General Practice and Primary Care - Research Publications

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    Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community
    Mullis, R ; Aquino, MRJR ; Dawson, SN ; Johnson, V ; Jowett, S ; Kreit, E ; Mant, J ; Carey, M ; Davies, M ; Doherty, Y ; Khunti, K ; Lim, L ; Mackintosh, B ; Mander, A ; McKevitt, C ; Roland, M ; Sutton, S ; Walker, M ; Warburton, E (BMJ PUBLISHING GROUP, 2019-08)
    INTRODUCTION: Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care. METHODS AND ANALYSIS: Improving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation. ETHICS AND DISSEMINATION: Favourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan. TRIAL REGISTRATION NUMBER: NCT03353519.
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    Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin-treated Type 2 diabetes mellitus
    Khunti, K ; Berkovic, MC ; Ludvik, B ; Moberg, E ; Lekdorf, JB ; Gydesen, H ; Pedersen-Bjergaard, U (WILEY, 2018-09)
    AIM: To determine participant knowledge and reporting of hypoglycaemia in the non-interventional Hypoglycaemia Assessment Tool (HAT) study. METHODS: HAT was conducted in 24 countries over a 6-month retrospective/4-week prospective period in 27 585 adults with Type 1 or insulin-treated Type 2 diabetes mellitus. Participants recorded whether hypoglycaemia was based on blood glucose levels, symptoms or both. RESULTS: Hypoglycaemia rates were consistently higher in the prospective compared with the retrospective period. Most respondents (96.8% Type 1 diabetes; 85.6% Type 2 diabetes) knew the American Diabetes Association/European Association for the Study of Diabetes hypoglycaemia definition, but there were regional differences in the use of blood glucose measurements and/or symptoms to define events. Confirmed symptomatic hypoglycaemia rates were highest in Northern Europe/Canada for Type 1 diabetes (63.9 events/year) and in Eastern Europe for Type 2 diabetes (19.4 events/year), and lowest in South East Asia (Type 1 diabetes: 6.0 events/year; Type 2 diabetes: 3.2 events/year). Unconfirmed symptomatic hypoglycaemia rates were highest in Eastern Europe for Type 1 diabetes (5.6 events/year) and South East Asia for Type 2 diabetes (4.7 events/year), and lowest for both in Russia (Type 1 diabetes: 2.1 events/year; Type 2 diabetes: 0.4 events/year). Participants in Latin America reported the highest rates of severe hypoglycaemia (Type 1 diabetes: 10.8 events/year; Type 2 diabetes 3.7 events/year) and severe hypoglycaemia requiring hospitalization (Type 1 diabetes: 0.56 events/year; Type 2 diabetes: 0.44 events/year). The lowest rates of severe hypoglycaemia were reported in South East Asia (Type 1 diabetes: 2.0 events/year) and Northern Europe/Canada (Type 2 diabetes: 1.3 events/year), and the lowest rates of severe hypoglycaemia requiring hospitalization were in Russia (Type 1 diabetes: 0.15 events/year; Type 2 diabetes: 0.09 events/year). The blood glucose cut-off used to define hypoglycaemia varied between regions (Type 1 diabetes: 3.1-3.6 mmol/l; Type 2 diabetes: 3.5-3.8 mmol/l). CONCLUSIONS: Under-reporting of hypoglycaemia rates in retrospective recall and regional variations in participant definitions of hypoglycaemia may contribute to the global differences in reported rates. Discrepancies between participant definitions and guidelines may highlight a need to redefine hypoglycaemia criteria. (Clinical Trials Registry No: NCT01696266).
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    Global burden of hypoglycaemia-related mortality in 109 countries, from 2000 to 2014: an analysis of death certificates
    Zaccardi, F ; Dhalwani, NN ; Webb, DR ; Davies, MJ ; Khunti, K (SPRINGER, 2018-07)
    AIMS/HYPOTHESIS: In the context of increasing prevalence of diabetes in elderly people with multimorbidity, intensive glucose control may increase the risk of severe hypoglycaemia, potentially leading to death. While rising trends of severe hypoglycaemia rates have been reported in some European, North American and Asian countries, the global burden of hypoglycaemia-related mortality is unknown. We aimed to investigate global differences and trends of hypoglycaemia-related mortality. METHODS: We used the WHO mortality database to extract information on death certificates reporting hypoglycaemia or diabetes as the underlying cause of death, and the United Nations demographic database to obtain data on mid-year population estimates from 2000 to 2014. We calculated crude and age-standardised proportions (defined as number of hypoglycaemia-related deaths divided by total number of deaths from diabetes [i.e. the sum of hypoglycaemia- and diabetes-related deaths]) and rates (hypoglycaemia-related deaths divided by mid-year population) of hypoglycaemia-related mortality and compared estimates across countries and over time. RESULTS: Data for proportions were extracted from 109 countries (31 had data from all years analysed [2000-2014] available). Combining all countries, the age-standardised proportion of hypoglycaemia-related deaths was 4.49 (95% CI 4.44, 4.55) per 1000 total diabetes deaths. Compared with the overall mean, most Central American, South American and (mainly) Caribbean countries reported higher proportions (five more age-standardised hypoglycaemia-related deaths per 1000 total diabetes deaths in Chile, six in Uruguay, 11 in Belize and 22 in Aruba), as well as Japan (11 more age-standardised hypoglycaemia-related deaths per 1000 total diabetes deaths). In comparison, lower proportions were noted in most European countries, the USA, Canada, New Zealand and Australia. For countries with data available for all years analysed, trend analysis showed a 60% increase in hypoglycaemia-related deaths until 2010 and stable trends onwards. Rising trends were most evident for Argentina, Brazil, Chile, the USA and Japan. Data for rates were available for 105 countries (30 had data for all years analysed [2000-2014] available). Combining all countries, the age-standardised hypoglycaemia-related death rate was 0.79 (95% CI 0.77, 0.80) per 1 million person-years. Most Central American, South American and Caribbean countries similarly reported higher rates of hypoglycaemia-related death, whilst virtually all European countries, the USA, Canada, Japan, New Zealand and Australia reported lower rates compared with the overall mean. Age-standardised rates were very low for most countries (lower than five per 1 million person-years in 89.5% of countries), resulting in small absolute differences among countries. As noted with the proportions analysis, trend analysis showed an overall 60% increase in hypoglycaemia-related deaths until 2010 and stable rate trends onwards; rising rates were particularly evident for Brazil, Chile and the USA. CONCLUSIONS/INTERPRETATION: Most countries in South America, Central America and the Caribbean showed the highest proportions of diabetes-related deaths attributable to hypoglycaemia and the highest rates of hypoglycaemia-related deaths. Between 2000 and 2014, rising trends were observed in Brazil, Chile and the USA for both rates and proportions of hypoglycaemia-related death, and in Argentina and Japan for proportions only. Further studies are required to unravel the contribution of clinical and socioeconomic factors, difference in diabetes prevalence and heterogeneity of death certification in determining lower rates and proportions of hypoglycaemia-related deaths in high-income countries in Europe, North America and Asia. DATA AVAILABILITY: Data used for these analyses are available at https://doi.org/10.17632/ndp52fbz8r.1.
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    Identification of barriers to insulin therapy and approaches to overcoming them
    Russell-Jones, D ; Pouwer, F ; Khunti, K (WILEY, 2018-03)
    Poor glycaemic control in type 2 diabetes (T2D) is a global problem despite the availability of numerous glucose-lowering therapies and clear guidelines for T2D management. Tackling clinical or therapeutic inertia, where the person with diabetes and/or their healthcare providers do not intensify treatment regimens despite this being appropriate, is key to improving patients' long-term outcomes. This gap between best practice and current level of care is most pronounced when considering insulin regimens, with studies showing that insulin initiation/intensification is frequently and inappropriately delayed for several years. Patient- and physician-related factors both contribute to this resistance at the stages of insulin initiation, titration and intensification, impeding achievement of optimal glycaemic control. The present review evaluates the evidence and reasons for this delay, together with available methods for facilitation of insulin initiation or intensification.
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    Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: Retrospective data for 10256 individuals from the United Kingdom and Germany
    Khunti, K ; Godec, TR ; Medina, J ; Garcia-Alvarez, L ; Hiller, J ; Gomes, MB ; Cid-Ruzafa, J ; Charbonnel, B ; Fenici, P ; Hammar, N ; Hashigami, K ; Kosiborod, M ; Nicolucci, A ; Shestakova, MV ; Ji, L ; Pocock, S (WILEY, 2018-02)
    AIM: To investigate determinants of change in glycated haemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM) at 6 months after initiating uninterrupted second-line glucose-lowering therapies. MATERIALS AND METHODS: This cohort study utilized retrospective data from 10 256 patients with T2DM who initiated second-line glucose-lowering therapy (switch from or add-on to metformin) between 2011 and 2014 in Germany and the UK. Effects of pre-specified patient characteristics on 6-month HbA1c changes were assessed using analysis of covariance. RESULTS: Patients had a mean (standard error [SE]) baseline HbA1c of 8.68% (0.02); 28.5% of patients discontinued metformin and switched to an alternative therapy and the remainder initiated add-on therapy. Mean (SE) unadjusted 6-month HbA1c change was -1.27% (0.02). When adjusted for baseline HbA1c, 6-month changes depended markedly on the magnitude of the baseline HbA1c (HbA1c <9%, -0.45% per unit increase in HbA1c; HbA1c ≥9%, -0.87% per unit increase in HbA1c). Adjusted mean 6-month HbA1c reductions showed slight treatment differences (range, 0.92-1.09%; P < .001). Greater reductions in HbA1c were associated with second-line treatment initiation within 6 months of T2DM diagnosis (1.36% vs 1.03% [P < .001]) and advanced age (≥70 years, 1.13%; <70 years, 1.02% [P < .001]). CONCLUSIONS: Many patients with T2DM have very high HbA1c levels when initiating second-line therapy, indicating the need for earlier treatment intensification. Patient-specific factors merit consideration when making treatment decisions.
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    Therapeutic inertia in the treatment of hyperglycaemia in patients with type 2 diabetes: A systematic review
    Khunti, K ; Gomes, MB ; Pocock, S ; Shestakova, MV ; Pintat, S ; Fenici, P ; Hammar, N ; Medina, J (WILEY, 2018-02)
    AIMS: Therapeutic inertia, defined as the failure to initiate or intensify therapy in a timely manner according to evidence-based clinical guidelines, is a key reason for uncontrolled hyperglycaemia in patients with type 2 diabetes. The aims of this systematic review were to identify how therapeutic inertia in the management of hyperglycaemia was measured and to assess its extent over the past decade. MATERIALS AND METHODS: Systematic searches for articles published from January 1, 2004 to August 1, 2016 were conducted in MEDLINE and Embase. Two researchers independently screened all of the titles and abstracts, and the full texts of publications deemed relevant. Data were extracted by a single researcher using a standardized data extraction form. RESULTS: The final selection for the review included 53 articles. Measurements used to assess therapeutic inertia varied across studies, making comparisons difficult. Data from low- to middle-income countries were scarce. In most studies, the median time to treatment intensification after a glycated haemoglobin (HbA1c) measurement above target was more than 1 year (range 0.3 to >7.2 years). Therapeutic inertia increased as the number of antidiabetic drugs rose and decreased with increasing HbA1c levels. Data were mainly available from Western countries. Diversity of inertia measures precluded meta-analysis. CONCLUSIONS: Therapeutic inertia in the management of hyperglycaemia in patients with type 2 diabetes is a major concern. This is well documented in Western countries, but corresponding data are urgently needed in low- and middle-income countries, in view of their high prevalence of type 2 diabetes.
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    Sedentary Time and MRI-Derived Measures of Adiposity in Active Versus Inactive Individuals
    Henson, J ; Edwardson, CL ; Morgan, B ; Horsfield, MA ; Khunti, K ; Davies, MJ ; Yates, T (WILEY, 2018-01)
    OBJECTIVE: The aim of this study was to examine cross-sectional associations between objectively measured sedentary time and magnetic resonance imaging (MRI)-assessed adiposity in a population at high risk for type 2 diabetes (T2DM) and to determine whether associations are modified by the recommended levels of moderate-to-vigorous physical activity (MVPA). METHODS: Sedentary time and MVPA were measured objectively by using accelerometers. Linear regression models examined the association of sedentary time with liver, visceral, subcutaneous, and total abdominal fat (quantified by using MRI). Interaction terms determined whether results were consistent across activity categories (active [> 150 min/wk of MVPA] vs. inactive [< 150 min/wk of MVPA]). RESULTS: One hundred and twenty-four participants (age = 64.0 ± 7.1 years; male = 65.3%; BMI = 31.8 ± 5.6 kg/m2 ) were included. Following adjustment, each 60 minutes of sedentary time was associated with 1.74 L higher total abdominal fat, 0.62 L higher visceral fat, 1.14 L higher subcutaneous fat, and 1.86% higher liver fat. When results were stratified by MVPA (active vs. inactive), sedentary time was associated with greater liver, visceral, and total abdominal fat in the inactive group only. CONCLUSIONS: These findings suggest that sedentary time is associated with higher levels of inter- and intraorgan fat, but associations with liver, visceral, and total abdominal fat were stronger in those who do not reach the current exercise recommendations for health.
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    Type 2 diabetes treatment and outcomes worldwide: A short review of the DISCOVER study programme
    Khunti, K ; Ji, L ; Medina, J ; Surmont, F ; Kosiborod, M (WILEY, 2019-11)
    The global burden of type 2 diabetes (T2D) is increasing, indicating an urgent need for improved disease prevention and management strategies. Contemporary, global, real-world data, collected in a consistent way, on the characteristics, treatment and outcomes of people with T2D are lacking, particularly in low- and middle-income countries where disease burden is increasing most rapidly. The DISCOVER study programme (ClinicalTrials.gov identifiers: NCT02322762 and NCT02226822) is a global, prospective, 3-year programme of observational research, which has been designed to fill this knowledge gap. DISCOVER is being conducted in 38 countries across six continents, including several lower-middle- and upper-middle-income countries where patients have rarely or never been studied previously. In total, 15 992 people with T2D who had initiated a second-line glucose-lowering therapy have been recruited. Data being collected include information on demographics, clinical and treatment characteristics, socio-economic status, clinical outcomes and patient-reported outcomes. Findings from DISCOVER will provide unique insights into current patterns of T2D care worldwide, which should contribute to informing clinical guidelines and health policy, and may help to improve patient care.
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    Association of depression and anxiety with clinical, sociodemographic, lifestyle and environmental factors in South Asian and white European individuals at high risk of diabetes
    Razieh, C ; Khunti, K ; Davies, MJ ; Edwardson, CL ; Henson, J ; Darko, N ; Comber, A ; Jones, A ; Yates, T (WILEY, 2019-09)
    AIM: To investigate the prevalence and correlates of depressive and anxiety symptoms within South Asian and white European populations at high risk of developing Type 2 diabetes. METHODS: Data were collected at baseline, and at 12, 24 and 36 months from 1429 white European individuals (age 64±7 years, 35.8% women) and 160 South Asian individuals (age 59±9 years, 30.6% women) who were at high risk of Type 2 diabetes and who took part in two Type 2 diabetes prevention trials in Leicestershire, UK. The Hospital Anxiety and Depression Scale was administered during each study visit. Clinical, sociodemographic, lifestyle and environmental data were collected. RESULTS: At baseline, the burden of depressive symptoms varied by ethnic group and gender, with 9.9% of white European men, 14.9% of white European women, 23.6% of South Asian men and 29.2% of South Asian women exceeding the cut-off score for mild-to-severe depression. During the course of the study and after adjustment for clinical, sociodemographic, lifestyle and environmental factors, depressive symptoms remained higher in the South Asian compared to the white European participants [score higher by 1.5, 95% CI 0.9-2.1]. Levels of anxiety were also higher in the South Asian participants, although associations were attenuated after adjustment. Social deprivation, BMI, proximity to fast-food outlets and physical activity were correlates for depression in both the South Asian and white European participants. CONCLUSIONS: A higher burden of depressive symptoms was consistently evident among the South Asian individuals, even after adjustment for multiple covariates. It is important to understand both the reasons why these differences are present, to help reduce health inequalities, and whether higher levels of depressive symptoms affect the uptake of and retention rates in diabetes prevention programmes in South Asian communities.
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    Efficacy of low- and very-low-energy diets in people with type 2 diabetes mellitus: A systematic review and meta-analysis of interventional studies
    Kloecker, DE ; Zaccardi, F ; Baldry, E ; Davies, MJ ; Khunti, K ; Webb, DR (WILEY, 2019-07)
    AIMS: To review systematically and quantify the weight loss achieved through low- (LEDs) and very-low-energy diets (VLEDs) in people with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Studies reporting the effects of diet-only interventions of up to 1600 kcal/d in people with T2DM were searched in MEDLINE, EMBASE and CINAHL up to July 2018. Changes in the primary (body weight and body mass index [BMI]) and secondary outcomes (glycated haemoglobin, blood lipids) according to energy restriction and duration of diet were modelled using restricted cubic splines. RESULTS: Forty-four studies (3817 participants) were included. The overall quality of the evidence was moderate and limited to short-term interventions up to 4 months. Baseline mean weight and BMI were 92.1 kg and 36.6 kg/m2 . VLEDs of 400 kcal/d led to 5.4% weight loss at 2 weeks, increasing to 17.9% at 3 months. More modest reductions of 7.3% were observed on LEDs of 1200 kcal/d and 2.0% on 1600 kcal/d after 3 months. No clear patterns emerged for secondary outcomes. Publication bias was significant for primary outcomes. CONCLUSIONS: Through modelling, we were able to describe effective dietary deficit strategies to achieve weight reduction up to 4 months in people with T2DM. High-quality studies are required to further support clinical practice with evidence-based dietary interventions.