In view of the recent implementation of a publicly funded rotavirus vaccination program in Ontario, we undertook studies to help guide the design of a safety evaluation of the vaccine with respect to intussusception. We used administrative data to develop and validate an algorithm for intussusception, and quantified its incidence in Ontario. We also conducted a systematic review of study designs used to evaluate post-licensure vaccine safety, and discussed each design’s strengths and weaknesses. The validated algorithm for intussusception was sensitive (89.3%) and highly specific (>99.9%). We observed the highest mean incidence (34 / 100,000) in males <1 year of age. While other designs are more robust, the inability to ascertain individual vaccination status from Ontario’s administrative data dictated our selection of an ecological design for safety evaluation of rotavirus vaccine. Data assimilated from this thesis represent a critical step toward the timely evaluation of rotavirus vaccine safety in Ontario.

In view of the recent implementation of a publicly funded rotavirus vaccination program in Ontario, we undertook studies to help guide the design of a safety evaluation of the vaccine with respect to intussusception. We used administrative data to develop and validate an algorithm for intussusception, and quantified its incidence in Ontario. We also conducted a systematic review of study designs used to evaluate post-licensure vaccine safety, and discussed each design’s strengths and weaknesses. The validated algorithm for intussusception was sensitive (89.3%) and highly specific (>99.9%). We observed the highest mean incidence (34 / 100,000) in males <1 year of age. While other designs are more robust, the inability to ascertain individual vaccination status from Ontario’s administrative data dictated our selection of an ecological design for safety evaluation of rotavirus vaccine. Data assimilated from this thesis represent a critical step toward the timely evaluation of rotavirus vaccine safety in Ontario.

Introduction: There has been increasing interest in evidence from pragmatic trials as healthcare providers and decision makers must determine if available evidence can be translated and used in real world practice. As a result, a number of tools have been developed to help researchers design and appraise randomized controlled trials (RCTs) within the pragmatic-explanatory continuum. It is unclear what role pragmatism plays in heterogeneity and if pragmatic and explanatory trials should be pooled in meta-analyses of systematic reviews. Objectives: Our primary objective was to explore the role of pragmatism (based on the Pragmatic-Explanatory Continuum Indicator Summary-2 [PRECIS-2] score) as a source of heterogeneity in Cochrane systematic reviews with at least substantial heterogeneity (I2≥ 50%). Our secondary objective was to compare and contrast the application of the established PRECIS-2 tool to the newly developed Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool. Methods: We conducted a cross-sectional methodological review on systematic reviews of RCTs published in the Cochrane Library from January 1, 2014 to January 1, 2017. Included systematic reviews had a minimum of 10 RCTs in the meta-analysis of the primary outcome and at least moderate heterogeneity (I2≥ 50%). Of the eligible systematic reviews, a random selection of 10 were included for quantitative evaluation. In each systematic review, RCTs were scored using the PRECIS-2 and RITES tools, in duplicate, to determine the amount of pragmatism. Meta-regression modelling was performed to evaluate how much variability in heterogeneity (quantified by I2) was due to pragmatism. Inter-rater reliability of both PRECIS-2 and RITES was measured using the intraclass correlation coefficient and Spearman’s correlation coefficient was used to determine the strength of the relation between PRECIS-2 and RITES. Results: Ten systematic reviews from nine Cochrane Review Groups were included in the quantitative analysis. The reviews included an average of 13 RCTs (standard deviation=2.6) for a total of 132 RCTs of which 128 could be obtained. When the PRECIS-2 summary score was entered as a covariate in random effects meta-regression models for each systematic review, there were minimal changes in heterogeneity. The changes in I2 ranged from 0.2% to 13.3%. Conclusion: Based on these findings it appears pragmatism as measured by PRECIS-2 does not explain heterogeneity in systematic reviews, therefore pooling of pragmatic and explanatory RCTs is unlikely to be detrimental to meta-analyses. / Thesis / Master of Science (MSc) / Systematic reviews and meta-analyses of randomized controlled trials (RCTs) are an important scientific activity that can lead to changes in health care. However, there is concern whether it is appropriate to meta-analyze data from RCTs that are performed under more controlled conditions (explanatory RCTs) and RCTs that are performed under more real world conditions (pragmatic RCTs) since there may be variability between them. The purpose of this research was to explore how much these trial types affect variability, otherwise known as heterogeneity, in systematic reviews. We applied a scoring tool called the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) to RCTs within 10 systematic reviews with at least moderate heterogeneity and performed statistical modelling to determine how much heterogeneity could be explained by a trial being more or less pragmatic. Results showed that trial type did not explain heterogeneity therefore it is probably reasonable to meta-analyze data from pragmatic and explanatory RCTs.

Educators and researchers continue to explore the benefits, real or imagined, of implementing pair programming as part of the computer science pedagogy. Current reviews of computer science educational research practices do not focus on educational pair programming. This thesis presents a review of the research methods used in recent educational pair programming research. The primary purpose of this review is to inform the ongoing dialogue about and to provide evidence-based recommendations for improving educational pair programming research. Replicating the design of a previous computer science education methodological review, this study inspected a sample of 108 articles from a population of 129 of articles related to educational pair programming published from 2000 to 2008. Articles were classified using a 112-variable taxonomy, identifying report elements, research methodology, research design, kinds of variables inspected, and statistical practices. Major findings include several differences between the methodological characteristics of educational pair programming research when compared to general computer science education research, including: (a) an increased proportion of studies involving human participants, (b) a decreased proportion of quantitative methodologies, and (c) an increased proportion of controlled research designs. There exists some minor evidence that researchers affiliated with institutions in the United States are more likely than their counterparts outside of the United States to inspect only student attitudes and implement a posttest-only research design, and less likely to implement an experimental or quasi-experimental methodology

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Introduction: Quality improvement (QI) encompasses a wide range of healthcare studies and activities with the common goal of improving patient outcomes, healthcare system performance, and professional development. QI is characterized by a diversity of definitions, stakeholders, clinical fields and study designs, which creates challenges for rigorous reporting and evaluation of these studies. Understanding and addressing the methodological issues that arise from conducting QI studies from multiple clinical disciplines is critical for generating good evidence for healthcare improvement to tackle health system challenges. Objectives: This thesis addressed three independent objectives: (i) Determine the quality of reporting of QI studies in neonatology. (ii) Compare different statistical methods that can be used to analyze data from a cluster randomized controlled trial with repeated measures data and examine how the estimate of intervention effects varies between these approaches. (iii) Determine the cost-effectiveness of providing timely surgery or timely rehabilitation for patients with hip fracture. Methods: Objective 1: We conducted a systematic survey of quality improvement studies in neonatology to examine the extent to which these publications adhered to SQUIRE 2.0, the guidelines for reporting studies that sought to improve the quality, safety, and value of healthcare. Using the same set of articles, we examined how various methodological attributes, such as stakeholder engagement, outcome measures, and statistical process controls, are reported in these studies. Objective 2: To compare the differences in the statistical estimates of intervention effects between linear mixed models and Generalized Estimating Equations, for the CP@Clinic Program cluster randomized RCT, which contains routinely collected monthly outcome data aggregated at the cluster level. Objective 3: We constructed a Markov cohort model to estimate the cost-effectiveness of receiving timely surgery within 24 hours of admission to the emergency department, receiving immediate admission to inpatient rehabilitation following acute care discharge, receiving both, or none. Results: Objective 1: In our assessment of reporting quality, we found that adherence to SQUIRE 2.0 guidelines was inadequate and that journals should endorse the SQUIRE 2.0 guideline for improvement publications to alleviate this issue. We found that process measures was the most frequently reported methodological attribute (89%), while stakeholder engagement with leadership (32%) or caregivers (10%) were infrequently reported or conducted. Objective 2: In comparing statistical methods for analyzing a cluster randomized controlled trial with correlated data, we found that it was critical to apply a correction to the variance estimator of generalized estimating equations to produce robust estimates of the intervention effects. Objective 3: In our economic evaluation, both timely surgery alone and the combination of timely surgery and timely rehabilitation yielded cost-effective improvements in the quality-adjusted life-years of patients with hip fracture. However, the combination of receiving timely surgery and timely rehabilitation requires a high willingness-to-pay threshold, above $128,000 per quality-adjusted life-years, to be considered cost-effective. Conclusions: Overall, understanding the state of reporting and the broad spectrum of methods and methodologic issues for evaluating quality improvement initiatives will advance its rigorous research, evaluation, reporting, and contribution towards informed decision-making for tackling pressing healthcare issues. / Thesis / Doctor of Philosophy (PhD) / Quality improvement (QI) is a field of healthcare research that can be defined in many ways, and research in this field is conducted by researchers from various medical disciplines. Consequently, challenges may arise in reporting and evaluating QI interventions. Thus, it is important to examine how QI interventions are reported in academic literature and the methods used to evaluate their effectiveness in improving health. The current thesis aims to address these issues through three independent objectives: (1) examine the details reported in QI studies in neonatology, (2) compare different statistical methods that can be used to analyze data from a community paramedicine cluster randomized controlled trial, and (3) investigate whether providing timely surgery and timely hospital-based rehabilitation is a cost-effective way to improve the quality of life of patients who have experienced hip fracture. The findings of these studies will provide insights into the challenges of reporting and evaluating QI interventions, and suggest ways to improve them.