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4th Advanced TB Diagnostic Research - McGill International TB Centre

Also, conventional and advanced methods for systematic reviews (meta-analyses) of diagnostic tests will be presented, along with the GRADE approach to diagnostic policies. More recently, there is growing appreciation that “test accuracy research” focused on sensitivity and specificity is not necessarily the same as “diagnostic research.” There is also a clearly felt need to go beyond test accuracy and evaluate accuracy of diagnostic algorithms (rather than single tests) and their relative contributions to the health care system, incremental value of new tests, impact of new tests on clinical decision-making and therapeutic choices, cost-effectiveness in routine programmatic settings, and impact on patient-important outcomes. This course will introduce multivariable approaches to diagnostic research, and cover alternative designs which evaluate patient outcomes, including the diagnostic RCT, and implementation research. The course will also cover mathematical modeling and cost-effectiveness studies. Panel discussions will cover topics such as market analyses, market dynamics, regulatory issues, target product profiles, and industry engagement in TB diagnostics development.


By the end of the course, participants will understand:

• the value chain for TB diagnostics development, current pipeline of diagnostics, market dynamics, WHO policies on new diagnostics, and challenges for scale-up
• principles and practice of diagnostic research focused on accuracy of tests
• principles of multivariable approaches to diagnostic research, and adjustment for imperfect reference standards
• principles of meta-analyses of diagnostic accuracy studies and GRADE approach to diagnostic policies
• principles of alternative designs to evaluate impact of new tests on clinical decision-making, therapeutic choices, and patient-important outcomes
• principles of implementation research, collecting evidence for scale-up, cost-effectiveness analyses and modeling studies in TB diagnostics


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