Download Annex 4 EPI Forms v4

ADMISSION FORM 1 (part 1)
PATIENT INFORMATION
Rayon’s TB doctor completes the form 1 (all 3 sections), when a patient is enrolled to treatment. For patients referred to a TB hospital
for initiation of treatment, rayon TB doctor includes the form 1 (parts 1&2, and part 3 - available information) with the referral
documents.
APID:
1. SURNAME:__________________________________ 2. NAME:_____________________________________
3. Date of Birth:
-
-
4. Gender:
Male
Female
5. Address:________________________________________________________________________________
6. Phone:
7. Number of people in household:
8. Number of children<14 in household:
10. Employment (check one):
9. Marital Status (check one):
Single
Married
Divorced
Widowed
Separated
Living together
Employed
Retired
Student
Housework
Unemployed
Disabled
Other
Risk factors
11. Patient ever been in prison?
12. Patient ever used injected illicit
drugs?
Yes
No
Unknown
Yes
No
Unknown
13. Alcohol intake currently:
Excessive (more than 5 drinks/day)
Moderate
None
14. Other risk factors
No known risks
Household contact with a TB case, please indicate:
Homeless
Contact with a drug-susceptible TB case
Health care worker
Prison worker
Contact with a drug-resistant TB case
Travel out of country for work
Tobacco use
Contact with a TB patient whose drug
susceptibility profile is unknown
No known household contact
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
Forms 1 (all 3 sections), 2 and 5 are carbon 3-copies format. One copy is kept in the patient file (TB MD) ; one is kept with MSF
epidemiology department for entry to the database; and one to remain in IPD with the patient while on treatment, then submitted to the
patient files archive department.
ADMISSION FORM 1 (part 1)
ADMISSION FORM 1 (part 2)
TB TREATMENT HISTORY
Rayon’s TB doctor completes the form 1 (all 3 sections), when a patient is enrolled to treatment. For patients referred to a TB hospital
for initiation of treatment, rayon TB doctor includes the form 1 (parts 1&2, and part 3 - available information) with the referral
documents.
APID:
1. Patient considers himself/herself having TB since (date):
-
-
(relates to the date of symptoms onset for the present episode based on patient recall and/or based on documentation
in the medical chart)
2. Has patient taken anti-TB drugs before?
Yes
If yes, please indicate:
1st line anti-Tb drugs
2nd line anti TB drugs
Unknown/not clear what type drugs
No
Unknown
3. Previous TB treatment episodes lasted more than 1 month):
Yes
No
If yes, indicate last APID:
4. Previous TB treatments > 1 months:
No.
Start date Stop date
Treatment category
Cat 1
Cat 2
Regimen (use drug abbreviations)
DR*
Outcome
NonDOTS
1st line anti-TB drugs: Isoniazid (H), Rifampicin (R), Ethambutol (E), Pyrazinamide (Z), Streptomycin (S)
2nd line anti-TB drugs: Amikacin (Am), Kanamycin (Km), Capreomycin (Cm), Ofloxacin (Ofx), Levofloxacin (Lfx), Moxifloxacin (Mfx), Ethionamide (Eto), Protionamide (Pto),
Cycloserine (Cs), Paser (PAS), Clofazamine (Cfz), Amoxicillin/Clavulanate (Amx/Clv), Clarithromycin (Clr), Linezolid (Lzd), High dose Isoniazid (HdH)
5. Registration Group for present TB episode (based on the overview of previous TB treatment history). Circle one:.
New
Relapse
Treatment after fail Cat I
Treatment after fail Cat II
Treatment after default
Treatment after fail with amplification
Transfer
Other*
* Patient in whom previous treatment history or outcome is unknown (includes patients that have had had non-DOTS treatment)
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
Forms 1 (all 3 sections), 2 and 5 are carbon 3-copies format. One copy is kept in the patient file (TB MD) ; one is kept with MSF
epidemiology department for entry to the database; and one to remain in IPD with the patient while on treatment, then submitted to the
patient files archive department.
ADMISSION FORM 1 (part 2)
ADMISSION FORM 1 (part 3)
CURRENT TB EPISODE – CLINICAL EXAMINATION
Rayon’s TB doctor completes the form 1 (all 3 sections), when a patient is enrolled to treatment. For patients referred to a TB hospital
for initiation of treatment, rayon TB doctor includes the form 1 (parts 1&2, and part 3 - available information) with the referral
documents. On admission, attending doctor in a hospital completes and/or updates missing information in part 3.
APID:
6. Site of disease (check one):
7. X-ray results (check one):
Normal
Abnormal, indicate:
Pulmonary
Extrapulmonary
Both
8. Initial weight (kg)
Cavitary
Noncavitary
9. Height (m )
Not done
Unknown
.
10. HIV
HIV test:
HIV test result :
Done
Not done
ARV start:
Positive
Negative
Unknown
No
Yes , Start date::
-
-
11. Co-morbidities (check all that apply):
None
Psychiatric
Seizures
Hearing disorder
Diabetes
Cardiovascular
Renal failure
Vision disorder
Hepatic disease
Other, specify other_________________
12. Clinical Laboratory examination (indicate results)
13. Pregnancy:
Yes
GRADE (*only for short regimen pilot patients)
ALT
Creatinine/
CrClear*.
Glucose
Hep C
ECG: QTc *
Hep B
Potassium
ECG: QT *
CD4
(if HIV)
Haemoglobin
ECG: RR*
HIV RNA VL
Indicate the trimester
________________________
QTc =
14. Diagnostic Bacteriology Lab Results:
Sputum Collection date
Lab number
Smear Result
Culture Result
DST test:
HAIN: H
R
result date: ____
Ofx*
result date: ____
GeneXpert: R
MGIT
H
R
result date: ____
LJ:
E
S
Z
K
Cm
Forms 1 (all 3 sections), 2 and 5 are carbon 3-copies format. One copy is kept in the patient file (TB MD) ; one is kept with MSF
epidemiology department for entry to the database; and one to remain in IPD with the patient while on treatment, then submitted to the
patient files archive department.
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
ADMISSION FORM 1 (part 3)
Ofx
15. Audiometry:
Yes date:
result: ____________________________________
_________________________________________________________________________________________
Forms 1 (all 3 sections), 2 and 5 are carbon 3-copies format. One copy is kept in the patient file (TB MD) ; one is kept with MSF
epidemiology department for entry to the database; and one to remain in IPD with the patient while on treatment, then submitted to the
patient files archive department.
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
ADMISSION FORM 1 (part 3)
FORM 2
CURRENT TB EPISODE - INITIAL TREATMENT
Rayon’s TB doctor completes the form 2, if a patient starts treatment in ambulatory setting. Attending doctor in hospital completes the
form 2, if a patient starts treatment in inpatient facility.
APID:
2. Treatment was initiated based on the consilium
1. Treatment start date:
-
-
decision:
No
Yes, Date of decision:
3. Initial Treatment location:
-
-
5. If the treatment has been started in the
inpatient facility, please indicate the reason:
Inpatient, Hospital admission date:
-
Infection control inadequate
Ambulatory treatment
Patient choice
Home-based treatment
Unable to visit outpatient department daily
Poor clinical condition
4. Name of the health facility (hospital or clinic), where the
patient started the treatment:
6. Category treatment:
Severe DST profile
Other, indicate other:
Cat I
Cat II
DR*
SHORT COURSE MDR TB REGIMEN **
*DR:
treatment regimens for MONO, PDR, MDR, and XDR patients
7. Initial Treatment regimen
Drug
Dosage (mg)
Comment
1
2
3
4
5
6
7
8
9
10
1st line anti-TB drugs: Isoniazid (H), Rifampicin (R), Ethambutol (E), Pyrazinamide (Z), Streptomycin (S)
2nd line anti-TB drugs: Amikacin (Am), Kanamycin (Km), Capreomycin (Cm), Ofloxacin (Ofx), Levofloxacin (Lfx), Moxifloxacin (Mfx), Ethionamide (Eto), Protionamide (Pto),
Cycloserine (Cs), Paser (PAS), Clofazamine (Cfz), Amoxicillin/Clavulanate (Amx/Clv), Clarithromycin (Clr), Linezolid (Lzd), High dose Isoniazid (HdH)
**SHORT COURSE MDR TB REGIMEN CONTAINS: Intensive phase: H (15-20 mg/kg), Z (30-40 mg/kg), E (30-40 mg/kg), Mfx (7.5-10 mg/kg), Pto (7.5-10 mg/kg), Cfz
(2-3 mg/kg), Km/Cm (15mg/kg), Continuation phase: Z, E, Mfx, Pto, Cfz – for detailed dosage refer to protocol.
Forms 1 (all 3 sections), 2 and 5 are carbon 3-copies format. One copy is kept in the patient file (TB MD) ; one is kept with MSF
epidemiology department for entry to the database; and one to remain in IPD with the patient while on treatment, then submitted to the
patient files archive department.
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
FORM 2
FORM 3
INTERIM FORM: Change in microbiological status
Rayon’s TB doctor, or MSF epi assistants, complete the form 4. The form is sent to MSF-Epi, after the entry into the database - the form is
kept in patient’s medical chart
APID:
1. Interim period (check one):
2 months (for sensitive, monoresistant, & PDR patients)
3 months (for sensitive, monoresistant, & PDR patients)
6 months (for MDR/XDR patients)
4 months (for SHORT COURSE MDR TB REGIMEN)
If the patient with susceptible, monoresistant, & PDR forms of TB has positive smear and/or culture results on 2nd month of
treatment then smear/culture testing should be repeated on 3rd month of treatment. In this case, the form 4 is being completed
twice, i.e, both on the 2nd and 3rd months of treatment.
2. LAB RESULTS at Interim
Sputum Collection date
Lab number
Smear Result
Culture Result
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
FORM 3
FORM 4
CHANGE IN TREATMENT LOCATION
Rayon’s TB doctor, or MSF epi assistants, complete the form 4. After completion the form is sent to MSF-EPi office
APID:
1. Date of location change:
-
-
2. Reason for treatment location change:
Change on bacteriological status
Improvement in clinical status
Worsening in clinical status
Patient moved to the other rayon/region
Other, please indicate
3. Rayon (check one):
Nukus
Takhiatash
Kanlikul
Muynak
Chimbay
Khodjeily
Shumanay
Ellikkala
Takhtakupir
Nukus Rayon
Kungrad
Beruni
Karauziak
Kegeily
Amudarya
Turtkul
Other
Specify Other__________
4. New treatment site
Inpatient , indicate the facility:
Nukus TB1-MDR ward
Chimbay NEG ward
Nukus TB1-PDR ward
Karauziak TB hospital
Nukus TB1-NEG ward
Takhtakupir NEG ward
Nukus TB2
Takhtakupir POS ward
Other Inpt
Specify Other_______________
Ambulatory, indicate Name of Polyclinic, SVP or FAP:
___________________________________________________________________________
Home-based care
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
FORM 4
FORM 5
OUTCOME
TB doctor, who presents a patient at the consilium, completes the form 5.
APID:
1. Date Treatment Stop:
-
-
2. Date outcome declared (by the consilium):
-
-
3. Outcome
New APID
(for patients who re-register without Tx interruption, with
outcomes – failed with amplification and transfer of DS to
DR)
Cured
Completed Tx
Other
Failed Tx
Defaulted
Died
Transferred Out
4. Smear Conversion?
Date of death:
-
-
Date transferred out:
-
-
Yes
No
Date of the last smear conversion (neg smear):
-
-
Unknown
5. Culture Conversion?
Yes
No
Date of the last culture conversion (neg culture ):
-
-
Unknown
6. Last Drug Susceptibility Test
( only for patients with the following outcomes – Failure, Default, Transfer to DR regimen, and Failure with amplification )
Sputum
Collection date
Lab
number
Smear
Result
Culture
Result
DST test:
HAIN
MGIT
LJ
Xpert
DST result (R-resistant S-susceptible N-not done U-unknown)
H
.
R
E
DST result date:
S
Z
Km
-
Cm
Ofx
Eto
CS
PAS
-
DEFINITIONS FOR SHORT COURSE MDR TB REGIMEN:
Cured: An MDR TB patient who has completed the treatment according to programme protocol and has at least five consecutive negative cultures from samples collected at least 30 days
apart. 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.
Treatment completed: An MDR TB patient who has completed treatment according to programme protocol but does not meet the definition for cure because of lack of bacteriological
results (i.e. fewer than five cultures were performed in the final months of treatment) or otherwise, completion of treatment with documented bacteriological conversion persisting through
the end of treatment, but fewer than five negative cultures. Treatment completion will only be an outcome for patients that are not able to produce sputum; in case of patients where the
lack of bacteriological results is due to other reasons the outcome will be registered as “other” in order to avoid misclassification.
Treatment outcome “other”: An MDR TB patient who has completed treatment according to programme protocol but does not meet the definition for cure because of lack of
bacteriological results due to programmatic reasons (reasons other than the lack of patient’s ability to produce sputum) such as culture contamination or no timely referral of sample by the
clinician, the outcome will be registered as “other” in order to avoid misclassification. In case of contamination of the culture tube, new sputum samples for culture will be collected and
culture tubes de-contaminated and re-inoculated following standard laboratory procedures.
Failed: Treatment will be considered failed when there is absence of bacteriological response that will be defined as follows:

Patient fails to show culture negative by the end of month 5 of a prolonged intensive phase.

Culture positive during the continuation phase: two cultures positive during the continuation phase or one culture positive during the last 3 months of treatment.

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
where the team decides the regimen is failing and treatment is changed. These latter failures can be indicated separately in order to do sub-analysis.
All failures with documented culture positive will have DST and investigation of resistance to document the rate of resistance amplification.
Defaulted: An MDR TB patient whose treatment was interrupted for two or more consecutive months for any reason without medical approval and not meeting the criteria for failure.
Died: An MDR TB patient who dies for any reason during the course of MDR TB treatment and is not already classified as a treatment failure prior to death. Assumed causes of death will be
recorded.
Transferred out: An MDR TB patient who has been transferred to another reporting and recording unit and for whom the treatment outcome is unknown. Patients that require a transfer
out will be informed that it is very unlikely that they can continue the same regimen and they will have to change to standard MDR TB regimen. In case that the treatment can be provided in
the receiving center and the outcome documented, this will be recorded.
Forms 1 (all 3 sections), 2 and 5 are carbon 3-copies format. One copy is kept in the patient file (TB MD) ; one is kept with MSF epidemiology department for entry
to the database; and one to remain in IPD with the patient while on treatment, then submitted to the patient files archive department.
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
FORM 5
FORM 6
SIDE EFFECTS FORM
The Form 6 is completed each time a patient is reviewed for/presents with side effects. Rayon’s TB doctor or attending doctor in a TB
inpatient facility completes this form (or pilot nurse in case of the Short Course project), depending on treatment location at the time
of the side effect episode. The form is sent to MSF-Epi, after the entry into the database - the form is kept in patient’s medical chart
.
APID:
Patient’s name (surname, name): ___________________________________________________________
Date form completed:
Month of treatment:
____________
1. Symptoms (check all that apply)
General:
systemic allergic reaction GRADE
arthralgia
rash;
prutitis;
Mental health:
Depression;
Psychosis;
Anxiety;
GRADE
GRADE
GRADE
GRADE
GRADE
-
for details refer to the protocol:
Gastrointestinal
Anorexia;
GRADE
Nausea;
GRADE
Vomiting;
GRADE
Abdominal pain; GRADE
Diarrhoea;
GRADE
Constipation;
GRADE
Dysphagia ;
GRADE
GRADE
Other, specify
________________________
Neurological:
Headache;
Decreased hearing;
Ringing in the ears;
Decreased vision;
Seizures;
Insomnia;
GRADE
GRADE
GRADE
GRADE
GRADE
GRADE
Neuromuscular weakness; GRADE
Neurosensory alteration; GRADE
Vertigo
GRADE
______________________
3. Diagnosis
2. Laboratory (indicate lab findings if present)
GRADE
Elevated ALT
Elevated creatinine
Abnormal TSH
K+
Haemoglobin
ECG baseline QTc
ECG
2 week
or 1 month
QT __________
RR__________
QTc __________
Allergic reaction
Hepato-toxicity
Renal toxicity
Ototoxicity
Ophthalmic toxicity
Peripheral neuropathy
Hypothyroidism
Other, specify:
__________________________________________
QTc – QTc baseline ______________ QTc =
4. Actions taken
Suspected drug
Actions
Date actions taken
Provide details
Discontinued temporarily
Discontinued permanently
Dosage changed
All anti-TB drugs stopped
Other
Discontinued temporarily
Discontinued permanently
Dosage changed
All anti-TB drugs stopped
Other
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
FORM 6
FORM 7
CHANGES IN TREATMENT REGIMEN FORM
Rayon’s TB doctor, or MSF epi assistants, complete the form 7.
The form is sent to MSF-Epi, after the entry into the database - the form is kept in patient’s medical chart
APID:
Patient’s name (surname, name): ___________________________________________________________
Date form completed:
Drug
Mark change (mark one)
-
Enter dosage, if
1) new dosage
2) start drug
Date (s) of change
(if drug stopped
temporarily – enter
dates from/to)
Reason
Dosage changed
Side effects
Start the drug
Additional drug resistance
Stop the drug permanently
Other, specify
Stop the temporarily
Dosage changed
Side effects
Start the drug
Additional drug resistance
Stop the drug permanently
Other, specify
Stop the temporarily
Dosage changed
Side effects
Start the drug
Additional drug resistance
Stop the drug permanently
Other, specify
Stop the temporarily
Dosage changed
Side effects
Start the drug
Additional drug resistance
Stop the drug permanently
Other, specify
Stop the temporarily
Dosage changed
Side effects
Start the drug
Additional drug resistance
Stop the drug permanently
Other, specify
Stop the temporarily
MSF-OCA Comprehensive TB care for all in Karakalpakstan, Uzbekistan.
FORM 7