Background: As part of this thesis work, we developed a Shower Technique protocol (‘STP’) for hemodialysis patients with healed central venous catheter (catheter) exit sites, designed to permit showering but not increase infection risk. Research question: Is it feasible to conduct a randomized control trial called the Hemodialysis Infection Prevention using Polysporin Ointment with Shower Technique in Satellite Centres (HIPPO SAT) study comparing the rate of CRB in adult satellite hemodialysis patients using STP versus standard catheter care alone with 6 month follow up? Study Design: The HIPPO SAT pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to STP versus standard care after meeting predefined criteria to confirm healed tunneled catheter exit site. Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, and percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and using aspects of STP (% of contaminated patients in the control arm). Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada. Patient Population: Adult satellite Hemodialysis patients dialyzing via catheter with healed catheter exit sites. Intervention: STP and standard catheter care; or Control: standard catheter care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible. Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and contamination. / Thesis / Master of Science (MSc)

Class of 2012 Abstract / Specific Aims: To explore whether publishing requirements for human-centered randomized control trials, particularly the CONSORT criteria, have any relationship to impact as measured by the Journal Citation Reports TM Impact Factor. Methods: A worksheet was used to evaluate a methodically selected list of journals, including types of articles published, requirements of authors for human-focused randomized control trials, JCR Impact Factor and other JCR metrics for each specific journal title. A worksheet was filled out for each journal by each member of the research team and answers combined for consensus. Group means and SDs were calculated and the Student’s t-Test applied to values for selected journals. Main Results: 50 candidate pharmacy journals were identified and 41 met the criteria for publishing human-centered randomized control trials. Journals were grouped according to whether they required CONSORT or had other reporting requirements for human RCTs, or had no requirements for such studies. Few (6; 15%) pharmacy journals required authors to use CONSORT; and additional 15 (37%) journals provided as least some author guidelines similar to CONSORT. Pharmacy journals using CONSORT or other guidelines had a higher average impact factor (3.5; SD = 1.5) than did journals without guidelines (2.4; SD = 0.9; p = 0.007). Conclusions: There appears to be a statistical difference in average JCR metrics between journals which require specific RCT guidelines and those which do not. The use of reporting guidelines, such as CONSORT, by pharmacy journals is associated with increased impact as represented by JCR influence measures.

Background: Stories may be an effective tool to communicate with and influence patients because of their ability to engage the reader. Objectives: To develop story booklets and evaluate their effectiveness compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods: A systematic process was followed to develop and pilot-test the story booklets. Parents were randomized to receive story booklets or standard information sheets during their ED visit. The primary outcome of change in anxiety during the ED visit was assessed using the State Trait Anxiety Inventory, which was completed upon recruitment and at discharge. Follow-up telephone interviews were conducted at 1 and 3 days post-ED visit to gather information on secondary outcomes: symptoms, expected anxiety for future croup, satisfaction, regret, knowledge, return for medical care, and resource use. Telephone interviews were conducted every other day until symptoms resolved or until day 9. Outcomes were compared using independent-groups t-tests, Mann Whitney tests, or Chi-square tests. Results: There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge. The story group (n=129) showed significantly greater decision regret regarding their decision to go to the ED than the comparison group (n=126) (p<0.001). The story group reported quicker resolution of symptoms: median days to no symptoms 3 versus 5; the survival distributions were significantly different (p=0.032). There were no differences for the remaining outcomes. Conclusions: This study provides preliminary evidence regarding the use of stories in the ED for an acute, self-limiting condition and contributes to a growing evidence matrix identifying when, where, and for whom storytelling may be most effective. Reasons for lack of significance for the primary and other outcomes may relate to choice of outcome, timing of outcome assessment, or disconnect between the intervention and needs of the end-user. Further research is needed to corroborate the significant findings and examine their underlying mechanism. An examination of risk of bias in a sample of pediatric trials demonstrates that there is room for improvement in the design, conduct, and reporting of research related to child health and provides direction for future research.

No description available.

It is widely accepted that breast milk is the optimal source of infant nutrition. Despite the World Health Organization (WHO) recommendation of exclusive breastfeeding for the first 6 months of infant life, many women discontinue breastfeeding as a result of perceived difficulties. Nipple pain is a highly prevalent, significant reason for breastfeeding cessation. Among the numerous interventions for nipple pain, the application of lanolin is commonly recommended, with endorsement by Health Canada, The La Leche League, and International Board Certified Lactation Consultants. The few studies that have evaluated the effectiveness of lanolin on nipple pain have lacked methodologic rigor, and are thus not reliable or generalizable. As such, the purpose of this trial was to rigourously evaluate the effect of lanolin for the treatment of nipple pain among breastfeeding women. This single-site randomized controlled trial (RCT) compared the application of lanolin (treatment) to usual postpartum care (not applying lanolin) for the treatment of nipple pain. The primary outcome for this trial was the effect on pain severity, as measured by a numeric rating scale (NRS) at 4 days post-randomization. Of 186 participants, 93 were randomized to the treatment group and 93 to the usual care group. At 4 and 7 days post-randomization there were no statistically significant differences in pain scores between groups. It is noteworthy that by 7 days post-randomization there were clinically relevant decreases in nipple pain in both groups. However, there were no statistically significant differences between groups for other outcomes, including pain measured with the short-form McGill Pain Questionnaire, breastfeeding duration, breastfeeding exclusivity, and breastfeeding self-efficacy. Despite these findings, women in the treatment group were significantly more satisfied receiving lanolin for their nipple pain than those receiving usual care. Since the use of lanolin is no more effective than applying nothing to the nipples for the management of nipple pain, the widespread use of lanolin is questionable. Further research is required on the role of interventions to prevent nipple pain and damage, and the effect of anticipatory guidance on improving breastfeeding outcomes for those experiencing nipple pain in the early postpartum period.

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