Effects of study design and allocation on participant behaviour-ESDA: study protocol for a randomized controlled trial

BACKGROUND: What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. METHODS/DESIGN: A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. DISCUSSION: The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000846022.

An investigation of the development of navigation design guidelines for online educational applications delivery to a primary school audience

Despite growing interest in educational websites for children, there has been surprisingly little research conducted into the design of websites intended for a younger audience. This research aims to determine how the design principles identified in the extant body of literature, might be fused with the development practices currently employed within a focus organisation (case study organisation), to synthesise and partially validate a set of website navigation design guidelines for use when developing website navigation for primary school students, between the ages of nine and twelve years.

Computational simulation of chassis design and manufacturing

Australian Universities including Deakin University are entering the Formula One SAE car competition this year which was initialised in USA many years ago and has attracted many universities to participate all over the world. There are many categories to be competed for novelty of the design. To achieve optimised design of the car, computational techniques have widely been used in all aspects of the design and manufacturing of the car for the team at Deakin University. In this work, the design and manufacturing of the chassis was computationally simulated to optimise the structure for stress and natural frequencies. The chassis is designed using solid modelling code IDEAS with the geometry exported to ABAQUS, a FEM software, for optimisation.

The importance of information design for small business web sites

Designing and maintaining websites can be costly for small business, therefore the decision to embark on a Web strategy should not be taken lightly. Critical to the success of a web site is its design. Most small business web sites focus on information provision yet for many it would appear there is a lack of understanding of how to design a web site that delivers information effectively to users. This paper presents research that examined the effectiveness of small business web sites from the perspective of users. Findings indicate that: users found many sites contained too much irrelevant information; users were critical of sites where not enough information was provided; how the text is organised is
important; and, the quality and quantity of information provided on the websites and the display and size of the text influenced the ability of users to complete the task and not be frustrated.

Chinese consumers' perceptions of country design, assembly and parts capabilities : does country considered or consumer acculturation matter?

Chinese consumers are facing a diverse range of choices in regards to products produced wholly or in part overseas or by overseas corporations based in China. This study examines how consumers from China, both residing at home and abroad, perceived capability of Germany, Japan, US and China in regard to three dimensions of country capabilities- design, assembly and parts/components. The findings show that consumers have different perceptions concerning country capabilities and that Chinese consumers residing overseas appear to have more positive perceptions of foreign countries’ capabilities.

Use of calcium, folate and vitamin D3-fortified milk for 6 months improves nutritional status but not bone mass or turnover, in a group of Australia aged care

In residential care, inadequate calcium and folate intakes and low serum vitamin D (25(OH)D) concentrations are common. We assessed whether daily provision of calcium, folate, and vitamin D3-fortified milk for 6 months improved nutritional status (serum micronutrients), bone quality (heel ultrasound), bone turnover markers (parathyroid hormone, C-terminal collagen I telopeptide, terminal propeptide of type I procollagen), and/or muscle strength and mobility in a group of Australian aged care residents. One hundred and seven residents completed the study (mean (SD) age: 79.9 (10.1) years; body weight: 68.4 (15.4) kg). The median (inter-quartile range) volume of fortified milk consumed was 160 (149) ml/day. At the end of the study, the median daily vitamin D intake increased to 10.4 (8.7) μg (P < .001), which is 70% of the adequate intake (15 μg); and calcium density (mg/MJ) was higher over the study period compared with baseline (161 ± 5 mg/MJ vs. 142 ± 4 mg/MJ, P < .001). Serum 25(OH)D concentrations increased by 23 ± 2 nmol/L (83 (107)%, P < .001), yet remained in the insufficient range (mean 45 ± 2 nmol/L). Consumption of greater than the median intake of milk (160 ml/day) (n = 54, 50%) increased serum 25(OH)D levels into the adequate range (53 ± 2 nmol/L) and reduced serum parathyroid hormone by 24% (P = .045). There was no effect on bone quality, bone turnover markers, muscle strength, or mobility. Consumption of fortified milk increased dietary vitamin D intake and raised serum 25(OH)D concentrations, but not to the level thought to reduce fracture risk. If calcium-fortified milk also was used in cooking and milk drinks, this approach could allow residents to achieve a dietary calcium intake close to recommended levels. A vitamin D supplement would be recommended to ensure adequate vitamin D status for all residents.

Are aspects of study design associated with the reported prevalence of female sexual difficulties?

Objective: To investigate associations between the prevalence of sexual  difficulties reported in published studies and design features of those studies to determine if differences in design contribute to variation in prevalence estimates.
Design: Systematic review, multivariate analysis.
Setting: Studies published internationally in English.
Patient(s): Not applicable.
Intervention(s): None.
Main Outcome Measure(s): Prevalence estimates of difficulty with desire, arousal, orgasm, and sexual pain reported in published studies.
Result(s): Our systematic literature search identified 1,380 publications. Fifty-five studies met our inclusion criteria (reporting prevalence, sample size and response rate, sample size greater than 100, not clinic based). Reported prevalence of sexual difficulty varied across studies (up to tenfold). Eleven aspects of research conduct in these studies were included in our multivariate analysis as explanatory variables. Five aspects of study design and conduct (data collection procedures, inclusion criteria, duration of sexual difficulty recorded, sample size, and response rate) were associated with the reported prevalence of at least one type of sexual difficulty independently of likely predictors of true variation in prevalence: study location, study year, and age range of participants.
Conclusion(s): This review provides evidence that study design may influence reported prevalence estimates of female sexual difficulties and contribute to the wide variation in published estimates.

The impact of study design on prevalence estimates of female sexual dysfunction

Introduction, objectives Despite increasing research, the true prevalence of Female Sexual Dysfunction (FSD) remains a contentious issue. Previous research suggests that aspects of study design affect the reported prevalence of FSD. We compare commonly used instruments for assessing FSD. Methods A random sample of 240 Australian women aged 20-70 participated in this population based, cross-sectional study. A questionnaire mailed to women across Australia included four instruments for assessing FSD. The Sexual Function Questionnaire combined with the Female Sexual Distress Scale (SFQ-FSDS) was employed as a standard, validated instrument. Alternative instruments were the SFQ alone and two modified versions of a set of questions originally developed by Laumann et al. Results When assessed by the SFQ-FSDS, prevalence estimates (and 95% confidence intervals) of Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder (genital subtype), Female Orgasmic Disorder, and Dysparunia were 16%(11-20%), 8%(4-11%), 9%(6-13%), 2%(0.1-3%) respectively. The prevalence estimates of these same disorders obtained using alternative instruments were 32-55%, 17-35%, 17-33% and 3-25% respectively. The sensitivity of alternative instruments varied widely (0 to 1.0). Specificities ranged from 0.51 to 0.99. Positive predictive values ranged from 0 to 0.57. Negative predictive values were all above 0.90. Changing the time span for recalling sexual experiences in an instrument altered the prevalence estimates, sensitivity and specificity. 32% of women with low desire, 31% with low genital arousal, 36% with orgasm difficulty and 57% with sexual pain were sexually distressed. Conclusion Over a third of women who were classified as suffering FSD by alternative instruments did not have FSD when assessed by SFQ-FSDS. Alternative instruments produced substantially higher prevalence estimates of FSD and identified different groups of women. Consequently, the instruments researchers choose to assess FSD may affect both the prevalence estimates and risk factors they report.