Showing papers by "Leicester General Hospital published in 2014"

Evidence for Anti-Inflammatory Effects of Exercise in CKD

Abstract: CKD is associated with a complex state of immune dysfunction characterized by immune depression, predisposing patients to infections, and immune activation, resulting in inflammation that associates with higher risk of cardiovascular disease. Physical exercise may enhance immune function and exert anti-inflammatory effects, but such effects are unclear in CKD. We investigated the separate effects of acute and regular moderate-intensity aerobic exercise on neutrophil degranulation (elastase release), activation of T lymphocytes (CD69 expression) and monocytes (CD86 and HLA-DR expression), and plasma inflammatory markers (IL-6, IL-10, soluble TNF-receptors, and C-reactive protein) in patients with predialysis CKD. A single 30-minute (acute) bout of walking induced a normal pattern of leukocyte mobilization and had no effect on T-lymphocyte and monocyte activation but improved neutrophil responsiveness to a bacterial challenge in the postexercise period. Furthermore, acute exercise induced a systemic anti-inflammatory environment, evidenced by a marked increase in plasma IL-10 levels (peaked at 1 hour postexercise), that was most likely mediated by increased plasma IL-6 levels (peaked immediately postexercise). Six months of regular walking exercise (30 min/d for 5 times/wk) exerted anti-inflammatory effects (reduction in the ratio of plasma IL-6 to IL-10 levels) and a downregulation of T-lymphocyte and monocyte activation, but it had no effect on circulating immune cell numbers or neutrophil degranulation responses. Renal function, proteinuria, and BP were also unaffected. These findings provide compelling evidence that walking exercise is safe with regard to immune and inflammatory responses and has the potential to be an effective anti-inflammatory therapy in predialysis CKD.

‘Treatment of the Sportsman's groin’: British Hernia Society's 2014 position statement based on the Manchester Consensus Conference

Abstract: Introduction The aim was to produce a multidisciplinary consensus to determine the current position on the nomenclature, definition, diagnosis, imaging modalities and management of Sportsman’s groin (SG). Methods Experts in the diagnosis and management of SG were invited to participate in a consensus conference held by the British Hernia Society in Manchester, UK on 11–12 October 2012. Experts included a physiotherapist, a musculoskeletal radiologist and surgeons with a proven track record of expertise in this field. Presentations detailing scientific as well as outcome data from their own experiences were given. Records were made of the presentations with specific areas debated openly. Results The term ‘inguinal disruption’ (ID) was agreed as the preferred nomenclature with the term ‘Sportsman’s hernia’ or ‘groin’ rejected, as no true hernia exists. There was an overwhelming agreement of opinion that there was abnormal tension in the groin, particularly around the inguinal ligament attachment. Other common findings included the possibility of external oblique disruption with consequent small tears noted as well as some oedema of the tissues. A multidisciplinary approach with tailored physiotherapy as the initial treatment was recommended with any surgery involving releasing the tension in the inguinal canal by various techniques and reinforcing it with a mesh or suture repair. A national registry should be developed for all athletes undergoing surgery. Conclusions ID is a common condition where no true hernia exists. It should be managed through a multidisciplinary approach to ensure consistent standards and outcomes are achieved.

Timing of pubertal stages and breast cancer risk: the Breakthrough Generations Study

Abstract: Introduction: Breast development and hormonal changes at puberty might affect breast cancer risk, but epidemiological analyses have focussed largely on age at menarche and not at other pubertal stages. Methods: We investigated associations between the timing of pubertal stages and breast cancer risk using data from a cohort study of 104,931 women (Breakthrough Generations Study, UK, 2003–2013). Pubertal variables were reported retrospectively at baseline. Breast cancer risk was analysed using Cox regression models with breast cancer diagnosis as the outcome of interest, attained age as the underlying time variable, and adjustment for potentially confounding variables. Results: During follow-up (mean = 4.1 years), 1094 breast cancers (including ductal carcinoma in situ) occurred. An increased breast cancer risk was associated with earlier thelarche (age when breast growth begins; HR [95% CI]=1.23 [1.02, 1.48], 1 [referent] and 0.80 [0.69, 0.93] for ≤10, 11–12 and ≥13 years respectively), menarche (initiation of menses; 1.06 [0.93, 1.21], 1 [referent] and 0.78 [0.62, 0.99] for ≤12, 13–14 and ≥15 years), regular periods (0.99 [0.83, 1.18], 1 [referent] and 0.74 [0.59, 0.92] for ≤12, 13–14 and ≥15 years) and age reached adult height (1.25 [1.03, 1.52], 1 [referent] and 1.07 [0.87, 1.32] for ≤14, 15–16 and ≥17 years), and with increased time between thelarche and menarche (0.87 [0.65, 1.15], 1 [referent], 1.14 [0.96, 1.34] and 1.27 [1.04, 1.55] for <0, 0, 1 and ≥ 2y ears), and shorter time between menarche and regular periods (1 [referent], 0.87 [0.73, 1.04] and 0.66 [0.50, 0.88] for 0, 1 and ≥2 years). These associations were generally similar when considered separately for premenopausal and postmenopausal breast cancer. Conclusions: Breast duct development may be a time of heightened susceptibility to risk of carcinogenesis, and greater attention needs to be given to the relation of breast cancer risk to the different stages of puberty.

The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study

Abstract: Objective To investigate the relationship between neighbourhood greenspace and type 2 diabetes. Design Cross-sectional. Setting 3 diabetes screening studies conducted in Leicestershire, UK in 2004–2011. The percentage of greenspace in the participant9s home neighbourhood (3 km radius around home postcode) was obtained from a Land Cover Map. Demographic and biomedical variables were measured at screening. Participants 10 476 individuals (6200 from general population; 4276 from high-risk population) aged 20–75 years (mean 59 years); 47% female; 21% non-white ethnicity. Main outcome measure Screen-detected type 2 diabetes (WHO 2011 criteria). Results Increased neighbourhood greenspace was associated with significantly lower levels of screen-detected type 2 diabetes. The ORs (95% CI) for screen-detected type 2 diabetes were 0.97 (0.80 to 1.17), 0.78 (0.62 to 0.98) and 0.67 (0.49 to 0.93) for increasing quartiles of neighbourhood greenspace compared with the lowest quartile after adjusting for ethnicity, age, sex, area social deprivation score and urban/rural status (Ptrend=0.01). This association remained on further adjustment for body mass index, physical activity, fasting glucose, 2 h glucose and cholesterol (OR (95% CI) for highest vs lowest quartile: 0.53 (0.35 to 0.82); Ptrend=0.01). Conclusions Neighbourhood greenspace was inversely associated with screen-detected type 2 diabetes, highlighting a potential area for targeted screening as well as a possible public health area for diabetes prevention. However, none of the risk factors that we considered appeared to explain this association, and thus further research is required to elicit underlying mechanisms. Trial registration number This study uses data from three studies (NCT00318032, NCT00677937, NCT00941954).

A meta‐analysis of prevalence estimates and moderators of low bone mass in people with schizophrenia

Abstract: Objective: To assess the prevalence and moderators of low bone mass, osteopenia and osteoporosis in schizophrenia patients. Method: Major electronic databases were searched from inception till December 2013 for studies reporting the prevalence of low bone mass (osteopenia + osteoporosis = primary outcome), osteopenia or osteoporosis in schizophrenia patients. Two independent authors completed methodological appraisal and extracted data. A random effects meta-analysis was utilized. Results: Nineteen studies were included (n = 3038 with schizophrenia; 59.2%male; age 24.5–58.9 years). The overall prevalence of low bone mass was 51.7%(95% CI = 43.1–60.3%); 40.0%(CI = 34.7–45.4%) had osteopenia and 13.2%(CI = 7.8–21.6%) had osteoporosis. Compared with controls, schizophrenia patients had significantly increased risk of low bone mass (OR = 1.9, CI = 1.30–2.77, P < 0.001, n = 1872) and osteoporosis (OR = 2.86, CI = 1.27–6.42, P = 0.01, n = 1824), but not osteopenia (OR = 1.33, CI = 0.934–1.90, P = 0.1, n = 1862). In an exploratory regression analysis, older age (P = 0.004) moderated low bone mass, while older age (P < 0.0001) and male sex (P < 0.0001) moderated osteoporosis. The subgroup analyses demonstrated high heterogeneity, but low bone mass was less prevalent in North America (35.5%, CI = 26.6–45.2%) than Europe (53.6%, CI = 38.0–68.5%) and Asia (58.4%, CI = 48.4–67.7%), and in mixed in-/out-patients (32.9%, CI = 49.6–70.1%) vs. in-patients (60.3%, CI = 49.6–70.1%). Conclusion: Reduced bone mass (especially osteoporosis) is significantly more common in people with schizophrenia than controls.

A survey of sitting time among UK employees

Abstract: Results A total of 1141 emplo yees completed the questionnaire, of which 504 completed all aspects of the Domain-Specific Sitting Time Questionnaire for work day sitting. Work time sitting accounted for more than half of the total daily sitting time on a work day (54%). Significantly more time was reported sitting on a work day than time reported sleeping (P < 0.001). Males spent more time sitting at work and using a personal computer at home compared with females. Workers in the telecommunications industry had the highest sitting times. There were significant positive associations between sitting time and body mass index.

Physiological benefits of exercise in pre‐dialysis chronic kidney disease

Abstract: Chronic kidney disease (CKD) is strongly associated with cardiovascular disease and muscle wasting, arising from numerous factors associated with declining renal function and lifestyle factors. Exercise has the ability to impact beneficially on the comorbidities associated with CKD and is accepted as an important intervention in the treatment, prevention and rehabilitation of other chronic diseases, however, the role of exercise in CKD is overlooked, with the provision of rehabilitation programmes well behind those of cardiology and respiratory services. Whilst there is now a large evidence base demonstrating the efficacy and safety of exercise training interventions in patients receiving dialysis, and this is now becoming incorporated into clinical guidelines for treatment of dialysis patients, there is a paucity of research evaluating the effectiveness of exercise in patients with CKD who are not on dialysis. Despite this, existing studies indicate that exercise can improve physical functioning and impact positively on the mediators of co-morbid diseases and upstream factors associated with progression of renal disease. Although preliminary evidence appears positive, more research is required to identify the best modes, frequency and intensities of exercise in order to optimise exercise prescription in pre-dialysis CKD patients. This review summarizes what is known about the main effects of exercise in pre-dialysis CKD patients, discusses the potential of exercise in the rehabilitation and treatment of disease and highlights the need for further research.

Subclinical diastolic dysfunction in young adults with Type 2 diabetes mellitus: a multiparametric contrast-enhanced cardiovascular magnetic resonance pilot study assessing potential mechanisms

Abstract: Aims To assess the cardiac, vascular, anthropometric, and biochemical determinants of subclinical diastolic dysfunction in younger adults with Type 2 diabetes mellitus (T2DM) using multiparametric contrast-enhanced cardiovascular magnetic resonance (CMR) imaging. Methods and results Twenty adults <40 years with T2DM [mean age 31.8(6.6) years, T2DM duration 4.7(4.0) years] and 20 age and sex-matched controls [10 obese non-diabetic controls and 10 lean controls (LC)] were studied. Cardiac volumes and function, circumferential strain and peak early diastolic strain rate (PEDSR), myocardial perfusion reserve, aortic stiffness (distensibility, pulse-wave velocity), focal fibrosis on late gadolinium enhancement, and pre- and post-contrast T1 mapping for contrast agent partition coefficient (subset, n = 26) were determined by CMR. In the T2DM cohort, mean aortic distensibility correlated with PEDSR ( r = 0.564, P = 0.023) and diabetes duration correlated inversely with PEDSR ( r = −0.534, P = 0.015) on univariate analysis. There was a close association between PEDSR and peak systolic strain ( r = −0.580, P = 0.007). Conclusion In young adults with T2DM, diabetes duration and aortic distensibility were associated with diastolic dysfunction. Interventional studies are required to assess whether cardiac dysfunction can be reversed in this phenotype of patients.

Stage, grade and pathological characteristics of bladder cancer in the UK: British Association of Urological Surgeons (BAUS) Urological Tumour Registry

Abstract: Objective To investigate Tumour-Node-Metastasis (TNM) stage and demographics at presentation in a very large, contemporary UK cohort of patients with bladder cancer and compare them with other published series, as little published data exists on the pathological characteristics of bladder cancer at presentation. Patients and Methods The British Association of Urological Surgeons (BAUS) Section of Oncology started a new urological tumour registry in 1998. We performed a data analysis of all bladder cancer cases between 1999 and 2008. Tumour TNM stage, grade and histopathological diagnosis were reviewed along with standard epidemiological data. Results In all, 69 712 bladder cancer registrations were recorded. Complete T, N and M stage and grade was available for 32 240 patients. The male to female ratio of the study population was 3:1 and the overall median (sd, range) age at presentation was 73 (11.6, 6–108) years. Final pathological T staging showed that non-muscle-invasive bladder cancer accounted for 75% of cases with the remaining 25% being muscle-invasive disease. Of these patients, 8% had nodal disease and 4% other metastatic sites at presentation. The tumour grade was G1–2 in 65% and G3 in 35% of cases. Transitional cell carcinoma (TCC) accounted for 92%, squamous cell carcinoma and adenocarcinomas 1.5% each, with 5% other histological variants. Conclusions Non-muscle-invasive TCC accounted for 75% of bladder cancer cases in the UK. The 1973 World Health Organization classification remains in widespread use amongst pathologists in the UK. Obtaining complete and standardised staging and pathology reporting systems in bladder cancer remains a challenge.

Thromboprophylaxis with dabigatran leads to an increased incidence of wound leakage and an increased length of stay after total joint replacement

Abstract: Since the introduction of the National Institute for Health and Care Excellence (NICE) guidelines on thromboprophylaxis and the use of extended thromboprophylaxis with new oral agents, there have been reports of complications arising as a result of their use. We have looked at the incidence of wound complications after the introduction of dabigatran for thromboprophylaxis in our unit. We investigated the rate of venous thromboembolism and wound leakage in 1728 patients undergoing primary joint replacement, both before and after the introduction of dabigatran, and following its subsequent withdrawal from our unit. We found that the use of dabigatran led to a significant increase in post-operative wound leakage (20% with dabigatran, 5% with a multimodal regimen; p < 0.001), which also resulted in an increased duration of hospital stay. The rate of thromboembolism in patients receiving dabigatran was higher (1.3%) than in those receiving the multimodal thromboprophylaxis regimen, including low molecular weight heparin as an inpatient and the extended use of aspirin (0.3%, p = 0.047). We have ceased the use of dabigatran for thromboprophylaxis in these patients. Cite this article: Bone Joint J 2014;96-B:122–6.

A Mediterranean diet improves HbA1c but not fasting blood glucose compared to alternative dietary strategies: a network meta-analysis.

Abstract: BACKGROUND: Overweight or obese individuals with type 2 diabetes are encouraged to lose weight for optimal glucose management, yet many find this difficult. Determining whether alterations in dietary patterns irrespective of weight loss can aid glucose control has not been fully investigated. METHODS: We conducted a systematic review and meta-analysis aiming to determine the effects of a Mediterranean diet compared to other dietary interventions on glycaemic control irrespective of weight loss. Electronic databases were searched for controlled trials that included a Mediterranean diet intervention. The interventions included all major components of the Mediterranean diet and were carried out in free-living individuals at high risk or diagnosed with type 2 diabetes. Network meta-analysis compared all interventions with one another at the same time as maintaining randomisation. Analyses were conducted within a Bayesian framework. RESULTS: Eight studies met the inclusion criteria, seven examined fasting blood glucose (n = 972), six examined fasting insulin (n = 1330) and three examined HbA1c (n = 487). None of the interventions were significantly better than the others in lowering glucose parameters. The Mediterranean diet reduced HbA1c significantly compared to usual care but not compared to the Palaeolithic diet. CONCLUSIONS: The effect of alterations in dietary practice irrespective of weight loss on glycaemic control cannot be concluded from the present review. The need for further research in this area is apparent because no firm conclusions about relative effectiveness of interventions could be drawn as a result of the paucity of the evidence.

Patient knowledge in inflammatory bowel disease: the Crohn's and Colitis Knowledge Score.

Abstract: In the UK, key professional organizations have joined to provide inflammatory bowel disease (IBD) standards to be delivered by the NHS, highlighting the importance of patient education and support. The Crohn's and Colitis Knowledge Score (CCKNOW) is a validated multiple-choice questionnaire on the subject of IBD that is able to objectively quantify the level of patient knowledge. The aim of this study was to summarize the findings of the CCKNOW, in particular, the current level of patient knowledge and the implications clinically. Literature search was conducted using Medline, Google Scholar and the Cochrane Library, compiling results of studies using the CCKNOW to date. In the UK, a median score of 10 was achieved by participants with IBD in Leicestershire in 1999. Recent surveys in the Northwest and Pennine Trust achieved median scores of 9 and 7, respectively. Knowledge deficits regarding fertility and pregnancy were found, as seen in 1999. Studies in Canada and Iran achieved median scores of 13 and 4, respectively. Sri Lanka achieved a mean score of 6.86 (range 1-16). Higher CCKNOW scores were associated with the use of adaptive coping strategies. A significant positive link was found between patient knowledge and anxiety levels. There was no significant difference in CCKNOW scores between patients with the complication of colorectal cancer versus control populations. In the UK, patient knowledge of IBD may be no better than in 1999. The subjects of fertility and implications for pregnancy are particular areas of deficit. Further knowledge shortfalls may exist in the developing countries. Evidence suggests that improving knowledge may empower patients to use more adaptive coping strategies but may not be effective in reducing anxiety or the risk complications such as colorectal cancer.

Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial.

Abstract: Aims The efficacy and safety of insulin degludec (IDeg) was compared with insulin detemir (IDet), both administered once daily (OD) as basal treatment in participants with type 1 diabetes mellitus (T1DM). The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin (HbA1c) reduction after 26 weeks. Methods This multinational, 26-week, controlled, open-label, parallel-group trial randomized adults with T1DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart (IAsp). Participants with T1DM treated with any basal–bolus insulin regimen for ≥12 months prior to the trial, a mean HbA1c ≤ 10.0% (85.8 mmol/mol) and body mass index (BMI) ≤35.0 kg/m2 at screening participated in the trial (IDeg: N = 302; IDet: N = 153). Results After 26 weeks, HbA1c decreased 0.73% (8.0 mmol/mol) (IDeg) and 0.65% (7.1 mmol/mol) (IDet) [estimated treatment difference (ETD) IDeg–IDet: −0.09% (−0.23; 0.05)95%CI (−10.0 mmol/mol [−2.6; 0.6]95% CI); confirming non-inferiority]. Mean fasting plasma glucose improved in both groups, and was lower with IDeg than IDet [ETD IDeg–IDet: −1.66 mmol/l (−2.37; −0.95)95% CI, p < 0.0001]. The rate of confirmed hypoglycaemia was similar with IDeg and IDet [45.83 vs. 45.69 episodes per patient-year of exposure (PYE); estimated rate ratio (RR) IDeg/IDet: 0.98 (0.80; 1.20)95% CI, p = 0.86]. The rate of nocturnal confirmed hypoglycaemia was lower with IDeg than IDet [4.14 vs. 5.93 episodes per PYE; RR IDeg/IDet: 0.66 (0.49; 0.88)95% CI, p = 0.0049]. Adverse event profiles were similar between groups. Conclusion IDeg administered OD in basal–bolus therapy effectively improved long-term glycaemic control in participants with T1DM with a lower risk of nocturnal confirmed hypoglycaemia than IDet.

Type 2 diabetes mellitus and obesity in young adults: the extreme phenotype with early cardiovascular dysfunction.

Abstract: Aim A pilot study to phenotype young adults (< 40 years) with Type 2 diabetes mellitus. Methods Twenty people with Type 2 diabetes (aged 18–40 years), 10 lean and 10 obese control subjects underwent detailed assessment, including tagged cardiac magnetic resonance imaging, inflammatory proteins, lipids, vitamin D and maximal oxygen uptake. Outcomes were compared between the group with Type 2 diabetes and the control group. Results Mean (standard deviation) age, Type 2 diabetes duration and BMI in the group with Type 2 diabetes were 31.8 (6.6) years, 4.7 (4.0) years and 33.9 (5.8) kg/m2 respectively. Compared with lean control subjects, those with Type 2 diabetes had more deleterious profiles of hyperlipidaemia, vitamin D deficiency, inflammation and maximal oxygen uptake relative to body mass. However, there was no difference between the group with Type 2 diabetes and the obese control group. The group with Type 2 diabetes had a higher left ventricular mass and a trend towards concentric remodelling compared with the lean control group (P = 0.002, P = 0.052) but not the obese control group (P > 0.05). Peak early diastolic strain rate was reduced in the group with Type 2 diabetes [1.51 (0.24)/s] compared with the lean control [1.97 (0.34)/s, P = 0.001] and obese control [1.78 (0.39)/s, P = 0.042] group. Conclusions Young adults with Type 2 diabetes and those with obesity have similar adverse cardiovascular risk profiles, higher left ventricular mass and a trend towards left ventricular concentric remodelling. In addition, those with Type 2 diabetes demonstrate diastolic dysfunction, a known risk marker for future heart failure and mortality.

Kaleidoscope model of diabetes care: time for a rethink?

Abstract: National Audit Data highlight persistent sub-optimum control among increasing numbers of people living with diabetes, with severe consequences for the individual and the NHS. The aim of the present review was to introduce a new cohesive, holistic model of care, tailored to individual needs to support optimum diabetes outcomes. This model of diabetes is necessary in order to understand the driving forces behind behaviour and their impact on diabetes management. Feelings (an emotional state or reaction) and beliefs (an acceptance that something is true or real) are fundamental behavioural drivers and influence diabetes self-management choices. Individually, these explain some of the complexities of behaviour and, collectively, they impact on personal motivation (rationale/desire to act) to achieve a specific outcome. Inevitably, they independently affect diabetes self-management and the environment in which individuals live. A model of care that proposes the encompassing of environment, intrinsic thought and therapy regimens to provide tailored, personalized healthcare should support enhanced diabetes self-management and outcomes from diagnosis. The Kaleidoscope model of care could be deliverable in routine care, incorporating each of the influences on diabetes self-management, and should benefit both individuals with diabetes and healthcare professionals.

Prevalence and characteristics in coding, classification and diagnosis of diabetes in primary care

Abstract: Introduction Approximately 366 million people worldwide live with diabetes and this figure is expected to rise. Among the correct diagnosis, there will be errors in the diagnosis, classification and coding, resulting in adverse health and financial implications. Aim To determine the prevalence and characteristics of diagnostic errors in people with diabetes managed in primary care settings. Methods We conducted a cross-sectional study in nine general practices in Leicester, UK, from May to August 2011, using a validated electronic toolkit. Searches identified cases with potential errors which were manually checked for accuracy. Results There were 54 088 patients and 2434 (4.5%) diagnosed with diabetes. Out of 316 people identified with potential errors with the toolkit, 180 (57%) had confirmed errors after manually reviewing the records, resulting in an error prevalence of 7.4%. Correctly coded people on registers had significantly greater glycated haemoglobin (HbA1c) reductions. There were no significant differences between patients with and without errors in their HbA1C, body mass index, age and size of practice. There was also no significant association of the errors with pay-for-performance initiatives; however, those patients not on disease register had worse glycaemic control. Conclusions A high prevalence of diabetic diagnostic errors was confirmed using medication, biochemical and demographic data. Larger studies are needed to more accurately assess the scale of this problem. Automation of these processes might be possible, which would allow searches to be even more user friendly.

Increasing capacity to deliver diabetes self-management education: results of the DESMOND lay educator non-randomized controlled equivalence trial.

Abstract: Aim To develop and test a format of delivery of diabetes self-management education by paired professional and lay educators. Methods We conducted an equivalence trial with non-randomized participant allocation to a Diabetes Education and Self Management for Ongoing and Newly Diagnosed Type 2 diabetes (DESMOND) course, delivered in the standard format by two trained healthcare professional educators (to the control group) or by one trained lay educator and one professional educator (to the intervention group). A total of 260 people with Type 2 diabetes diagnosed within the previous 12 months were referred for self-management education as part of routine care and attended either a control or intervention format DESMOND course. The primary outcome measure was change in illness coherence score (derived from the Diabetes Illness Perception Questionnaire-Revised) between baseline and 4 months after attending education sessions. Secondary outcome measures included change in HbA1c level. The trial was conducted in four primary care organizations across England and Scotland. Results The 95% CI for the between-group difference in positive change in coherence scores was within the pre-set limits of equivalence (difference = 0.22, 95% CI 1.07 to 1.52). Equivalent changes related to secondary outcome measures were also observed, including equivalent reductions in HbA1c levels. Conclusion Diabetes education delivered jointly by a trained lay person and a healthcare professional educator with the same educator role can provide equivalent patient benefits. This could provide a method that increases capacity, maintains quality and is cost-effective, while increasing access to self-management education.

Aspirin May Prevent Cholangiocarcinoma: A Case–Control Study from the United Kingdom

Abstract: The proliferation of cholangiocarcinoma cells is suppressed in cell culture by nonsteroidal antiinflammatory drugs (NSAIDs) through the inhibition of cyclo-oxygenase-2 enzyme and also by statins which decrease the production of mediators of the cell cycle. To investigate whether there is an inverse association between NSAIDs, including aspirin, and the development of cholangiocarcinoma and, for the first time in a Western population, between statin use and the development of cholangiocarcinoma. This epidemiological study had a case–control design in which cases of cholangiocarcinoma diagnosed in Norwich between 2004 and 2010 and in Leicester in 2007 were identified from clinical databases. Controls were patients with basal cell carcinomas treated in the respective dermatology departments. The case notes of all subjects were reviewed to confirm diagnoses and obtain information on medication use. The data were analyzed using unconditional logistic regression to calculate odds ratios (OR) with 95 % confidence intervals (CI). In total, 81 cases of cholangiocarcinoma and 275 controls were identified. For all cases there was radiological evidence of cancer and 86 % of the cases involved the extrahepatic biliary system. Aspirin use was inversely associated with the development of cholangiocarcinoma (OR 0.45, 95 % CI 0.22–0.92), but there were no significant associations between the development of cholangiocarcinoma and NSAIDs (OR 0.39; 95 % CI 0.11–1.42) or statins (OR 0.58; 95 % CI 0.28–1.19). The epidemiological data from this study support the biological evidence for aspirin having a protective effect against the development of cholangiocarcinoma. Aspirin use should be measured in future etiological studies and assessed as a chemoprevention agent in those at high risk of developing this type of cancer.

Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial

Abstract: Background: In the UK around 22% of men and 24% of women are obese, and there are varying but worrying levels in other European countries. Obesity is a chronic condition that carries an important health risk. National guidelines, for use in England, on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence (NICE, 2006). NICE recommendations for primary care teams are: determine the degree of overweight and obesity; assess lifestyle, comorbidities and willingness to change; offer multicomponent management of overweight and obesity; referral to external services when appropriate. This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams. Methods/Design: The study is a cluster randomised controlled trial. Primary care teams will be recruited from the East Midlands of England, and randomised into two study arms: 1) the study group, in which primary care teams are offered a set of tailored interventions to help implement the NICE guidelines for overweight and obesity; or 2) the control group in which primary care teams continue to practice usual care. The primary outcome is the proportion of overweight or obese patients for whom the primary care team adheres to the NICE guidelines. Secondary outcomes include the proportion of patients with a record of lifestyle assessment, referral to external weight loss services, the proportion of obese patients who lose weight during the intervention period, and the mean weight change over the same period.

Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial.

Abstract: Aims Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory In the absence of long-term data on hard outcomes, we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis, and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years Methods In a pragmatic, cluster-randomized, parallel-group trial in Denmark, the Netherlands and the UK, 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive (1) routine care of diabetes according to national guidelines (1379 patients) or (2) intensive multifactorial target-driven management (1678 patients) Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine (version 3β) Results Among 2101 individuals with complete data at follow up (734%), 10-year modelled cardiovascular disease risk was 273% (sd 139) at baseline and 213% (sd 138) at 5-year follow-up (intensive treatment group difference –69, sd 90; routine care group difference –50, sd 122) Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years, after adjustment for baseline cardiovascular disease risk and clustering (–20; 95% CI –31 to –09) Conclusions Despite increasing age and diabetes duration, there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis Compared with routine care, 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory, where the rate of cardiovascular disease risk progression may be slowed

Diabetes self-management education: acceptability of using trained lay educators

Abstract: Background The use of lay people to deliver education programmes for people with chronic conditions is a potential method of addressing healthcare staff capacity and increasing the cost efficiency of delivering education. This qualitative substudy is embedded within an equivalence trial (2008–2011 including development stage). Objectives In the qualitative substudy, we aimed to elicit the views of key stakeholders (patients, educators) about using lay people to deliver education to people recently diagnosed with type 2 diabetes, alongside a healthcare professional educator with an equal role. In this way, we sought to explore perceptions about acceptability and also contribute to understanding the reasons underlying positive or negative quantitative findings from main trial. Methods We conducted 27 telephone interviews with a purposive sample of patients, lay educators and healthcare professional educators involved in the main trial. Thematic analysis of transcribed data was underpinned by the constant comparative approach and structured using Framework methodology. Results Overall, the data suggested that the use of lay educators was acceptable to educators and patients. Perceived difference in knowledge levels between lay and healthcare professional educators did not appear to have an impact on perceived acceptability or the effectiveness of the education received. Additional themes explored were related to peer status of educators and feasibility. Some concerns were raised about lay educators with diabetes, transferring personal issues and about the impact of healthcare professional time taken up by mentoring and supporting lay educators. Conclusions Positive perceptions about the use of lay educators support the positive quantitative findings from the main trial. Acceptability is an important consideration in relation to implementation of the model of delivery studied. Concerns raised within the interviews should be considered in the design of training for lay educators. Trial registration number ISRCTN 99350009.