At present most of the districts in India have a TB clinic at the district headquarters, where TB patients are diagnosed and treated. Most of the clinics serve the town population and only a small proportion of the rural population are able to attend the clinics due to long distances. The wide distribution of patients in rural areas will necessitate the provision of extensive anti-tuberculosis services and they should be provided as near to the patients' home as possible. This cannot be achieved by creating large number of specialised services (TB clinics) in the district, as this will not only be beyond the resources but wasteful. As such, provision of anti-tuberculosis services in rural areas can be achieved by integration of the primary health centres and dispensaries. The problems of treatment in rural areas are envisaged as technical, organizational and personnel. Under the technical problems, the choice of anti-microbials is considered. The anti-microbials should be effective, cheap and acceptable to the patients. INH PAS, INH alone or INH Thiacetazone are considered suitable. Streptomycin containing drug regimens are difficult for the health services to deliver them to the patients in rural areas. Even with oral drugs INH + PAS or INH alone, drug regularity are 26.3% and 24.6%. The other technical limitation of treatment is the probability of increase in drug resistance due to the wide application of drug treatment which might be irregular. This has not been considered as enough justification for withholding treatment to the vast majority of patients, as its epidemiological and clinical significance in India are yet to be fully understood. The District TB Programme provides a firm organisational structure on the basis of which improvement can constantly be introduced for smooth functioning, constant supervision, proper orientation training and demonstration of the programme by the District TB Centre if necessary.

The organisational problems listed are: irregularity of drug intake and drug collection; their identification, default at drug collection, intake and remedial action, maintenance of records, check up while on treatment and follow up after completion of treatment. The paper suggests that regular collection could be taken as an index of regular drug intake. Defaulter actions could retrieve about 30% of the defaulters. Check up during treatment as well as follow up after treatment were found to be not acceptable to the patients due to a number of reasons. Training of staff to render services is also one of the biggest hurdles. The remedial measures are stressing tuberculosis as a community problem at the undergraduate and post graduate levels, training of the staff at every level of the programme and arrangement of seminars and group discussions with the administrators and medical personnel.

There is a wide spread prejudice among the staff of health centres that patients invariably prefer injection and it was felt by many health workers that streptomycin containing intermittent regimens would be more acceptable to rural patients. A study was carried out to find out the acceptability and applicability of an intermittent supervised drug regimen containing streptomycin 1 gm and INH 650 mgm once a week in a rural area as well as the regularity with which the rural folk took this treatment. Association between the observed regularity and factors like age, sex etc., was also analysed. 107 rural patients of tuberculosis, diagnosed at 5 taluk hospitals in Ananthapur district of Andhra Pradesh on the basis of sputum examination by direct smear and/or X-ray examination with the help of mobile X-rays, consented to treatment with intermittent regimen mentioned above. About half of them were new patients and the rest were old patients who were mostly regular on an earlier oral regimen. 94 of the above were available for analysis.

The regimen was found quite practicable in the sense that at no centre the study was interrupted or discontinued because of the inability of the health centre staff to give injection. If regularity is expressed as a proportion of patients who at any given time had taken the optimal amount of treatment (no. of injections), then 40 patients (42%) were found regular on the intermittent regimen, 36 patients were classified as lost and the remaining had 3 or less injections due and had not yet had the chance to become lost according to the definition adopted. Thus, the regularity of those accepting the regimen was quite low. There was very steep fall in regularity during the first 10 weeks of treatment, nearly a half of the total cases became irregular during the first 6 weeks. Beyond 4 months of treatment, patients who continued to attend centres regularly for treatment became negligible, thus pointing that injection was not a key variable in the treatment regularity of tuberculosis.

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

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

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

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
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               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.