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BACKGROUND: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. METHODS: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n\u2009=\u20093292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n\u2009=\u20093287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. RESULTS: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N\u2009=\u20099933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p\u2009=\u20090.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. CONCLUSIONS: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.
\n \n\n \n \nContext: Corporate engagement with food and beverage companies who produce food associated with health harms is a divisive topic in the global nutrition community, with high-profile cases of conflict of interest increasingly coming under scrutiny. There is a need for an agreed method to support health organizations in deciding whether and how to engage with large food and beverage manufacturers. Aim: The aim of this study was to develop a method to quantify the proportion of sales from food and beverage companies that are derived from unhealthy foods to support organizations in determining which companies might be considered high-risk for engagement. Methods: The 2015 WHO Euro nutrient profile model was applied to 35,550 products from 1294 brands manufactured by the top 20 global food and beverage companies from seven countries (Australia, Brazil, China, India, South Africa, UK and USA). For the purpose of this study, products that met the WHO Euro criteria were classified as \u201chealthier\u201d and those that failed were classified as \u201cunhealthy\u201d. Products were grouped by brand and weighted by the brand\u2019s value sales for 2020. The primary outcome was the proportion of each company\u2019s sales that were classified as unhealthy and healthier by company and category. Results: Overall, 89% of the top 20 companies\u2019 brand sales were classified as unhealthy. For every USD$10 spent on the top 20 companies\u2019 brands, only $1.10 was spent on products considered healthier. All companies saw the majority of their sales come from unhealthy foods, including soft drinks, confectionery and snacks. None of Red Bull or Ferrero\u2019s sales were classified as healthier and less than 5% of total sales were healthier for Mondel\u0113z, Mars, and PepsiCo. Some companies had higher proportions of sales deriving from healthier products, including Grupo Bimbo (48%), Danone (34%) and Conagra (32%), although the majority of their sales were still derived from unhealthy foods. Discussion: The results presented in this study highlight the reliance the leading food and beverage companies have on sales of unhealthy products that are contributing to diet-related disease globally. The method and steps we have laid out here could be used by organizations in the global health community to identify companies that have conflicts of interest when it comes to engaging with governments, international organizations and public health bodies on issues of policy and regulation.
\n \n\n \n \nBackground: Achieving a sustained energy deficit is essential for weight loss, but the cognitive and behavioral strategies that support this goal are unclear. Objective: The goal of this study was to investigate the number and type of cognitive and behavioral strategies used by participants who were enrolled in a 1-year weight loss trial and to explore associations between strategies and magnitude of weight loss at 3 months and 1 year. Design: The study is a secondary post-hoc exploratory analysis of data collected as part of the Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET), a randomized controlled trial conducted in general practices in England, United Kingdom, between January 2016 and August 2017. Participants/setting: This study involved 164 participants from both intervention and control groups of the DROPLET trial who completed the Oxford Food and Behaviours (OxFAB) questionnaire to assess the use of 115 strategies grouped into 21 domains used to manage their weight. Interventions: Participants were randomized to either a behavioral weight loss program involving 8 weeks total diet replacement (TDR) and 4 weeks of food reintroduction or a program delivered by a medical practice nurse over a 3-month period (usual care [UC]). Main outcome measures: Weight was objectively measured at baseline, 3 months, and 1 year. Cognitive and behavioral strategies used to support weight loss were assessed using the OxFAB questionnaire at 3 months. Statistical analysis performed: Exploratory factor analysis was used to generate data-driven patterns of strategy use, and a linear mixed-effects model was used to examine associations between use of these patterns and weight change. Results: No evidence was found of a difference in the number of strategies (mean difference, 2.41; 95% confidence interval [CI], \u22120.83, 5.65) or the number of domains used (mean difference, \u22120.23; 95% CI, \u22120.69, 0.23) between the TDR group and the UC group. The number of strategies was not associated with weight loss at either 3 months (\u22120.02 kg; 95% CI, \u22120.11, 0.06) or 1 year (\u22120.05 kg; 95% CI, \u22120.14, 0.02). Similarly, the number of domains used was not associated with weight loss at 3 months (\u22120.02 kg; 95% CI, \u22120.53, 0.49) or 1 year (\u22120.07 kg; 95% CI, \u22120.60, 0.46). Factor analysis identified four coherent patterns of strategy use, identified as Physical Activity, Motivation, Planned Eating, and Food Purchasing patterns. Greater use of strategies in the Food Purchasing (\u22122.6 kg; 95% CI, \u22124.42, \u22120.71) and Planned Eating patterns (\u22123.20 kg; 95% CI, \u22124.94, \u22121.46) was associated with greater weight loss at 1 year. Conclusions: The number of cognitive and behavioral strategies or domains used does not appear to influence weight loss, but the types of strategy appear of greater importance. Supporting people to adopt strategies linked to planned eating and food purchasing may aid long-term weight loss.
\n \n\n \n \nOverconsumption of foods high in fat, sugars, and salt (HFSS) poses a significant risk to health. The government in England has passed legislation that would limit some price promotions of HFSS foods within supermarkets, but evidence regarding likely impacts of these policies, especially in online settings, is limited. This study aimed to determine whether there were any differences in the energy and nutrient content of shopping baskets after removing promotions on HFSS foods in an online experimental supermarket. UK adults (n = 511) were asked to select food from four categories with a \u00a310 budget in an online experimental supermarket: confectionery; biscuits and crackers; crisps, nuts and snacking fruit; cakes and tarts. They were randomly allocated to one of two trial arms: (1) promotions present (matched to promotion frequency seen in a major UK retailer) (n = 257), or (2) all promotions removed from all products within the target food categories (n = 254). The primary outcome analysis used linear regression to compare total energy (kcal) of items placed in shopping baskets when promotions were present vs. absent, while secondary analyses investigated differences in nutrients and energy purchased from individual food categories. Mean energy in food selected without promotions was 5156 kcal per basket (SD 1620), compared to 5536 kcal (SD 1819) with promotions, a difference of \u2212552kcal (95%CIs: \u2212866, \u2212238), equivalent to 10%. There were no significant differences in energy purchased for any individual category between groups. No evidence was found of other changes in nutritional composition of baskets or of significant interactions between the impact of promotions and participant characteristics (gender, age, ethnicity) on energy purchased. Removing promotions on HFSS foods resulted in significantly less total energy selected in an online experimental supermarket study.
\n \n\n \n \nThe aim of this review is to provide an overview of dietary interventions delivered during pregnancy for the prevention of gestational diabetes mellitus (GDM). GDM increases the risk of adverse pregnancy and neonatal outcomes, and increases future cardio-metabolic risks for both the mother and the offspring. Carrying or gaining excessive weight during pregnancy increases the risk of developing GDM, and several clinical trials in women with overweight or obesity have tested whether interventions aimed at limiting gestational weight gain (GWG), could help prevent GDM. Most dietary interventions have provided general healthy eating guidelines, while some had a specific focus, such as low glycaemic index, increased fibre intake, reducing saturated fat, or a Mediterraneanstyle diet. Although trials have generally been successful in attenuating GWG, the majority have been unable to reduce GDM risk, which suggests that limiting GWG may not be sufficient in itself to prevent GDM. The trials which have shown effectiveness in GDM prevention, have included intensive face-to-face dietetic support, and/or provision of key foods to participants, but it is unclear whether these strategies could be delivered in routine practice. The mechanism behind the effectiveness of some interventions over others remains unclear. Dietary modifications from early stages of pregnancy seem to be key, but the optimum dietary composition is unknown. Future research should focus on designing acceptable and scalable dietary interventions to be tested early in pregnancy in women at risk of GDM.
\n \n\n \n \nBackground: Unhealthy dietary patterns (DP) have been frequently linked to avoidable ill-health, mediated in part through higher body mass index. However it is unclear how these patterns relate to specific components of body composition or fat distribution, and whether this may explain reported gender differences in the relationship between diet and health. Methods: Data from 101,046 UK Biobank participants with baseline bioimpedance analysis and anthropometric measures and dietary information on two or more occasions were used, of which 21,387 participants had repeated measures at follow up. Multivariable linear regressions estimated the associations between DP adherence (categorised in quintiles Q1\u2013Q5) and body composition measures adjusted for a range of demographic and lifestyle confounders. Results: After 8.1 years of follow-up, individuals with high adherence (Q5) to the DP showed significantly positive changes in fat mass (mean, 95 % CI): 1.26 (1.12\u20131.39) kg in men, 1.11 (0.88\u20131.35) kg in women vs low adherence (Q1) \u2212 0.09 (\u2212 0.28 to 0.10) kg in men and \u2212 0.26 (\u2212 0.42 to \u2212 0.11) kg in women; as well as in waist circumference (Q5): 0.93 (0.63\u20131.22) cm in men and 1.94 (1.63, 2.25) cm in women vs Q1 \u2212 1.06 (\u2212 1.34 to \u2212 0.78) cm in men and 0.27 (\u2212 0.02 to 0.57) cm in women. Conclusion: Adherence to an unhealthy DP is positively associated with increased adiposity, especially in the abdominal region, which may help explain the observed associations with adverse health outcomes.
\n \n\n \n \nThis systematic review critically appraised and synthesized evidence from economic evaluations of interventions targeting childhood excess weight. We conducted systematic searches in 11 databases from inception to April 19, 2023. Studies were eligible if they evaluated interventions targeting children up to 18 years and the study intervention(s) targeted childhood excess weight or sought to improve diet or physical activity, regardless of the type of economic evaluation or the underpinning study design. We synthesized evidence using narrative synthesis methods. One-hundred fifty-one studies met the eligibility criteria and were classified into three groups based on the intervention approach: prevention-only (13 studies), prevention and treatment (100 studies), and treatment-only (38 studies). The predominant setting and study design differed considerably between the three groups of studies. However, compared with usual care, most interventions were deemed cost-effective. The study participants' ages, sex, and socioeconomic status were crucial to intervention cost-effectiveness. Interventions whose effects were projected beyond childhood, such as bariatric surgery, lower protein infant formula, and home-based general practitioner consultations, tended to be cost-effective. However, cost-effectiveness was sensitive to the assumptions underlying the persistence and intensity of such effects. Our findings can inform future recommendations on the conduct of economic evaluations of interventions targeting childhood overweight and obesity, as well as practice and policy recommendations.
\n \n\n \n \nAim: To test the feasibility and acceptability of a reduced-carbohydrate dietary program, intended to reduce the risk of gestational diabetes. Materials and Methods: Fifty-one pregnant women at <20 weeks' gestation, with body mass index \u226530 kg/m2, and a normal baseline oral glucose tolerance test (OGTT), were randomized 2:1 to an intervention or control group and followed-up until delivery. The dietary intervention aimed at providing 130\u2013150 g carbohydrate/day. Feasibility outcomes assessed at 24\u201328 weeks' gestation, included adoption of the reduced-carbohydrate diet by the intervention group, and retention of all participants, assessed by completion of a second OGTT. Changes in glycemia, weight gain and dietary intake, and the maternal and neonatal outcomes were also assessed. Participants were interviewed about their experience of the intervention and the study. Results: Forty-nine of 51 participants attended the follow-up OGTT, a retention rate of 96% (95% confidence interval [CI] 86.8%\u201398.9%). In the intervention group, carbohydrate intake at follow-up was 190.4 (95% CI 162.5\u2013215.6) g/day, a reduction of \u221224.6 (95% CI \u221251.5\u20132.4) g/day from baseline. Potentially favourable effects of the intervention on glucose control, weight gain and blood pressure were observed, but the study was not powered to detect significant differences in these. Participants found the intervention acceptable, and were content with the study processes, but some reported barriers to sustained adherence, mainly pertaining to competing priorities. Conclusions: Retention was high, suggesting the study processes are feasible, but the carbohydrate reduction in the intervention group was small, and did not meet progression criteria, limiting the likelihood of achieving the desired goal to prevent gestational diabetes. Trial registration number: ISRCTN16235884.
\n \n\n \n \nIntroduction: There is strong evidence that type 2 diabetes (T2D) remission can be achieved by adopting a low-energy diet achieved through total dietary replacement products. There is promising evidence that low-carbohydrate diets can achieve remission of T2D. The Dietary Approaches to the Management of type 2 Diabetes (DIAMOND) programme combines both approaches in a behaviourally informed low-energy, low-carbohydrate diet for people with T2D, delivered by nurses in primary care. This trial compares the effectiveness of the DIAMOND programme to usual care in inducing remission of T2D and in reducing risk of cardiovascular disease. Methods and analysis: We aim to recruit 508 people in 56 practices with T2D diagnosed within 6 years, who are demographically representative of the UK population. We will allocate general practices, based on ethnicity and socioeconomic status, to provide usual care for diabetes or offer the DIAMOND programme. Participants in practices offering DIAMOND will see the nurse seven times over 6 months. At baseline, 6 months, and 1 year we will measure weight, blood pressure, HbA1c, lipid profile and risk of fatty liver disease. The primary outcome is diabetes remission at 1 year, defined as HbA1c < 48 mmol/mol and off glucose-lowering medication for at least 6 months. Thereafter, we will assess whether people resume treatment for diabetes and the incidence of microvascular and macrovascular disease through the National Diabetes Audit. Data will be analysed using mixed-effects generalised linear models. This study has been approved by the National Health Service Health Research Authority Research Ethics Committee (Ref: 22/EM/0074). Trial Registration number: ISRCTN46961767.
\n \n\n \n \nBackground: Overconsumption is one of the most serious public health challenges in the UK and has been linked to increased consumption of food ordered through delivery platforms. This study tested whether repositioning foods and/or restaurant options in a simulated food delivery platform could help to reduce the energy content of users\u2019 shopping basket. Methods: UK adult food delivery platform users (N = 9,003) selected a meal in a simulated platform. Participants were randomly allocated to a control condition (choices listed randomly) or to one of four intervention groups, (1) food options listed in ascending order of energy content, (2) restaurant options listed in ascending order of average energy content per main meal, (3) interventions 1 and 2 combined (4) interventions 1 and 2 combined, but food and restaurant options repositioned based on a kcal/price index to display options lower in energy but higher in price at the top. Gamma regressions assessed the impact of interventions on total energy content of baskets at checkout. Results: The energy content of participants\u2019 baskets in the control condition was 1382 kcals. All interventions significantly reduced energy content of baskets: Compared to control, repositioning both foods and restaurants purely based on energy content of options resulted in the greatest effect (-209kcal; 95%CIs: -248,-168), followed by repositioning restaurants (-161kcal; 95%CIs: -201,-121), repositioning restaurants and foods based on a kcal/price index (-117kcals; 95%CI: -158,-74) and repositioning foods based on energy content (-88kcals; 95%CI: -130,-45). All interventions reduced the basket price compared to the control, except for the intervention repositioning restaurants and foods based on a kcal/price index, which increased the basket price. Conclusions: This proof-of-concept study suggests repositioning lower-energy options more prominently may encourage lower energy food choices in online delivery platforms and can be implemented in a sustainable business model.
\n \n\n \n \nBackground: Frailty becomes more prevalent and healthcare needs increase with age. Information on the impact of frailty on population level use of health services and associated costs is needed to plan for ageing populations. Aim: To describe primary and secondary care service use and associated costs by electronic Frailty Index (eFI) category. Design and Setting: Retrospective cohort using electronic health records. Participants aged \u226550 registered in primary care practices contributing to the Oxford Royal College of General Practitioners Research and Surveillance Centre, 2006\u20132017. Methods: Primary and secondary care use (totals and means) were stratified by eFI category and age group. Standardised 2017 costs were used to calculate primary, secondary and overall costs. Generalised linear models explored associations between frailty, sociodemographic characteristics. Adjusted mean costs and cost ratios were produced. Results: Individual mean annual use of primary and secondary care services increased with increasing frailty severity. Overall cohort care costs for were highest in mild frailty in all 12 years, followed by moderate and severe, although the proportion of the population with severe frailty can be expected to increase over time. After adjusting for sociodemographic factors, compared to the fit category, individual annual costs doubled in mild frailty, tripled in moderate and quadrupled in severe. Conclusions: Increasing levels of frailty are associated with an additional burden of individual service use. However, individuals with mild and moderate frailty contribute to higher overall costs. Earlier intervention may have the most potential to reduce service use and costs at population level.
\n \n\n \n \nINTRODUCTION: Emerging evidence suggests improved quality of life, reduced symptom burden and lower health services costs when integrated palliative care and cancer care are implemented. Integrated palliative care aims to achieve care continuity by integrating organisational, administrative and clinical services involved in patient care networks. However, integrated palliative care for cancer is not common practice. This project, therefore, aims to understand how integrated palliative care and cancer care works in different healthcare settings (inpatient/outpatient), and for which groups of people (at what stage of the cancer journey), so we can develop guidance for optimal delivery. METHODS AND ANALYSIS: We will conduct a realist synthesis to develop a programme theory of how integrated palliative care in cancer works, for whom and in what contexts to achieve improved symptom management and quality of life for patients and their families.This realist synthesis will follow the five stages outlined by Pawson: (1) locating existing theories, (2) searching for evidence, (3) article selection, (4) extracting and organising data and (5) synthesising the evidence and drawing conclusions. We will work closely with our expert stakeholder group, which includes health and social care professionals providing palliative care and oncology; management and policy groups and members of the public and patients. We will adhere to RAMESES quality standards for undertaking a realist synthesis. ETHICS AND DISSEMINATION: Ethics approval for this project is not required.The realist synthesis will develop a programme theory that provides clarity on the optimal delivery of palliative care for adults with cancer. We will use the programme theory to coproduce guidance and user-friendly outputs, working with stakeholders to inform delivery of best practice. Findings will inform further research in integrated palliative care and cancer. Stakeholder engagement will assist in the dissemination of our findings. PROSPERO REGISTRATION NUMBER: CRD42023389791.
\n \n\n \n \nBACKGROUND: In the aftermath of the Coronavirus disease 2019 (Covid-19) pandemic, allocation of non-urgent medical interventions is a persistent ethical challenge as health systems currently face an unprecedented backlog of patients requiring treatment. Difficult decisions must be made that prioritise certain patients over others. Ethical resource allocation requires that the needs of all patients are considered properly, but at present there is no guidance that can help support such decision-making which explicitly considers the needs of children with chronic and complex conditions. METHODS: This paper reviews the NHS guidance for priorities and operational planning and examines how the needs of children with chronic illness are addressed in NHS objectives for restoring services and meeting elective care demands. RESULTS: The usual criteria for prioritisation featured in the NHS guidance fail to account for the distinct needs of children with chronic illnesses and fail to match more general considerations of what constitutes fair resource allocation decisions. To address this issue, two considerations, namely 'protecting age-related opportunity' and 'recognising complexity of care,' are proposed as additions to the existing approach. CONCLUSION: By providing a broader conception of needs, these criteria address inefficiencies of the current guidance and relevant ethical frameworks and help to embed a currently missing children-related ethical approach to healthcare policy making in general.
\n \n\n \n \nMany research institutions and funders have recently stated their commitment to actively support and promote \u2018Equality, Diversity and Inclusion\u2019 (EDI) in various aspects of health research including Patient and Public Involvement (PPI). However, translating this commitment into specific research projects presents significant challenges that existing approaches, practical guidelines and initiatives have not adequately addressed. In this paper, we explore how the lack of clear justifications for the EDI commitment in existing guidelines inadvertently complicates the work of those involved with PPI and we stress the need for conceptual clarity for any EDI effort to yield meaningful results. Our focus centres on the first principle of the EDI discourse, \u2018equality\u2019, particularly in the form of \u2018equality of opportunity\u2019 as outlined in current guidance provided by the National Institute of Health Research in the United Kingdom. We examine challenges related to justifying and implementing a general, unspecified commitment to equality of opportunity and explain that this reflects a lack of consensus regarding the moral value of PPI in research \u2013 a profound problem that remains unaddressed. We then discuss how the presence of several opposing moral perspectives on PPI, makes determining the most appropriate way of addressing barriers to involvement complex and controversial, raising ethical implications for the work of health researchers, PPI specialists and coordinators. Finally we make suggestions on how future research can enrich the concept of \u2018equality of opportunity\u2019 in PPI and improve practice. While our primary focus is on the NIHR, a strong advocate of PPI in research, this analysis will point to normative and ethical considerations that may be relevant to other research institutions and funding organisations aiming to promote equality of opportunity in their public and patient involvement strategies.
\n \n\n \n \nBackgroundNon-allergist delivered PADL is supported by UK and World Health Organization guidelines but is not yet routine in UK hospitals. Understanding the views of healthcare workers (HCWs) on managing patients with penA records and exploring perspectives on delivering a PADL inpatient pathway are required to inform the development of non-allergist delivered PADL pathways.ObjectiveTo explore the perspectives of non-allergist HCWs working in medical specialties on managing patients with penA records, and to explore the enablers and barriers to embedding PADL as a standard of care for inpatients.MethodsSemi-structured interviews with doctors, nurses, pharmacists and medicines optimization pharmacy technicians working in a district general hospital in the UK. Thematic analysis was used to analyse the data.ResultsThe PADL pathway was considered a shared responsibility of the multidisciplinary team, which needed to be structured and supported by a framework. PADL aligns with HCW roles but time to deliver PADL was a barrier. Training for HCWs on the benefits of PADL and delivering PADL for those patients where a penicillin might be beneficial during the current episode of care would both motivate HCWs to deliver PADL.Discussion and conclusionThe PADL pathway was acceptable to HCWs and aligned with their roles and current healthcare processes but their capacity to deliver PADL in a time pressured environment was a significant barrier.
\n \n\n \n \nBackgroundNon-allergist-delivered penicillin allergy de-labelling (PADL) is supported by UK and other national guidelines but is not yet routine practice in UK hospitals. Those who have undergone PADL report high rates of acceptance, but it is unknown why some continue to avoid penicillin, and why some decline testing.ObjectivesTo explore the experiences of patients recently approached for penicillin allergy (penA) assessment and de-label by non-allergists in a UK hospital to determine the barriers and enablers to patient acceptance of PADL.MethodsQualitative study using semi-structured interviews with patients who were penA assessed and de-labelled during an inpatient stay between November 2022 and January 2023. Thematic analysis was used to analyse the data.ResultsNineteen patients were interviewed. Patients were largely unaware of the negative impact of penA on their healthcare. Patients had differing views on challenging their penA status while they were acutely unwell, some agreeing that it is the right time to test and others not. Patients declined testing because they felt they were at higher potential risk because they were older or had multiple comorbidities. Some patients who declined testing felt they would have been persuaded if they had received a better explanation of the risks and benefits of PADL.ConclusionsPatients who were successfully de-labelled were positive about the experience. Those who declined testing did so for a variety of reasons including frailty/comorbidities or a fear of testing whilst unwell. Patients highlighted the importance of good communication about the personalized risks and benefits of testing.
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