Synopsis for PG Dissertation for MD/MS, under RajivGandhiUniversity of Health Sciences, Bangalore.
1 / Name of the Candidate& address / Dr Maria NelliyanilD/oVarkey Nelliyanil
House no 26/A Serene Shanthinagar
Hubli Karnataka
2 / Name of the Institution & address / BangaloreMedicalCollege and Research Institute,
Bangalore, FortArea, K R Road, Bangalore 560002
3 / Course of study and subject / M D Community Medicine
4 / Date of admission to course / 31/5/2008
5 / Title of the study / A study of the socio demografic profile and treatment outcome of paediatric tuberculosis patients in Bangalore Mahanagar Palike area.
6 / 6.1
Brief resume of the intended work
6.2 / Need for the Study
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. Global estimates of 1.5 million new cases and 130,000 deaths due to TB per year amongst children is reported.1,2
Childhood TB prevalence indicates:
– 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 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
-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 tuberculosisdisease for a young child infected withMycobacterium tuberculosis as indicated by positivetuberculin test is about 10 percent. About5 per cent of those infected are likely to developdisease in the first year after infection and theremaining 5 per cent during their lifetime.Nearly 8-20 per cent of the deaths caused by TB occurin 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 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 extrapulmonaryB 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 andcompletion rates were both above 90%. Comparative figures for those cases not treated under RNTCPwere 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.
7
8 / 7.1
7.2
7.3 / 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 selectedTuberculosis 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 sociodemographic 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 software will be utilized for analysis.
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.
Has ethical committee clearance been obtained from your institution in case of clause of 7.2?
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.
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)GlobalBcontrolreport2008,obtained from
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 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,19thed,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, 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.
9 / Signature of the candidate
10 / Remarks of the guide / Very relevant and important subject
11 / Name and designation 11.1 Guide
11.2 Signature / Dr.Sharada M.P
Professor and H.O.D
Dept of Community Medicine
BangaloreMedicalCollege and Research
Institute, Bangalore.
11.3 Head of Department
11.4 Signature / Dr.Sharada M.P
Professor and H.O.D
Dept of Community Medicine
BangaloreMedicalCollege and Research
Institute, Bangalore.
12 / 12.1 Remarks of the Principal
12.2 Signature
1