Recording and Reporting in

MDR-TB - Revisions

Sixth Meeting of the Working Group on

MDR-TB of the Stop TB Partnership

20 - 22 September 2007, Tbilisi, Georgia.

Einar Heldal, LHL

The revision of the R&R system:

• Intention: to clarify, simplify and shorten the R&R

system for drug resistant TB (ch 4, ch 18, forms).

• On-site visits to 6 countries (Romania,

Arkhangelsk/Russia, Rwanda, Nepal, The

Philippines, Peru) to assess implementation and

get input to improvements

• Workshop in Geneva May 2007

• Revisions drafted and discussed by a group

(Carole Mitnick, Refiloe Matji, Arnaud Trebucq,

Vija Riekstina, Matteo Zignol and Einar Heldal)

Aims of the R&R system:

• To allow managers of NTPs at different

levels to monitor overall programme

performance to provide the basis for

programme and policy developments.

• To aid staff in treatment units to provide

adequate management of individual

patients.

Performance indicators (basic):

• Final outcome of MDR-TB treatment

• Interim treatment outcome at 6-months of

MDR-TB cases

• Half-yearly or quarterly interim treatment

outcome (optional)

• Number of patients started on category IV

treatment

• Number of patients registered with

diagnostic category IV (burden of MDR-

TB)

Performance indicators

(additional):

• MDR-TB treatment coverage and

delay.

• DST coverage in patient groups

targeted for DST.

• Failures of Category II treatment (?)

• MDR-TB percentage in different

patient groups.

Page 1 of 4

Category IV Treatment Card

Name: _____________________________

Category IV registration Number: ______

Date of category IV registration: __/__/__

District Tb registration number:___

Date of district TB registration:_____

Address: __________________________

Country /District: ____________________

Treatment Centre: ____________________

Sex: M/F

Age:____ Date of Birth: __/__/____

Initial Weight(Kg): ____

Site: Pulmonary / Extrapulmonary/Both

If extrapulmonary, specific site: _________

Review panel meetings - dates and decisions:

* backlog of cases who have waited with

no or inadequate treatment for a period

of time

HIV INFORMATION

HIV Testing done: Y/ N/ Unknown

Date of Test: Result:

Started on ART: Y/N Date:

Started on CPT: Y/N Date:

Type of resistance: MDR-

TB/XDR-TB/polyresistant

Previous Tuberculosis Treatment Episodes

NO.

Start

Date(if unknown

put year)

Regimen(write regimen in

drug abbreviations)

Outcome

Used second-line drugs previously?

If yes, specify:________________________________________

Date Decision Next Date

Registration Group

Choose

only

one

New

Relapse

Treatment after default

Treatment after failure of

Category I treatment

Treatment after recent failure of

Category II treatment

Transfer in

Other

Treatment after failure of

Category II or several

treatments in the past *

Yes

No

Drug Abbreviations

First-line drugs Second-line drugsAm = Amikacin

H = Isoniazid Km = Kanamycin

R = Rifampicin Cm = CapreomycinE = Ethambutol Cfx = Ciprofloxacin

Z = Pyrazinamide Ofx = Ofloxacin

S = Streptomycin Lfx = Levofloxin(T = Thiazetazone) Moxi = Moxifloxacin

Gati = GatifloxacinPto = ProthionamideEto = Ethionamide

CS = Cycloserine

PAS = p-aminosalycilic acid

Registration group

Unique

CAtego

ry IV

registra

tion

number

Date of

Categor

y IV

Registra

tion

Name (in full) SexM

Or

F

Age__

Date of

Birth

D/Mo/Yr

AddressDistrict

TB

Registrati

on

Number/

Year

Site

of

disea

se

(P/EP

)

New

Rela

pse

Afte

r defau

lt

After failu

re of

Ceteg

ory I treatm

ent

After recen

t failure

of C

ategory II

Tran

sfer In

Other

Treatm

ent after

failure o

fCateg

ory II o

rsev

eraltreatm

ents in

the p

ast *

1 / /

2 / /

3 / /

4 / /

5 / /

6 / /

7 / /

8 / /

9 / /

10 / /

Smear (S) and Culture (C) Results During

Treatment [

Result of Drug Resistance Test(Enter the DST that resulted in the patient being

registered as a category IV patient. If the DST is

pending it should be filled in when the results are known.

See treatment card for full history of DST data)

R= resistant S = Susceptible C = contaminated

Reasons for

entering in

Category IV

Registry:

Category IV

Treatment

Start of

treat-

ment

Month

0

Month

1

Month

2

Month

3

Month

4

2.line

drugs

already

received

Date

sample

taken for

DST

R H E S Km

Cm

FQ

Pto

/Eto

Oth

er

Oth

er

Oth

er

MDR-

TB

docume

nted

MDR-TB

suspectedRegimen (in

drug initials)

Date started

S C S C S C S C S C

Smear (S) and Culture (C) Results During Treatment

Mont

h 5

Mont

h 6

Mont

h 7

Month

8

Mont

h 9

Mont

h 12

Mont

h 15

Mont

h 18

Mont

h 21

Mont

h 24

Mont

h 27

Mont

h 30

Mont

h 33

Mont

h 36

S C S C S C S C S C S C S C S C S C S C S C S C S C S C

Result and Date TB/HIV activities

HIV testing

Cured Completed Failed DiedDefault

ed

Transferr

ed OutTesting done(Y/N/Unknown)

Date ofTest

Result

ARTY/NStartdate

CPTY/NStartdate

Comments

Notation method for recording smears

No AFB 0

1 – 9 AFB per 100 HPF Scanty (and report

number of AFB)

10 – 99 AFB per 100 HPF +

1 – 10 AFB per HPF + +

> 10 AFB per HPF + + +

Notation method for recording cultures

No growth reported 0

Fewer than 10 colonies Report number of

colonies

10 -100 colonies +

More than 100 colonies + +

Innumerable or confluent grwoth + + +

Drug Abbreviations

First-line drugs Second-line drugsH = Isoniazid Km = Kanamycin

R = Rifampicin Cm = Capreomycin

E = Ethambutol Cfx = CiprofloxacinZ = Pyrazinamide Ofx = Ofloxacin

S = Streptomycin Lfx = Levofloxin

(T = Thiazetazone) Moxi = MoxifloxacinGati = Gatifloxacin

Pto = Prothionamide

Eto = EthionamideCS = Cycloserine

PAS = p-aminosalycilic acid

Definitions:

Diagnostic category IV includes:

• Confirmed MDR-TB.

• Suspected MDR-TB. The relevant health

authority recommends that the patient

should receive Category IV treatment.

• Polyresistant TB with prolonged treatment

(18 months or more) with two or more

2.line drugs and who are entered in the

Category IV register.

Registration groups (I)

• Based on treatment history, since this is a major

factor to assess risk for MDR-TB.

• Defined by group at the time when sputum was

collected that confirmed MDR-TB, which may

be several weeks or months earlier, reflecting the

target group for DST.

• Patients without lab confirmation of MDR-TB,

should be grouped by the status when they were

registered as diagnostic Category IV.

Registration groups (II)

• As before: new case, relapse and treatment after

default

• Revised failures of Category II to assess 2 groups:

a) MDR-TB cases who develop every year,

b) backlog of cases

Registration groups: Treatment after

• Failure of Category I

• Recent failure of Category II: patients who have

developed TB disease, started Category II treatment and

then failed, at which time DST was taken.

• Failure of Category II in the past: patients who have

failed Category II treatment in the past or who have

received several unsuccessful TB treatments, considered

incurable by health staff, and who have lived with active

TB disease with no or inadequate treatment for a period of

time until DST was finally taken when Category IV

treatment became available

Treatment result

• Still under discussion:

– Cured - defined by culture or by smear and/or

culture?

Two different cohorts

• The treatment cohort: started

Category IV treatment during a

specific period.

• The diagnostic cohort: entered in

the Category IV register during a

specific period.

Country-specific:

• The Laboratory register could be fused to

a single Lab register for culture and DST or

kept as two separate registers (one for

culture and one for DST).

• Quarterly report on case registration:

two versions:

Quarterly report on Category IV case registration and treatment

start [version 1]

Name of district: Patients registered in the Category IV

register

District No.: during ___ quarter of year ______

Name of district coordinator: Date of completing this form:

Signature:

Block 1: MDR-TB cases entered in the Category IV register during the

quarter: confirmed cases by history of previous treatment and all suspected

cases

Patient registration group: Number

I. Confirmed MDR-TB:

New pulmonary

Relapse

After default

After failure of Category I treatment

After recent failure of Category II treatment

After failure of Category II treatment in the past

Other*

=Total confirmed MDR-TB:

II. Suspected MDR-TB:*Other cases include previously treated pulmonary patients without known outcome status,

and all extrapulmonary cases

Block 2: Patients with start date of Category IV treatment during the quarter

Confirmed MDR-TB Suspected MDR-TB

Tuberculosis Program DOTS-Plus Form 07

Form 7: Quarterly reaport on Cat IV case registration and treatment start [version 2]

Name of district_____________________________________________

Patients identified during _______ quarter of year ______

Name of district coordinator __________________________

Date _____________

Confirmed MDR

Number of patients

Naew case Previously treated

Suspected MDR

MDR-TB patients with Category IV date of registrationduring the quarter

MDR-TB patients with start date of Category IVtreatment during the quarter

a

1er quarer : 1

st January - 31 march

2ème quarer : 1

er April - 30 June

3ème quarer : 1

er Juiy - 30 September Signature

4ème quarer : 1

er October - 31 December

Six Month Interim Outcome Assessment of confirmed MDR-TB cases(to be filled out 9 months after treatment start )

Name of Unit:________________________

Date filled in: ________________________

Quarter treatment was started: ______________________

Date of the report: ____________________________

Negative

(Smear and

culture

negative)

Positive

(Smear

and/or

culture

positive)

Unknown Died Default Transfer out

Quarter of

MDRTB

treatment

start

Number

started on

MDR-TB

treatment

Bacteriological results at 6 months of

treatment

No longer on treatment

At how many

months after

treatment

start

assessment is

made

Patient group CuredTreatment

Completed Failed

Default

ed DiedTransferred

Out

Still on

Treat-

ment

Total

New Previously treated

with 1.line drugs only Previously treated

also with 2.line drugs

Total

Annual report of treatment result of confirmed MDR-TB patients

starting Category IV treatment(to be filled in 24 and 36 months past the closing date of year of treatment)

Year of Treatment start:_____

Tuberculosis Program Form 10

Proportion of confirmed MDR-TB cases started on MDR-TB treatment by quarter registered

as MDR-TB case and reason for not yet starting MDR-TB treatment

Date filled in:

short

medium,

acceptable

unacce

ptably

long

Died

before

treatment

Treatable

with 2.line

drugs but

drugs not

available

Untreat-

able

resistance

pattern

Patient

refusal/or

disappear

ed

Disease too

advanced Other

Delay from DST result to

treatment start (TB program

need to define short etc)

The quarter

patients were

registered

with MDRTB

Total

MDRTB

cases

registered

during the

quarter

Total

MDRTB

cases

started

on

treatment

Not yet started on MDRTB treatment because of:

Interim result of MDRTB treatment by quarter of treatment start in confirmed MDR-TB cases:

Negative

(Smear and

culture

negative)

Positive

(Smear

and/or

culture

positive)

Unknown Died Default Transfer out

Quarter of

MDRTB

treatment

start

Number

started on

MDR-TB

treatment

Bacteriological results at assessment No longer on treatment

At how many

months after

treatment

start

assessment is

made

Conclusion:• Basic content of R&R system continues in

revised version, with some simplifications

and some additions

• Should describe minimal content and

optional additions

• Need to strengthen implementation and

analysis of data, with more training and

supervision

• Electronic systems can be very helpful

• Draft to be further discussed.

If R&R system not fully

implemented - why?

• Guidelines ch 4 and 18 not correct

and clear enough? Definitions,

forms, etc

• And/or implementation main

challenge?

Discussion

• Changes in the R&R system?

– Minimum vs optional

– Definition of Cat IV

– Groups of patients: recent and past failure of cat

II, smear pos 3-4 months?

– Cure: smear and/or culture?

– Optional form coverage and delay

– Optional form interim treatment result

Discussion (II):

• Challenges in implementation:

– Training

– Supervision

– Coordination with DOTS R&R system

– Quality assurance of data

– Use/Analysis of data

– Computerized systems

Country visits

• Some only included in Cat IV register

patients started on treatment

• How decentralised the Cat IV register?

• Some programs very extensive R&R

systems oriented to research, now being

simplified

• All countries measured number started on

treatment and treatment outcomes but little

else. How to measure impact?

Definition of cured, completed and failed?

Month sm cu sm cu

0 +' +' +' +'

1 +' +' +' +'

2 +' +' +' +'

3 +' +' +' +'

4 +' +' -' -'

5 +' +' -' -' conversion

6 +' +' -'

7 -' -' -'

8 -' -' conversion -' -'

9 -' -'

10 -' -'

11 -' -' -' -' 5

12 -' -'

13 -' -'

14 -' -' 5 -' -' 4

15 -' -'

16 -' -'

17 -' -' 4 -' -' 3

18 -' -'

19 -' -'

20 -' -' 3 -' -' 2

21 -' -'

22 -' -'

23 -' -' 2 -' -' 1

24 -'

25 -'

26 -' -' 1

Case 1 Case 2

”Once established, rigorous

recording and reporting systems of

DR-TB programs can be a rich

source of evaluation data, and

additionally, provide a platform for

epidemiological and operational

research”

(Research agenda on drug resistant

tuberculosis, draft 23.8.2007)