Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial

Background Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. Methods AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2–15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Findings Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76–1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months. Interpretation Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke

A systematic scoping review of the habitual dietary costs in low socioeconomic groups compared to high socioeconomic groups in Australia

Low socioeconomic groups (SEGs) in Australia are less likely to consume diets consistent with the Australian Dietary Guidelines (ADGs) and suffer poorer health than the broader population. The unaffordability, or perceived high cost, of healthy diets may be a factor. Detailed data on the cost of habitually consumed diets is required in order to inform strategies to alleviate socioeconomic impacts on dietary intake. This systematic scoping review aims to identify the cost of the habitual dietary intake of low SEGs in Australia, in terms of the whole diet and its composite foods, in comparison to the cost in higher SEGs.A systematic search of peer-reviewed literature since 2000 and key government and non-government organisation (NGO) websites was undertaken. Data were extracted, synthesised and analysed in relation to study populations, dietary cost assessment measures, socioeconomic measures, and dietary cost and affordability.The review identified four studies meeting inclusion criteria. Results confirmed that overall, low SEGs spend a lower amount, yet a higher proportion of household income, on food and drinks than higher SEGs. Quantitative comparison of the dietary costs between included studies was not possible due to difference in populations and study metrics. Costs of the habitual diet in these studies were not reported for ADG food groups, so did not allow for assessment of the healthfulness of the dietary intake or comparison with costs of recommended diets at food group level.Existing research does not provide sufficiently granular data of the costs of habitual diets of low SEGs in comparison to higher SEGs or data in a form that can inform strategies and interventions to improve dietary intake and diet-related health of low SEGs in Australia. Future empirical health research requires more granular measures of habitual spending on ADG food groups across SEGs

Dietary Intake, Cost, and Affordability by Socioeconomic Group in Australia

Few Australians consume diets consistent with the Australian Dietary Guidelines. A major problem is high intake of discretionary food and drinks (those not needed for health and high in saturated fat, added sugar, salt and/or alcohol). Low socioeconomic groups (SEGs) suffer particularly poor diet-related health. Surprisingly, detailed quantitative dietary data across SEGs was lacking. Analysis of the most recent national nutrition survey data produced habitual intakes of a reference household (two adults and two children) in SEG quintiles of household income. Cost and affordability of habitual and recommended diets for the reference household were determined using methods based on the Healthy Diets Australian Standardised Affordability and Pricing protocol. Low SEGs reported significantly lower intakes of healthy food and drinks yet similarly high intakes of discretionary choices to high SEGs (435 serves/fortnight). Total habitual diets of low SEGs cost significantly less than those of high SEGs (AU$751/fortnight to AU$853/fortnight). Results confirmed low SEGs cannot afford a healthy diet. Lower intakes of healthy choices in low SEGs may help explain their higher rates of diet-related disease compared to higher SEGs. The findings can inform potential policy actions to improve affordability of healthy foods and help drive healthier diets for all Australians

Measuring Men’s Gender Norms and Gender Role Conflict/Stress in a High HIV-Prevalence South African Setting

Gender norms and gender role conflict/stress may influence HIV risk behaviors among men; however scales measuring these constructs need further development and evaluation in African settings. We conducted exploratory and confirmatory factor analyses to evaluate the Gender Equitable Men's Scale (GEMS) and the Gender Role Conflict/Stress (GRC/S) scale among 581 men in rural northeast South Africa. The final 17-item GEMS was unidimensional, with adequate model fit and reliability (alpha&nbsp;=&nbsp;0.79). Factor loadings were low (0.2-0.3) for items related to violence and sexual relationships. The final 24-item GRC/S scale was multidimensional with four factors: Success, power, competition; Subordination to women; Restrictive emotionality; and Sexual prowess. The scale had adequate model fit and good reliability (alpha&nbsp;=&nbsp;0.83). While GEMS is a good measure of inequitable gender norms, new or revised scale items may need to be explored in the South African context. Adding the GRC/S scale to capture men's strain related to gender roles could provide important insights into men's risk behaviors