Yes / This article recounts our experience of eliciting, cataloguing and prioritizing conjectured Context-Mechanism-Outcome configurations at the outset of a realist evaluation, to provide new insight into how Context-Mechanism-Outcome configurations can be generated and theorized. Our construction of Context-Mechanism-Outcome configurations centred on how, why and in what circumstances teamwork was impacted by robotic surgery, rather than how and why this technology improved surgical outcomes as intended. We found that, as well as offering resources, robotic surgery took away resources from the theatre team, by physically reconfiguring the operating theatre and redistributing the surgical task load, essentially changing the context in which teamwork was performed. We constructed Context-Mechanism-Outcome configurations that explain how teamwork mechanisms were both constrained by the contextual changes, and triggered in the new context through the use of informal strategies. We conclude by reflecting on our application of realist evaluation to understand the potential impacts of robotic surgery on teamwork.

Systematic reviews have consistently found that moderate intensity physical activity levels at or above a threshold value of 150 minutes per week reliably deliver cardiovascular, metabolic and musculo-skeletal health benefits. As a result, this threshold value has been widely adopted as an aspirational, public health goal throughout the world. However, while epidemiological and laboratory studies have established clear links between physical activity and sleep outcomes, the evidence base does not yet provide guidelines on minimum levels of exercise likely to reduce insomnia symptoms and improve sleep quality. Such a guideline, if evidence based, could greatly clarify advice, and accelerate the use of physical activity goals to improve sleep outcomes in behavioural sleep medicine and public health. This thesis examined the current public-health recommendation of 150 minutes of moderate intensity activity per week in relation to sleep outcomes. To commence, it established a population-level pattern of the relationship between levels of physical activity and sleep quality by reviewing relevant epidemiological evidence. Exploratory analyses were then conducted using data from an ongoing longitudinal study of physical activity and health outcomes among older people (aged 65 years and above) in which respondents were classified as walking at or above, or below the recommended threshold of 150 minutes per week. In regression models controlling for health and demographic factors, these analyses showed that higher levels of walking were significantly and independently associated with a lower likelihood of either reporting insomnia symptoms (OR = 0.67 (95% CI = 0.45 0.91) p=0.04), or experiencing poor sleep efficiency (OR = 0.70 (95% CI = 0.52 0.94 p=0.02). Using the same data, the predictive validity of this activity threshold was then confirmed in a 27-year survival analysis which showed a significantly decreased all-cause mortality risk associated with the higher level of walking (HR = 0.75 (95% CI = 0.65 - 0.86) p<0.01). These findings offered proof of concept that physical activity-sleep relationships operated on a continuum, with sleep benefits possible even at relatively low levels of activity. Experimental evidence on the acute and sustained effects of physical activity on sleep quality was then analysed and discussed. Outcomes from this review, together with the preliminary analyses described above, were then used to inform the design of a randomised controlled trial to investigate the effects on sleep quality of increasing physical activity to currently recommended levels among sedentary people with insomnia. A total of 41 sedentary adults meeting DSM-IV criteria for insomnia (30 female; mean age 59.8??9.5) were randomised to a physical activity group (???150 minutes moderate intensity activity/week) or a waiting list control group. The principal outcome was Insomnia Severity Index (ISI) change 6 months post baseline; secondary outcomes were anxiety (using the State Trait Anxiety Inventory) and depression (Beck Depression Inventory II). Physical activity was assessed using Actigraph GTX3+ accelerometers. Outcomes were assessed in univariate general linear models, adjusted for baseline confounders. Activity and sleep assessments did not differ at baseline. At 6 months post baseline the intervention group engaged in 213 min/week of moderate intensity PA, compared to the control group (82 min/week). Compared to the control group, the intervention group showed significant improvement in the ISI score at 6 months F(1,28) = 5.16, p=0.03), adjusted means difference = 3.37, with an adjusted Cohen's d =.78 (95% CI 0.10 1.45). There was a significant improvement in trait anxiety, and depression outcomes post-intervention, F(6,28)=4.41, p=0.05, and F(6,28)=5.61, p=0.02, respectively. The results showed that increasing activity in line with current guidelines could deliver clinically significant improvements in sleep quality and mood outcomes among inactive adults with insomnia. While the effect sizes are modest, the pattern of results reported here allow for two conclusions with clear implications for public health: 1) measures to increase levels of physical activity above the currently recommended threshold of 150 minutes per week could usefully be added to other approaches to insomnia management; and 2) the likelihood of improved sleep quality should be routinely added to those evidence-based cardiovascular and metabolic benefits most frequently associated with increased physical activity in behaviour change initiatives.

Breastfeeding is recommended as the optimal source of nutrition for newborns for the first 6 months of life and beyond with the addition of complementary foods. While breastfeeding initiation rates have been increasing, duration rates remain a concern as many women prematurely discontinue due to difficulties encountered rather than maternal choice. In addition, there is a sizable gap between rates of exclusive breastfeeding and current recommendations. Targeting modifiable variables that may be amenable to intervention is one strategy to improve breastfeeding outcomes. One such modifiable variable is breastfeeding self-efficacy. Although research has clearly shown that breastfeeding self-efficacy is predictive of breastfeeding duration and exclusivity, it is unknown whether it can be enhanced to improve breastfeeding outcomes. The purpose of this pilot randomized controlled trial was to examine the feasibility and compliance of a newly developed trial protocol and the acceptability of an intervention to increase breastfeeding self-efficacy in the immediate postpartum period. Secondary outcomes included determining whether there were any trends between groups related to breastfeeding self-efficacy, duration, and exclusivity. Participants included 150 primiparous mothers who were breastfeeding their healthy, full-term infants. Eligible and consenting mothers were randomized to either a control group (standard postpartum care) or an intervention group (standard postpartum care plus the self-efficacy intervention). Participants allocated to the intervention group received three individualized, self-efficacy enhancing sessions with the researcher; two sessions were conducted in hospital, and one was administered via telephone 1 week following hospital discharge. A research assistant blinded to group allocation collected outcome data at 4 and 8 weeks postpartum. The results suggested that the administration of the intervention was feasible and that there was a high degree of protocol compliance; the majority of participants reported that the intervention was beneficial. Secondary outcomes identified that there was a trend among participants in the intervention group to have improved breastfeeding outcomes, including higher rates of breastfeeding self-efficacy, duration, and exclusivity at 4 and 8 weeks postpartum. Preliminary evidence also suggested that the self-efficacy intervention may have assisted to decrease perceptions of insufficient milk supply among the intervention group participants. Overall, the findings from this pilot trial indicated that a larger trial is warranted.

Hyperacusis is a type of decreased sound tolerance where the individual has decreased loudness discomfort levels (LDL), normal hearing thresholds and is sensitive to ordinary environmental sounds. Persons with hyperacusis frequently seek help at audiological departments as they are often affected by other audiological problems. Regrettably, there is neither a consensus-based diagnostic procedure nor an evidence-based treatment for hyperacusis. The principal aim of this thesis was to gain knowledge about the clinical condition hyperacusis. The specific aim of Paper I was to compare hyperacusis measurement tools in order to determine the most valid measures for assessing hyperacusis. Items from a constructed clinical interview were compared with the LDL test, the Hyperacusis Questionnaire (HQ) and the Hospital Anxiety and Depression Scale (HADS). LDLs were significantly correlated with the anxiety subscale of the HADS. A third of the 62 investigated patients scored below the previously recommended cut-off for the HQ. The results suggest that HQ and HADS in combination with a clinical interview are useful as part of the assessment procedure in patients with hyperacusis. The aim of Paper II was to further investigate the patient group with respect to individual characteristics, psychiatric morbidity and personality traits. It was shown that anxiety disorders and anxiety-related personality traits were over-represented, which suggests common or cooperating mechanisms. Avoidance behaviour proved to be very common in the patient group, as was being unable to work due to hyperacusis. In Paper III it was investigated in a randomized controlled trial whether Cognitive Behaviour Therapy (CBT) could be helpful for patients with hyperacusis. The effect of CBT for hyperacusis was assessed with measures of LDLs, symptoms of hyperacusis and of anxiety and depression, fear of (re)injury due to exposure to sounds, and quality of life, compared to a waiting list control group. There were significant group effects for a majority of the measures with moderate and strong effect sizes within- and between groups. After assessment the waiting list group was also given CBT, and was then reassessed with similar effects. The results were maintained for 12 months, concluding CBT to be potentially helpful for these patients.

Background: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited. Methods: Four ancillary studies were added. Each drew from the same population but had independent objectives and an endpoint other than prostate cancer. These studies fell into two categories: those prospectively enrolling and following participants (studies of Alzheimer's disease and respiratory function) and those requiring a retrospective medical record review after a reported event (cataracts/age-related macular degeneration and colorectal screening). An examination of the challenges and opportunities of adding ancillary studies is provided. The impact of the ancillary studies on adherence to SELECT was evaluated using a Cox proportional hazards model. Results: While the addition of ancillary studies appears to have improved participant adherence to the primary trial, this did not come without added complexity. Activation of the ancillary studies happened after the SELECT randomizations had begun resulting in accrual problems to some of the studies. Study site participation in the ancillary trials varied greatly and depended on the interest of the study site principal investigator. Procedures for each were integrated into the primary trial and all monitoring was done by the SELECT Data and Safety Monitoring Committee. The impact of the early closure of the primary trial was different for each of the ancillary trials. Conclusions: The ancillary studies allowed study sites to broaden the research opportunities for their participants. Their implementation was efficient because of the established infrastructure of the primary trial. Implementation of these ancillary trials took substantial planning and coordination but enriched the overall primary trial.

<p>The HIV epidemic in the United States continues to be a significant public health problem, with approximately 50,000 new infections occurring each year. National public health priorities have shifted in recent years towards targeted HIV prevention efforts among people living with HIV/AIDS (PLWHA) that include: increasing engagement in and retention in care, improving HIV treatment adherence, and increasing screening for and treatment of substance use and psychological difficulties. This study evaluated the efficacy of Positive Choices (PC), a brief, care-based, theory-driven, 3-session counseling intervention for newly HIV-diagnosed men who have sex with men (MSM), in the context of current national HIV prevention priorities. The study involved secondary analysis of data from a preliminary efficacy trial of the PC intervention (n=102). Descriptive statistics examined baseline substance use, psychological characteristics and strategies, and care engagement and HIV-related biological outcomes. Generalized Estimating Equations (GEE) examined longitudinal changes in these variables by study condition. Results indicated that PC improved adherence to HIV treatment, but increased use of illicit drugs, specifically amyl nitrates and other stimulant drugs; additionally, moderation analyses indicated differences in patterns of change over time in viral load by baseline depression status. Implications of the findings and suggestions for future research are discussed.</p> / Dissertation

Rationale Within Australia, cardiac rehabilitation attendance is poor, with typically thirty percent of eligible patients attending programs. The majority of cardiac patients are not receiving the support or detailed information required to increase physical activity participation after hospitalisation. Further, many cardiac patients are not exercising independently, regardless of their attendance at cardiac rehabilitation. As physical activity is important in the prevention and treatment of heart disease, there could be substantial benefits to the individual and cost savings for the health system if cardiac patients were more active. Physical activity interventions based on social cognitive theory have demonstrated success in improving physical activity among people with chronic diseases. However, there is little research conducted with cardiac patients, in particular, with those who do not attend cardiac rehabilitation. This research addresses this gap in public health practice by providing an intervention to cardiac patients, irrespective of their attendance at cardiac rehabilitation, thereby addressing a population that is often overlooked and hard to reach. Research aims ?? To determine the uptake rate of cardiac rehabilitation in the north Illawarra and Shoalhaven areas of New South Wales and identify the characteristics of cardiac rehabilitation attendees and non attendees. ?? To evaluate the efficacy of a pedometer based physical activity intervention in cardiac patients referred to cardiac rehabilitation. Methodology This thesis consisted of three related studies: a cross sectional analysis of the characteristics of cardiac rehabilitation referrals (n = 944) over a 10 month period; and two randomised controlled trials conducted simultaneously. The Cardiac Rehabilitation Trial participants (n = 110) were patients who had attended cardiac rehabilitation; Community Trial participants (n = 215) were those who did not attend cardiac rehabilitation. The six week intervention evaluated in the trials included self monitoring of daily physical activity using a pedometer and step calendar, and two behavioural counselling and goal setting sessions delivered via telephone. Additional support for intervention group participants was provided through two brief telephone calls made after the six week intervention period. Self reported physical activity levels were collected at baseline, six weeks and six months. The questionnaire also collected information about psychosocial factors affecting physical activity participation. The exercise capacity of the participants in the Cardiac Rehabilitation Trial was objectively measured at baseline, six weeks and six months using a gas exchange analysis system. Results The cardiac rehabilitation uptake rate was 28.8 per cent of referred patients. Cardiac rehabilitation attendees were significantly younger and more likely to have had a coronary artery bypass graft surgery (CABGS) or percutaneous coronary intervention (PCI) procedure than non attendees. Study groups in both trials were not significantly different at baseline. In the Cardiac Rehabilitation Trial, improvements in total weekly physical activity sessions (p=0.002), walking time (p=0.013) and walking sessions (p<0.001) in the intervention group were significantly greater than the change in the control group at the end of the six week intervention. At six months, improvements in the intervention group remained significantly greater than the control group in total physical activity time (p=0.044), total physical activity sessions (p=0.016) and walking sessions (p=0.035) after adjusting for baseline differences. These self reported behavioural changes were corroborated by improvements in cardiorespiratory fitness at six months in the intervention group (p=0.010). Improvements in the intervention group in behavioural (p=0.039) and cognitive (p=0.024) self management strategy use were significantly greater than the controls at six weeks after adjusting for baseline differences. The improvement in cognitive strategy use (p=0.001) remained significantly greater in the intervention group compared to controls at six months after adjusting for baseline differences. Self efficacy, outcome expectancies and psychological distress were not significantly different between groups at six weeks or six months after adjusting for baseline differences. In the Community Trial, improvements in total weekly physical activity time (p=0.027), total physical activity sessions (p=0.003), walking time (p=0.013) and walking sessions (p=0.002) in the intervention group were significantly greater than the control group at six weeks after adjusting for baseline differences. At six months, improvements in total physical activity time (p=0.015), total physical activity sessions (p=0.019), walking time (p=0.002) and walking sessions (p=0.026) in the intervention group remained significantly greater than the control group after adjusting for baseline differences. Improvements in outcome expectancies (p=0.038) and cognitive self management strategy use (p=0.028) in the intervention group were significantly greater than the change in the control group at six weeks, after adjusting for baseline differences. However, these differences did not remain significant at six months. Conclusion This research showed that participation in a six week pedometer based intervention significantly increased the physical activity level and psychosocial status of people with heart disease. These findings suggest the pedometer based intervention could be offered as an effective and accessible option for those who do not attend cardiac rehabilitation to increase their physical activity levels. This intervention could also be promoted as an important adjunct to existing cardiac rehabilitation programs to promote adherence to physical activity after cardiac rehabilitation attendance. These studies provide community based evidence of an effective physical activity intervention for those eligible for cardiac rehabilitation, including those who do not attend. This provides a public health approach to cardiac rehabilitation programs and has the potential to improve health outcomes in this population.

Philosophy(PhD) / This thesis presents a randomised controlled trial of the Lidcombe Program of Early Stuttering Intervention. The Lidcombe Program was developed for the treatment of stuttering in preschool-age children. The effectiveness of the Lidcombe Program was compared to a control group in a parallel group randomised controlled trial with blinded outcome assessment. A number of supplementary studies were conducted in support of the trial; two literature reviews, two retrospective file audits and a statistical simulation study. A review of randomised studies of treatments for stuttering showed that there have been 27 such studies published in English language journals. Of these only one was devoted to a treatment for early stuttering and that was the Lidcombe Program. The randomised study showed that 3 months of this treatment was associated with a lower level of stuttering compared to a control group who received no treatment. However, with a sample size of 23, this study lacked power and the children did not receive a full course of treatment. Despite these limitations, this study provided evidence that a medium to large effect size could be anticipated in an adequately powered and properly conducted randomised controlled trial. The second review was of sample size and power in stuttering research studies that had been published in two speech pathology journals; the Journal of Speech, Language and Hearing Research (Vol 39, No. 1 to Vol 40, No, 4) and the Journal of Fluency Disorders (Vol 21, No. 1 to Vol 22, No, 3). Results suggested that the majority (73%) of the 26 studies reviewed were insufficiently powered to detect even large effects. However it was acknowledged that it is very difficult to recruit even moderate sample sizes of people who stutter. It was concluded that one way to help improve this situation is collaboration of multiple research centres or, in the case of a randomised controlled trial, inclusion of multiple recruitment sites in one study. This strategy was adopted in the randomised controlled trial reported in this thesis. Two retrospective file audit studies of children treated with the Lidcombe Program were conducted in Australia and Britain. One purpose of these file audits was to obtain information relevant to the design and conduct of the randomised controlled trial. Data from the case reports on more than 300 children from the two sites were included in a meta-analysis. Results showed that a median of 11 weekly clinic sessions were required for children to attain the criteria for low levels of stuttering for completion of Stage 1 of the Lidcombe Program. Approximately 90% of children had achieved those criteria within 6 months of beginning treatment and almost all children had achieved them within 1 year. In addition two variables were found to be associated with longer treatment duration: more severe pre-treatment stuttering and shorter times from onset of stuttering to the start of treatment. The latter was apparent in the meta-analysis but not for the individual cohorts. As a result of these findings, pre-treatment stuttering severity was stratified along with other relevant variables in the randomised controlled trial and follow up for participants was a minimum of 9 months. A simulation study was conducted prior to analysis of data from the primary outcome measure of the randomised controlled trial: percentage of syllables stuttered (%SS). The distribution of %SS scores is positively skewed. Nonetheless, simulation showed t-test to be an appropriate analysis for this primary outcome measure. There were two treatment sites for the randomised controlled trial: the University of Canterbury (Christchurch, New Zealand) and the Stuttering Treatment and Research Trust (Auckland, New Zealand). A total of 54 preschool-age children were recruited: 29 to the Lidcombe Program and 25 to the control group. Half the proposed sample size was achieved due to slower than anticipated recruitment. This occurred because, as the trial progressed, treatment with the Lidcombe Program became common knowledge among parents in New Zealand and they became increasingly reluctant to agree to have their child randomised to the trial. Analysis with t-test showed a highly statistically significant difference (p = 0.003) at 9-months post-randomisation. The mean percentage of syllables stuttered (%SS) at 9-months post-randomisation was 1.5 (SD = 1.4) for the Lidcombe Program group compared to 3.9 (SD = 3.5) for the control group, resulting in a treatment effect of 2.3 %SS (95% confidence interval: 0.8-3.9). This treatment effect was more than double the minimum clinically worthwhile difference specified in the trial protocol. These results show that the Lidcombe Program is significantly more effective than natural recovery for reducing stuttering levels in preschool children. The Lidcombe Program is the first early stuttering treatment to be shown to be more effective than natural recovery in a randomised controlled trial.

The purpose of the current study was to develop a manualized treatment for fibromyalgia syndrome (FM) and to examine the efficacy of the treatment in a randomized controlled clinical trial. FM is a chronic musculoskeletal pain disorder characterized by tender points and generalized pain. Depression, chronic fatigue, and sleep disturbance are common. A biopsychosocial model served as a framework for understanding FM by integrating psychological, social, and physical factors. Cognitive-behavioural therapy (CBT), an empirically validated treatment for arthritis, has also been used with FM patients in an attempt to improve pain control, reduce disability, and increase self-efficacy. Overall, the attention/placebo controlled studies employing CBT as a treatment for FM show that it is not superior to a credible attention placebo. The current study attempted to combine the necessary components of CBT with interpersonal therapy to address relational patterns and personality characteristics that can affect ability to cope with chronic pain. One hundred and five women diagnosed with FM by a rheumatologist were randomly assigned to the CBT-interpersonal treatment condition or an attention-control condition. There were 8 treatment groups with a mean of 6-7 participants in each. The treatment consisted of weekly 2-hour sessions over 8 consecutive weeks. Outcome measures included: FM impact, pain, health care utilization, depression, coping, and self-efficacy. An intention-to-treat analysis was conducted. Results showed that the impact of FM symptoms was reduced following treatment compared to the control group and this was statistically and clinically significant, but was not maintained at 3-month follow-up. Significant improvements were also observed in coping strategies, some of which were maintained at follow-up. Importantly, self-efficacy improved significantly following treatment compared to the control group. Self-efficacy beliefs have been related to pain, coping efforts, disability, and psychological functioning. Directions for future research may include a focus on long-term maintenance of treatment gains that may be mediated by improvements in self-efficacy. There is strong evidence that changes in self-efficacy are enduring and affect changes in health behaviours and health status.

The purpose of the current study was to develop a manualized treatment for fibromyalgia syndrome (FM) and to examine the efficacy of the treatment in a randomized controlled clinical trial. FM is a chronic musculoskeletal pain disorder characterized by tender points and generalized pain. Depression, chronic fatigue, and sleep disturbance are common. A biopsychosocial model served as a framework for understanding FM by integrating psychological, social, and physical factors. Cognitive-behavioural therapy (CBT), an empirically validated treatment for arthritis, has also been used with FM patients in an attempt to improve pain control, reduce disability, and increase self-efficacy. Overall, the attention/placebo controlled studies employing CBT as a treatment for FM show that it is not superior to a credible attention placebo. The current study attempted to combine the necessary components of CBT with interpersonal therapy to address relational patterns and personality characteristics that can affect ability to cope with chronic pain. One hundred and five women diagnosed with FM by a rheumatologist were randomly assigned to the CBT-interpersonal treatment condition or an attention-control condition. There were 8 treatment groups with a mean of 6-7 participants in each. The treatment consisted of weekly 2-hour sessions over 8 consecutive weeks. Outcome measures included: FM impact, pain, health care utilization, depression, coping, and self-efficacy. An intention-to-treat analysis was conducted. Results showed that the impact of FM symptoms was reduced following treatment compared to the control group and this was statistically and clinically significant, but was not maintained at 3-month follow-up. Significant improvements were also observed in coping strategies, some of which were maintained at follow-up. Importantly, self-efficacy improved significantly following treatment compared to the control group. Self-efficacy beliefs have been related to pain, coping efforts, disability, and psychological functioning. Directions for future research may include a focus on long-term maintenance of treatment gains that may be mediated by improvements in self-efficacy. There is strong evidence that changes in self-efficacy are enduring and affect changes in health behaviours and health status.