Is Economic Evaluation and Care Commissioning Focused on Achieving the Same Outcomes? Resource-Allocation Considerations and Challenges Using England as a Case Study.

Commissioning describes the process of contracting appropriate care services to address pre-identified needs through pre-agreed payment structures. Outcomes-based commissioning (i.e., paying services for pre-agreed outcomes) shares a common goal with economic evaluation: achieving value for money for relevant outcomes (e.g., health) achieved from a finite budget. We describe considerations and challenges as to the practical role of relevant outcomes for evaluation and commissioning, seeking to bridge a gap between economic evaluation evidence and care commissioning. We describe conceptual (e.g., what are 'relevant' outcomes) alongside practical considerations (e.g., quantifying and using relevant endpoint or surrogate outcomes) and pertinent issues when linking outcomes to commissioning-based payment mechanisms, using England as a case study. Economic evaluation often focuses on a single endpoint health-focused maximand, e.g., quality-adjusted life-years (QALYs), whereas commissioning often focuses on activity-based surrogate outcomes (e.g., health monitoring), as easier-to-measure key performance indicators that are more acceptable (e.g., by clinicians) and amenable to being linked with payment structures. However, payments linked to endpoint and/or surrogate outcomes can lead to market inefficiencies; for example, when surrogates do not have the intended causal effect on endpoint outcomes or when service activity focuses on only people who can achieve prespecified payment-linked outcomes. Accounting for and explaining direct links from commissioners' payment structures to surrogate and then endpoint economic outcomes is a vital step to bridging a gap between economic evaluation approaches and commissioning. Decision-analytic models could aid this but they must be designed to account for relevant surrogate and endpoint outcomes, the payments assigned to such outcomes, and their interaction with the system commissioners purport to influence.

Appropriate Categorization of Inequality to Inform Policy Decisions: Estimating Distribution of Lifetime Health Using Alternative Approaches to Socioeconomic Stratification.

OBJECTIVES: Estimation of gradients in lifetime health, notably quality-adjusted life expectancy (QALE), has largely focused on index of multiple deprivation to categorize the population by socioeconomic position. In this article, we estimate QALE using alternate, individual- rather than area-level, indicators of socioeconomic position. METHODS: Building on previous research methods, the distribution of QALE is estimated across education and income groups based on data from the Health Survey for England and the Office for National Statistics. QALE is estimated for each group by combining multivariate mortality rates and health-related quality of life (HRQL) weights using life tables. HRQL weights were estimated using ordinary least squares and missing data were handled using multiple imputation. RESULTS: The estimated lifetime HRQL weights decreased with increased age, lower educational attainment, and lower income. For example, the QALE at birth for males in the lowest educational attainment group was 61.69 quality-adjusted life-years (QALYs), 1.54 QALYs lower than females in the same group. This is in contrast to 76.58 and 75.89 QALYs for males and females in the highest educational attainment group, respectively. A similar trend was observed across income quintiles albeit the gap was less pronounced. CONCLUSIONS: The use of index of multiple deprivation to assess health inequalities may be masking important information about individual-level variation. Decisions makers should consider this alongside the merits of using area-level approaches to categorizing the population if individual-level approaches are preferable.

Safety, resource use and nutritional content of home-blended diets in children who are gastrostomy fed: findings from 'YourTube' - a prospective cohort study.

OBJECTIVE: To assess the risks, benefits and resource implications of using home-blended food in children with gastrostomy tubes compared with currently recommended formula feeds. DESIGN: This is a cohort study. Data were collected at months 0, 12 and 18 from parents and clinicians using standardised measures. SETTING: 32 sites across England: 28 National Health Service trusts and 4 children's hospices. PATIENTS: Children aged 6 months-18 years who were gastrostomy fed. MAIN OUTCOME MEASURE: The main outcome measure was the PedsQL Gastrointestinal Symptoms Scales score. Secondary outcomes included quality of life, sleep (child, parent), dietary intake, anthropometry, healthcare usage, safety outcomes and resource use. RESULTS: 180 children and families completed the baseline data collection, with 134 (74%) and 105 (58%) providing follow-up data at 12 and 18 months. There were fewer gastrointestinal (GI) symptoms at all time points in the home-blended diet group, but there was no difference in change over time within or between the groups. The nutritional intake of those on a home-blended diet had higher calories per kilogram and fibre, and both home-blended and formula-fed children have values above the dietary reference values for most micronutrients. Safety outcomes were similar between groups and over time. The total costs to the statutory sector were higher among children who were formula fed, but the costs of purchasing special equipment for home-blended food and the total time spent on childcare were higher for families with home-blended diet. CONCLUSIONS: Children who are gastrostomy fed a home-blended diet have similar safety profile, adequate nutritional intake and lower burden of GI symptoms than formula-fed children.Trial registration number ISRCTN13977361.

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis.

INTRODUCTION: Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population. METHODS AND ANALYSIS: An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives. ETHICS AND DISSEMINATION: Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings. TRIAL REGISTRATION NUMBER: IsRCTNhttps://doi.org/10.1186/ISRCTN31836167.

'YourTube' the role of different diets in gastrostomy-fed children: Baseline findings from a prospective cohort study.

AIM: To assess the risks, benefits, and resource implications of home-blended food for children with gastrostomy tubes compared with a formula diet. METHOD: This prospective cohort study of children (aged 0-18 years) collected baseline data on gastrointestinal symptoms, nutritional intake, anthropometric outcomes, parent and child quality of life, and resource use. A propensity score-weighted generalized linear mixed model was used to compare children receiving a home-blended versus formula diet. RESULTS: Baseline data were obtained for 180 children (2019-2021; 107 males, 73 females; mean age 9 years 7 months [SD 4 years 5 months]). Children receiving a home-blended diet (n = 104) had similar diagnoses and age but more lived in areas of lower deprivation and parental education was higher compared to the parents of children receiving a formula diet (n = 76). Children receiving home-blended diets had significantly better gastrointestinal scores than those receiving formula diets (B = 13.8, p < 0.001). The number of gut infections and tube blockages were similar between the two groups but with fewer stoma site infections in the group receiving home-blended food. Children receiving a home-blended diet had more fibre in their diet compared to children receiving a formula diet. INTERPRETATION: Home-blended diets should be seen as a safe option for children who are gastrostomy-fed unless clinically contraindicated. Equality of access to home-blended diets for children with gastrostomy should be assessed by local clinical teams.

A multicomponent intervention to reduce daily sitting time in office workers: the SMART Work & Life three-arm cluster RCT.

Background: Office workers spend 70-85% of their time at work sitting. High levels of sitting have been linked to poor physiological and psychological health. Evidence shows the need for fully powered randomised controlled trials, with long-term follow-up, to test the effectiveness of interventions to reduce sitting time. Objective: Our objective was to test the clinical effectiveness and cost-effectiveness of the SMART Work & Life intervention, delivered with and without a height-adjustable workstation, compared with usual practice at 12-month follow-up. Design: A three-arm cluster randomised controlled trial. Setting: Councils in England. Participants: Office workers. Intervention: SMART Work & Life is a multicomponent intervention that includes behaviour change strategies, delivered by workplace champions. Clusters were randomised to (1) the SMART Work & Life intervention, (2) the SMART Work & Life intervention with a height-adjustable workstation (i.e. SMART Work & Life plus desk) or (3) a control group (i.e. usual practice). Outcome measures were assessed at baseline and at 3 and 12 months. Main outcome measures: The primary outcome was device-assessed daily sitting time compared with usual practice at 12 months. Secondary outcomes included sitting, standing, stepping time, physical activity, adiposity, blood pressure, biochemical measures, musculoskeletal issues, psychosocial variables, work-related health, diet and sleep. Cost-effectiveness and process evaluation data were collected. Results: A total of 78 clusters (756 participants) were randomised [control, 26 clusters (n = 267); SMART Work & Life only, 27 clusters (n = 249); SMART Work & Life plus desk, 25 clusters (n = 240)]. At 12 months, significant differences between groups were found in daily sitting time, with participants in the SMART Work & Life-only and SMART Work & Life plus desk arms sitting 22.2 minutes per day (97.5% confidence interval -38.8 to -5.7 minutes/day; p = 0.003) and 63.7 minutes per day (97.5% confidence interval -80.0 to -47.4 minutes/day; p < 0.001), respectively, less than the control group. Participants in the SMART Work & Life plus desk arm sat 41.7 minutes per day (95% confidence interval -56.3 to -27.0 minutes/day; p < 0.001) less than participants in the SMART Work & Life-only arm. Sitting time was largely replaced by standing time, and changes in daily behaviour were driven by changes during work hours on workdays. Behaviour changes observed at 12 months were similar to 3 months. At 12 months, small improvements were seen for stress, well-being and vigour in both intervention groups, and for pain in the lower extremity and social norms in the SMART Work & Life plus desk group. Results from the process evaluation supported these findings, with participants reporting feeling more energised, alert, focused and productive. The process evaluation also showed that participants viewed the intervention positively; however, the extent of engagement varied across clusters. The average cost of SMART Work & Life only and SMART Work & Life plus desk was £80.59 and £228.31 per participant, respectively. Within trial, SMART Work & Life only had an incremental cost-effectiveness ratio of £12,091 per quality-adjusted life-year, with SMART Work & Life plus desk being dominated. Over a lifetime, SMART Work & Life only and SMART Work & Life plus desk had incremental cost-effectiveness ratios of £4985 and £13,378 per quality-adjusted life-year, respectively. Limitations: The study was carried out in one sector, limiting generalisability. Conclusions: The SMART Work & Life intervention, provided with and without a height-adjustable workstation, was successful in changing sitting time. Future work: There is a need for longer-term follow-up, as well as follow-up within different organisations. Trial registration: Current Controlled Trials ISRCTN11618007.

Office workers spend a large proportion of their day sitting. High levels of sitting have been linked to diseases, such as type 2 diabetes, heart disease and some cancers. The SMART Work & Life intervention is designed to reduce office workers' sitting time inside and outside work. The SMART Work & Life intervention involves organisational, environmental, group and individual strategies to encourage a reduction in sitting time and was designed to be delivered with and without a height-adjustable workstation (which allows the user to switch between sitting and standing while working). To test whether or not the SMART Work & Life intervention worked, we recruited 756 office workers from councils in Leicester/Leicestershire, Greater Manchester and Liverpool, UK. Participants were from 78 office groups. One-third of the participants received the intervention, one-third received the intervention with a height-adjustable workstation and one-third were a control group (and carried on as usual). Workplace champions in each office group were given training and resources to deliver the intervention. Data were collected at the start of the study, with follow-up measurements at 3 and 12 months. We measured sitting time using a small device worn on the thigh and collected data on weight, body fat, blood pressure, blood sugar and cholesterol levels. We asked participants about their health and work and spoke to participants to find out what they thought of the intervention. Our results showed that participants who received the intervention without workstation sat for 22 minutes less per day, and participants who received the intervention with workstation sat for 64 minutes less per day, than participants in the control group. Levels of stress, well-being, vigour (i.e. personal and emotional energy and cognitive liveliness) and pain in the lower extremity appeared to improve in the intervention groups. Participants viewed the intervention positively and reported several benefits, such as feeling more energised, alert, focused and productive; however, the extent to which participants engaged with the intervention varied across groups.

Evaluating an intervention to improve the safety and experience of transitions from hospital to home for older people (Your Care Needs You): a protocol for a cluster randomised controlled trial and process evaluation.

BACKGROUND: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home. METHODS: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. DISCUSSION: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. TRIAL REGISTRATION: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

A quasi-experimental effectiveness evaluation of the 'Incredible Years Toddler' parenting programme on children's development aged 5: A study protocol.

Child behavioural and mental health problems have become a public health crisis. The consequences of poor mental health in childhood have large economic costs and consequences for the individual, their families, and for society. Early intervention through parenting programmes can reduce the onset of poor mental health in childhood, hence evaluating the effectiveness of parenting programmes is critical. The 'Incredible Years Toddler' parent programme is an education and training intervention designed to enhance the social and emotional wellbeing of children aged 1-3 years. Whilst previous studies show Incredible Years Toddler to provide promising effects on child outcomes in the short term, the research samples have lacked ethnic diversity and representation from socioeconomically deprived families. This quasi-experimental study is registered on ISRCTN (ISRCTN49991769). We will investigate the effectiveness of Incredible Years Toddler being delivered in three neighbourhoods in inner city Bradford, England. These neighbourhoods contain a socially and ethnically diverse population with 84% living in the poorest decile for England and Wales. Parents with a child aged 1-3 years old who are enrolled in Born in Bradford's Better Start interventional family cohort study are eligible for this study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. This study will use retrospective and prospective data from participants who attended Incredible Years groups between September 2018 and April 2024. The required minimum sample is n = 1336 (ratio 1:3) to detect a small effect (odds = 1.5, d = .20) on the Early Years Foundation Stage profile total score at age 5; a measure of early child development that is routinely collected by teachers. We will also establish whether these effects are moderated by child age at entry to intervention, programme delivery mode, socioeconomic status, and ethnicity. We will also estimate the cost of the intervention and conduct a cost-consequence analysis.

Protocol for the effectiveness evaluation of an antenatal, universally offered, and remotely delivered parenting programme 'Baby Steps' on maternal outcomes: a Born in Bradford's Better Start (BiBBS) study.

BACKGROUND: Poor perinatal mental health and maternal sensitivity towards a child in the early years can carry a long-term cost to individuals and to society, and result in negative child outcomes such as poor mental health and social emotional issues. Despite the recognition of early intervention and prevention, there is mixed evidence regarding antenatal parenting interventions that aim to enhance perinatal mental health and maternal sensitivity to prevent negative child outcomes. 'Baby Steps' is a relationship-based antenatal and postnatal parenting programme. The service evaluated in this study is delivered in a low-income and ethnically diverse community via Better Start Bradford. This study aims to assess whether the universally, and remotely delivered Baby Steps programme is effective in improving postnatal maternal sensitivity (primary outcome) and postnatal maternal mental health (secondary outcome) when compared to services as usual 6-10 weeks post-birth. It will also assess differences in birth outcomes, and differences in the prevalence of poor perinatal mental ill health through routine data. The feasibility of collecting cost and health related resource use data for a future economic evaluation will be explored. METHODS: The study is a quasi-experimental evaluation in a single centre. All participants are drawn from Born in Bradford's Better Start (BiBBS) interventional family cohort study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. The required minimum sample is n = 130 (ratio 1:1) to detect a medium effect (± 2.35, d = .50) on the primary outcome-maternal-child sensitivity, using the Mothers Object Relations Scale Short Form (MORS-SF). Secondary outcomes include the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder assessment 7 (GAD-7), identification of poor perinatal mental health through routine data, and birth outcomes (delivery method, gestation period, low birth weight). Service delivery costs and health resource use will be gathered from routine data. DISCUSSION: This study will evaluate the effectiveness of Baby Steps for enhancing maternal-child sensitivity and maternal mental health when delivered universally and remotely. The findings regarding programme effectiveness, process, and costs will be relevant for researchers, service commissioners, and service staff. TRIAL REGISTRATION: This study was prospectively registered with ISRCTN (22/04/2022, ISRCTN12196131).

Methods of assessing value for money of UK-based early childhood public health interventions: a systematic literature review.

INTRODUCTION: Economic evaluation has an important role to play in the demonstration of value for money of early childhood public health interventions; however, concerns have been raised regarding their consistent application and relevance to commissioners. This systematic review of the literature therefore aims to collate the breadth of the existing economic evaluation evidence of these interventions and to identify the approaches adopted in the assessment of value. SOURCE OF DATA: Recently published literature in Medline, EMBASE, EconLit, Health Management Information Consortium, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, Health Technology Assessment, NHS EED and Web of Science. AREAS OF AGREEMENT: The importance of the early childhood period on future health and well-being as well as the potential to impact health inequalities making for a strong narrative case for expenditure in early childhood public health. AREAS OF CONTROVERSY: The most appropriate approaches to evaluating value for money of such preventative interventions relevant for UK decision-makers given the evident challenges. GROWING POINTS: The presented review considered inconsistencies across methodological approaches used to demonstrate value for money. The results showed a mixed picture in terms of demonstrating value for money. AREAS TIMELY FOR DEVELOPING RESEARCH: Future resource allocations decisions regarding early childhood public health interventions may benefit from consistency in the evaluative frameworks and health outcomes captured, as well as consistency in approaches to incorporating non-health costs and outcomes, incorporating equity concerns and the use of appropriate time horizons.

The Cost-Effectiveness of the SMART Work & Life Intervention for Reducing Sitting Time.

Sedentary behaviours continue to increase and are associated with heightened risks of morbidity and mortality. We assessed the cost-effectiveness of SMART Work & Life (SWAL), an intervention designed to reduce sitting time inside and outside of work, both with (SWAL-desk) and without (SWAL-only) a height-adjustable workstation compared to usual practice (control) for UK office workers. Health outcomes were assessed in quality-adjusted life-years (QALY) and costs in pound sterling (2019-2020). Discounted costs and QALYs were estimated using regression methods with multiply imputed data from the SMART Work & Life trial. Absenteeism, productivity and wellbeing measures were also evaluated. The average cost of SWAL-desk was £228.31 and SWAL-only £80.59 per office worker. Within the trial, SWAL-only was more effective and costly compared to control (incremental cost-effectiveness ratio (ICER): £12,091 per QALY) while SWAL-desk was dominated (least effective and most costly). However, over a lifetime horizon, both SWAL-only and SWAL-desk were more effective and more costly than control. Comparing SWAL-only to control generated an ICER of £4985 per QALY. SWAL-desk was more effective and costly than SWAL-only, generating an ICER of £13,378 per QALY. Findings were sensitive to various worker, intervention, and extrapolation-related factors. Based on a lifetime horizon, SWAL interventions appear cost-effective for office-workers conditional on worker characteristics, intervention cost and longer-term maintenance in sitting time reductions.

Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care.

BACKGROUND: The 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. METHODS: A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. RESULTS: Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences. CONCLUSIONS: If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. TRIAL REGISTRATION: ISRCTN: 51154948.

Effectiveness of an intervention for reducing sitting time and improving health in office workers: three arm cluster randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of an intervention, with and without a height adjustable desk, on daily sitting time, and to investigate the relative effectiveness of the two interventions, and the effectiveness of both interventions on physical behaviours and physical, biochemical, psychological, and work related health and performance outcomes. DESIGN: Cluster three arm randomised controlled trial with follow-up at three and 12 months. SETTING: Local government councils in Leicester, Liverpool, and Greater Manchester, UK. PARTICIPANTS: 78 clusters including 756 desk based employees in defined offices, departments, or teams from two councils in Leicester, three in Greater Manchester, and one in Liverpool. INTERVENTIONS: Clusters were randomised to one of three conditions: the SMART Work and Life (SWAL) intervention, the SWAL intervention with a height adjustable desk (SWAL plus desk), or control (usual practice). MAIN OUTCOMES MEASURES: The primary outcome measure was daily sitting time, assessed by accelerometry, at 12 month follow-up. Secondary outcomes were accelerometer assessed sitting, prolonged sitting, standing and stepping time, and physical activity calculated over any valid day, work hours, workdays, and non-workdays, self-reported lifestyle behaviours, musculoskeletal problems, cardiometabolic health markers, work related health and performance, fatigue, and psychological measures. RESULTS: Mean age of participants was 44.7 years, 72.4% (n=547) were women, and 74.9% (n=566) were white. Daily sitting time at 12 months was significantly lower in the intervention groups (SWAL -22.2 min/day, 95% confidence interval -38.8 to -5.7 min/day, P=0.003; SWAL plus desk -63.7 min/day, -80.1 to -47.4 min/day, P<0.001) compared with the control group. The SWAL plus desk intervention was found to be more effective than SWAL at changing sitting time (-41.7 min/day, -56.3 to -27.0 min/day, P<0.001). Favourable differences in sitting and prolonged sitting time at three and 12 month follow-ups for both intervention groups and for standing time for the SWAL plus desk group were observed during work hours and on workdays. Both intervention groups were associated with small improvements in stress, wellbeing, and vigour, and the SWAL plus desk group was associated with improvements in pain in the lower extremity, social norms for sitting and standing at work, and support. CONCLUSIONS: Both SWAL and SWAL plus desk were associated with a reduction in sitting time, although the addition of a height adjustable desk was found to be threefold more effective. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11618007.

Numbers, characteristics, and medical complexity of children with life-limiting conditions reaching age of transition to adult care in England: a repeated cross-sectional study [version 1; peer review: 2 approved].

Background: The number of children with life-limiting conditions in England is known to be increasing, which has been attributed in part to increased survival times. Consequently, more of these young people will reach ages at which they start transitioning to adult healthcare (14-19 years). However, no research exists that quantifies the number of young people with life-limiting conditions in England reaching transition ages or their medical complexity, both essential data for good service planning. Methods: National hospital data in England (Hospital Episode Statistics) from NHS Digital were used to identify the number of young people aged 14-19 years from 2012/13 to 2018/19 with life-limiting conditions diagnosed in childhood. The data were assessed for indicators of medical complexity: number of conditions, number of main specialties of consultants involved, number of hospital admissions and Accident & Emergency Department visits, length of stay, bed days and technology dependence (gastrostomies, tracheostomies). Overlap between measures of complexity was assessed. Results: The number of young people with life-limiting conditions has increased rapidly over the study period, from 20363 in 2012/13 to 34307 in 2018/19. There was evidence for increased complexity regarding the number of conditions and number of distinct main specialties of consultants involved in care, but limited evidence of increases in average healthcare use per person or increased technology dependence. The increasing size of the group meant that healthcare use increased overall. There was limited overlap between measures of medical complexity. Conclusions: The number of young people with life-limiting conditions reaching ages at which transition to adult healthcare should take place is increasing rapidly. Healthcare providers will need to allocate resources to deal with increasing healthcare demands and greater complexity. The transition to adult healthcare must be managed well to limit impacts on healthcare resource use and improve experiences for young people and their families.

The cost-effectiveness of a proportionate parenting programme for primary caregivers and their child: an economic evaluation using evidence from the E-SEE Trial.

BACKGROUND: Behavioural and mental disorders have become a public health crisis; averting mental ill-health in early years can achieve significant longer-term health benefits and cost savings. This study assesses whether the Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE-Steps)-a proportionate universal delivery model comprising the Incredible Babies book (IY-B) and the Incredible Years Infant (IY-I) and Toddler (IY-T) parenting programmes is cost-effective compared to services as usual (SAU) for the primary caregiver, child and dyad. METHODS: Using UK data for 339 primary caregivers from the E-SEE trial, we conducted a within-trial economic evaluation assessing the cost-effectiveness of E-SEE Steps. Health outcomes were expressed in quality-adjusted life-years (QALY) and costs in UK pounds sterling (2018-19). Missing data were populated via multiple imputation and costs and QALYs discounted at 3.5% per annum. Cost-effectiveness results were conducted for primary caregivers, children and dyad using econometric modelling to control for patient co-variables. Uncertainty was explored through scenario and sensitivity analyses. RESULTS: The average cost of E-SEE Steps intervention was £458.50 per dyad. E-SEE Steps was associated with modest gains in primary caregiver HRQoL but minor decrements in child HRQoL compared to SAU. For primary caregivers, E-SEE Steps was more effective (0.034 QALYs) and more costly (£446) compared to SAU, with a corresponding incremental cost-effectiveness ratio (ICER) of £13,011 per QALY. In children, E-SEE Steps was strictly dominated with poorer outcomes (-0.005 QALYs) and greater costs (£178) relative to SAU. QALY gains in primary caregivers exceeded those QALY losses found in children, meaning E-SEE Steps was more effective (0.031 QALYs) and costly (£621) for the dyad (ICER: £20,062 per QALY). All scenario analyses found E-SEE Steps cost-effective for the dyad at a £30,000 per QALY threshold. Sensitivity analyses found significant cost reductions from expansions in programme delivery and attendance. CONCLUSIONS: E-SEE Steps achieved modest health gains in primary caregivers but small negative effects on children and was more costly than SAU. E-SEE Steps appears cost-effective for the dyad, but the results should be interpreted with caution given the potential detrimental impact on children. TRIAL REGISTRATION: ISRCTN11079129 ; Pre participant trial enrolment, 11/05/2015.

The effectiveness of the Structured Health Intervention For Truckers (SHIFT): a cluster randomised controlled trial (RCT).

BACKGROUND: Long distance heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related co-morbidities, and are underserved in terms of health promotion initiatives. The purpose of this study was to evaluate the effectiveness of the multicomponent 'Structured Health Intervention For Truckers' (SHIFT), compared to usual care, at 6- and 16-18-month follow-up. METHODS: We conducted a two-arm cluster RCT in transport sites throughout the Midlands, UK. Outcome measures were assessed at baseline, at 6- and 16-18-month follow-up. Clusters were randomised (1:1) following baseline measurements to either the SHIFT arm or usual practice control arm. The 6-month SHIFT programme included a group-based interactive 6-h education and behaviour change session, health coach support and equipment provision (Fitbit® and resistance bands/balls to facilitate a 'cab workout'). The primary outcome was device-assessed physical activity (mean steps/day) at 6 months. Secondary outcomes included the following: device-assessed sitting, physical activity intensity and sleep; cardiometabolic health, diet, mental wellbeing and work-related psychosocial variables. Data were analysed using mixed-effect linear regression models using a complete-case population. RESULTS: Three hundred eighty-two HGV drivers (mean ± SD age: 48.4 ± 9.4 years, BMI: 30.4 ± 5.1 kg/m2, 99% male) were recruited across 25 clusters (sites) and randomised into either the SHIFT (12 clusters, n = 183) or control (13 clusters, n = 199) arms. At 6 months, 209 (55%) participants provided primary outcome data. Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145-1871, p = 0.022). Favourable differences were also seen in the SHIFT group, relative to the control group, in time spent sitting (- 24 mins/day, 95% CI: - 43 to - 6), and moderate-to-vigorous physical activity (6 mins/day, 95% CI: 0.3-11). Differences were not maintained at 16-18 months. No differences were observed between groups in the other secondary outcomes at either follow-up. CONCLUSIONS: The SHIFT programme led to a potentially clinically meaningful difference in daily steps, between trial arms, at 6 months. Whilst the longer-term impact is unclear, the programme offers potential to be incorporated into driver training courses to promote activity in this at-risk, underserved and hard-to-reach essential occupational group. TRIAL REGISTRATION: ISRCTN10483894 (date registered: 01/03/2017).

A randomized controlled trial of a proportionate universal parenting program delivery model (E-SEE Steps) to enhance child social-emotional wellbeing.

BACKGROUND: Evidence for parenting programs to improve wellbeing in children under three is inconclusive. We investigated the fidelity, impact, and cost-effectiveness of two parenting programs delivered within a longitudinal proportionate delivery model ('E-SEE Steps'). METHODS: Eligible parents with a child ≤ 8 weeks were recruited into a parallel two-arm, assessor blinded, randomized controlled, community-based, trial with embedded economic and process evaluations. Post-baseline randomization applied a 5:1 (intervention-to-control) ratio, stratified by primary (child social-emotional wellbeing (ASQ:SE-2)) and key secondary (maternal depression (PHQ-9)) outcome scores, sex, and site. All intervention parents received the Incredible Years® Baby Book (IY-B), and were offered the targeted Infant (IY-I)/Toddler (IY-T) program if eligible, based on ASQ:SE-2/PHQ-9 scores. Control families received usual services. Fidelity data were analysed descriptively. Primary analysis applied intention to treat. Effectiveness analysis fitted a marginal model to outcome scores. Cost-effectiveness analysis involved Incremental Cost-Effectiveness Ratios (ICERs). RESULTS: The target sample (N = 606) was not achieved; 341 mothers were randomized (285:56), 322 (94%) were retained to study end. Of those eligible for the IY-I (n = 101), and IY-T (n = 101) programs, 51 and 21 respectively, attended. Eight (of 14) groups met the 80% self-reported fidelity criteria. No significant differences between arms were found for adjusted mean difference scores; ASQ:SE-2 (3.02, 95% CI: -0.03, 6.08, p = 0.052), PHQ-9 (-0.61; 95% CI: -1.34, 0.12, p = 0.1). E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control. Serious adverse events (n = 86) were unrelated to the intervention. CONCLUSIONS: E-SEE Steps was not effective, but was borderline cost-effective. The model was delivered with varying fidelity, with lower-than-expected IY-T uptake. Changes to delivery systems and the individual programs may be needed prior to future evaluation. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN11079129.

Adult healthcare is associated with more emergency healthcare for young people with life-limiting conditions.

BACKGROUND: Children with life-limiting conditions receive specialist paediatric care in childhood, but the transition to adult care during adolescence. There are concerns about transition, including a lack of continuity in care and that it may lead to increases in emergency hospital visits. METHODS: A retrospective cohort was constructed from routinely collected primary and hospital care records for young people aged 12-23 years in England with (i) life-limiting conditions, (ii) diabetes or (iii) no long-term conditions. Transition point was estimated from the data and emergency inpatient admissions and Emergency Department visits per person-year compared for paediatric and adult care using random intercept Poisson regressions. RESULTS: Young people with life-limiting conditions had 29% (95% CI: 14-46%) more emergency inpatient admissions and 24% (95% CI: 12-38%) more Emergency Department visits in adult care than in paediatric care. There were no significant differences associated with the transition for young people in the diabetes or no long-term conditions groups. CONCLUSIONS: The transition from paediatric to adult healthcare is associated with an increase in emergency hospital visits for young people with life-limiting conditions, but not for young people with diabetes or no long-term conditions. There may be scope to improve the transition for young people with life-limiting conditions. IMPACT: There is evidence for increases in emergency hospital visits when young people with life-limiting conditions transition to adult healthcare. These changes are not observed for comparator groups - young people with diabetes and young people with no known long-term conditions, suggesting they are not due to other transitions happening at similar ages. Greater sensitivity to changes at transition is achieved through estimation of the transition point from the data, reducing misclassification bias.

People's preferences for self-management support.

OBJECTIVE: To identify and assess the preferences of people with long-term health conditions toward generalizable characteristics of self-management support interventions, with the objective to inform the design of more person-centered support services. DATA SOURCES: Primary qualitative and quantitative data collected on a representative sample of individuals with at least one of the fifteen most prevalent long-term conditions in the UK. STUDY DESIGN: Targeted literature review followed by a series of one-to-one qualitative semistructured interviews and a large-scale discrete choice experiment. DATA COLLECTION: Digital recording of one-to-one qualitative interviews, one-to-one cognitive interviews, and a series of online quantitative surveys, including two best-worst scaling and one discrete choice experiment, with individuals with long-term conditions. PRINCIPAL FINDINGS: On average, patients preferred a self-management support intervention that (a) discusses the options available to the patient and make her choose, (b) is individual-based, (c) face to face (d) with doctor or nurse, (e) at the GP practice, (f) sessions shorter than 1 hour, and (g) occurring annually for two-third of the sample and monthly for the rest. We found heterogeneity in preferences via three latent classes, with class sizes of 41% (C1), 30% (C2), and 29% (C3). The individuals' gender [P < 0.05(C1), P < 0.01(C3)], age [P < 0.05(C1), P < 0.05(C2)], type of long-term condition [P < 0.05(C1), P < 0.01(C3)], and presence of comorbidity [P < 0.01(C1), P < 0.01(C3), P < 0.01(C3)] were able to characterize differences between these latent classes and help understand the heterogeneity of preferences toward the above mentioned features of self-management support interventions. These findings were then used to profile individuals into different preference groups, for each of whom the most desirable form of self-management support, one that was more likely to be adopted by the recipient, could be designed. CONCLUSIONS: We identified several factors that could be used to inform a more nuanced self-management support service design and provision that take into account the recipient's characteristics and preferences.

Estimation of age of transition from paediatric to adult healthcare for young people with long term conditions using linked routinely collected healthcare data.

INTRODUCTION: Healthcare transitions, including from paediatric to adult services, can be disruptive and cause a lack of continuity in care. Existing research on the paediatric-adult healthcare transition often uses a simple age cut-off to assign transition status. This risks misclassification bias, reducing observed changes at transition (adults are included in the paediatric group and vice versa) possibly to differing extents between groups that transition at different ages. OBJECTIVE: To develop and assess methods for estimating the transition point from paediatric to adult healthcare from routine healthcare records. METHODS: A retrospective cohort of young people (12 to 23 years) with long term conditions was constructed from linked primary and secondary care data in England. Inpatient and outpatient records were classified as paediatric or adult based on treatment and clinician specialities. Transition point was estimated using three methods based on record classification (First Adult: the date of first adult record; Last Paediatric: date of last paediatric record; Fitted: a date determined by statistical fitting). Estimated transition age was compared between methods. A simulation explored impacts of estimation approaches compared to a simple age cut-off when assessing associations between transition status and healthcare events. RESULTS: Simulations showed using an age-based cut-off at 16 or 18 years as transition point, common in research on transition, may underestimate transition-associated changes. Many health records for those aged <14 years were classified as adult, limiting utility of the First Adult approach. The Last Paediatric approach is least sensitive to this possible misclassification and may best reflect experience of the transition. CONCLUSIONS: Estimating transition point from routine healthcare data is possible and offers advantages over a simple age cut-off. These methods, adapted as necessary for data from other countries, should be used to reduce risk of misclassification bias in studies of transition in nationally representative data.