General Practice and Primary Care - Research Publications

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    Effectiveness of a Pragmatic Education Program Designed to Promote Walking Activity in Individuals With Impaired Glucose Tolerance A randomized controlled trial
    Yates, T ; Davies, M ; Gorely, T ; Bull, F ; Khunti, K (AMER DIABETES ASSOC, 2009-08)
    OBJECTIVE To investigate whether a pragmatic structured education program with and without pedometer use is effective for promoting physical activity and improving glucose tolerance in those with impaired glucose tolerance (IGT). RESEARCH DESIGN AND METHODS Overweight and obese individuals with IGT were recruited from ongoing screening studies at the University Hospitals of Leicester, U.K. Participants were randomly assigned to one of three groups. Group 1 received a 3-h group-based structured education program designed to promote walking activity using personalized steps-per-day goals and pedometers. Group 2 received a 3-h group-based structured education program designed to promote walking activity using generic time-based goals. Group 3 received a brief information leaflet (control condition). Outcomes included an oral glucose tolerance test, standard anthropometric measures, ambulatory activity, and psychological variables. Follow-up was conducted at 3, 6, and 12 months. RESULTS A total of 87 individuals (66% male, mean age 65 years) were included in this study. At 12 months, significant decreases in 2-h postchallenge glucose and fasting glucose of -1.31 mmol/l (95% CI -2.20 to -0.43) and -0.32 mmol/l (-0.59 to -0.03), respectively, were seen in the pedometer group compared with the control group. No significant improvements in glucose control were seen in those given the standard education program. CONCLUSIONS This study suggests that a pragmatic structured education program that incorporates pedometer use is effective for improving glucose tolerance in those with IGT. This result is likely to have important implications for future primary care-based diabetes prevention initiatives.
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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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    Stepwise screening for diabetes identifies people with high but modifiable coronary heart disease risk. The ADDITION study
    Sandbaek, A ; Griffin, SJ ; Rutten, G ; Davies, M ; Stolk, R ; Khunti, K ; Borch-Johnsen, K ; Wareham, NJ ; Lauritzen, T (SPRINGER, 2008-07)
    AIMS/HYPOTHESIS: The Anglo-Danish-Dutch study of intensive treatment in people with screen-detected diabetes in primary care (ADDITION) is a pragmatic randomised controlled trial of the effectiveness of intensified multi-factorial treatment on 5 year cardiovascular morbidity and mortality rates in people with screen-detected type 2 diabetes in the Netherlands, UK and Denmark. This paper describes the baseline characteristics of the study population, their estimated risk of coronary heart disease and the extent to which that risk is potentially modifiable. METHODS: Stepwise screening strategies were performed using risk questionnaires and routine general practice data plus random blood glucose, HbA(1c) and fasting blood glucose measurement. Diabetes was diagnosed using the 1999 World Health Organization criteria and estimated 10 year coronary heart disease risk was calculated using the UK Prospective Diabetes Study risk engine. RESULTS: Between April 2001 and December 2006, 3,057 people with screen-detected diabetes were recruited to the study (mean age 59.7 years, 58% men) after a stepwise screening programme involving 76,308 people screened in 334 general practices in three countries. Their median estimated 10 year risk of coronary heart disease was 11% in women (interquartile range 7-16%) and 21% (15-30%) in men. There were differences in the distribution of risk factors by country, linked to differences in approaches to screening and the extent to which risk factors had already been detected and treated. The mean HbA(1c) at recruitment was 7.0% (SD 1.6%). Of the people recruited, 73% had a blood pressure > or =140/90 and of these 58% were not on antihypertensive medication. Cholesterol levels were above 5.0 mmol/l in 70% of participants, 91% of whom were not being treated with lipid-lowering drugs. CONCLUSIONS/INTERPRETATION: People with type 2 diabetes detected by screening and included in the ADDITION study have a raised and potentially modifiable risk of CHD. ClinicalTrials.gov ID no.: NCT 00237549.
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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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    The National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for Leicestershire, Northamptonshire and Rutland (LNR): a programme protocol
    Baker, R ; Robertson, N ; Rogers, S ; Davies, M ; Brunskill, N ; Khunti, K ; Steiner, M ; Williams, M ; Sinfield, P (BMC, 2009-11-12)
    BACKGROUND: In October 2008, the National Institute for Health Research launched nine new research projects to develop and investigate methods of translating research evidence into practice. Given the title Collaborations for Leadership in Applied Health Research and Care (CLAHRC), all involve collaboration between one or more universities and the local health service, but they are adopting different approaches to achieve translation. METHODS: The translation and implementation programme of this CLAHRC has been built around a pragmatic framework for undertaking research to address live concerns in the delivery of care, in partnership with the managers, practitioners, and patients of the provider organisations of the CLAHRC. Focused on long-term conditions, the constituent research themes are prevention, early detection, self-management, rehabilitation, and implementation. Individual studies have various designs, and include both randomised trials of new ways to deliver care and qualitative studies of, for example, means of identifying barriers to research translation. A mix of methods will be used to evaluate the CLAHRC as a whole, including use of public health indicators, social research methods, and health economics. DISCUSSION: This paper describes one of the nine collaborations, that of Leicestershire, Northamptonshire, and Rutland. Drawing a distinction between translation as an organising principle for healthcare providers and implementation as a discrete activity, this collaboration is built on a substantial programme of applied research intended to create both research generation and research use capacity in provider organisations. The collaboration in Leicestershire, Northamptonshire, and Rutland has potential to provide evidence on how partnerships between practitioners, patients, and researchers can improve the transfer of evidence into practice.
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    The Prevalence of Depression in White-European and South-Asian People with Impaired Glucose Regulation and Screen-Detected Type 2 Diabetes Mellitus
    Aujla, N ; Abrams, KR ; Davies, MJ ; Taub, N ; Skinner, TC ; Khunti, K ; Domschke, K (PUBLIC LIBRARY SCIENCE, 2009-11-09)
    BACKGROUND: There is a clear relationship between depression and diabetes. However, the directionality of the relationship remains unclear and very little research has considered a multi-ethnic population. The aim of this study was to determine the prevalence of depression in a White-European (WE) and South-Asian (SA) population attending a community diabetes screening programme, and to explore the association of depression with screen-detected Type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR). METHODOLOGY/PRINCIPAL FINDINGS: Participants were recruited from general practices in Leicestershire (United Kingdom) between August 2004 and December 2007. 4682 WE (40-75 years) and 1327 SA participants (25-75 years) underwent an Oral Glucose Tolerance Test, detailed history, anthropometric measurements and completed the World Health Organisation-Five (WHO-5) Wellbeing Index. Depression was defined by a WHO-5 wellbeing score < or =13. Unadjusted prevalence of depression for people in the total sample with T2DM and IGR was 21.3% (21.6% in WE, 20.6% in SA, p = 0.75) and 26.0% (25.3% in WE, 28.9% in SA, p = 0.65) respectively. For people with normal glucose tolerance, the prevalence was 25.1% (24.9% in WE, 26.4% in SA, p = 0.86). Age-adjusted prevalences were higher for females than males. Odds ratios adjusted for age, gender, and ethnicity, showed no significant increase in prevalent depression for people with T2DM (OR = 0.95, 95%CI 0.62 to 1.45) or IGR (OR = 1.17, 95%CI 0.96 to 1.42). CONCLUSIONS: Prior to the knowledge of diagnosis, depression was not significantly more prevalent in people with screen detected T2DM or IGR. Differences in prevalent depression between WE and SA people were also not identified. In this multi-ethnic population, female gender was significantly associated with depression.
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    Ethnic disparities in diabetes management and pay-for-performance in the UK: The Wandsworth prospective diabetes study
    Millett, C ; Gray, J ; Saxena, S ; Netuveli, G ; Khunti, K ; Majeed, A ; Home, P (PUBLIC LIBRARY SCIENCE, 2007-06)
    BACKGROUND: Pay-for-performance rewards health-care providers by paying them more if they succeed in meeting performance targets. A new contract for general practitioners in the United Kingdom represents the most radical shift towards pay-for-performance seen in any health-care system. The contract provides an important opportunity to address disparities in chronic disease management between ethnic and socioeconomic groups. We examined disparities in management of people with diabetes and intermediate clinical outcomes within a multiethnic population in primary care before and after the introduction of the new contract in April 2004. METHODS AND FINDINGS: We conducted a population-based longitudinal survey, using electronic general practice records, in an ethnically diverse part of southwest London. Outcome measures were prescribing levels and achievement of national treatment targets (HbA1c < or = 7.0%; blood pressure [BP] < 140/80 mm Hg; total cholesterol < or = 5 mmol/l or 193 mg/dl). The proportion of patients reaching treatment targets for HbA1c, BP, and total cholesterol increased significantly after the implementation of the new contract. The extents of these increases were broadly uniform across ethnic groups, with the exception of the black Caribbean patient group, which had a significantly lower improvement in HbA1c (adjusted odds ratio [AOR] 0.75, 95% confidence interval [CI] 0.57-0.97) and BP control (AOR 0.65, 95% CI 0.53-0.81) relative to the white British patient group. Variations in prescribing and achievement of treatment targets between ethnic groups present in 2003 were not attenuated in 2005. CONCLUSIONS: Pay-for-performance incentives have not addressed disparities in the management and control of diabetes between ethnic groups. Quality improvement initiatives must place greater emphasis on minority communities to avoid continued disparities in mortality from cardiovascular disease and the other major complications of diabetes.
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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].