Impact of the COVID-19 pandemic on type 2 diabetes care and factors associated with care disruption in Kenya and Tanzania.

BACKGROUND: The COVID-19 pandemic affected healthcare delivery globally, impacting care access and delivery of essential services. OBJECTIVES: We investigated the pandemic's impact on care for patients with type 2 diabetes and factors associated with care disruption in Kenya and Tanzania. METHODS: A cross-sectional study was conducted among adults diagnosed with diabetes pre-COVID-19. Data were collected in February-April 2022 reflecting experiences at two time-points, three months before and the three months most affected by the COVID-19 pandemic. A questionnaire captured data on blood glucose testing, changes in medication prescription and access, and healthcare provider access. RESULTS: We recruited 1000 participants (500/country). Diabetes care was disrupted in both countries, with 34.8% and 32.8% of the participants reporting change in place and frequency of testing in Kenya, respectively. In Tanzania, 12.4% and 17.8% reported changes in location and frequency of glucose testing, respectively. The number of health facility visits declined, 14.4% (p < 0.001) in Kenya and 5.6% (p = 0.001) in Tanzania. In Kenya, there was a higher likelihood of severe care disruption among insured patients (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI][1.05-2.34]; p = 0.029) and a lower likelihood among patients residing in rural areas (aOR, 0.35[95%CI, 0.22-0.58]; p < 0.001). Tanzania had a lower likelihood of severe disruption among insured patients (aOR, 0.51[95%CI, 0.33-0.79]; p = 0.003) but higher likelihood among patients with low economic status (aOR, 1.81[95%CI, 1.14-2.88]; p = 0.011). CONCLUSIONS: COVID-19 disrupted diabetes care more in Kenya than Tanzania. Health systems and emergency preparedness should be strengthened to ensure continuity of service provision for patients with diabetes.

Main findings: The COVID-19 pandemic disrupted diabetes care in Kenya and Tanzania resulting in changes in place and frequency of blood glucose testing, medication prescribed (less oral hypoglycaemics and more insulin), fewer health facility visits and more difficulty accessing healthcare providers.Added knowledge: This study quantifies the impact of the COVID-19 pandemic on diabetes care in Kenya and Tanzania, and describes the factors associated with care disruption in both countries.Global health impact for policy and action: Evidence on diabetes care disruption is useful in making plans and policies responsive to the needs of diabetes patients during pandemics or related emergency situations.

Randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3): study protocol.

INTRODUCTION: The aim of the STOPPIT-3 study is to determine the clinical and cost effectiveness of antenatal corticosteroids (ACS) prior to planned birth of twins in a multicentre placebo-controlled trial with internal pilot. METHODS AND ANALYSIS: This study will comprise a multicentre, double-blinded, randomised, placebo-controlled trial in at least 50 UK obstetric units. The target population is 1552 women with a twin pregnancy and a planned birth between 35 and 38+6 weeks' gestation recruited from antenatal clinics. Women will be randomised to Dexamethasone Phosphate (24 mg) or saline administered via two intramuscular injections 24 hours apart, 24-120 hours prior to scheduled birth. OUTCOMES: The primary outcome is need for respiratory support within 72 hours of birth. Secondary and safety outcomes will be included. Cognitive and language development at age 2 years will be assessed in a subset of participants using the Parent report of Children's Abilities-Revised questionnaire. We will also determine the cost effectiveness of the treatment with ACS compared with placebo. ETHICS AND DISSEMINATION: STOPPIT-3 has been funded and approved by the National Institute of Healthcare Research. It has been approved by the West Midlands Research Ethics Committee (22/WM/0018). The results will be disseminated via publication in peer-reviewed journals and conference presentation and will also be communicated to the public via links with charity partners and social media. TRIAL SPONSOR: The University of Edinburgh and Lothian Health Board ACCORD, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ. TRIAL REGISTRATION NUMBER: ISRCTN59959611.

Evaluation of the Healthy Start voucher scheme on maternal vitamin use and child breastfeeding: a natural experiment using data linkage.

Background: Having a good start in life during pregnancy and infancy has been shown to be important for living both a healthy life and a longer life. Despite the introduction of many policies for the early-years age group, including voucher schemes, with the aim of improving nutrition, there is limited evidence of their impact on health. Objectives: To assess the effectiveness of the Healthy Start voucher scheme on infant, child and maternal outcomes, and to capture the lived experiences of the Healthy Start voucher scheme for low-income women. Design: This was a natural experiment study using existing data sets, linked to routinely collected health data sets, with a nested qualitative study of low-income women and an assessment of the health economics. Setting: Representative sample of Scottish children and UK children. Participants: Growing Up in Scotland cohort 2 (n = 2240), respondents to the 2015 Infant Feeding Study (n = 8067) and a sample of 40 participants in the qualitative study. Interventions: The Health Start voucher, a means-tested scheme that provides vouchers worth £3.10 per week to spend on liquid milk, formula milk, fruit and vegetables. Main outcome measures: Infant and child outcomes - breastfeeding initiation and duration; maternal outcomes - vitamin use pre and during pregnancy. Results: The exposed group were women receiving the Healthy Start voucher (R), with two control groups: eligible and not claiming the Healthy Start voucher (E) and nearly eligible. There was no difference in vitamin use during pregnancy for either comparison (receiving the Healthy Start voucher, 82%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.10 vs. receiving the Healthy Start voucher, 87%; nearly eligible, 88%; p = 0.43) in the Growing Up in Scotland cohort. Proportions were similar for the Infant Feeding Study cohort (receiving the Healthy Start voucher, 89%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.01 vs. receiving the Healthy Start voucher, 89%; nearly eligible, 87%; p = 0.01); although results were statistically significantly different, these were small effect sizes. There was no difference for either comparison in breastfeeding initiation or breastfeeding duration in months in Growing Up in Scotland, but there was a negative effect of the Healthy Start voucher in the Infant Feeding Survey. This contrast between data sets indicates that results are inconclusive for breastfeeding. The qualitative study found that despite the low monetary value the women valued the Healthy Start voucher scheme. However, the broader lives of low-income women are crucial to understand the constraints to offer a healthy diet. Limitations: Owing to the policy being in place, it was difficult to identify appropriate control groups using existing data sources, especially in the Infant Feeding Study. Conclusions: As the Healthy Start voucher scheme attempts to influence health behaviour, this evaluation can inform other policies aiming to change behaviour and use voucher incentives. The null effect of Healthy Start vouchers on the primary outcomes may be due to the value of the vouchers being insufficient to change the broader lives of low-income women to offer a healthy diet. Future work: The methods developed to undertake an economic evaluation alongside a natural experiment using existing data can be used to explore the cost-effectiveness of the Healthy Start voucher scheme. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 11. See the NIHR Journals Library website for further project information.

United Kingdom governments have introduced many policies to support infants and their families. Most of these policies have not been evaluated in terms of health outcomes. Therefore, there is limited evidence for policy-makers about whether or not the right policies are in place to make a difference to the health of young children and their families. We investigated the impact of the Healthy Start voucher scheme (worth £3.10 per week to spend on milk, fruit and vegetables) on the health of low-income mothers, and their infants and young children, in particular vitamin use of mothers and breastfeeding of infants. Using survey data, there were high rates of vitamin use during pregnancy, but fewer women taking vitamins before pregnancy. There was no effect of Healthy Start vouchers on taking vitamins before or during pregnancy. There was inconclusive evidence of the effect of Healthy Start vouchers on breastfeeding, indicating that use of the vouchers does not discourage breastfeeding in women with low incomes. From interviews with mothers, we found that they valued the Healthy Start vouchers and understood the aims of the policy. Healthy Start vouchers were not mentioned in decision-making around breastfeeding. Women's choice to breast or formula feed was based on a range of other factors, such as support to breastfeed. They wanted to provide a healthy diet for their families, but owing to living on low incomes did not always manage it. Policy-makers still need more evidence about the effects of voucher schemes to improve the health of low-income mothers, and their infants and young children. The decision-makers require evidence to determine where to allocate limited resources. There is a need to improve support for low-income families to provide their families with a healthy diet.

Relationship of the SITLESS intervention on medication use in community-dwelling older adults: an exploratory study.

Background: Sedentary behavior (SB) and physical activity (PA) interventions in older adults can improve health outcomes. Problems related with aging include prevalent comorbidity, multiple non-communicable diseases, complaints, and resulting polypharmacy. This manuscript examines the relationship between an intervention aiming at reducing SB on medication patterns. Method: This manuscript presents a local sub-analysis of the SITLESS trial data on medication use. SITLESS was an exercise referral scheme (ERS) enhanced by self-management strategies (SMS) to reduce SB in community-dwelling older adults. We analyzed data from the ERS + SMS, ERS and usual care (UC) groups. Patient medication records were available at baseline and at the end of the intervention (4-month period) and were analyzed to explore the effect of SITLESS on medication patterns of use. Result: A sample of 75 participants was analyzed, mostly older overweight women with poor body composition scores and mobility limitations. There was a significant reduction of 1.6 medicines (SD = 2.7) in the ERS group (p < 0.01), but not in the UC or ERS + SMS groups. Differences were more evident in medicines used for short periods of time. Conclusion: The findings suggest that an exercise-based program enhanced by SMS to reduce SB might influence medication use for acute conditions but there is a need to further investigate effects on long-term medicine use in older adults.

Is education level, as a proxy for socio-economic position, related to device-measured and self-reported sedentary behavior in European older adults? A cross-sectional study from the SITLESS project.

Background: Sedentary behavior (SB) is a determinant of health in older adult people. Educational level is a primary driver of health disparities and is demonstrated to be a reliable measure of socioeconomic position. We aimed to examine the associations between educational level and self-reported along with device-measured SB in older adults living in Europe and the association of mentally active and passive SB domains with the educational level and gender in these associations. Methods: The design is cross-sectional. One thousand three hundred and sixty participants aged 65 and over (75.3±6.3 years old, 61.8% women) participated. Inclusion criteria were scored with the Short Physical Performance Battery. Variables that describe the sample were assessed with an interview, and device-measured SB was assessed with an accelerometer. SB was assessed with the Sedentary Behavior Questionnaire and an accelerometer. Multiple linear regression models were used to study the association between the level of education and SB. Results: Participants self-reported an average of 7.82 (SD: 3.02) daily waking hours of SB during weekend days, and the average of device-measured SB was 11.39 (1.23) h. Total mentally active SB (weekdays and weekends) was associated with the education level (p < 0.000). Participants were more sedentary during the week than during weekends, regardless of level of education (p < 0.000). Education level was significantly associated with self-reported mean hours per day in 46SB (p = 0.000; R=0.026; 95%CI). Conclusion: Low education level in older adults is associated with self-reported SB but not with objective SB measures.

Cost-effectiveness of a programme to address sedentary behaviour in older adults: results from the SITLESS RCT.

BACKGROUND: This study details the within-trial economic evaluation and long-term economic model of SITLESS, a multi-country, three-armed randomized controlled trial comparing a combined intervention of exercise referral schemes (ERS) enhanced by self-management strategies (SMS) against ERS alone and usual care (UC). METHODS: A cost-utility analysis, conducted from the base-case perspective of the National Health Service and personal and social services, estimated the incremental cost per incremental quality-adjusted life year (QALY) and years in full capability (YFC). A secondary analysis combined the costs with a broad set of outcomes within a cost-consequence framework, from a societal perspective. A Markov-type decision-analytic model was developed to project short-term changes in physical activity to long-term outcomes and costs, over a 5- and 15-year time horizon. RESULTS: The results of the within-trial analysis show that SMS+ERS is highly likely to be cost-effective compared to ERS alone (ICER €4270/QALY), but not compared to UC. Participants allocated to the SMS+ERS group also showed an improvement in YFC compared to ERS alone and UC. The long-term analysis revealed that SMS+ERS is likely to be a cost-effective option compared to ERS and UC over a 5-year, but not with a 15-year horizon, being then dominated by ERS alone. CONCLUSION: This research provides new evidence that SMS is a cost-effective add-on to ERS strategies. This economic evaluation informs the case for further, cost-effective, refinement of lifestyle change programmes targeted to older adults, with the aim of ultimately reducing the impact of non-communicable diseases in this population.

Propensity score methods for comparative-effectiveness analysis: A case study of direct oral anticoagulants in the atrial fibrillation population.

OBJECTIVE: To explore methodological challenges when using real-world evidence (RWE) to estimate comparative-effectiveness in the context of Health Technology Assessment of direct oral anticoagulants (DOACs) in Scotland. METHODS: We used linkage data from the Prescribing Information System (PIS), Scottish Morbidity Records (SMR) and mortality records for newly anticoagulated patients to explore methodological challenges in the use of Propensity score (PS) matching, Inverse Probability Weighting (IPW) and covariate adjustment with PS. Model performance was assessed by standardised difference. Clinical outcomes (stroke and major bleeding) and mortality were compared for all DOACs (including apixaban, dabigatran and rivaroxaban) versus warfarin. Patients were followed for 2 years from first oral anticoagulant prescription to first clinical event or death. Censoring was applied for treatment switching or discontinuation. RESULTS: Overall, a good balance of patients' covariates was obtained with every PS model tested. IPW was found to be the best performing method in assessing covariate balance when applied to subgroups with relatively large sample sizes (combined-DOACs versus warfarin). With the IPTW-IPCW approach, the treatment effect tends to be larger, but still in line with the treatment effect estimated using other PS methods. Covariate adjustment with PS in the outcome model performed well when applied to subgroups with smaller sample sizes (dabigatran versus warfarin), as this method does not require further reduction of sample size, and trimming or truncation of extreme weights. CONCLUSION: The choice of adequate PS methods may vary according to the characteristics of the data. If assumptions of unobserved confounding hold, multiple approaches should be identified and tested. PS based methods can be implemented using routinely collected linked data, thus supporting Health Technology decision-making.

The Mediating Role of Self-Regulation and Self-Efficacy on Physical Activity Change in Community-Dwelling Older Adults (≥65 Years): An Experimental Cross-Lagged Analysis Using Data From SITLESS.

Improving the capacity for physical activity interventions to maintain behavior change is a key public health concern and an important strategy for the health and independence of older adults. Ways of ensuring effective maintenance of physical activity levels in older adults are unclear. This study includes the objective measure of moderate-to-vigorous physical activity (MVPA); self-reported self-efficacy; and self-regulation at four timepoints (baseline, intervention completion at 4 months, 12-, and 18-month follow-up) from the SITLESS study, a clinical trial conducted with a cohort of community-dwelling older adults (≥65 years) from Denmark, Germany, Spain, and the United Kingdom. A cross-lagged analysis found that self-regulation and self-efficacy may be key determinants of MVPA behavior in community-dwelling older adults. More specifically, the use of behavioral support strategies represents an important correlate of MVPA behavior, and its association with MVPA may be mediated by self-regulation and self-efficacy in older adults in the short and long term.

Older Adults' Experiences of a Physical Activity and Sedentary Behaviour Intervention: A Nested Qualitative Study in the SITLESS Multi-Country Randomised Clinical Trial.

BACKGROUND: The SITLESS programme comprises exercise referral schemes and self-management strategies and has been evaluated in a trial in Denmark, Spain, Germany and Northern Ireland. The aim of this qualitative study was to understand the implementation and contextual aspects of the intervention in relation to the mechanisms of impact and to explore the perceived effects. METHODS: Qualitative methodologies were nested in the SITLESS trial including 71 individual interviews and 12 focus groups targeting intervention and control group participants from postintervention to 18-month follow-up in all intervention sites based on a semi-structured topic guide. RESULTS: Overarching themes were identified under the framework categories of context, implementation, mechanisms of impact and perceived effects. The findings highlight the perceived barriers and facilitators to older adults' engagement in exercise referral schemes. Social interaction and enjoyment through the group-based programmes are key components to promote adherence and encourage the maintenance of targeted behaviours through peer support and connectedness. Exit strategies and signposting to relevant classes and facilities enabled the maintenance of positive lifestyle behaviours. CONCLUSIONS: When designing and implementing interventions, key components enhancing social interaction, enjoyment and continuity should be in place in order to successfully promote sustained behaviour change.

Associations of sedentary behavior bouts with community-dwelling older adults' physical function.

The study aim was to explore associations between sedentary behavior (SB) bouts and physical function in 1360 community-dwelling older adults (≥65 years old). SB was measured using an ActiGraph wGT3X + accelerometer for seven consecutive days at the dominant hip and processed accordingly. Various SB bout lengths were assessed including: 1- to 9-minutes; 10- to 29-minutes; 30- to 59-minutes; and ≥60-minutes, as well as maximum time spent in a SB bout. Total SB time was adjusted for within the SB bout variables used (percentage SB time in the SB bout length and number of SB bouts per total SB hour). Physical function was assessed using the 2-minute walk test (2MWT), 5-times sit-to-stand (chair stand) test, and unipedal stance test (UST). Hierarchical linear regression models were utilized. Covariates such as moderate-vigorous physical activity (MVPA), demographic and health characteristics were controlled for. Lower percentage time spent in ≥60-minute SB bouts was significantly (P < .05) associated with longer 2MWT distance while lower numbers of ≥60-minute SB bouts were associated with longer 2MWT distance, shorter chair stand time and longer UST time. There were mixed associations with physical function for 10- to 29-minute SB bouts. In a large cohort of European older adults, prolonged SB bouts lasting ≥60-minutes appear to be associated with reduced physical function after controlling for MVPA and numerous other important covariates. Besides reducing SB levels, these findings suggest there is a need to regularly interrupt prolonged SB to improve physical function in older adults.

Sedentary behavior, physical activity, and mental health in older adults: An isotemporal substitution model.

INTRODUCTION: Regular moderate-to-vigorous physical activity (MVPA) is associated with improved mental health, but the evidence for the effect of reducing sedentary behavior (SB) or increasing light PA (LPA) in older adults is lacking. Using isotemporal substitution (IS) models, the aim of this paper was to investigate the effect of substituting SB with LPA or MVPA on associations with mental health in older adults. METHODS: Data from 1360 older adults (mean age 75.18 years) in four countries were utilized. PA and SB was measured using ActiGraph wGT3X-BT + accelerometers worn for 7 days. Self-rated mental health was measured using the Hospital and Anxiety Depression Scale (HADS). IS models estimated cross-sectional associations when 30 minutes of one behavior was substituted with another. Models were adjusted for age, sex, marital status, and educational attainment. RESULTS: Substituting 30 minutes of SB with LPA (ß -.37; 95% CI -0.42, -0.32) or MVPA (ß -.14; 95% CI -0.21, -0.07) and substituting LPA with MVPA (ß -.11; 95% CI -0.18, -0.04) were associated with improvements in anxiety. However, substituting 30 minutes of SB with LPA (ß .55; 95% CI 0.49, 0.62) was associated with increased depression. CONCLUSION: Replacing 30 minutes of SB with LPA or MVPA was associated with improved anxiety symptoms in older adults. Greater benefits were observed when shifting SB and LPA to MVPA.

The effectiveness and complexity of interventions targeting sedentary behaviour across the lifespan: a systematic review and meta-analysis.

BACKGROUND: Evidence suggests that sedentary behaviour (SB) is associated with poor health outcomes. SB at any age may have significant consequences for health and well-being and interventions targeting SB are accumulating. Therefore, the need to review the effects of multicomponent, complex interventions that incorporate effective strategies to reduce SB are essential. METHODS: A systematic review and meta-analysis were conducted investigating the impact of interventions targeting SB across the lifespan. Six databases were searched and two review authors independently screened studies for eligibility, completed data extraction and assessed the risk of bias and complexity of each of the included studies. RESULTS: A total of 77 adult studies (n=62, RCTs) and 84 studies (n=62, RCTs) in children were included. The findings demonstrated that interventions in adults when compared to active controls resulted in non-significant reductions in SB, although when compared to inactive controls significant reductions were found in both the short (MD -56.86; 95%CI -74.10, -39.63; n=4632; I2 83%) and medium-to-long term (MD -20.14; 95%CI -34.13, -6.16; n=4537; I2 65%). The findings demonstrated that interventions in children when compared to active controls may lead to relevant reductions in daily sedentary time in the short-term (MD -59.90; 95%CI -102.16, -17.65; n=267; I2 86%), while interventions in children when compared to inactive controls may lead to relevant reductions in the short-term (MD -25.86; 95%CI -40.77, -10.96; n=9480; I2 98%) and medium-to-long term (MD -14.02; 95%CI -19.49, -8.55; n=41,138; I2 98%). The assessment of complexity suggested that interventions may need to be suitably complex to address the challenges of a complex behaviour such as SB, but demonstrated that a higher complexity score is not necessarily associated with better outcomes in terms of sustained long-term changes. CONCLUSIONS: Interventions targeting reductions in SB have been shown to be successful, especially environmental interventions in both children and adults. More needs to be known about how best to optimise intervention effects. Future intervention studies should apply more rigorous methods to improve research quality, considering larger sample sizes, randomised controlled designs and valid and reliable measures of SB.

Is Sedentary Behavior or Physical Activity Associated With Loneliness in Older Adults? Results of the European-Wide SITLESS Study.

Research has found that social relationships are central to the health and well-being of an aging population. Evidence exploring the association between physical activity (PA) and sedentary behavior (SB) with social isolation and loneliness is limited. This study uses objectively measured PA and SB (ActiGraph®) and self-reported measures of loneliness (the De Jong Gierveld Loneliness Scale) and social engagement (the Lubben Social Network Scale) from the SITLESS study, a European-wide study of community-dwelling older adults. Social isolation was associated with SB where higher levels of SB were associated with an increase in the level of social isolation, controlling for age, sex, living arrangements, employment status, body mass index, educational background, marital status, and self-reported general health. In contrast, PA was not associated with social isolation, and neither SB nor PA was a statistically significant predictor of loneliness. SB may be linked to social isolation in older adults, but PA and SB are not necessarily linked to loneliness in older community-dwelling adults.

Exercise referral schemes enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity among community-dwelling older adults from four European countries: protocol for the process evaluation of the SITLESS randomised controlled trial.

INTRODUCTION: SITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in community-dwelling older citizens. The intervention is complex and requires a process evaluation to understand how implementation, causal mechanisms and context shape outcomes. The specific aims are to assess fidelity and reach of the implementation, understand the contextual aspects of each intervention site, evaluate the mechanisms of impact, and explore perceived effects. METHODS AND ANALYSIS: Following the Medical Research Council guidance on complex interventions, a combination of qualitative and quantitative procedures is applied, including observational checklists and attendance registries, standardised scales (ie, Marcus's Self-Efficacy Questionnaire, Physical Activity Self-Regulation Scale and the Lubben Social Network Scale) at baseline, postintervention and follow-up assessments, semistructured questionnaires gathering contextual characteristics, and participant observations of the sessions. Semistructured interviews and focus groups with the participants and trainers are conducted at postintervention and during the follow-up to explore their experiences. Outcomes from the standardised scales are analysed as moderators within the impact evaluation. Descriptive results on context and perceived effects complement results on impact. The qualitative and quantitative findings will help to refine the logic model to finally support the interpretation of the results on the effectiveness of the intervention. ETHICS AND DISSEMINATION: The study design was approved by the respective Ethical Committee of Ramon Llull University, Southern Denmark, Northern Ireland and Ulm University. Participation is voluntary, and all participants are asked to sign informed consent before starting the study. A dissemination plan operationalises how to achieve a social impact by reaching academic and non-academic stakeholders. A data management plan describes the specific data sets and regulates its deposition and curation. All publications will be open access. TRIAL REGISTRATION NUMBER: NCT02629666; Pre-results.

A framework for conducting economic evaluations alongside natural experiments.

Internationally, policy makers are increasingly focussed on reducing the detrimental consequences and rising costs associated with unhealthy diets, inactivity, smoking, alcohol and other risk factors on the health of their populations. This has led to an increase in the demand for evidence-based, cost-effective Population Health Interventions (PHIs) to reverse this trend. Given that research designs such as randomised controlled trials (RCTs) are often not suited to the evaluation of PHIs, Natural Experiments (NEs) are now frequently being used as a design to evaluate such complex, preventive PHIs. However, current guidance for economic evaluation focusses on RCT designs and therefore does not address the specific challenges of NE designs. Using such guidance can lead to sub-optimal design, data collection and analysis for NEs, leading to bias in the estimated effectiveness and cost-effectiveness of the PHI. As a consequence, there is a growing recognition of the need to identify a robust methodological framework for the design and conducting of economic evaluations alongside such NEs. This paper outlines the challenges inherent to the design and conduct of economic evaluations of PHIs alongside NEs, providing a comprehensive framework and outlining a research agenda in this area.

Cost-effectiveness of exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: protocol for an economic evaluation alongside the SITLESS three-armed pragmatic randomised controlled trial.

INTRODUCTION: Promoting physical activity (PA) and reducing sedentary behaviour (SB) may exert beneficial effects on the older adult population, improving behavioural, functional, health and psychosocial outcomes in addition to reducing health, social care and personal costs. This paper describes the planned economic evaluation of SITLESS, a multicountry three-armed pragmatic randomised controlled trial (RCT) which aims to assess the short-term and long-term effectiveness and cost-effectiveness of a complex intervention on SB and PA in community-dwelling older adults, based on exercise referral schemes enhanced by a group intervention providing self-management strategies to encourage lifestyle change. METHODS AND ANALYSIS: A within-trial economic evaluation and long-term model from both a National Health Service/personal social services perspective and a broader societal perspective will be undertaken alongside the SITLESS multinational RCT. Healthcare costs (hospitalisations, accident and emergency visits, appointment with health professionals) and social care costs (eg, community care) will be included in the economic evaluation. For the cost-utility analysis, quality-adjusted life-years will be measured using the EQ-5D-5L and capability well-being measured using the ICEpop CAPability measure for Older people (ICECAP-O) questionnaire. Other effectiveness outcomes (health related, behavioural, functional) will be incorporated into a cost-effectiveness analysis and cost-consequence analysis.The multinational nature of this RCT implies a hierarchical structure of the data and unobserved heterogeneity between clusters that needs to be adequately modelled with appropriate statistical and econometric techniques. In addition, a long-term population health economic model will be developed and will synthesise and extrapolate within-trial data with additional data extracted from the literature linking PA and SB outcomes with longer term health states.Methods guidance for population health economic evaluation will be adopted including the use of a long-time horizon, 1.5% discount rate for costs and benefits, cost consequence analysis framework and a multisector perspective. ETHICS AND DISSEMINATION: The study design was approved by the ethics and research committee of each intervention site: the Ethics and Research Committee of Ramon Llull University (reference number: 1314001P) (Fundació Blanquerna, Spain), the Regional Committees on Health Research Ethics for Southern Denmark (reference number: S-20150186) (University of Southern Denmark, Denmark), Office for Research Ethics Committees in Northern Ireland (ORECNI reference number: 16/NI/0185) (Queen's University of Belfast) and the Ethical Review Board of Ulm University (reference number: 354/15) (Ulm, Germany). Participation is voluntary and all participants will be asked to sign informed consent before the start of the study.This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement number 634 270. This article reflects only the authors' view and the Commission is not responsible for any use that may be made of the information it contains.The findings of the study will be disseminated to different target groups (academia, policymakers, end users) through different means following the national ethical guidelines and the dissemination regulation of the Horizon 2020 funding agency.Use of the EuroQol was registered with the EuroQol Group in 2016.Use of the ICECAP-O was registered with the University of Birmingham in March 2017. TRIAL REGISTRATION NUMBER: NCT02629666; Pre-results.

Protocol for the economic evaluation of a complex intervention to improve the mental health of maltreated infants and children in foster care in the UK (The BeST? services trial).

INTRODUCTION: Children who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors. Evidence suggests that early intervention can mitigate the negative consequences of child maltreatment, exerting long-term positive effects on the health of maltreated children entering foster care. However, evidence on cost-effectiveness of such complex interventions is limited. This protocol describes the first economic evaluation of its kind in the UK. METHODS AND ANALYSIS: An economic evaluation alongside the Best Services Trial (BeST?) has been prospectively designed to identify, measure and value key resource and outcome impacts arising from the New Orleans intervention model (NIM) (an infant mental health service) compared with case management (CM) (enhanced social work services as usual). A within-trial economic evaluation and long-term model from a National Health Service/Personal Social Service and a broader societal perspective will be undertaken alongside the National Institute for Health Research (NIHR)-Public Health Research Unit (PHRU)-funded randomised multicentre BeST?. BeST? aims to evaluate NIM compared with CM for maltreated children entering foster care in a UK context. Collection of Paediatric Quality of Life Inventory (PedsQL) and the recent mapping of PedsQL to EuroQol-5-Dimensions (EQ-5D) will facilitate the estimation of quality-adjusted life years specific to the infant population for a cost-utility analysis. Other effectiveness outcomes will be incorporated into a cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA). A long-term economic model and multiple economic evaluation frameworks will provide decision-makers with a comprehensive, multiperspective guide regarding cost-effectiveness of NIM. The long-term population health economic model will be developed to synthesise trial data with routine linked data and key government sector parameters informed by literature. Methods guidance for population health economic evaluation will be adopted (lifetime horizon, 1.5% discount rate for costs and benefits, CCA framework, multisector perspective). ETHICS AND DISSEMINATION: Ethics approval was obtained by the West of Scotland Ethics Committee. Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal as well as published in the peer-reviewed NIHR journals library (Public Health Research Programme). TRIAL REGISTRATION NUMBER: NCT02653716; Pre-results.

The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial.

BACKGROUND: Older adults are the fastest growing segment of the world's population. Recent evidence indicates that excessive sitting time is harmful to health, independent of meeting the recommended moderate to vigorous physical activity (PA) guidelines. The SITLESS project aims to determine whether exercise referral schemes (ERS) can be enhanced by self-management strategies (SMSs) to reduce sedentary behaviour (SB), increase PA and improve health, quality of life and function in the long term, as well as psychosocial outcomes in community-dwelling older European citizens from four countries, within a three-armed pragmatic randomised controlled trial, compared with ERS alone and also with general recommendations about PA. METHODS: A total of 1338 older adults will be included in this study, recruited from four European countries through different existing primary prevention pathways. Participants will be randomly allocated into an ERS of 16 weeks (32 sessions, 45-60 min per session), ERS enhanced by seven sessions of SMSs and four telephone prompts, or a control group. Outcomes will be assessed at baseline, month 4 (end of ERS intervention), month 16 (12 months post intervention) and month 22 (18 months post intervention). Primary outcomes will include measures of SB (time spent sedentary) and PA (counts per minute). Secondary outcomes will include muscle and physical function, health economics' related outcomes, anthropometry, quality of life, social networks, anxiety and depressive symptoms, disability, fear of falling, executive function and fatigue. A process evaluation will be conducted throughout the trial. The full analysis set will follow an intention-to-treat principle and will include all randomised participants for whom a baseline assessment is conducted. The study hypothesis will be tested with mixed linear models with repeated measures, to assess changes in the main outcomes (SB and PA) over time (baseline to month 22) and between study arms. DISCUSSION: The findings of this study may help inform the design and implementation of more effective interventions to reduce SB and increase PA levels, and hence improve long-term health outcomes in the older adult population. SITLESS aims to support policy-makers in deciding how or whether ERS should be further implemented or restructured in order to increase its adherence, impact and cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02629666 . Registered 19 November 2015.

A Serosurvey for Brucellosis in Wild Boar (Sus scrofa) in Sardinia, Italy.

Porcine brucellosis is a zoonotic disease caused by Brucella suis and hosted by pigs (Sus scrofa). Both domestic pigs and wild boars are affected. We measured the prevalence of antibody to Brucella spp. in wild boars in Sardinia, Italy. During 1 November 2009 to 31 January 2010, we collected 570 serum samples from legally hunted wild boars and tested them using a commercial competitive enzyme-linked immunosorbent assay. Sex and age class of the sampled wild boars were also recorded. Thirty-five samples were positive for an apparent antibody prevalence of 6.1%. Antibody prevalences did not differ between sexes or among age classes.