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    Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups-practical guidance to support better practice
    Dawson, S ; Banister, K ; Biggs, K ; Cotton, S ; Devane, D ; Gardner, H ; Gillies, K ; Gopalakrishnan, G ; Isaacs, T ; Khunti, K ; Nichol, A ; Parker, A ; Russell, AM ; Shepherd, V ; Shiely, F ; Shorter, G ; Starling, B ; Williams, H ; Willis, A ; Witham, MD ; Treweek, S (BMC, 2022-08-17)
    Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities.This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are (1) ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend, (2) ensure your trial materials are developed with inclusion in mind, (3) ensure staff are culturally competent and (4) build trusting partnerships with community organisations that work with ethnic minority groups. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion problem tackled by the recommendation, or strategies to mitigate the problem, as well as a collection of resources to support implementation of the recommendations.We encourage trial teams to follow the recommendations and, where possible, evaluate the strategies they use to implement them. Finally, while our primary audience is those designing, running and reporting trials, we hope funders, grant reviewers and approvals agencies may also find our guidance useful.
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    Cohort Profile: The United Kingdom Research study into Ethnicity and COVID-19 outcomes in Healthcare workers (UK-REACH)
    Bryant, L ; Free, RC ; Woolf, K ; Melbourne, C ; Guyatt, AL ; John, C ; Gupta, A ; Gray, LJ ; Nellums, L ; Martin, CA ; McManus, IC ; Garwood, C ; Modhawdia, V ; Carr, S ; Wain, L ; Tobin, MD ; Khunti, K ; Akubakar, I ; Pareek, M (OXFORD UNIV PRESS, 2022-08-27)
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    Frameworks for Implementation, Uptake, and Use of Cardiometabolic Disease-Related Digital Health Interventions in Ethnic Minority Populations: Scoping Review.
    Ramasawmy, M ; Poole, L ; Thorlu-Bangura, Z ; Chauhan, A ; Murali, M ; Jagpal, P ; Bijral, M ; Prashar, J ; G-Medhin, A ; Murray, E ; Stevenson, F ; Blandford, A ; Potts, HWW ; Khunti, K ; Hanif, W ; Gill, P ; Sajid, M ; Patel, K ; Sood, H ; Bhala, N ; Modha, S ; Mistry, M ; Patel, V ; Ali, SN ; Ala, A ; Banerjee, A (JMIR Publications Inc., 2022-08-11)
    BACKGROUND: Digital health interventions have become increasingly common across health care, both before and during the COVID-19 pandemic. Health inequalities, particularly with respect to ethnicity, may not be considered in frameworks that address the implementation of digital health interventions. We considered frameworks to include any models, theories, or taxonomies that describe or predict implementation, uptake, and use of digital health interventions. OBJECTIVE: We aimed to assess how health inequalities are addressed in frameworks relevant to the implementation, uptake, and use of digital health interventions; health and ethnic inequalities; and interventions for cardiometabolic disease. METHODS: SCOPUS, PubMed, EMBASE, Google Scholar, and gray literature were searched to identify papers on frameworks relevant to the implementation, uptake, and use of digital health interventions; ethnically or culturally diverse populations and health inequalities; and interventions for cardiometabolic disease. We assessed the extent to which frameworks address health inequalities, specifically ethnic inequalities; explored how they were addressed; and developed recommendations for good practice. RESULTS: Of 58 relevant papers, 22 (38%) included frameworks that referred to health inequalities. Inequalities were conceptualized as society-level, system-level, intervention-level, and individual. Only 5 frameworks considered all levels. Three frameworks considered how digital health interventions might interact with or exacerbate existing health inequalities, and 3 considered the process of health technology implementation, uptake, and use and suggested opportunities to improve equity in digital health. When ethnicity was considered, it was often within the broader concepts of social determinants of health. Only 3 frameworks explicitly addressed ethnicity: one focused on culturally tailoring digital health interventions, and 2 were applied to management of cardiometabolic disease. CONCLUSIONS: Existing frameworks evaluate implementation, uptake, and use of digital health interventions, but to consider factors related to ethnicity, it is necessary to look across frameworks. We have developed a visual guide of the key constructs across the 4 potential levels of action for digital health inequalities, which can be used to support future research and inform digital health policies.
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    Device-assessed sleep and physical activity in individuals recovering from a hospital admission for COVID-19: a multicentre study
    Plekhanova, T ; Rowlands, A ; Evans, RA ; Edwardson, CL ; Bishop, NC ; Bolton, CE ; Chalmers, JD ; Davies, MJ ; Daynes, E ; Dempsey, PC ; Docherty, AB ; Elneima, O ; Greening, NJ ; Greenwood, SA ; Hall, AP ; Harris, VC ; Harrison, EM ; Henson, J ; Ho, L-P ; Horsley, A ; Houchen-Wolloff, L ; Khunti, K ; Leavy, OC ; Lone, N ; Marks, M ; Maylor, B ; McAuley, HJC ; Nolan, CM ; Poinasamy, K ; Quint, JK ; Raman, B ; Richardson, M ; Sargeant, JA ; Saunders, RM ; Sereno, M ; Shikotra, A ; Singapuri, A ; Steiner, M ; Stensel, DJ ; Wain, L ; Whitney, J ; Wootton, DG ; Brightling, CE ; Man, WD-C ; Singh, SJ ; Yates, T (BMC, 2022-07-28)
    BACKGROUND: The number of individuals recovering from severe COVID-19 is increasing rapidly. However, little is known about physical behaviours that make up the 24-h cycle within these individuals. This study aimed to describe physical behaviours following hospital admission for COVID-19 at eight months post-discharge including associations with acute illness severity and ongoing symptoms. METHODS: One thousand seventy-seven patients with COVID-19 discharged from hospital between March and November 2020 were recruited. Using a 14-day wear protocol, wrist-worn accelerometers were sent to participants after a five-month follow-up assessment. Acute illness severity was assessed by the WHO clinical progression scale, and the severity of ongoing symptoms was assessed using four previously reported data-driven clinical recovery clusters. Two existing control populations of office workers and individuals with type 2 diabetes were comparators. RESULTS: Valid accelerometer data from 253 women and 462 men were included. Women engaged in a mean ± SD of 14.9 ± 14.7 min/day of moderate-to-vigorous physical activity (MVPA), with 12.1 ± 1.7 h/day spent inactive and 7.2 ± 1.1 h/day asleep. The values for men were 21.0 ± 22.3 and 12.6 ± 1.7 h /day and 6.9 ± 1.1 h/day, respectively. Over 60% of women and men did not have any days containing a 30-min bout of MVPA. Variability in sleep timing was approximately 2 h in men and women. More severe acute illness was associated with lower total activity and MVPA in recovery. The very severe recovery cluster was associated with fewer days/week containing continuous bouts of MVPA, longer total sleep time, and higher variability in sleep timing. Patients post-hospitalisation with COVID-19 had lower levels of physical activity, greater sleep variability, and lower sleep efficiency than a similarly aged cohort of office workers or those with type 2 diabetes. CONCLUSIONS: Those recovering from a hospital admission for COVID-19 have low levels of physical activity and disrupted patterns of sleep several months after discharge. Our comparative cohorts indicate that the long-term impact of COVID-19 on physical behaviours is significant.
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    Cultural adaptation of a diabetes self-management education and support (DSMES) programme for two low resource urban settings in Ghana, during the COVID-19 era
    Lamptey, R ; Davies, MJ ; Khunti, K ; Schreder, S ; Stribling, B ; Hadjiconstantinou, M (BMC, 2022-08-05)
    BACKGROUND: Type 2 diabetes is a significant public health problem globally and associated with significant morbidity and mortality. Diabetes self-management education and support (DSMES) programmes are associated with improved psychological and clinical outcomes. There are currently no structured DSMES available in Ghana. We sought to adapt an evidence-based DSMES intervention for the Ghanaian population in collaboration with the local Ghanaian people. METHODS: We used virtual engagements with UK-based DSMES trainers, produced locally culturally and linguistically appropriate content and modified the logistics needed for the delivery of the self-management programme to suit people with low literacy and low health literacy levels. CONCLUSIONS: A respectful understanding of the socio-cultural belief systems in Ghana as well as the peculiar challenges of low resources settings and low health literacy is necessary for adaptation of any DSMES programme for Ghana. We identified key cultural, linguistic, and logistic considerations to incorporate into a DSMES programme for Ghanaians, guided by the Ecological Validity Model. These insights can be used further to scale up availability of structured DSMES in Ghana and other low- middle- income countries.
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    Risk of covid-19 related deaths for SARS-CoV-2 omicron (B.1.1.529) compared with delta (B.1.617.2): retrospective cohort study.
    Ward, IL ; Bermingham, C ; Ayoubkhani, D ; Gethings, OJ ; Pouwels, KB ; Yates, T ; Khunti, K ; Hippisley-Cox, J ; Banerjee, A ; Walker, AS ; Nafilyan, V (BMJ, 2022-08-02)
    OBJECTIVE: To assess the risk of covid-19 death after infection with omicron BA.1 compared with delta (B.1.617.2). DESIGN: Retrospective cohort study. SETTING: England, United Kingdom, from 1 December 2021 to 30 December 2021. PARTICIPANTS: 1 035 149 people aged 18-100 years who tested positive for SARS-CoV-2 under the national surveillance programme and had an infection identified as omicron BA.1 or delta compatible. MAIN OUTCOME MEASURES: The main outcome measure was covid-19 death as identified from death certification records. The exposure of interest was the SARS-CoV-2 variant identified from NHS Test and Trace PCR positive tests taken in the community (pillar 2) and analysed by Lighthouse laboratories. Cause specific Cox proportional hazard regression models (censoring non-covid-19 deaths) were adjusted for sex, age, vaccination status, previous infection, calendar time, ethnicity, index of multiple deprivation rank, household deprivation, university degree, keyworker status, country of birth, main language, region, disability, and comorbidities. Interactions between variant and sex, age, vaccination status, and comorbidities were also investigated. RESULTS: The risk of covid-19 death was 66% lower (95% confidence interval 54% to 75%) for omicron BA.1 compared with delta after adjusting for a wide range of potential confounders. The reduction in the risk of covid-19 death for omicron compared with delta was more pronounced in people aged 18-59 years (number of deaths: delta=46, omicron=11; hazard ratio 0.14, 95% confidence interval 0.07 to 0.27) than in those aged ≥70 years (number of deaths: delta=113, omicron=135; hazard ratio 0.44, 95% confidence interval 0.32 to 0.61, P<0.0001). No evidence of a difference in risk was found between variant and number of comorbidities. CONCLUSIONS: The results support earlier studies showing a reduction in severity of infection with omicron BA.1 compared with delta in terms of hospital admission. This study extends the research to also show a reduction in the risk of covid-19 death for the omicron variant compared with the delta variant.
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    Physical activity and the 'pediatric inactivity triad' in children living with chronic kidney disease: a narrative review
    Wilkinson, TJ ; O'Mahoney, LL ; Highton, P ; Viana, JL ; Ribeiro, HS ; Lightfoot, CJ ; Curtis, F ; Khunti, K (SAGE PUBLICATIONS LTD, 2022-07-01)
    The 'paediatric inactivity triad' (PIT) framework consists of three complex inter-related conditions that influence physical inactivity and related health risks. In those living with chronic kidney disease (CKD), a multi-factorial milieu of components likely confound the PIT elements, resulting in a cycle of decreased physical functioning and reduced physical activity. In this review, we explore and summarize previous research on each of the three principal PIT components (exercise deficit disorder, dynapenia, and physical illiteracy) in the pediatric CKD population. We found those living with CKD are significantly physically inactive compared to their peers. Physical inactivity occurs early in the disease process and progressively gets worse as disease burden increases. Although physical activity appears to increase post-transplantation, it remains lower compared to healthy controls. There is limited evidence on interventions to increase physical activity behaviour in this population, and those that have attempted have had negligible effects. Studies reported profound reductions in muscle strength, physical performance, and cardiorespiratory fitness. A small number of exercise-based interventions have shown favourable improvements in physical function and cardiorespiratory fitness, although small sample sizes and methodological issues preclude the generalization of findings. Physical activity must be adapted and individualized to the needs and goals of the children, particularly those with acute and chronic medical needs as is the case in CKD, and further work is needed to define optimal interventions across the life course in this population if we aim to prevent physical activity declining further.
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    Access to personal protective equipment in healthcare workers during the COVID-19 pandemic in the United Kingdom: results from a nationwide cohort study (UK-REACH)
    Martin, CA ; Pan, D ; Nazareth, J ; Aujayeb, A ; Bryant, L ; Carr, S ; Gray, LJ ; Gregary, B ; Gupta, A ; Guyatt, AL ; Gopal, A ; Hine, T ; John, C ; McManus, IC ; Melbourne, C ; Nellums, LB ; Reza, R ; Simpson, S ; Tobin, MD ; Woolf, K ; Zingwe, S ; Khunti, K ; Pareek, M (BMC, 2022-07-05)
    BACKGROUND: Healthcare workers (HCWs) are at high risk of SARS-CoV-2 infection. Effective use of personal protective equipment (PPE) reduces this risk. We sought to determine the prevalence and predictors of self-reported access to appropriate PPE (aPPE) for HCWs in the UK during the COVID-19 pandemic. METHODS: We conducted cross sectional analyses using data from a nationwide questionnaire-based cohort study administered between December 2020-February 2021. The outcome was a binary measure of self-reported aPPE (access all of the time vs access most of the time or less frequently) at two timepoints: the first national lockdown in the UK in March 2020 (primary analysis) and at the time of questionnaire response (secondary analysis). RESULTS: Ten thousand five hundred eight HCWs were included in the primary analysis, and 12,252 in the secondary analysis. 35.2% of HCWs reported aPPE at all times in the primary analysis; 83.9% reported aPPE at all times in the secondary analysis. In the primary analysis, after adjustment (for age, sex, ethnicity, migration status, occupation, aerosol generating procedure exposure, work sector and region, working hours, night shift frequency and trust in employing organisation), older HCWs and those working in Intensive Care Units were more likely to report aPPE at all times. Asian HCWs (aOR:0.77, 95%CI 0.67-0.89 [vs White]), those in allied health professional and dental roles (vs those in medical roles), and those who saw a higher number of COVID-19 patients compared to those who saw none (≥ 21 patients/week 0.74, 0.61-0.90) were less likely to report aPPE at all times. Those who trusted their employing organisation to deal with concerns about unsafe clinical practice, compared to those who did not, were twice as likely to report aPPE at all times. Significant predictors were largely unchanged in the secondary analysis. CONCLUSIONS: Only a third of HCWs in the UK reported aPPE at all times during the first lockdown and that aPPE had improved later in the pandemic. We also identified key determinants of aPPE during the first UK lockdown, which have mostly persisted since lockdown was eased. These findings have important implications for the safe delivery of healthcare during the pandemic.
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    Predictors and determinants of albuminuria in people with prediabetes and diabetes based on smoking status: A cross-sectional study using the UK Biobank data.
    Kar, D ; El-Wazir, A ; Delanerolle, G ; Forbes, A ; Sheppard, JP ; Nath, M ; Joy, M ; Cole, N ; Arnold, JR ; Lee, A ; Feher, M ; Davies, MJ ; Khunti, K ; de Lusignan, S ; Goyder, E (Elsevier BV, 2022-09)
    Background: Smoking is attributed to both micro- and macrovascular complications at any stage of metabolic deregulation including prediabetes. Current global diabetes prevention programmes appear to be glucocentric, and do not fully acknowledge the ramifications of cardiorenal risk factors in smokers and ex-smokers. A more holistic approach is needed to prevent vascular complications in people with prediabetes and diabetes before and after quitting. Methods: A cross-sectional study was carried out on participants who agreed to take part in the UK Biobank dataset at the time of their first attendances between March 01, 2006, and December 31, 2010. Those who had their urinary albumin concentration (UAC) data available were included, and those who did not have this data, were excluded. A logistic regression model was fitted to explore the relationship between cardiorenal risk factors and albuminuria in people with prediabetes and diabetes, based on smoking status. Findings: A total of 502,490 participants were included in the UK Biobank dataset. Of them, 30.4% (n=152,896) had their UAC level recorded. Compared with non-smokers, the odds of albuminuria in smokers with prediabetes and diabetes were 1.21 (95% CI 1.05 - 1.39, p=0.009), and 1.26 (95% CI 1.10 - 1.44, p=0.001), respectively. The odds declined after quitting in both groups, but it was not statistically significant (p>0.05). Each unit increase in HbA1c was associated with equivalent increased odds of albuminuria in current and ex-smokers, OR 1.035 (95% CI 1.030 - 1.039, p<0.001), and 1.026 (95% CI 1.023 - 1.028, p <0.001), respectively. Compared to females, male ex-smokers were at 15% increased odds of albuminuria. In ex-smokers, each unit increase in waist circumference was associated with 1% increased risk of albuminuria. Compared with the least deprived quintiles, the odds of albuminuria in the most deprived quintiles, in current and ex-smokers were identical, OR 1.18 (95% CI 1.04-1.324, p=0.010), and 1.19 (95% CI 1.11 - 1.27, p<0.001), respectively. Interpretation: Male smokers are at a higher risk of albuminuria after smoking cessation. Monitoring waist circumference in quitters may identify those who are at a higher risk of albuminuria. Combining smoking cessation intervention in smokers with prediabetes in the current diabetes prevention programmes may offset post-cessation weight gain and reduce the risk of albuminuria. Funding: University of Sheffield.