Effects of study design and allocation on self-reported alcohol consumption: randomized trial.

BACKGROUND: What participants think about the nature of a study might affect their behaviour and bias findings. We tested two hypotheses: (1) participants told they were in an intervention trial would report lower alcohol consumption at follow-up than those told they were in a cohort study; (2) participants told they were in the intervention group in a trial would have lower alcohol consumption at follow-up than those told they were in the control group. METHODS: Students from four universities (N = 72,903) were invited to participate in a 'research project on student drinking'. Of 10,415 respondents, 6,788 were moderate to heavy drinkers and were randomized. Group A ('cohort') were informed their drinking would be assessed at baseline and again in one month. Group B ('control') were told the study was an intervention trial and they were in the control group. Group C ('intervention') were told the study was an intervention trial and they were to receive the intervention. All were assessed and directed to read identical online alcohol education material. Whether and how long they accessed the material were recorded. One month later, alcohol intake was reassessed. RESULTS: In relation to hypothesis 1, there were no differences between the groups on the prespecified outcome measures. In relation to hypothesis 2, there were no differences though all point estimates were in the hypothesized direction (that is, 'intervention' < 'control'). The 'cohort' and 'control' groups accessed the material to a similar extent (59% versus 57%) while the 'intervention' group were more likely to access it (78%) and to read it for longer (median 35 s (25th and 75th percentiles: 6, 97) versus medians of 7 s (0, 28) and 8 s (4, 42) for the 'cohort' and 'control' groups, respectively). CONCLUSIONS: Although the context given to the research participants significantly influenced access to the online information and reading time, this did not translate into any effect on drinking behaviour, for either hypothesis. This might be because of failure in the experimental paradigm or the possibility of weaker effects using the online approach. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000846022

Exploring the Design of mHealth Systems for Health Behavior Change using Mobile Biosensors

A person’s health behavior plays a vital role in mitigating their risk of disease and promoting positive health outcomes. In recent years, mHealth systems have emerged to offer novel approaches for encouraging and supporting users in changing their health behavior. Mobile biosensors represent a promising technology in this regard; that is, sensors that collect physiological data (e.g., heart rate, respiration, skin conductance) that individuals wear, carry, or access during their normal daily activities. mHealth system designers have started to use the health information from physiological data to deliver behavior-change interventions. However, little research provides guidance about how one can design mHealth systems to use mobile biosensors for health behavior change. In order to address this research gap, we conducted an exploratory study. Following a hybrid approach that combines deductive and inductive reasoning, we integrated a body of fragmented literature and conducted 30 semi-structured interviews with mHealth stakeholders. From this study, we developed a theoretical framework and six general design guidelines that shed light on the theoretical pathways for how the mHealth interface can facilitate behavior change and provide practical design considerations

Germline Missense Changes in the APC Gene and Their Relationship to Disease

Familial adenomatous polyposis (FAP) is characterized by the presence of hundreds to thousands of adenomas that carpet the entire colon and rectum. Nonsense and frameshift mutations in the adenomatous polyposis coli (APC) gene account for the majority of mutations identified to date and predispose primarily to the typical disease phenotype. Some APC mutations are associated with a milder form of the disease known as attenuated FAP. Virtually all mutations that have been described in the APC gene result in the formation of a premature stop codon and very little is known about missense mutations apart from a common Ashkenazi Jewish mutation (1307 K) and a British E1317Q missense change. The incidence of missense mutations in the APC gene has been underreported since the APC gene lends itself to analysis using an artificial transcription and translation assay known as the Protein Truncation Test (PTT) or the In Vitro Synthetic Protein assay (IVSP)

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

Can a multicomponent multidisciplinary implementation package change physicians' and nurses' perceptions and practices regarding thrombolysis for acute ischemic stroke? : an exploratory analysis of a cluster-randomized trial

Background: The Thrombolysis ImPlementation in Stroke (TIPS) trial tested the effect of a multicomponent, multidisciplinary, collaborative intervention designed to increase the rates of intravenous thrombolysis via a cluster randomized controlled trial at 20 Australian hospitals (ten intervention, ten control). This sub-study investigated changes in self-reported perceptions and practices of physicians and nurses working in acute stroke care at the participating hospitals. Methods: A survey with 74 statements was administered during the pre-and post-intervention periods to staff at 19 of the 20 hospitals. An exploratory factor analysis identified the structure of the survey items and linear mixed modeling was applied to the final survey domain scores to explore the differences between groups over time. Result: The response rate was 45% for both the pre-(503 out of 1127 eligible staff from 19 hospitals) and post-intervention (414 out of 919 eligible staff from 18 hospitals) period. Four survey domains were identified: (1) hospital performance indicators, feedback, and training; (2) personal perceptions about thrombolysis evidence and implementation; (3) personal stroke skills and hospital stroke care policies; and (4) emergency and ambulance procedures. There was a significant pre-to post-intervention mean increase (0.21 95% CI 0.09; 0.34; p < 0.01) in scores relating to hospital performance indicators, feedback, and training; for the intervention hospitals compared to control hospitals. There was a corresponding increase in mean scores regarding perceptions about the thrombolysis evidence and implementation (0.21, 95% CI 0.06; 0.36; p < 0.05). Sub-group analysis indicated that the improvements were restricted to nurses' responses. Conclusion: TIPS resulted in changes in some aspects of nurses' perceptions relating to the evidence for intravenous thrombolysis and its implementation and hospital performance indicators, feedback, and training. However, there is a need to explore further strategies for influencing the views of physicians given limited statistical power in the physician sample

Interns are from Venus, consultants are from Mars: differential perception among clinicians

OBJECTIVE: To test for the presence of sex-based differences in perception (the notion that men and women &quot;think&quot; differently, and that differences in perception are biologically based) among healthcare professionals. DESIGN: Prospective survey. SETTING AND PARTICIPANTS: 90 medical personnel at a tertiary care hospital in Newcastle, NSW. INTERVENTION: Healthcare professionals were shown two pictures that could be interpreted as depicting either a young or an old person, and a word that could be seen as geometric shapes. MAIN OUTCOME MEASURES: The effects of sex, age, seniority, and specialisation in relation to the first impression of the image, the ability to change one\u27s perception, and the speed of perception. RESULTS: Contrary to popular opinion, male physicians were more likely to perceive the older figures, and just as likely as women to be able to change their perception. Surgeons and junior staff were more likely to see, as well as being faster to form, an impression requiring abstract thought, and were more able to change their perceptions. CONCLUSIONS: Traditional sex stereotypes do not apply to medical personnel, but other age-based stereotypes, and professional rivalries (medical versus surgical) may have some empiric basis

Thrombolysis implementation intervention and clinical outcome : a secondary analysis of a cluster randomized trial

Background: Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. Still, many of them did not measure individual-level impact. This study aimed to make a posthoc comparison of the clinical outcomes of patients in the "Thrombolysis ImPlementation in Stroke (TIPS)"study, which aimed to improve rates of intravenous thrombolysis in Australia. Methods: A posthoc analysis was conducted using individual-level patient data. Excellent (Three-month post treatment modified Rankin Score 0-2) and poor clinical outcome (Three-month post treatment modified Rankin Score 5-6) and post treatment parenchymal haematoma were the three main outcomes, and a mixed logistic regression model was used to assess the difference between the intervention and control groups. Results: There was a non-significant higher odds of having an excellent clinical outcome of 57% (odds ratio: 1.57; 95% CI: 0.73-3.39) and 33% (odds ratio: 1.33; 95% CI: 0.73-2.44) during the active-And post-intervention period respectively, for the intervention compared to the control group. A non-significant lower odds of having a poor clinical outcome was also found in the intervention, relative to control group of 4% (odds ratio: 0.96; 95% CI: 0.56-2.07) and higher odds of having poor outcome of 44% (odds ratio: 1.44 95% CI: 0.61-3.41) during both active and post-intervention period respectively. Similarly, a non-significant lower odds of parenchymal haematoma was also found for the intervention group during the both active-(odds ratio: 0.53; 95% CI: 0.21-1.32) and post-intervention period (odds ratio: 0.96; 95% CI: 0.36-2.52). Conclusion: The TIPS multi-component implementation approach was not effective in reducing the odds of post-Treatment severe disability at 90 days, or post-thrombolysis hemorrhage

High polygenic risk score for exceptional longevity is associated with a healthy metabolic profile

Healthy metabolic measures in humans are associated with longevity. Dysregulation leads to metabolic syndrome (MetS) and negative health outcomes. Recent exceptional longevity (EL) genome wide association studies have facilitated estimation of an individual's polygenic risk score (PRS) for EL. We tested the hypothesis that individuals with high ELPRS have a low prevalence of MetS. Participants were from five cohorts of middle-aged to older adults. The primary analyses were performed in the UK Biobank (UKBB) (n = 407,800, 40-69 years). Replication analyses were undertaken using three Australian studies: Hunter Community Study (n = 2122, 55-85 years), Older Australian Twins Study (n = 539, 65-90 years) and Sydney Memory and Ageing Study (n = 925, 70-90 years), as well as the Swedish Gothenburg H70 Birth Cohort Studies (n = 2273, 70-93 years). MetS was defined using established criteria. Regressions and meta-analyses were performed with the ELPRS and MetS and its components. Generally, MetS prevalence (22-30%) was higher in the older cohorts. In the UKBB, high EL polygenic risk was associated with lower MetS prevalence (OR = 0.94, p = 1.84 × 10-42) and its components (p < 2.30 × 10-8). Meta-analyses of the replication cohorts showed nominal associations with MetS (p = 0.028) and 3 MetS components (p < 0.05). This work suggests individuals with a high polygenic risk for EL have a healthy metabolic profile promoting longevity