Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: Qualitative study

Background: The purpose of this study was to explore women's views of the design of a large pragmatic cost-effectiveness randomised controlled trial of the policy of offering a health professional-delivered intervention to promote early presentation with breast symptoms in older women and thereby improve survival, with a view to informing protocol development. The trial will recruit over 100,000 healthy women aged 67+, and outcome data will be collected on those who develop breast cancer. The scale of the trial and the need for long-term follow-up presented a number of design challenges in relation to obtaining consent, ascertaining and contacting participants who developed breast cancer, and collecting outcome data. Methods: Qualitative study involving 69 women participating in 7 focus groups and 17 in-depth interviews. 15 women had a previous diagnosis of breast cancer and 54 did not. Results: The women held strong views and had a good understanding of the rationale of the design of clinical trials. The women recognised that in a very large trial with long-term follow-up it was necessary to incorporate design features to make the trial feasible and efficient. Most strikingly, they supported the idea of opt-out consent and identifying women with breast cancer using routine datasets. Conclusions: This model of user involvement engaged women well with the design challenges of the trial and led to improvements to the protocol. The study strengthens the case for user involvement, in particular through focus groups and in-depth interviews, in the design of trials

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

Novice research:Central venous access device care infections

This article describes a literature review of published evidence on infection prevention and control in central venous access device (CVAD) care conducted by a novice researcher (lead author) under the supervision of her lecturer (second author). It includes details of the search as well as of the analysis which led to the selection and critical appraisal of a selected article identified and, importantly, discussion of the limitations and lessons learned by the novice researcher with her experimental approach. Infection control is paramount within nursing practice as a result of the number of healthcare-associated infections, which are preventable if evidence-based practice is followed and when trust protocols are informed by evidence. The question posed by the author prior to undertaking the literature search related to whether the use of sterile gloves for CVADs reduces infections in the oncology patient population compared with the use of non-sterile gloves. The question was formulated using the PICO (Population, Intervention, Comparison, Outcome) process and relevant literature was located using CINAHL and MEDLINE databases. The results of the review demonstrated no significant difference in infection rates using sterile or non-sterile gloves when handling CVADs but further research in this area is needed to validate the findings. </jats:p

Communication Studies’ Top 10 EdTech Success Stories!

While technology is moving communication goalposts out of the newsroom/corporate world/classroom and into newer media, we’re looking more at how to be a collaborative community. Thanks to guidance from IT and the Teaching and Technology Center, this panel of (relatively) new faculty are branching into technologies such as “wordle” and podcasts, with new online courses and Moodle on the horizon. Our Top 10 List of educational technology success stories will highlight our accomplishments in Communication Studies with online student research that ties into ATP events, journalism and theory courses with great web presence, and student-created public relations sites such as http://www.freewebs.com/freecampaign2008 for sustainability! In addition, we want to hear about your own success stories

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