Eleanor Grieve

A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial

BACKGROUND The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. METHODS We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. FINDINGS 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). INTERPRETATION The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. FUNDING Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).

Double trouble: the impact of multimorbidity and deprivation on preference-weighted health related quality of life a cross sectional analysis of the Scottish Health Survey

ObjectiveTo investigate the association between multimorbidity and Preference_Weighted Health Related Quality of Life (PW_HRQoL), a score that combines physical and mental functioning, and how this varies by socioeconomic deprivation and age.DesignThe Scottish Health Survey (SHeS) is a cross-sectional representative survey of the general population which included the SF-12, a survey of HRQoL, for individuals 20 years and over.MethodsFor 7,054 participants we generated PW_HRQoL scores by running SF-12 responses through the SF-6D algorithm. The resulting scores ranged from 0.29 (worst health) to 1 (perfect health). Using ordinary least squares, we first investigated associations between scores and increasing counts of longstanding conditions, and then repeated for multimorbidity (2+ conditions). Estimates were made for the general population and quintiles of socioeconomic deprivation. For multimorbidity, the analyses were repeated stratifying the population by age group (20–44, 45–64, 65+).Results45% of participants reported a longstanding condition and 18% reported multimorbidity. The presence of 1, 2, or 3+ longstanding conditions were associated with average reductions in PW_HRQoL scores of 0.081, 0.151 and 0.212 respectively. Reduction in scores associated with multimorbidity was 33% greater in the most deprived quintile compared to the least deprived quintile, with the biggest difference (80%) in the 20–44 age groups. There were no significant gender differences.ConclusionsPW_HRQoL decreases markedly with multimorbidity, and is exacerbated by higher deprivation and younger age. There is a need to prioritise interventions to improve the HRQoL for (especially younger) adults with multimorbidity in deprived areas.Box 1What Is Known?Prevalence and premature onset of multimorbidity increases as socioeconomic position worsens. Previous studies have investigated the effect of multimorbidity on Health Related Quality of Life (HRQoL) on separate physical and mental health states. There is limited data on how HRQoL falls as the number of conditions increase, and how estimates vary across the general population.Leaving physical and mental health as separate categories can inhibit assessment of overall HRQoL. The use of a Preference_Weighted Health Related Quality of Life (PW_HRQoL) score provides a single summary measure of overall health, by weighting mental and physical states by their perceived importance as part of overall HRQoL. The use of a single score enables a simple and consistent assessment of the impact of conditions and how this varies across the population. Economists term PW_HRQoL scores health utilities.What this study adds?This is the first study to estimate how the impact of multimorbidity on PW_HRQoL scores varies by age group and socioeconomic deprivation. Multimorbidity has a substantial negative impact on HRQoL which is most severe in areas of deprivation, especially in younger adults.Measuring the burden of multimorbidity using PW_HRQoL provides consistency with how economists measure HRQoL; changes in which can be used in economic evaluation to assess the cost effectiveness of interventions.

Feasibility and indicative results from a 12-month low-energy liquid diet treatment and maintenance programme for severe obesity

BACKGROUND There is no established primary care solution for the rapidly increasing numbers of severely obese people with body mass index (BMI) > 40 kg/m(2). AIM This programme aimed to generate weight losses of ≥15 kg at 12 months, within routine primary care. DESIGN AND SETTING Feasibility study in primary care. METHOD Patients with a BMI ≥40 kg/m(2) commenced a micronutrient-replete 810-833 kcal/day low-energy liquid diet (LELD), delivered in primary care, for a planned 12 weeks or 20 kg weight loss (whichever was the sooner), with structured food reintroduction and then weight-loss maintenance, with optional orlistat to 12 months. RESULT Of 91 patients (74 females) entering the programme (baseline: weight 131 kg, BMI 48 kg/m(2), age 46 years), 58/91(64%) completed the LELD stage, with a mean duration of 14.4 weeks (standard deviation [SD] = 6.0 weeks), and a mean weight loss of 16.9 kg (SD = 6.0 kg). Four patients commenced weight-loss maintenance omitting the food-reintroduction stage. Of the remaining 54, 37(68%) started and completed food reintroduction over a mean duration of 9.3 weeks (SD = 5.7 weeks), with a further mean weight loss of 2.1 kg (SD = 3.7 kg), before starting a long-term low-fat-diet weight-loss maintenance plan. A total of 44/91 (48%) received orlistat at some stage. At 12 months, weight was recorded for 68/91 (75%) patients, with a mean loss of 12.4 kg (SD = 11.4 kg). Of these, 30 (33% of all 91 patients starting the programme) had a documented maintained weight loss of ≥15 kg at 12 months, six (7%) had a 10-15 kg loss, and 11 (12%) had a 5-10 kg loss. The indicative cost of providing this entire programme for wider implementation would be £861 per patient entered, or £2611 per documented 15 kg loss achieved. CONCLUSION A care package within routine primary care for severe obesity, including LELD, food reintroduction, and weight-loss maintenance, was well accepted and achieved a 12-month-maintained weight loss of ≥15 kg for one-third of all patients entering the programme.

The disproportionate economic burden associated with severe and complicated obesity: a systematic review.

Burden of disease studies typically classify individuals with a body mass index (BMI) ≥ 30 kg m−2 as a single group (‘obese’) and make comparisons to those with lower BMIs. Here, we review the literature on the additional economic burden associated with severe obesity or classes 3 and 4 obesity (BMI ≥ 40 kg m−2), the fastest growing category of obesity, with the aim of exploring and disaggregating differences in resource use as BMI increases beyond 40 kg m−2. We recognize the importance of comparing classes 3 and 4 obesity to less severe obesity (classes 1 and 2) as well as quantifying the single sub‐class impacts (classes 3 and 4). Although the latter analysis is the aim of this review, we include results, where found in the literature, for movement between the recognized subclasses and within classes 3 and 4 obesity. Articles presenting data on the economic burden associated with severe obesity were identified from a search of Ovid MEDLINE, EMBASE, EBSCO CINAHL and Cochrane Library databases. Data were extracted on the direct costs, productivity costs and resource use associated with severe obesity along with estimates of the multiplier effects associated with increasing BMI. Fifteen studies were identified, of which four disaggregated resource use for BMI ≥ 40 kg m−2. The multiplier effects derived for a variety of different types of costs incurred by the severely obese compared with those of normal weight (18.5 kg m−2 < BMI < 25 kg m−2) ranged from 1.5 to 3.9 for direct costs, and from 1.7 to 8.0 for productivity costs. There are few published data on the economic burden of obesity disaggregated by BMI ≥ 40 kg m−2. By grouping people homogenously above a threshold of BMI 40 kg m−2, the multiplier effects for those at the highest end of the spectrum are likely to be underestimated. This will, in turn, impact on the estimates of cost‐effectiveness for interventions and policies aimed at the severely obese.

Delivering Digital Health and Well-Being at Scale: Lessons Learned during the Implementation of the dallas Program in the United Kingdom

Abstract Objective To identify implementation lessons from the United Kingdom Delivering Assisted Living Lifestyles at Scale (dallas) program—a large-scale, national technology program that aims to deliver a broad range of digital services and products to the public to promote health and well-being. Materials and Methods Prospective, longitudinal qualitative research study investigating implementation processes. Qualitative data collected includes semi-structured e-Health Implementation Toolkit–led interviews at baseline/mid-point ( n = 38), quarterly evaluation, quarterly technical and barrier and solutions reports, observational logs, quarterly evaluation alignment interviews with project leads, observational data collected during meetings, and ethnographic data from dallas events ( n > 200 distinct pieces of qualitative data). Data analysis was guided by Normalization Process Theory, a sociological theory that aids conceptualization of implementation issues in complex healthcare settings. Results Five key challenges were identified: 1) The challenge of establishing and maintaining large heterogeneous, multi-agency partnerships to deliver new models of healthcare; 2) The need for resilience in the face of barriers and set-backs including the backdrop of continually changing external environments; 3) The inherent tension between embracing innovative co-design and achieving delivery at pace and at scale ; 4) The effects of branding and marketing issues in consumer healthcare settings; and 5) The challenge of interoperability and information governance, when commercial proprietary models are dominant. Conclusions The magnitude and ambition of the dallas program provides a unique opportunity to investigate the macro level implementation challenges faced when designing and delivering digital health and wellness services at scale. Flexibility, adaptability, and resilience are key implementation facilitators when shifting to new digitally enabled models of care.

Practice nurse health checks for adults with intellectual disabilities: a cluster-design, randomised controlled trial

BACKGROUND Adults with intellectual disabilities have substantial health inequalities and poor access to health care. We assessed whether practice nurse-delivered health checks could improve the health of adults with intellectual disabilities compared with standard care. METHODS In this cluster-design, single-blind, randomised controlled trial, we included general practices in Scotland, UK. From June to December, 2011, we randomly assigned (1:1) these general practices to either health checks plus standard care (health-checks group), or standard care only (control group), and we recruited the patients from these practices. Randomisation was done with stratification by number of GPs per practice and number of registered patients with intellectual disabilities (<20 or ≥20). Two research assistants were masked to allocation, and undertook the review of 9 month medical records and interviews. Participants and carers were not masked. The intervention was one health check designed especially for people with intellectual disabilities delivered by a practice nurse. The objective was improvement in health and health care 9 months after randomisation, and the primary outcome was the incidence of newly detected health needs being met by this timepoint. Whether needs were met was established by the investigators being masked to group allocation. The analysis was by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN43324841. FINDINGS Between June 26 and Dec 20, 2011, we recruited 38 practices. 85 participants (from 16 practices) were randomly assigned to intervention and 67 (from 17 practices) to standard care; five of the identified practices did not supply any participants. 83 intervention and 66 standard care participants completed the trial. More newly detected health needs were met in the intervention group than in the control standard care group (median 1 [range 0-8], 76·4% met [SD 36·5] vs 2 [0-11], 72·6% met [35·4]; odds ratio [OR] 1·73 [95% CI 0·93-3·22], p=0·085), although this difference was not significant. Significantly more health monitoring needs were met in the intervention group than standard care (median 2 [0-20], 69·9% [SD 34·2] vs 2 [0-22], 56·8% [29·4], OR 2·38 [95% CI 1·31-4·32, p=0·0053]). The probability that health checks are cost effective was between 0·6 and 0·8, irrespective of the cost-effectiveness threshold level. Costs per patient were -£71·48 for health checks and -£20·56 for standard care. The difference (-£50·92) was not significant [95% CI -434 to 362]. No adverse events were attributable to the intervention. INTERPRETATION Health checks given by practice nurses to adults with intellectual disabilities produced health-care improvements that were more conducive to longer-term health than standard care given to this population. The intervention dominated standard care, being both cheaper and more effective. Health-check programmes might therefore be indicated for adults with intellectual disabilities. FUNDING Scottish Government Change Fund, NHS Greater Glasgow and Clyde Research and Development.

Cost-effectiveness of malaria diagnosis using rapid diagnostic tests compared to microscopy or clinical symptoms alone in Afghanistan

BackgroundImproving access to parasitological diagnosis of malaria is a central strategy for control and elimination of the disease. Malaria rapid diagnostic tests (RDTs) are relatively easy to perform and could be used in primary level clinics to increase coverage of diagnostics and improve treatment of malaria.MethodsA cost-effectiveness analysis was undertaken of RDT-based diagnosis in public health sector facilities in Afghanistan comparing the societal and health sector costs of RDTs versus microscopy and RDTs versus clinical diagnosis in low and moderate transmission areas. The effect measure was ‘appropriate treatment for malaria’ defined using a reference diagnosis. Effects were obtained from a recent trial of RDTs in 22 public health centres with cost data collected directly from health centres and from patients enrolled in the trial. Decision models were used to compare the cost of RDT diagnosis versus the current diagnostic method in use at the clinic per appropriately treated case (incremental cost-effectiveness ratio, ICER).ResultsRDT diagnosis of Plasmodium vivax and Plasmodium falciparum malaria in patients with uncomplicated febrile illness had higher effectiveness and lower cost compared to microscopy and was cost-effective across the moderate and low transmission settings. RDTs remained cost-effective when microscopy was used for other clinical purposes. In the low transmission setting, RDTs were much more effective than clinical diagnosis (65.2% (212/325) vs 12.5% (40/321)) but at an additional cost (ICER) of US

Readiness for Delivering Digital Health at Scale: Lessons From a Longitudinal Qualitative Evaluation of a National Digital Health Innovation Program in the United Kingdom

4.5 per appropriately treated patient including a health sector cost (ICER) of US

Economic evaluation of integrated new technologies for health and social care: Suggestions for policy makers, users and evaluators.

2.5 and household cost of US

A flexible toolkit for evaluating person-centred digital health and wellness at scale

2.0. Sensitivity analysis, which varied drug costs, indicated that RDTs would remain cost-effective if artemisinin combination therapy was used for treating both P. vivax and P. falciparum. Cost-effectiveness of microscopy relative to RDT is further reduced if the former is used exclusively for malaria diagnosis. In the health service setting of Afghanistan, RDTs are a cost-effective intervention compared to microscopy.ConclusionsRDTs remain cost-effective across a range of drug costs and if microscopy is used for a range of diagnostic services. RDTs have significant advantages over clinical diagnosis with minor increases in the cost of service provision.Trial RegistrationThe trial was registered at ClinicalTrials.gov under identifier NCT00935688.