overview of current mdr-tb case definitions and treatment outcome dennis falzon consultation :...
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Overview of current MDR-TB case definitions and treatment outcome
Dennis Falzon
Consultation : Impact of WHO-endorsed molecular diagnostics on TB and MDR-TB case- and treatment
outcome definitions
WHO/HQ, Geneva, Switzerland – 12-13 May 2011
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Reference
whqlibdoc.who.int/publications/2008/9789241547581_eng.pdf
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Definitions (1)
- Allow different workers throughout the programme to think in the same way
- Standardize the assignment of treatment to patients
- Define a cohort for outcome monitoring
- Make meaningful comparisons- Between projects and countries- Over time
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Definitions (2)
1. Bacteriology
2. Case registration
3. Treatment outcomes
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Bacteriology (1)
- DR-TB is a laboratory definition
- Laboratory needed for
- diagnosis
- follow-up
- outcome determination
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Bacteriology (2)• Mono-resistance: resistance to one anti-TB drug*.
• Poly-resistance: resistance to more than one anti-
TB drug, other than both isoniazid and rifampicin*.
• Multidrug-resistance: resistance to at least isoniazid
and rifampicin.
• Extensive drug-resistance: resistance to any
fluoroquinolone, and at least one of three injectable
second-line drugs (capreomycin, kanamycin and
amikacin), in addition to multidrug-resistance.
*For cases tested to all the "usual" anti-TB drugs (RHEZS+SLDs)
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Bacteriology (3)
Sputum conversion
2 samples at least 30 days apart with negative results
The date of the first set of negative tests used as the date of conversion for interim outcome, and length of the initial phase and treatment
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Case registration (1)
Category IV includes :
- Confirmed MDR-TB
- Suspected MDR-TB: country criteria
- Poly-resistant TB: certain types
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Case registration (2)
1. By previous drug use
- New
- Previously treated*, first-line drugs only
- Previously treated*, second-line drugs
* Treated for TB, for at least one month or 4-weeks
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Case registration (3)
2. By patient registration group- New
- Relapse
- After default
- After failure of Category I
- After failure of Category II
- Transfer in
- Other
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Case registration (4)
Other
- smear positive, previous history unknown
- smear positive, previous history not Cat I / II
- previously treated extrapulmonary
- "chronics"
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Treatment outcomes (1)
1) interim outcomes : 6-months
2) definitive outcomes : 24-, 36-months
- mutually exclusive
- "first outcome met" principle
- cured & failed defined by culture
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Treatment outcomes (2)
1) Cured
2) Treatment completed
3) Died
4) Failed
5) Defaulted
6) Transferred out
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Treatment outcomes (3)
Cured: A Category IV patient who has completed treatment according to programme protocol and has at least five consecutive negative cultures from samples collected at least 30 days apart in the final 12 months of treatment. If only one positive culture is reported during that time, and there is no concomitant clinical evidence of deterioration, a patient may still be considered cured, provided that this positive culture is followed by a minimum of three consecutive negative cultures taken at least 30 days apart.
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Treatment outcomes (4)
Failed: Treatment will be considered to have failed if two or more of the five cultures recorded in the final 12 months of therapy are positive, or if any one of the final three cultures is positive. (Treatment will also be considered to have failed if a clinical decision has been made to terminate treatment early because of poor clinical or radiological response or adverse events. These latter failures can be indicated separately in order to do subanalysis)
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Definition of Failed
Can only be applied retrospectively
Does not indicate point in time when failure occurs
Change of a failing regimen not accounted for
Focused primarily on bacteriology
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Treatment outcomes (5)
CURED : last 12 months, 5 negative cultures
Months 22 23 24 25 26
Sputumculture N
PATIENT 1
21
N P N N N
Months 11 12 13 14 15
Sputumculture P
PATIENT 2
10
N N N P N
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Minimum MDR Indicators, 2010
whqlibdoc.who.int/hq/2010/WHO_HTM_TB_2010.11_eng.pdf
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Revised R&R for MDR (1)
Indicator GroupDisaggregation
Detection (4)Risk categories
Enrolment (4)Children, females, HIV-positive on ARV
Interim results (5)None
Final outcomes (6)HIV positive; XDR (success and death) *
* Recommended stratification as per conditions specified in instructions
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Changes (1)
Separate stratifications for
– Risk categories (detection)– Children (enrolment)– Females (enrolment)– HIV-positive individuals (+/- ART) (enrolment, outcome)
Coverage of DSTing and DST results in risk groups
No stratification of outcome by prior treatment history
Separate outcomes for XDR and HIV positive where indicated
Intervals (delays) in diagnosis and in start of treatment
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Changes (2)
Detection & enrolment: minimum frequency
Ratio of "enrolled to identified" MDR
Interim outcome: just 6-month conversion of culture
Outcomes : “transferred out” merged with unevaluated; information on unwarranted MDR/XDR treatment
No changes in the definitions, registers or treatment card
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Acknowledgements for the Minimal MDR indicators
- Working group : Dennis Falzon, Philippe Glaziou, Nico Kalisvaart, Joël Keravec, Carole Mitnick, Pierre-Yves Norval, Edine Tiemersma, Arnaud Trébucq, Francis Varaine
- Substantive comments : Amal Bassili, Jaime Bayona, Salem G Barghout, Léopold Blanc, Haileyesus Getahun, Agnes Gebhard, Christian Gunneberg, Peter Metzger, Nani Nair, Norbert Ndjeka, Wilfred Nkhoma, Mamel Quelapio, Vija Riekstina, Sarah Royce, Patricia Shirey, Fraser Wares, Matteo Zignol