Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes. Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level. Setting 207 general practices in 13 primary care sites in the United Kingdom. Participants 824 adults (55% men, mean age 59.5 years). Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. Main outcome measures Haemoglobin A 1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months. Main results Haemoglobin A 1c levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval −0.10% to 0.20%). The intervention group showed a greater weight loss: −2.98 kg (95% confidence interval −3.54 to −2.41) compared with 1.86 kg (−2.44 to −1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was −0.50 (95% confidence interval −0.96 to −0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=0.12; P=0.008). Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A 1c levels up to 12 months after diagnosis. Trial registration Current Controlled Trials ISRCTN17844016.
SummaryBackgroundHigh-volume prescribing of antibiotics in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We assessed whether internet-based training methods could alter prescribing practices in multiple health-care systems.MethodsAfter a baseline audit in October to December, 2010, primary-care practices in six European countries were cluster randomised to usual care, training in the use of a C-reactive protein (CRP) test at point of care, in enhanced communication skills, or in both CRP and enhanced communication. Patients were recruited from February to May, 2011. This trial is registered, number ISRCTN99871214.ResultsThe baseline audit, done in 259 practices, provided data for 6771 patients with lower-respiratory-tract infections (3742 [55·3%]) and upper-respiratory-tract infections (1416 [20·9%]), of whom 5355 (79·1%) were prescribed antibiotics. After randomisation, 246 practices were included and 4264 patients were recruited. The antibiotic prescribing rate was lower with CRP training than without (33% vs 48%, adjusted risk ratio 0·54, 95% CI 0·42–0·69) and with enhanced-communication training than without (36% vs 45%, 0·69, 0·54–0·87). The combined intervention was associated with the greatest reduction in prescribing rate (CRP risk ratio 0·53, 95% CI 0·36–0·74, p<0·0001; enhanced communication 0·68, 0·50–0·89, p=0·003; combined 0·38, 0·25–0·55, p<0·0001).InterpretationInternet training achieved important reductions in antibiotic prescribing for respiratory-tract infections across language and cultural boundaries.FundingEuropean Commission Framework Programme 6, National Institute for Health Research, Research Foundation Flanders.
Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years.Design Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level.Setting 207 general practices in 13 primary care sites in the United Kingdom.Participants 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants.Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. Main outcome measuresThe primary outcome was glycated haemoglobin (HbA 1c ) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years. ResultsHbA 1c levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference −0.02, 95% confidence interval −0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years.Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. Trial registration Current Controlled Trials ISRCTN17844016. IntroductionType 2 diabetes mellitus is a serious, progressive condition presenting with chronic hyperglycaemia, and its prevalence is increasing globally. In the short term, type 2 diabetes may lead to symptoms and debility and in the long term to serious complications, including blindness, renal failure, and amputation.1 Furthermore, three quarters of people with type 2 Research RESEARCH diabetes will die from cardiovascular disease. 2 Traditionally, treatment for the condition has centred on drug interventions to stabilise hyperglycaemia and to manage cardiovascular risk factors, including blood pressure and lipids, to prevent associated symptoms and reduce the risk of vascular complications over time.3 Long term follow-up data from the United Kingdom Prospective Diabetes Study has shown that despite early successes, metabolic control progressively worsens with time, warranting exploration of alternative approaches for long term management of type 2 diabetes. 4 Anyone with diabetes, including type 2 diabetes, has to make multiple daily choices about the management of their condition, such as appropriate dietary intake, physical activity, and adherence to drugs, often with m...
Objectives To assess the long term clinical and cost effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) intervention compared with usual care in people with newly diagnosed type 2 diabetes. Design We undertook a cost-utility analysis that used data from a 12 month, multicentre, cluster randomised controlled trial and, using the Sheffield type 2 diabetes model, modelled long term outcomes in terms of use of therapies, incidence of complications, mortality, and associated effect on costs and health related quality of life. A further cost-utility analysis was also conducted using current "real world" costs of delivering the intervention estimated for a hypothetical primary care trust. Setting Primary care trusts in the United Kingdom. Participants Patients with newly diagnosed type 2 diabetes. Intervention A six hour structured group education programme delivered in the community by two professional healthcare educators. Main outcome measures Incremental costs and quality adjusted life years (QALYs) gained. Results On the basis of the data in the trial, the estimated mean incremental lifetime cost per person receiving the DESMOND intervention is £209 (95% confidence interval −£704 to £1137; €251, −€844 to €1363; $326, −$1098 to $1773), the incremental gain in QALYs per person is 0.0392 (−0.0813 to 0.1786), and the mean incremental cost per QALY is £5387. Using "real world" intervention costs, the lifetime incremental cost of the DESMOND intervention is £82 (−£831 to £1010) and the mean incremental cost per QALY gained is £2092. A probabilistic sensitivity analysis indicated that the likelihood that the DESMOND programme is cost effective at a threshold of £20 000 per QALY is 66% using trial based intervention costs and 70% using "real world" costs. Results from a one way sensitivity analysis suggest that the DESMOND intervention is cost effective even under more modest assumptions that include the effects of the intervention being lost after one year. Conclusion Our results suggest that the DESMOND intervention is likely to be cost effective compared with usual care, especially with respect to the real world cost of the intervention to primary care trusts, with reductions in weight and smoking being the main benefits delivered.
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