Outcome of standardized treatment for patients with MDR-TB from Tamil Nadu, India.

Background & objectives Programmatic management of MDR-TB using a standardized treatment regimen (STR) is being implemented under the Revised National Tuberculosis Control Programme (RNTCP) in India. This study was undertaken to analyse the outcomes of MDR-TB patients treated at the Tuberculosis Research Centre, Chennai, with the RNTCP recommended 24 months STR, under programmatic conditions. Methods Patients failed to the category II re-treatment regimen and confirmed to have MDR-TB, were treated with the RNTCP's STR in a prospective field trial on a predominantly ambulatory basis. Thirty eight patients were enrolled to the trial from June 2006 to September 2007. Results Time to culture conversion was two months or less for 82 per cent of patients. Culture conversion rates at 3 and 6 months were 84 and 87 per cent respectively. At the end of treatment, 25 (66%) were cured, 5 defaulted, 3 died and 5 failed. At 24 months, 30 (79%) patients, including 5 defaulters, remained culture negative for more than 18 months. Twenty two (58%) patients reported adverse drug reactions (ADRs) which required dose reduction or termination of the offending drug. No patient had XDR-TB initially, but 2 failure cases emerged as XDR-TB during treatment. Interpretation & conclusions Outcomes of this small group of MDR-TB patients treated with the RNTCP's STR is encouraging in this setting. Close attention needs to be paid to ensure adherence, and to the timely recognition and treatment of ADRs.

Assessment of long term status of sputum positive pulmonary TB patients successfully treated with short course chemotherapy.

Background: Long term status of pulmonary tuberculosis (PTB) patients treated with short course chemotherapy (SCC) regimens remains unknown. Objective: To assess the clinical, bacteriological, radiological status and health related quality of life (HRQoL) of PTB patients 14 -18 years after successful treatment with SCC. Methodology: In a cross-sectional study, cured PTB patients treated during 1986 – 1990 at the Tuberculosis Research Centre (TRC) were investigated for their current health status including pulmonary function tests (PFT). The St Georges respiratory questionnaire (SGRQ) was used to assess the HRQoL Results: The mean period after treatment completion for the 363 eligible participants was 16.5yrs (range 14-18 yrs, 84% coverage) ; 25 (7 %) had been re-treated and 52 (14%) died. Among the investigated, 58 (29%) had persistent respiratory symptoms; 170(86%) had radiological sequelae but none had active disease. Abnormal PFT was observed in 96 (65%) with predominantly restrictive type of disease in 66(45%). The SGRQ scores for activity and impact were high implying impairment in HRQoL. Conclusion: Assessment of long term status of cured PTB patients showed an impairment of lung functions and HRQoL highlighting the need to address these issues in the management of TB that may provide added value to patient care.

Psycho-social dysfunction: perceived and enacted stigma among tuberculosis patients registered under revised national tuberculosis control programme.

OBJECTIVE: To examine the perceived and enacted stigma experienced by TB patients and the community. METHODS: We interviewed 276 TB patients registered for treatment during January-March 2004 in government health facilities of two Tuberculosis Units of south India. Data on perceived and enacted stigma were collected after two months of starting treatment, using a semi-structured interview schedule. In addition, four Focus Group Discussions were conducted among Directly Observed Treatment (DOT) providers and community members. Narrative summaries were also taken down to collect additional qualitative information. RESULTS: Of the 276 patients, 190 (69%) were males. There was no significant difference between the genders in relation to social stigma. Perceived stigma was higher than enacted stigma in both genders and significantly higher among males (Low self esteem p < 0.05), change of behavior of community (p < 0.05), ashamed to cough in front of others (p < 0.05). CONCLUSION: Considering the social and emotional impact of the disease, it is essential to adopt support strategies to enhance acceptance and for a successful health programme.

Sputum conversion at the end of intensive phase of Category-1 regimen in the treatment of pulmonary tuberculosis patients with diabetes mellitus or HIV infection: An analysis of risk factors.

BACKGROUND & OBJECTIVE: New smear-positive pulmonary tuberculosis (PTB) patients in the Revised National Tuberculosis Control Programme (RNTCP) are treated with a 6-month short-course chemotherapy (SCC) regimen irrespective of co-morbid conditions. We undertook this retrospective analysis to compare sputum conversion rates (smear, culture) at the end of intensive phase (IP) of Category-1 regimen among patients admitted to concurrent controlled clinical trials: pulmonary tuberculosis alone (PTB) or with type 2 diabetes mellitus (DM-TB) or HIV infection (HIV-TB), and to identify the risk factors influencing sputum conversion. METHODS: In this retrospective analysis sputum conversion rates at the end of intensive phase (IP) in three concurrent studies undertaken among PTB, DM-TB and HIV-TB patients, during 1998 - 2002 at the Tuberculosis Research Centre (TRC), Chennai, were compared. Sputum smears were examined by fluorescent microscopy. HIV infected patients did not receive anti-retroviral treatment (ART). Patients with DM were treated with oral hypoglycaemic drugs or insulin (sc). RESULTS: The study population included 98, 92 and 88 patients in the PTB, DM-TB and HIV-TB studies. At the end of IP the smear conversion (58, 61, and 62%) and culture conversion (86, 88 and 92%) rates were similar in the three groups respectively. The variables associated with lack of sputum smear or culture conversion were age >45 yr, higher pre-treatment smear and culture grading, and extent of the radiographic involvement. INTERPRETATION & CONCLUSION: Our findings confirm that the current policy of the control programme to treat all pulmonary TB patients with or with out co-morbid conditions with Category-I regimen appears to be appropriate.

Evaluation of an intermittent six-month regimen in new pulmonary tuberculosis patients with diabetes mellitus.

BACKGROUND: The treatment of tuberculosis (TB) with category I regimen of the Revised National Tuberculosis Control Programme (RNTCP) for patients with diabetes mellitus (DM) needs evaluation. OBJECTIVE: To assess the cure and relapse rates in 3 years, among the new smear-positive TB patients with Type-2 DM (DMTB) treated with CAT-I regimen (2E3H3R3Z3/4R3H3) of RNTCP. METHODOLOGY: TB suspects attending the diabetology units and the TB research centre (TRC) Chennai, were investigated. Eligible DMTB cases were enrolled. Baseline estimation of cardiac, renal, liver function tests and glycosylated-HBA1c were undertaken. All patients received 2E3H3R3Z3/4R3H3 under supervision at TRC. Clinical and sputum (smear and culture) examinations and monitoring of diabetic status were undertaken every month up to 24 months, then once in 3 months up to 36 months. RESULTS: Of 100 patients admitted, 7 were excluded for various reasons from analysis. Of 93 patients, 87 (94%) had a favourable response at the end of treatment. Pre and post treatment mean glycosylated-HBA1c were 9.7% and 8.4% (>7% poor control). During follow-up period, 6 died and one lost to follow-up. Of the remaining, four relapsed. CONCLUSION: Category-I regimen, recommended for all the new smear-positive patients in the Indian TB programme, is effective in the treatment of DMTB patients, despite poor control of diabetes.

Management of multi drug resistance tuberculosis in the field: Tuberculosis Research Centre experience.

SETTING: Multi-drug TB resistant (resistant to isoniazid and rifampicin) patients identified from a rural and urban area. OBJECTIVE: To study the feasibility of managing MDR TB patients under field conditions where DOTS programme has been implemented. METHODS: MDR TB Patients identified among patients treated under DOTS in the rural area and from cases referred by the NGO when MDR TB was suspected form the study population. Culture and drug susceptibility testing were done at Tuberculosis Research Centre (TRC). Treatment regimen was decided on individual basis. After a period of initial hospitalization, treatment was continued in the respective peripheral health facility or with the NGO after identifying a DOT provider in the field. Patients attended TRC at monthly intervals for clinical, sociological and bacteriological evaluations. Drugs for the month were pre-packed and handed over to the respective center. RESULTS: A total of 66 MDR TB patients (46 from the rural and 20 from the NGO) started on treatment form the study population and among them 20 (30%) were resistant to one or more second line drugs (Eto, Ofx, Km) including a case of "XDR TB". Less than half the patients stayed in the hospital for more than 10 days. The treatment was provided partially under supervision. Providing injection was identified to be a major problem. Response to treatment could be correctly predicted based on the 6-month smear results in 40 of 42 regular patients. Successful treatment outcome was observed only in 37% of cases with a high default of 24%. Adverse reactions necessitating modification of treatment was required only for three patients. IMPLICATIONS: Despite having reliable DST and drug logistics, the main challenge was to maintain patients on such prolonged treatment by identifying a provider closer to the patient who can also give injection, have social skills and manage of minor adverse reactions.

Identifying effective communication channels in a rural community: A field report from south India.

Background: There is scarcity of information on communication channels in rural areas where about 38% of people are illiterate. Objective: To identify the channels of communication available in rural areas by interviewing key informants. Method: This study was conducted in 51 villages of Ellapuram block, Tiruvallur district, Tamil Nadu in the year 2004. Key informants selected from the villages were interviewed by a Medical Social Worker. The questionnaire included information on modes of communication channels, availability of markets, public facilities, and local associations. Result: The study block included 9893 households covering a population of 39255. Their main occupation was agriculture (86%). Electricity was available in all the villages. More than 80% of the villagers had community TV/cable connections, >50% of the villages had cinema star fan associations, mahila mandals, youth clubs, self-help groups, anganwadi centres and ration shops. The main source of communication as per interview was television (100%), wallposters (55%); publicity through panchayat office meetings (53%) and dandora or beat of drums(43%). Conclusion: Main communication channels, commonly used to disseminate information were TV and wall posters. More than 50% of villages had local associations which can be used for effective communication. This information is vital for disseminating important information on public health programmes and educating the rural community.

Costs to patients with Tuberculosis treated under DOTS Programme.

Background: The economic burden of TB in India is enormous as TB perpetuates and exacerbates poverty. Revised National Tuberculosis Control Programme (RNTCP) based on DOTS strategy is currently being implemented in India. The purpose of this study is to estimate the costs incurred by tuberculosis patients treated under RNTCP in a district in Tamilnadu where services are decentralized for diagnosis and treatment. Method: In all, 455 patients registered under RNTCP between June and December 2000, in Tiruvallur district were interviewed to collect the following information: Demographic, socio-economic characteristics of patients, expenditure incurred due to illness and effect of illness on employment. Based on the data collected, various costs (direct medical, nonmedical, indirect and total costs incurred on account of tuberculosis before and during treatment) were estimated. In addition Standard of Living Index (SLI) was calculated for patients. Results: Of 455 patients, 62% had low SLI. The median direct, indirect and total costs for 343 patients who successfully completed treatment were as follows: pre treatment direct costs were Rs 340, during treatment direct costs Rs 100; more than 50% of patients did not incur any indirect costs in both pre treatment and during treatment periods and overall total costs were Rs 1398. About 12% of patients lost more than 60 workdays and after completing treatment, 88% returned to work. Conclusion: For patients registered under RNTCP in Tiruvallur district in Tamilnadu, the findings that the total patient costs were Rs 1398/- and also the patients returned to work early establishes the economic benefits to patients treated under DOTS and lend support to rapid expansion of DOTS programme, particularly in low-income countries.