Indmedica Home | About Indmedica | Medical Jobs | Advertise On Indmedica
Search Indmedica Web
Indmedica - India's premier medical portal

Indian Journal of Community Medicine

A Study on Performance, Response and Outcome of Treatment Under RNTCP in a Tuberculosis Unit of Howrah District, West Bengal

Author(s): Sukamal Bisoi, Amitabha Sarkar, Sharmila Mallik, Anima Haldar, Dibakar Haldar

Vol. 32, No. 4 (2007-10 - 2007-12)

ISSN No. 0970-0218

Sukamal Bisoi, Amitabha Sarkar, Sharmila Mallik, Anima Haldar, Dibakar Haldar

Abstract

Objectives: To evaluate the Revised National Tuberculosis Control Programme (RNTCP) through assessment of performance, response and outcome of treatment of patients. Study Design: Cross-sectional observational study. Materials and Methods: In Domjur Tuberculosis Unit of Howrah district, West Bengal. Two hundred and eightysix cases registered in the first two quarters (1 January to 30 June 2001) were selected for the study. Data were collected by review of records from all peripheral health units with a pre-designed and pre-tested schedule. Results: Sputum-positive among chest symptomatic were 89 (11.5%). Overall 78.3% were new cases and among them 67.1% were pulmonary, 48.4% were sputum-positive among new pulmonary cases detected. Sputum conversion rate of new sputum-positive cases at 2 or 3 months was 74.2%. Cure rate for new sputum-positive pulmonary TB cases was 53.8% and out of all smear-positive cases was 56.5%. Default among new smear-positive cases was 24.7%. Conclusion: Low sputum conversion rate after intensive phase of treatment, high defaulter rate and low cure rate among new sputum-positive cases in comparison to RNTCP norm have been reß ected in this study.

Keywords: Assessment of performance, DOTS, RNTCP, treatment outcome

Despite the existence of NTCP since 1962, tuberculosis remains the leading infectious cause of death in India. Around 2.2 million people are detected to have tuberculosis every year (25% of the global cases) and over 0.5 million die of this disease every year (17% of global TB deaths).1 Total population suffering from active disease in India is 14 million of which 3 to 3.5 million are positive for sputum (20% to 25% of total). About one million sputum-positive cases are added every year.2

With this background, in 1992 the government of India together with WHO and SIDA reviewed the national programme and launched its revised strategy, i.e., Revised National Tuberculosis Control Programme (RNTCP) with the objectives of achieving at least 85% cure rate through DOTS and case finding 70% of the estimated cases.2 This revised strategy was introduced in the country as a pilot project since 1993 in a phased manner and proposed to be expanded throughout the country by the year 2005.3 Studies have shown that treatment success under RNTCP has increased for all types of patients between 1995 and 1998.4 RNTCP being a switch-over programme from the previous NTCP, more and more operational researches are needed at this juncture when it is moving from one phase to another to know whether it is heading towards the right direction as far as pace and quality of implementation are concerned. Keeping this in view, the present study is an attempt to evaluate the RNTCP through assessment of the performance, response and outcome of treatment of patients registered for treatment under RNTCP in a Tuberculosis Unit (TU) of Howrah district, West Bengal.

Materials and Methods

The present study was a cross-sectional observational study undertaken at Domjur TU of Howrah district, West Bengal from January 2002 to June 2002. Total population of Domjur Tuberculosis units was 5,28,141 (as per census 2001). The programme has started fully in the district in phase – III of RNTCP implementation in the year 1998.

The TU consisted of 2 blocks – Domjur and Bally - Jagacha. Under Domjur block, there were five peripheral health units – Domjur BPHC, Bankra PHC, LK hospital, Nonakundu PHC and Kolora PHC – among which the first three were microscopy centres. Under Bally-Jagacha block, the peripheral health units were Jagadishpur BPHC, Belgachia, Kismat PHC, Bally – Ghoshpara PHC, Baltikuri MCW and Jagacha PHC. Here also, the first three were microscopy centres. A total of 286 patients registered for treatment under RNTCP in the first and second quarters (i.e., 1 January 2001 to 30 June 2001) were included in the study. Detailed information on chest symptomatic attending OPD, percentage of sputumpositive among chest symptomatic, sputum positivity rate, sputum conversion rate and treatment outcome about those 286 registered patients were collected from all the peripheral health units (as mentioned above) under the Domjur TU by review of records with the help of a predesigned and pre-tested schedule. Data thus collected were analyzed with suitable statistical methods.

Results

From records analysis, it was found that attendance of new adult patients at OPD of different health units under Domjur TU was 44,130 during the first and second quarters of the year 2001, and among them altogether 777 (1.8%) were chest symptomatic, and the sputumpositive among chest symptomatic were 89 (11.5%).

Table 1 shows that most of the 286 patients put on DOTS during the first and second quarters were male (64.0%). Most of the patients (25.2%) were in the age group of 15-24 years.

Among 286 patients, total new cases were 224 (78.3%) and 192 (67.1%) were new pulmonary cases. Overall 2.1% were relapse, 1.0% failure, 3.8% treatment after default and 14.7% were other category. Out of the total 286 cases, pulmonary cases were 248 (86.7%) and extra-pulmonary 38 (13.3%) [Table 2]. Among the total 248 pulmonary tuberculosis cases, 113 (45.6%) were sputum smear-positive and among 192 new pulmonary tuberculosis cases, 93 were sputum smear-positive (48.4%).Out of total 286 patients, 103 (36%) were given Cat I regimen, 63 (22%) Cat II regimen and 120 (42%) Cat III regimen. Among 103 Cat I cases, 93 (90.3%) were sputum smear-positive and 10 (9.7%) were seriously-ill smear-negative or extra-pulmonary cases.

It was observed [Table 3] that sputum conversion rate for new sputum-positive TB cases at 2 or 3 months was 74.2%, and among all 113 sputum smear-positive cases it was 76.1%.

All the 286 patients put on DOTS were analyzed for treatment outcome. In new sputum-positive pulmonary TB cases, cure rate was 53.8% and cure rate out of all smear-positive cases (new smear-positive + re-treatment smear-positive) was 64 out of 113, i.e., 56.5%. Fifty-two percent of total patients, 9.7% of new sputum smear-positive and 78.8% of new sputum smear-negative completed the treatment. Altogether 16.4% patients defaulted from treatment. Default patients among the new smear-positive cases were 24.7%, among smearpositive relapse 16.7%, among smear-positive failure 33.3% and among other cases treated with Cat II regimen were 14.2%.

Table 1: Age and sex distribution of tuberculosis patients registered for treatment in the period from January to June 2001 (n = 286)

Age group
(years)
No. (%)
Male Female Total
0-4 0 (0) 1 (0.3) 1 (0.3)
5-14 6 (2.1) 6 (2.1) 12 (4.2)
15-24 35 (12.2) 37 (13.0) 72 (25.2)
25-34 29 (10.1) 27 (9.4) 56 (19.6)
35-44 43 (15.0) 13 (4.6) 56 (19.6)
45-54 35 (12.2) 7 (2.5) 42 (14.7)
55-64 18 (6.30) 7 (2.5) 25 (8.7)
>65 17 (6.0) 5 (1.8) 22 (7.8)
Total 183 (64.0) 103 (36.0) 286 (100)

Table 2: Distribution of tuberculosis patients according to their type in DOTS (n = 286)

Type No. (%)
Pulmonary Extra
pulmonary
Total
New 192 (67.1) 32 (11.2) 224 (78.3)
Relapse 6 (2.1) 0 (0) 6 (2.1)
Failure 3 (1.0) 0 (0) 3 (1.0)
Treatment
after default
11 (3.8) 0 (0) 11 (3.8)
Others (*) 36 (12.6) 6 (2.1) 42 (14.7)
Total 248 (86.7) 38 (13.3) 286 (100)
*‘Others’ include those patients who do not fit in any category according to the definition. Most of the patients among ‘other’ type were those who were previously on NTCP and after starting RNTCP M.O. decided to put under DOTS

Table 3: Distribution of sputum-positive tuberculosis cases according to their pre-treatment and follow up sputum examination result at 2 or 3 months (n = 113)

Type of
patient
Pre-treatment sputum-positive cases Sputum smear status at 2 or 3 months Sputum
conversion rate
(%)
Positive Negative Not available
New 93 11 69 13 74.2
Relapse 6 1 5 0 83.8
Failure 3 0 3 0 100
Treatment
after default
11 0 9 2 81.8
Total 113 12 86 15 76.1

Percentage of death was 2.6% among new smearpositive cases, 5.1% among new smear-negative, 9.1% among smear-positive treatment after default cases, and total death rate was 3.1%.

Failure percentage among new smear-positive cases was 8.6% and out of all cases it was 4.2%. Total transferred-out cases were 4 out of 286, i.e., 1.4%

Discussion

The present study revealed that the chest symptomatics among the total new adult OPD attendants at different peripheral health units of Domjur TU during the period from January to June 2001 was 1.8% as against the expected RNTCP norm of at least 2%.5,6 As per the 4th Quarter Report on performance of the RNTCP of the district, state and country, the detection of chest symptomatics were 2.2%, 1.5% and 1.9%, respectively.6 The sputum positivity rate among the chest symptomatics of the TU during the study period was 11.5%, which tallies with the RNTCP norm of 10%.5

Out of the total 286 patients, 248 (86.7%) were pulmonary and 38 (13.3%) were extra-pulmonary. The ratio between the two was 6.5:1 as compared to the expected RNTCP norm of 10:1.5,6 Keeping in view the higher sputum positivity rate in this study compared to the expected norm of RNTCP, the relatively higher caseload of extrapulmonary cases points towards its over-diagnosis.

Again, out of the total 286 cases, 224 (78.3%) were new cases and 62 (21.7%) were re-treatment cases. The ratio was 3.6:1. In one study in China, after 10 years of DOTS among the smear-positive pulmonary cases, 70.8% were new, 7.2% were relapse and 22% were other re-treatment cases.7 Average treatment completion rate under the current NTP was less than 30%. So it was assumed that the proportion of re-treatment cases would be high to start with but would gradually decrease with improvement of patient compliance and cure rate.7

The ratio between sputum-positive and sputum-negative among the new pulmonary cases in this study was 93:99, i.e., 1:1.06, very close to the RNTCP norm of 1:1.(5,6) Regarding the drug regimen given to diagnosed TB cases, the ratio of Cat I, Cat II and Cat III was 1.6:1:1.9 against the RNTCP norms of 2.48:1:1.92 (on the basis of an expected 135 cases per lakh).5 This denotes that the number of patients who received Cat I regimen in the present study was less. This disproportionate presentation of the disease categorization might be due to inclusion of patients under treatment before RNTCP regimen as Cat II thereafter, rather than misclassification of cases. As per norms, seriously-ill patients should be less than 20% of the total Cat I patients. In the present study, it followed the RNTCP norms.

Table 4: Distribution of tuberculosis patients according to their treatment outcome (n = 286)

Type of patients Cured Treatment
completed
Died Failure Defaulted Transferred
out
Total
No. % No. % No. % No. % No. % No. % No. %
New cases
Sm. positive 50 53.8 9 9.7 2 2.6 8 8.6 23 24.7 1 1.1 93 100
Sm. negative NA - 78 78.8 5 5.1 3 3.0 13 13.1 0 0 99 100
Extra pulmonary NA - 29 90.6 0 0 0 0 3 9.4 0 0 32 100
Total 50   116   7   11   39   1   224 100
Re-treatment cases
Sm. positive relapses 5 83.3 0 0 0 0 0 0 1 16.7 0 0 6 100
Sm. positive failure 2 66.7 0 0 0 0 0 0 1 33.3 0 0 3 100
Sm. positive treatment
after dafault
7 63.6 0 0 1 9.1 0 0 0 0 3 27.3 11 100
Others treated
with Cat II
0 0 34 81.0 1 2.4 1 2.4 6 14.2 0 0 42 100
Total Cat II 14 22.6 34 54.8 2 3.2 1 1.6 8 12.9 3 4.8 62 100
Total cases 64 56.5 150 52.4 9 3.1 12 4.2 47 16.4 4 1.4 286

The finding of relatively low conversion rate [74.2%, expected 90%5] after intensive phase of treatment is more likely to be due to the fact that some of the denominator population were not considered in the numerator due to unknown sputum conversion status (sputum examination after intensive phase was not in due time). However, the possibility of misclassification of sputum-positive category II as category I and the role of high default rate (24.7%) can also not be ignored.

The status report2 of the first 1,00,000 patients (1993- 1998) of different project areas of the country among new smear-positive cases showed cure rate 78.9%, completed treatment 2%, died 3.6%, failure rate 3.5%, defaulter rate 8.8%. The cure rate of Domjur TU was far behind the country?s status report and RNTCP norms of 85%. The probable reasons might be inaccurate history taking and wrong categorization, high default rate (24.7% against RNTCP norms of <5%), not following technical guidelines, taking non-observed dose and not performing the last sputum examination in due time (9.7% new smear-positive cases reported as treatment completed as against the RNTCP norms of not more than 3%). Failure rate was also higher in the present study (8.6% against the RNTCP norms <4%). For new smear-negative patients and extra-pulmonary cases, treatment outcome was more or less similar to the country?s status report. So from the above study, it can be concluded that sputum positivity rate among the chest symptomatics was at par with the norm of RNTCP, which signifies that the quality of sputum microscopy was satisfactory but sputum conversion rate after intensive phase of treatment was low in comparison to the RNTCP norm (74.2% vs 85%), which probably had reß ected in the high defaulter rate and low cure rate among new sputum-positive cases in this study. Periodic re-orientation training of Medical Officers and DOTS providers, ensuring proper supervision from TU and district level, review of performance and timely feedback regarding performance of each health unit can be undertaken at the present moment for improvement of performance. This is just the beginning to win skirmishes in the battle against tuberculosis in Domjur TU; and so it is high time to assess the various lacunae and to take corrective measures for better implementation and sustenance of the programme in the area.

Acknowledgments

The authors are grateful to Professor R. Biswas, Head of the Dept. of Preventive and Social Medicine, All India Institute of Hygiene and Public Health, Kolkata for his constructive suggestions and kind support. Dr. T.K. Sen, District Tuberculosis Officer of Howrah District, deserves special mention for his generous assistance during the field study.

References

  1. A Guide for Practicing Physician-Revised National Tuberculosis Control Programme. Central TB Division. DGHS, Nirman Bhabhan: New Delhi; p. 4.
  2. Khatri GR. A status report on first 1,00,000 patients. Indian J Tuberculosis 1999;46:157-66.
  3. Editorial. Indian J Tuberculosis 1996;43:3.
  4. Ninth Five Year Plan (1997-2002). Development goals, strategy and politics, Planning Commission, Government of India: New Delhi; 1999. p. 1.
  5. Technical and operational guidelines for T.B. control. Central T.B. Division, DGHS, Nirman Bhavan: New Delhi, India; July 1999.
  6. Implementing the RNTCP: A training course module 7. Central division, DGHS, Ministry of Health and Family Welfare. Nirman Bhavan: New Delhi.
  7. Xianyi C, Fengzeng Z, Hongjin D, Liya W, Lixia W, Xin D, et al. The DOTS strategy in China: Results and lessons after 10 years. Bull World Health Organ 2002;80:430-6.

Department of Community Medicine, Burdwan Medical College, Burdwan, West Bengal, India

Correspondence to:
Dr. Amitabha Sarkar,
69/2, Ghoshpara Road, Bagmore, P.O. Kanchrapara, North 24 Parganas, West Bengal – 743 145, India.
E-mail: mtbhsarkar(at)yahoo.co.in
Received: 31.08.05
Accepted: 28.12.06

Access free medical resources from Wiley-Blackwell now!

About Indmedica - Conditions of Usage - Advertise On Indmedica - Contact Us

Copyright © 2005 Indmedica