Objective To test whether StandingTall, a home based, e-health balance exercise programme delivered through an app, could provide an effective, self-managed fall prevention programme for community dwelling older people. Design Assessor blinded, randomised controlled trial. Setting Older people living independently in the community in Sydney, Australia. Participants 503 people aged 70 years and older who were independent in activities of daily living, without cognitive impairment, progressive neurological disease, or any other unstable or acute medical condition precluding exercise. Interventions Participants were block randomised to an intervention group (two hours of StandingTall per week and health education; n=254) or a control group (health education; n=249) for two years. Main outcome measures The primary outcomes were the rate of falls (number of falls per person year) and the proportion of people who had a fall over 12 months. Secondary outcomes were the number of people who had a fall and the number who had an injurious fall (resulting in any injury or requiring medical care), adherence, mood, health related quality of life, and activity levels over 24 months; and balance and mobility outcomes over 12 months. Results The fall rates were not statistically different in the two groups after the first 12 months (0.60 falls per year (standard deviation 1.05) in the intervention group; 0.76 (1.25) in the control group; incidence rate ratio 0.84, 95% confidence interval 0.62 to 1.13, P=0.071). Additionally, the proportion of people who fell was not statistically different at 12 months (34.6% in intervention group, 40.2% in control group; relative risk 0.90, 95% confidence interval 0.67 to 1.20, P=0.461). However, the intervention group had a 16% lower rate of falls over 24 months compared with the control group (incidence rate ratio 0.84, 95% confidence interval 0.72 to 0.98, P=0.027). Both groups had a similar proportion of people who fell over 24 months (relative risk 0.87, 95% confidence interval 0.68 to 1.10, P=0.239), but the proportion of people who had an injurious fall over 24 months was 20% lower in the intervention group compared with the control group (relative risk 0.80, 95% confidence interval 0.66 to 0.98, P=0.031). In the intervention group, 68.1% and 52.0% of participants exercised for a median of 114.0 min/week (interquartile range 53.5) after 12 months and 120.4 min/week (38.6) after 24 months, respectively. Groups remained similar in mood and activity levels. The intervention group had a 0.03 (95% confidence interval 0.01 to 0.06) improvement on the EQ-5D-5L (EuroQol five dimension five level) utility score at six months, and an improvement in standing balance of 11 s (95% confidence interval 2 to 19 s) at six months and 10 s (1 to 19 s) at 12 months. No serious training related adverse events occurred. Conclusions The StandingTall balance exercise programme did not significantly affect the primary outcomes of this study. However, the programme significantly reduced the rate of falls and the number of injurious falls over two years, with similar but not statistically significant effects at 12 months. E-health exercise programmes could provide promising scalable fall prevention strategies. Trial registration ACTRN12615000138583

Aims/hypothesisSulfonylureas are widely prescribed glucose-lowering medications for diabetes, but the extent to which they improve glycaemia is poorly documented. This systematic review evaluates how sulfonylurea treatment affects glycaemic control.MethodsMedline, EMBASE, the Cochrane Library and clinical trials registries were searched to identify double-blinded randomised controlled trials of fixed-dose sulfonylurea monotherapy or sulfonylurea added on to other glucose-lowering treatments. The primary outcome assessed was change in HbA1c, and secondary outcomes were adverse events, insulin dose and change in body weight.ResultsThirty-one trials with a median duration of 16 weeks were included in the meta-analysis. Sulfonylurea monotherapy (nine trials) lowered HbA1c by 1.51% (17 mmol/mol) more than placebo (95% CI, 1.25, 1.78). Sulfonylureas added to oral diabetes treatment (four trials) lowered HbA1c by 1.62% (18 mmol/mol; 95% CI 1.0, 2.24) compared with the other treatment, and sulfonylurea added to insulin (17 trials) lowered HbA1c by 0.46% (6 mmol/mol; 95% CI 0.24, 0.69) and lowered insulin dose. Higher sulfonylurea doses did not reduce HbA1c more than lower doses. Sulfonylurea treatment resulted in more hypoglycaemic events (RR 2.41, 95% CI 1.41, 4.10) but did not significantly affect the number of other adverse events. Trial length, sulfonylurea type and duration of diabetes contributed to heterogeneity.Conclusions/interpretationSulfonylurea monotherapy lowered HbA1c level more than previously reported, and we found no evidence that increasing sulfonylurea doses resulted in lower HbA1c. HbA1c is a surrogate endpoint, and we were unable to examine long-term endpoints in these predominately short-term trials, but sulfonylureas appear to be associated with an increased risk of hypoglycaemic events.Electronic supplementary materialThe online version of this article (doi:10.1007/s00125-013-2856-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

BackgroundTrials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to determine if daily fluoxetine for 6 months after stroke improves functional outcome in Australasian and Vietnamese patients. MethodsAFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial conducted in 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10). Eligible patients were adults with a clinical diagnosis of stroke in the previous 2-15 days and a persisting neurological deficit. Patients were randomised via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20mg or matching placebo for 6 months. Patients, investigators and outcome assessors were masked to the treatment allocation. The primary outcome was functional outcome, measured by the modified Rankin scale (mRS), at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Analyses were according to the patient's treatment allocation. The trial is registered with the ACTRN registry, number 12611000774921. FindingsPowered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation 1280 patients were recruited in Australia (n=532), New Zealand (n=42) and Vietnam (n=706) between 11 January 2013 and 30 June 2019; 642 were allocated fluoxetine and 638 placebo. Adherence to trial medication (mean 167 [SD 48] days) was similar between groups. At 6 months, mRS data were available in 624 (97.2%) patients allocated fluoxetine and 632 (99.1%) placebo. The distribution of mRS categories at 6 months was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0.936, 95% CI 0.762-1.150; p=0.53), and consistent among all pre-defined subgroups. Compared to placebo, patients allocated fluoxetine had more falls (20 [3.12%] vs 7 [1.10%]; p=0.02), bone fractures (19 [2•96%] vs 6 [0.94%]; p=0.01) and epileptic seizures (10 [1.56%] vs 2 [0.31%]; p=0.04) at 6 months. InterpretationFluoxetine 20mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and seizures. These results do not support the use of fluoxetine to improve outcome after stroke.

The projected rise in obesity severe obesity will have more substantial cost and healthcare system implications than in previous decades. Having a robust epidemiological model is key to predicting these long-term costs and health outcomes into the future.

Objective: To determine the costs and cost-effectiveness of an early childhood home visiting program delivered to families in socio-economically disadvantaged areas of Sydney, Australia during 2007-2010. Methods: Economic evaluation of a randomized controlled trial, the healthy beginnings (HB) trial, from the perspective of the health funder. Intervention resources were determined from local health district records in 2012 $AUD. Health-care resource utilization was determined through patient-level data linkage. Results: The cost of HB intervention in the clinical trial over 2 years was $1309 per child (2012 $AUD). The incremental cost-effectiveness ratio was $4230 per unit BMI avoided and $631 per 0.1 reduction in BMI z-score. It was estimated that the program could be delivered in practice for $709 per child; with incremental cost-effectiveness ratios of $2697 per unit BMI avoided and $376 per 0.1 reduction in BMI z-score. Conclusions: We present the first economic evaluation of an effective obesity prevention initiative in early childhood. HB is a moderately priced intervention with demonstrated effectiveness that offers similar or better value for money than existing obesity prevention or treatment interventions targeted at older children.

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BackgroundIn Australia, clinical guidelines for primary prevention of cardiovascular disease recommend the use of the Framingham model to help identify those at high risk of developing the disease. However, this model has not been validated for the Indigenous population.DesignCohort study.MethodsFramingham models were applied to the Well Person’s Health Check (WPHC) cohort (followed 1998–2014), which included 1448 Aboriginal and Torres Strait Islanders from remote Indigenous communities in Far North Queensland. Cardiovascular disease risk predicted by the original and recalibrated Framingham models were compared with the observed risk in the WPHC cohort.ResultsThe observed five- and 10-year cardiovascular disease probability of the WPHC cohort was 10.0% (95% confidence interval (CI): 8.5–11.7) and 18.7% (95% CI: 16.7–21.0), respectively. The Framingham models significantly underestimated the cardiovascular disease risk for this cohort by around one-third, with a five-year cardiovascular disease risk estimate of 6.8% (95% CI: 6.4–7.2) and 10-year risk estimates of 12.0% (95% CI: 11.4–12.6) and 14.2% (95% CI: 13.5–14.8). The original Framingham models showed good discrimination ability (C-statistic of 0.67) but a significant lack of calibration (χ2 between 82.56 and 134.67). After recalibration the 2008 Framingham model corrected the underestimation and improved the calibration for five-year risk prediction (χ2 of 18.48).ConclusionsThe original Framingham models significantly underestimate the absolute cardiovascular disease risk for this Australian Indigenous population. The recalibrated 2008 Framingham model shows good performance on predicting five-year cardiovascular disease risk in this population and was used to calculate the first risk chart based on empirical validation using long-term follow-up data from a remote Australian Indigenous population.