1. 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

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. 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

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 = 32 subcategories for routine surveillance,
less than the current 36 in paper-based quarterly report form

9. Treatment outcome categories and definitions

10. 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?

11. 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

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 of first 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)