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Continuing Medical Education(CME) :
Role of SSJGIMSR Almora in TB Management of
Uttarakhand
World TB day- 24th March 2023
Prof Dr Sanjev Dave
Department of Community
medicine,
Soban Singh Jeena
Government Institute of
Medical Sciences, Almora
(Uttarakhand) India-263601
It is observed annually on March 24
----to raise awareness about TB and
------efforts to end the global epidemic,
--------marking the day in 1882 when the
bacterium causing TB was discovered.
World TB Day Celebration???
World TB day- 24th March 2023 Theme ā€“ Yes ! We can End TB
TB ā€“ A Social Disease
Vulnerable
Malnutrition
Poor
housing
Elderly,
children
& women
Overcrowding
Rural &
Urban
Develop
ment
TB Burden ā€“ Comparison With Other Diseases
T
uberculosis is (India)-
ā€¢ Leading cause of death
among communicable diseases
ā€¢ 5th leading cause of death
among all diseases
Deaths attributed to
disease
Source: IHME,Global
disease burden (2019)
Estimated Case Fatality Rate for TB
is 17% (2019)
Tb Disease Burden In India
ā€¢ Estimated incidence rate ofTB šŸ”» 193 cases / lakh population
ā€¢ EstimatedTB cases in 2019 in India šŸ”» 26.4 lakh
ā€¢ Reported TB cases šŸ”» 24 lakh (2019) šŸ”» 18 lakh (2020) šŸ”» 12.8 lakhs (So
far-Augā€™21)
33
%
Urban
2.5
%
Drug
Resistant
38%
Men 62%
Women
Children 6%
65
%
15-45 years
(Age)
2
%
HIV-
Positive
58
%
Rural
9
%
Tribal
End TB Targets ā€“ TB Incidence And Mortality
2015 2020 2023 2025
TB Notification Progress
21.
02
24.
02 18.
12
2021:Jan-Aug : Source -
Evolution Of NTEP
1962
Govt.of India launched the
National TB Program and set up
DistrictTB Centres
1993
WHO declares TB as a global
emerge
ncy
2005 ā€“ 11
Second phase of RNTCP ā€“ Pan
India coverage and improved
quality and scale up of services
2017 ā€“ 25
NSP (2017 ā€“ 25) ā€“ patient
centric care for TB
elimination
1997
GoI revised NTP to RNTCP ā€“
introduction of DOTS (Directly
ObservedTreatment Short
course)
2012 -17
National Strategic Plan (2012 -17)
- mandatory notification ofTB,
rapid molecular testing, active case
finding and integration of the
program with National Health
Mission
2021
TB Mukt BharatAbhiyaan 2020
In January 2020,GoI revised
RNTCP to National TB
Elimination Program (NTEP)
NATIONAL STRATEGIC PLAN
(2017-2025)
Treat
Prevent
Build
Detect
Find all TB cases with an emphasis on reaching
every TB patient in the private sector
Treat all TB cases with high quality anti TB drugs
Prevent the emergence of TB in susceptible
populations and stop catastrophic expenditure
due to TB by all
Build & strengthen supportive systems
including enabling policies, empowered
institutions & human resources
DETECT Decentralize TB
screening to
AB-HWC
levels
Scale up Molecular
Diagnostics to the
Peripheral Levels
Early Detection of
DRTB-
Universal DST
Vulnerability
Mapping &
Active case
finding
Private Sector
Engagement
Technology 2014 2021
Microscopy 13,657 21,717
Rapid Molecular
Test
119 3164
Culture lab
(for drug 50 87
resistance test)
Active case
finding
through
mobile
medical van
Patient Provider Support Agency
2018 : 48 large cities (JEET)
2019 ā€“ 156 (domestic)+95 (JEET)
2020 ā€“ 266 (domestic) + 109 (JEET)
Daily regimen
ā€“Fixed Dose
Combination
Injection free
treatment
regimens
Scale up of
Newer
drugs/regimens
>4 lakhASHA &
Community Volunteer
as DOT provider
ICT based
adherence
ā€¢ 800 treatment
centre for DR-TB
ā€¢ Bedaquline &
Delamaind
Treat
PREVENT
Sustaining COVID
appropriate
behavior
Contact Tracing & TB
Preventive Treatment
Airborne Infection
Control in
community &
Health Facilities
Community
Mobilization &
Peopleā€™s
Movement
1.64
lakh
treat
ed
with
11 lakh
ā€¢ People
living
with
HIV/AI
DS
given
TPT
Expansi
on of
policy
in
househ
old
contact
s for all
age
group
Contact
tracing and
screening of
all
household
contact and
TB
Preventive
Treatment
BUILD
IEC
Capacity Building
Human
Resources
Development
Multisec
toral
Collabor
ation
Digital Interventions
Surveillance
Procurement &
SupplyChain
National
Training
on
T
ubercul
osis at
NIRT
TB Arogya
SaathiApp
Engaging line
ministries
Case based web-
based
surveillance for
TB
Nikshay PoshanYojana:
DBT of >Rs.1200 Cr
PROGRAMME
PERFORMANCE
-
NTEP 2020
HIV Status Known: 92%
UDST: 67%
MDR TB Treatment
Initiation:86%
IPT among children:
34% TPT among
PLHIV:47%
NIKSHAY Poshan
NIKSH
AY
PF
M
S
Ba
n
k
Pati
ent
TB
patients
provide
d
benefit
4
6
lak
h
Public
sector
ā€“ 73%,
ā€¢Private ā€“
39%
Covera
ge
ā€¢Rs. 500/- per month
given to every TB patient
through DBT for
duration of treatment
ā€¢Scheme rolled out from
April 2018
ā€¢Rs. 1204 Cr of
amount disbursed to
beneficiaries
Period - April 2018 to June 2021
NIKSHAY POSHAN YOJANA (NPY)
Proportion of TB patients paid out of those eligible
Year
Total
(Pub + Pvt)
(%)
Public
(%)
Private
(%)
2018 61 70 22
2019 67 78 38
2020 73 80 55
2021
(Jan-Mar)
75 82 54
Year Current
Patients
Bank
details
available
Bank
details
validated
Paid at
least once
2020 18.13 14.60 13.67 13.22
(In lakhs) (81%) (75%) (73%)
2019 24.00 22.95 17.56 16.08
(In lakhs) (96%) (73%) (67%)
Mechanisms for Monitoring
and Evaluation
Internal
ā€¢ Quarterly Review
meeting at National,
State and District levels
ā€¢ Central & State Internal
Evaluations
ā€¢ External and
Internal Quality
assessment of labs
by IRLs and NRLs
ā€¢ Annual Common Review
Mission as part of NHM
ā€¢ Sub National TB free
certification
External
ā€¢State Health Index
report by NITI Aayog
(Annual)
ā€¢World Bank
review mission (6
monthly)
ā€¢Joint monitoring
mission by WHO (once
in 3 years)
Proposed Activity
Joint supportive supervision by deputing central teams
State wise review by HFM
Sub-National Certification of Progress Towards TB Free
Status
Ministry of Health & Family Welfare, Government of India,
rolled out the initiative of Sub-national certification of
progress towards TB Free Status in 2020-21 to track the
progress made towards achieving the goal of total TB
elimination by 2025.
To achieve the goal, the Ministry of Health & Family Welfare,
Govt. of India has developed a sub-national TB free certification
process.
An important step in the sub-national TB free certification
process is validation of claims of reduction in TB incidence at
District/State/UT level.
The Govt. of India has resolved to end
Tuberculosis (TB Free) in India by 2025.
Vision: TB Free
13 March 2018:
India committed to End TB by
2025,
five years ahead of Global SDG
target
Indicators
(compared to
2015)
Global End
TB Targets
Global
SDG
TB
Target
s
TB Free India
Targets
1. Reduction in
number of TB
deaths
95% 90%
90%
(3 per 1,00,000
population)
2. Reduction in
TB incidence rate
90% 80%
80%
(44 per 1,00,000
population)
3. TB-affected
families facing
catastrophic
costs due to TB
0% 0%
0%
(Zero catastrophic
costs due to TB )
Rationale for the Initiative
ā€¢ Currently certification of elimination of the disease is
done only at national level, by WHO
ā€¢ Targeted initiatives required at State & District levels for
disease elimination
ā€¢ Different epidemiological scenario across country
demands a differential strategy to reach to the
elimination targets & sub-national measurements
ā€¢ Incentivizing and rewarding well performing states &
districts:
ā€¢ Achieving target that are within their control and capacity,
ā€¢ Motivation to prioritize and undertake implementation of
programme to achieve milestones towards TB Free district
ā€¢ Generates sense of healthy competition among
States/Districts.
Award Details
Awards Bronze Silver Gold TB Free
Criteria
(Incidence decline
compared to 2015)
šŸ”»20% šŸ”»40% šŸ”»60% šŸ”»80% /
ā‰¤ 44/Lakh
State Rs. 25
lakhs
Rs. 50
lakhs
Rs. 75 lakhs Rs. 100 lakhs
District Rs. 2 lakhs Rs. 3 lakhs Rs. 5 lakhs Rs. 10 lakhs
Process
Submission of Claim by
District/State/UT
Preparation for verification and data
availability
Verification of claim by Independent
Agency
Distribution of award
Release of award money
24th
March
Pre-requisites for Submission of
Claims (District/State/UT)
Decline in patient months from 2015
(based on drug consumption / sales data)
ā‰„20%
Increase in Number Needed to Test to
diagnose 1 TB patient
ā‰„20%
TB score for the latest year ā‰„80%
Methodology for Verification
ā€¢ Review of records
ā€¢ Patient & other stakeholder
interviews
Verification of TB
Score & NNT
ā€¢ Review of drug sale/consumption
reports/records
ā€¢ Interviews & discussions with Private
Practitioners, Chemists, Drug
Inspectors, etc
Verification of Drug
Sale/Consumption
Data
ā€¢ Community Survey using inverse
sampling methodology
ā€¢ Mapping of incident TB patients on
Nikshay
Estimation of TB
incidence and
under-reporting at
community level
Key Stakeholders
ā€¢ National Level ā€“ NHM, CTD, WHO, ICMR -NIRT,
ICMR-NIE, SNC Task Force, Partner Organizations
ā€¢ State Level
ā€¢ State NHM, State TB Cell & STDC
ā€¢ Medical colleges
ā€¢ State Drug Controller
ā€¢ Clearing & Forwarding Agency(Drugs), Drug
Distributors,
ā€¢ Private Healthcare Providers/Chemist Associations
ā€¢ District Level
ā€¢ District Collector/Magistrate
ā€¢ Medical College
ā€¢ NHM & DTC, MOTCs, STS, STLS, Labs
ā€¢ Drug inspectors
ā€¢ Private Healthcare Providers & associations
ā€¢ Chemists
Advantages of Submitting Claims
Understanding of TB
Disease Burden in
the geography
Successf
ul Not
Successful
MoHFW
invites
Claims
Districts
submit
claims to
State
States submit
claims to
MoHFW
Independent
Agency
(ICMR)
verifies
claims
Successful
claims
awarded on
World TB Day
August 31 March 24
Verification
ā€¢ Community survey to
find out incidence &
under-reporting
ā€¢ Interviews & FGDs with private
doctors & chemists to verify
drug sale
ā€¢ Review of records &
patient interviews to
verify TB score
Sub National TB Free Certification
Awards Bronze Silver Gold TB Free
Criter
ia
(Incid
ence
declin
e)
ā–” 20
%
ā–” 40
%
ā–” 60
%
ā–” 80
%
State
Awards
(Rs In
lakhs)
25 50 75 100
District
Awards (Rs
In lakhs)
2 3 5 10
SUB NATIONAL CERTIFICATION-2020 AWARDS
TB
FREE
State of Kerala and
UT of Puducherry
and 29 Districts across
11 States.
ā€¢ Lahul Spiti,
Himachal
Pradesh,
ā€¢ Kolhapur
District of
Maharashtra
ā€¢ Parel
(ward) of
Mumbai,
ā€¢ West Tripura
District of Tripura
ā€¢ District
Diu of
DNH&D
D
ā€¢ UT of
Lakshadweep,
ā€¢ District
Budgam of
J&K
Advantages of Submitting Claims
Understanding of TB
Disease Burden in
the geography
Successf
ul Not
Successful
Role of Dept of Community Medicine
SSJGIMSR Almora in
District Level Annual Survey (DLAS)
for
Evaluation and Certification of Sub-
national progress towards ā€˜TB Freeā€™ status
in India(2021-24) For
District CHAMPAWAT
Independent Verifying Agency
ICMR-National Institute for Research in Tuberculosis, Chennai
Collaborators
Central TB Division, Ministry of Health & Family Welfare, New Delhi
World Health Organization-India
ICMR-National Institute of Epidemiology, Chennai
Indian Association for Preventive & Social Medicine
As per the decision by Central TB Division, Govt. of India, ICMR-National Institute
for Research in Tuberculosis has been identified as the independent verification agency for
Sub-National certification of TB elimination efforts along with ICMR-NIE, Indian Association
of Preventive and Social Medicine (IAPSM) and World Health Organization (WHO), India
Office. This year, TB free claims have been received from 302 districts and 13 States/UTs.
The Dept. of Community Medicine of institutes were assigned this validation exercise
along with other stakeholders in the district where the Medical College is located or the
allotted nearby district .
The faculties & PG students have to train field teams, undertake supervision of field
work, verify secondary data, conduct qualitative interviews and submit a report.
All expenditure were borne out of the budget provided for this purpose by CTD.
Aim
To verify the eligibility of the districts &
states that have submitted claims for
Sub-National Certification based on:
-reported trends in TB incidence &
prevalence,
-number needed to test &
-TB score
Objectives
Specific objectives
a) To estimate incidence of TB in the surveyed sample population
(direct estimation) & by adjusting for under-reporting in NIKSHAY
(indirect method) in the district.
a) To estimate the incidence of TB in the community based on anti-
TB drug sale in the private sector & anti-TB drug consumption in
the public sector.
a) To calculate the reduction in TB incidence between 2015 &
assessment year (2021-24).
a) To estimate the prevalence of symptomatic & currently as well as
previously treated TB patients in the community.
Methods (1)
Study Design
Mixed method study with a triangulation design
Quantitative component - cross-sectional study
ā€¢ Primary data collection through a district level survey
ā€¢ Secondary data review (review of records from NIKSHAY notification
systems & NTEP reports, utilisation of drugs in public & private sector)
Qualitative component
ā€¢ Nominal Group Techniques (NGT) involving nominal group technique
ā€¢ Key informant interviews (KII)
Triangulation and Analytics component
ā€¢ Quantifying incident patients belonging to other district
ā€¢ Quantification of under-notification
Methods (2)
Duration - 2021-2024
Settings
Districts in India
ā€¢ Phase 1- Verify the districts/State/UT that have submitted the
claims
ā€¢ Phase 2- Evaluate State/UT that have not submitted the
State/UT level claims
Methods (3)
Random review of
records
(2015-2022(23,24)
Households
Qualitative
NGT KII
Secondary data
review
ā€¢ Anti-TB drugs
sale/consumption
data (private &
Public)
ā€¢ TB notification data
(NIKSHAY)
Villages/wards
Survey units
TB units
Survey
Districts
Quantitative
Analytics
(quantification)
Incident
cases
Under-
notificatio
n
Activities ā€“National level & NTEP (1)
ā€¢ Planning & Preparation -
ā€¢ Review of claims (districts and States/UTs)
ā€¢ Selection and finalization of districts for State/UT claims
ā€¢ Finalization of survey areas, clusters listing, cluster selection
Finalization of survey teams and volunteers
ā€¢ Logistics
ā€¢ Ensuring adequate falcons tubes,
ā€¢ molecular test kits and machines
ā€¢ testing capacity and linkages for sample transport mechanism
ā€¢ Coordination
ā€¢ Identifying suitable dates for training and survey as well as
potential conflicting priorities
Activities ā€“Evaluation /verification (2)
ā€¢ Training of trainers & data collectors
ā€¢ Sensitization of program managers
ā€¢ District level community survey
ā€¢ Secondary data review
NIKSHAY data ā€“TB notification ,TB Score
Drug sales in private sector & consumption in public sector
ā€¢ Nominal Group Techniques & Key Informant Interviews
ā€¢ Verification of eligibility of districts & states for claims
ā€¢ Calculation of TB burden (Prevalence/Incidence) for 2015 & most
recent year
ā€¢ Estimation of decline in TB incidence from 2015
Training of trainers & data collectors
(Supervision structure for Verification of Sub-national claims)
National coordinating team
(NIRT/NIE/IAPSM/WHO)
State coordinating team
(IAPSM/Medical college/ICMR institutes/WHO consultants)
District verification team
(IAPSM/ Medical college/ WHO consultants)
Survey team
(5/10 teams/district)
(20 data collectors*/district)
Discuss implementation
plan & resources
Train state teams
Field level hands on
training workshop -
methods & study
tools (NGT & KII)
*TB Champions
Volunteers
Social workers
NGOs
ASHAs
Train survey teams
Secondary data review
NGT/ KII
Household survey
Sputum sample collection & transport
Survey
Methods-Survey
Study Population
Community-based survey
Individuals of all age groups
Inclusion criteria:
ā€¢ Residing in selected village for previous one month
ā€¢ Available in the household at the time of survey
Exclusion criteria:
ā€¢ Institutional populations ā€“ schools, offices, prisons, defence
establishments, hospitals, nursing homes, hostels etc.
ā€¢ Refusing to give consent for participation
ā€¢ Hospitalized residents
Methods-Survey
Sampling technique
ā€¢ Survey Units will be defined
at village/ ward level
ā€¢ The first household in SU
randomly selected
ā€¢ Households visited
sequentially till desired
sample size is achieved
ā€¢ Inverse sampling method*
TUs-Tuberculosis Units
*A fixed number of bacteriologically positive TB cases to be found by each team in the survey unit
Households
Inverse sampling
Survey Units
(Villages/wards)
PPS sampling
Districts
Methods-Survey
Number of Survey units to be studied within a district & number of bacteriologically
positive TB cases (X) to be identified in each Survey Unit
Districts with number of
TB Units
Desired number of Survey team
(Sample type)
X**
(30/No. of survey
teams)
ā‰¤5 5 6
>5 10 3
**X- number of bacteriologically positive TB cases to be identified in each Survey Unit
ā€¢ First household of selected survey unit will be randomly selected
ā€¢ The survey team will continue in one direction till the X patients
is found in that unit.
ā€¢ Sample size = total number screened till the Xth patient is found
on examination as bacteriologically positive
(Criteria for stopping survey - achieving 30 microbiologically confirmed TB patients
or covering 10,000 households or covering 5% of current population of the district,
whichever is lesser )
Example: 1
ā€¢ District A.
ā€¢ No. of Survey teams: 10
ā€¢ Survey units in the district: 150 villages + 50 wards
ā€¢ PPS sampling: 10 Survey units selected (8 villages + 2
wards)
ā€¢ Stop rule for teams: 3 cases per team (not restricted
to the starting unit). If they cannot find the 3 cases,
teams should continue to the next nearby survey
unit (village/ward) till they find 3 cases each or till
all the teams together cover 10000HH or 5% of
District population.
Methods-Survey
Study procedures
Screening algorithm for sputum sample collection for TB
Site visit
Household
selection
Symptom
screening
Collection
of sample
Testing of
sample
Treatment
initiation
Data collection in DLAS application (WHO India)
Methods-Survey
Data analysis
Indicators from survey
1. Assessment of ā€˜under-reportingā€™ of notification in NIKSHAY
2. TB incidence (indirect method) - adjusting under-reporting for
notification rate of incident TB cases
3. TB incidence (direct method) - all incident cases counted in
last one year in the surveyed population during survey
4. Bacteriologically positive pulmonary TB load (point prevalence)
5. Calculation of Prevalence : notification ratio
Indirect method ā€“measuring the level of underreporting of
incident cases in a cross section (proportion of TB patients not
notified in NIKSHAY out of those reported as currently on
treatment during the survey); applying the level of underreporting
to notified incident cases with adjustment of accuracy in reporting
incident cases).
Direct measurement - as observation and count of incident cases
(diagnosed in last one year among those currently on Rx and
whose with past history) as found during the survey with
adjustment for those died (survey information) and
underdetected.
Underdetection adjustment based on additional cases diagnosed during
survey further adjusted for additional yield due to CXR based screening as well
as that of second sample testing for culture will be adjusted by the standard
correction factor of 0.35)
Secondary data review
Secondary data review
TB Score
ā€¢ 9 key performance parameters reported on NIKSHAY & on PFMS
ā€¢ Review of treatment cards of 25% of patients who have completed
treatment in previous quarter & financial records in the district
ā€¢ Interaction with 10% of patients completed treatment
ā€¢ TB notification
ā€¢ Screened for HIV
ā€¢ UDST
ā€¢ Treatment Success rate
ā€¢ Beneficiaries paid under NIKSHAY Poshan Yojana
ā€¢ Drug resistant TB Treatment initiation
ā€¢ Expenditure
ā€¢ Chemoprophylaxis for children
ā€¢ TB preventive therapy for PLHIV
UDST-Universal Drug Susceptibility Testing
Sl No TB Score Domain Numerator Denominator
Points
(100)
1 TB notification
TB cases notified Public &
Private
Annual Target 20
2 Screened for HIV
# of TB notified patients
screened for HIV
Total TB notified cases 10
3 UDST UDST tested
Target TB notified cases
eligible for UDST
10
4
Treatment success
rate
# of TB notified patients
with outcome - Success
TB notified patients 15
5
Beneficiaries paid
under NPY
Beneficiaries paid (at least
one payment)
Total beneficiaries eligible 10
6
DR-TB treatment
initiation
DRTB regimen initiated MDR patients diagnosed 15
7 Expenditure Expenditure (in lakhs)
Finance ROP to the State
(in lakhs)
10
8 Chemoprophylaxis
Children given
chemoprophylaxis
Children eligible for
Chemoprophylaxis
5
9 TPT for PLHIV PLHIV initiated on TPT PLHIV eligible for TPT 5
Secondary data review
TB Score
UDST-Universal Drug Susceptibility Testing, NPY- NIKSHAY Poshan Yojana, TPT ā€“ TB preventive therapy
Secondary data review
Anti-TB drug sales in public & private sector
ā€¢ Drug sale data from private & drug utilization data from public
ā€¢ Source of information
ā€¢ Schedule H1 register/Drug Inspector
ā€¢ Clearing and Forwarding (C & F) Agency
ā€¢ State Drug Controller/ Food & Drug Commissioner/Distributors
ā€¢ Quarterly report on drug inventory/WRDR format/ monthly PHI
report format collected manually/NIKSHAY Aushadhi)
Secondary data review
Anti-TB drug consumption/sales in public & private sector
Study procedures
ā€¢ Public sector ā€“ patient months calculated (total no. FDC &
intermittent packs consumed in the year)
ā€¢ Private sector -Trends in data & assumptions (sales coverage,
treatment duration, extend of prescription of products for TB
treatment, treatment covered by each unit of product) ā€“
NGTs/KII.
ā€¢ Data analysis for each year starting from 2015 till recent year
ā€¢ Deviation in trends of drug sale/consumption & assumptions in
calculation noted
ā€¢ Calculation of total Patient months for each year & decline in
patient months using revised data
Secondary data review
Anti-TB drug consumption/sales in public & private sector
Data analysis
ā€¢ Estimation of ā€˜patient months in public sectorā€™ using drug consumption
data
ā€¢ Total number of FDCs & intermittent packages ā€œRifampicin tabletsā€ consumed in
a year & Average treatment duration
ā€¢ Total number of patient months in public sector = Sum of patient
months in public sector for each product as calculated below
ā€¢ Total No. of patient months in public sector for a given product =
Total no. of Rifampicin tablets consumed in one year x No. of
Treatment Months represented by a unit of drug (*)
(*) Number of Treatment Months represented by a unit of drug sale for a given product is
calculated by averaging out the required number of tablets per patient (based on drug
consumption data)
Secondary data review
Anti-TB drug consumption/sales in public & private sector
Data analysis
Estimation of ā€˜patient months in private sectorā€™
Patient months = āˆ‘i [ Ni(Si/Ci)(Ti) ]
N - Total no. of tablets of Rifampicin sold
S - Proportion of Prescriptions Intended for Tuberculosis
T - No. of Treatment Months represented by a formulation
C - Coverage of Sales Data for a given product
ā€œiā€ indicates a given product containing Rifampicin
S & C Assumptions/estimations of the parameters is based on NGTs & KIIs
N is drug sale data with Rif tablets as Unit
T is treatment months for for that formulation
Calculate for each formulation using above formula and then add up
Secondary data review
Anti-TB drug consumption/sales in public & private sector
Data analysis
Estimation of ā€˜total patient monthsā€™ & decline in ā€˜total patient monthsā€™
from 2015
1) Total patient months = patient months in public sector + patient
months in private sector
2) Calculations will be done for each year staring 2015, & decline in
patient months will be calculated from 2015 till current year
3) % Decline in total patient months
(No. of total patient months 2015 ā€“ No. of total patient months in current year)
No. of patient months in 2015
Qualitative methods
Methods-Qualitative
Study Population
ā€¢ Chemists
ā€¢ Private practitioners (clinics, nursing homes/ hospitals, not for
profit organizations)
ā€¢ Chemists & Druggists Association
ā€¢ Drug commissioners
ā€¢ Drug inspectors
Sampling Technique
ā€¢ Participants (NGT & KII)- purposive sampling
(list of chemists from drug controller authorities & list of private
medical practitioners from state or central MCI)
ā€¢ 1-3 NGTs & 3-5 KIIs per district
Methods-Qualitative
Study procedures
ā€¢ Convenient place & time
ā€¢ A pre-designed topic guide with probes
ā€¢ Two data collectors - facilitator & note taker
ā€¢ Purpose of NGT & KII explained
ā€¢ Audio recording after an informed consent
ā€¢ Each session 45 mins -1hour
ā€¢ At the end of each session-information read out to validate
Both NGT & KIIs will be conducted until saturation of information is
attained
Methods-Qualitative
Data analysis
ā€¢ KIIs & Nominal NGTs will be recorded, transcribed & translated to
English
ā€¢ Transcripts prepared on the same day by data collectors to prevent
missing information
ā€¢ Analysed using standard tools
ā€¢ Independently reviewed by two researchers trained in qualitative
research
ā€¢ Themes & information pertaining to drug sales will be synthesised
from interview transcripts, notes & documentation taken during the
nominal group process & re-viewed
ā€¢ Synthesised themes & information will be used to attain a consensus
on drug sales
Eligibility for verification process
ā€¢ TB claims from various districts & States/UTā€™s obtained from CTD
ā€¢ Data from State/UTs/districts obtained - TB score, Number Needed to
Test , Drug sales/ consumption data (Public & Private) &
Epidemiological data
ā€¢ Eligibility criteria
1) TB Score for the latest year is ā‰„ 80%
Between 2015 ā€“ 2020
2) Increase in Number Needed to Test ā‰„ 20%
3) % decline in patient months ā‰„20% (drug sale/consumption data)
ā€¢ At least 2 out of 3 criteria fulfilled for further secondary data
verification & survey
Districts that have submitted claims for different levels of achievement of TB free status, activities
will be prioritised & first evaluated/verified, followed by districts that have not submitted any claims
Year 2015 - baseline for comparison of these indicators
Eligibility for verification process
(State/UT level claims)
Claims for State/UT level certification were verified by
(1) State TB Score
(2) Public sector drug consumption and Private sector anti-TB drug
sale data at State level & in a sample of districts
(3) Estimating under-reporting & incidence from district level
survey in 25% districts ensuring regional representation
TB incidence (recent year)
ā€¢ Data on drug sale verified at State level & in sample of districts
ā€¢ Notification rate at State level adjusted for under-reporting,
identified through surveys in 25% of districts
ā€¢ State level TB incidence computed by extrapolating average of
district level TB incidence found through surveys in 25% districts to
the entire State
Criteria for certification
Triangulated Data analysis
ā€¢ TB incidence calculation for the most recent year using
ā€¢ Drug sales & consumption data
ā€¢ Notification rate adjusted for under-reporting
ā€¢ Reported incidence from district survey
ā€¢ Calculation of decline from estimated TB incidence in 2015
through each method
ā€¢ If decline in incidence calculated through 2 out of 3 methods is >
20% or as claimed by District, certification under appropriate
category
Additional Criteria for certification
Criteria Recommendation about verification of
claim
Any of the three incidence estimates
higher than 10% of the baseline estimate
Not recommended under any category
Any two out of three-point estimates of
decline in incidence support claimed
category & no estimate of incidence shows
an increase from baseline incidence
Recommended under eligible/ claimed
category
Any two out of three-point estimates of
decline in incidence support claimed
category & the other estimate of
incidence shows an increase of up to 10%
from baseline incidence
If lower bound of the incidence estimate is
more than 10% of the baseline estimate,
then not recommended for award
Any two out of three-point estimates of
decline in incidence support higher than
the claimed category
If lower bounds of CIs of those estimates of
decline in incidence found to support higher
category, recommended under higher
category
All three incidence estimates are
<44/100,000 population
TB free status for that year.
Expected outcomes
ā€¢ Incidence of TB & decline in incidence (from 2015) of TB
ā€¢ Progress of all the districts towards TB Free status will be evaluated
ā€¢ Verification of TB free claims submitted by district & state
Means of estimation Step
NIKSHAY portal TB notification rate
Survey Incidence of TB based on date of diagnosis
Drug sales/utilisation data TB patient months
Average duration of treatment
Human participant protection
ā€¢ Ethics committee approval from ICMR-NIRT
ā€¢ Informed consent/assent process
ā€¢ Information to participants on study procedure & key elements &
informed written consent from participants
ā€¢ Assent & informed written parental consent for 0-18 years aged
participants
ā€¢ Consent for audio recording during NGT & KII
Confidentiality
ā€¢ Concealed name & identity of the participants
ā€¢ Usage of identification numbers & code number
ā€¢ Reporting using aggregate information
Risk/Benefit for participants
ā€¢ No possible risk
ā€¢ Direct benefit ā€“ Screened & newly diagnosed cases linked to nearest
TB unit for treatment
Flow of the process from claims submission to
certification of districts/ states/UTs
The MoHFW sought claims for award from States/UTs/Districts:
āœ”CTD screened for the claims received.
āœ”Claims forwarded for verification to ICMR ā€“ NIRT.
āœ”NIRT will submit report to CTD after verification.
āœ”Report review by CTD and final decision on awarding.
āœ”Awarding and felicitation of districts/ states.
MoHFW
invite
claim
District
assess
eligibility
District
submit
claims to
States/UTs
State/UT
review the
claim
(pre-
requisite)
State/UT
forward
the claim
to CTD
CTD record
& screen
the claim
Forwardes
to
verification
Agency
Independent
Agency/Institut
e undertake
claim
verification
(NTF consulted
if required)
Claim
acceptted/re
jected
Successful
claims
awarded
TB Volunteers ā€“ Survey Verification
SNC Survey Report of District Champawat by DNO 1
(Dr. Sanjeev Davey) and DNO 2 (Dr. Preeti)
ā€¢ The SNC survey in Champawat was done on 17th Jan 2023 and 18th Jan 2023 by DNO 1 & 2 i.e, Dr. Sanjeev Davey
and Dr. Preeti along with WHO consultant Dr. Biswajeet. In these supervisory visits, we had
cross checked data of random patients on treatment, their treatment cards were cross
checked and no disparity was found in them, also random patients were visited and
interviewed to know their status and services provided to them.
ā€¢ On 1st day of the visit, a private practitioner named, Dr. P.K.Karnatak, was interviewed and
according to him in district Champawat, there was a drastic reduction of more than 25% in
tuberculosis patients, also he admitted that these days he is referring tuberculosis patient
directly to government hospital and if in case started treatment inform the government
hospital or the DTO.
ā€¢ On the same day, 2 chemists were interviewed, Mr. Harish Kharkwal and Mr. R.S. Dhoni.
According to Mr. Harish Kharkwal, tuberculosis drugs consumption reduced to near about
90%. They sent the patient to DOTS centre.
ā€¢ According to Mr. R.S. Dhoni, there was reduction in tuberculosis patient, now it seems to
be of only 5-7%. Patients interviewed were Ms. Anjali and Mr. Bittu to know there status and
services provided to them, they were found satisfied.
ā€¢ On 18th Jan 2023, NGT was conducted among private practitioners and chemists in
Tanakpur. In this 4 private practitioners and 2 medical store owners were involved. In this
with common concense, 90% reduction in tuberculosis patients was found. They refer
patient to government hospital and provide information to the government hospital or DTO
directly. Patients visited and interviewed were Mr. Jitendra singh and Mrs. Saraswati and
found satisfied response.
ā€¢ On the same day, the team visited and supervised 2 teams for field visits and found their
work appropriate.
ā€¢ On the basis of overall data triangulation, DNO 1&2 recommend the district for Bronze
category.
ā€¢
Thank you

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WTD CME 24th March 2023 Prof Dr sanjev Dave.pptx

  • 1. Continuing Medical Education(CME) : Role of SSJGIMSR Almora in TB Management of Uttarakhand World TB day- 24th March 2023 Prof Dr Sanjev Dave Department of Community medicine, Soban Singh Jeena Government Institute of Medical Sciences, Almora (Uttarakhand) India-263601
  • 2. It is observed annually on March 24 ----to raise awareness about TB and ------efforts to end the global epidemic, --------marking the day in 1882 when the bacterium causing TB was discovered. World TB Day Celebration???
  • 3. World TB day- 24th March 2023 Theme ā€“ Yes ! We can End TB
  • 4. TB ā€“ A Social Disease Vulnerable Malnutrition Poor housing Elderly, children & women Overcrowding Rural & Urban Develop ment
  • 5.
  • 6.
  • 7. TB Burden ā€“ Comparison With Other Diseases T uberculosis is (India)- ā€¢ Leading cause of death among communicable diseases ā€¢ 5th leading cause of death among all diseases Deaths attributed to disease Source: IHME,Global disease burden (2019) Estimated Case Fatality Rate for TB is 17% (2019)
  • 8.
  • 9. Tb Disease Burden In India ā€¢ Estimated incidence rate ofTB šŸ”» 193 cases / lakh population ā€¢ EstimatedTB cases in 2019 in India šŸ”» 26.4 lakh ā€¢ Reported TB cases šŸ”» 24 lakh (2019) šŸ”» 18 lakh (2020) šŸ”» 12.8 lakhs (So far-Augā€™21) 33 % Urban 2.5 % Drug Resistant 38% Men 62% Women Children 6% 65 % 15-45 years (Age) 2 % HIV- Positive 58 % Rural 9 % Tribal
  • 10. End TB Targets ā€“ TB Incidence And Mortality 2015 2020 2023 2025
  • 11. TB Notification Progress 21. 02 24. 02 18. 12 2021:Jan-Aug : Source -
  • 12.
  • 13. Evolution Of NTEP 1962 Govt.of India launched the National TB Program and set up DistrictTB Centres 1993 WHO declares TB as a global emerge ncy 2005 ā€“ 11 Second phase of RNTCP ā€“ Pan India coverage and improved quality and scale up of services 2017 ā€“ 25 NSP (2017 ā€“ 25) ā€“ patient centric care for TB elimination 1997 GoI revised NTP to RNTCP ā€“ introduction of DOTS (Directly ObservedTreatment Short course) 2012 -17 National Strategic Plan (2012 -17) - mandatory notification ofTB, rapid molecular testing, active case finding and integration of the program with National Health Mission 2021 TB Mukt BharatAbhiyaan 2020 In January 2020,GoI revised RNTCP to National TB Elimination Program (NTEP)
  • 14. NATIONAL STRATEGIC PLAN (2017-2025) Treat Prevent Build Detect Find all TB cases with an emphasis on reaching every TB patient in the private sector Treat all TB cases with high quality anti TB drugs Prevent the emergence of TB in susceptible populations and stop catastrophic expenditure due to TB by all Build & strengthen supportive systems including enabling policies, empowered institutions & human resources
  • 15. DETECT Decentralize TB screening to AB-HWC levels Scale up Molecular Diagnostics to the Peripheral Levels Early Detection of DRTB- Universal DST Vulnerability Mapping & Active case finding Private Sector Engagement Technology 2014 2021 Microscopy 13,657 21,717 Rapid Molecular Test 119 3164 Culture lab (for drug 50 87 resistance test) Active case finding through mobile medical van Patient Provider Support Agency 2018 : 48 large cities (JEET) 2019 ā€“ 156 (domestic)+95 (JEET) 2020 ā€“ 266 (domestic) + 109 (JEET)
  • 16. Daily regimen ā€“Fixed Dose Combination Injection free treatment regimens Scale up of Newer drugs/regimens >4 lakhASHA & Community Volunteer as DOT provider ICT based adherence ā€¢ 800 treatment centre for DR-TB ā€¢ Bedaquline & Delamaind Treat
  • 17. PREVENT Sustaining COVID appropriate behavior Contact Tracing & TB Preventive Treatment Airborne Infection Control in community & Health Facilities Community Mobilization & Peopleā€™s Movement 1.64 lakh treat ed with 11 lakh ā€¢ People living with HIV/AI DS given TPT Expansi on of policy in househ old contact s for all age group Contact tracing and screening of all household contact and TB Preventive Treatment
  • 18. BUILD IEC Capacity Building Human Resources Development Multisec toral Collabor ation Digital Interventions Surveillance Procurement & SupplyChain National Training on T ubercul osis at NIRT TB Arogya SaathiApp Engaging line ministries Case based web- based surveillance for TB Nikshay PoshanYojana: DBT of >Rs.1200 Cr
  • 19. PROGRAMME PERFORMANCE - NTEP 2020 HIV Status Known: 92% UDST: 67% MDR TB Treatment Initiation:86% IPT among children: 34% TPT among PLHIV:47%
  • 20. NIKSHAY Poshan NIKSH AY PF M S Ba n k Pati ent TB patients provide d benefit 4 6 lak h Public sector ā€“ 73%, ā€¢Private ā€“ 39% Covera ge ā€¢Rs. 500/- per month given to every TB patient through DBT for duration of treatment ā€¢Scheme rolled out from April 2018 ā€¢Rs. 1204 Cr of amount disbursed to beneficiaries Period - April 2018 to June 2021
  • 21. NIKSHAY POSHAN YOJANA (NPY) Proportion of TB patients paid out of those eligible Year Total (Pub + Pvt) (%) Public (%) Private (%) 2018 61 70 22 2019 67 78 38 2020 73 80 55 2021 (Jan-Mar) 75 82 54 Year Current Patients Bank details available Bank details validated Paid at least once 2020 18.13 14.60 13.67 13.22 (In lakhs) (81%) (75%) (73%) 2019 24.00 22.95 17.56 16.08 (In lakhs) (96%) (73%) (67%)
  • 22. Mechanisms for Monitoring and Evaluation Internal ā€¢ Quarterly Review meeting at National, State and District levels ā€¢ Central & State Internal Evaluations ā€¢ External and Internal Quality assessment of labs by IRLs and NRLs ā€¢ Annual Common Review Mission as part of NHM ā€¢ Sub National TB free certification External ā€¢State Health Index report by NITI Aayog (Annual) ā€¢World Bank review mission (6 monthly) ā€¢Joint monitoring mission by WHO (once in 3 years) Proposed Activity Joint supportive supervision by deputing central teams State wise review by HFM
  • 23. Sub-National Certification of Progress Towards TB Free Status Ministry of Health & Family Welfare, Government of India, rolled out the initiative of Sub-national certification of progress towards TB Free Status in 2020-21 to track the progress made towards achieving the goal of total TB elimination by 2025. To achieve the goal, the Ministry of Health & Family Welfare, Govt. of India has developed a sub-national TB free certification process. An important step in the sub-national TB free certification process is validation of claims of reduction in TB incidence at District/State/UT level. The Govt. of India has resolved to end Tuberculosis (TB Free) in India by 2025.
  • 24. Vision: TB Free 13 March 2018: India committed to End TB by 2025, five years ahead of Global SDG target Indicators (compared to 2015) Global End TB Targets Global SDG TB Target s TB Free India Targets 1. Reduction in number of TB deaths 95% 90% 90% (3 per 1,00,000 population) 2. Reduction in TB incidence rate 90% 80% 80% (44 per 1,00,000 population) 3. TB-affected families facing catastrophic costs due to TB 0% 0% 0% (Zero catastrophic costs due to TB )
  • 25. Rationale for the Initiative ā€¢ Currently certification of elimination of the disease is done only at national level, by WHO ā€¢ Targeted initiatives required at State & District levels for disease elimination ā€¢ Different epidemiological scenario across country demands a differential strategy to reach to the elimination targets & sub-national measurements ā€¢ Incentivizing and rewarding well performing states & districts: ā€¢ Achieving target that are within their control and capacity, ā€¢ Motivation to prioritize and undertake implementation of programme to achieve milestones towards TB Free district ā€¢ Generates sense of healthy competition among States/Districts.
  • 26. Award Details Awards Bronze Silver Gold TB Free Criteria (Incidence decline compared to 2015) šŸ”»20% šŸ”»40% šŸ”»60% šŸ”»80% / ā‰¤ 44/Lakh State Rs. 25 lakhs Rs. 50 lakhs Rs. 75 lakhs Rs. 100 lakhs District Rs. 2 lakhs Rs. 3 lakhs Rs. 5 lakhs Rs. 10 lakhs
  • 27. Process Submission of Claim by District/State/UT Preparation for verification and data availability Verification of claim by Independent Agency Distribution of award Release of award money 24th March
  • 28. Pre-requisites for Submission of Claims (District/State/UT) Decline in patient months from 2015 (based on drug consumption / sales data) ā‰„20% Increase in Number Needed to Test to diagnose 1 TB patient ā‰„20% TB score for the latest year ā‰„80%
  • 29. Methodology for Verification ā€¢ Review of records ā€¢ Patient & other stakeholder interviews Verification of TB Score & NNT ā€¢ Review of drug sale/consumption reports/records ā€¢ Interviews & discussions with Private Practitioners, Chemists, Drug Inspectors, etc Verification of Drug Sale/Consumption Data ā€¢ Community Survey using inverse sampling methodology ā€¢ Mapping of incident TB patients on Nikshay Estimation of TB incidence and under-reporting at community level
  • 30. Key Stakeholders ā€¢ National Level ā€“ NHM, CTD, WHO, ICMR -NIRT, ICMR-NIE, SNC Task Force, Partner Organizations ā€¢ State Level ā€¢ State NHM, State TB Cell & STDC ā€¢ Medical colleges ā€¢ State Drug Controller ā€¢ Clearing & Forwarding Agency(Drugs), Drug Distributors, ā€¢ Private Healthcare Providers/Chemist Associations ā€¢ District Level ā€¢ District Collector/Magistrate ā€¢ Medical College ā€¢ NHM & DTC, MOTCs, STS, STLS, Labs ā€¢ Drug inspectors ā€¢ Private Healthcare Providers & associations ā€¢ Chemists
  • 31. Advantages of Submitting Claims Understanding of TB Disease Burden in the geography Successf ul Not Successful
  • 32. MoHFW invites Claims Districts submit claims to State States submit claims to MoHFW Independent Agency (ICMR) verifies claims Successful claims awarded on World TB Day August 31 March 24 Verification ā€¢ Community survey to find out incidence & under-reporting ā€¢ Interviews & FGDs with private doctors & chemists to verify drug sale ā€¢ Review of records & patient interviews to verify TB score Sub National TB Free Certification Awards Bronze Silver Gold TB Free Criter ia (Incid ence declin e) ā–” 20 % ā–” 40 % ā–” 60 % ā–” 80 % State Awards (Rs In lakhs) 25 50 75 100 District Awards (Rs In lakhs) 2 3 5 10
  • 33. SUB NATIONAL CERTIFICATION-2020 AWARDS TB FREE State of Kerala and UT of Puducherry and 29 Districts across 11 States. ā€¢ Lahul Spiti, Himachal Pradesh, ā€¢ Kolhapur District of Maharashtra ā€¢ Parel (ward) of Mumbai, ā€¢ West Tripura District of Tripura ā€¢ District Diu of DNH&D D ā€¢ UT of Lakshadweep, ā€¢ District Budgam of J&K
  • 34. Advantages of Submitting Claims Understanding of TB Disease Burden in the geography Successf ul Not Successful
  • 35.
  • 36. Role of Dept of Community Medicine SSJGIMSR Almora in District Level Annual Survey (DLAS) for Evaluation and Certification of Sub- national progress towards ā€˜TB Freeā€™ status in India(2021-24) For District CHAMPAWAT Independent Verifying Agency ICMR-National Institute for Research in Tuberculosis, Chennai Collaborators Central TB Division, Ministry of Health & Family Welfare, New Delhi World Health Organization-India ICMR-National Institute of Epidemiology, Chennai Indian Association for Preventive & Social Medicine
  • 37. As per the decision by Central TB Division, Govt. of India, ICMR-National Institute for Research in Tuberculosis has been identified as the independent verification agency for Sub-National certification of TB elimination efforts along with ICMR-NIE, Indian Association of Preventive and Social Medicine (IAPSM) and World Health Organization (WHO), India Office. This year, TB free claims have been received from 302 districts and 13 States/UTs. The Dept. of Community Medicine of institutes were assigned this validation exercise along with other stakeholders in the district where the Medical College is located or the allotted nearby district . The faculties & PG students have to train field teams, undertake supervision of field work, verify secondary data, conduct qualitative interviews and submit a report. All expenditure were borne out of the budget provided for this purpose by CTD.
  • 38. Aim To verify the eligibility of the districts & states that have submitted claims for Sub-National Certification based on: -reported trends in TB incidence & prevalence, -number needed to test & -TB score
  • 39. Objectives Specific objectives a) To estimate incidence of TB in the surveyed sample population (direct estimation) & by adjusting for under-reporting in NIKSHAY (indirect method) in the district. a) To estimate the incidence of TB in the community based on anti- TB drug sale in the private sector & anti-TB drug consumption in the public sector. a) To calculate the reduction in TB incidence between 2015 & assessment year (2021-24). a) To estimate the prevalence of symptomatic & currently as well as previously treated TB patients in the community.
  • 40. Methods (1) Study Design Mixed method study with a triangulation design Quantitative component - cross-sectional study ā€¢ Primary data collection through a district level survey ā€¢ Secondary data review (review of records from NIKSHAY notification systems & NTEP reports, utilisation of drugs in public & private sector) Qualitative component ā€¢ Nominal Group Techniques (NGT) involving nominal group technique ā€¢ Key informant interviews (KII) Triangulation and Analytics component ā€¢ Quantifying incident patients belonging to other district ā€¢ Quantification of under-notification
  • 41. Methods (2) Duration - 2021-2024 Settings Districts in India ā€¢ Phase 1- Verify the districts/State/UT that have submitted the claims ā€¢ Phase 2- Evaluate State/UT that have not submitted the State/UT level claims
  • 42. Methods (3) Random review of records (2015-2022(23,24) Households Qualitative NGT KII Secondary data review ā€¢ Anti-TB drugs sale/consumption data (private & Public) ā€¢ TB notification data (NIKSHAY) Villages/wards Survey units TB units Survey Districts Quantitative Analytics (quantification) Incident cases Under- notificatio n
  • 43. Activities ā€“National level & NTEP (1) ā€¢ Planning & Preparation - ā€¢ Review of claims (districts and States/UTs) ā€¢ Selection and finalization of districts for State/UT claims ā€¢ Finalization of survey areas, clusters listing, cluster selection Finalization of survey teams and volunteers ā€¢ Logistics ā€¢ Ensuring adequate falcons tubes, ā€¢ molecular test kits and machines ā€¢ testing capacity and linkages for sample transport mechanism ā€¢ Coordination ā€¢ Identifying suitable dates for training and survey as well as potential conflicting priorities
  • 44. Activities ā€“Evaluation /verification (2) ā€¢ Training of trainers & data collectors ā€¢ Sensitization of program managers ā€¢ District level community survey ā€¢ Secondary data review NIKSHAY data ā€“TB notification ,TB Score Drug sales in private sector & consumption in public sector ā€¢ Nominal Group Techniques & Key Informant Interviews ā€¢ Verification of eligibility of districts & states for claims ā€¢ Calculation of TB burden (Prevalence/Incidence) for 2015 & most recent year ā€¢ Estimation of decline in TB incidence from 2015
  • 45. Training of trainers & data collectors (Supervision structure for Verification of Sub-national claims) National coordinating team (NIRT/NIE/IAPSM/WHO) State coordinating team (IAPSM/Medical college/ICMR institutes/WHO consultants) District verification team (IAPSM/ Medical college/ WHO consultants) Survey team (5/10 teams/district) (20 data collectors*/district) Discuss implementation plan & resources Train state teams Field level hands on training workshop - methods & study tools (NGT & KII) *TB Champions Volunteers Social workers NGOs ASHAs Train survey teams Secondary data review NGT/ KII Household survey Sputum sample collection & transport
  • 47. Methods-Survey Study Population Community-based survey Individuals of all age groups Inclusion criteria: ā€¢ Residing in selected village for previous one month ā€¢ Available in the household at the time of survey Exclusion criteria: ā€¢ Institutional populations ā€“ schools, offices, prisons, defence establishments, hospitals, nursing homes, hostels etc. ā€¢ Refusing to give consent for participation ā€¢ Hospitalized residents
  • 48. Methods-Survey Sampling technique ā€¢ Survey Units will be defined at village/ ward level ā€¢ The first household in SU randomly selected ā€¢ Households visited sequentially till desired sample size is achieved ā€¢ Inverse sampling method* TUs-Tuberculosis Units *A fixed number of bacteriologically positive TB cases to be found by each team in the survey unit Households Inverse sampling Survey Units (Villages/wards) PPS sampling Districts
  • 49. Methods-Survey Number of Survey units to be studied within a district & number of bacteriologically positive TB cases (X) to be identified in each Survey Unit Districts with number of TB Units Desired number of Survey team (Sample type) X** (30/No. of survey teams) ā‰¤5 5 6 >5 10 3 **X- number of bacteriologically positive TB cases to be identified in each Survey Unit ā€¢ First household of selected survey unit will be randomly selected ā€¢ The survey team will continue in one direction till the X patients is found in that unit. ā€¢ Sample size = total number screened till the Xth patient is found on examination as bacteriologically positive (Criteria for stopping survey - achieving 30 microbiologically confirmed TB patients or covering 10,000 households or covering 5% of current population of the district, whichever is lesser )
  • 50. Example: 1 ā€¢ District A. ā€¢ No. of Survey teams: 10 ā€¢ Survey units in the district: 150 villages + 50 wards ā€¢ PPS sampling: 10 Survey units selected (8 villages + 2 wards) ā€¢ Stop rule for teams: 3 cases per team (not restricted to the starting unit). If they cannot find the 3 cases, teams should continue to the next nearby survey unit (village/ward) till they find 3 cases each or till all the teams together cover 10000HH or 5% of District population.
  • 51. Methods-Survey Study procedures Screening algorithm for sputum sample collection for TB Site visit Household selection Symptom screening Collection of sample Testing of sample Treatment initiation Data collection in DLAS application (WHO India)
  • 52. Methods-Survey Data analysis Indicators from survey 1. Assessment of ā€˜under-reportingā€™ of notification in NIKSHAY 2. TB incidence (indirect method) - adjusting under-reporting for notification rate of incident TB cases 3. TB incidence (direct method) - all incident cases counted in last one year in the surveyed population during survey 4. Bacteriologically positive pulmonary TB load (point prevalence) 5. Calculation of Prevalence : notification ratio
  • 53. Indirect method ā€“measuring the level of underreporting of incident cases in a cross section (proportion of TB patients not notified in NIKSHAY out of those reported as currently on treatment during the survey); applying the level of underreporting to notified incident cases with adjustment of accuracy in reporting incident cases). Direct measurement - as observation and count of incident cases (diagnosed in last one year among those currently on Rx and whose with past history) as found during the survey with adjustment for those died (survey information) and underdetected. Underdetection adjustment based on additional cases diagnosed during survey further adjusted for additional yield due to CXR based screening as well as that of second sample testing for culture will be adjusted by the standard correction factor of 0.35)
  • 55. Secondary data review TB Score ā€¢ 9 key performance parameters reported on NIKSHAY & on PFMS ā€¢ Review of treatment cards of 25% of patients who have completed treatment in previous quarter & financial records in the district ā€¢ Interaction with 10% of patients completed treatment ā€¢ TB notification ā€¢ Screened for HIV ā€¢ UDST ā€¢ Treatment Success rate ā€¢ Beneficiaries paid under NIKSHAY Poshan Yojana ā€¢ Drug resistant TB Treatment initiation ā€¢ Expenditure ā€¢ Chemoprophylaxis for children ā€¢ TB preventive therapy for PLHIV UDST-Universal Drug Susceptibility Testing
  • 56. Sl No TB Score Domain Numerator Denominator Points (100) 1 TB notification TB cases notified Public & Private Annual Target 20 2 Screened for HIV # of TB notified patients screened for HIV Total TB notified cases 10 3 UDST UDST tested Target TB notified cases eligible for UDST 10 4 Treatment success rate # of TB notified patients with outcome - Success TB notified patients 15 5 Beneficiaries paid under NPY Beneficiaries paid (at least one payment) Total beneficiaries eligible 10 6 DR-TB treatment initiation DRTB regimen initiated MDR patients diagnosed 15 7 Expenditure Expenditure (in lakhs) Finance ROP to the State (in lakhs) 10 8 Chemoprophylaxis Children given chemoprophylaxis Children eligible for Chemoprophylaxis 5 9 TPT for PLHIV PLHIV initiated on TPT PLHIV eligible for TPT 5 Secondary data review TB Score UDST-Universal Drug Susceptibility Testing, NPY- NIKSHAY Poshan Yojana, TPT ā€“ TB preventive therapy
  • 57. Secondary data review Anti-TB drug sales in public & private sector ā€¢ Drug sale data from private & drug utilization data from public ā€¢ Source of information ā€¢ Schedule H1 register/Drug Inspector ā€¢ Clearing and Forwarding (C & F) Agency ā€¢ State Drug Controller/ Food & Drug Commissioner/Distributors ā€¢ Quarterly report on drug inventory/WRDR format/ monthly PHI report format collected manually/NIKSHAY Aushadhi)
  • 58. Secondary data review Anti-TB drug consumption/sales in public & private sector Study procedures ā€¢ Public sector ā€“ patient months calculated (total no. FDC & intermittent packs consumed in the year) ā€¢ Private sector -Trends in data & assumptions (sales coverage, treatment duration, extend of prescription of products for TB treatment, treatment covered by each unit of product) ā€“ NGTs/KII. ā€¢ Data analysis for each year starting from 2015 till recent year ā€¢ Deviation in trends of drug sale/consumption & assumptions in calculation noted ā€¢ Calculation of total Patient months for each year & decline in patient months using revised data
  • 59. Secondary data review Anti-TB drug consumption/sales in public & private sector Data analysis ā€¢ Estimation of ā€˜patient months in public sectorā€™ using drug consumption data ā€¢ Total number of FDCs & intermittent packages ā€œRifampicin tabletsā€ consumed in a year & Average treatment duration ā€¢ Total number of patient months in public sector = Sum of patient months in public sector for each product as calculated below ā€¢ Total No. of patient months in public sector for a given product = Total no. of Rifampicin tablets consumed in one year x No. of Treatment Months represented by a unit of drug (*) (*) Number of Treatment Months represented by a unit of drug sale for a given product is calculated by averaging out the required number of tablets per patient (based on drug consumption data)
  • 60. Secondary data review Anti-TB drug consumption/sales in public & private sector Data analysis Estimation of ā€˜patient months in private sectorā€™ Patient months = āˆ‘i [ Ni(Si/Ci)(Ti) ] N - Total no. of tablets of Rifampicin sold S - Proportion of Prescriptions Intended for Tuberculosis T - No. of Treatment Months represented by a formulation C - Coverage of Sales Data for a given product ā€œiā€ indicates a given product containing Rifampicin S & C Assumptions/estimations of the parameters is based on NGTs & KIIs N is drug sale data with Rif tablets as Unit T is treatment months for for that formulation Calculate for each formulation using above formula and then add up
  • 61. Secondary data review Anti-TB drug consumption/sales in public & private sector Data analysis Estimation of ā€˜total patient monthsā€™ & decline in ā€˜total patient monthsā€™ from 2015 1) Total patient months = patient months in public sector + patient months in private sector 2) Calculations will be done for each year staring 2015, & decline in patient months will be calculated from 2015 till current year 3) % Decline in total patient months (No. of total patient months 2015 ā€“ No. of total patient months in current year) No. of patient months in 2015
  • 63. Methods-Qualitative Study Population ā€¢ Chemists ā€¢ Private practitioners (clinics, nursing homes/ hospitals, not for profit organizations) ā€¢ Chemists & Druggists Association ā€¢ Drug commissioners ā€¢ Drug inspectors Sampling Technique ā€¢ Participants (NGT & KII)- purposive sampling (list of chemists from drug controller authorities & list of private medical practitioners from state or central MCI) ā€¢ 1-3 NGTs & 3-5 KIIs per district
  • 64. Methods-Qualitative Study procedures ā€¢ Convenient place & time ā€¢ A pre-designed topic guide with probes ā€¢ Two data collectors - facilitator & note taker ā€¢ Purpose of NGT & KII explained ā€¢ Audio recording after an informed consent ā€¢ Each session 45 mins -1hour ā€¢ At the end of each session-information read out to validate Both NGT & KIIs will be conducted until saturation of information is attained
  • 65. Methods-Qualitative Data analysis ā€¢ KIIs & Nominal NGTs will be recorded, transcribed & translated to English ā€¢ Transcripts prepared on the same day by data collectors to prevent missing information ā€¢ Analysed using standard tools ā€¢ Independently reviewed by two researchers trained in qualitative research ā€¢ Themes & information pertaining to drug sales will be synthesised from interview transcripts, notes & documentation taken during the nominal group process & re-viewed ā€¢ Synthesised themes & information will be used to attain a consensus on drug sales
  • 66. Eligibility for verification process ā€¢ TB claims from various districts & States/UTā€™s obtained from CTD ā€¢ Data from State/UTs/districts obtained - TB score, Number Needed to Test , Drug sales/ consumption data (Public & Private) & Epidemiological data ā€¢ Eligibility criteria 1) TB Score for the latest year is ā‰„ 80% Between 2015 ā€“ 2020 2) Increase in Number Needed to Test ā‰„ 20% 3) % decline in patient months ā‰„20% (drug sale/consumption data) ā€¢ At least 2 out of 3 criteria fulfilled for further secondary data verification & survey Districts that have submitted claims for different levels of achievement of TB free status, activities will be prioritised & first evaluated/verified, followed by districts that have not submitted any claims Year 2015 - baseline for comparison of these indicators
  • 67. Eligibility for verification process (State/UT level claims) Claims for State/UT level certification were verified by (1) State TB Score (2) Public sector drug consumption and Private sector anti-TB drug sale data at State level & in a sample of districts (3) Estimating under-reporting & incidence from district level survey in 25% districts ensuring regional representation TB incidence (recent year) ā€¢ Data on drug sale verified at State level & in sample of districts ā€¢ Notification rate at State level adjusted for under-reporting, identified through surveys in 25% of districts ā€¢ State level TB incidence computed by extrapolating average of district level TB incidence found through surveys in 25% districts to the entire State
  • 68. Criteria for certification Triangulated Data analysis ā€¢ TB incidence calculation for the most recent year using ā€¢ Drug sales & consumption data ā€¢ Notification rate adjusted for under-reporting ā€¢ Reported incidence from district survey ā€¢ Calculation of decline from estimated TB incidence in 2015 through each method ā€¢ If decline in incidence calculated through 2 out of 3 methods is > 20% or as claimed by District, certification under appropriate category
  • 69. Additional Criteria for certification Criteria Recommendation about verification of claim Any of the three incidence estimates higher than 10% of the baseline estimate Not recommended under any category Any two out of three-point estimates of decline in incidence support claimed category & no estimate of incidence shows an increase from baseline incidence Recommended under eligible/ claimed category Any two out of three-point estimates of decline in incidence support claimed category & the other estimate of incidence shows an increase of up to 10% from baseline incidence If lower bound of the incidence estimate is more than 10% of the baseline estimate, then not recommended for award Any two out of three-point estimates of decline in incidence support higher than the claimed category If lower bounds of CIs of those estimates of decline in incidence found to support higher category, recommended under higher category All three incidence estimates are <44/100,000 population TB free status for that year.
  • 70. Expected outcomes ā€¢ Incidence of TB & decline in incidence (from 2015) of TB ā€¢ Progress of all the districts towards TB Free status will be evaluated ā€¢ Verification of TB free claims submitted by district & state Means of estimation Step NIKSHAY portal TB notification rate Survey Incidence of TB based on date of diagnosis Drug sales/utilisation data TB patient months Average duration of treatment
  • 71. Human participant protection ā€¢ Ethics committee approval from ICMR-NIRT ā€¢ Informed consent/assent process ā€¢ Information to participants on study procedure & key elements & informed written consent from participants ā€¢ Assent & informed written parental consent for 0-18 years aged participants ā€¢ Consent for audio recording during NGT & KII Confidentiality ā€¢ Concealed name & identity of the participants ā€¢ Usage of identification numbers & code number ā€¢ Reporting using aggregate information Risk/Benefit for participants ā€¢ No possible risk ā€¢ Direct benefit ā€“ Screened & newly diagnosed cases linked to nearest TB unit for treatment
  • 72. Flow of the process from claims submission to certification of districts/ states/UTs The MoHFW sought claims for award from States/UTs/Districts: āœ”CTD screened for the claims received. āœ”Claims forwarded for verification to ICMR ā€“ NIRT. āœ”NIRT will submit report to CTD after verification. āœ”Report review by CTD and final decision on awarding. āœ”Awarding and felicitation of districts/ states. MoHFW invite claim District assess eligibility District submit claims to States/UTs State/UT review the claim (pre- requisite) State/UT forward the claim to CTD CTD record & screen the claim Forwardes to verification Agency Independent Agency/Institut e undertake claim verification (NTF consulted if required) Claim acceptted/re jected Successful claims awarded
  • 73.
  • 74.
  • 75. TB Volunteers ā€“ Survey Verification
  • 76. SNC Survey Report of District Champawat by DNO 1 (Dr. Sanjeev Davey) and DNO 2 (Dr. Preeti) ā€¢ The SNC survey in Champawat was done on 17th Jan 2023 and 18th Jan 2023 by DNO 1 & 2 i.e, Dr. Sanjeev Davey and Dr. Preeti along with WHO consultant Dr. Biswajeet. In these supervisory visits, we had cross checked data of random patients on treatment, their treatment cards were cross checked and no disparity was found in them, also random patients were visited and interviewed to know their status and services provided to them. ā€¢ On 1st day of the visit, a private practitioner named, Dr. P.K.Karnatak, was interviewed and according to him in district Champawat, there was a drastic reduction of more than 25% in tuberculosis patients, also he admitted that these days he is referring tuberculosis patient directly to government hospital and if in case started treatment inform the government hospital or the DTO. ā€¢ On the same day, 2 chemists were interviewed, Mr. Harish Kharkwal and Mr. R.S. Dhoni. According to Mr. Harish Kharkwal, tuberculosis drugs consumption reduced to near about 90%. They sent the patient to DOTS centre. ā€¢ According to Mr. R.S. Dhoni, there was reduction in tuberculosis patient, now it seems to be of only 5-7%. Patients interviewed were Ms. Anjali and Mr. Bittu to know there status and services provided to them, they were found satisfied. ā€¢ On 18th Jan 2023, NGT was conducted among private practitioners and chemists in Tanakpur. In this 4 private practitioners and 2 medical store owners were involved. In this with common concense, 90% reduction in tuberculosis patients was found. They refer patient to government hospital and provide information to the government hospital or DTO directly. Patients visited and interviewed were Mr. Jitendra singh and Mrs. Saraswati and found satisfied response. ā€¢ On the same day, the team visited and supervised 2 teams for field visits and found their work appropriate. ā€¢ On the basis of overall data triangulation, DNO 1&2 recommend the district for Bronze category. ā€¢
  • 77.