Members of the THETA Clinical Research Division have considerable experience with the design and implementation of provincial, national and international experimental and observational studies and registries. We have extensive methodological and infrastructure support for items such as database architecture and management and statistical support.
THETA has gained unique experience in conducting trials in the community and in the long-term care and home care settings in which it is extremely difficult to perform clinical research. Furthermore, THETA has substantial experience with the design, implementation and evaluation of complex health interventions using a mixed-methods approach. While for policy decisions, it is critical to know whether an intervention works; with complex health interventions, it is essential to also understand why something works (or fails to work). Using an overarching complex interventions methodological framework, the need for a range of studies becomes clearer, including qualitative and observational research designs.
The division specializes in and has published in the areas of:
- Experimental studies:
- Randomized controlled trials (RCTs)
- Pragmatic randomized trials
- Stepped-wedge cluster randomized trials
- Observational studies (longitudinal cohort studies)
- Complex health interventions
- Program evaluations
Members of Clinical Research Division possess a broad range of methodological expertise and practical experience including: pragmatic trials, evaluation of complex interventions and large provincial, national and international programs including effectiveness, cost-effectiveness, patient and provider preferences, and feasibility of implementation and scalability applying mixed method approach. We have extensive methodological and infrastructure support for items such as database architecture and management and statistical guidance.
New technologies and drugs are reaching the market at an astounding rate, creating extreme pressures within our publicly-funded health system. The Ontario Ministry of Health and Long-Term Care relies on the Ontario Health Technology Advisory Committee (OHTAC) and its Medical Advisory Secretariat (MAS) to provide evidence-based policy advice on the adoption of new health technologies THETA provides health policy analysts at MAS with a wide variety of methodological and technical support, including: field evaluations, comprehensive evidence synthesis and economic evaluation. Technical support is provided in complex decision modeling, Bayesian methods, utility assessment, and the use of administrative data for health technology assessment.
Health utility and quality of life provide researchers and decision-makers with the ability to measure improvements in health outcomes beyond mortality figures. These measures are significant in health technology assessments because they also capture issues of quality of life from the perspective of the patient.
Health-related quality of life may be measured using non-preference or preference-based approaches. Preference-based approaches measure quality of life using utility, a global measure of health status, scaled from 0-1. Utility is used to calculate quality-adjusted life years (QALY) in cost-effectiveness analyses and decision models.
- THETA investigators have particular interest in:
- developing population-based reference values for utilities
- measuring disease/condition-specific utilities
- developing and assessing quality of life and health outcome scales using classical and modern measurement methods, including Rasch and Mokken analyses
- exploring the relationship between patient and surrogate values/utilities, and
- measuring utilities in special populations (e.g., patients with HIV, Hepatitis C and Alzheimer's Disease, and children).
Shabbir Alibhai, MD, MSc, FRCPC
Ahmed M. Bayoumi, MD, MSc, FRCPC
Murray Krahn, MD, MSc, FRCPC
Linda D MacKeigan, BSc, Phm, PhD
Gary Naglie, MD, FRCPC
George Tomlinson, MSc, PhD
Wendy Ungar, MSc, PhD
THETA research activities include the novel application of existing Biostatistics and Epidemiology methods or development of new ones in an effort to facilitate all phases of prospective or retrospective studies for generating and strengthen clinical evidence for HTA. Examples include designing and analyzing pragmatic stepped wedge design trials, measuring the impact of treatment uptake increase on mortality and others.
Nicholas Mitsakakis, MSc, PhD
Lusine Abrahamyan, MD, MPH, PhD
Petros Pechlivanoglou PhD
Ba' Pham, MSc, PhD
Eleanor Pullenayegum, PhD
George Tomlinson, MSc, PhD
Andrew Willan, MSc, PhD