OUTCOME AMONGST PATIENTS REGISTERED UNDER REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME OF INDIA AFTER THREE YEARS OF COMPLETION OF TREATMENT DR. RAHUL RAMESH BOGAM* SUNIL M. SAGARE** *Assistant Lecturer, Dept. of Community Medicine, Bharati Vidyapeeth Deemed University Medical College, Pune, India **Associate Professor, Dept. of Community Medicine, Bharati Vidyapeeth Deemed University Medical College, Pune, India ABSTRACT India accounts for nearly one fifth of global problem of tuberculosis. Revised National Tuberculosis Control Programme (RNTCP) came into existence by formulating and adopting internationally recommended DOTS strategy as a most systemic and cost-effective approach to revitalize tuberculosis control programme in India. Despite high cure rates, several queries have been raised about the effectiveness of RNTCP regimens including inadequate diagnosis, wrong categorization, methods of administration and possibility of increased rate of MDR TB. The present study was carried out to assess various outcomes amongst patients registered under RNTCP during 2007 at Pune, India. The present study was carried out in areas covered by Sahakarnagar Tuberculosis Unit of Pune Municipal Corporation, Pune. All TB patients who had been registered during period of 1st January 2007 to 31st December 2007 under RNTCP were followed up for study purpose. Treatment success rate in present study was 61.97% and very few number of symptomatic subjects i.e. 9(3.17%) of which, 4(1.41%) had URTIs, 2(0.70%) had allergic bronchitis and three (1.06%) were relapsed cases. RNTCP was found to be effective as revealed by present study where treatment success rate was more i.e.61.97% than any other unfavourable outcomes in study subjects. KEYWORDS: Follow Up, Outcome, RNTCP, Symptomatics, Tuberculosis INTRODUCTION India accounts for nearly one fifth of global problem of tuberculosis. Everyday more than 20,000 people become infected with TB bacilli. Almost two people die of every three minutes in our country. Unfortunately, despite the existence of National Tuberculosis Control Programme since 1962 to 1992, desired results were not achieved. RNTCP came into existence by formulating and adopting internationally recommended DOTS strategy as a 153
most systemic and cost-effective approach to revitalize tuberculosis control programme in India. (4) The goal of RNTCP is to reduce morbidity and mortality associated with tuberculosis and to break the chain of transmission of infection until TB ceases to be a public health problem. The first objective is to achieve and maintain cure rate of at least 85% among newly detected smear positive cases and to achieve and maintain detection of at least 70% among chest symptomatics in community. (4) Treatment success rate of tuberculosis has been increased from 25% to 86%. Death rate has been brought down seven fold from 29% to 4%. Despite high cure rates, several queries have been raised about the effectiveness of RNTCP regimens including inadequate diagnosis, wrong categorization, method of administration and possibility of increased rate of Multidrug Resistant Tuberculosis. (MDR-TB). (6) Till date very few studies have been conducted to find out the current status of patients registered under RNTCP of India. Therefore present study was carried out to assess the present status of patients registered under RNTCP during 2007 at Pune City, India. OBJECTIVE To assess the various outcomes amongst the tuberculosis patients after three years of completion of treatment under RNTCP Programme of India. MATERIAL AND METHODS 1. Study area The present study was undertaken in areas covered by Sahakarnagar Tuberculosis Unit, Pune which is located in South Zone of Pune City of Maharashtra State of India. The Tuberculosis Unit (TU) caters for approximately 5.10 lakh population. There are total 90 DOT centers and 90 DOT providers under the said centre. 2. Study design A Cross Sectional Study 3. Study population The study population comprised of all patients who had been registered during period of 1st January 2007 to 31st December 2007 under Revised National Tuberculosis Control Programme (RNTCP) in Sahakarnagar Tuberculosis Unit, Pune. 154
4. Sample size estimation Personal visit was done to Sahakarnagar Tuberculosis Unit (TU), Pune. A total number of patients registered under RNTCP as per TB register maintained at TU were 896 for the period of 1st January 2007 to 31st December 2007. After applying exclusion criteria (excluding persons less than 15 years of age i.e. 35), the sample size (n) for study was 861 (896-35). To test the sampling adequacy, The KMO (Kaiser - Meyer - Olkin) (1) test was applied. The KMO index ranges from 0 to 1, with 0.50 considered suitable for factor analysis. For present study, KMO value was 0.493 (approximately 0.5). Hence the sample size of 861 in the present study was found to be adequate. 5. Time utilization calendar A. Preliminary planning of study Four months (May 2010 August 2010) It includes: A1. Arriving at final decision to conduct a cross sectional study and preparation of questionnaire. A2. Submission of research protocol for approval from ethics committee. (The study was approved by Institutional Ethics Committee Letter no BVDU/MC/1556/2010-11). B. Pilot testing of questionnaire - Two months (September 2010 October 2010) C. Data collection C1.Twelve months (November 2010 to November 2011) C2.Average time required for interviewing study subject with recording of information in proforma was 40-45 minutes. D. Analysis of data - Six months (December 2011- May 2012) 6. Selection of study subjects Inclusion Criteria All patients who had been registered during period of 1st January 2007 to 31st December 2007 under RNTCP in Sahakarnagar Tuberculosis Unit, Pune. Exclusion Criteria All patients less than 15 years of age. 155
7. Collection of data A list of study subjects during specified period was obtained from Tuberculosis Register (TB Register) maintained at Sahakarnagar Tuberculosis Unit (TU), Pune. Information about their name, age, sex, address, initial sputum smear result, treatment category, date of start of treatment, sputum smear result during and at the end of their treatment and outcome was collected from the tuberculosis register maintained at TU. All the subjects along with their addresses were approached by door-to-door visit with the help of a health visitor and stake holders of communities. Maximum three attempts were done to trace out the subject. The subjects with more than three attempts to trace out were included in category of not traceable. Informed consent was taken from subjects who were traced after three years of treatment to participate in the study. During visit every effort was taken to relax the subject. He/she was explained about the nature of study and was assured that the information given by him/her is required only for study purpose and will be kept confidential completely. Written informed consent was taken from subjects who were willing to participate in study. Relevant information about socio demographic characteristics of subject, detailed information regarding present complaints and its duration, past history and family history pertaining to tuberculosis was noted in pretested and predesigned proforma. History of risk habits like tobacco, smoking, alcohol with their duration and frequency was noted. Symptomatic subjects were clinically evaluated. Information about clinical evaluation was filled up in respective proforma. The study subjects with symptoms suggestive of tuberculosis were referred to various hospitals in their residential areas where diagnostic facilities for tuberculosis (sputum smear and radiological examination) were available. Examination report of referred subjects was confirmed. Every subject was specifically counselled for treatment compliance, adoption of healthful habits etc. On an average, 40-45 minutes were required to collect information from each study subject. On each day, two to three subjects were covered. 8. Data analysis After collection and editing of data, classification and tabulation was done under appropriate heading so as to obtain the summary values for further statistical treatment. 156
Statistical analysis was done by using analysis tool pack from Microsoft Office Excel, and SPSS 15 statistical package. RESULTS AND DISCUSSION The study was carried out to determine the present status of subjects registered under RNTCP with respect to tuberculosis. A total of 861 study subjects were included in the study who were registered patients in TB register. Table 1: Age and sex distribution of study subjects as per TB register. (n = 861). Study subjects Sr. Age group Male Female Total No. No % No % No % 1. <20 years 39 4.53 62 7.20 101 11.73 2. 21-30 years 162 18.82 109 12.66 271 31.48 3. 31-40 years 171 19.86 59 6.85 230 26.71 4. 41-50 years 79 9.17 40 4.65 119 13.82 5. >51 years 102 11.85 38 4.41 140 16.26 Total 553 64.23 308 35.77 861 100 Table 1 shows age and sex distribution of study subjects as per TB register. Out of 861 subjects, 553(64.23%) were males and 308(35.77%) were females. This shows that more number of males were registered for DOTS treatment at Tuberculosis Unit as compared to females. The probable reasons for over-presentation of males as compared to females may be due to the facts that males have fairly large number of contacts due to more outdoor activities whereas females stay at home, males are prone for exposure to tuberculosis infection and treatment seeking behaviour may be more in males than females. The present study also revealed that majority of subjects were in the age bracket of 21-30 years i.e.31.48% followed by age group of 31-40 years i.e.26.71%. It showed that more than half of subjects (58.19%) were found in the economically productive age group i.e.21-40 years. 157
Table 2: Category wise distribution of study subjects as per TB register. (n=861). Sr. No. Category Study subjects Male Female Total No % No % No % 1. I 474 55.05 272 31.59 746 86.64 2. II 75 8.72 28 3.25 103 11.97 3. III 04 0.46 08 0.93 12 1.39 Total 553 64.23 308 35.77 861 100 From above table, category wise distribution of study subjects revealed that 746 (86.64%) subjects belonged to category I, 103(11.97%) belonged to category II and only 12(1.39%) subjects were from category III. Out of three categories, majority of subjects belonged to category I followed by category II and then category III respectively. Amongst total enrolled 861 subjects, pulmonary tuberculosis cases were 681(79.09%) and extra pulmonary cases were 180(20.91%) i.e. in proportion of 3.8:1. Out of 861 registered subjects in the year 2007(January 2007-December 2007), only 328(38.09%) subjects could be actually traced. Of these, 44(5.11%) subjects were not willing to participate in the study. Hence follow up outcome was studied amongst 284(32.98%) subjects only. Table 3 shows major outcomes amongst study subjects. Table 3: Follow up outcome of study subjects at the time of visit. (n=861). Sr. No. Outcome Study subjects Male Female Total No % No % No % 1. No Symptoms 104 12.08 72 8.36 176 20.44 2. URTI 03 0.34 01 0.11 04 0.46 3. Allergic Bronchitis 02 0.23 0 0 02 0.23 4. Relapsed 03 0.35 0 0 03 0.35 5. Expired 74 8.59 25 2.90 99 11.51 6. Not willing to participate 27 3.14 17 1.97 44 5.11 7. Migrated 105 12.20 60 6.97 165 19.16 8. Not traceable 235 27.29 133 15.45 368 42.74 Total 553 64.23 308 35.77 861 100 URTI- upper respiratory tract infection Of remaining 533(61.90%) subjects, 165(19.16%) could not be traced out due to migration and 368(42.74%) subjects were not found due to improper or wrong address mentioned in TB 158
register. Low socio-economic status of subjects who live in temporary shelters or huts in slum areas and lack of appropriate permanent residential addresses might be the reasons for non-traceable subjects. All traceable subjects were contacted directly by home to home visit. For those subjects who were reported dead, information regarding the cause of death was ascertained from family members and scrutiny of available records including death certificate. However the percentage of traceable subjects i.e.38.09% (including subjects not willing to participate) in present study was slightly less as compared to five-year follow-up study of RNTCP of India at Lucknow (8) patients were traced out amongst 187 followed up patients at DOTS center. N.Pandit and S.K.Choudhary (5) traced more number of patients (98.3%) as compared to the present study (32.98%).This might be due to short duration of study i.e. one quarter of year and repeated visits to patient s homes. Migration rate in present study was 165(19.16%). As stated by relatives and neighbours of subjects, 110(66.67%) subjects were shifted for unknown reasons and 31(18.79%) went to their home-towns. Twenty four (14.54%) study subjects migrated for search of employment. Migration was found to be more in males (12.19%) as compared to females (6.96%).This could be attributed to more employment seeking behaviour of males as compared to females. Another probable reason for higher migration rate in the present study might be due prolonged duration between treatment period of subjects and actual period of longer duration of follow-up. In comparison of present study, higher migration rate was found i.e. 36.4% by S.K.Verma et al. (8) and 25.8% by Dhingra V.K. et al. (9) However migration rate was found to be same in 18 months follow-up study from rural South Africa conducted by Connoly C et al.(2) Table 4: Follow up outcome of traceable subjects. (n=284). Sr.No. Follow up outcome 1. Asymptomatic Subjects No % Cured with no symptoms 105 36.97 TC with no symptoms 71 25 Total 176 61.97 2. Symptomatic Subjects URTI 04 1.41 Allergic Bronchitis 02 0.70 Relapsed 03 1.06 Total 09 3.17 3. Expired 99 34.86 Total 284 100 TC-treatment completed, URTI-upper respiratory tract infection 159
Table 4 shows that out of 284 subjects traced out, 71(25%) subjects were from Treatment Completed category and 105(36.97%) subjects were from Cured category were asymptomatic. Hence the present study revealed overall treatment success rate of 61.97%. In comparison with present study, S.K. Verma et al. (8) reported the percentage of asymptomatic patients was 91.3%. Higher numbers of asymptomatic patients (83%) were also found in study conducted by Yatin D et al. (3) However similar study findings (62%) were observed in another 18 months follow-up study from South Africa.(2) Nine (3.17%) subjects in present study were found to be symptomatic. Of which five (1.76%) were referred for sputum smear and Chest X ray examination. Of symptomatic 9 subjects, none of them were diagnosed for tuberculosis. Two subjects (0.70%) were diagnosed for allergic bronchitis and 4(1.41%) were suffered from upper respiratory tract infection. Three (1.06%) subjects were found to be relapsed in present study. The relapse rate at the end of three years in the present study was 1.06%. Comparatively higher relapse rate of 2.8% and 3.82% was found by V.K.Dhingra et al. (9) and Yatin Dholakia et al.(3) in their one and half year and two year follow up study respectively. However P. Jagota et al. (7) reported very high relapse rate i.e.7.42% amongst tuberculosis patients in Kolar and Tumkur districts of Karnataka State of India. The present study delineated that out of 861registered study subjects, 533(61.90%) subjects could not be contacted due to migration (19.16%) and improper or wrong address of subjects (42.74%) mentioned in TB register. Only 328 (38.09%) could be actually traced. As 44(5.11%) subjects were not willing to participate in the study, follow up outcome was studied amongst only 284(32.98%) subjects. Death rate amongst traced out subjects (328) in the present study was 30.18 %. The death rate due to tuberculosis in studies conducted by Sophia Vijay et al.(10), Yatin Dholakia et al. (3) and Jagota P et al.(7) were 5.2%, 7.2% and 8.5% respectively which was much lower than death rate of present study. Connoly C et al. (2) also reported lower mortality rate in TB patients of rural South Africa i.e.14 %. Death rate in present study was found to be higher than above mentioned studies. The probable reason for higher death rate might be due to deaths reported only amongst traceable subjects i.e.328 as 533(61.90%) subjects could not traced out because of migration and improper or wrong address of subjects mentioned in TB register. 160
CONCLUSION Revised National Tuberculosis Control Programme (RNTCP) of India was found to be effective as revealed by present study where treatment success rate was more i.e.61.97% than any other unfavourable outcomes in study subjects. FUNDING This work was supported by Revised National Tuberculosis Control Programme (RNTCP), Government of Maharashtra, India. (Grant number -32578/506/2010) Acknowledgements We heartily acknowledge the cooperation and support of State Task Force and State TB Officer, Maharashtra, Dr. Narendra Thakur, City Tuberculosis Officer, Pune Municipal Corporation, Dr. Chougule S.G., Medical Officer (RNTCP) and Dr. Medha Bargage, Associate Professor, Department of Pulmonary Medicine, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune for accomplishment of this study. REFERENCES 1. Brett Williams, Ted Brown, Andrys Onsman. (2010). Exploratory Factor Analysis: A five step Guide for Novices. Journal of Emergency Primary Health Care. 8(3): 1-13. 2. Connolly C, Reid A, Davies G et al.(1999). Relapse and Mortality among HIV Infected and Uninfected Patients with Tuberculosis Successfully Treated with Twice Weekly Directly Observed Therapy in Rural South Africa. AIDS.13:1543-47. 3. Dholakia Y, Danani U, Desai C. (2000).Relapse Following Directly Observed Therapy Short Course (DOTS) - A Follow up Study. Indian Journal of Tuberculosis.; 47(4):233-36. 4. J. Kishore. (2012). National Health Programmes of India. 10th ed. India, Century Publications. 5. N. Pandit, S. K. Choudhary. (2006). A Study of Treatment Compliance in Directly Observed Therapy for Tuberculosis. Indian Journal of Community Medicine. 31(4): 241-43. 6. Park. K. (2009). Textbook of Preventive and Social Medicine. 21st ed. India Banarsidas Bhanot Publishers. 7. P.Jagota Chandrasekaran, Sujatha and Sumathi, G. (1998). Follow-up of pulmonary tuberculosis patients treated with short course chemotherapy through traditional birth attendants (Dais). Indian Journal of Tuberculosis. 45:89-93. 8. S.K. Verma, Sanjay Kumar Verma, Surya Kant et al. (2008). A Five-Year Follow-up Study of Revised National Tuberculosis Control Programme of India at Lucknow. The Indian Journal of Chest Diseases & Allied Sciences; 50: 195-98. 9. V.K. Dhingra, S. Rajpal, Nishi Aggarwal et al. (2004).Treatment of Tuberculous Pleural Effusion Patients and Their Satisfaction with DOTS- One and half year follow up. Indian Journal of Tuberculosis; 51: 209-12. 10. Sophia Vijay, V. H. Balasangameswara, P. S. Jagannatha et al. (2004). Treatment Outcome and Two and half Years Follow up Status of New Smear Positive Patients Treated under RNTCP. Indian Journal of Tuberculosis; 51: 199-208. 161