Stellenbosch University: Developing a framework for design of clinical trials to measure the impact of TB diagnostic tests on patient outcomes.

The need for better case detection for tuberculosis (TB) has spurred research into development of new diagnostic tests, such as the Xpert MTB/RIF test. While much focus has been placed on test performance characteristics and evaluating test accuracy, less thought has been given to the best way of evaluating the impact of these tests on treatment decisions (in the face of empiric therapy) or on TB-related morbidity and mortality. In this project I aim to evaluate randomised controlled trial (RCT) designs for measuring the impact of TB diagnostic tests on patient outcomes and develop a framework that will guide researchers in designing suitable trials for TB diagnostic tests. Specifically I aim to: -Identify, compare and critique the types of study designs for RCTs evaluating the impact of TB diagnostic tests on patient- centered outcomes. -Identify the commonly measured patient-centered outcomes in RCTs for TB tests, evaluate their suitability to study and the potential for bias in t heir measurement. -Assess the effect of different RCT diagnostic study designs on patient-centered outcomes in statistical models -Develop a framework that provides methodological guidance to researchers planning RCTs to evaluate the impact of TB diagnostic tests

Programme: International Training Fellowship

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