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.

ObjectivesUS and UK suicide prevention strategies suggest that bereavement by the suicide of a relative or friend is a risk factor for suicide. However, evidence is lacking that the risk exceeds that of any sudden bereavement, is specific to suicide, or applies to peer suicide. We conducted the first controlled UK-wide study to test the hypothesis that young adults bereaved by suicide have an increased risk of suicidal ideation and suicide attempt compared with young adults bereaved by other sudden deaths.DesignNational cross-sectional study.SettingStaff and students at 37 UK higher educational institutions in 2010.Participants3432 eligible respondents aged 18–40 exposed to sudden bereavement of a friend or relative after the age of 10.ExposuresBereavement by suicide (n=614), by sudden unnatural causes (n=712) and by sudden natural causes (n=2106).Primary outcome measuresIncident suicidal ideation and suicide attempt.FindingsAdults bereaved by suicide had a higher probability of attempting suicide (adjusted OR (AOR)=1.65; 95% CI 1.12 to 2.42; p=0.012) than those bereaved by sudden natural causes. There was no such increased risk in adults bereaved by sudden unnatural causes. There were no group differences in probability of suicidal ideation. The effect of suicide bereavement was similar whether bereaved participants were blood-related to the deceased or not. The significant association between bereavement by suicide and suicide attempt became non-significant when adding perceived stigma (AOR=1.11; 95% CI 0.74 to 1.67; p=0.610). When compared with adults bereaved by sudden unnatural causes, those bereaved by suicide did not show significant differences in suicide attempt (AOR=1.48; 95% CI 0.94 to 2.33; p=0.089).ConclusionsBereavement by suicide is a specific risk factor for suicide attempt among young bereaved adults, whether related to the deceased or not. Suicide risk assessment of young adults should involve screening for a history of suicide in blood relatives, non-blood relatives and friends.

Background:People with Down syndrome (DS) are an ultra-high risk population for Alzheimer’s disease (AD). Understanding the factors associated with age of onset and survival in this population could highlight factors associated with modulation of the amyloid cascade.Objective:This study aimed to establish the typical age at diagnosis and survival associated with AD in DS and the risk factors associated with these.Methods:Data was obtained from the Aging with Down Syndrome and Intellectual Disabilities (ADSID) research database, consisting of data extracted from clinical records of patients seen by Community Intellectual Disability Services (CIDS) in England. Survival times when considering different risk factors were calculated.Results:The mean age of diagnosis was 55.80 years, SD 6.29. Median survival time after diagnosis was 3.78 years, and median age at death was approximately 60 years. Survival time was associated with age of diagnosis, severity of intellectual disability, living status, anti-dementia medication status, and history of epilepsy. Age at diagnosis and treatment status remained predictive of survival time following adjustment.Conclusion:This study provides the best estimate of survival in dementia within the DS population to date, and is in keeping with previous estimates from smaller studies in the DS population. This study provides important estimates and insights into possible predictors of survival and age of diagnosis of AD in adults with DS, which will inform selection of participants for treatment trials in the future.

ObjectiveTo test the hypothesis that perceived stigma scores in young adults bereaved by suicide are significantly higher than in young adults bereaved by other sudden deaths, whether blood-related to the deceased or not.MethodsWe conducted a cross-sectional study of all staff and students aged 18–40 at 37 UK higher educational institutions in 2010, and identified 3432 respondents who had experienced a sudden bereavement of a close contact since reaching the age of 10, either due to sudden natural causes, sudden unnatural causes, or suicide. We used multivariable regression to compare scores on the stigma, shame, responsibility and guilt subscales of the Grief Experience Questionnaire, adjusting for socio-demographic factors and pre-bereavement psychopathology.ResultsPeople bereaved by suicide (n = 614) had higher stigma scores than people bereaved by sudden natural death (n = 2106; adjusted coefficient = 2.52; 95% CI = 2.13–2.90; p = < 0.001) and people bereaved by sudden unnatural death (n = 712; adjusted coefficient = 1.69; 95% CI = 1.25–2.13; p = < 0.001). Shame, responsibility and guilt scores were also significantly higher in people bereaved by suicide, whether compared with bereavement by sudden natural death or sudden unnatural death. Associations were not modified by whether the bereaved was blood-related to the deceased or not.ConclusionsStigma was perceived more acutely by the relatives and friends of those who died by suicide than those bereaved by other causes of sudden natural or sudden unnatural death. Their high levels of perceived stigma, shame, responsibility and guilt require qualitative investigation to identify whether these grief dimensions limit social functioning, help-seeking behaviour and/or support offered.

Master protocols have received a growing interest during the last years. By assigning patients to specific substudies, they aim at targeting and accelerating clinical development. Given their complexity, basket, umbrella, and platform designs have raised challenging regulatory and statistical questions, especially the control of multiplicity in confirmatory trials. In basket trials, regulatory assessment of the benefit/risk in pooled populations and choice of the treatment indication is challenging. We provide here our perspectives on these topics. In master protocols, as long as the statistical hypotheses tested between the different substudies are independent, no supplementary adjustment for multiplicity over the different substudies should be required. Moreover, sharing a control arm within an umbrella or a platform trial investigating different drugs would not require a correction for the type I error rate, whereas the chance of multiple false positive regulatory decisions should be recognized. In basket trials, pooling across substudies requires a rationale supporting the intended indication and should be preplanned. Assessment of the benefit/risk in pooled target populations can be complicated by differences in design or in efficacy/safety signals between the substudies. While trials governed by a master protocol can offer logistic and financial advantages, more experience is needed to gain a deeper insight into this novel framework.