General Practice and Primary Care - Research Publications

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    The impact of COVID-19 restrictions on accelerometer-assessed physical activity and sleep in individuals with type 2 diabetes
    Rowlands, AV ; Henson, JJ ; Coull, NA ; Edwardson, CL ; Brady, E ; Hall, A ; Khunti, K ; Davies, M ; Yates, T (WILEY, 2021-10)
    AIMS: Restrictions during the COVID-19 crisis will have impacted on opportunities to be active. We aimed to (a) quantify the impact of COVID-19 restrictions on accelerometer-assessed physical activity and sleep in people with type 2 diabetes and (b) identify predictors of physical activity during COVID-19 restrictions. METHODS: Participants were from the UK Chronotype of Patients with type 2 diabetes and Effect on Glycaemic Control (CODEC) observational study. Participants wore an accelerometer on their wrist for 8 days before and during COVID-19 restrictions. Accelerometer outcomes included the following: overall physical activity, moderate-to-vigorous physical activity (MVPA), time spent inactive, days/week with ≥30-minute continuous MVPA and sleep. Predictors of change in physical activity taken pre-COVID included the following: age, sex, ethnicity, body mass index (BMI), socio-economic status and medical history. RESULTS: In all, 165 participants (age (mean±S.D = 64.2 ± 8.3 years, BMI=31.4 ± 5.4 kg/m2 , 45% women) were included. During restrictions, overall physical activity was lower by 1.7 mg (~800 steps/day) and inactive time 21.9 minutes/day higher, but time in MVPA and sleep did not statistically significantly change. In contrast, the percentage of people with ≥1 day/week with ≥30-minute continuous MVPA was higher (34% cf. 24%). Consistent predictors of lower physical activity and/or higher inactive time were higher BMI and/or being a woman. Being older and/or from ethnic minorities groups was associated with higher inactive time. CONCLUSIONS: Overall physical activity, but not MVPA, was lower in adults with type 2 diabetes during COVID-19 restrictions. Women and individuals who were heavier, older, inactive and/or from ethnic minority groups were most at risk of lower physical activity during restrictions.
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    Improved diabetes-related distress and self-efficacy outcomes in a self-management digital programme for people with type 2 diabetes, myDESMOND
    Hadjiconstantinou, M ; Barker, MM ; Brough, C ; Schreder, S ; Northern, A ; Stribling, B ; Khunti, K ; Davies, MJ (WILEY, 2021-05)
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    Effects of liraglutide versus sitagliptin on circulating cardiovascular biomarkers, including circulating progenitor cells, in individuals with type 2 diabetes and obesity: Analyses from the LYDIA trial
    Ahmad, E ; Waller, HL ; Sargeant, JA ; Webb, MA ; Htike, ZZ ; McCann, GP ; Gulsin, G ; Khunti, K ; Yates, T ; Henson, J ; Davies, MJ ; Webb, DR (WILEY, 2021-06)
    The mechanisms behind the beneficial cardiovascular effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) compared with dipeptidyl peptidase-4 inhibitors (DPP4is) remain largely unknown, despite both targeting the incretin pathway to improve glycaemic control. In these prespecified secondary analyses of the LYDIA trial, we examined the impact of the GLP-1RA liraglutide (1.8 mg once-daily) and the DPP4i sitagliptin (100 mg once-daily) on circulating cardiovascular biomarkers associated with atherosclerotic risk, including circulating progenitor cells (CPCs). LYDIA was a 26-week, randomized, active-comparator trial in 61 adults with type 2 diabetes and obesity (mean ± SD: age 43.8 ± 6.5 years, body mass index 35.3 ± 6.4 kg/m2 , HbA1c 7.5% ± 0.83% [58.5 ± 9.1 mmol/mol]). Vascular endothelial growth factor (VEGF) and stromal cell-derived factor-1-alpha (SDF-1ɑ), both of which are implicated in endothelial function, were higher at 26 weeks with liraglutide therapy compared with sitagliptin (mean between-group difference [95% CI]: 77.03 [18.29, 135.77] pg/mL, p = .010; and 996.25 [818.85, 1173.64] pg/mL, p < .001, respectively). There were no between-group differences in CPCs, nitric oxide, C-reactive protein, interleukin-6, tumour necrosis factor alpha and advanced glycation end-products. These analyses suggest a favourable impact of liraglutide on VEGF and SDF-1ɑ levels compared with sitagliptin. These factors may therefore be implicated in the differential cardiovascular effects observed between these agents in large cardiovascular outcome trials. However, these are secondary analyses from a previous trial and thus hypothesis-generating. Purposive trials are required to examine these findings further.
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    Rates and estimated cost of primary care consultations in people diagnosed with type 2 diabetes and comorbidities: A retrospective analysis of 8.9 million consultations
    Coles, B ; Zaccardi, F ; Seidu, S ; Gillies, CL ; Davies, MJ ; Hvid, C ; Khunti, K (WILEY, 2021-06)
    AIMS: To determine whether telephone and face-to-face primary care consultation rates, costs, and temporal trends during 2000 to 2018 differed by the number of comorbidities in people with type 2 diabetes (T2DM). METHODS: A total of 120 409 adults with newly diagnosed T2DM between 2000 and 2018 were classified by the number of prevalent and incident comorbidities. Data on face-to-face and telephone primary care consultations with a nurse or physician were obtained. Crude and sex- and age-adjusted annual consultation rates and associated costs were calculated based on the number of comorbidities at the time of consultation. RESULTS: The crude rate of face-to-face primary care consultations for patients without comorbidities was 10.3 (95% confidence interval [CI] 10.3-10.4) per person-year, 12.7 (95% CI 12.7-12.7) for patients with one comorbidity, 15.1 (95% CI 15.1-15.2) for those with two comorbidities, and 18.7 (95% CI 18.7-18.8) for those with three or more comorbidities. The mean annual inflation-adjusted cost for face-to-face consultations was £412.70 per patient without comorbidities, £516.80 for one comorbidity, £620.75 for two comorbidities, and £778.83 for three or more comorbidities. The age- and sex-adjusted face-to-face consultation rate changed by an average of -3.3% (95% CI -4.4 to -2.3) per year from 2000 to 2018 for patients without comorbidities, -2.7% (95% CI -4.0 to -1.3) for those with one comorbidity, -2.2% (95% CI -3.3 to -1.2) for those with two comorbidities, and -4.3% (95% CI -8.7 to +0.3) for those with three or more comorbidities. CONCLUSIONS: Although consultation rates for all patients decreased from 2000 to 2018, there was a significant disparity between the rate for patients with and without comorbidities. Patients with T2DM and comorbidities may require different models of service delivery.
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    Effectiveness of the Transformation model, a model of care that integrates diabetes services across primary, secondary and community care: A retrospective study
    Brady, EM ; Bodicoat, DH ; Zaccardi, F ; Seidu, S ; Idris, I ; Khunti, K ; Farooqi, A ; Davies, MJ (WILEY, 2021-06)
    AIMS: The primary aim was to evaluate the effectiveness of a model integrating diabetes services across primary, secondary and community care (Transformation model). The secondary aim was to understand whether changes resulted from the model. METHODS: The model was implemented In Leicester, Leicestershire and Rutland (UK) across three clinical commissioning groups, the acute trust and accompanying stakeholders. One clinical commissioning group (Leicester City) implemented the entire model and was the primary evaluation population. A quasi-experimental interrupted time series design was employed. The primary outcome was number of Type 2 diabetes-related bed-days per 1000 patients. RESULTS: In the primary population, the mean number of Type 2 diabetes-related bed-days per 1000 patients was increasing before model implementation by 0.33/month (95% confidence interval: -0.07, 0.72), whereas it was decreasing after implementation by a mean value of -0.14/month (-0.33, 0.06); a statistically significant difference (p = 0.04). Secondary analyses showed: nationally, there was no significant change between the pre- and post-periods so it is unlikely that large secular change drove the improvement; the other two Leicestershire clinical commissioning groups saw improvement or stability; underlying processes worked as hypothesised overall; diabetes biomedical markers deteriorated in the primary care population suggesting a change in case-mix due to moving some patients out of secondary care. CONCLUSIONS: Given that the initial aim was to shift services from secondary to primary care without causing harm, an improvement is better than expected. This observational evaluation cannot show conclusively that improvements were due to the Transformation model, but secondary analyses support this.
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    Physical, cognitive, and mental health impacts of COVID-19 after hospitalisation (PHOSP-COVID): a UK multicentre, prospective cohort study
    Evans, RA ; McAuley, H ; Harrison, EM ; Shikotra, A ; Singapuri, A ; Sereno, M ; Elneima, O ; Docherty, AB ; Lone, N ; Leavy, OC ; Daines, L ; Baillie, JK ; Brown, JS ; Chalder, T ; De Soyza, A ; Bakerly, ND ; Easom, N ; Geddes, JR ; Greening, NJ ; Hart, N ; Heaney, LG ; Heller, S ; Howard, L ; Hurst, JR ; Jacob, J ; Jenkins, RG ; Jolley, C ; Kerr, S ; Kon, OM ; Lewis, K ; Lord, JM ; McCann, GP ; Neubauer, S ; Openshaw, PJM ; Parekh, D ; Pfeffer, P ; Rahman, NM ; Raman, B ; Richardson, M ; Rowland, M ; Semple, MG ; Shah, AM ; Singh, SJ ; Sheikh, A ; Thomas, D ; Toshner, M ; Chalmers, JD ; Ho, L-P ; Horsley, A ; Marks, M ; Poinasamy, K ; Wain, L ; Brightling, CE (ELSEVIER SCI LTD, 2021-11)
    BACKGROUND: The impact of COVID-19 on physical and mental health and employment after hospitalisation with acute disease is not well understood. The aim of this study was to determine the effects of COVID-19-related hospitalisation on health and employment, to identify factors associated with recovery, and to describe recovery phenotypes. METHODS: The Post-hospitalisation COVID-19 study (PHOSP-COVID) is a multicentre, long-term follow-up study of adults (aged ≥18 years) discharged from hospital in the UK with a clinical diagnosis of COVID-19, involving an assessment between 2 and 7 months after discharge, including detailed recording of symptoms, and physiological and biochemical testing. Multivariable logistic regression was done for the primary outcome of patient-perceived recovery, with age, sex, ethnicity, body-mass index, comorbidities, and severity of acute illness as covariates. A post-hoc cluster analysis of outcomes for breathlessness, fatigue, mental health, cognitive impairment, and physical performance was done using the clustering large applications k-medoids approach. The study is registered on the ISRCTN Registry (ISRCTN10980107). FINDINGS: We report findings for 1077 patients discharged from hospital between March 5 and Nov 30, 2020, who underwent assessment at a median of 5·9 months (IQR 4·9-6·5) after discharge. Participants had a mean age of 58 years (SD 13); 384 (36%) were female, 710 (69%) were of white ethnicity, 288 (27%) had received mechanical ventilation, and 540 (50%) had at least two comorbidities. At follow-up, only 239 (29%) of 830 participants felt fully recovered, 158 (20%) of 806 had a new disability (assessed by the Washington Group Short Set on Functioning), and 124 (19%) of 641 experienced a health-related change in occupation. Factors associated with not recovering were female sex, middle age (40-59 years), two or more comorbidities, and more severe acute illness. The magnitude of the persistent health burden was substantial but only weakly associated with the severity of acute illness. Four clusters were identified with different severities of mental and physical health impairment (n=767): very severe (131 patients, 17%), severe (159, 21%), moderate along with cognitive impairment (127, 17%), and mild (350, 46%). Of the outcomes used in the cluster analysis, all were closely related except for cognitive impairment. Three (3%) of 113 patients in the very severe cluster, nine (7%) of 129 in the severe cluster, 36 (36%) of 99 in the moderate cluster, and 114 (43%) of 267 in the mild cluster reported feeling fully recovered. Persistently elevated serum C-reactive protein was positively associated with cluster severity. INTERPRETATION: We identified factors related to not recovering after hospital admission with COVID-19 at 6 months after discharge (eg, female sex, middle age, two or more comorbidities, and more acute severe illness), and four different recovery phenotypes. The severity of physical and mental health impairments were closely related, whereas cognitive health impairments were independent. In clinical care, a proactive approach is needed across the acute severity spectrum, with interdisciplinary working, wide access to COVID-19 holistic clinical services, and the potential to stratify care. FUNDING: UK Research and Innovation and National Institute for Health Research.
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    Clustering of comorbidities.
    Chudasama, YV ; Khunti, K ; Davies, MJ (Elsevier BV, 2021-07)
    Within the last decade, clustering of comorbidities has become an increasing health problem on a global scale and will continue to challenge healthcare professionals in the coming years. People with multiple diseases find difficulties in managing their daily lives due to the implications each disease brings; attending and keeping up to date with hospital appointments, being prescribed and taking various medications, the effects of mental health and quality of life, and the impact it has on their families. Most research in clinical trials often exclude individuals with multimorbidity and observational studies mainly focus on single disease outcomes, therefore there is an opportunity to encourage future research in an area which could help prevent further cases and improve the lives of those already living with multimorbidity. This review aims to summarise the rising prevalence and most common clusters, highlight the challenges faced in healthcare, and explore ways to improve future research.
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    An audit of people admitted to hospital with diabetes and coronavirus (SARS-CoV-2): data collection methods. The Association of British Clinical Diabetologists (ABCD) Nationwide Audit
    Nagi, D ; Ryder, REJ ; Ruan, Y ; Field, BCT ; Narendran, P ; Gandhi, R ; Harris, S ; Varnai, KA ; Davies, J ; Wild, SH ; Wilmot, EG ; Khunti, K ; Rea, R (ASSOC BRITISH CLINICAL DIABETOLOGISTS, 2021-06)
    We describe the rationale, aims and objectives and the methodology of data collection for the ABCD nationwide audit of individuals admitted to hospital with coronavirus (SARS-CoV-2; COVID-19) and diabetes. The audit was inspired and undertaken by the urgent need to understand the clinical course of COVID-19 in patients with diabetes admitted to hospital in the UK during the pandemic. We wished to understand the clinical behaviour of diabetes per se, post hospital admission and the factors with may be associated with admission to the Intensive Care Unit (ICU) and death due to COVID-19. This was a clinically-led audit. We used existing infrastructure and expertise to collect data using an electronic tool specifically designed and piloted by the steering group members. The clinical variables were chosen to fulfil the main aim of this audit as stated above, and factors influencing the clinical course of COVID-19 in individuals with both type 1 and type 2 diabetes at the time of admission to hospital and during the whole length of stay, until discharge or death from COVID-19. The data collected so far represent a large, multicentre audit with more than 3,500 admissions during the pandemic. We plan to continue collecting additional data and publish ongoing reports of interest to diabetes clinicians with the aim of enhancing knowledge and understanding and thereby improving clinical care of, and outcomes for, people with diabetes who are admitted to hospital with COVID-19 in the UK.
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    01 The effects of a leaflet-based intervention, ‘hypos can strike twice’, on recurrent hypoglycaemic attendances by ambulance services: a non-randomised stepped wedge study
    Botan, V ; Law, GR ; Laparidou, D ; Rowan, E ; Smith, MD ; Ridyard, C ; Brewster, A ; Spaight, R ; Spurr, K ; Mountain, P ; Dunmore, S ; James, J ; Roberts, L ; Khunti, K ; Siriwardena, AN (BMJ, 2021-09)
    Background Hypoglycaemia is a common complication of diabetes therapy needing prompt recognition and treatment. It often results in ambulance attendance incurring health services costs and patient morbidity. Patient education is important for maintaining glycaemic control and preventing recurrent hypoglycaemia. We aimed to investigate the effect of an intervention in which ambulance staff were trained to provide advice supported by a booklet – ‘Hypos can strike twice’- issued following a hypoglycaemic event to prevent future attendances. Methods We used a non-randomised stepped wedge-controlled design. The intervention was introduced at different times (steps) in different areas (clusters) of operation of East Midlands Ambulance Service NHS Trust (EMAS). During the first step (T0) no clusters were exposed to the intervention and during the last step (T3) all clusters were exposed. The main outcome was the number of unsuccessful ambulance attendances (i.e. attendances followed by a repeat attendance). Data were analysed using a general linear mixed model (GLMM) and an interrupted-time series analysis (ITSA). Results The study included 4825 patients (mean age= 65.42, SD=19.42; 2166 females) experiencing hypoglycaemic events attended by EMAS. GLMM indicated a reduction in the number of unsuccessful attendances in the final step of the intervention when compared to the first (OR: 0.50, 95%CI: 0.33-0.76, p=0.001). ITSA indicated a significant decrease in repeat ambulance attendances for hypoglycaemia – relative to the pre-intervention trend (p=0.008). The hypoglycaemia care bundle (i.e. blood glucose recorded before and after treatment for hypoglycaemia) was delivered in 66% of attendances during the intervention period, demonstrating a significant level of practice change (χ2=30.16, p<0.001). Conclusions The ‘Hypos can strike twice’ intervention had a positive effect on reducing numbers of repeat attendances for hypoglycaemia and in achieving the care bundle. The study supports the use of informative booklets by ambulance clinicians to prevent future attendances for recurrent hypoglycaemic events.
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    A secondary qualitative analysis exploring the emotional and physical challenges of living with type 2 diabetes
    Hadjiconstantinou, M ; Eborall, H ; Troughton, J ; Robertson, N ; Khunti, K ; Davies, MJ (ASSOC BRITISH CLINICAL DIABETOLOGISTS, 2021-12)
    Background: Many feel that their new identity as ‘someone living with diabetes’ does not fit with their biography. Some individuals may be able to re-assess life goals, adapt their identity and adjust to living with type 2 diabetes mellitus (T2DM). For others, the biographical disruption experienced with their condition may negatively affect their emotional well-being and identity. Aim: To conceptualise and explore the emotional challenges experienced living with T2DM, using biographical disruption as analytical references. Design and setting: Secondary qualitative analysis of data collected from 31 semi-structured interviews. Method: Semi-structured interviews were conducted with people with T2DM in England. Data analysis was informed by constant comparative techniques. Results: People with T2DM undergo a cognitive process when their biography suddenly becomes interrupted. Suboptimal T2DM can bring a feeling of loss of control over one’s future, and loss of independence. What used to be perceived as ‘normal’ is now perceived as something that requires regular management, negatively impacting their daily routine and ability to carry out activities that once used to be effortless. Conclusions: Living with T2DM that is socially stigmatised can lead to poor well-being and may disturb one’s life biography. Strategies must take place to bring awareness to healthcare professionals of the impact and disruption that T2DM can have on an individual’s biography, identity and diabetes management.