BACKGROUND. Pre-exposure prophylaxis (PrEP) is an experimental HIV prevention approach whereby antiretroviral pills are used before anticipated exposure. It is unclear how ethical considerations have been addressed by investigators. METHODS. A systematic review of PrEP controlled prospective studies was conducted. Pre-determined data items were extracted from registries, protocols, reports, and consent forms. Study characteristics, methods, and ethics considerations were synthesized. RESULTS. Among sixteen studies included, twelve involved resource-limited countries. Quality scores were generally high and overall risk of bias was low. Considerations for social value were the least reported whereas considerations for the fair selection of study population were the most reported. More ethics considerations tend to be reported with time. No meta-analysis was performed, as few data were available. CONCLUSION. As critical as clinical data generation is for scientific progress, ethics should be monitored and adequately reported, lest lack of consideration for key principles be uncovered after the facts.

Protocols of randomized controlled trials (RCT) are important for many stakeholders including trialists, consumers, ethics boards, funding agencies and journal editors. However, RCT protocols often incompletely describe important trial details or describe inadequate methods. Biased methodological changes are also prevalent. This thesis' objective was to provide the evidence-base for the SPIRIT (Standard Protocol Items for RandomIzed T rials) Initiative, which aims to increase transparency by developing a reporting guideline for RCT protocols. Guideline content was developed and refined by: 1) a Delphi survey of key stakeholders and 2) a systematic review of empirical evidence. These two components yielded divergent yet complementary perspectives for concepts that RCT protocols should address. Cumulatively, 41 concepts related to trial methodology, administration/organization, ethics and dissemination were recommended for inclusion and 24 concepts for further discussion. These findings inform the SPIRIT guideline content and may ultimately help to improve protocol transparency and the validity of healthcare literature.

Many Canadian children are not eating in accordance with the recommendations of Canada's Food Guide. The health effects of such behaviours are widely unknown. Using the Generalized Estimating Equations technique and data from the Quebec Longitudinal Study of Child Development, this study longitudinally explored the effects of low, medium, and high dietary intake of grain products, vegetables, fruits, milk and alternatives, and meat and alternatives on three indicators of child health, namely: the frequency of physician consultations, infections, and antibiotic treatments, in children from age1 to 7. Using multivariable models, high intake of vegetables (two or more times per day) was found to significantly reduce the risk of physician consultations and antibiotic treatments. Low intake of meat and alternatives (less than once per day) reduced the risk of physician consultations, and high intake of fruits (two or more times per day) reduced the risk of general infections.

Background: Studies assessing the effects of air pollution on health have traditionally relied upon ground-monitoring stations to measure ambient concentrations. Use of satellite derived air pollution measures poses the advantage of providing global coverage. Objective: To undertake a global assessment of mortality associated with chronic exposure to fine particulate air pollution using remote sensory data. Methods: Global PM2.5 exposure levels were derived from MODIS and MISR satellite instruments. Relative risks and attributable fractions of mortality were modelled using previously developed concentration-response functions for the association between PM2.5 and mortality. Results: The global fraction of adult mortality attributable to the anthropogenic component of PM2.5 was 4.5% (95% confidence interval: 2.9-6.0) for cardiopulmonary disease, 5.6% (2.5-8.3) for lung cancer, and 8.2% (5.6-10.4) for ischemic heart disease. Conclusion: This study demonstrated that it is feasible to use satellite derived pollution concentrations in a global assessment of mortality and air pollution.

Objectives: To update a Cochrane review of interventions to improve outpatient referral and to assess changes in referrals to nephrologists after initiating automatic estimated glomerular filtration rate (eGFR) reporting. Methods: Systematic review using standardized Cochrane methods. Before and after study with interrupted time series analysis using data from retrospective chart review on referrals from family medicine to nephrology. Results: Review added one new study and removed one for total of 17 studies. Referrals improved with education and structured referral sheets. Of 2766 eligible referrals for one-year pre-eGFR reporting to one-year post, 96.6% were reviewed. There was a 68.2% increase in referrals for chronic kidney disease (P < 0.01) and a 64.1% increase in total appropriate referrals (P =0.01) with no significant change in proportion of appropriate referrals (-2.5%, P=0.56). Conclusion: Systematic review findings did not change from the previous review. eGFR reporting increased both appropriate and inappropriate referrals.

Inappropriate transfusions overexpose patients to the risk of transfusions. The objective of this thesis was to better understand the determinants of watching and waiting instead of transfusing red blood cells among orthopaedic surgeons using 1) a systematic review of interventions to reduce inappropriate transfusions; 2) interviews with orthopaedic surgeons; and 3) a theory based predictive survey of transfusion intentions and behaviour. The results of the systematic review suggest that the literature is insufficient to determine the effectiveness of interventions designed to reduce inappropriate blood transfusions. The interviews with surgeons identified six theories potentially relevant to our behaviour. The analysis of the survey identified the Theory of Planned Behaviour as the best predictor of intention to transfuse, accounting for 37% variation. These findings can be used to support the development of a theory based knowledge translation intervention to improve appropriate use of blood transfusions by Canadian orthopaedic surgeons.

This thesis was undertaken to investigate the cost-effectiveness of various antiplatelet regimens used in the secondary prevention of vascular events in adults undergoing percutaneous coronary intervention (PCI). Analyses include the first economic evaluation to evaluate three antiplatelet regimens (clopidogrel + ASA, ticlopidine + ASA, and ASA alone) for the PCI indication from the perspective of the Canadian provincial/territorial healthcare payer, budget impact analyses investigating potential consequences of changing prescribing patterns, and a value of information analysis indicating future research priorities. Results demonstrate that, for a population of patients undergoing PCI at age 60, one year of antiplatelet therapy with ticlopidine + ASA, followed by lifetime ASA therapy, dominates clopidogrel + ASA therapy due to lower costs and better health outcomes (ICER = $523.44 vs. ASA alone). The clinical effectiveness of ticlopidine is proven to be the most uncertain variable in the model, and further clinical research is recommended.

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