RESEARCH IN DIAGNOSTICS FOR TUBERCULOSIS: FUNDAMENTALS, BEST PRACTICES, AND PRIORITIES 29 November to 1 December 2015 UCT Lung Institute, Cape Town http://www.lunginstitute.co.za/ Course schedule 1 Day 1, 29 November 2015 (Sunday) 8.30-9.30 Registration 9.30-9.45 Welcome, introductions, and goals Morning chairs: Keertan Dheda and Grant Theron THE BIG PICTURE: SETTING THE SCENE 9:45-10:15 Lecture A new era: progress and challenges in TB diagnostics 10.15-10.45 Lecture The END TB strategy: where do diagnostics fit in? 10.45-11.15 Refreshments METHODS 11.15-11.45 Lecture The diagnostic pathway 11.45-12.15 Lecture Study designs for diagnostic research 12.15-12.30 Questions and answers 12.30-13.30 Lunch (buffet lunch provided) Afternoon chair: Karen Steingart HOT TOPICS AND LESSONS FOM THE FIELD 13.30-14.00 Lecture Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial 14.00-14.30 Lecture The XTEND study: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF 14.30-15.00 Lecture The impact of point-of-care urine lipoarabinomannan testing for tuberculosis on mortality: a multi-country RCT 15.00-15.30 Refreshments PANEL DISCUSSION 15.30-16.30 Panel discussion When do we need randomized trials for TB diagnostics? Xpert has revolutionized TB diagnosis and control. Do you agree or disagree and why? Where in the clinical pathway should Xpert be placed along with other tests, such as urine LAM? What have we learned about diagnostic research from the rollout of Xpert and its impact on patient/public health? 17.00-18.00 Social reception Lobby, University Of Cape Town Lung Institute Keertan Dheda and Karen Steingart Keertan Dheda Khairunisa Suleiman Ruth McNerney Andre Kengne All Facilitator: Grant Theron Grant Theron Gavin Churchyard Jonny Peter All Panelists: Grant Theron, Gavin Churchyard, and Jonny Peter Facilitator: Karen Steingart 2 Day 2, 30 November 2015 (Monday) 9.00-9.15 Summing up/questions Lessons from day 1 Morning chair: Grant Theron THE BIG PICTURE: LESSONS FROM OTHER FIELDS 9.15-9.45 Lecture Diagnostic approaches in cardiology Grant Theron 9.45-10.15 Lecture Childhood pneumonia in the Drakenstein study Mark Nicol 10.15-10.35 10.35-11.00 METHODS 11.00-11.30 Lecture Refreshments IVD Regulatory landscape and HTA Ruth McNerney Lecture Understanding operational research Anthony Harries 11.30-12.00 Lecture The consensus clinical case definitions for childhood TB Stephen Graham 12.00-12.30 Discussion Involving stakeholders (e.g. TB programmes, communities, end users, patients) in diagnostic research All Facilitator: Ruth McNerney 12.30-13.15 Lunch (buffet lunch provided) Afternoon chairs: Molebogeng Rangaka and Stephen Graham HOT TOPICS AND LESSONS FROM THE FIELD 13.15-13.45 Lecture Research on diagnosing TB in children 13.45-14.15 Lecture Operational research in action PANEL DISCUSSION 14.15-15.00 Panel discussion National TB programmes should not be doing their own operational research. Do you agree or disagree and why? How do we overcome the challenges in diagnostic research for childhood TB? Scientific rigor versus pragmatism in TB diagnostic studies, how do we get the right balance? 15.00-15.30 Refreshments 15.30-16.00 Lecture Systematic reviews: what they are and why they are needed 16.00-16.30 Lecture GRADE approach for developing recommendations for TB diagnostics 16.30-17.00 Lecture WHO policy recommendations: the three most important lessons I have learned Bongani Mayosi Heather Zar Jacob Creswell All Panelists: Heather Zar, Anthony Harries, and Jacob Creswell Facilitators: Molebogeng Rangaka and Stephen Graham Taryn Young Karen Steingart Chris Gilpin 3 Day 3, 1 December 2015 (Tuesday) 9.00-9.15 Summing up/questions Morning chair: Karen Steingart THE BIG PICTURE: THE WAY FORWARD 9.15-9.45 Lecture 9.45-10.15 Lecture 10.15-10.45 Refreshments METHODS 10.45-11.15 Lecture 11.15-11.45 Lecture 11.45-12.30 Debate Lessons from day 2 Karen Steingart TB diagnostic research agenda, perspective from FIND Diagnosis of HIV-associated TB Claudia Denkinger Stephen Lawn Impact and cost-effectiveness: the contribution of modelling Added value of a new test Active case finding (ACF) refers to a strategy of actively searching for TB in a defined population, including community screening programmes. Is ACF the answer? David Dowdy Molebogeng Rangaka Pro: Liz Corbett Con: David Dowdy Moderator: Karen Steingart 12.30-13.30 Lunch (buffet lunch provided) Afternoon chair: Ruth McNerney HOT TOPICS AND LESSONS FROM THE FIELD 13.30-14.00 Lecture Fast followers and the NAAT pipeline 14.00-14.30 Lecture Whole genome sequencing for the detection of DR-TB 14.30-15.00 Lecture PET/CT for LTBI 15.00 -15.05 Small groups Allocate small groups 15.05-15.30 Refreshments 15.30-15.50 The future agenda, small group Priorities in TB diagnostic research discussion 15.50-16.10 Reporting back to the full Priorities top ten group 16.10-16.30 Course evaluation and distribution of certificates 16.30-16:45 Closing remarks Adjourn David Boyle Megan Murray Cliff Barry Facilitator: Ruth McNerney All All Facilitator: Ruth McNerney Karen Steingart Keertan Dheda 4