A study was carried out to investigate the applicability of INH-Thiacetazone (TH) combination with special reference to acceptability and toxicity in Tumkur district. 150 patients from Tumkur town and some nearby villages were discovered during a mass Case-finding programme. Of them, 127 including 43 sputum positives were given chemotherapy with 300 mgm INH and 150 mgm thiacetazone (TH), in a single tablet to be taken once a day. All but one patient had the treatment on an ambulatory basis. Results of treatment in respect of 103 patients are presented in the paper.

The overall death rate was of the order of 15%. About twice the number of deaths occurred among the sputum positive patients than among the negative ones. About 40% of deaths occurred during the first quarter. In all, 23 patients developed side effects, in 18 of them thiacetazone had to be withdrawn. Serious side effects occurred among 5 (4%) patients. These patients did not report to the treatment centre by themselves and could not have been detected, if home visits were not made, thus giving an erroneous impression about side effects with TH. The sputum conversion at the end of one year was of the order of 50% among all survivors. Among those who were drug sensitive and examined at one year, conversion rate was 63%. Favourable radiological response was seen in 74%.

Thus, though cheap and clinically effective, Thioacetazone in combination with INH was found to produce serious and significant side effects. Hence, vigilance by the treatment centres were thought to be necessary when the patients are on this regimen.

Application of a combined regimen of INH and Thioacetazone (TH) under conditions of District Tuberculosis Programme having become a distinct possibility, the study observed its applicability and toxicity. In all, 127 patients discovered during a mass Case-finding investigation were treated in their homes with 300 mgm of INH and 150 mgm of thioacetazone in a single tablet once a day. Close supervision of patients, laboratory or clinical examination to elicit toxic/side effects were not practicable. During their initial motivation, patients were asked to report back in the event of occurrence of unpleasant symptoms. At subsequent drug collection, indirect questioning for side effects was done. An active search for toxicity was also made by the home visiting staff when they visited patients' homes for defaulter retrieval.

In all, 23 patients complained of possible side effects of thioacetazone, of which 5 were major and 18 of minor nature. Among the 5 patients, two had exfoliative dermatitis and three had generalised petechial haemorrhages. All were males above the age of 40 years. All recovered with withdrawal of drugs and anti histamines. The minor side effects were giddiness and vomiting. None died of thioacetazone toxicity. It is concluded that TH regimen can be used for mass application on account of therapeutic efficacy and low price but consequences of side effects must be borne in mind while using this drug combination under district programme conditions.

Tuberculosis Control Programme in the cities should be a component of the National Programme which ensures that the patients diagnosed anywhere should be treated in their own villages through a smooth transfer and efficient referral system. With this objective analysis of a large scale work done in Delhi Tuberculosis Centre (Annual Report 1962-63) and Lady Willingdon TB Demonstration & Training Centre, Bangalore in 1961 was made to identify the role of State TB clinics in the National Control Programme. The following observations were made: (i) Case-finding activity can be easily carried out as seen in Bangalore city. 17100 (47.5%) smear positive patients were diagnosed during 61-63 from the estimated prevalence of 3600. (ii) It was further observed from both New Delhi & Bangalore TB programmes that they have the heavy burden on their curative services leading to constant flow of rural patients to the city TB clinics. This will deprive the legitimate development of the rural health institutions in carrying out the TB control activities and decrease the efficiency of urban clinics. (iii) From both epidemiological and sociological point of view it is important to provide tuberculosis services in the rural areas to avoid the heavy burden on the urban clinics providing curative services. (iv) Existing facilities for tuberculosis services and beds are adequate if proper co operation and coordination inside and outside city is maintained. (v) Within cities similar coordination and uniformity is maintained through central case index system. (vi) The services and anti TB drugs are provided free of cost. (vii) Treatment of bacteriologically confirmed cases, recording and defaulter retrieval are more necessary than hospital beds and mass Case-finding. (viii) BCG vaccination has to be pursued intensively within the city and elsewhere in the country. House to house vaccination, neonatal vaccination in the hospitals should be attempted.

Control of tuberculosis may be defined as a deliberate interference in the relationship between man and bacillus that changes favourably the epidemiological trend. Compared with the other factors at play on this relationship, the weapons available for a control programme are narrow in their range and must be used with great foresight if they are to benefit the country. Under Indian conditions, with tuberculosis ubiquitous in its occurrence, with no striking focality of infection and disease that would justify selective restricted efforts, control measures must necessarily cover the whole community and the programme must be maintained for a long time. Control will be a slow process, demanding continued investment of men and supplies, persistent and careful organisation. There is no short cut.

The assessment of programme (performance) requires similar approach. Evaluation (impact) must concern itself initially with examining the operational and technical performance, enquiring in detail how the immediate achievement has compared with the forecast, as changes in prevalence are expensive to detect and may not be due to control measures applied. In general, supervision asks if a rule is obeyed: assessment enquires whether it has really been obeyed, whether it can and should be obeyed and whether there might be a better rule. For e.g. evaluation of BCG campaign encompasses the whole series of activities undertaken and not only confined to occasional surveys of post-vaccination allergy. It is important for curative work also. Pilot evaluation report of Anantapur programme after one year in 1962 is given as an example of simple assessment. A great majority of patients diagnosed at district centre came from outside, while at peripheral hospitals 90% came from the same taluk. Treatment completion were 38% to 40% among patients belonging to the same town and very low among those living outside. This gives importance of Case-finding in peripheral centres. Referral also played very little part. The accuracy of diagnosis, proportion of cases diagnosed, number completed treatment and rendered negative, are included in the assessment. Besides these, cost of the programme and expansion of the programme to the whole district, accuracy of the case index, operational achievements at individual centre/district, prevalence of initial drug resistance among clinic patients, should also be considered. Even such an elementary evaluation demands careful organization and clear procedures: staff must be allotted and trained for the purpose and equipment must be provided. The assessment must be objective and independent: it seems appropriate that the procedures would be undertaken, in each state, by staff from the State Tuberculosis Centre, Regional Offices under the Union Government could also be involved. The responsible centres must have portable, hand operated punching equipment and facilities for sputum culture. If tuberculosis in India is to be controlled by human intervention and health to be effectively promoted, independent assessment of programmes, feeding back into research so that problems will be solved and the solutions timely applied, is absolutely essential. As yet, both methodology and the organisation needed are embryonic and demand therefore particular attention and priority. Administrators and scientists alike face, in nurturing evaluation, an unusually difficult and promising challenge. Recognising and accepting a challenge is in itself an important development.