Sputum microscopy is the main casefinding tool in tuberculosis control programmes. The technique of smear preparation is an important step which needs to be simple for wide applicability. It is often stressed that smear should be prepared from the purulent portions of the sputum as they are likely to have more number of bacilli. It may not be possible for the microscopist/paramedical worker at the periphery to strictly follow this procedure. Hence, a study was conducted to compare the sensitivity of 4 methods of sputum smear preparation viz., direct smear prepared (i) blindly without making any selection of portions of sputum specimen, (ii) from portions of sputum material likely to contain the bacilli, (iii) after mixing up the sputum specimens thoroughly, and (iv) from centrifuged deposit after homogenization of sputum with sodium hydroxide and concentration by centrifugation. Culture was also done for Mycobacterium tuberculosis.

A total of 549 specimens were employed. Positivity rates by four methods were: 79.6% by method (i), 80.3% by method (ii), 80.7% by method (iii) and 77.2% by method (iv). There was no statistically significant difference in the number of positives obtained from different methods. Centrifuged deposit smears proved to be in no way better than the direct smears. The differences in the methods lay only in the classification of positive smear as of a low or high grade.

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.

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.

In 1975 recognising the importance of the TB problem, Govt. of India, Ministry of Health & FW, on suggestion of TB Association of India, requested ICMR to constitute an Assessment Committee who should evaluate the National Tuberculosis Programme (NTP) and submit a report. A committee consisting of five members reviewed the NTP in terms of i) aims & objectives of the programme, ii) implementation and iii) performance at various levels. Its shortcomings and various factors responsible were identified. Recommendations to improve the functioning of NTP in all the aspects were suggested. The country was divided into 5 zones; south, west, centre, north and east. Two District TB Centres (DTCs) from each zone were selected for the study. The data was collected by posting proformas to all the State and Union Territories and by visits of the expert committee members in groups to different regions in the country. The members obtained information from state headquarters, DTC, Primary Health Centre (PHC) and villages.

The committee observed that the general pattern of the District TB Programme (DTP) does not require any change; however, it requires strengthening in many ways. The performance of the DTC and Peripheral Health Institutions (PHIs) was found to be far from satisfactory in terms of Case-finding, case holding and BCG vaccination. Since the implementation and supervision of the programme was the responsibility of the State and which were found to be the weakest components of the programme, it was strongly felt by the committee that the programme should be made a truly national programme by making it centrally sponsored for the next 10 15 years and the centre should exert direct control over the programme instead of being left to the state for administering it. The committee observed that the programme has not been implemented in 57 districts in 15 States especially in Bihar where out of 31 districts only in 3 districts the programme has been implemented. Utmost priority should be given to implement the programme in the remaining districts especially in Bihar. The integration of programme with the General Health Services has not been satisfactory thus leading to poor functioning of Peripheral Health Institutions (PHIs). The poor performance of DTP was mainly due to limited contribution by the PHIs. The other shortfalls observed by the programme were lack of adequate supervision and control by the State TB Officer (STO), District TB Officer (DTO). Most of the centres including DTC were mainly serving the patients of the town in which they were situated. Thus, a large part of the rural area was not covered by the programme. The drug supply was adequate throughout the country except SM & PAS in some states where doctors were fond of using SM for every patient and preferred PAS to Thioacetazone as standard companion drug. There was shortage of MMR films and lab reagents in many of the DTCs. Equipments like MMR, microscopes, and vehicles were out of order for long periods for want of maintenance facilities. It was recommended that the Central Government should have equipment maintenance organisation and should be responsible for supply of the drugs, equipments, films and maintenance of the equipments. The status of the Tuberculosis Adviser should be of the rank of Deputy Director General, State TB Officer that of Deputy Director, Health Services and the DTO that of the DHO/DMO. There should be 5 Regional Centres with a Deputy Director In charge, supervisory staff and adequate funds. The functions of the Regional Centres will be to exercise supervisory control over the programme in the region. BCG vaccination coverage in the eligible population of 0 19 years age was found to be 10%. It was decided to change the strategy of BCG from mass approach to the integrated one i.e., with immunisation programme, for effective coverage. It is desirable to have periodic evaluation of the NTP. Therefore, there should be a permanent evaluation cell at the centre. There should be one TB worker and one microscopist exclusively for tuberculosis work at every PHC. There should be active community participation in the villages. The village headman and teachers should give adequate publicity for sputum examination and regular treatment. The TB workers at all levels should be debarred from private practice and should be given suitable non- practicing allowance. Active involvement of other governmental bodies like ESI, Army Health Services, CGHS, Railways etc., in the tuberculosis control by providing Case-finding and treatment facilities to all their beneficiaries and eligible patients as per the programme recommendation. Of the five State TB Demonstration Centres the work was found satisfactory only in Nagpur. Some training activity was going on there. Lack of political will and all pervading human apathy was visible at all levels. The committee felt that a strong 'political will' to give due priority to the programme was required.

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.