Synopsis for PG Dissertation for MD/MS, under RajivGandhiUniversity of Health Sciences, Bangalore.
1 / Name of the Candidate& address / Dr.Shashidhara Barki.S/O S.Lalithamma.(Teacher)
Holalu road, Upparapet.
Harapanahalli -583131(P& TQ)
Davanagere (Dist)
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 / 29/05/07
5 / Title of the study / A Prospective study to know the type of Tuberculosis, treatment out come and reasons for default among Pediatric Tuberculosis cases 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 among 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:3
– 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.
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 scarcely available both in global and national contexts. Reliable data on the burden of all forms of TB among 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 prospective study of Pediatric TB cases will be carried out over a one year period from November 2007 to October 2008 with respect to socio demographic profile, type of Tuberculosis, treatment out come and reasons for default in the selected Tuberculosis units of Bangalore Mahanagar Palike area.
Review of literature;(For sources please look at clause 8)
Global burden of TB
- 2 billion infected, i.e. 1 in 3 of global population
- 9 8million (140/lakh) new cases in 2004, 80% in 22 high-burden countries
- 3.9 million new smear positive PTB (62/lakh) casesin 2004
- Global incidence of TB is increasing by 0.6% per annum.
- 1.7 million deaths in 2004, 98% in low-income countries.6
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 amongchildren. A global estimate of 1.5 million new cases and 130,000 deaths due to TB per year amongchildren is reported.1,2
Problem of TB in India.8
Estimated incidence
Annually an estimated 1.8 million new cases of tuberculosis are reported of which 0.8 million are new smear positive cases. The incidence of new smear positive PTB cases is estimated to be
75 /1lakh population per year.
Estimated prevalence of TB disease
In 2000about 3.8 million bacillary cases and 1.7 million new smear positive caseswere reported.
Estimated mortality
It has been estimated that 370,000 deaths occurs due to TB each year (Over 1000 deaths a day )
Prevalence of TB infection
It has been estimated that 40% (~400m) are infected with M. Tuberculosis (with a 10% lifetime risk of TB disease in the absence of HIV) and 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%8.
Pulmonary tuberculosis estimated among pediatric age group for 0 to 19 years old is only 7% of the total prevalence.9
Revised National TB Control Programme
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. 10
In 2002, over 6.2 lakh patients were initiated on treatment under RNTCP. Of these, almost 2.5 lakh were infectious new sputum smear positive pulmonary TB.4 Over 70,000 patients are now being placed on treatment each month.
In 2002, of the 2, 45,051 new smear positive PTB 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. 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.”10
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 PTB, 21.3% with smear –negative PTB 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% 5
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. To know the reasons for default.
7
8 / 7.1
7.2
7.3
7.4 / Materials and Methods:
Study design
A prospective study to be conducted from November 2007 to October 2008.
Study area
Selected Tuberculosis unit (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 and registered under RNTCP and put on DOTS regimen.
Exclusion criteria.
Patients put on NON- DOTS regimen. Cases not registered under RNTCP
Study period
November 2007 to October 2008
Study sample size
Bangalore Mahanagar Palike has a total of 8 Tuberculosis units (5 lakh population each)and each Tuberculosis unit has under 4 to 7 Designated Microscopic centers (DMC),each covering one lakh population. Three out of 8 Tuberculosis units will be selected by simple random sampling. From each selected Tuberculosis units, 4 designated microscopic centers will be selected by simple random sampling method .All Pediatric cases registered at selected designated microscopic centers will be taken for the sample.
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 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 .Defaulters identified from the treatment card will be traced &reasons recorded by interview method.
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 7.3?
Obtained.
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, vol; 71, issue 4, 2004.page; 341-343.
4).Khatri, G.R., Friden, T.R,: Rapid DOTS expansion in India. Bull WHO 2002; 80: page; 457-463.
5).Arora.V.K. Gupta, R,: Directly observed treatment for tuberculosis .Indian journal of pediatrics 2003;70(11);885-89.
6) Global tuberculosis control, Surveillance, planning, financing; World Health Organization report 2006.Geneva, WHO (who/htm/tb/2006.362).
8).Gopi et al,”Estimation of burden of tuberculosis in India for the year 2000”.The Indian journal of medical residents 122,September 2005,page;243-248.
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, 2/09/2007.
10).Chakraborty.A.K.”Prevalance and incidence of tuberculosis infection and disease in India” .Geneva; WHO, TB, 1997, 231.
11).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.
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