Measuring the association between the opening of a new multi-national restaurant with young people's eating behaviours.

Out-of-home eating (takeaway, take-out and fast-foods) is associated with intakes of higher energy and fat, and lower intakes of micronutrients, and is associated with excess weight gain. In 2017, a unique opportunity arose to measure the association between the opening of a new multi-national fast-food restaurant (McDonald's) and consumption of fast-food on young people aged 11-16. This study uses a repeated cross-sectional design to explore group level change over time with respect to out-of-home eating behaviours of young people. Two secondary schools in Redcar and Cleveland agreed to participate and facilitated the completion of a questionnaire on their pupils eating behaviours at three timepoints a) prior to the new restaurant opening, b) three months post-opening and c) nine months post opening. Reported frequency of visits to McDonald's showed a statistically significant increase in visits between 3 and 9 months of the restaurant opening. This research asks and explores the question of whether the introduction of a new multi-national fast-food restaurant influences eating habits of young people attending schools near the new outlet.

'Acceleration' of the food delivery marketplace: Perspectives of local authority professionals in the North-East of England on temporary COVID regulations.

In January 2021, we assessed the implications of temporary regulations in the United Kingdom allowing pubs and restaurants to operate on a takeaway basis without instigating a change of use. Local authorities (LAs) across the North-East of England were unaware of any data regarding the take-up of these regulations, partially due to ongoing capacity issues; participants also raised health concerns around takeaway use increasing significantly. One year on, we repeated the study aiming to understand the impact of these regulations on the policy and practice of key professional groups. Specifically, we wanted to understand if LAs were still struggling with staff capacity to address the regulations, whether professionals still had public health trepidations, and if any unexpected changes had occurred across the local food environment because of the pandemic. We conversed with 16 public health professionals, planners and environmental health officers across seven LAs throughout the North-East of England via focus groups and interviews. Data collated were analysed via an inductive and semantic, reflexive-thematic approach. Through analysis of the data, three themes were generated and are discussed throughout: popular online delivery services as a mediator to increased takeaway usage; potential long-term health implications and challenges; continued uncertainty regarding the temporary regulations. This paper highlights important changes to local food environments, which public health professionals should be aware of, so they are better equipped to tackle health inequalities across urban and sub-urban areas.

Co-located Heroin Assisted Treatment within primary care: A preliminary analysis of the implications for healthcare access, cost, and treatment delivery in the UK.

BACKGROUND: The UK is experiencing its highest rate of drug related deaths in 25 years. Poor and inconsistent access to healthcare negatively impacts health outcomes for people who use drugs. Innovation in models of care which promote access and availability of physical treatment is fundamental. Heroin Assisted Treatment (HAT) is a treatment modality targeted at the most marginalised people who use drugs, at high risk of mortality and morbidity. The first service-provider initiated HAT service in the UK ran between October 2019 and November 2022 in Middlesbrough, England. The service was co-located within a specialist primary care facility offering acute healthcare treatment alongside injectable diamorphine. METHODS: Analysis of anonymised health records for healthcare costs (not including drug treatment) took place using descriptive statistics prior and during engagement with HAT, at both three (n=15) and six (n=12) months. Primary outcome measures were incidents of wound care, skin and soft tissue infections (SSTIs), overdose (OD) events, unplanned overnight stays in hospital, treatment engagement (general and within hospital care settings) and ambulance incidents. Secondary outcome measures were costs associated with these events. RESULTS: A shift in healthcare access for participants during HAT engagement was observed. HAT service attendance appeared to support health promoting preventative care, and reduce reactive reliance on emergency healthcare systems. At three and six months, engagement for preventative wound care and treatment for SSTIs increased at the practice. Unplanned emergency healthcare interactions for ODs, overnight hospital stays, serious SSTIs, and ambulance incidents reduced, and there was an increase in treatment engagement (i.e. a reduction in appointments which were not engaged with). There was a decrease in treatment engagement in hospital settings. Changes in healthcare utilisation during HAT translated to a reduction in healthcare costs of 58% within six months compared to the same timeframe from the period directly prior to commencing HAT. CONCLUSION: This exploratory study highlights the potential for innovative harm reduction interventions such as HAT, co-located with primary care services, to improve healthcare access and engagement for a high-risk population. Increased uptake of primary healthcare services translated to reductions in emergency healthcare use and associated costs. Although costs of HAT provision are substantial, the notable cost-savings in health care should be an important consideration in service implementation planning.

Process evaluation of a primary care-based type 2 diabetes remission project in the North East of England.

A type 2 diabetes remission project, Remission in Diabetes (REMI.D), funded by Sport England, was developed by stakeholders based in the North East of England and begun in early 2020. This local delivery pilot sought to tackle health inequalities by working with multiple organisations to demonstrate a way of scaling up an effective type 2 diabetes remission strategy which included both physical activity and dietary components. The intended delivery of the original project was impacted by the COVID-19 pandemic and changes were made to the project delivery in 2022. The aim of this process evaluation was to learn from the reactive decisions taken by stakeholders which altered the REMI.D project in response to the COVID-19 pandemic. Twelve stakeholders (from local authorities, secondary care, universities, NHS England commissioning, Diabetes UK, Sport England, Everyone Active and Active Partnerships) involved in the design and delivery of the intervention took part in a semi-structured interview lasting up to 60 min. Interviews were recorded and transcribed verbatim. Thematic analysis used the pre-determined 'core content' themes from the Medical Research Council and National Institute for Health Research framework for developing and evaluating complex interventions. Three topics for discussion emerged as follows: (a) lack of effective collaboration, (b) perception of change and (c) scalability of the intervention. Hierarchy within the stakeholder group initially hampered collaboration. Change was reactive as a result of the COVID-19 pandemic. Project changes reduced project sustainability and scalability but offered valuable learning about the need for explicit project theory for partnership working, co-production with service users and project flexibility for long-term health behaviour change.

Identification of tax options for high fat, sugar, salt foods for the HEALTHEI Project: a mixed-methods study.

BACKGROUND: The health economic analysis incorporating effects on labour outcomes, households, environment, and inequalities (HEALTHEI) explores which food taxes would have greatest benefits to health, labour, and work outcomes; household expenditure; environmental sustainability; and inequalities within the UK food system. Work package 1 includes a rapid review and workshops, aiming to explore the effects of price increases in food and non-alcoholic beverages to facilitate the specification of food taxes and research design. METHODS: In this mixed-methods study, we first did a rapid review to examine relevant published evidence. A preplanned framework ensured a systematic approach, in which we searched PubMed, HMIC, Scopus, Google, Mintel/Mintel Food and Drink, and Business Source Ultimate for papers published in English from Jan 1, 2010, to Nov 2, 2022. This review was followed by three online workshops (in March, 2023), which used interactive padlets to explore food systems, food taxation policy, tax rationales, and a rapid review infographic. 14 stakeholders from non-governmental organisations (n=10), academia (n=2), the Civil Service (n=1), and a local authority (n=1) took part (gender or ethnicity were not recorded). A stakeholder recruitment grid was developed to ensure representation across public sectors and disciplines of public health, nutrition, environment, and economics. FINDINGS: The rapid review identified six tax options with a broadly positive impact on consumption and health (high fat, high sugar, high salt, "junk food", sugar-sweetened-beverages, and meats plus sugar-sweetened beverages). It generated five core rationales for a food tax: change consumption, reduce or prevent harm, change product affordability, raise revenue, and industry impact. Using the workshop feedback, health inequalities, economics, ease of implementation and animal welfare were additional key areas for a so-called real-world application of tax. Stakeholders questioned the taxes in the current economic and political climate. INTERPRETATION: The work highlights the need to develop an impactful food tax option that encompasses the five core rationales identified in the findings. The workshops identified key areas to explore further to understand the feasibility, impact, and logistics of implementing future food taxes. Being unable to deliver workshops in person due to difficulties of participants travelling to London was a limitation. However, switching online allowed for varied and well attended workshops. FUNDING: National Institute of Health Research (Ref: NIHR133927).

'This is hardcore': a qualitative study exploring service users' experiences of Heroin-Assisted Treatment (HAT) in Middlesbrough, England.

BACKGROUND: Heroin-Assisted Treatment (HAT) is well evidenced internationally to improve health and social outcomes for people dependent on opioids who have not been helped by traditional treatment options. Despite this evidence base, England has been slow to implement HAT. The first service outside of a trial setting opened in 2019, providing twice-daily supervised injections of medical-grade heroin (diamorphine) to a select sample of high-risk heroin users in Middlesbrough. This paper explores their experiences, including the negotiation of the strict regularly controls required of a novel intervention in the UK context. METHODS: We conducted in-depth interviews with service providers and users of the Middlesbrough HAT service between September and November 2021. Data from each group were thematically analysed and reported separately. This paper details the experiences of the twelve heroin dependent men and women accessing HAT. RESULTS: Participants' accounts of HAT treatment evidenced a tension between the regulatory constraints and uncertainty of treatment provision, and the positive outcomes experienced through supportive service provision and an injectable treatment option. Limited confidence was held in treatment efficacy, longevity of funding, and personal capacity for treatment success. This was counteracted by a strong motivation to cease engagement with the illicit drug market. While attendance requirements placed restrictions on daily activities, participants also experienced benefits from strong, supportive bonds built with the service providers through their continued engagement. CONCLUSIONS: The Middlesbrough HAT programme provided benefits to a high-risk population of opioid dependent people who were unable or disinclined to participate in conventional opioid substitution treatments. The findings in this paper highlight the potential for service modifications to further enhance engagement. The closure of this programme in 2022 prohibits this opportunity for the Middlesbrough community, but holds potential to inform advocacy and innovation for future HAT interventions in England.

Opportunities to improve population health: possibilities for healthier food environments.

The recent Covid-19 pandemic highlighted stark social inequalities, notably around access to food, nutrition and to green or blue space (i.e. outdoor spaces with vegetation and water). Consequently, obesity is socio-economically patterned by this inequality; and while the environmental drivers of obesity are widely acknowledged, there is currently little upstream intervention. We know that living with obesity contributes to increasing health inequalities, and places healthcare systems under huge strain. Our environment could broadly be described obesogenic, in the sense of supporting unhealthful eating patterns and sedentary behaviour. Evidence points to the existence of nearly 700 UK obesity policies, all of which have had little success. Obesity prevention and treatment has focused on educational and behavioural interventions targeted at individual consumers. A more sustainable approach would be to try and change the environments that promote less healthy eating and high energy intake as well as sedentary behaviour. Approaches which modify the environment have the potential to assist in the prevention of this complex condition. This review paper focuses on the role of wider food environments or foodscapes. While there is an imperfect evidence base relating to the role of the foodscape in terms of the obesity crisis, policy, practice, civic society and industry must work together and take action now, in areas where current evidence suggests change is required. Despite the current cost-of-living crisis, shaping the foodscape to better support healthful eating decisions has the potential to be a key aspect of a successful obesity prevention intervention.

More than just 'free heroin': Caring whilst navigating constraint in the delivery of diamorphine assisted treatment.

BACKGROUND: In 2020, drug related deaths in the United Kingdom (UK) reached the highest rate in over 25 years, with hospitalisations and deaths particularly impacting people who use illicit opioids such as heroin. Treatment systems are increasingly required to be innovative to engage the most vulnerable at risk from premature morbidity and mortality. Heroin Assisted Treatment (HAT) is an alternative treatment modality for people for whom more traditional forms of opioid substitution therapy, such as methadone, have been ineffective. Middlesbrough, a town in the North-East England, was home to the first service in the UK to implement HAT outside of a clinical trial setting which closed for operation in November 2022. METHODS: Qualitative in-depth interviews with patients and health care providers (n =17) involved in the delivery of HAT were undertaken during 2021. This paper focuses on the health care provider interviews, the majority of which took place remotely. Interviews were audio recorded and thematically analysed. RESULTS: Health care providers navigated multiple layers of constraint during HAT implementation and delivery. We explore this in relation to three themes: 1) Negotiating risk and safety within treatment 2) More than a prescription: care beyond diamorphine 3) Internal and external delivery barriers and impact on treatment acceptability, identity and longevity. Negotiating and managing risks of polysubstance use was a complex task. Benefits regarding access to holistic care, improved therapeutic and social relationships were recognised by practitioners. The rigorous delivery schedule was the biggest barrier to engagement. Outside the treatment room, socio-structural factors posed additional challenges. CONCLUSION: Despite some operational complexities, health care providers viewed HAT as an effective method of engaging a high risk population with drug treatment services, with holistic benefits for clients over and above the treatment of opioid dependency. Findings will inform advocacy and innovation for future HAT interventions in England.

An analysis of food and beverage advertising on bus shelters in a deprived area of Northern England.

OBJECTIVE: To quantify the extent of food and beverage advertising on bus shelters in a deprived area of the UK, to identify the healthfulness of advertised products, and any differences by level of deprivation. The study also sought to assess the creative strategies used and extent of appeal to young people. DESIGN: Images of bus shelter advertisements were collected via in person photography (in 2019) and Google Street View (photos recorded in 2018). Food and beverage advertisements were grouped into one of seventeen food categories and classified as healthy/less healthy using the UK Nutrient Profile Model. The deprivation level of the advertisement location was identified using the UK Index of Multiple Deprivation. SETTING: Middlesbrough and Redcar and Cleveland in South Teesside. PARTICIPANTS: N/A. RESULTS: Eight hundred and thirty-two advertisements were identified, almost half (48·9 %) of which were for foods or beverages. Of food and non-alcoholic beverage adverts, 35·1 % were less healthy. Most food advertisements (98·9 %) used at least one of the persuasive creative strategies. Food advertisements were found to be of appeal to children under 18 years of age (71·9 %). No differences in healthiness of advertised foods were found by level of deprivation. CONCLUSIONS: Food advertising is extensive on bus shelters in parts of the UK, and a substantial proportion of this advertising is classified as less healthy and would not be permitted to be advertised around television programming for children. Bus shelter advertising should be considered part of the UK policy deliberations around restricting less healthy food marketing exposure.

Clinicians' perceived barriers and enablers to the dietary management of adults with type 2 diabetes in primary care: A systematic review.

BACKGROUND: Dietary management of type 2 diabetes is considered as a key remission and management strategy. This review explored clinicians' perceived barriers and enablers to the dietary management of adults with type 2 diabetes in primary care. METHODS: MEDLINE, EMBASE, CINAHL, PsycINFO and ASSIA were searched from 1980 to 16 June 2020. RESULTS: Of 2021 records, 14 studies met the inclusion criteria, describing the 14 domains of the refined Theoretical Domains Framework. The data synthesised to the domains of environmental context and resources, intentions and beliefs about capabilities were considered most trustworthy, closely followed by knowledge, behavioural regulation and beliefs about consequences. Two-thirds of studies cited time for staff training or patient education as major constraints to type 2 diabetes management. Clinicians also identified lack of patient engagement and poor dietary adherence as issues. Despite this, clinician confidence about giving dietary advice to patients was high. With further exploration, knowledge gaps were apparent and feelings of despondency as a result of poor outcomes were visible. CONCLUSIONS: This review revealed four clinician behaviours: (2) the perception of the dietitian; (2) the definition of a clinician qualified to give dietary advice; (3) clinician belief in dietary management as a treatment; and (4) clinician belief in a patient's capability to change dietary behaviour. These behaviours, if challenged and changed, have the potential to improve dietary management and outcomes for people with type 2 diabetes in primary care.

Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.

BACKGROUND: Omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3)), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) may benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this. OBJECTIVES: To assess the effects of increased intake of fish- and plant-based omega-3 fats for all-cause mortality, cardiovascular events, adiposity and lipids. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to February 2019, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to August 2019, with no language restrictions. We handsearched systematic review references and bibliographies and contacted trial authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation or advice to increase LCn3 or ALA intake, or both, versus usual or lower intake. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression. MAIN RESULTS: We included 86 RCTs (162,796 participants) in this review update and found that 28 were at low summary risk of bias. Trials were of 12 to 88 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most trials assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet. LCn3 doses ranged from 0.5 g a day to more than 5 g a day (19 RCTs gave at least 3 g LCn3 daily). Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.93 to 1.01; 143,693 participants; 11,297 deaths in 45 RCTs; high-certainty evidence), cardiovascular mortality (RR 0.92, 95% CI 0.86 to 0.99; 117,837 participants; 5658 deaths in 29 RCTs; moderate-certainty evidence), cardiovascular events (RR 0.96, 95% CI 0.92 to 1.01; 140,482 participants; 17,619 people experienced events in 43 RCTs; high-certainty evidence), stroke (RR 1.02, 95% CI 0.94 to 1.12; 138,888 participants; 2850 strokes in 31 RCTs; moderate-certainty evidence) or arrhythmia (RR 0.99, 95% CI 0.92 to 1.06; 77,990 participants; 4586 people experienced arrhythmia in 30 RCTs; low-certainty evidence). Increasing LCn3 may slightly reduce coronary heart disease mortality (number needed to treat for an additional beneficial outcome (NNTB) 334, RR 0.90, 95% CI 0.81 to 1.00; 127,378 participants; 3598 coronary heart disease deaths in 24 RCTs, low-certainty evidence) and coronary heart disease events (NNTB 167, RR 0.91, 95% CI 0.85 to 0.97; 134,116 participants; 8791 people experienced coronary heart disease events in 32 RCTs, low-certainty evidence). Overall, effects did not differ by trial duration or LCn3 dose in pre-planned subgrouping or meta-regression. There is little evidence of effects of eating fish. Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20; 19,327 participants; 459 deaths in 5 RCTs, moderate-certainty evidence),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25; 18,619 participants; 219 cardiovascular deaths in 4 RCTs; moderate-certainty evidence), coronary heart disease mortality (RR 0.95, 95% CI 0.72 to 1.26; 18,353 participants; 193 coronary heart disease deaths in 3 RCTs; moderate-certainty evidence) and coronary heart disease events (RR 1.00, 95% CI 0.82 to 1.22; 19,061 participants; 397 coronary heart disease events in 4 RCTs; low-certainty evidence). However, increased ALA may slightly reduce risk of cardiovascular disease events (NNTB 500, RR 0.95, 95% CI 0.83 to 1.07; but RR 0.91, 95% CI 0.79 to 1.04 in RCTs at low summary risk of bias; 19,327 participants; 884 cardiovascular disease events in 5 RCTs; low-certainty evidence), and probably slightly reduces risk of arrhythmia (NNTB 91, RR 0.73, 95% CI 0.55 to 0.97; 4912 participants; 173 events in 2 RCTs; moderate-certainty evidence). Effects on stroke are unclear. Increasing LCn3 and ALA had little or no effect on serious adverse events, adiposity, lipids and blood pressure, except increasing LCn3 reduced triglycerides by ˜15% in a dose-dependent way (high-certainty evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and low-certainty evidence suggests that increasing LCn3 slightly reduces risk of coronary heart disease mortality and events, and reduces serum triglycerides (evidence mainly from supplement trials). Increasing ALA slightly reduces risk of cardiovascular events and arrhythmia.

Determinants of change in accelerometer-assessed sedentary behaviour in children 0 to 6 years of age: A systematic review.

Sedentary behaviour tracks from early to middle childhood, suggesting the need to intervene early. The aim of this systematic review was to identify determinants of change in accelerometer-assessed sedentary behaviour in young children, with a view to informing interventions. Ten electronic databases were searched. Longitudinal and intervention studies were included if they (a) targeted sedentary behaviour in young children (less than of equal to 6 years), (b) assessed change in accelerometer-assessed sedentary behaviour, and (c) reported on at least one determinant of change in sedentary behaviour. Intervention components were coded according to clusters of behaviour change technique (BCT) (ie, grouping similar BCTs components). Data synthesis was guided by the socioecological model. Sixteen studies (four longitudinal; 12 intervention) met the inclusion criteria. Two (out of five identified determinants) were associated with an increase in sedentary behaviour in longitudinal studies: the after childcare/school period and transition from childcare to school. Three (out of 21 identified determinants) were associated with a decrease in sedentary behaviour in intervention studies: "goals and planning" (ie, "behavioural contract"), "repetition and substitution" (ie, "graded tasks"), and "reward and treat" (ie, "incentives"). The environmental and interpersonal determinants identified in this review may help to inform behavioural strategies, timing, and settings for future interventions.

Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.

BACKGROUND: Researchers have suggested that omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this. OBJECTIVES: To assess effects of increased intake of fish- and plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events, adiposity and lipids. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to April 2017, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to September 2016, with no language restrictions. We handsearched systematic review references and bibliographies and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation and/or advice to increase LCn3 or ALA intake versus usual or lower intake. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression. MAIN RESULTS: We included 79 RCTs (112,059 participants) in this review update and found that 25 were at low summary risk of bias. Trials were of 12 to 72 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most studies assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet. LCn3 doses ranged from 0.5g/d LCn3 to > 5 g/d (16 RCTs gave at least 3g/d LCn3).Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (RR 0.98, 95% CI 0.90 to 1.03, 92,653 participants; 8189 deaths in 39 trials, high-quality evidence), cardiovascular mortality (RR 0.95, 95% CI 0.87 to 1.03, 67,772 participants; 4544 CVD deaths in 25 RCTs), cardiovascular events (RR 0.99, 95% CI 0.94 to 1.04, 90,378 participants; 14,737 people experienced events in 38 trials, high-quality evidence), coronary heart disease (CHD) mortality (RR 0.93, 95% CI 0.79 to 1.09, 73,491 participants; 1596 CHD deaths in 21 RCTs), stroke (RR 1.06, 95% CI 0.96 to 1.16, 89,358 participants; 1822 strokes in 28 trials) or arrhythmia (RR 0.97, 95% CI 0.90 to 1.05, 53,796 participants; 3788 people experienced arrhythmia in 28 RCTs). There was a suggestion that LCn3 reduced CHD events (RR 0.93, 95% CI 0.88 to 0.97, 84,301 participants; 5469 people experienced CHD events in 28 RCTs); however, this was not maintained in sensitivity analyses - LCn3 probably makes little or no difference to CHD event risk. All evidence was of moderate GRADE quality, except as noted.Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20, 19,327 participants; 459 deaths, 5 RCTs),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25, 18,619 participants; 219 cardiovascular deaths, 4 RCTs), and CHD mortality (1.1% to 1.0%, RR 0.95, 95% CI 0.72 to 1.26, 18,353 participants; 193 CHD deaths, 3 RCTs) and ALA may make little or no difference to CHD events (RR 1.00, 95% CI 0.80 to 1.22, 19,061 participants, 397 CHD events, 4 RCTs, low-quality evidence). However, increased ALA may slightly reduce risk of cardiovascular events (from 4.8% to 4.7%, RR 0.95, 95% CI 0.83 to 1.07, 19,327 participants; 884 CVD events, 5 RCTs, low-quality evidence with greater effects in trials at low summary risk of bias), and probably reduces risk of arrhythmia (3.3% to 2.6%, RR 0.79, 95% CI 0.57 to 1.10, 4,837 participants; 141 events, 1 RCT). Effects on stroke are unclear.Sensitivity analysis retaining only trials at low summary risk of bias moved effect sizes towards the null (RR 1.0) for all LCn3 primary outcomes except arrhythmias, but for most ALA outcomes, effect sizes moved to suggest protection. LCn3 funnel plots suggested that adding in missing studies/results would move effect sizes towards null for most primary outcomes. There were no dose or duration effects in subgrouping or meta-regression.There was no evidence that increasing LCn3 or ALA altered serious adverse events, adiposity or lipids, except LCn3 reduced triglycerides by ˜15% in a dose-dependant way (high-quality evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event and arrhythmia risk.

Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.

BACKGROUND: Researchers have suggested that omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this. OBJECTIVES: To assess effects of increased intake of fish- and plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events, adiposity and lipids. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to April 2017, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to September 2016, with no language restrictions. We handsearched systematic review references and bibliographies and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation and/or advice to increase LCn3 or ALA intake versus usual or lower intake. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression. MAIN RESULTS: We included 79 RCTs (112,059 participants) in this review update and found that 25 were at low summary risk of bias. Trials were of 12 to 72 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most studies assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet.Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (RR 0.98, 95% CI 0.90 to 1.03, 92,653 participants; 8189 deaths in 39 trials, high-quality evidence), cardiovascular mortality (RR 0.95, 95% CI 0.87 to 1.03, 67,772 participants; 4544 CVD deaths in 25 RCTs), cardiovascular events (RR 0.99, 95% CI 0.94 to 1.04, 90,378 participants; 14,737 people experienced events in 38 trials, high-quality evidence), coronary heart disease (CHD) mortality (RR 0.93, 95% CI 0.79 to 1.09, 73,491 participants; 1596 CHD deaths in 21 RCTs), stroke (RR 1.06, 95% CI 0.96 to 1.16, 89,358 participants; 1822 strokes in 28 trials) or arrhythmia (RR 0.97, 95% CI 0.90 to 1.05, 53,796 participants; 3788 people experienced arrhythmia in 28 RCTs). There was a suggestion that LCn3 reduced CHD events (RR 0.93, 95% CI 0.88 to 0.97, 84,301 participants; 5469 people experienced CHD events in 28 RCTs); however, this was not maintained in sensitivity analyses - LCn3 probably makes little or no difference to CHD event risk. All evidence was of moderate GRADE quality, except as noted.Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20, 19,327 participants; 459 deaths, 5 RCTs),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25, 18,619 participants; 219 cardiovascular deaths, 4 RCTs), and it may make little or no difference to CHD events (RR 1.00, 95% CI 0.80 to 1.22, 19,061 participants, 397 CHD events, 4 RCTs, low-quality evidence). However, increased ALA may slightly reduce risk of cardiovascular events (from 4.8% to 4.7%, RR 0.95, 95% CI 0.83 to 1.07, 19,327 participants; 884 CVD events, 5 RCTs, low-quality evidence), and probably reduces risk of CHD mortality (1.1% to 1.0%, RR 0.95, 95% CI 0.72 to 1.26, 18,353 participants; 193 CHD deaths, 3 RCTs), and arrhythmia (3.3% to 2.6%, RR 0.79, 95% CI 0.57 to 1.10, 4,837 participants; 141 events, 1 RCT). Effects on stroke are unclear.Sensitivity analysis retaining only trials at low summary risk of bias moved effect sizes towards the null (RR 1.0) for all LCn3 primary outcomes except arrhythmias, but for most ALA outcomes, effect sizes moved to suggest protection. LCn3 funnel plots suggested that adding in missing studies/results would move effect sizes towards null for most primary outcomes. There were no dose or duration effects in subgrouping or meta-regression.There was no evidence that increasing LCn3 or ALA altered serious adverse events, adiposity or lipids, although LCn3 slightly reduced triglycerides and increased HDL. ALA probably reduces HDL (high- or moderate-quality evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event risk, CHD mortality and arrhythmia.

A description of interventions promoting healthier ready-to-eat meals (to eat in, to take away, or to be delivered) sold by specific food outlets in England: a systematic mapping and evidence synthesis.

BACKGROUND: Ready-to-eat meals (to eat in, to take away or to be delivered) sold by food outlets are often more energy dense and nutrient poor compared with meals prepared at home, making them a reasonable target for public health intervention. The aim of the research presented in this paper was to systematically identify and describe interventions to promote healthier ready-to-eat meals (to eat in, to take away, or to be delivered) sold by specific food outlets in England. METHODS: A systematic search and sift of the literature, followed by evidence mapping of relevant interventions, was conducted. Food outlets were included if they were located in England, were openly accessible to the public and, as their main business, sold ready-to-eat meals. Academic databases and grey literature were searched. Also, local authorities in England, topic experts, and key health professionals and workers were contacted. Two tiers of evidence synthesis took place: type, content and delivery of each intervention were summarised (Tier 1) and for those interventions that had been evaluated, a narrative synthesis was conducted (Tier 2). RESULTS: A total of 75 interventions were identified, the most popular being awards. Businesses were more likely to engage with cost neutral interventions which offered imperceptible changes to price, palatability and portion size. Few interventions involved working upstream with suppliers of food, the generation of customer demand, the exploration of competition effects, and/or reducing portion sizes. Evaluations of interventions were generally limited in scope and of low methodological quality, and many were simple assessments of acceptability. CONCLUSIONS: Many interventions promoting healthier ready-to-eat meals (to eat in, to take away, or to be delivered) sold by specific food outlets in England are taking place; award-type interventions are the most common. Proprietors of food outlets in England that, as their main business, sell ready-to-eat meals, can be engaged in implementing interventions to promote healthier ready-to-eat-food. These proprietors are generally positive about such interventions, particularly when they are cost neutral and use a health by stealth approach.

Assessing the feasibility of evaluating and delivering a physical activity intervention for pre-school children: a pilot randomised controlled trial.

BACKGROUND: Few evidence-based physical activity interventions for pre-school children are available. This two-armed pilot cluster randomised controlled trial aimed to evaluate the feasibility of conducting a full-scale trial and of delivering an outdoor physical activity intervention for pre-school children. METHODS: School was the unit of randomisation, and follow-up occurred at 10 and 52 weeks. Trial feasibility was assessed by recruitment, retention and completion rates of primary (daily moderate-to-vigorous physical activity (MVPA)) and secondary (anthropometric, quality of life, self-efficacy) outcomes. Potential effectiveness was assessed for the primary outcome using a linear regression model comparing MVPA between trial arms adjusting for clustering by school. Feasibility of delivering the intervention was assessed by intervention fidelity and attendance. Semi-structured interviews with parents, intervention facilitators, and head teachers explored acceptability and capability to deliver the intervention as well as acceptability of the study design. RESULTS: Recruitment rates were 37 % of schools (n = 10 schools) and 48 % of pre-school children (n = 164 children). Retention of children to the trial at 52 weeks was 83.5 %. Thirty-nine percent of children had valid primary outcome accelerometer data at baseline and 52 weeks. Response rates for secondary outcome measures ranged from 52 to 88 % at 10 weeks and 59 to 80 % at 52 weeks. The mean difference in daily MVPA between trial arms at 52 weeks was 0.4, 95 % CI 16.3 to 17.0; p = 0.96. Fidelity of intervention implementation was 81 %. Intervention attendance was higher (82 %) during the summer initiation phase compared to autumn/spring initiation (50 %). Parents, facilitators and head teachers found the intervention acceptable and beneficial. CONCLUSIONS: Recruitment and retention rates suggest a trial in this outdoor setting with this population was feasible but is weather sensitive. However, strategies to increase accelerometer wear-time would need to be implemented for reliable primary outcome data to be obtained. There was high implementation fidelity by facilitators, and the intervention was seen as acceptable and deliverable. However, attendance was low and preliminary data showed no evidence of intervention effectiveness. A revised intervention, building on the successful elements of this pilot alongside adapting implementation strategies to improve attendance, should therefore be considered. TRIAL REGISTRATION: Trial registry name and number: Current Controlled Trials, ISRCTN54165860. Date of registration: 4 September 2012.

Searching and synthesising 'grey literature' and 'grey information' in public health: critical reflections on three case studies.

BACKGROUND: Grey literature includes a range of documents not controlled by commercial publishing organisations. This means that grey literature can be difficult to search and retrieve for evidence synthesis. Much knowledge and evidence in public health, and other fields, accumulates from innovation in practice. This knowledge may not even be of sufficient formality to meet the definition of grey literature. We term this knowledge 'grey information'. Grey information may be even harder to search for and retrieve than grey literature. METHODS: On three previous occasions, we have attempted to systematically search for and synthesise public health grey literature and information-both to summarise the extent and nature of particular classes of interventions and to synthesise results of evaluations. Here, we briefly describe these three 'case studies' but focus on our post hoc critical reflections on searching for and synthesising grey literature and information garnered from our experiences of these case studies. We believe these reflections will be useful to future researchers working in this area. RESULTS: Issues discussed include search methods, searching efficiency, replicability of searches, data management, data extraction, assessing study 'quality', data synthesis, time and resources, and differentiating evidence synthesis from primary research. CONCLUSIONS: Information on applied public health research questions relating to the nature and range of public health interventions, as well as many evaluations of these interventions, may be predominantly, or only, held in grey literature and grey information. Evidence syntheses on these topics need, therefore, to embrace grey literature and information. Many typical systematic review methods for searching, appraising, managing, and synthesising the evidence base can be adapted for use with grey literature and information. Evidence synthesisers should carefully consider the opportunities and problems offered by including grey literature and information. Enhanced incentives for accurate recording and further methodological developments in retrieval will facilitate future syntheses of grey literature and information.

Reduced or modified dietary fat for preventing cardiovascular disease.

BACKGROUND: Reduction and modification of dietary fats have differing effects on cardiovascular risk factors (such as serum cholesterol), but their effects on important health outcomes are less clear. OBJECTIVE: To assess the effect of reduction and/or modification of dietary fats on mortality, cardiovascular mortality, cardiovascular morbidity and individual outcomes including myocardial infarction, stroke and cancer diagnoses in randomised clinical trials of at least 6 months duration. SEARCH METHODS: For this review update, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline and Embase, were searched through to June 2010. References of Included studies and reviews were also checked. SELECTION CRITERIA: Trials fulfilled the following criteria: 1) randomized with appropriate control group, 2) intention to reduce or modify fat or cholesterol intake (excluding exclusively omega-3 fat interventions), 3) not multi factorial, 4) adult humans with or without cardiovascular disease, 5) intervention at least six months, 6) mortality or cardiovascular morbidity data available. DATA COLLECTION AND ANALYSIS: Participant numbers experiencing health outcomes in each arm were extracted independently in duplicate and random effects meta-analyses, meta-regression, sub-grouping, sensitivity analyses and funnel plots were performed. MAIN RESULTS: This updated review suggested that reducing saturated fat by reducing and/or modifying dietary fat reduced the risk of cardiovascular events by 14% (RR 0.86, 95% CI 0.77 to 0.96, 24 comparisons, 65,508 participants of whom 7% had a cardiovascular event, I2 50%). Subgrouping suggested that this reduction in cardiovascular events was seen in studies of fat modification (not reduction - which related directly to the degree of effect on serum total and LDL cholesterol and triglycerides), of at least two years duration and in studies of men (not of women). There were no clear effects of dietary fat changes on total mortality (RR 0.98, 95% CI 0.93 to 1.04, 71,790 participants) or cardiovascular mortality (RR 0.94, 95% CI 0.85 to 1.04, 65,978 participants). This did not alter with sub-grouping or sensitivity analysis. Few studies compared reduced with modified fat diets, so direct comparison was not possible. AUTHORS' CONCLUSIONS: The findings are suggestive of a small but potentially important reduction in cardiovascular risk on modification of dietary fat, but not reduction of total fat, in longer trials. Lifestyle advice to all those at risk of cardiovascular disease and to lower risk population groups, should continue to include permanent reduction of dietary saturated fat and partial replacement by unsaturates. The ideal type of unsaturated fat is unclear.

Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial.

BACKGROUND: For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. METHODS/DESIGN: This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. DISCUSSION: We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12595588 .