Household coverage, quality and costs of care provided by community health worker teams and the determining factors: findings from a mixed methods study in South Africa.

OBJECTIVE: Community health workers (CHWs) are undertaking more complex tasks as part of the move towards universal health coverage in South Africa. CHW programmes can improve access to care for vulnerable communities, but many such programmes struggle with insufficient supervision. In this paper, we assess coverage (proportion of households visited by a CHW in the past year and month), quality of care and costs of the service provided by CHW teams with differing configurations of supervisors, some based in formal clinics and some in community health posts. PARTICIPANTS: CHW, their supervisors, clinic staff, CHW clients. METHODS: We used mixed methods (a random household survey, focus group discussions, interviews and observations of the CHW at work) to examine the performance of six CHW teams in vulnerable communities in Sedibeng, South Africa. RESULTS: A CHW had visited 17% of households in the last year, and we estimated they were conducting one to two visits per day. At household registration visits, the CHW asked half of the questions required. Respondents remembered 20%-25% of the health messages that CHW delivered from a visit in the last month, and half of the respondents took the action recommended by the CHW. Training, supervision and motivation of the CHW, and collaboration with other clinic staff, were better with a senior nurse supervisor. We estimated that if CHW carried out four visits a day, coverage would increase to 30%-90% of households, suggesting that some teams need more CHW, as well as better supervision. CONCLUSION: Household coverage was low, and the service was limited. Support from the local facility was key to providing a quality service, and a senior supervisor facilitated this collaboration. Greater investment in numbers of CHW, supervisors, training and equipment is required for the potential benefits of the programme to be delivered.

Randomised controlled trial evaluating the effectiveness and cost-effectiveness of 'Families for Health', a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years.

BACKGROUND: Effective programmes to help children manage their weight are required. 'Families for Health' focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. OBJECTIVE: The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). DESIGN: The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. SETTING: Three sites in the West Midlands, England, UK. PARTICIPANTS: Children aged 6-11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. INTERVENTIONS: Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. MAIN OUTCOME MEASURES: Joint primary outcome measures were change in children's BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months' follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. RESULTS: The study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the 'usual-care' control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) -0.001 to 0.229; p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (-0.118, 95% CI -0.203 to -0.034; p = 0.007), but not in the Families for Health arm (-0.005, 95% CI -0.085 to 0.078; p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548; p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators', parents' and children's experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. CONCLUSIONS: Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6-11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45032201. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.

Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.

OBJECTIVE: Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). DESIGN: Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. SETTING: Three National Health Service Primary Care Trusts in West Midlands, England. PARTICIPANTS: Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. INTERVENTIONS: FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. MAIN OUTCOME MEASURES: Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. RESULTS: 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. CONCLUSIONS: FFH was neither effective nor cost-effective for the management of obesity compared with UC. TRIAL REGISTRATION NUMBER: ISRCTN45032201.

Building the capacity to solve complex health challenges in sub-Saharan Africa: CARTA's multidisciplinary PhD training.

OBJECTIVES: To develop a curriculum (Joint Advanced Seminars [JASs]) that produced PhD fellows who understood that health is an outcome of multiple determinants within complex environments and that approaches from a range of disciplines is required to address health and development within the Consortium for Advanced Research Training in Africa (CARTA). We sought to attract PhD fellows, supervisors and teaching faculty from a range of disciplines into the program. METHODS: Multidisciplinary teams developed the JAS curriculum. CARTA PhD fellowships were open to academics in consortium member institutions, irrespective of primary discipline, interested in doing a PhD in public and population health. Supervisors and JAS faculty were recruited from CARTA institutions. We use routine JAS evaluation data (closed and open-ended questions) collected from PhD fellows at every JAS, a survey of one CARTA cohort, and an external evaluation of CARTA to assess the impact of the JAS curriculum on learning. RESULTS: We describe our pedagogic approach, arguing its centrality to an appreciation of multiple disciplines, and illustrate how it promotes working in multidisciplinary ways. CARTA has attracted PhD fellows, supervisors and JAS teaching faculty from across a range of disciplines. Evaluations indicate PhD fellows have a greater appreciation of how disciplines other than their own are important to understanding health and its determinants and an appreciation and capacity to employ mixed methods research. CONCLUSIONS: In the short term, we have been effective in promoting an understanding of multidisciplinarity, resulting in fellows using methods from beyond their discipline of origin. This curriculum has international application.

Dementia and Physical Activity (DAPA) - an exercise intervention to improve cognition in people with mild to moderate dementia: study protocol for a randomized controlled trial.

BACKGROUND: Dementia is more common in older than in younger people, and as a result of the ageing of the population in developed countries, it is becoming more prevalent. Drug treatments for dementia are limited, and the main support offered to people with dementia and their families is generally services to mitigate against loss of function. Physical exercise is a candidate non-pharmacological treatment for dementia. METHODS/DESIGN: DAPA is a randomised controlled trial funded by the National Institute for Health Research Health Technology Assessment programme to estimate the effect of a 4-month, moderate- to hard-intensity exercise training programme and subsequent advice to remain active, on cognition (primary outcome) at 12 months in people with mild to moderate dementia. Community-dwelling participants (with their carers where possible), who are able to walk 3 metres without human assistance, able to undertake an exercise programme and do not have any unstable or terminal illness are recruited. Participants are then randomised by an independent statistician using a computerised random number generator to usual care or exercise at a 2:1 ratio in favour of exercise. The exercise intervention comprises 29, 1-hour-long exercise classes, run twice weekly at suitable venues such as leisure centres, which include aerobic exercise (on static bikes) and resistance exercise (using weights). Goals for independent exercise are set while the classes are still running, and supported thereafter with phone calls. The primary outcome is measured using ADAS-cog. Secondary outcome measures include behavioural symptoms, functional ability, quality of life and carer burden. Primary and secondary outcomes will be measured at baseline and at 6 and 12 months after randomisation, by researchers masked to participant randomisation in the participants' own homes. An economic evaluation will be carried out in parallel to the RCT, as will a qualitative study capturing the experiences of participants, carers and staff delivering the intervention. DISCUSSION: The DAPA study will be the first large, randomised trial of the cognitive effects of exercise on people with dementia. The intervention is designed to be capable of being delivered within the constraints of NHS service provision, and the economic evaluation will allow assessment of its cost-effectiveness. TRIAL REGISTRATION: DAPA was registered with the ISRCTN database on 29 July 2011, registration number ISRCTN32612072 .

Behaviour change strategies for reducing blood pressure-related disease burden: findings from a global implementation research programme.

BACKGROUND: The Global Alliance for Chronic Diseases comprises the majority of the world's public research funding agencies. It is focussed on implementation research to tackle the burden of chronic diseases in low- and middle-income countries and amongst vulnerable populations in high-income countries. In its inaugural research call, 15 projects were funded, focussing on lowering blood pressure-related disease burden. In this study, we describe a reflexive mapping exercise to identify the behaviour change strategies undertaken in each of these projects. METHODS: Using the Behaviour Change Wheel framework, each team rated the capability, opportunity and motivation of the various actors who were integral to each project (e.g. community members, non-physician health workers and doctors in projects focussed on service delivery). Teams then mapped the interventions they were implementing and determined the principal policy categories in which those interventions were operating. Guidance was provided on the use of Behaviour Change Wheel to support consistency in responses across teams. Ratings were iteratively discussed and refined at several group meetings. RESULTS: There was marked variation in the perceived capabilities, opportunities and motivation of the various actors who were being targeted for behaviour change strategies. Despite this variation, there was a high degree of synergy in interventions functions with most teams utilising complex interventions involving education, training, enablement, environmental restructuring and persuasion oriented strategies. Similar policy categories were also targeted across teams particularly in the areas of guidelines, communication/marketing and service provision with few teams focussing on fiscal measures, regulation and legislation. CONCLUSIONS: The large variation in preparedness to change behaviour amongst the principal actors across these projects suggests that the interventions themselves will be variably taken up, despite the similarity in approaches taken. The findings highlight the importance of contextual factors in driving success and failure of research programmes. Forthcoming outcome and process evaluations from each project will build on this exploratory work and provide a greater understanding of factors that might influence scale-up of intervention strategies.

The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.

BACKGROUND: South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension. METHODS/DESIGN: The Nkateko trial will test the effectiveness of clinic-based lay health workers (LHWs) in supporting hypertension management. It is a pragmatic, cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa, and it is underpinned by long-term health and demographic surveillance. Eight primary care facilities, with their catchment communities, are randomised to usual care or the addition of LHWs focused on chronic care. All clinics (intervention and control) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records. Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions, particularly hypertension. The LHWs will be supported by an implementation manager, who will work with clinic staff to develop the most effective role for the LHWs. Control clinics will continue to provide usual care. The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease. A process evaluation will be based on a realist approach using patient exit interviews, clinic observations and interviews with health professionals, LHWs and patients to document the intervention and its implementation. DISCUSSION: There are challenges in the design of this trial. Assessing change through population surveys may reduce measurable effects; however, we feel this is appropriate because we aim to attract those who currently do not use clinics, and we hope to improve care for clinic users. Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community. We are constantly working to achieve an effective balance between the intervention and process evaluations. TRIAL REGISTRATION: ISRCTN12128227 (registered 5 March 2014).

Social conditions and disability related to the mortality of older people in rural South Africa.

BACKGROUND: South Africa is experiencing a health and social transition including an ageing population and an HIV epidemic. We report mortality experience of an older rural South African population. METHODS: Individual survey data and longer-term demographic data were used to describe factors associated with mortality. Individuals aged 50 years and over (n»4085) answered a health and quality of life questionnaire in 2006 and were followed for 3 years thereafter. Additional vital events and socio-demographic data were extracted from the Agincourt Health and Demographic Surveillance System from 1993 to 2010, to provide longer-term trends in mortality. Cox regression analysis was used to determine factors related to survival. RESULTS: In 10 967 person-years of follow-up between August 2006 and August 2009,377 deaths occurred. Women had lower mortality {hazard ratio [HR] 0.35 [95% confidence interval (CI) 0.28­0.45]}. Higher mortality was associated with being single[HR 1.48 (95% CI 1.16­1.88)], having lower household assets score [HR 1.79 (95%CI 1.28­2.51)], reporting greater disability [HR 2.40 (95% CI 1.68­3.42)] and poorer quality of life [HR 1.59 (95% CI 1.09­2.31)]. There was higher mortality in those aged under 69 as compared with those 70 to 79 years old. Census data and cause specific regression models confirmed that this was due to deaths from HIV/TB in the younger age group. CONCLUSIONS: Mortality due to HIV/TB is increasing in men, and to some extent women,aged over 50. Policy makers and practitioners should consider the needs of this growing and often overlooked group.

Social Conditions and Disability Related to the Mortality of Older People in Rural South Africa.

BACKGROUND: South Africa is experiencing a health and social transition including an ageing population and an HIV epidemic. We report mortality experience of an older rural South African population. METHODS: Individual survey data and longer-term demographic data were used to describe factors associated with mortality. Individuals aged 50 years and over (n = 4085) answered a health and quality of life questionnaire in 2006 and were followed for 3 years thereafter. Additional vital events and socio-demographic data were extracted from the Agincourt Health and Demographic Surveillance System from 1993 to 2010, to provide longer-term trends in mortality. Cox regression analysis was used to determine factors related to survival. RESULTS: In 10 967 person-years of follow-up between August 2006 and August 2009, 377 deaths occurred. Women had lower mortality {hazard ratio [HR] 0.35 [95% confidence interval (CI) 0.28-0.45]}. Higher mortality was associated with being single [HR 1.48 (95% CI 1.16-1.88)], having lower household assets score [HR 1.79 (95% CI 1.28-2.51)], reporting greater disability [HR 2.40 (95% CI 1.68-3.42)] and poorer quality of life [HR 1.59 (95% CI 1.09-2.31)]. There was higher mortality in those aged under 69 as compared with those 70 to 79 years old. Census data and cause specific regression models confirmed that this was due to deaths from HIV/TB in the younger age group. CONCLUSIONS: Mortality due to HIV/TB is increasing in men, and to some extent women, aged over 50. Policy makers and practitioners should consider the needs of this growing and often overlooked group.

Sleep problems and mortality in rural South Africa: novel evidence from a low-resource setting.

OBJECTIVE: Sleep problems are associated with mortality in Western populations. In low-resource settings, evidence of sleep problems and their potential association with mortality is lacking. Our study aimed to fill this gap by examining the prospective association of sleep problems with mortality among older adults in rural South Africa, as well as potential sex differences in this association. METHODS: The study was conducted in 2006 in Agincourt (South Africa), as part of the Health and Demographic Surveillance System. A community-wide sample of 4044 men and women aged 50 years or older participated in the survey. Two measures of sleep quality over the last 30 days were assessed alongside sociodemographic variables, measures of quality of life (QoL), and functional ability. Cox proportional hazard models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for mortality risk over time associated with the two sleep measures at baseline, while allowing adjustment for other covariates. RESULTS: Overall, 394 deaths occurred during 3 years of follow-up. Both men and women reporting severe/extreme nocturnal sleep problems (vs none/mild/moderate) experienced a significantly greater mortality risk in models adjusted for sociodemographic variables only (HR, 1.65 [95% CI, 1.18-2.31] and HR, 1.42 [95% CI, 1.07-1.88], respectively). However, these associations were nonsignificant in fully adjusted models (HR, 1.23 [95% CI, 0.85-1.79] and HR, 1.07 [95% CI, 0.78-1.47], respectively). Men who reported severe/extreme difficulty related to daytime function (vs none/mild/moderate) experienced a 2-fold increased mortality risk (HR, 2.01 [95% CI, 1.32-3.07]) in fully adjusted models, whereas no significant association was observed for women (1.16 [95% CI, 0.80-1.67]). CONCLUSIONS: In this population, nocturnal sleep problems were not associated with mortality once analyses were adjusted for QoL, functional ability, and psychologic comorbidities. By contrast, severe or extreme problems with feeling unrested or unrefreshed during the day were associated with a 2-fold increased mortality risk, but this association was only significant in men.

'Mediterranean' dietary pattern for the primary prevention of cardiovascular disease.

BACKGROUND: The Seven Countries study in the 1960s showed that populations in the Mediterranean region experienced lower cardiovascular disease (CVD) mortality probably as a result of different dietary patterns. Later observational studies have confirmed the benefits of adherence to a Mediterranean dietary pattern on CVD risk factors. Clinical trial evidence is limited, and is mostly in secondary prevention. OBJECTIVES: To determine the effectiveness of a Mediterranean dietary pattern for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 9 of 12, September 2012); MEDLINE (Ovid, 1946 to October week 1 2012); EMBASE (Ovid, 1980 to 2012 week 41); ISI Web of Science (1970 to 16 October 2012); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (Issue 3 of 12, September 2012). We searched trial registers and reference lists of reviews and applied no language restrictions. SELECTION CRITERIA: We selected randomised controlled trials in healthy adults and adults at high risk of CVD. A Mediterranean dietary pattern was defined as comprising at least two of the following components: (1) high monounsaturated/saturated fat ratio, (2) low to moderate red wine consumption, (3) high consumption of legumes, (4) high consumption of grains and cereals, (5) high consumption of fruits and vegetables, (6) low consumption of meat and meat products and increased consumption of fish, and (7) moderate consumption of milk and dairy products. The comparison group received either no intervention or minimal intervention. Outcomes included clinical events and CVD risk factors. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and contacted chief investigators to request additional relevant information. MAIN RESULTS: We included 11 trials (15 papers) (52,044 participants randomised). Trials were heterogeneous in the participants recruited, in the number of dietary components and follow-up periods. Seven trials described the intervention as a Mediterranean diet. Clinical events were reported in only one trial (Women's Health Initiative 48,835 postmenopausal women, intervention not described as a Mediterranean diet but increased fruit and vegetable and cereal intake) where no statistically significant effects of the intervention were seen on fatal and non-fatal endpoints at eight years. Small reductions in total cholesterol (-0.16 mmol/L, 95% confidence interval (CI) -0.26 to -0.06; random-effects model) and low-density lipoprotein (LDL) cholesterol (-0.07 mmol/L, 95% CI -0.13 to -0.01) were seen with the intervention. Subgroup analyses revealed statistically significant greater reductions in total cholesterol in those trials describing the intervention as a Mediterranean diet (-0.23 mmol/L, 95% CI -0.27 to -0.2) compared with control (-0.06 mmol/L, 95% CI -0.13 to 0.01). Heterogeneity precluded meta-analyses for other outcomes. Reductions in blood pressure were seen in three of five trials reporting this outcome. None of the trials reported adverse events. AUTHORS' CONCLUSIONS: The limited evidence to date suggests some favourable effects on cardiovascular risk factors. More comprehensive interventions describing themselves as the Mediterranean diet may produce more beneficial effects on lipid levels than those interventions with fewer dietary components. More trials are needed to examine the impact of heterogeneity of both participants and the intervention on outcomes.

Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial.

BACKGROUND: Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. METHODS: We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277. FINDINGS: Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI -0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI -0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group. INTERPRETATION: This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required. FUNDING: National Institute for Health Research Health Technology Assessment.

Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial.

BACKGROUND: Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base. METHODS/DESIGN: This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children's BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style will also be assessed.Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. DISCUSSION: This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. TRIAL REGISTRATION: Current Controlled Trials http://ISRCTN45032201.

Building capacity for public and population health research in Africa: the consortium for advanced research training in Africa (CARTA) model.

BACKGROUND: Globally, sub-Saharan Africa bears the greatest burden of disease. Strengthened research capacity to understand the social determinants of health among different African populations is key to addressing the drivers of poor health and developing interventions to improve health outcomes and health systems in the region. Yet, the continent clearly lacks centers of research excellence that can generate a strong evidence base to address the region's socio-economic and health problems. OBJECTIVE AND PROGRAM OVERVIEW: We describe the recently launched Consortium for Advanced Research Training in Africa (CARTA), which brings together a network of nine academic and four research institutions from West, East, Central, and Southern Africa, and select northern universities and training institutes. CARTA's program of activities comprises two primary, interrelated, and mutually reinforcing objectives: to strengthen research infrastructure and capacity at African universities; and to support doctoral training through the creation of a collaborative doctoral training program in population and public health. The ultimate goal of CARTA is to build local research capacity to understand the determinants of population health and effectively intervene to improve health outcomes and health systems. CONCLUSIONS: CARTA's focus on the local production of networked and high-skilled researchers committed to working in sub-Saharan Africa, and on the concomitant increase in local research and training capacity of African universities and research institutes addresses the inability of existing programs to create a critical mass of well-trained and networked researchers across the continent. The initiative's goal of strengthening human resources and university-wide systems critical to the success and sustainability of research productivity in public and population health will rejuvenate institutional teaching, research, and administrative systems.

Health inequalities among older men and women in Africa and Asia: evidence from eight Health and Demographic Surveillance System sites in the INDEPTH WHO-SAGE Study.

BACKGROUND: Declining rates of fertility and mortality are driving demographic transition in all regions of the world, leading to global population ageing and consequently changing patterns of global morbidity and mortality. Understanding sex-related health differences, recognising groups at risk of poor health and identifying determinants of poor health are therefore very important for both improving health trajectories and planning for the health needs of ageing populations. OBJECTIVES: To determine the extent to which demographic and socio-economic factors impact upon measures of health in older populations in Africa and Asia; to examine sex differences in health and further explain how these differences can be attributed to demographic and socio-economic determinants. METHODS: A total of 46,269 individuals aged 50 years and over in eight Health and Demographic Surveillance System (HDSS) sites within the INDEPTH Network were studied during 2006-2007 using an abbreviated version of the WHO Study on global AGEing and adult health (SAGE) Wave I instrument. The survey data were then linked to longitudinal HDSS background information. A health score was calculated based on self-reported health derived from eight health domains. Multivariable regression and post-regression decomposition provide ways of measuring and explaining the health score gap between men and women. RESULTS: Older men have better self-reported health than older women. Differences in household socio-economic levels, age, education levels, marital status and living arrangements explained from about 82% and 71% of the gaps in health score observed between men and women in South Africa and Kenya, respectively, to almost nothing in Bangladesh. Different health domains contributed differently to the overall health scores for men and women in each country. CONCLUSION: This study confirmed the existence of sex differences in self-reported health in low- and middle-income countries even after adjustments for differences in demographic and socio-economic factors. A decomposition analysis suggested that sex differences in health differed across the HDSS sites, with the greatest level of inequality found in Bangladesh. The analysis showed considerable variation in how differences in socio-demographic and economic characteristics explained the gaps in self-reported health observed between older men and women in African and Asian settings. The overall health score was a robust indicator of health, with two domains, pain and sleep/energy, contributing consistently across the HDSS sites. Further studies are warranted to understand other significant individual and contextual determinants to which these sex differences in health can be attributed. This will lay a foundation for a more evidence-based approach to resource allocation, and to developing health promotion programmes for older men and women in these settings.

Identifying individuals for primary cardiovascular disease prevention in UK general practice: priorities and resource implications.

Targeted cardiovascular disease prevention relies on risk-factor information held in primary care records. A risk algorithm, the 'e-Nudge', was applied to data from a population of >or=50-year-olds in 19 West Midlands practices, to identify those individuals at risk of cardiovascular disease. Altogether, 5.9% were identified aged 50-74 years at >or=20% 10-year risk based on existing data, and a further 26.4% were potentially at risk but had missing risk-factor information; 9.2% of patients aged over 50 years with established cardiovascular disease had at least one modifiable risk factor outside the audit target of the Quality and Outcomes Framework. Implications for resource allocation are discussed.

A cross-sectional study of vascular risk factors in a rural South African population: data from the Southern African Stroke Prevention Initiative (SASPI).

BACKGROUND: Rural sub-Saharan Africa is at an early stage of economic and health transition. It is predicted that the 21st century will see a serious added economic burden from non-communicable disease including vascular disease in low-income countries as they progress through the transition. The stage of vascular disease in a population is thought to result from the prevalence of vascular risk factors. Already hypertension and stroke are common in adults in sub-Saharan Africa. Using a multidisciplinary approach we aimed to assess the prevalence of several vascular risk factors in Agincourt, a rural demographic surveillance site in South Africa. METHODS: We performed a cross sectional random sample survey of adults aged over 35 in Agincourt (population approximately 70 000). Participants were visited at home by a trained nurse who administered a questionnaire, carried out clinical measurements and took a blood sample. From this we assessed participants' history of vascular risk, blood pressure using an OMRON 705 CP monitor, waist circumference, body mass index (BMI), ankle brachial index (ABI), and total and HDL cholesterol. RESULTS: 402 people (24% men) participated. There was a high prevalence of smoking in men, but the number of cigarettes smoked was small. There was a striking difference in mean BMI between men and women (22.8 kg/m2 versus 27.2 kg/m2), but levels of blood pressure were very similar. 43% of participants had a blood pressure greater than 140/90 or were on anti-hypertensive treatment and 37% of participants identified with measured high blood pressure were on pharmacological treatment. 12% of participants had an ABI of < 0.9, sugesting the presence of sub-clinical atheroma. 25.6% of participants had a total cholesterol level > 5 mmol/l. CONCLUSION: We found a high prevalence of hypertension, obesity in women, and a suggestion of subclinical atheroma despite relatively favourable cholesterol levels in a rural South African population. South Africa is facing the challenge of an emerging epidemic of vascular disease. Research to establish the social determinates of these risk factors and interventions to reduce both individual and population risk are required.

Understanding and managing hypertension in an African sub-district: a multidisciplinary approach.

AIMS: To use a multidisciplinary approach to describe the prevalence, lay beliefs, health impact, and treatment of hypertension in the Agincourt sub-district. METHODS: A multidisciplinary team used a range of methods including a cross-sectional random sample survey of vascular risk factors in adults aged 35 years and older, and rapid ethnographic assessment. People who had suffered a stroke were identified by a screening questionnaire followed by a detailed history and examination by a clinician to confirm the likely diagnosis of stroke. Workshops were held for nurses working in the local clinics and an audit of blood pressure measuring devices was carried out. RESULTS: Some 43% of the population 35 and over had hypertension. There was no relationship with gender but a strong positive relationship with age. Illnesses were classified by the population as being either African, with personal or social causes, or White/Western, with physical causes. The causes of hypertension were stated to be both physical and social. Main sources of treatment were the clinics and hospitals but people also sought help from churches and traditional healers. Some 84% of stroke survivors had evidence of hypertension. Few people received treatment for hypertension, although good levels of control were achieved in some. Barriers to providing effective treatment included unreliable drug supply and unreliable equipment to measure blood pressure. CONCLUSIONS: Hypertension is a major problem among older people in Agincourt. There is potential for effective secondary prevention. The potential for primary prevention is less clear. Further information on diet is required.

What is eHealth (5): a research agenda for eHealth through stakeholder consultation and policy context review.

BACKGROUND: In 2003, the National Health Service in England and Wales, despite its large investment in information and communication technology, had not set a national research agenda. The National Health Service has three main research and development programs: one is the Service Delivery and Organisation program, commissioned in 2003, and the others are two parallel "scoping exercises" to help set a research agenda. This paper reports on one of those projects. A parallel literature review was carried out by others and has been reported elsewhere. OBJECTIVE: The objective was to explore the concerns of stakeholders and to review relevant policy in order to produce recommendations and a conceptual map of eHealth research. METHODS: There were two parallel strands. For the stakeholder consultation, 37 professionals representing 12 "stakeholder" groups participated in focus groups or interviews. Discussion was prompted by eHealth "scenarios" and analyzed using thematic content analysis. Subsequently, 17 lay participants, in three focus groups, discussed and prioritized these themes. For the policy review, 26 policy makers were interviewed, and 95 policy documents were reviewed. Recommendations were subsequently reviewed in a conference workshop. Recommendations for research from both strands were combined into a conceptual map. RESULTS: Themes from stakeholder consultation and policy review were combined as 43 recommendations under six headings. Four of these headings (using, processing, sharing, and controlling information) describe the scope of eHealth research. The other two relate to how research should be carried out (ensuring best practice is first identified and disseminated) and to the values considered important by stakeholders (in particular, measuring improvement in health). CONCLUSIONS: The scope of eHealth research (using, processing, sharing, controlling information) derived empirically from this study corresponds with "textbook" descriptions of informatics. Stakeholders would like eHealth research to include outcomes such as improved health or quality of life, but such research may be long term while changes in information technology are rapid. Longer-term research questions need to be concerned with human behavior and our use of information, rather than particular technologies. In some cases, "modelling" longer-term costs and benefits (in terms of health) may be desirable.