Correlates of non-compliance to follow up sputum examination and treatment outcomes among tuberculosis patients under RNTCP in tribal area of Thane district.
The Revised National Tuberculosis Control Program (RNTCP) has successfully completed 15 years of implementation till 2013. Since its inception more than 15.8 million patients are initiated on treatment with more than 2.8 million lives saved. The program has been consistently achieving its objectives of treatment success rate >85% and case detection rate (CDR) >70% among the new smear positive patients, since 2007, which is in alignment with the global targets. RNTCP is well on track to achieve the Millennium Development Goal (MDG) of halting and beginning to reverse the spread of the disease.  The program is now looking toward achieving "universal access," reaching out to the unreached and ensuring that all TB patients receive the highest quality diagnostic and treatment facilities. This therefore now urges to look beyond the objectives of 85/70. The program is also facing the challenge of multidrug resistant TB (MDR TB) and that of human immunodeficiency virus (HIV) coinfection with TB. It is recognized that management of TB control program has relatively complex diagnostics, treatment, and follow-up dimensions. The Joint Monitoring Mission (2009) has also recommended a need to have transition from target-focused monitoring of performance to analysis of key process and outcome indicators. 
Also it is need of a time to figure out reasons behind treatment interruption and non-compliance to follow up sputum examinations. Keeping this aspect in mind, this study was planned to assess response and outcome of treatment, various demographic factors associated with treatment outcome and to find out reasons for non-compliance to Directly Observed Treatment Short-course (DOTS) in a tribal area of Thane district of Maharashtra.
Materials and Methods
This study was a cross-sectional observational study undertaken at Designated Microscopy and Treatment Centre in Ganeshpuri, a tribal area in Thane district of Maharashtra state which is also a rural field practice area of institution from May 2014 to October 2014. A total of 126 patients registered for treatment under RNTCP in all four quarters of year 2013 (i.e., 1 January 2013 to 31 December 2013) were included in the study. Though performance indicators ideally should be calculated at tuberculosis unit (TU) level but here we applied it for study purpose. Detailed information on chest symptomatic attending OPD, proportion of sputum positivity in chest symptomatic, proportion of sputum positive in all registered TB cases, sputum conversion rate, treatment outcome about those 126 registered TB cases were collected by reviewing records with the help of a predesigned and pretested schedule. Of these 126 cases, defaulters of treatment and those cases not reported to any one of follow-up sputum examination were contacted through local health volunteers and home visits. After taking an informed consent they are interviewed with the use of pretested proforma for reasons for not attending follow-up sputum examination and treatment interruption. Outpatient registers, various registers maintained under RNTCP and TB treatment cards of patients were reviewed to collect secondary data about TB patients. Permission for study was obtained from concerned authorities under RNTCP and ethical approval was obtained from institutional ethics committee. Operational definitions from RNTCP module issued by Government of India were used for data collection and calculating various proportions. [3,4] Data were entered using Microsoft Excel 2013 version and analyzed with SPSS-v.16.
As shown in Table 1, of the total 126 patients 84.9% and 15.1% were registered for Category 1 and Category 2, respectively. Cure rate was highest (56.5) among patients aged between 45 and 54 years. As age advanced, proportion of death also increased. Treatment completion rate was high in female (50%), but cure rate was more in male (44.9%). No female was defaulter when compared 5.1% default rate in male. Mortality is more in male (10.3%) than female. Of the patients of pulmonary TB 56.1%, 27.6% and 9.2% were cured, treatment completed and died respectively whereas 3.1% were switched to MDR TB treatment. No case was found to be cured in extra pulmonary TB whereas treatment completion rate was 92.9%. The cure rate among Category 1 was calculated to be 47.7% as compared to 21.1% for Category 2. Treatment completed rate was more in Category 2 (52.6%) than in Category 1 (40.2%). No case of transferred out and failure was observed in this study. Proportion of defaulters and death was more in Category 2 as compared to Category 1. The observed differences were not statistically significant (p > 0.05).
As evident from Table 2, in new sputum positive pulmonary TB cases, cure rate was 83.6% and cure rate out of all smear positive cases was 43.7%. Ninety two percent of new smear negative patients had completed treatment. All patients with new extra pulmonary TB had completed treatment. High proportion of mortality was noted in retreatment cases (15.8%) as compared to new cases (7.5%). In new cases, cured rate was highest (47.7%) than other outcomes whereas in retreatment cases treatment completed rate was highest (52.6%).
As observed in Table 3, at pretreatment phase, of the 126 patients 76 (60.3%) were smear positive, 32 (25.4%) were smear negative, and in 18 (14.3%) patients sputum smear examination was not carried out as they were having extra-pulmonary TB without any respiratory symptoms and sign. At end of intensive phase, 83 (65.9%) became negative and 3 (2.4%) remained positive, whereas 40 (31.7%) did not reported for follow-up sputum examination. No sputum positive case was reported in continuation phase and at end of treatment. Highest proportion of non-reporting to follow-up sputum examination found in continuation phase (55.6%). At end of treatment 57.9% cases were negative and 42.1% were not reported. Sputum conversion rate among all smear positive was 96.1%. Sputum conversion rate was 96.7% and 93.3% in new smear positive and previously treated smear positive patients, respectively.
As seen in Figure 1, of the 169 various responses to reasons for not attending follow-up sputum smear examination, lack of awareness (23.1%) and work commitments (18.9%) were commonly given. Negligent about the role of follow-up examination (10.1%), dissatisfaction of drugs (13.6%), too far distance of institution (9.5%) and inconvenient timings (8.9%) were also reasons for non-reporting. Eleven (6.5%) cases were died during follow up.
Table 4 shows various annual performance indicators of designated microscopy and treatment center. Proportion of new smear positive cases among all new pulmonary cases was 68.5% which was satisfying the criteria (at least 50%) set by RNTCP. Ninety-six percent of registered TB patients were tested for HIV. Of these 9.1% were found HIV positive. Sputum conversion rate was 96.1% which was more than criteria (at least 90%) set by program. Proportion of cured and treatment completed were reported nearly same (43%), it might be due to not-attending follow-up sputum examination and cases of extra-pulmonary TB. Treatment failure rate was zero in that year. Defaulters of 3.2% and 2.4% cases were switched to MDR TB treatment.
This study showed that pulmonary TB accounted for 77.8% cases whereas the extra-pulmonary TB accounted for 22.2% cases. The ratio between the two was 3.5:1 as compared to the expected RNTCP criteria of 10:1. [2,4] This relatively higher caseload of extra-pulmonary cases points towards its over-diagnosis. Of the total 126 cases, 107 (84.9%) were new cases and 19 (15.1%) were retreatment cases. the ratio between two was 5.6:1. Treatment success rate (cured and treatment completed) for Category 1 and Category 2 in this study were 87.9% and 73.7%, respectively. Slightly higher proportions were noted in study done by Verma et al.  in Lucknow [Category 1 (89.8%) and Category 2 (84%)]. Death during treatment was reported more in men than women. In men maximum death were reported in cases more than 54 years of age. No female case was defaulter whereas 4 (5.1%) of male defaulted treatment. Reasons given by defaulter were side-effects of drugs, sense of well-being, lack of faith in treatment center, and having faith in traditional healing methods.
Sputum conversion rate at end of intensive phase was 96.1% and failure rate was 3.9%. This satisfied criteria set by RNTCP (i.e., at least 90%).  Dembele et al.  found that conversion rate was 82.9%. Lack of awareness and work commitments were commonly given reasons for not reporting for follow-up sputum examination. Similar findings were noted in study carried out by Kizito et al. 
This study showed that sputum positive rate among chest symptomatic was equal to norm of RNTCP, which indicates good quality of sputum microscopy. Sputum conversion rate was at par with norm of RNTCP indicating toward satisfactory quality of treatment. Proportion of defaulters also satisfied norms by RNTCP (maximum 5%). Success rate of treatment was 85.8% which satisfied set criteria (at least 85%) by RNTCP.  Cure rate and treatment completed rate were nearly equal. This might be due to not-attending follow-up sputum examination and cases of extra-pulmonary TB.
Though many of performance indicators were satisfying norms of RNTCP but still study showed one-third of the cases did not reported for follow-up sputum examination at the end of intensive phase and half of the cases at end of the treatment. Lack of awareness was the most common reason. This finding underlines the need of health education and counselling in current TB case management. So health educating and counselling of patients and their families about various aspects of tuberculosis and its management will improve their compliance toward treatment and follow-up sputum examinations. This ultimately improves the performance of program.
Authors would like to express their deep sense of gratitude to the Dr. S. R. Suryawanshi & Dr. G.D. Velhal, Department of Community Medicine, T.N. Medical College, Mumbai. They would also acknowledge the help and support of Dr. R. S. Pandey, In-charge DMC and Staff of DMC.
[1.] TB India 2013, RNTCP status report. New Delhi: Central TB division, Ministry family of health and family welfare, Nirman Bhawan, 2013. pp. 11-15.
[2.] Supervision and Monitoring strategy in RNTCP. New Delhi: Central TB division, Ministry family of health and family welfare, Nirman Bhawan, 2012. pp. 1-5.
[3.] Managing the Revised National Tuberculosis Control Programme in your area. A Training Course--modules (1-4). New Delhi: Central TB Division, Ministry of Health and Family Welfare, Nirman Bhavan, New Delhi, 2010. pp. 1-195.
[4.] Managing the Revised National Tuberculosis Control Programme in your area. A Training Course--modules (5). New Delhi: Central TB Division, Ministry of Health and Family Welfare, Nirman Bhavan, 2010. pp. 1-71.
[5.] Verma SK, Kant S, Kumar S, et al. A Five-Year Follow-up Study of Revised National Tuberculosis Control Programme of India, Lucknow. Indian J Chest Dis Allied Sci 2008;50:195-8.
[6.] Dembele SM, Quedraogo HZ, Combary A, Saleri N, Macq J, Dujardin B. conversion rate at two month follow-up of smear positive TB patients in Burkina Faso. Int J Tuberc Lung Dis 2007;11:1339-44.
[7.] Kizito KW, Dunkley S, Kingori M, Reid T. Lost to follow up from tuberculosis treatment in an urban informal settlement (Kibera), Nairobi, Kenya: what are the rates and determinants? Trans R Soc Trop Med Hyg 2011;105:52-7.
Kalpak S Kadarkar (1), Daniel A Saji (2), Purushottam A Giri (3)
(1) Department of Community Medicine, Government Medical College, Aurangabad, Maharashtra, India.
(2) Department of Community Medicine, Topiwala National Medical College, Mumbai, Maharashtra, India.
(3) Department of Community Medicine, Indian Institute of Medical Science & Research Medical College, Badnapur, Jalna, Maharashtra, India.
Correspondence to: Kalpak S Kadarkar, E-mail: firstname.lastname@example.org
Received Mar 01,2016. Accepted March 16, 2016
Table 1: Distribution of tuberculosis patients according to treatment outcomes (n = 126) Cured (%) Treatment completed (%) Sex Male 35(44.9) 29 (37.2) Female 20(41.7) 24 (50) Age (years) 0-14 1(11.1) 7 (77.8) 15-24 12(42.9) 14 (50) 25-34 20(52.6) 13 (34.2) 35-44 5(29.4) 9 (52.9) 45-54 13(56.5) 8 (34.8) >54 4(36.4) 2 (18.2) Type of TB Pulmonary 55(56.1) 27 (27.6) Extra-pulmonary Nil 26 (92.9) Treatment types Category 1 51(47.7) 43 (40.2) Category 2 4(21.1) 10 (52.6) Defaulted (%) Died (%) Sex Male 4 (5.1) 8 (10.3) Female 0 (0) 3 (6.3) Age (years) 0-14 0 (0) 1 (11.1) 15-24 1 (3.6) 1 (3.6) 25-34 1 (2.6) 2 (5.3) 35-44 2(11.8) 1 (5.9) 45-54 Nil 2 (8.7) >54 Nil 4 (36.4) Type of TB Pulmonary 4 (4.1) 9 (9.2) Extra-pulmonary Nil 2 (7.1) Treatment types Category 1 3 (2.8) 8 (7.5) Category 2 1 (5.3) 3 (15.8) Transferred Switched to out (%) MDR TB T/t (%) Sex Male Nil 2 (2.6) Female Nil 1 (2.1) Age (years) 0-14 Nil Nil 15-24 Nil Nil 25-34 Nil 2 (5.3) 35-44 Nil Nil 45-54 Nil Nil >54 Nil 1 (9.1) Type of TB Pulmonary Nil 3 (3.1) Extra-pulmonary Nil Nil Treatment types Category 1 Nil 2 (1.9) Category 2 Nil 1 (5.3) Total (%) Sex Male 78 (100) Female 48 (100) Age (years) 0-14 9 (100) 15-24 28 (100) 25-34 38 (100) 35-44 17 (100) 45-54 23 (100) >54 11 (100) Type of TB Pulmonary 98 (100) Extra-pulmonary 28 (100) Treatment types Category 1 107 (100) Category 2 19 (100) Table 2: Treatment outcomes in new and retreatment cases (n = 126) Treatment outcomes Cured Treatment (%) completed (%) Types of New cases SS *. +ve 51 (83.6) 0 (0) patients SS. -ve NA (0) 25 (92.6) Extra pulmonary ** NA (0) 18 (100) Total 51 (47.7) 43 (40.2) Retreatment SS. +ve relapses 4 (57.1) 1 (16.3) cases SS. +ve failure 0 (0) 1 (50) SS. +ve treatment 0 (0) 4 (57.1) after default Others *** 0 (0) 4 (100) Total 4 (21.1) 10 (52.6) Treatment outcomes Defaulted Died (%) (%) Types of New cases SS *. +ve 3 (4.9) 5 (8.2) patients SS. -ve 0 (0) 3 (7.4) Extra pulmonary ** 0 (0) 0 (0) Total 3 (2.8) 8 (7.5) Retreatment SS. +ve relapses 0 (0) 0 (0) cases SS. +ve failure 0 (0) 1 (50) SS. +ve treatment 1 (14.3) 2 (28.6) after default Others *** 0 (0) 0 (0) Total 1 (5.3) 3 (15.8) Treatment outcomes Transferred Switched out (%) to MDR TB T/t (%) Types of New cases SS *. +ve 0 (0) 2 (3.3) patients SS. -ve 0 (0) 0 (0) Extra pulmonary ** 0 (0) 0 (0) Total 0 (0) 2 (1.9) Retreatment SS. +ve relapses 0 (0) 1 (16.3) cases SS. +ve failure 0 (0) 0 (0) SS. +ve treatment 0 (0) 0 (0) after default Others *** 0 (0) 0 (0) Total 0 (0) 1 (5.3) Treatment outcomes Total (%) Types of New cases SS *. +ve 61 (100) patients SS. -ve 28 (100) Extra pulmonary ** 18 (100) Total 107 (100) Retreatment SS. +ve relapses 6 (100) cases SS. +ve failure 2 (100) SS. +ve treatment 7 (100) after default Others *** 4 (100) Total 19 (100) * SS- Sputum smear ** Sputum smear negative extra pulmonary cases excluded from sample. *** In rare and exceptional cases, patients who are sputum smear- negative or who have extra-pulmonary disease can have recurrence or non-response. This diagnosis in all such cases should always be made by an MO and should be supported by culture or histological evidence of current, active TB. In these cases, the patient should be typed as 'Others' and given treatment regimen for previously treated. Table 3: Distribution of tuberculosis patients according to their pretreatment and follow-up sputum examination results (n = 126) Sputum smear results New Relapse Failure Positive 61 6 2 Pretreatment Negative 28 0 0 Not done 18 0 0 Total 107 6 2 Positive 2 0 0 End of Intensive Negative 73 5 1 phase Not reported 32 1 1 Total 107 6 2 Positive 0 0 0 Into Continuation Negative 51 5 0 phase Not reported 56 1 2 Total 107 6 2 Positive 0 0 0 End of treatment Negative 65 3 1 Not reported 42 3 1 Total 107 6 2 Sputum smear results Treatment Others after default Positive 7 0 Pretreatment Negative 0 4 Not done 0 0 Total 7 4 Positive 1 0 End of Intensive Negative 3 1 phase Not reported 3 3 Total 7 4 Positive 0 0 Into Continuation Negative 0 0 phase Not reported 7 4 Total 7 4 Positive 0 0 End of treatment Negative 3 1 Not reported 4 3 Total 7 4 Sputum smear results Total (%) Positive 76 (60.3) Pretreatment Negative 32 (25.4) Not done 18 (14.3) Total 126 (100) Positive 3 (2.4) End of Intensive Negative 83 (65.9) phase Not reported 40 (31.7) Total 126 (100) Positive 0 Into Continuation Negative 56 (44.4) phase Not reported 70 (55.6) Total 126 (100) Positive 0 End of treatment Negative 73 (57.9) Not reported 53 (42.1) Total 126 (100) Table 4: Performance indicators Performance Indicators Percentage Case finding indicators Proportion of new smear positive cases among all new 68.5 pulmonary cases Proportion of new extra pulmonary TB cases among all 16.8 new TB cases Proportion of smear positive previously treated cases 19.7 among all smear positive cases Proportion of new pediatric cases among all new cases 7.5 TB-HIV status indicators Proportion of registered TB patients with known HIV 96.0 status Proportion of registered TB patients found to be 9.1 HIV-positive Sputum Conversion indicators Sputum Conversion rate among all smear +ve 96.1 Sputum Conversion among new smear +ve 96.7 Sputum Conversion among previously treated smear +ve 93.3 Treatment outcome indicators Cured 43.7 Treatment completed 42.1 Died 8.7 Failure Nil Default 3.2 Transferred out Nil Switched to MDR TB treatment 2.4 Figure 1: Reasons for not attending for sputum smear follow-up examination (*, Multiple responses; ** Designated microscopy center (DMC)). Reasons for not attending for sputum smear follow up examination: * Died 6.5 Migration 5.3 Work commitments 18.9 Lack of awareness 23.1 Inconvenient timings 8.9 of the institution Health personnel not available 1.2 Place of D.M.C too far Dissatisfaction of drugs 13.6 Sense of wellbeing 3.0 Neglegence 10.1 Note: Table made from bar graph.
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|Title Annotation:||Research Article|
|Author:||Kadarkar, Kalpak S.; Saji, Daniel A.; Giri, Purushottam A.|
|Publication:||International Journal of Medical Science and Public Health|
|Date:||Oct 1, 2016|
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