Goal

1. Goal • To discuss and refine current definitions of cases and treatment outcomes for non MDR-TB and MDR-TB, especially in anticipation of widespread use of Xpert MTB/RIF • Objectives • To review and propose refinements to current case definitions for non MDR-TB and MDR-TB • To review and propose refinements to current definitions of treatment outcomesfor non MDR-TB and MDR-TB • Expected Outcomes • Agreement on a proposed set of case and treatment outcome definitions, and steps required to adopt these definitions, for consideration by WHO's Strategic and Technical Advisory Group for TB (STAG-TB) in June 2011

2. Topics covered in discussions • Current case definitions and two options for revised case definitions • Disaggregations for reporting of cases i.e. for TB surveillance • keep as simple as possible, make sure there is a good reason for collecting the data • Treatment outcome categories for non-MDR TB, and definitions for each outcome • Treatment outcome categories for MDR-TB, and definitions for each outcome

3. Case Definitions

4. Definite TB case A patient with Mtb complex identified from a clinical specimen, either by culture or by a newer method such as molecular line probe assay + in countries that lack the laboratory capacity to routinely identify Mtb, a pulmonary case with ≥1 initial sputum smear examinations AFB-positive, IF there is a functional EQA system with blind rechecking TB case Definite cases + Patients that a health worker (clinician or other medical practitioner) has diagnosed with TB and has decided to treat with a full course of TB treatment Current Case Definitions MDR-TB case TB caused by Mtb resistant in vitro to isoniazid and rifampicin, with or without resistance to other drugs

5. Current Case Definitions - disaggregations • Cases are classified according to: • anatomical site of disease • bacteriological results (including drug resistance) • history of previous treatment • HIV status Source: 2009 WHO treatment guidelines These and further disaggregations are requested on WHO R&R forms and in global data collection form

6. Proposed case definitions Confirmed, probable, possible (option 2) ruled out Confirmed TB C+, WRD+ or Sm+ TB, for pulmonary and EPTB Not confirmed TB TB case put on full course of TB treatment who is not C+, WRD+ or sm+ Confirmed MDR-TB TB case with Mtb resistant in vitro to H and R, with/wo resistance to other drugs Probable MDR-TB TB case whose treatment was changed following interruption or failure and who is WRD+ for R resistance

7. Proposed disaggregations (1) 1) New 2) recurrent 3) treatment change Confirmed TB MDR-TB status among above 3 case types Probable MDR-TB among treatment change Not confirmed TB 1) New + recurrent 2) treatment change ??? Pulmonary/EP disaggregation Confirmed MDR-TB HIV and XDR status 17 subcategories for new + recurrent confirmed + not confirmed cases

8. Proposed disaggregations for new + recurrent (incident) TB cases Confirmed TB, new + recurrent HIV status (tested, HIV+, on ART) + 12 age and sex categories 0-4, 5-14,15-24, 25-44, 45-64, 65+ Not confirmed TB, new + recurrent 15 subcategories for new + recurrent confirmed + not confirmed cases Total of 17+15 = 32 subcategories for routine surveillance, less than the current 36 in paper-based quarterly report form

9. Treatment outcome categories and definitions

10. New (confirmed + not confirmed) Recurrent + treatment change (confirmed + not confirmed) New and recurrent HIV+(confirmed + not confirmed) First outcome of treatment XDR and HIV+ among MDR in countries with ERR Treatment outcomes – which categories of case? – Option 1 Non-MDR-TB MDR-TB Question: disaggregate all outcome categories by sex in countries with ERR?

11. New (confirmed) Recurrent + treatment change (confirmed) New + recurrent + treatment change (not confirmed) New and recurrent HIV+(confirmed) First outcome of treatment XDR and HIV+ among MDR in countries with ERR Treatment outcomes – which categories of case? – Option 2 Non-MDR-TB MDR-TB

12. Treatment outcome categories No transfer out, interrupted replaces default • Non MDR • Cure, completed treatment, failed, died, interrupted, not evaluated (national level) • Report cure and completed as collapsed category for global level, using terminology of treatment success • MDR (outcome offirst treatment) • Cure, failed,died, interrupted, not evaluated

13. MDR-TB treatment outcome definitions(first outcome of treatment) Existing definitions do not work for surveillance purposes • Success • Completed prescribed treatment course • Sputum or culture conversion • Remains negative • Failure • Need for permanent treatment change (of 2 classes of drugs) or termination of treatment because • lack of sputum or culture conversion, or • reversion to positive with or without clinical deterioration • adverse effects • Interrupted: > 2mo • Died • Not evaluated

14. Next steps • Update discussion document (keep background, then insert case definitions and treatment outcomes agreed in this meeting with questions requiring further discussion highlighted (end May) • Consider frequency/timing of reporting • Where does histology+ fit • Improve wording for MDR treatment outcomes (p15 discussion doc) • Check what is/is not captured vis à vis global report • Send feedback on MDR-TB treatment outcome definitions to MDR-TB WG for consideration (existing don't work for surveillance, but proposal from this group needs to be discussed by MDR-TB group that developed recent guidelines) (end May) • Present to STAG for feedback (June) • Consultation with multiple countries and other stakeholders (by October) • Pilot in sites rolling out Xpert (end 2011)