The paper has illustrated the use of mathematical model (epidemetric model) for the prediction of the trend of tuberculosis in a given situation with or without the influence of specific tuberculosis control programme. The paper also advocates the use of models for evolving applicable control measures by reflecting their interference in the natural trend of tuberculosis in control areas. These models were constructed by applying methods which have been developed and utilised in other social sciences.
The precise estimates of the various parameters entering the model must be available if realistic long term results are to be achieved through model methodology. The need for exact data regarding prevalence and incidence of infection and disease, necessitates longitudinal surveys in large random population groups. It is, however, the present authors firm opinion that it would be fruitful for almost any health department, to compare their best available epidemiological knowledge in a system of relationships in order to quantify their concept of the situation. Such an exercise in mathematics would, in any case, serve to sharpen the epidemiologists thinking and would lead them to appreciate what data they need most urgently. The model may help in predicting the trend of tuberculosis in a given situation.

This paper estimates the natural trend of tuberculosis in rural south India and the potential epidemiological impact of a few selected programmes on this trend, by using the values of important variables and parameters derived from a longitudinal epidemiological study conducted in 1961-68 in Bangalore district by the National Tuberculosis Institute (NTI), Bangalore. The values are fed into an epidemetric model and the final outputs of computerization derived are incidence of disease (in both absolute and relative terms) and cumulative future prevalence of disease.

(1) An annual average input of new generations of 3.16% has been derived for a population of 1 million by using a simplified fertility rate formula. A constant reduction 0f 1% per year has been assumed until fertility rate has reached 50% of its starting value. The assumption is that any reduction in fertility due to current family planning programmes will have a considerable impact on the size of the population and on the epidemiological situation. Further demographic assumptions are, excess mortality applied to groups of active cases and fatality among untreated cases. (2) The population is subdivided into the following epidemiological groups: (i) non-infected, (ii) infected for – (a)< 5 years, (b)= 5 years, (iii) protected by BCG, (iv) active cases - (a) non-infectious, (b) infectious and (v) previous cases. Initially groups (iii) and (v) are given zero values. The future risk of infection is adjusted to the force of infection, which is assumed to be reduced to 1/7th when a case is successfully treated. Morbidity rates include transfers from infected group to active cases group during 5 year periods. (3) A spontaneous healing rate of 50% and a cure rate of 80% after chemotherapy are assumed. Protective effect of BCG is given three values: 30%, 50% and 80%, with uniform annual reduction of 1% (4) Case detection and treatment (CF/T) is given two values: 66% and 20%. Coverage for BCG limited to 0-20 years is assumed to be 66% or 30%.

The computer simulation output for natural trend shows that the absolute number of new cases increases considerably while the incidence rate do not warrant firm conclusions about any long term trend. All programmes considered have considerable potential impact. The CF/T programmes will reduce the incidence after 25 years by only 12% compared to reduction of 17% by the BCG programme. In general, the effect of CF/T will be more immediate and of BCG will be seen much later. To avoid the drawbacks of incidence as an indicator of tuberculosis situation, the cumulated future prevalence is taken as the tuberculosis problem. To adjust for the present significance of future cases as part of the problem certain discount rate have been applied. The CF/T programme and the BCG programme with 50% protection lead to 69% problem reduction, if not discounted. With increasing discount rates, CF/T has an advantage over BCG. The actual problem reduction will be higher than that estimated if improvements in the standard of living are expected during the coming years.

In conclusion, data on the dynamics of tuberculosis situation in rural south India, obtained by NTI, Bangalore when fed into a mathematical model, many predictions about the future tuberculosis situation were made under a wide range of hypothetical assumptions.

Health problems in India form only a small part of the large variety of pressing socio-economic problems that face the community. Pulmonary tuberculosis, among the health problems, is one of the many problems which need immediate attention. In the resources that are available for dealing with the different problems, the share which could be given to tuberculosis could not be big. If, due to some special reasons, a disproportionate slice of the resources is used up in applying advanced technological methods to satisfy a fraction of the total needs of the community, other problems may be accentuated. Logically a solution of the tuberculosis problem in India should form an integral part of a comprehensive overall social development plan for the community. If the tuberculosis control programme is according to the felt need, generated by the disease in the community, it would be in consonance with the other health and social programmes evolved for dealing with the other felt needs. Available information shows that it is possible to develop a minimal nation wide tuberculosis casefinding and treatment programme through the general health services. If the available resources in the future improve, then a corresponding qualitative and quantitative improvement in the working of the tuberculosis programme could be easily affected. It also appears reasonable to expect such a programme to produce an impact on the epidemiology of the disease.

Persons suffering from pulmonary tuberculosis generally experience symptoms such as cough, chest pain, fever and haemoptysis. It is possible to identify the symptomatics by interviewing them during community health surveys. The symptom survey was carried out in 62 villages and 4 town blocks of Tumkur district in Karnataka as a sequel to an epidemiological survey undertaken to estimate the prevalence of tuberculosis. The data was collected through structured schedule. The interviewers were given the identification details of individuals having X-ray shadows suggestive of tuberculosis and an equal number of matched controls within 4 weeks of the survey. A total of 1752 persons were taken into the study of whom 875 had x ray shadows and 877 were normals. Of the total persons under study 89.7% were satisfactorily interviewed. It was observed that 42.6% of the total symptomatics gave history of one symptom at the first general question, 13% responded having symptoms after being asked specific questions. In conclusion a 42.6% affirmative response to the initial question of 'How is your health' is noteworthy that an investigator is acceptable health agency as the interviewee is willing to confide in him regarding his health problems. Additional number of persons responded to direct specific questions.

It must be pointed out that interview is a generic term applied to a tool that may be used for obtaining information through verbal communication. As a tool in surveys for screening for tuberculosis it is amenable to divese techniques and has great potentialities of being applied to different situations and various categories of respondents. Hence, it is necessary to identify the nature of data to be obtained and to decide on the technique that would be most suitable. Proper training, skill and supervision of the interviewer can obviate any possible bias and subjectivity that could vitiate an interview. As compared to many of the tools of social science research, the interview is simple, easy and amenable to being used in live situations. It is also of prime importance among populations for whom vocalisation is the most important medium of communication. Hence, in a community survey for the estimation of the prevalence of chest symptomatics the interview can be a valuable tool. It also shows that the interview is adequate as a tool of community survey in tuberculosis.

A study on awareness of symptoms of pulmonary tuberculosis and action taking was repeated in the 62 villages and 4 town blocks of Tumkur district of Karnataka after an interval of 12 years. In the earlier study, 2106 persons formed the study population. In the present study, 1752 were intaken to obtain a comparison of these 1752 intaken persons who were eligible for interview, 875 were X-ray positive and 877 X-ray normal (matched control).

The study showed that 95% of patients having radiologically active tuberculosis by both X-ray readers, 70% by one reader, 49.5% inactive by both readers, were aware of symptoms. According to the bacteriological status 79.5% had symptoms among those who were sputum positive by both microscopy and culture, 62.2% among those positive by culture alone and 73.7% among patients sputum positive by any method. Regarding action taking it was observed that 49.5% of the bacteriologically positive patients took some action compared by 70% of those found to have radiologically active disease by both X-ray readers. Thus action taking was higher among the latter category in both the studies. It may be due to the fact that extent of lesions are less advanced among those bacteriologically positive than among those who were in radiologically positive stage.

The findings of the study are similar to the earlier awareness study carried out in 1963 in the same area (Tumkur). This also indicates that in spite of having advantage of DTP for a decade actual and total benefits have not reached the people.

The National Sample Survey demonstrated that tuberculosis is one of India's major public health problems, disease being equally prevalent in both rural and urban areas. To bring about the reduction of the tuberculosis problem in a limited time the programmes developed at National Tuberculosis Institute (NTI) must have the following characteristics: i) they must be firmly rooted in the general health services and contribute to their development. ii) they must be applicable to the large majority of the districts of India. The existing clinical knowledge of tuberculosis should be brought to the realm of public health application, for which NTI must accumulate a body of knowledge on the efficiency of various control programmes under field conditions and their operational feasibility.

Operations Research at NTI consists of following elements (i) Data collection on (a) epidemiological factors by conducting base line and longitudinal surveys (b) operational factors by comparing Mass Campaign approaches and Community Development Approaches (c) Sociological and economic factors by studying the awareness of symptoms among TB patients, economic consequences of TB and acceptability of long term drug treatment (ii) construction of various epidemetric and operational models to give information on the efficacy of various tuberculosis programmes (iii) test run at the moment NTI is operating a District TB Programme (DTP) in Anantapur and a city programme in Bangalore. These programmes have been formulated to a large extent on the basis of preliminary data not organised in model form. Some provisional conclusions are beginning to emerge from the various elements of the Operations Research Programme operating for a year. The general health services are proving to be capable of playing their essential role in the diagnosis and treatment of tuberculosis, provided they are assisted, at district level, by a special tuberculosis service for planning, partial supervision, evaluation and referral. With existing chemotherapy the treatment organisation is the most crucial part of the tuberculosis services, and the decisive role is played by the field organization engaged in preventing and curing treatment default. The most critical requirement of any control programme is an ample provision of drugs, to be supplied free of cost to the patients. Over half the X-ray active cases (including more than three quarters of the sputum positive cases) are aware of symptoms of the disease, and Case-finding can therefore, for some time to come, be based on the self advertising attraction of a free treatment service within a walking distance, associated with a simple sputum diagnosis at Primary Health Centre level and referral X-ray diagnosis at taluk or district level. NTI's task is formidable, its resources limited. We believe that through its Operations Research Approach, NTI utilises most effectively its limited facilities towards the solution of India's tuberculosis problem.

The study was carried out at Lady Willingdon Tuberculosis Demonstration & Training Centre, Bangalore to inquire into the epidemiological and sociological characteristics of patients attending a city TB clinic for the first time, to ascertain the reason for attendance and the nature of previous treatment if any. It was also to see whether there was a preference for seeking specialists and specialised services for alleviation of the symptoms experienced and whether there were any differences amongst the urban and rural attenders. A fifty per cent random sample of 2,658 out patients during 6l working days, formed the study population. They were interviewed by using a questionnaire based on the above mentioned objectives. 247 were not eligible due to incomplete record and below 5 years of age.

Majority of the out patients were in 20 30 years of age and were wage earners. Nearly 80% were aware of their symptoms and contained 95% of the tuberculosis cases detected at the clinic. Most of them were having 2 3 symptoms. No difference in time of reporting was observed among urban or rural patients; 61% of the urban and 42% of the rural patients attended the clinic within 3 months from the onset of their symptoms. Distance is a major obstacle. Upto 4.8 km the number of new outpatients was large but the case yield was poor. As the distance increased the out patients decreased but the case yield was more, suggesting a selective process influenced by distance. It was also found that 20% of the out patients came of their own without any prior contact with any other source of treatment, 32% had previous contact with other health institutions, 31% were actually referred by them and 17% were advised by BCG workers. Further analysis that of the 1,642 patients who had previous contact with health institutions, 84% were at general health institutions, 10% at specialised TB clinics and 6% were others. Of the remaining eligible 2,403 patients, 83% were from urban and 17% from rural areas. Sputum was collected from 2,308 patients. Of them, 179 (7.8%) were found to be positive by direct microscopy or culture or both and 169 were positive by culture (91% confirmation by culture). 131 (80%) were sensitive to isoniazid and 32 were isoniazid resistant.

The data obtained suggests that attendance at a specialized tuberculosis centre is not necessarily a function of awareness of symptoms and of the knowledge that such specialised services exist. It also does not support the theory that people prefer specialized institutions in cities. It is also seen than urban and rural patients behave in almost the same way in that their first contact for symptoms suggestive of tuberculosis, is initially at the general medical services and they should be strengthened with adequate means for diagnosis and treatment of tuberculosis.

In the District Tuberculosis Programme (DTP) the diagnosis is based on sputum microscopy. Majority of health institutions in the district are provided with microscopes for this purpose. In the Peripheral Health Institutions, the programme activities have to be carried out by its staff after a short period of training given by District TB Centre personnel on the spot. So the microscopy work in the PHIs is likely to be carried out by any paramedical personnel and not necessarily by a qualified laboratory technician. It is therefore, necessary to know whether the standard of microscopy carried out by these paramedical personnel after a short training will be upto the mark. To assess the efficiency of smear examination done by these individuals, a study was conducted in Bangalore district covering nine microscopy centres in various types of health institutions, a few months after the implementation of the programme. Under the DTP a spot specimen is collected from every chest symptomatic attending the health institutions and a smear is made and examined for the presence of AFB and all positive cases are put under treatment. The sputum specimens and the smears examined in these nine centres were brought to National TB Institute laboratory. The smears were examined by an experienced laboratory technician. Duplicate smears were also prepared from these specimens and their results compared with results of re examination and centre's examination. All specimens were cultured by swab method and all positive cultures were subjected to sensitivity and identification tests.

Analysis of the results based on culture showed that barring a few centres where the performance was poor, the standard of examination was fairly good. The under and over diagnosis based on culture were 38.2% and 2.6% respectively, and these were within the limits observed generally. Comparison of results on re examination of centre smears and duplicate smears indicated that both reading variation and defective smear preparations and staining could have influenced under diagnosis in these centres. The study has also thrown some light on methodology of assessment of sputum examination that could be adopted wherever a tuberculosis control programme is functioning.

At present, Case-finding activity of tuberculosis through the self reporting chest symptomatics attending Peripheral Health Institutions, is at a low ebb. With the introduction of Multi Purpose Workers (MPW) scheme, a machinery has emerged through which this activity could be augmented. An operational study was therefore undertaken in five Primary Health Centres (PHCs) of Chittoor district, Andhra Pradesh in June 1978.

The study has revealed that if the MPWs collect sputum smears from the symptomatics of the age group of 20 years and above during their routine visits to each household of the specified population allotted to them and despatch the smears to the PHC for examination, there is a possibility of augmenting the existing Case-finding activity by 4 5 times. An intensive training of 2 3 days for this purpose seems adequate. The average work load for a MPW would be preparation of one smear a day initially for a couple of months and thereafter as a routine one smear a week. In an average PHC, the work load for the microscopist would be to examine 10 to 12 slides a day initially, the load will then progressively decline and subsequently as a routine it will not be more than 3 4 slides a day. An additional microscopist would probably be needed at PHC laboratory for examination of sputum smears as well as to assist the existing microscopist who at present is primarily engaged in malaria work. Meticulous supervision and regular flow of supplies and equipment is however a 'must' for the success of the scheme.

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.

This investigation was to find out the drug consumption among tuberculosis patients put on domiciliary self administered chemotherapy, in terms of proportion of patients that make various levels of drug collections and proportion among them that consume drugs at different points of time during the course of treatment. In all, 816 tuberculosis patients aged 5 years and above residing in Bangalore city were admitted to the study. They were randomly divided into 6 groups at the time of inclusion into the study, for examination of urine samples for the presence of INH and PAS. One surprise urine sample was collected from each patient at the pre determined time after the drug collection. The samples of urine were collected from one group at first month, another at second month, third at fourth month, fourth at sixth month, fifth at ninth month and sixth at twelfth month of treatment. Urine samples were collected within 33 days of drug collection for the month because the drugs were supplied at a time for the said period. Urine specimens were examined for the presence of drugs or their metabolites. For INH, NM test & acetyl INH test and for PAS, ferriechloride and case test were performed. The drug collection was judged on the basis of treatment record and its consumption on the basis of results of urine examination.

Of the total patients included in the study, 54% made 10 or more drug collections over a period of 15 months. The initial radiological or bacteriological status or severity of disease did not influence the drug collection; however smaller proportion of old persons in both sexes collected the drugs for 10 months or more. Urine specimens of 71% of patients who had collected drugs were positive for INH on any one day. Bacteriological quiescence was obtained among the 82% INH sensitive patients who had made 10 or more collections. The above findings suggest that the patients who collect drugs also consume with fair amount of regularity and achieve a high degree of bacteriological quiescence.

The relative merits of a fully supervised twice weekly regimen of Streptomycin and INH (SHtW) and an unsupervised daily regimen of INH and Thioacetazone (TH) in routine programme conditions in an urban area are compared in terms of acceptability and response to treatment at one year. Of the 474 newly diagnosed sputum positive cases at Lady Willingdon TB Demonstration & Training Centre, Bangalore during 1968-69, 134 were allocated to SHtW regimen and 189 to TH regimen. All others who were unwilling to take the allocated regimen or were excretors of bacilli resistant to INH and or SM were analysed as a subsidiary group.

About 25% of the patients allocated to SHtW regimen expressed unwillingness to start treatment on account of unsuitability of working hours and or distance. Refusal to TH regimen was negligible (5%). As regards drug acceptability after start of treatment, while the duration of treatment taken was similar for both the regimens, the level of drug intake achieved by the SHtW patients was lower compared with TH patients i.e., 31.3% of the SHtW patients and 56.1% of TH patients took more than 80% of treatment. If concealed irregularity among TH patients is taken into consideration, it is likely that the drug intake among TH patients would be similar to the drug intake among SHtW patients. The acceptability was therefore almost similar among SHtW and TH patients. Very low level (28%) of treatment completion was achieved by SHtW patients. With TH regimen, 46% had made 10 or more monthly collections during 12 months. Among the SHtW patients there was greater irregularity in the later months which was not apparent among TH patients. However, the favourable response among patients on SHtW and on TH regimen was 68% and 60% respectively. Deaths among SHtW patients were 4%, 13.5% among TH patients, the difference being statistically significant. The response was directly related to the level of drug collection or supervised consumption. The large proportion of the patients who stopped treatment prematurely, continued to remain positive with drug sensitive organisms, if initially they were so. In the subsidiary group there were 62 patients who were excretors of drug resistant organisms. They were treated with drugs to which their organisms were resistant and nearly 30% of these patients had negative culture at the end of one year.

It is concluded that (i) SHtW regimen was superior to TH as it prevented deaths and showed better bacteriological conversion among patients with level 3 & 4 of treatment and (ii) treatment organization is the most important factor in obtaining better results in routine chemotherapy with available drug regimens.

The paper presents some aspects of domiciliary management of tuberculosis patients in a District Tuberculosis Programme (DTP) viz., the interval between diagnosis and initiation of treatment, regularity in collection of drugs, role of motivation of patients for collection of drugs and pattern of defaulter retrieval actions by health institutions. The treatment cards of 3089 patients of pulmonary tuberculosis belonging to Bangalore DTP diagnosed during 1964 were analysed. The cohort of 2479 patients was divided into 3 groups according to the place of treatment, viz., (i) those treated at District Tuberculosis Centre (DTC) where better trained staff motivated tuberculosis patients & took defaulter actions (ii) the Urban Peripheral Health Institutions (UPHIs) where motivation and defaulter actions were taken by specialised staff and (iii) rural PHIs where non- specialised general health workers along with general duties did motivation and took defaulter actions.

The study has shown that in the entire district about 94% of patients were put on treatment within 10 days of diagnosis. In rural PHIs, among 14.5% of patients the treatment was started after 10 days of diagnosis. For the 149 initial defaulter patients, actions were taken only for 39% of the patients, lowest being in rural PHIs (10.8%). The defaulter actions for 69% were taken in time, more promptly by DTC staff for DTC & UPHI i.e. 71.5%, whereas rural PHIs were poor in this respect and only 37.5% of the actions were taken on time. Sputum positive cases collected drugs more often than sputum negative and also more patients collected drugs on due dates at DTC in comparison with PHIs. Both the differences were statistically significant.

About one third of the lost patients came from those who made the first default. About 55-63% and 75-82% of this group defaulted by the second and third collections respectively. Defaulter actions were not taken by rural PHIs for 66.7 to 72.5% defaults, while DTC staff had not taken defaulter action for about 20% of defaulters and 67.8% of such actions were prompt in DTC, whereas it was only 19.3% in rural PHIs.

Case-finding and treatment activities in the National Tuberculosis Programme (NTP) are mainly dependent on self reporting chest symptomatics. It was of main interest to find out that patients who report to the health institutions due to suffering remain symptom free later on or there is a recurrence of symptoms among sputum positive patients during 14 intervening years i.e., from 1961-1974. The follow up was carried out in 1974, in spite of such a long interval, information from 20.3% of the patients including dead was collected.

At the time of diagnosis in 1961 at LWC, 91.6% of patients had symptoms. During the total period from 1961 to the time of interview 7-16% had recurrence during each of the intervening years. Recall was possible because majority of them have taken action. But at the time of interview 29.7% reported to be having symptoms, of them nearly half had symptoms for more than 6 months. It is likely that during preceding years also there might have been a higher percentage of symptoms but the recall was poor. Considering the total duration of symptoms, 52% had experienced symptoms for more than 6 months.

The effect of initial motivation on pulmonary tuberculosis patients in terms of regularity of drug collection and pattern of default for three months was studied at Lady Willingdon Tuberculosis Demonstration & Training Centre (LWTDTC), by adopting three different schedules of motivation (i) motivation as per routine procedures of District Tuberculosis Programme (ii) issue of simple brief instructions only and (iii) motivation with reduced contents and with change in sequence of points. The patients without history of previous treatment were randomly allocated to these 3 groups. All the three groups were similar in respect of age and sex composition, sputum status, extent of disease, duration of symptoms, education level and the distance that the patient had to travel for collection of drugs. However, there were more housewives in Group II.

The findings of the investigations were: Of the 139 patients in Group I, 49.6%, of the 126 in Group II, 46.7% and of the 142 in Group III, 47.2%, had made all the three collections. On the whole different schedules of motivation did not significantly affect the behaviour of the patients in making all the three monthly collections. However, patients in Group II with simple instructions were more regular and made less number of defaults. There was also a suggestion that sputum negative patients required more than mere instructions. The best response in such cases was in Group III, wherein motivation was neither very elaborate nor very brief and in which sequence of points was so arranged that stress on important points was laid early enough to remain within the recalling memory of the patients.

A controlled study was conducted at Lady Willingdon Tuberculosis Demonstration and Training Centre (LWTDTC), Bangalore among 250 patients randomly selected urban patients of pulmonary tuberculosis of whom 155 were in the 'motivation' group and 95 were in the 'control' group. In the motivation group, patients were interviewed by National Tuberculosis Institute health visitor and motivated by LWC staff; a month of drugs (TH) were given. Within 3 days of initiation of treatment they were motivated along with their household members during home visit by NTI staff every month for a period of three months. Control group patients were motivated at the clinic as per the programme guidelines.

In the motivation group, 59.9% of patients had made all the three collections during the first three months compared to 27.8% in the 'control' group. During the remaining months also the drug collection was 47% and 35.6% respectively. The drug collection pattern among the patients in the motivation group was found to be better than among the patients in control group who did not have the benefit of home visiting. Sputum conversion was also found accordingly better among the motivation group as compared to control group.

An operational study to understand the influence of training of Peripheral Health Institution (PHI) Medical Officers (MOs) at District Tuberculosis Centre (DTC) in comparison to on the job training in their own PHIs in carrying out case-finding activity, was carried out in districts of Mysore, Mandya, Bellary and Hassan of Karnataka State in 1980 81. These districts are now being referred as I, II, III and IV respectively. From each district, 20 Microscopy Centres (MCs) were selected. All the selected MCs of the above four districts after stratified random allocation were divided into two groups, i.e., A & B. The MOs of Group A of each district were trained for 2 days in Case-finding activity at the respective DTCs by District Tuberculosis Officer and District Health Officer, while the MOs of Group B were given on the job training as per manual. In all, 108 MOs: 52 in Group A and 56 in Group B were under study. The performance of each PHI was monitored in terms of number of new Out patient Attendance, selection of chest symptomatics for sputum examination and number of smear positive cases detected, for a period of 12 months after the training.

At the end of one year it was observed that there was a boosting in case detection in districts I and III, no effect in district II and negative effect in district IV. The efficiency in districts I and III was higher by methodology A. It was enhanced from 7.6% pre-training efficiency to 16.7% after training and in district III, 18% to 65.8%. The enhancement with methodology B was from 5.5% to 8.1% in district I and from 19.1% to 43.2% in district III. The average increase by amalgamating all the four districts was from 8.5% to 17.8% with methodology A and from 9.7% to 12.3% with methodology B. There was a suggestion of better improvement through methodology A, which, however, did not attain statistical significance.

In the districts under study, Case-finding was at a very low ebb. Systematic training by either of the two methodologies, did improve the activity in I and II i.e., in two of the four districts. In districts II and IV other variables might also have been at work e.g., training variables of knowledge, skill and communication abilities of DTOs who were trainers could have influenced the outcome.

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.

During last two decades, the health care delivery system has undergone several changes. The implementation of the concept of Primary Health Care and of the Multi Purpose Health Workers (MPWs) Scheme can be utilised to improve both Case-finding and case holding activities of the District Tuberculosis Programme. A study was undertaken by National Tuberculosis Institute (NTI) to obtain a profile of work of MPWs, observe their work on time and motion analogy and to ascertain output of tuberculosis services and other works. The study was carried out in a contiguous area of 6 PHCs of a district. The work of 16 MPWs was observed by a Social Investigator of NTI who accompanied them during a day's work; one month period was selected as reference period. 160 MPWs were asked to give details of their activities through self administered questionnaire and records of the six PHCs were studied in terms of output of the services.

On an average a MPW travelled 15 kms, spent 4 hours in the village, visited 70 homes; Of them, 25% were locked. The time spent on different activities during home visits were 34% for minor ailments, 26% on malaria, 12% on family welfare and 11% on tuberculosis. Profile of activities carried out on a randomised day were, 77.5% did not perform any anti tuberculosis activities. Those who did anti tuberculosis work identified 4 symptomatics, prepared two smears and followed up 13 patients. The highest performance was with regard to Family Welfare (68%) and treatment of ailments (64%). As per the opinion of MPWs tuberculosis was 7th, 8th and 9th rank, malaria was lst and 3rd and family welfare was 1st and 2nd. As per the actual output of work from the PHC records, anti malaria (70%) and minor treatment had the maximum performance and family welfare averaged, as only 35 of the eligible couples were registered. Findings suggest that tuberculosis was given lower priority in terms of all the three points i.e., actual performance, profile of work of MPW, actual day's work of MPW and diverse health activities among rural population. Integration of tuberculosis at periphery needs more important considerations.

Feasibility of introducing limited active case-finding in tuberculosis involving Multi-purpose Health Workers (HWs) to supplement the existing methodology of detecting the cases through chest symptomatics attending Peripheral Health Institutions (PHIs) on their own, was studied earlier with encouraging results. The present study was undertaken to understand the existing working system of HWs and within that the priority areas of input which may lead to better case yield.

The study revealed that the population available at any beat schedule of HWs was about 42% of the eligible population of age 20 years and above. Only 60-75% of the field days were utilized for routine multi-purpose duties. Of the total area, 25% to 40% remained uncovered. The effective tuberculosis work was done only on 5% of the beat schedule days and the work was not uniformly spread throughout the month. Even so, the contribution by HWs was twice the number of cases diagnosed at PHIs under study in one year. Had the HWs covered the entire area of their beat schedule, 80 against 26 cases would have been diagnosed. Moreover, there is possibility of detecting more cases among the elderly patients who normally do not attend their area health centres. However, the success depends upon meticulous supervision and regular flow of supplies.

In a study of feasibility of treatment of smear positive patients with Short Course Chemotherapy (SCC) regimens under District TB Programme (DTP) conditions in a city, adverse drug reactions in terms of frequency of episodes, incidence in the cohort of patients, time of occurrence, major adverse reactions requiring modification of chemotherapy and or symptomatic treatment, were investigated.

Patients were allocated to one of the two 8 month SCC regimens i.e., Regimen 'A' 1 SHRZ/6TH, Regimen 'B' 2SHR/6TH. Overall incidence of adverse drug reaction in cohort of 265 patients was 37%, 9% of which were considered as major in nature. 34 episodes of such reactions resulted in modification of chemotherapy in 15 patients during intensive phase. Though gastro intestinal symptoms were predominant, cutaneous toxicity was the pre eminent cause of modification of regimen. No case of exfoliative dermatitis occurred. A total of 333 episodes of adverse drug reactions of minor nature occurred; 50% being gastro intestinal symptoms followed by cutaneous symptoms. More than 70% of all adverse drug reactions of intensive phase occurred in the first half of the period. There was no significant difference between the two regimens in the incidence of adverse drug reactions of either major or minor in nature.

SCC is being implemented in a phased manner in the DTP. Before introducing SCC in large number of districts, it would be prudent to find out whether SCC would be acceptable to both doctor and patient in terms of adverse drug reactions.
It can, therefore, be concluded that adverse reactions may not be a major constraint for inclusion of SCC under DTP for treating sputum positive tuberculosis patients provided that additional resources and man power are allocated to the DTCs to manage patients in the centre and extend effective guidance to staff working in peripheral centres.

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.

A study was conducted to augment Case-finding in the programme by increasing case yield through repeated sputum examinations by collecting 2-3 samples on the same day. The study was conducted in nine Peripheral Health Institutions (PHIs) of Bangalore district. They were all Microscopy Centres and were drawn on the basis of random allocation. A Health Visitor (HV), Laboratory Technician and Laboratory Attendants of National TB Institute (NTI) were posted at the PHIs during the entire study period. After collection of first sputum sample from the eligible chest symptomatics, 2nd, 3rd or 4th samples were collected at an interval of half an hour from those whose first specimen was negative. Separate smears were prepared from all the specimens for examination at NTI. The duration of the study was nine months.

From among 4233 total new outpatients, 458 chest symptomatics were identified. Of them, 451 gave the first specimen, 416 the second specimen and 379 and 332 the 3rd and 4th specimen respectively. There were a total of 25 smear positive cases; 18 were detected by the first specimen, 3 were added by second and the remaining 4 by the 4th specimen. Of the 451 chest symptomatics, 185 were selected by the PHI Medical Officers (MOs) and 266 were picked up by the NTI HVs from the remaining outpatients. Of the 25 cases detected, 10 came from the chest symptomatics selected by the MOs and 15 came from those selected by the NTI HV. The study has shown the feasibility of collecting multiple specimens of sputum from each symptomatic on the same day. A loss of 60% cases was due to casual symptom questioning by the MOs. It was further observed that the intensity of the physical suffering has influenced the behaviour of patients towards action taking. The sputum positivity rate was 5.5%

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.

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.

Under the District Tuberculosis Programme, the key personnel at the District Tuberculosis Centre are expected to supervise the Peripheral Health Institutions (PHIs) periodically in order to assess and improve the programme activities. A supervision form is used for the purpose of recording the observations made during supervisory visits. This procedure is subjective and does not offer an objective assessment. In this paper, an objective scoring method has been described for supervision of PHI laboratories. The total score suggested is 200 which is apportioned as follows: cleanliness-15, registration & recording-35, sputum collection-10, smear preparation-30, staining-35, microscopy-35, and maintenance of microscope-40. Each category in turn is subdivided according to specific task performed. Minimum satisfactory score is 75% for each topic individually. High level of efficiency is thus recommended, as microscopy is the mainstay in casefinding of tuberculosis. A similar scoring procedure can also be used at the State TB Centre for the purpose of supervising the DTCs. However, this is only a quality control procedure and does not reflect the quantum of work.

This paper highlights some of the Technical, Economical and Operational problems encountered in 1955 60 when the National Tuberculosis Programme was being evolved wherein considerable importance was laid on diagnosis of patients using mass miniature radiography. Technological imperfections seen were: 1) High breakdown rates of X-ray units 2) Though power supply was available, the quality of powerline was such that X-ray could not work satisfactorily in 75% of them. Moreover, running cost of X-ray unit when using petrol generator was very high. This can be reduced by connecting the unit to power supply. Reduced sensitivity and specificity of the X-ray is another operational deficiency. The number of suspects diagnosed was 7 times the actual number of cases and probably 60% of cases were being missed also.

In order to solve these problems, the suggestions given were 1) X-ray equipment capable of working from low capacity powerlines without loss in standard of performance is desirable. 2) Flouroscopic image intensifiers using solid state panels which are easy to operate and maintain can probably improve the reliability of flouroscopic examinations without increasing the radiation dose. 3) Electronic contrast enhancement of films are possible and this could improve the diagnostic reliability. Research is needed to improve contrast perceptibility without increase in radiation.

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.

The present definition of the objectives of the National Tuberculosis Programme is too vague. A proper definition of the objectives, both longterm and intermediate, is needed. It should clearly state the index to be used for measurement of the problem and the expected values of this index at specific points of time. Another serious problem in assessment is to find out how much of the observed problem reduction is due to the impact of the programme and how much due to (or in spite of) the natural trend (downward or upward). Repeated surveys cannot provide this information and keeping of control groups is not feasible. Epidemetric models help in choosing the index for measuring the problem and fixing intermediate and long term objectives in terms of this index. They also help to take the natural trend into account, while assessing the programme.

Prevalence of infection is the least sensitive index. Prevalence of disease and incidence of infection may lead to over optimism. Incidence of disease is most suitable but difficult to get in developing countries. Hence, prevalence of infection or disease has to be chosen. Difficulties of the former are interference by BCG vaccination and non- specific sensitivity. The use of BCG induration to estimate prevalence of infection has some advantages and it is worthwhile to investigate further this possibility. Using epidemetric models, two methods of assessment of effectiveness are suggested. One to carry out prevalence surveys but need not be attempted unless programme efficiency has been quite high for at least 10 years. The other is the assessment of efficiency of the programme which can be easily carried out.

BCG vaccination (prevention) and Case-finding followed by treatment (cure) are two universally accepted methods for controlling tuberculosis. BCG trials in selected populations have provided some information on the protective value of BCG, generally over short periods of time (below 20 years) and mainly among younger populations. Efficacy of different drug regimens for treatment of tuberculosis are well established and a number of studies on the effectiveness of different types of treatment programmes on the patient population are available. However, the manner in which BCG and treatment affect the four epidemiological indices of prevalence & incidence of infection and prevalence & incidence of disease in the community, over a period of time, has not been reported in detail.

This paper describes a simple set of models which can be used to predict the trend from these indices under different types of TB programmes (including no programme) which can be depicted as a combination of 5 programme parameters. How these models can be used for planning and assessment of programmes have been demonstrated by some examples. The trend in the incidence of disease obtained from this model is similar to that reported by Waaler et al in 1974. Unlike earlier models, the present model starts with cases and the calculations involved are simple enough to be handled by calculators and computer facilities are not necessary.

The results of the tuberculosis prevalence surveys carried out in 59 villages of Tumkur district, Karnataka in 196l before launching the District Tuberculosis Control Programme (1964) and the second one, nine years after the introduction of the programme (1973), were compared.

The prevalence rates in both the surveys were similar viz. 0.41 per cent in 1961 and 0.44 per cent in 1973 indicating the poor impact of the programme. The present analysis provides information on long term cumulative performance of the District Tuberculosis Programme (DTP) in diagnosing the cases detected in a prevalence survey at a point of time. Of the 70 cases diagnosed during I survey 12 (17.1%), and of 121 during II survey 20 (16.5%) were diagnosed by the District TB Programme independently over a total period of 19 years. Of the 12 DTP cases of I survey, 1/3rd were diagnosed by DTP within 3 years and the remaining were distributed over a period of 12 years. Similarly, of the 20 cases of II survey, 45% were found within 3 years after the survey and 25% within 3 year periods immediately prior to it. In subsequent years, Case-finding activity about these prevalence cases was erratic and at much lower rate. There was no difference between smear positive and culture positive survey cases with respect to their diagnosis by DTP. The changes brought about in the prevalence of cases from year to year by death, cure, incidence and performance of DTP, in diagnosing such prevalence cases, could not be studied from the available material. Under reporting of the diagnosed cases and missed diagnosis are attributed to be the main factors for poor performance of the DTP.

The current National Tuberculosis Programme (NTP) was evolved by the NTI, Bangalore in 1962 after conducting a series of Epidemiological, Sociological and Operational Studies. The programme is integrated with the General Health Services (GHS). In spite of its sound conceptual and structural foundation, the programme performance was below expectation. Government of India had evaluated the reasons of low performance through a study group constituted by Indian Council of Medical Research (ICMR), in 1975 but the programme did not improve either due to non-implementation of the recommendations of the ICMR committee or they were not effective. The Institute of Communication, Operations Research And Community Involvement (ICORCI), an independent agency was asked by the Government of India to have an in depth evaluation of NTP. The terms of reference for this evaluation were to review the Objectives, Implementations & Expectations of the NTP along with various factors responsible for short fall and give recommendations to improve its performance. The evaluation was generally through routine quarterly reports received by NTI and information collected on the spot during the actual field visits made by the multi disciplinary expert group of ICORCI. A total of five states were selected. From among the total districts of these states, nine districts were picked up by composite index methodology and from each district, two PHCs were selected on the basis of performance.

OBSERVATIONS: About 15% of the districts are still without DTP. There was an increase of X-ray examinations per DTP by 1.4 times from 1981 to 1987, the percentage contribution of PHIs to new sputum examination increased from 34 in 1981 to 72 in 1987 leading to 1.44 increase in diagnosis of cases. Sputum positivity rate decreased from 13.6 in 1978 to 6.7 in 1987. The percentage contribution by PHI in case detection increased from 35 in 1981 to 40 in 1987. Number of suspect cases increased 1.8 times in 1987. There were wide variations in the X-ray positivity rates between the states, throwing doubt about the quality of X-ray reading. Suspect cases form 78% of all types of Tuberculosis cases diagnosed in 1987. This was much higher than the expected 43% according to NTI studies and indicates considerable over-diagnosis of suspect cases under NTP. From 1986 only 27% of Tuberculosis patients had made 12 or more monthly collections of Anti-TB drugs. It is a matter of serious concern and the reasons have to be investigated. In 1987, only 27% of the DTPs had a full DTC team and only 65% had DTC vehicle. This indicates deterioration in supervision. The other factors like lack of NTI training of DTC key personnel, Communication, Health Education, Community Involvement and contradictory instructions from the DTP manuals, central & state guidelines etc., influence the performance of the programme adversely. Most of the medical officers of the PHC wanted integration to continue. They only wanted that the additional inputs may be provided.

RECOMMENDATIONS: Most of the recommendations given are for improvement of the system which is essential for the success of NTP. Some specific recommendations for NTP are also given. Integration of health programme may be effected at district and state levels in a phased manner. It would be desirable to have integration with the central level also with one Director General of Health Services monitoring all programmes in one region of the country. A common budget for all health programmes/activities will solve many of the problems and will be in accordance with the principles of integration. Develop a proper two way referral system covering all programmes and activities. Orientation training may be given to all officers regarding budgeting, administration, monitoring and technical aspects. A vehicle pool may be maintained at the district level under the control of DCMO and monitored by CMO. The Central Government may supply microscopes of good quality instead of providing funds. Working facilities at DTCs and PHCs may be reviewed periodically to ensure good working conditions for efficient functioning. Local level recruitments may be made for Health Assistants and Health Workers. A careful review of the reasons for indiscipline, particularly at PHC level may be made before the situation deteriorates further. The entire staff structure and recruitment may be reviewed to provide promotional opportunities to all categories of staff. All suspect cases may be put under observation as per WHO recommendations instead of straight away giving them anti TB treatment for long periods. Sputum collection by Health Workers may be re introduced. Reasons for deviation from DTP manuals may be investigated, particularly in STCs which are required to train the staff as well as supervise the DTPs. Short Course Chemotherapy may be extended to all DTPs in the country. Steps may be taken to ensure that follow up examinations are carried out regularly and the results recorded on treatment cards. A drug testing laboratory may be set up in each state as proposed for the VIII plan. Procurement of drugs may be made only from reputed firms. In order to have a reliable monitoring, sample checks have to be carried out to ensure the validity of the records and reports. Targets for NTP may be withdrawn, particularly those regarding case detection to avoid over diagnosis. A monitoring and evaluation cell headed by a statistician may be created under the CMO to cater the needs of all programmes. The recommendations made for improvement may be introduced only after proper testing by field trials following operations research methodology. Changes introduced on adhoc basis may create more problems than are solved.

The review of the National Tuberculosis Programme (NTP) of India was carried out in 1992 by a team representing the Government of India (GOI), the World Health Organization and the Swedish International Development Agency (SIDA). The purpose of the review was to evaluate present policies and practices, analyse their adequacy to reduce the tuberculosis problem and recommend organizational, technical and administrative measures to improve the programme. The review team analysed the available documents including epidemiological data and reports of previous evaluations of the programme, discussed with officers of major institutions involved in disease control and in training, and made field visits in three States (Gujarat, Uttar Pradesh and Tamil Nadu) to assess the programme at the State, District and Peripheral levels. The National Tuberculosis Programme (NTP) was formulated in 1962 with major objectives of finding cases among the self reporting chest symptomatics, providing effective treatment near their homes, giving priority to smear positive patients and providing free diagnosis and treatment facilities. Human and financial resources are provided by Govt. of India and the States.

Situation Analysis: The constraints and shortcomings observed in the programme are giving low priority to NTP in allocation of funds and political commitment, wide gap between expectations and achievements, no change in the trend of tuberculosis, and threat of HIV infection aggravating the problem. The programme is integrated with General Health Services (GHS); however, the population growth and the proliferation of public health services has made the districts unwieldy for effective supervision by a single District TB Centre. The present management structure at national level requires strengthening, reorganisation and training at the state level. Improvement in the methods and management of Case-finding is needed as there is undue dependence on X-ray and clinical examinations. Standards of carrying out microscopy are low and laboratories are not well equipped. The treatment regimens are too many and standard regimens are ineffective and of long duration. Short Court Chemotherapy (SCC) implementation is very slow. The drug supplies are occasionally interrupted by lack of timely funding and of buffer stock. The Health Workers (HWs) are not utilised to prevent defaulting and to achieve treatment completion. The cure rate as the main indicator of programme efficiency is not available due to lack of followup examinations. The recording and reporting is complex and seriously deficient. Health infrastructure in metropolitan and urban areas is inadequate. The findings of previous programme evaluations have not been applied nor has adequate use of the results of operations research for the improvement of programme has been made.

However, the basic strengths of the India's TB Programme are considerable. The objectives on which the programme was established thirty years ago integration, decentralization, free services, priority to treatment of infectious cases are still valid today. They provide a sound revitalization of the national TB strategy. An updated and strengthened programme can expect to reduce the magnitude of the problem by about half in each 10-15 years. This will require political commitment, initial investment and strong leadership.

RECOMMENDATIONS Formulation of an executive task force at apex level, upgrading the central tuberculosis control unit in the Directorate to enhance the efficiency and effectiveness of the NTP. Quality of sputum examination to be improved by multiple smear examination, ensuring quality of microscope, training and quality control. Giving priority to smear positive cases, adopting SCC regimens, establishing criteria of treatment completion and cure. Ensuring an uninterrupted supply of drugs of good quality, revise the registration and notification system of NTP and giving due emphasis to cohort analysis. Policy of decentralization of treatment services closer to the community. Strengthening of administrative structure at the sub district level by providing Medical Officer, Treatment Organizer and Laboratory Supervisor to facilitate decentralization of supervision and tuberculosis programme. Development of training capabilities by utilizing state training facilities, medical colleges, public health institutes and voluntary agencies. In the light of the recommendations and concerns expressed by the Central Health Council, a revised strategy for NTP has been implemented in some selected areas of the country with the World Bank assistance. Operations Research must be carried out as an integral part of the revised NTP to evaluate performance and obtain baseline epidemiological information to measure reduction in the risk of infection.

Potentials of Case-finding and case holding through operational studies conducted by National TB Institute (NTI) and elsewhere have been quantified. The potential of case holding is not satisfactory and needs revision of strategy to obtain better treatment completion. The present report reviews the programme in its ability to meet the potential in Case-finding and treatment (CFT), and bring about a reduction in the problem. Outcome at the current levels of efficiency of activities as well as following hypothetical changes in them, are studied. Further it identifies the areas for carrying out studies on structural changes to be introduced in the programme, so as to obtain higher results in terms of epidemiological gains.

A set of hypothesis which have been used in constructing the model are based on the currently available information on the epidemiology of tuberculosis and performance of the programme. An average Indian district as per 1991 census is considered to have: (a) a population of 1.9 million; (b) 6460 smear and culture positive patients (prevalence rate of 4 per thousand) in all at any time; (b1) 2584 of the prevalence cases are smear positive; (b2) 2196 newly occurring cases every year (annual incidence of 34% of prevalence); (b3) 879 of the b1 being the annual incidence of smear positive cases; (c) 3230 of the prevalence cases who present themselves for diagnosis (50% of b); (d) 2584 can be diagnosed if all the available PHIs participate in the programme as per the manual. This is called Case-finding potential (CFP). The Case-finding Efficiency (CFE) is expressed as a proportion of the cases being diagnosed out of the CFP by a DTP. The current CFE is calculated at 36% of CFP, as 936 cases are being diagnosed (as per the periodic DTP reports prepared by NTI). The result of treatment at the current treatment efficiency TE1 for the cases on Standard Regimen (SR) (Compliance 45% at level 4) is 50%, TE2 for those on SCC (compliance 56% at level 4) is 79%, TE3 WHO recommended 85% cure rate (compliance level and regimen not stated). DTP efficiency (DTPE) is the proportion of cases which could be cured with the respective TE, calculated out of the CFP. DTPE under SR l8%, under SCC is 28.44%.

Epidemiological impact is calculated while taking into consideration the natural dynamics of tuberculosis without intervention and the dynamics of the programme where the cases are diagnosed and treated with SR under the current efficiency, the same is computed for the patients treated with SCC with present level of efficiency. The cure and death rates among treated cases is added to the natural cure without a programme (Case fatality rate of 14% and cure rate of 20% is equal to 34% of incidence rate which keeps the prevalence rate unchanged in natural dynamics). With all the cases treated with SR, programme appears to show a problem reduction of 4.6% annually and with SCC of 6.5%. The latter shows a relative benefit of 41% over the former besides causing prevention of deaths at the end of treatment.

 Addl decline alternative in question
------------------------------------------------- X 100
               Relative Benefit

Decline with 36% CFE & on SR with 45% compliance level IV

Intervention alternatives with fixed CFE by raising compliance level 4 from 45% to two higher levels to 70% and 90%, are studied. They give an additional decline of 2.1% and 3.0% respectively. While raising compliance level 4 of patients on SCC from current 56% to 70% and 90%, the additional decline is marginal (2.6% & 2.9%). At the same time raising the compliance to the level 4 is not only operationally a difficult task but does not commensurate with epidemiological gains also.

Intervention Alternative Recommended by WHO : To further epidemiological gains, it is obvious that CFE also needs to be raised. The WHO has recommended the target of CFE as 70% of all smear positive cases, TE as 85%. For this alternative, DTPE is 59.5%; epidemiological gain 13.7%, additional decline 9.5% on SR with 45% compliance level and relative benefit of 206.5%. This alternative appears to be feasible provided coverage of implementation of PHIs and treatment compliance are high and use of SCC regimens in the programme are ensuring for such achievements.

Operational Alternatives on Improving Treatment Compliance To improve treatment compliance level it is essential that patients are treated free, get supply of drugs regularly as near to their homes as possible and may be given supervised treatment specially in the intensive phase. Recent development of infrastructure makes it possible to consider alternatives to ensure the supply of drugs close to patients residence. Some of the health functionaries below the level of PHIs are: Health Worker (HW) Anganwadi Worker, Dai (Traditional Birth Attender), Community Health Volunteers (CHV) and Private Practitioner. The possibility of involving them in some or other manner in tuberculosis treatment activity under a programme may be explored.

There is no generally acceptable definition for developing countries. On account of multiple demands of varying urgency on small resources, public health often receives lower priority than it deserves. To change the equilibrium between man and bacilli in the direction of positive health it would be necessary to invest resources on many key factors. Control of tuberculosis can only be a part of the effort to achieve the positive health. It is also now known that undue importance to quick conversion of sputum or early return of patients to work, need not be given. But the objective of TB programme for developing countries should be i) not to neglect service to actual sufferers and ii) to apply specific control measures in harmony with measures aiming at the overall improvement of socio economic conditions.

For developing countries domiciliary chemotherapy is the treatment of choice. Applying chemotherapy on a long term basis poses many problems, the main being the fall out of patients from treatment. The key factors are: a practical and economically feasible Case-finding and treatment programme, an adequate supply of anti TB drugs and effective executive cum supervisory organization. The District Tuberculosis Programme for a population of 1-1.5 million in each district, comprises one specialised district TB Centre which makes use of the area general health services for tuberculosis Case-finding and treatment. Several stages of development are envisaged and a start can be made from any stage, according to the facilities already available. The emphasis is on providing treatment for the patients nearest to their homes, along with effective supervision exercised by general health services staff under the guidance of the district centre. The choice of a drug regimen in the programme will depend upon efficacy of the regimen, availability of drugs, average cost of treatment, suitability for self administration and acceptability by patients/organisation. INH+PAS daily or supervised streptomycin containing intermittent regimen for smear positive cases, INH alone daily for sputum negative appear to be the regimens of choice for developing countries. It is unfortunate that a powerful regimen like S + H + PAS is very expensive and less acceptable. Thus a planned and systematic approach is needed to deal with the problem of TB. For running an organised and coordinated tuberculosis control programme, the national character of the Campaign should be recognised right at the start and maintained till the objective has been achieved.

It has been shown that most of the infectious tuberculosis cases in a rural community in south India are at least conscious of symptoms of the disease; about three fourths of them are worried about their symptoms and about half are seeking relief at rural medical institutions. It is well known that the existing facilities deal with only a very small fraction of even those patients who are actively seeking treatment. India's National Tuberculosis Programme has been designed to mobilise the existing resources in order to offer suitable diagnostic and treatment services to those who already have felt - need. India's health administrators have to initiate suitable administrative and organizational reorientation of the existing medical and health services to satisfy this already existing felt needs. The more provision of such services could very well motivate the remaining tuberculosis patients to seek the help from the medical institutions. This motivational force is expected to get reinforced as a result of progress in the field of education, mass communication, transport and industrial and agricultural production. Simultaneously, progress in the social and economic plans will offer the needed resources for strengthening the existing health services in terms of personnel, funds, equipments and supplies. Further more, social and economic development, by increasing awareness of the population, will ensure a more effective utilization of the existing services. Thus, social and economic growth will not only help in the development of an epidemiologically effective tuberculosis control programme, but the very rise in the standard of living itself might make a significant impact in controlling the disease in the country.

The Health Care Delivery System (HCDS) consists of the governmental (public) and non-governmental (private) health agencies and the facilities they provide for one or more of the three main aspects of comprehensive health care viz., curative, preventive and promotive. The delivery of comprehensive health care in a country like India poses many problems. An adequate network of organisation, particularly governmental, has to be built up. This has to be primarily directed towards delivery of health care in the rural areas with considerable emphasis on preventive and promotive health. Such an organisational set up has to be manned by a large army of personnel with varying types and levels of basic professional education. At present both the know how for practical application of professional knowledge under varying conditions and proper attitude for the same are often inadequate among the health personnel. These can be improved and maintained only on the basis of a long term plan for job training. Permanent facilities should be available so that training of new recruits and staff on promotion/transfer can be taken care of regularly and systematically. Also, refresher courses have to be undertaken regularly to keep the staff abreast of the developments in delivery of health care. At present juncture, Multi Purpose Worker (MPW), community level workers and health assistants in the public sector of HCDS, also require the training.

To make such training more purposeful, it must be emphasised that planning for training has to come well ahead so that implementation of any programme is not unduly delayed due to absence or shortage of properly trained health workers. To illustrate this, the training requirements of the National Tuberculosis Programme (NTP) which is integrated with general health services have been dealt below: Governmental Agency: i)Programme workers who attend patients and community should be trained by the District TB Centre (DTC) key personnel as in service training or on the job training, ii)Programme supporter PHC doctors in addition to being programme workers, DHO, ADHO, ADHS (TB) etc should undergo orientation course for 8 to 9 working days. iii)Trainer Professors and lecturers of preventive & social medicine, tuberculosis and medicine of medical colleges, trainers of central training institute also undergo orientation course for 8-9 days. iv)Research Worker in research methodology for 4 weeks. v)Programme planners & Decision Makers a)Ministers of Health, Secretaries & Directors of Health both at state and central-levels By periodic meetings, personal discussions, participation in Central Council of Health meetings. b)TB Adviser, TB-Officer By periodic meetings, written communication, attending seminars. Similar estimates have to be made for other components of HCDS. Taking all these into consideration, the number of training institutions/facilities which are required to meet all the training needs can be worked out, keeping in view their proper regional or geographic distribution. The next step would be to organise the education and training of private health workers and health consumers. Adequate information for the detailed planning is not available for these two categories. But, a beginning has to be made as quickly as possible.

This paper describes the need for Health Education Component in the National Tuberculosis Programme (NTP). The potential achievement of the programme activities viz., prevention, Case-finding and treatment has been established by studies conducted by the National Tuberculosis Institute. Corrective measures to achieve the potential would no doubt have to tackle all the three constituents of the programme viz., objectives, activities and resources. However, incorporation of a health education component in the crucial activities of the programme would help, where under achievement is due to the lack of knowledge and proper attitude both on the part of the patient and the health worker. In order to evolve an effective methodology, the goals of the health education component should be synchronised with those of the programme. While the health education aspects in the Case-finding and treatment activities can be incorporated at health institutions and on an individual or group basis, education for the preventive activities has to be on a mass or community basis. While the nucleus of the community education should be on BCG vaccination, the mass media could be utilised for the overall tuberculosis education in the general population. Thus, there is scope for employing a variety of material, methods and media of health education in the NTP.