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Background: Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain., Objective: To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes., Design: Pragmatic, multicentre, cluster-randomised, parallel-group trial., Setting: Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK., Participants: Individuals aged 40-69 years with screen-detected diabetes., Interventions: Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol., Main Outcome Measures: The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3; (©) Isis Innovation Ltd 2010; see www.dtu.ox.ac.uk/outcomesmodel (accessed 27 January 2016)]., Results: We included 3055 (RC, n = 1377; IT, n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient., Conclusions: Compared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted., Trial Registration: ClinicalTrials.gov NCT00237549., Funding Details: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

Background: Based on the results from randomized controlled trials (RCTs), new oral anticoagulants (NOACs) seem attractive alternatives to vitamin K antagonists (VKAs) because of their effectiveness, safety, and ease of use. However, the use of NOACs in unselected elderly patients with atrial fibrillation (AF) in primary care is arguable., Objectives: To assess the evidence for the effectiveness and safety of NOACs compared with VKAs in elderly patients with nonvalvular AF in primary care., Methods: Starting from the meta-analysis of Ruff et al. (Lancet 2014;383:955-62), we used the GRADE-approach to make a transparent and explicit judgement of the quality of evidence., Results: The meta-analysis reviewed four non-inferiority RCTs, including 58 634 AF patients with an average age of 70-73 years. Inconsistency of results, indirectness of evidence, and imprecision of risk reductions resulted in downgrading of the quality of evidence available from these studies. The quality of evidence for a decrease in all-cause stroke and systemic embolism (RR: 0.81; 95%CI: 0.73-0.91) for elderly patients using NOACs compared to VKAs in routine primary care was low. The quality of evidence for a lower risk for haemorrhagic stroke (RR: 0.49; 95% CI: 0.38-0.64) and for a lower risk of intracranial bleeding (RR: 0.48; 95% CI: 0.39-0.59) was moderate., Conclusion: There is uncertainty about effectiveness and safety of NOACs in unselected elderly patients with AF in primary care. Therefore, the balance between benefit and harm is still unclear. For this reason, routine use of NOACs is not recommended in elderly patients in primary care.

Purpose: Computerized decision support systems (CDSSs) are often part of a multifaceted intervention to improve diabetes care. We reviewed the effects of CDSSs alone or in combination with other supportive tools in primary care for type 2 diabetes mellitus (T2DM)., Materials and Methods: A systematic literature search was conducted for January 1990-July 2011 in PubMed, Embase, and the Cochrane Database and by consulting reference lists. Randomized controlled trials (RCTs) in general practice were selected if the interventions consisted of a CDSS alone or combined with a reminder system and/or feedback on performance and/or case management. The intervention had to be compared with usual care. Two pairs of reviewers independently abstracted all available data. The data were categorized by process of care and patient outcome measures., Results: Twenty RCTs met inclusion criteria. In 14 studies a CDSS was combined with another intervention. Two studies were left out of the analysis because of low quality. Four studies with a CDSS alone and four studies with a CDSS and reminders showed improvements of the process of care. CDSS with feedback on performance with or without reminders improved the process of care (one study) and patient outcome (two studies). CDSS with case management improved patient outcome (two studies). CDSS with reminders, feedback on performance, and case management improved both patient outcome and the process of care (two studies)., Conclusions: CDSSs used by healthcare providers in primary T2DM care are effective in improving the process of care; adding feedback on performance and/or case management may also improve patient outcome.

Background: Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring., Methods and Design: The study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care) or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c < or = 7.5%, systolic blood pressure < or = 145 mmHg and total cholesterol < or = 5.2 mmol/l. The intervention group (six-monthly monitoring) will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring). The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use intention-to-treat analysis with repeated measures. For outcomes that have only baseline and final measurements, we will use ANCOVA. Depending on the results, a cost-minimisation analysis or an incremental cost-effectiveness analysis will be done., Discussion: This study will provide valuable information on the most efficient control frequency of well-controlled type 2 diabetes patients in primary care.

Aim: Because Dutch health care organisations did want to establish well-defined diabetes shared care groups, we investigated the organisation of insulin therapy in general practice in the Netherlands and assessed factors that were associated with providing insulin therapy in type 2 diabetes (DM2) patients., Methods: Questionnaire to half of the Dutch general practitioners (GPs) (n=3848). We compared GPs who both start insulin treatment and monitor the dosages with those who always refer patients requiring insulin therapy or only monitor insulin dosages., Results: Total response was 42% (n=1621). 67% of the GPs start insulin therapy in patients with DM2, especially male GPs and those above the age of 40, as well as GPs working in a health centre and those working together with a practice nurse. GPs working in urban regions less often start insulin. The most often mentioned barriers for starting and/or monitoring insulin therapy are lack of knowledge of insulin therapy, lack of time and insufficient financial incentives., Conclusion: This nation-wide overview shows that insulin therapy is no longer a secondary care based activity. However, there is still need to enlarge the practice staff and to overcome the perceived skills deficit.