Synopsis for PG Dissertation for MD/MS, under Rajiv Gandhi

University of Health Sciences, Bangalore.

1 Name of the Dr Maria Nelliyanil

Candidate& D/oVarkey Nelliyanil
House no 26/A Serene Shanthinagar
address
Hubli Karnataka
2 Name of the Bangalore Medical College and Research Institute,
Institution Bangalore, Fort Area, K R Road, Bangalore 560002
& address
3 Course of M D Community Medicine
study and
subject
4 Date of 31/5/2008
admission
to course
5 Title of the A study of the socio demografic profile and treatment outcome of paediatric
study tuberculosis patients in Bangalore Mahanagar Palike area.
6 6.1 Need for the Study
Brief The actual global disease burden of childhood TB is not known, but it has been
assumed that 10% of the actual total TB caseload is found amongst children.
resume of
Global estimates of 1.5 million new cases and 130,000 deaths due to TB per year
the amongst children is reported.1,2
intended Childhood TB prevalence indicates:
work – community prevalence of sputum smear-positive pulmonary tuberculosis
– age-related prevalence of sputum smear-positive pulmonary tuberculosis
– prevalence of childhood risk factors for disease
– stage of epidemic.3
Proper identification and treatment of infectious cases will prevent childhood
TB. However often Childhood TB is accorded low priority by National TB
Control programme. Probable reasons include: – Diagnostic difficulties, Rarely
infectious, Limited resources, Misplaced faith in BCG, Lack of data on
treatment.3

The Indian DOTS programme- the RNTCP – has achieved high treatment
success for both pulmonary and extra pulmonary forms of TB.4

However, studies of pediatric TB are scantily available both in global and

national contexts. Reliable data on the burden of all forms of TB amongst
children in India are not available. Most surveys conducted have focused on
pulmonary TB and no significant population based studies on extra pulmonary
TB are available.

Hence, A study of pediatric TB cases will be carried out over one year period

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 from November 2008 to October 2009 with respect to socio demographic profile,
type of TB and treatment out come in the selected Tuberculosis units of
Bangalore Mahanagar Palike area.

Review of literature ;
Global burden of TB
-
Incidence of disease 139/100,000 population
-
Incidence smear positive 62/100,000
-
6.2 Prevalence of disease 219/100,000
-
Mortality due to TB 25/100,000.5
Global burden of tuberculosis in pediatric age group:-
The actual global disease burden of childhood TB is not known, but it has been
assumed that 10% of the actual total TB caseload is found amongst children. A
global estimate of 1.5 million new cases and 130,000 deaths due to TB per year
amongst children is reported. 1,2
Problem of TB in India
India accounts for one fifth of world new TB cases
Annually an estimated 1.8 million new cases of tuberculosis are reported of
which 0.8 million are new smear positive cases6
Problem of paediatric TB in India
Annual risk of tuberculosis infection is 2-5%
Prevalence of tuberculosis infection among pediatric age group is, for 0 to 4
years it is 1.0%,5 to 9 years is 6.4%,10 to 14 years is 15.4%
The estimated lifetime risk of developing tuberculosis disease for a young child
infected with Mycobacterium tuberculosis as indicated by positive tuberculin test
is about 10 percent. About 5 per cent of those infected are likely to develop
disease in the first year after infection and the remaining 5 per cent during their
lifetime. Nearly 8-20 per cent of the deaths caused by TB occur in children7,8

India–has had a National Tuberculosis Programme (NTP) in operation since

1962. In 1992, a joint Government of India / World Health Organization review
found that despite the existence of the NTP, TB patients were not being
accurately diagnosed and that the majority of diagnosed patients did not
complete treatment. Based on the recommendations of the review, the Revised
National Tuberculosis Control Programme (RNTCP), incorporating the
internationally recommended DOTS strategy, was developed. In 1993, RNTCP
was started in pilot areas covering a population of 18 million .Large-scales
Implementation of the RNTCP began in 1998, with a World Bank credit of Rs
604 crore. Since 1998, the RNTCP has been rapidly expanding and to date
covers over 740 million of the population. RNTCP is the fastest expanding TB
control programme in the history of DOTS, and nationwide coverage is planned
by 2005. 9

In 2002, of the 2, 45,051 new smear positive pulmonary TB cases initiated on

treatment under RNTCP, 4,159 (1.7%) were aged 0-14 years. From a survey of

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 RNTCP implementing districts, Pediatric cases were seen to make up 3% of the
total load of new cases registered under RNTCP. Lymph node (LN) TB cases
predominated (>75%) amongst the paediatric Extrapulmonary TB cases
registered under RNTCP. Many extrapulmonary B cases(>40% of LN cases)
were diagnosed on clinical grounds with no confirmatory examinations
performed. An almost equivalent number of Pediatric TB cases were being
diagnosed in the same health facilities,but were not being registered under
RNTCP. Of those Pediatric cases treated under RNTCP, cure and completion
rates were both above 90%. Comparative figures for those cases not treated
under RNTCP were 80% and 70%, with default rates between 27-33%. (Central
TB Division. Unpublished data) Hence for RNTCP, there are the issues of under
diagnosis and under registration of Pediatric TB cases in the programme.
To seek consensus on improved case detection and improved treatment outcomes
for all diagnosed pediatric TB cases, a workshop on the “Formulation of
guidelines for diagnosis and treatment of Pediatric TB cases under RNTCP” was
held in New Delhi on 6th and 7th August 2003.” 9
A retrospective study done in Malawi by A.D.Harries et al on nation wide case
finding and treatment outcome of childhood TB, showed that ,there were 22,982
cases of TB registered in Malawi, of whom 2739(11.9%) were children. Children
accounted for 1.3% of all case notifications with smear positive pulmonaryTB,
21.3% with smear –negative pulmonary TB and 15.9% with extra pulmonary
TB. Only 45% of children completed treatment. There were high rates of
death(17%),default(13%) and unknown treatment outcomes (21%).10
A retrospective analysis of pediatric TB cases was carried out over a six –year
period from 1996 to 2001 at the L R S institute of TB and Respiratory diseases,
New Delhi, showed that children constituted 9.4% of the total case finding.
Extra pulmonary TB was seen in 47% of children ,new smear positive Tb was
5% smear negative cases was 56% .Overall ,sputum conversion rate was 93%
and treatment success was observed to be 96%.11
A study was conducted in the PediatricTuberculosis (TB) Clinic of a tertiary care
hospital in North India by S. K. Kabra, Rakesh Lodha and V. Seth A total of 459
patients were started on antituberculosis drugs and were available for analysis.
Pulmonary tuberculosis was the commonest followed by lymph node
tuberculosis. Identification of AFB was possible only in 52 (11 %) of the patients
and was more commonly seen in lymph node tuberculosis. The mean age of the
children was 93 months and sex distribution was almost equal. 323 patients were
in category I, 12 in category II, 120 in category III and 4 in category IV. 365
(80%) children completed the treatment12

6 6.3 Objective of the study :

1. To know the socio-demographic profile of pediatric tuberculosis patients.
2. To know the type of tuberculosis and treatment outcome in pediatric tuberculosis patients.

3
7 7.1 Materials and Methods:

Study design
A longitudinal study to be conducted from November 2008 to October 2009.

Study area
Tuberculosis units (TU) under Bangalore Mahanagar Palike.

Study population.
All pediatric patients in the age group of 0 to 14 years diagnosed as TB and registered under
RNTCP.

Inclusion criteria
All pediatric cases in the age group of 0 to 14 years diagnosed as TB, registered under
RNTCP put on DOTS regimen and willing to participate in the study.

Exclusion criteria.
Patients who are not willing to participate in the study.

Study period
November 2008 to October 2009.

Study sample size

Bangalore Mahanagar Palike has a total of 9 TU (5 lakh population each) and for each TU 3
to 7 Designated Microscopic centers (DMC) and 4 to 14 DOTS center are there. Tuberculosis
units will be selected by simple random sampling, from the above selected Tuberculosis units
Designated Microscopic centers will be selected by simple random sampling method. All
pediatric cases registered at selected Designated Microscopy centers will be taken as sample
size.

Sampling method
Simple random sampling.

Method of collection of data

Data collection will be started after obtaining clearance from ethical committee, respective
authorities from Bangalore Mahanagar Palike and health center.
Informed consent will be obtained from the patients/guardians /parents. Data regarding
socio demographic profile will be collected by pre tested questionnaire/proforma of pediatric
TB patients registered under RNTCP during their visit to hospital /health center.
Data regarding pattern and treatment out come as per RNTCP definitions will be collected at
the end of treatment regimen from the treatment cards from respective health center and TU.

Methodology for data analysis

Data will be analyzed using descriptive statistics and chi-square test. Suitable statistical

4
 software will be utilized for analysis.
7.2
Does the study require any investigation or intervention to be conducted on subjects or
animals? If so, describe briefly.

No laboratory investigations or interventions will be carried out.

7.3
Has ethical committee clearance been obtained from your institution in case of clause of
7.2?

8
LIST OF REFERENCES:

1). Kochi, A.; The global tuberculosis situation and the new control strategy of the World
Health Organization .Tubercle 1991; 72: 1-6.

5
2).World Health Organization (WHO); WHO report on the tuberculosis epidemic .Geneva;
WHO; 1996.

3).Chauhan. L. S, Arora. V. K., “Management of pediatric tuberculosis under Revised

National Tuberculosis Control Programme”. The Indian Journal of pediatrics;2004:71(4):
341-43.

4).Khatri, G.R., Friden, T.R,: Rapid DOTS expansion in India. Bull WHO 2002; 80: page;
457-63.
.
5)Global B control report 2008,obtained from
http://www.who.int/tb/publications/global_report/2008/pdf/report_without_annexes.pdf
On 10/10/08

6)TB India 2008 RNTCP status report released by Directorate General of Health Services
Ministry of health and Family Welfare obtained from http://www.tbcindia.org/pdfs/TB-India-
2008.pdf on 29/08/08.

7)Kabra,S K, Lodha, Rakesh, Seth,V “Some current concepts on childhood tuberculosis”

Indian Journal of Medical Research, Oct 2004 : 1.

8)K Park,Text book of preventive and social medicine,19 thed,Jabalpur,Banarsidas

bhanot,2007.page 151.

9)A joint statement of the central TB division, Directorate General of Health Services,
Ministry of Health and Family Welfare, and experts from Indian academy of pediatrics.
Quoted in the web site, www.tbcindia.ac.in.dated 14/0808.

10).Harries .A.D, et al “Childhood tuberculosis in Malawi; Nationwide case finding and

treatment out comes”. International journal of tuberculosis and lung diseases, 6(5),
2002.page; 424-431.

11)Arora.V.K. Gupta, R,: Directly observed treatment for tuberculosis .Indian journal of
pediatrics 2003;70(11);885-89.

12) S. K. Kabra, Rakesh Lodha, V. Seth: Category based Treatment of Tuberculosis in

Children. Indian paediatrics,2004,41;page;227-237.

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9 Signature
of the
candidate

10 Remarks of Very relevant and important subject

the guide

11 Name and
designation Dr.Sharada M.P
11.1 Guide Professor and H.O.D
Dept of Community Medicine
Bangalore Medical College and Research
Institute, Bangalore.

11.2
Signature

11.3 Head
of Dr.Sharada M.P
Department Professor and H.O.D
Dept of Community Medicine
Bangalore Medical College and Research
11.4 Institute, Bangalore.
Signature

12 12.1
Remarks of
the
Principal

12.2
Signature