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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
The effect of single-component sleep restriction therapy on depressive symptoms: A systematic review and meta-analysis.
Sleep restriction therapy is a behavioural component within cognitive behavioural therapy for insomnia and is an effective standalone treatment for insomnia, but its effect on depressive symptoms remains unclear. This review aimed to synthesise and evaluate the impact of single-component sleep restriction therapy on depressive symptoms relative to a control intervention. We searched electronic databases and sleep-related journals for randomised controlled trials and uncontrolled clinical trials, published from 1 January 1986 until 19 August 2023, that delivered sleep restriction therapy to adults with insomnia. Random-effects meta-analysis of standardised mean differences and Cochrane risk of bias assessment were performed on randomised controlled trials, while uncontrolled clinical trials were discussed narratively. The meta-analysis was pre-registered on PROSPERO (ID: CRD42020191803). We identified seven randomised controlled trials (N = 1102) and two uncontrolled clinical trials (N = 22). Findings suggest that sleep restriction therapy is associated with a medium effect for improvement in depressive symptoms at post-treatment (Nc = 6, g = -0.45 [95% confidence interval = -0.70 to -0.21], p
A systematic review of the performance of actigraphy in measuring sleep stages.
The accuracy of actigraphy for sleep staging is assumed to be poor, but examination is limited. This systematic review aimed to assess the performance of actigraphy in sleep stage classification of adults. A systematic search was performed using MEDLINE, Web of Science, Google Scholar, and Embase databases. We identified eight studies that compared sleep architecture estimates between wrist-worn actigraphy and polysomnography. Large heterogeneity was found with respect to how sleep stages were grouped, and the choice of metrics used to evaluate performance. Quantitative synthesis was not possible, so we performed a narrative synthesis of the literature. From the limited number of studies, we found that actigraphy-based sleep staging had some ability to classify different sleep stages compared with polysomnography.
The feasibility of population screening for paroxysmal atrial fibrillation using handheld ECGs.
BACKGROUND AND AIMS: There are few data on the feasibility of population screening for paroxysmal AF using hand-held ECG devices outside a specialist setting or in people over the age of 75. We investigated the feasibility of screening when conducted without face-to-face contact ('remote') or via in-person appointments in primary care, and explored impact of age on screening outcomes. METHODS: People aged ≥65 years from 13 general practices in England participated in screening during 2019-20. This involved attending a practice nurse appointment (10 practices) or receiving an ECG device by post (3 practices). Participants were asked to use a handheld ECG for 1-4 weeks. Screening outcomes included: uptake, quality of ECGs, AF detection rates, and uptake of anticoagulation if AF was detected. RESULTS: Screening was carried out by 2,141 (87.5%) of people invited to practice nurse-led screening and by 288 (90.0%) invited to remote screening. At least 56 interpretable ECGs were provided by 98.0% of participants who participated for 3 weeks, with no significant differences by setting or age, except people aged 85 or over (91.1%). Overall, 2.6% (64/2,429) screened participants had AF, with detection rising with age (9.2% in people aged 85 or over). 53/64 (82.8%) people with AF commenced anticoagulation. Uptake of anticoagulation did not vary by age. CONCLUSION: Population screening for paroxysmal AF is feasible in general practice and without face-to-face contact, and in all ages over 64 years, including in people aged 85 and over.
Cognitive dysfunction after covid-19
As of March 2023, when the Office for National Statistics stopped collecting data on this condition, 1.879 million individuals had self-assessed as having long covid - symptoms lasting more than 12 weeks following acute covid-19 infection. Of these, the proportion of individuals with symptoms lasting two years or more is around 42%, suggesting a decline in new cases of long covid but a persistence of those with ongoing symptoms.1 Some systematic reviews and meta-analyses have reported that up to a third of such individuals have persistent symptoms of cognitive impairment,23 but estimates vary widely and are complicated by methodological heterogeneity - eg, study size, assessment approach, follow-up duration, and different sampling frames (from self-reported surveys4 to large retrospective matched cohort studies of health records5), as discussed in a recent meta-analysis.6
Experience-based Investigation and Co-design of Psychosis Centred Integrated Care Services for Ethnically Diverse People with Multimorbidity (CoPICS): study protocol.
INTRODUCTION: Ethnic minorities (also called racialised groups) are more likely to experience severe mental illness (SMI). People with SMI are more likely to experience multimorbidity (MM), making psychosis among racialised groups more likely to lead to MM, poor outcomes, disability and premature mortality. METHODS AND ANALYSIS: This National Institute for Health and Care Research-funded study (151887) seeks to use innovative participatory methods including photovoice and biographical narrative interviews in urban and rural areas of England to assemble experience data. These data will be subjected to polytextual thematic analysis, and alongside pictures and captions, will inform an experienced-based co-design of interventions, the implementation of which will be evaluated. There will be an economic analysis and a process evaluation of the implementation. ETHICS AND DISSEMINATION: This programme of work has received ethical (IRAS 322421; Newcastle North Tyneside Research Ethics Committee 23/NE/0143) and sponsor approval. The findings will be disseminated in galleries showing the creative work, as lay and academic summaries and infographics; as practice briefings for practitioners, commissioners and policy makers; peer-reviewed publications. TRIAL REGISTRATION NUMBER: https://www.researchregistry.com/browse-the-registry%23home/registrationdetails/649c08111c037d0027b17d17/.
M13 ACCURATE DIAGNOSIS OF ASTHMA USING EITHER SINGLE OR LONGITUDINAL BREATH RECORDS CAPTURED ON A NOVEL FAST RESPONSE CAPNOMETER
Introduction The diagnosis of asthma can be challenging and often requires multiple diagnostic tests and forced expiratory manoeuvres, such as spirometry with reversibility testing or regular peak flow measurements in order to capture variable airflow obstruction. Objective To assess the performance of a diagnostic model in its classification of participants with and without asthma, built using interpretable data processing and machine learning techniques applied to a dataset of CO2 breath records (75 seconds of tidal breathing), captured on TidalSense’s N-Tidal™ handheld capnometer. Methods Participant records were drawn from 4 clinical studies (GBRS, ABRS, CBRS, CBRS2). This pooled dataset included participants recruited from primary and secondary care. Two XGBoost models were trained and validated on 82 features derived from the high-resolution CO2 data of 146 asthmatic and 133 non-asthmatic participants (which included healthy volunteers, those with COPD, bronchiectasis, pulmonary fibrosis, heart failure, anaemia, and other cardiorespiratory conditions). The model used breath waveform features from a single breath record. The model was trained using 117 asthmatic, and 106 non-asthmatic participants and performance metrics were generated from an unseen validation set of 29 asthmatic, and 27 non-asthmatic participants. This was repeated 20 times with different validation participants for additional statistical power, and the average and variability of these metrics were recorded. Results The classification model achieved AUROC of 0.908 ± 0.016, sensitivity of 0.800 ± 0.043, specificity of 0.883 ± 0.012, positive predictive value (PPV) of 0.873 ± 0.010, and negative predictive value (NPV) of 0.817 ± 0.031 in detecting asthma from a single breath record. Conclusion TidalSense’s N-TidalTM capnometer and machine learning classifier could be used as an accurate, rapid, point-of-care diagnostic test for asthma, particularly in primary care. Future work will incorporate longitudinal capnography data into a diagnostic classifier.
Identifying Preferred Features of Weight Loss Programs for Adults With or at Risk of Type 2 Diabetes: A Discrete Choice Experiment With 3,960 Adults in the U.K.
OBJECTIVE: To understand preferences for features of weight loss programs among adults with or at risk of type 2 diabetes in the U.K. RESEARCH DESIGN AND METHODS: We conducted a discrete choice experiment with 3,960 U.K. adults living with overweight (n = 675 with type 2 diabetes). Preferences for seven characteristics of weight loss programs were analyzed. Simulations from choice models using the experimental data predicted uptake of available weight loss programs. Patient groups comprising those who have experience with weight loss programs, including from minority communities, informed the experimental design. RESULTS: Preferences did not differ between individuals with and without type 2 diabetes. Preferences were strongest for type of diet. Healthy eating was most preferred relative to total diet replacement (odds ratio [OR] 2.24; 95% CI 2.04-2.44). Individual interventions were more popular than group interventions (OR 1.40; 95% CI 1.34-1.47). Participants preferred programs offering weight loss of 10-15 kg (OR 1.37; 95% CI 1.28-1.47) to those offering loss of 2-4 kg. Online content was preferred over in-person contact (OR 1.24; 95% CI 1.18-1.30). There were few differences in preferences by gender or ethnicity, although weight loss was more important to women than to men, and individuals from ethnic minority populations identified more with programs where others shared their characteristics. Modeling suggested that tailoring programs to individual preferences could increase participation by ∼17 percentage points (68% in relative terms). CONCLUSIONS: Offering a range of weight loss programs targeting the preferred attributes of different patient groups could potentially encourage more people to participate in weight loss programs and support those living with overweight to reduce their weight.
Family Group Conference Provision in UK Local Authorities and Associations with Children Looked after Rates
Abstract Family group conferences (FGCs) in child welfare share decision-making with family members by bringing the immediate and wider family together to make a plan to meet a child’s needs. This paper reports survey findings on FGC provision in the UK in 2022 and explores whether in England the presence of an FGC service and the rate of FGC provision is associated with the rate of children in care, entering care, in kinship foster care and leaving care. Seventy-nine per cent (n = 167) of local authorities in the UK provided FGCs to families, and 14 per cent (n = 29) did not. Services that were more established offered a more diverse range of FGCs. The introduction of FGCs in English local authorities was associated with a higher rate of children in care, but also higher rates of kinship foster care, a key goal of FGCs where it is not possible for children to stay with their parents. Higher rates of FGCs were associated with more children leaving care, possibly due to reunification with birth families. To understand in more detail, the circumstances of children in and leaving care in local authorities with FGCs, individual data linkage studies are needed.
The diagnostic odyssey in children and adolescents with X-linked hypophosphataemia: population-based, case-control study.
CONTEXT: X-linked hypophosphataemia (XLH) is a rare genetic disorder causing renal phosphate wasting, which predicates musculoskeletal manifestations such as rickets. Diagnosis is often delayed. OBJECTIVE: To explore the recording of clinical features, and the diagnostic odyssey of children and adolescents with XLH in primary care electronic healthcare records (EHR) in the United Kingdom. METHODS: Using the Optimum Patient Care Research Database, individuals aged 20 years or younger after 1st Jan 2000 at date of recorded XLH diagnosis were identified using SNOMED/Read codes, and age-matched to 100 controls. Recording of XLH-related clinical features was summarised, then compared between cases and controls using Chi-squared or Fisher's exact tests. RESULTS: 261 XLH cases were identified; 99 met inclusion criteria. Of these, 84/99 had at least 1 XLH-related clinical feature recorded in their primary care EHR. Clinical codes for rickets, genu varum and low phosphate were recorded prior to XLH diagnosis in under 20% of cases (median of 1, 1, and 3 years prior, respectively). Rickets, genu varum, low phosphate, nephrocalcinosis and growth delay were significantly more likely to be recorded in cases. CONCLUSION: This characterisation of the EHR phenotypes of children and adolescents with XLH may inform future case-finding approaches to expedite diagnosis in primary care.
Weight trends amongst adults with diabetes or hypertension during the COVID-19 pandemic: an observational study using OpenSAFELY.
BACKGROUND: COVID-19 pandemic restrictions may have influenced behaviours related to weight. AIMS: To describe patterns of weight change amongst adults living in England with Type 2 Diabetes (T2D) and/or hypertension during the COVID-19 pandemic. Design and Setting With the approval of NHS England, we conducted an observational cohort study using the routinely collected health data of approximately 40% of adults living in England, accessed through the OpenSAFELY service inside TPP. METHOD: We investigated clinical and sociodemographic characteristics associated with rapid weight gain (>0·5kg/m2/year) using multivariable logistic regression. RESULTS: We extracted data on adults with T2D (n=1,231,455, 44% female, 76% white British) or hypertension (n=3,558,405, 50% female, 84% white British). Adults with T2D lost weight overall (median δ = -0.1kg/m2/year [IQR: -0.7, 0.4]), however, rapid weight gain was common (20.7%) and associated with sex (male vs female: aOR 0.78[95%CI 0.77, 0.79]); age, older age reduced odds (e.g. 60-69-year-olds vs 18-29-year-olds: aOR 0.66[0.61, 0.71]); deprivation, (least-deprived-IMD vs most-deprived-IMD: aOR 0.87[0.85, 0.89]); white ethnicity (Black vs White: aOR 0.95[0.92, 0.98]); mental health conditions (e.g. depression: aOR 1.13 [1.12, 1.15]); and diabetes treatment (non-insulin treatment vs no pharmacological treatment: aOR 0.68[0.67, 0.69]). Adults with hypertension maintained stable weight overall (median δ = 0.0kg/m2/year [ -0.6, 0.5]), however, rapid weight gain was common (24.7%) and associated with similar characteristics as in T2D. CONCLUSION: Amongst adults living in England with T2D and/or hypertension, rapid pandemic weight gain was more common amongst females, younger adults, those living in more deprived areas, and those with mental health condition.
Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform
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 = 3292) 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 = 3287) 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 = 9933). 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 = 0.70). 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.
The development of a method for the global health community to assess the proportion of food and beverage companies’ sales that are derived from unhealthy foods
Context: 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 “healthier” and those that failed were classified as “unhealthy”. Products were grouped by brand and weighted by the brand’s value sales for 2020. The primary outcome was the proportion of each company’s sales that were classified as unhealthy and healthier by company and category. Results: Overall, 89% of the top 20 companies’ brand sales were classified as unhealthy. For every USD$10 spent on the top 20 companies’ 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’s sales were classified as healthier and less than 5% of total sales were healthier for Mondelēz, 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.
Use of Cognitive and Behavioral Strategies During a Weight Loss Program: A Secondary Analysis of the Doctor Referral of Overweight People to Low-Energy Total Diet Replacement Treatment (DROPLET) Trial
Background: 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], −0.83, 5.65) or the number of domains used (mean difference, −0.23; 95% CI, −0.69, 0.23) between the TDR group and the UC group. The number of strategies was not associated with weight loss at either 3 months (−0.02 kg; 95% CI, −0.11, 0.06) or 1 year (−0.05 kg; 95% CI, −0.14, 0.02). Similarly, the number of domains used was not associated with weight loss at 3 months (−0.02 kg; 95% CI, −0.53, 0.49) or 1 year (−0.07 kg; 95% CI, −0.60, 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 (−2.6 kg; 95% CI, −4.42, −0.71) and Planned Eating patterns (−3.20 kg; 95% CI, −4.94, −1.46) 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.
The impact of price promotions on confectionery and snacks on the energy content of shopping baskets: A randomised controlled trial in an experimental online supermarket
Overconsumption 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 £10 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 −552kcal (95%CIs: −866, −238), 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.
Dietary interventions in pregnancy for the prevention of gestational diabetes: a literature review
The 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.
Dietary pattern adherence in association with changes in body composition and adiposity measurements in the UK Biobank study
Background: 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–Q5) 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 (1.12–1.39) kg in men, 1.11 (0.88–1.35) kg in women vs low adherence (Q1) − 0.09 (− 0.28 to 0.10) kg in men and − 0.26 (− 0.42 to − 0.11) kg in women; as well as in waist circumference (Q5): 0.93 (0.63–1.22) cm in men and 1.94 (1.63, 2.25) cm in women vs Q1 − 1.06 (− 1.34 to − 0.78) cm in men and 0.27 (− 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.