Goal Objectives Expected Outcomes 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 outcomes for 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

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

Case Definitions

Current Case Definitions 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 MDR-TB case TB caused by Mtb resistant in vitro to isoniazid and rifampicin, with or without resistance to other drugs

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

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

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

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

Treatment outcome categories and definitions

Treatment outcomes – which categories of case? – Option 1 Non-MDR-TB MDR-TB 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 Question: disaggregate all outcome categories by sex in countries with ERR?

Treatment outcomes – which categories of case? – Option 2 Non-MDR-TB MDR-TB 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 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 of first treatment) Cure, failed, died, interrupted, not evaluated

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

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)