In the wake of implementation of Short Course Chemotherapy (SCC) in the programme, some of the organizational aspects of SCC as observed in a clinical trial at the Lady Willingdon State TB Centre (LWSTC), Bangalore vis-a-vis to those recommended in the programme were evaluated. The efficacy of 3 SCC regimens of 3-5 months duration under clinical trial were studied among 381 patients. The efforts and the resources employed to achieve the results in the trial are compared with that of those recommended in the District TB Programme (DTP).

It is observed that there is a wide gap between the clinical trial and the programme in organisational efforts and resources. Although the trials cannot act as a model, if benefits associated with the SCC are to be availed, extra staff and transport for home visiting should be provided. The aspects of the organisation which need strengthening are motivation, timely defaulter action (preferably on the same day mainly as home visit) and efficient management of large number of patients attending the clinic for supervised drug administration, adverse reaction etc., before recommending the use of SCC in the DTP.

The high rate of treatment completion and the regularity of drug intake achieved in clinical trials of Short Course Chemotherapy (SCC), could possibly be attributed to efficient organizational set-up, careful selection of cases and all-out effort to control defaulters. The organizational effort put forth to achieve the regularity is relevant to the applicability of SCC in the existing set-up of District Tuberculosis Centres (DTCs) under National Tuberculosis Programme (NTP). First 300 patients admitted to SCC trial to assess the efficacy of three drug regimens of 3/5 months duration under fully supervised conditions, carried out jointly by National Tuberculosis Research Centre, Madras and National Tuberculosis Institute (NTI), Bangalore, have been analysed for the purpose.

To keep up the regularity, 1/3rd of the patients required home visits-some of them repeatedly. If the actions of the same intensity of defaulter retrieval in the form of home visiting are envisaged to be taken in a DTC with the normal working pattern catering to 500 patients, 250 to 300 home visits will have to be made in a month. This may not be feasible in the existing set-up of NTP. A new strategy of defaulter retrieval actions for programme conditions may have to be devised. Further, selection of drug regimen which has the maximum potential of being given on self-administered basis may reduce the work-load to a considerable extent. Drug toxicity, side effects and the cost of drugs may not be major handicaps. However, the only way to understand various operational problems is to undertake scientific operational studies in actual working conditions of NTP.

An operational study of two regimens of Short Course Chemotherapy (SCC) to assess their efficacy under programme conditions, applicability and feasibility in District TB Programme (DTP) was undertaken in an urban TB centre. The two regimens studied were 1SHRZ/7TH and 2SHR/6TH. Their operational efficacy (efficiency) was found to be 87% and 92% respectively which had already been reported in an earlier paper. The various factors i.e., initial willingness, drug default, treatment completion pattern, adverse drug reactions and initial drug resistance with their potential harmful effects on the treatment outcome as well as work load and extra cost these regimens entail for DTP organisation are discussed in this paper.

Out of a total of 1822 smear positive patients diagnosed at the Lady Willingdon State TB Centre during intake period (Feb '84 to March '85), 1126 were residents of Bangalore City. Of these 695 (61.7%) were unwilling to attend the clinic daily for 2 months, 27 were unfit and one was excluded by mistake. Thus, 403 (38.3%) initially willing patients were classified either as 'core group' or 'Non core group’, according to the history of previous anti TB treatment (321 and 82 respectively). Of the 695 (77.6%) unwilling persons, majority were those who pleaded inability to attend daily for 2 months without specifying any particular reason. Refusal of SCC due to injections accounted for 12.8% and 9.5% wanted to take treatment elsewhere. Old age influenced willingness adversely.

Of the 321 patients in the core group, 56 were excluded due to missing more than 50% of intensive phase doses. Among the remaining patients, 61 (48%) out of 127 patients on Regimen A and 48 (34%) out of 138 on Regimen B, did not make a single default in the intensive phase. Of the total 910 defaults for which actions were taken, 640 (70%) were retrieved by letter writing, among the remaining 293 (72%) were retrieved by home visiting. Main reasons for default elicited during home visits were: going out of station (52.9%) followed by patients being busy with work (19.1%). Compensatory phase was availed by 156 of the 265 patients who missed one or more doses due to default in the treatment. The pattern of treatment completion of 321 core group patients in the two regimens were similar i.e., in both the phases 65% for Regimen A and 63% for Regimen B. Incidence of minor adverse reactions was 28% and major toxic reactions were experienced by 8.4% of patients. Workload for treating 321 patients was due to supervised administration of drug 45 patients per day. Letter writing to 3.1 per patients, home visiting 1.1 per patient and doctor's attention for adverse reaction 2 occasions per patient. This could be managed with the existing staff. The cost of Regimen A was Rs.220/ per patient and for Regimen B, 268/ per patient. Cost to patient for transportation was Rs.70/ and Rs.113/ for Regimen A and B respectively.The major disturbing finding of the study was initial low acceptability of about 40% for SCC. The home visiting which was crucial in increasing the completion rate in this study is usually not available in most of the DTCs. Workload, adverse reactions etc. were not of any problem for implementation of SCC in the programme.

The fate of patients with isoniazid (H) resistant pulmonary tuberculosis, treated with 3 different Short Course Chemotherapy regimens (Regimen A-1 SHRZ/7TH, Regimen B-2SHR/6TH, Regimen C-2EHR/4H2R2) was examined in two sequential studies. One hundred H resistant patients belonging to two groups-one without history of previous treatment(core group) and second with history of previous treatment >=15 days (non-core group), were followed up at the end of 12th, 15th and 24th/36th month of chemotherapy. Bacteriological favourable response among patients in the core group at the end of chemotherapy with Regimen A, B and C were 65.2% of 23 patients, 50% of l8 patients, and 57.1% of 18 patients respectively. The response among patients in the non-core group were 27.3% with Regimen A and 52.6% with Regimen B.

At the end of 24/36th month of chemotherapy, 62.5% patients in the core group and 2 out of 7 in the non-core group on regimen A and 68.7% patients on regimen C in the core group and 5 out of 15 in the core group and 41.7% in the non-core group on regimen B were culture negative. The relapses were significantly high in regimen B & C in comparison with regimen A. Thus, of the total 100 patients, 99.3% were eligible for examination (1 died during chemotherapy), 67 were examined and of them 37 (62.7%) were culture negative, 22 positive and 8 were dead. The development of drug resistance to rifampicin was directly related to the duration of its use.

Five districts in which short course chemotherapy (SCC) was introduced during 1987-88 (DTP-SCC) and an equal number of districts without an SCC programme (DTP-SR) but having comparable new sputum examinations performance (NSE) in 1986 were selected from the states of Gujarat and Tamilnadu. Data obtained by the monitoring cell of the National Tuberculosis Institute (NTI) for 15 consecutive quarters from the lst quarter of 1986 were analysed. It was possible to study operational variables: NSE, number of pulmonary patients diagnosed (TBP) and number of bacillary cases detected (BCASE). While the figures of first six quarters were used to represent pre SCC performance, those of the last six quarters depicted the post SCC scenario. However, the trend analysis has been done using the whole data.

The growth rates of NSE, TBP and BCASE were 14.1%, 1.7% and 13.0% respectively for DTP-SCC compared with 17.0%, 5.3% and 29% for DTP-SR. Both the DTCs and PHIs in DTP-SR showed negative growth in BCASE, inspite of their efforts as evidenced by increase in NSE and TBP, the introduction of SCC led to an increase in BCASE for both DTC and PHIs. While the PHIs in DTP-SCC showed increased efficiency in all the aspects (NSE 24.4%, TBP 19%, BCASE 16.7%), DTCs showed decreased activity in NSE ( -2.4) and TBP (-6.6%), indicating improvement at the periphery. Trend analysis corroborated the above findings.

The treatment results of an unsupervised Short Course Chemotherapy (SCC) regimen used under conditions of District Tuberculosis Programme (DTP) are presented. The District Tuberculosis Centre (DTC), Kolar and six of its Peripheral Health Institutions (PHIs) formed the study area. No extra efforts except ensuring of adequate availability of drugs at the participating centres were made to obtain patients' compliance. In all, 584 smear positive tuberculosis patients were diagnosed during the study period but 28.3% of the patients could not be initiated on treatment with the chosen self administered SCC regimen -2EHRZ/6TH(EH).

Of the 382 put on treatment, only 33.2% completed over 75% drug collections in both intensive and continuation phases. The pattern of treatment compliance did not vary with the place of treatment, i.e. DTC or PHI. Irrespective of treatment compliance, nearly 72-77% of the patients attained smear negative status at the end of the period of treatment, there being no difference between PHI and DTC. However, deaths were higher in the PHI patients. This could be attributed to a significantly higher proportion of aged patients taking treatment at PHI than at DTC. Considering death as an unfavourable outcome, overall favourable response was 65.9%. Patients with drug sensitive bacilli had a higher rate of culture negativity (70%), as compared to those with drug resistant bacilli (48%). It was concluded that unsupervised SCC could give encouraging results in a DTP setting, provided adequate drug supply was ensured.

Culture examination of sputum is known to be the best tool for assessing the prognosis of pulmonary tuberculosis patients. Controlled clinical trials with Short Course Chemotherapy (SCC) have shown that culture examination of sputum at the end of two months elicited a high degree of conversion, while smear results were inferior due to presence of dead organisms in the sputum. But, it is not possible to provide sputum culture facilities in the District TB Programme (DTP). Since smear examination facilities is widely available under the DTP, this paper examines the comparability of smear results with culture in patients treated with SCC. It also examines the value if any, of an early evaluation of the treatment outcome with SCC under operational conditions by doing smear examination at two months. Data from two operational studies on SCC are utilised for this purpose.

Of 256 total patients examined, 62 were smear positive at the end of two months, but 41 of them were excreting non- viable bacilli and were culture negative. Nevertheless, in predicting the final outcome of chemotherapy, no significant difference was observed between smear and culture examination at the end of two months. Smear positivity at the end of 2 months, by itself, cannot be considered to bode an unfavourable response, whereas negativity had a good probability of a favourable response. Microscopy in SCC gave as reliable a result as culture both during and at the end of chemotherapy. Hence, a properly conducted smear examination is as good as culture for diagnostic and prognostic purposes under operational conditions.