; focus groups provided data on the experience, acceptability and feasibility of rehabilitation interventions. An intervention to enhance usual rehabilitation was developed to target these theory areas comprising: a physical component consisting of six additional therapy sessions; and a psychological component consisting of a workbook to enhance self-efficacy and a patient-held goal-setting diary for self-monitoring. CONCLUSIONS: A realist approach may have advantages in the development of evidence-based interventions and can be used in conjunction with other established methods to contribute to the development of potentially more effective interventions. A rehabilitation intervention was developed which can be tested in a future randomised controlled trial (MRC framework phases II and III). TRIAL REGISTRATION NUMBER: ISRCTN22464643, Pre-results.