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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    Ethnic Differences in Diabetes Management in Patients With and Without Comorbid Medical Conditions A cross-sectional study
    Alshamsan, R ; Majeed, A ; Vamos, EP ; Khunti, K ; Curcin, V ; Rawaf, S ; Millett, C (AMER DIABETES ASSOC, 2011-03)
    OBJECTIVE: To examine ethnic disparities in diabetes management among patients with and without comorbid medical conditions after a period of sustained investment in quality improvement in the U.K. RESEARCH DESIGN AND METHODS: This cross-sectional study examined associations between ethnicity, comorbidity, and intermediate outcomes for mean A1C, total cholesterol, and blood pressure levels in 6,690 diabetes patients in South West London. RESULTS: The presence of ≥ 2 cardiovascular comorbidities was associated with similar blood pressure control among white and South Asian patients when compared with whites without comorbidity but with worse blood pressure control among black patients, with a mean difference in systolic blood pressure of +1.5, +1.4, and +6.2 mmHg, respectively. CONCLUSIONS: Despite major reforms to improve quality, disparities in blood pressure management have persisted in the U.K., particularly among patients with cardiovascular comorbidities. Policy makers should consider the potential impacts of quality initiatives on high-risk groups.
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    Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial
    Byrne, J ; Khunti, K ; Stone, M ; Farooqi, A ; Carr, S (BMJ PUBLISHING GROUP, 2011)
    Objectives We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention. Design This was an open randomised pilot trial. Participants were randomly assigned to either: A control group (n=41) receiving standard clinical management of hypertension. An intervention group (n=40) receiving standard clinical care plus the educational intervention. Setting Renal outpatient clinics at a single study centre. Participants Patients with early CKD and hypertension were identified and approached for recruitment. Intervention An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills. Outcomes Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention. Measures Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction. Results A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0.034). Conclusion The findings suggest that delivering and evaluating an effective structured group educational intervention to promote better blood pressure control in patients with CKD would be challenging in the current context of kidney care.
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    A review of exenatide: optimizing glycemic control and associated cardiovascular risk factors in type 2 diabetes.
    Htike, ZZ ; Khunti, K ; Davies, M (Springer Science and Business Media LLC, 2012-11)
    Type 2 diabetes mellitus (T2DM) is a well-recognized risk factor for the development of cardiovascular disease. With an increasing prevalence of obesity, this risk has increased further. Management of T2DM in obese patients is particularly challenging as treatment with the majority of glucose-lowering agents results in weight gain. Thus, the development of a therapeutic option which could improve glycemic control without weight gain or hypoglycemia, such as the glucagon-like peptide-1 (GLP-1) analog exenatide, is a welcome addition to the currently available therapies in the management of T2DM. With recognition and better understanding of the role of incretin hormones in T2DM, exenatide was developed and introduced into clinical practice in 2005. Both randomized controlled trials and retrospective observational studies have shown that treatment with exenatide not only improves glycemic control, with a low risk of hypoglycemia, but also results in concurrent weight loss and the additional benefit of improvement in cardiovascular risk factors. This article will provide an overview of both short- and long-acting exenatide in the management of T2DM and associated cardiovascular risk factors.
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    Evaluating tools to support a new practical classification of diabetes: excellent control may represent misdiagnosis and omission from disease registers is associated with worse control
    Sadek, NH ; Sadek, A-R ; Tahir, A ; Khunti, K ; Desombre, T ; de Lusignan, S (WILEY-BLACKWELL, 2012-09)
    AIMS: To conduct a service evaluation of usability and utility on-line clinical audit tools developed as part of a UK Classification of Diabetes project to improve the categorisation and ultimately management of diabetes. METHOD: We conducted the evaluation in eight volunteer computerised practices all achieving maximum pay-for-performance (P4P) indicators for diabetes; two allowed direct observation and videotaping of the process of running the on-line audit. We also reported the utility of the searches and the national levels of uptake. RESULTS: Once launched 4235 unique visitors accessed the download pages in the first 3 months. We had feedback about problems from 10 practices, 7 were human error. Clinical audit naive staff ran the audits satisfactorily. However, they would prefer more explanation and more user-familiar tools built into their practice computerised medical record system. They wanted the people misdiagnosed and misclassified flagged and to be convinced miscoding mattered. People with T2DM misclassified as T1DM tended to be older (mean 62 vs. 47 years old). People misdiagnosed as having T2DM have apparently 'excellent' glycaemic control mean HbA1c 5.3% (34 mmol/mol) vs. 7.2% (55 mmol/mol) (p<0.001). People with vague codes not included in the P4P register (miscoded) have worse glycaemic control [HbA1c 8.1% (65 mmol/mol) SEM=0.42 vs.7.0% (53mmol/mol) SEM=0.11, p=0.006]. CONCLUSIONS: There was scope to improve diabetes management in practice achieving quality targets. Apparently 'excellent' glycaemic control may imply misdiagnosis, while miscoding is associated with worse control. On-line clinical audit toolkits provide a rapid method of dissemination and should be added to the armamentarium of quality improvement interventions.
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    Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation
    Gray, LJ ; Khunti, K ; Williams, S ; Goldby, S ; Troughton, J ; Yates, T ; Gray, A ; Davies, MJ (BMC, 2012-05-20)
    BACKGROUND: The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose) identified through a validated risk score screening programme in primary care. DESIGN: Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention. METHODS: The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009-2014. DISCUSSION: This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom. TRIAL REGISTRATION: Clinicaltrials.gov NCT00677937.
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    A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial
    Armstrong, N ; Baines, D ; Baker, R ; Crossman, R ; Davies, M ; Hardy, A ; Khunti, K ; Kumar, S ; O'Hare, JP ; Raymond, N ; Saravanan, P ; Stallard, N ; Szczepura, A ; Wilson, A (BMC, 2012-09-12)
    BACKGROUND: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. METHODS/DESIGN: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or CONTROL GROUP: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. DISCUSSION: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012. TRIAL REGISTRATION: [ClinicalTrials.gov: Identifier NCT00945204].
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    Association of chronic kidney disease (CKD) and failure to monitor renal function with adverse outcomes in people with diabetes: a primary care cohort study
    McGovern, AP ; Rusholme, B ; Jones, S ; van Vlymen, JN ; Liyanage, H ; Gallagher, H ; Tomson, CRV ; Khunti, K ; Harris, K ; de Lusignan, S (BMC, 2013-09-18)
    BACKGROUND: Chronic kidney disease (CKD) is a known risk factor for cardiovascular events and all-cause mortality. We investigate the relationship between CKD stage, proteinuria, hypertension and these adverse outcomes in the people with diabetes. We also study the outcomes of people who did not have monitoring of renal function. METHODS: A cohort of people with type 1 and 2 diabetes (N = 35,502) from the Quality Improvement in Chronic Kidney Disease (QICKD) cluster randomised trial was followed up over 2.5 years. A composite of all-cause mortality, cardiovascular events, and end stage renal failure comprised the outcome measure. A multilevel logistic regression model was used to determine correlates with this outcome. Known cardiovascular and renal risk factors were adjusted for. RESULTS: Proteinuria and reduced estimated glomerular filtration rate (eGFR) were independently associated with adverse outcomes in people with diabetes. People with an eGFR < 60 ml/min, proteinuria, and hypertension have the greatest odds ratio (OR) of adverse outcome; 1.58 (95% CI 1.36-1.83). Renal function was not monitored in 4460 (12.6%) people. Unmonitored renal function was associated with adverse events; OR 1.35 (95% CI 1.13-1.63) in people with hypertension and OR 1.32 (95% CI 1.07-1.64) in those without. CONCLUSIONS: Proteinuria, eGFR < 60 ml/min, and failure to monitor renal function are associated with cardiovascular and renal events and mortality in people with diabetes.
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    Association of Primary Care Characteristics with Variations in Mortality Rates in England: An Observational Study
    Levene, LS ; Bankart, J ; Khunti, K ; Baker, R ; Gorlova, OY (PUBLIC LIBRARY SCIENCE, 2012-10-24)
    BACKGROUND: Wide variations in mortality rates persist between different areas in England, despite an overall steady decline. To evaluate a conceptual model that might explain how population and service characteristics influence population mortality variations, an overall null hypothesis was tested: variations in primary healthcare service do not predict variations in mortality at population level, after adjusting for population characteristics. METHODOLOGY/PRINCIPAL FINDINGS: In an observational study of all 152 English primary care trusts (geographical groupings of population and primary care services, total population 52 million), routinely available published data from 2008 and 2009 were modelled using negative binomial regression. Counts for all-cause, coronary heart disease, all cancers, stroke, and chronic obstructive pulmonary disease mortality were analyzed using explanatory variables of relevant population and service-related characteristics, including an age-correction factor. The main predictors of mortality variations were population characteristics, especially age and socio-economic deprivation. For the service characteristics, a 1% increase in the percentage of patients on a primary care hypertension register was associated with decreases in coronary heart disease mortality of 3% (95% CI 1-4%, p = 0.006) and in stroke mortality of 6% (CI 3-9%, p<0.0001); a 1% increase in the percentage of patients recalling being better able to see their preferred doctor was associated with decreases in chronic obstructive pulmonary disease mortality of 0.7% (CI 0.2-2.0%, p = 0.02) and in all cancer mortality of 0.3% (CI 0.1-0.5%, p = 0.009) (continuity of care). The study found no evidence of an association at primary care trust population level between variations in achievement of pay for performance and mortality. CONCLUSIONS/SIGNIFICANCE: Some primary healthcare service characteristics were also associated with variations in mortality at population level, supporting the conceptual model. Health care system reforms should strengthen these characteristics by delivering cost-effective evidence-based interventions to whole populations, and fostering sustained patient-provider partnerships.
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    Balancing risk in ophthalmic prescribing: assessing the safety of anti-VEGF therapies and the risks associated with unlicensed medicines
    Kaiser, PK ; Cruess, AF ; Bogaert, P ; Khunti, K ; Kelly, SP (SPRINGER, 2012-11)
    Vascular endothelial growth factor (VEGF) inhibitor medications such as ranibizumab, pegaptanib and bevacizumab are in use for the treatment of neovascular age-related macular degeneration (AMD) and other retinal conditions, although only ranibizumab and pegaptanib are approved for these conditions. In contrast, bevacizumab was developed for the intravenous systemic treatment of colorectal cancer and is not formulated for intravitreal use, but is commonly used off-label in ophthalmology. European Union legislation permits the use of drugs outside the terms of their licence ('off-label') only under certain circumstances, such as during clinical trials, compassionate/named patient use in the absence of a licensed alternative, emergency scenarios (e.g., pandemics) or at the discretion of a treating physician. In such cases, patients should be fully informed regarding their treatment and any potential risks involved. Off-label drug use can be an important tool to provide patients with treatment in cases of unmet medical need. However, the use of an unlicensed medicinal product, when a suitable licensed alternative is available, puts prescribing physicians at risk of liability if safety issues arise. Emerging clinical evidence suggests safety differences exist between ranibizumab and bevacizumab.