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Definitions and reporting framework

for tuberculosis – 2013 revision

Dennis Falzon Global Forum of Xpert MTB/RIF Implementers

Annecy – 17 April 2013

2 Definitions and reporting framework for TB – 2013 revision Annecy - 17 April 2013

2-year revision process

WHO/HTM/TB/2013.2 www.who.int/iris/bitstream/10665/79199/1/9789241505345_eng.pdf

http://www.who.int/iris/bitstream/10665/79199/1/9789241505345_eng.pdf


Revision process Collaborative work of World Health Organization (WHO) staff at different levels, technical partners and national staff.

• May 2011: expert consultation in Geneva, Switzerland.

• June 2011: WHO’s Strategic and Technical Advisory Group on TB (STAG-TB)

• July 2011: presentations and discussions with WHO regional and country staff, Geneva, and subsequent further consultation with WHO staff.

• October 2011: meeting of the DOTS Expansion Working Group, Lille, France.

• E-mail consultation with a wide range of countries and technical partners between November 2011 and March 2013.

• Seven countries (Belarus, Brazil, Cambodia, Djibouti, Estonia, Pakistan, Philippines) pilot the definitions and forms in 2012 and provide feedback


Objectives

Outline the main changes in the 2013 document :

1) Definitions: basic TB & rifampicin-resistant TB (RR-TB)

2) Reporting framework: basic TB & RR-TB


Definitions (1)

Basic TB (2009) M/XDR-TB (2008)


1. Bacteriological confirmation needs to consider results from new WHO-approved rapid diagnostics (WRD), including Xpert MTB/RIF

2. Patients diagnosed with rifampicin-resistant TB (RR-TB) using WRD need separate enumeration from confirmed MDR-TB cases for surveillance and monitoring

3. Simplification of definitions of Cured and Treatment failed in RR-TB cohorts to allow their application while patient is still on treatment

4. Less judgmental language : defaulter replaced by Lost to follow-up and TB suspect by presumptive TB

Definitions (2) Main motivation for revisions


Presumptive TB : a patient who presents with symptoms or signs suggestive of TB (previously TB suspect)

TB case

A bacteriologically confirmed TB case : a biological specimen is positive by smear microscopy, culture or WRD. All such cases should be notified, regardless of whether TB treatment has started (previously Definite TB case; now includes explicit mention of WRD)

A clinically diagnosed TB case : not bacteriologically confirmed but diagnosed with active TB by a clinician or other medical practitioner who has decided to give the patient a full course of TB treatment (previously a case of TB, not considered Definite)

Definitions (3)


Classification by site of disease

Pulmonary tuberculosis (PTB) : any TB case with involvement of the lung parenchyma or the tracheobronchial tree. Includes miliary and mixed PTB/extrapulmonary (specific mention of tracheobronchial tree)

Extrapulmonary tuberculosis (EPTB) : any TB case with involvement of organs other than the lungs, e.g. pleura, lymph nodes, abdomen, genitourinary tract, skin, joints and bones, meninges (no change)

Definitions (4)


Classification by previous TB treatment history (1)

New : never been treated for TB or have taken anti-TB drugs for less than 1 month (no change)

Previously treated : have received 1 month or more of anti-TB drugs in the past (no change)

Definitions (5)



Main change is for the Previously treated cases in whom the focus is now on previous treatment history, independent of bacteriological confirmation or site of disease (NB: for RR-TB these groups are different).

Relapse : previously treated for TB, were declared cured or treatment completed at the end of their most recent course of treatment, and are now diagnosed with a recurrent episode of TB (either a true relapse or a new episode of TB caused by reinfection)

Treatment after failure : previously treated for TB and whose treatment failed at the end of their most recent course of treatment

Definitions (6)



Treatment after loss to follow-up : previously treated for TB and were lost to follow-up at the end of their most recent course of treatment (previously known as treatment after default)

Other previously treated : previously treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented (cases with unknown previous TB treatment history classified separately)

Unknown previous TB treatment history : do not fit into any of the other categories (new group)

Definitions (7)


Classification by HIV status

HIV-positive TB patient refers to any TB case who has a positive result from HIV testing conducted at the time of TB diagnosis or other documented evidence of enrolment in HIV care1, such as enrolment in the pre-ART register or in the ART register once ART has been started.

HIV-negative TB patient refers to any TB case who has a negative result from HIV testing conducted at the time of TB diagnosis. Any HIV-negative TB patient subsequently found to be HIV-positive should be reclassified accordingly.

HIV status unknown TB patient refers to any TB case who has no result of HIV testing and no other documented evidence of enrolment in HIV care1. If the patient’s HIV status is subsequently determined, he or she should be reclassified accordingly. 1) A guide to monitoring and evaluation for collaborative TB/HIV activities (whqlibdoc.who.int/publications/2009/9789241598194_eng.pdf)

Definitions (8)

http://whqlibdoc.who.int/publications/2009/9789241598194_eng.pdf









Classification based on drug resistance (1)

Main change : inclusion of rifampicin-resistant TB (RR-TB). RR-TB includes any resistance to rifampicin, whether monoresistance, multidrug resistance, polydrug resistance or extensive drug resistance.

Category is not mutually exclusive with the others.

Rifampicin resistance: resistance to rifampicin detected using phenotypic or genotypic methods, with or without resistance to other anti-TB drugs. (new definition)

Definitions (9)



Monoresistance: resistance to one first-line anti-TB drug only (no change)

Polydrug resistance: resistance to more than one first-line anti-TB drug (other than both isoniazid and rifampicin) (no change)

Multidrug resistance: resistance to at least both isoniazid and rifampicin. (no change)

Extensive drug resistance: resistance to any fluoroquinolone and to at least one of three second-line injectable drugs (capreomycin, kanamycin and amikacin), in addition to multidrug resistance. (no change)

Definitions (10)



NOTE:

Monoresistance and polydrug resistance are usually applied to first-line drugs only (R, H, E and S). Future drug regimens may make it important to classify patients by their strain resistance patterns to fluoroquinolones, second-line injectable agents and any other drug for which reliable DST becomes available.

Definitions (11)


Two sets of definitions for two, mutually-exclusive treatment outcome cohorts :

1) Outcomes for TB patients, excluding patients treated for RR-TB (“Basic TB”)

2) Outcomes for RR-TB/MDR-TB/XDR-TB patients treated using second-line treatment (“RR-TB”)

Treatment outcome definitions (1)


The first group (“Basic TB”) may include cases who have drug-susceptible TB, or other forms of resistance (eg, INH-resistance) not requiring a full second-line regimen for MDR-TB. Outcomes are assigned to all bacteriologically confirmed and clinically diagnosed TB cases including those who die or who are lost to follow-up before starting treatment.

The second group (“RR-TB”) includes all RR-TB, MDR-TB and XDR-TB cases, confirmed or presumptive, started on combination second-line regimen for MDR-TB as per the local policy. Outcomes are assigned to all. For treatment outcome monitoring, only laboratory confirmed RR-TB (+ MDR-TB/XDR-TB ) are enumerated.

A patient included under “Basic TB” who is later switched to a combination second-line regimen for MDR-TB, because of confirmed or presumptive RR-TB, is removed from the first group and included only in the RR-TB cohort. If no combination second-line regimen for MDR-TB is started the patient is retained in the first group and assigned an outcome accordingly.



Basic TB: outcomes for TB patients, excluding patients treated for RR-TB (1)

Two significant changes.

1) Treatment failed : a case confirmed to be MDR-TB is no longer automatically assigned this outcome. If the patient is started on a combination second-line regimen for MDR-TB the case is excluded from the “Basic TB” cohort when calculating treatment outcomes and transferred to the “RR-TB cohort”. If treatment with a combination second-line regimen for MDR-TB is not possible, the patient is kept in the “Basic TB” cohort and assigned an outcome from among those below.

2) Previous category Transfer out merged with Not evaluated




Cured : a pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment who was smear- or culture-negative in the last month of treatment and on at least one previous occasion (only pulmonary; initial bacteriological confirmation may be based on WRD)

Treatment completed : a TB patient who completed treatment without evidence of failure BUT with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative, either because tests were not done or because results are unavailable (no change)




Treatment failed : sputum smear or culture is positive at month 5 or later during treatment (no longer includes systematically any case with confirmed MDR-TB) Died : for any reason before starting or during the course of treatment (no change) Lost to follow-up : did not start treatment or treatment interrupted for 2 consecutive months or more (previously Default) Not evaluated : no treatment outcome is assigned. Includes cases “transferred out” to another treatment unit as well as cases for whom the treatment outcome is unknown to the reporting unit (now also includes previous Transfer out category) Treatment success : cured + treatment completed (no change)



RR-TB: outcomes for RR-TB/MDR-TB/XDR-TB patients treated using second-line treatment (1)

Cured : Treatment completed as recommended by the national policy without evidence of failure AND three or more consecutive cultures taken at least 30 days apart are negative after the intensive phase (negative cultures counted after the intensive phase no longer limited to last 12 months of treatment)

Treatment completed : Treatment completed as recommended by the national policy without evidence of failure BUT no record that three or more consecutive cultures taken at least 30 days apart are negative after the intensive phase (changes only insofar as applied to Cured)




Treatment failed : Treatment terminated or need for permanent regimen change of at least two anti-TB drugs because of: - lack of conversion by the end of the intensive phase, or - bacteriological reversion in the continuation phase after conversion to negative, or - evidence of additional acquired resistance to fluoroquinolones or second-line injectable drugs, or - adverse drug reactions (ADRs) (definition now determined primarily by changes required to the regimen as a result of non response as determined by lack of conversion, reversion, amplification or ADRs)




Lack of conversion by the end of the maximum intensive phase used by the programme.

If no maximum duration is defined, an 8-month cut-off is proposed.

If regimens do not have a clear distinction between intensive and continuation phases, a cut-off 8 months after the start of treatment is suggested to determine when the criteria for Cured, Treatment completed and Treatment failed start to apply.

Reversion (to positive): after an initial conversion, 2 consecutive cultures, at least 30 days apart, are positive. For Treatment failed, reversion considered only when it occurs in the continuation phase.




Died : for any reason during the course of treatment (no change)

Lost to follow-up : treatment interrupted for 2 consecutive months or more (previously Defaulted)

Not evaluated : no treatment outcome is assigned (This includes cases “transferred out” to another treatment unit and whose treatment outcome is unknown) (now also includes previous Transferred out category)

Treatment success: cured and treatment completed (no change)



Reporting framework (1)

2006 M/XDR-TB (2008)


1. Combining outcome reporting for drug-sensitive and RR-TB for countries where programmatic management of DR-TB is incorporated (“mainstreamed”) in the NTP

2. Childhood TB reporting was incomplete because age disaggregation was previously limited to sputum smear-positive TB, which is uncommon in children

3. There was a delay of two calendar years in the reporting of co-trimoxazole preventive therapy (CPT) and antiretroviral therapy (ART) in TB/HIV because these data were collected only in the treatment outcome reports and not in the case registration reports

Reporting framework (2) Main motivation for revisions


8 revised forms, registers and reports

Forms for human resource or management of consumables not covered in this document

Revised forms and reports for RR-TB will be discussed in greater detail in the forthcoming “Companion handbook to the 2011 WHO guidelines for the programmatic management of drug-resistant tuberculosis”



Reporting framework (4) Request for examination of biological specimen for TB (1)

Main changes : not focused solely on sputum; inclusion of LPA & Xpert MTB/RIF test results; HIV-status

HIV status and previous treatment status included to assess adherence to, and results of, testing algorithms. HIV status may have to be omitted to comply with national confidentiality regulations

If several types of specimen (e.g. sputum and other fluids) are to be analysed, separate request forms to accompany each specimen

If multiple analyses (e.g. culture and DST on the same sputum sample) are requested, results should be sent from the laboratory to the requestor as they become available. It may therefore be practical to produce the request forms in booklets with self-carbonated paper. Some countries may want to use separate forms to request smear, culture, Xpert MTB/RIF or DST separately.


Reporting framework (5) Request for examination of biological specimen for TB (2)

Xpert MTB/RIF results reporting codes

T = MTB detected, rifampicin resistance not detected

RR = MTB detected, rifampicin resistance detected

TI = MTB detected, rifampicin resistance indeterminate

N = MTB not detected

I = invalid / no result / error


Reporting framework (6) Basic management unit (BMU) TB register (1)

This register (sometimes called the district TB register) is used for recording the data needed to monitor BMU performance. It is intended primarily to generate indicators and reports about TB patients. It is also commonly used to summarize testing results and treatment decisions in order to determine whether basic diagnostic and treatment guidelines are correctly implemented.

The register should contain the records of all patients diagnosed with TB and eligible for TB treatment, including those diagnosed with RR-TB or MDR-TB, regardless of whether treatment was actually started. All of these cases are notifiable and should be included in the summary case notification reports sent to higher levels. The registration date is the date on which the BMU decides that a patient has TB and is eligible for treatment.


Reporting framework (7) Basic management unit (BMU) TB register (2)

Bacteriological examination before the start of treatment (“month 0”) now allows for results from Xpert MTB/RIF test. Space is provided for recording whether the case is RR-TB or MDR-TB, replacing X-ray result

Treatment categories have now changed: - initial regimen with first line drugs (previously Category 1 or 3) - retreatment regimen with first line drugs (previously Category 2) - second-line treatment regimen (previously Category 4)

Unknown previous TB treatment history – new

Revised treatment outcome definitions

Dates for HIV testing and start of ART/CPT removed from register


Reporting framework (9) Second-line TB treatment register (1)

This register is intended primarily to keep a record of those data needed for generating indicators and reports of patients on combination second-line regimens for MDR-TB (including RR-TB).

This register is also commonly used to follow, at a glance, the adequacy of testing and treatment decisions.

In contrast to the BMU register, it is restricted to patients who have actually started on a second-line TB treatment regimen.


Reporting framework (10) Second-line TB treatment register (2)

Replaces “Category IV Register”

RR-TB or MDR-TB cases registered, confirmed or presumptive

Bacteriological examination before the start of treatment (“month 0”) now allows for results from Xpert MTB/RIF test.

Unknown previous TB treatment history – new

Revised treatment outcome definitions

Dates for HIV testing and start of ART/CPT removed from register


Reporting framework (11) Laboratory register for smear microscopy and Xpert MTB/RIF

For laboratories undertaking both sputum-smear microscopy and Xpert MTB/RIF examinations.

When serial sputa are tested using microscopy, results are recorded on the same line. This also applies if both direct sputum smear microscopy and Xpert MTB/RIF examinations are carried out for the same patient.

HIV status and previous treatment status are included so that adherence to, and effectiveness of, testing algorithms can be assessed. HIV status can be omitted if necessary to comply with national confidentiality laws.

Programmes could have separate registers for smear and Xpert MTB/RIF examinations rather than a combined register if these tests are performed in different locations. In such cases common fields should appear in both registers, and fields specific to each test should appear only in the relevant register.


Reporting framework (12) Laboratory register for culture, Xpert MTB/RIF and drug susceptibility testing (1)

For laboratories capable of undertaking more advanced specimen testing (culture, Xpert MTB/RIF, DST), such as reference labs.

The diagnostic method (culture or Xpert MTB/RIF) is indicated in the first two columns under “Type of examination”.

HIV status and previous treatment status are included so that adherence to, and effectiveness of, testing algorithms can be assessed. HIV status can be omitted if necessary to comply with national confidentiality laws.


Reporting framework (14) Laboratory register for culture, Xpert MTB/RIF and drug susceptibility testing (2)

Programmes could have registers with any combination of culture, Xpert MTB/RIF or DST rather than a combined register with all tests, depending on circumstances. In such cases common fields should appear in both registers, and fields specific to each test should appear only in the relevant register.

Laboratories using different methods for DST may include a separate column to indicate details of the test (solid media DST; liquid media DST; direct LPA; indirect LPA) if they wish to compile reports based on test type.


Reporting framework (15) Quarterly report on TB case registration in the BMU (1)

The standard aggregated report of cases as in the BMU TB register and of laboratory activity as in the laboratory register

Cases are now stratified by three different categories of site of disease + bacteriological confirmation / clinical diagnosis combinations, as well as four previous TB history categories

Incident cases (new and relapses) are broken down by age group and sex


Reporting framework (16) Quarterly report on TB case registration in the BMU (2)

Yield of all bacteriological confirmatory testing of patients with presumptive TB

Number of HIV-positive patients on ART and CPT during the quarter. This is a change from the 2006 version of the forms and reports where ART and CPT coverage was compiled only in the treatment outcome report, meaning that assessment of ART and CPT coverage became available nationally a minimum of 12 months after registration


Reporting framework (17) Quarterly report on TB treatment outcomes in the BMU

The standard quarterly report for all TB cases that have not been started on combination second-line regimens for MDR-TB (or RR-TB)

4 outcome cohorts for (i) new & relapse by bacteriological confirmation, (ii) other retreatment and (iii) TB/HIV cases

+ Coverage of ART and CPT among HIV-positive TB patients


Reporting framework (18) Combined annual treatment outcomes report for basic TB and for RR-TB/MDR-TB

This new form captures on one sheet the outcomes for annual cohorts of patients on first-line and second-line TB treatment. It is targets decentralized MDR-TB services where both types of treatment are available

Block 1 is the standard basic TB treatment cohort annual report for the year minus 2 (e.g. the 2011 cohort is assessed in 2013), with four separate cohorts (as per quarterly report)

Block 2 is for the second-line treatment outcome cohort of the year before that of Block 1 (i.e. year minus 3; e.g. the 2010 RR-TB cohort is assessed in 2013) (Now includes all types of RR-TB combined)


Reporting framework (19) Combined annual treatment outcomes report for basic TB and for RR-TB/MDR-TB


Move towards automated solutions

WHO/HTM/TB/2011.22

whqlibdoc.who.int/publications/2012/9789241564465_eng.pdf


Additional slides : Indicators


Compendium of Indicators for M&E of NTPs

WHO/HTM/TB/2004.344

www.who.int/tb/publications/tb_compendium_of_indicators


Indicators for RR-TB / MDR-TB / XDR-TB (1)

2010

• Released just before WHO’s endorsement of Xpert MTB/RIF

• Focused on MDR-TB

and XDR-TB


- Objective: minimum indicators for national or project level monitoring and

- suitable for different partners (WHO, TGF)

- easily extracted manually or electronically

- conform to what was used in past and DOTS system

- Focus on indicators rather than forms



Indicators being updated in the «Companion handbook to the 2011 WHO guidelines for PMDT», due out in 2013 Dedicated Chapter & Annexes



Stratification Computed Cohort Indicator Group

Risk categories 3 months after

end of semester

6 months Detection (4)

Children, females,

HIV-positive on

ARV

1 month after

end of semester

6 months Enrolment (4)

None 9 months after

end of quarter

3 months Interim results (5)

HIV positive

(success and

death); XDR *

24 months after

end of year

12 months Final outcomes (6)

* Recommended stratification as per conditions specified in instructions



2013 2012 2011 2010

Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1

Detection, Enrolment : 2 yearly Interim results : 4 yearly Final outcomes : 1 yearly


Overall timeline


Indicators for RR-TB / MDR-TB / XDR-TB (6) Detection

Number of TB cases Risk category

(list as many as

exist) With MDR

and tested for

FQN & 2nd

line inj.

Resistant to

both H & R

(MDR)

With results

for H & R

Total

Risk category 1

(specify)

Risk category 2

(specify) …

…

Total

Interval between suspicion and DST results (days) No. of MDR-TB

cases with

information on

interval

Maximum Minimum Mean


TB patient type Identified during assessment period

Enrolled on M(X)DR-TB treatment during period of assessment

All patients eligible for treatment*

< 15 y

Female

Confirmed MDR

Confirmed MDR, HIV+ on ART

Confirmed MDR, HIV+ not on ART

Confirmed XDR

Interval between DST results and start of treatment (in days) Number of MDR-TB cases with information on interval

Mean Minimum Maximum

* suspected or confirmed MDR

Indicators for RR-TB / MDR-TB / XDR-TB (7) Enrolment


Number of patients started on MDR-TB treatment found not to have MDR

Number of patients started on treatment for XDR-TB found not to have XDR

Indicators for RR-TB / MDR-TB / XDR-TB (8) Interim results


Not

evaluated

Lost to

follow-up

Died Treatment

failed

Treatment

completed

Cured No of

cases started on treatment

TB patient type

N N N N N N

All confirmed

RR-TB/MDR-TB

cases

HIV+ve RR-

TB/MDR-TB

cases*

All confirmed

XDR-TB cases *

* Recommended stratification only when conditions are frequent (see main document)

Indicators for RR-TB / MDR-TB / XDR-TB (9) Final outcomes

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