TB is primarily the problem of human suffering. The author, in 1967, presented some ways of measuring suffering. Eleven thousand, three hundred and fifteen persons from 2,135 rural Bangalore (Karnataka) families were questioned for the presence of TB symptoms two months preceding an interview. Four thousand, six hundred and ninety persons (41.4%) with symptoms were identified. Suffering was measured in terms of death, sick man-days, absence from work and loss of wages, hiring alternative labor, cost of treatment etc. Sick man-days were categorized as completely bed-ridden, partially bed-ridden and ambulatory days. The calculated rough specific mortality of 17.6% compared poorly with the overall crude mortality of 2.2%, without adjustment for age and sex. The overall economic penalty inflicted was about five times more for TB patients compared to other sick persons.

From a review of longitudinal surveys conducted in Singapore and Korea (1975) and in the Philippines (1981-1983), it was shown that the duration of symptoms (suffering man-days), before diagnosis in a fresh case, could be developed into a sociological parameter with cough, the most frequent symptom, being taken as the index symptom. For reliability, information on the duration of cough should be elicited in homes in the presence of the entire family by trained health workers. Specific mortality could also be used as a sociological yardstick. If information on TB deaths cannot be related to the entire community, the yardstick should be applied to patients placed on treatment by NTP. Effective NTPs should be able to bring down specific mortality fairly close to crude mortality. Finally, if the estimate of epidemiological prevalence of the bacteriologically confirmed cases in the community is available, it is desirable to calculate the proportion of the prevalence cases under the current treatment of NTP, from time to time.

The present report gives information on the age, family conditions, severity of the disease and its onset in relation to the beginning of the patient`s unsocial behaviour, length of treatment, reasons for interruption of treatment etc. On the basis of these, the results that might be possible with normal and compulsory treatment are discussed, and attention is drawn to the consideration that would make treatment and isolation desirable.

A modified medico-social survey of Mati village in the area of the Rural Health Training Centre, Sarojini Nagar, Lucknow was carried out during January to October 1967. A total population of 2,544 persons living in 419 families was investigated. One hundred and eighty-six (7.31 %) persons were found to be symptomatics, 70 (37.6 % of symptomatics) X-ray suspects and 21 (30.0% of X-ray suspects) bacillary cases. The most frequent symptom was cough followed by pain in chest, dyspnoea, fever and haemoptysis. Duration of symptoms was more than one month. The prevalence of X-ray suspects among symptomatics increased with advancing age. Social classes III (lower middle), IV (poor) and V (very poor) suffered increasingly more from the disease. Tendency amongst the patients was to attend the nearest health facility for relief of symptoms. Default was common due to ignorance and lack of proper supervision of patients.

To determine the extent and causes of Fall-out (premature abandonment of chemotherapy) and Irregularities (chemotherapy continued with interruption), 1,274 TB cases registered at the domiciliary treatment section of the Chest Department, Medical College, Calcutta, were accepted for study. Among 668 who stopped attending the clinic, 277 (21.74%) fell-out (most fell-out within the first 3 months suggesting that home visits and other efforts for patient recall should be intensified at this time). After quiescence of lesions and stoppage of chemotherapy, 21.28% (of 329 cases) fell-out during a follow-up of 1-7 years, with the trend showing an increase in fall-out with time. The Irregulars who had at least 3 months of treatment (854 cases) were defined as Major and, Minor and Regular cases. Comparative studies of these two groups with regard to several factors revealed that the Irregulars fared much worse than the Regulars except in the group with minimal (extent I) lesions. Suggestions are offered to decrease the above problems.

A study was conducted at the NDTC to study 450 patients who included 225 patients who were non-cooperative in treatment. The patients were interviewed by six students from the Delhi School of Social Work and data on the patients’ socio-economic background, the period of treatment until they became irregular (those who failed to visit the clinic twice or more after repeated attempts at retrieval) or non-cooperative, their diagnosis, status at the time of their irregularity or non-cooperation, and the patients’ reasons for irregularity or non-cooperation, were filled in uniform schedules. The results and the major reasons for the patients’ irregularity and leaving treatment are presented. Measures to minimise patients’ default in treatment are recommended. Some supplementary remarks and suggestions on this study are presented by S.P. Pamra in the report on the 20th National Conference of TB and Chest Diseases Workers, Ahmedabad, India, Feb. 1965, p. 225-230.

The necessity for this study arose due to our desire to learn first hand the reactions and reasons for irregularity and non-cooperation of the party i.e the patients. No doubt health visitors on repeated visits try to find out the main cause of irregularity; yet we felt that since health visitors are known to be a part of this institution, the patients may not tell them the real behind their non-cooperation. We felt that the students of the Delhi school of social work being unconnected with the centre and also by possessing proper attitude for this work would be able to bring out the real reasons.

The study was conducted in 1965-66 to ascertain whether an additional visit by a senior member of the domiciliary service staff at the NDTC, such as a Medical Officer or the Chief Public Health Nurse, could help retrieve defaulting patients, after three visits by the Health Visitor during a period of 2-3 weeks had failed. Of the 786 non-cooperators, 531 were visited by the Chief Public Health Nurse. The results showed that more than half (58%) of the non-cooperators could be retrieved by the senior staff member, while 24% completed the treatment thereafter and, 8% were still continuing. Only partial success was achieved with the remaining 16%. Counting those who did not attend at all (331) and those who did not complete treatment after being called (73), the experiment was successful in nearly half the cases (382 out of 786). Therefore, it is recommended that the health visitors’ attempts to retrieve the defaulters must be supplemented by at least one visit from a senior staff member for maximum effort.

The panel discussion highlighted some basic administrative, organizational, technical and patient factors relevant to the problem of Treatment Default in the TB programme. In urban areas, the proper motivation of the patients, keeping of suitable records, prompt defaulter-action, adequate supply of drugs and the need to provide suitable facilities for patients coming from outside the clinic area, constituted the key administrative and organizational factors affecting treatment default. Regarding technical considerations, there was a need for a more precise definition of a case. It was pointed out that a large proportion of the patients were not really defaulters either because they were not cases of pulmonary TB at all or the patients took treatment from outside the clinic. Also, many so-called defaulters took the treatment after the expiry of the 12 months, while some were resistant to the treatment offered at the time of their first registration. In rural areas, the TB programme could only be strengthened with a concurrent strengthening of the over-all health administration.

To understand the reasons for TB patients’ default in treatment behaviour, data available at the Rajendra Nagar TB Clinic, Lucknow, from patients registered during 1964-66, were analysed. 3,609 (43%) cases out of 8,374 patients proven to have pulmonary TB were given treatment. The particulars and behaviours towards treatment, of these patients, is described. Initial and subsequent defaulters were reminded to resume treatment through: 1) a personal appeal posted to the defaulter (Type 1 action), 2) a local community leader or the head of the office was requested by post to persuade the patient (Type II action), 3) a member of the staff personally contacted the patient (Type III action). Default was not associated with gender, distance or severity of TB. Retrieved patients’ versions for possible causes of default were more reasonable than those who did not come back to treatment. Some suggestions to reduce default are offered.

A two-year follow-up study of treatment default among 193 patients with pulmonary TB, who were receiving domiciliary treatment in a Delhi urban clinic, revealed that the percentage of defaulting (that is, collecting drugs for less than 10 months) fell from 57% to 44% when the duration for calculating drug collection was raised from 12 to 24 months. The propensity to default appeared to be inversely related to the precision of diagnosis and the extent of lesions. While the default rate was 20.2% among those who were initially sputum positive, it was 100% among those sputum negative cases who had only minimal radiological lesions. This study, thus, questions the rationality of assessing the performance of a TB clinic on the basis of the ‘traditional’ definition of a defaulter. It has presented data to make a case for a more precise definition of a defaulter by offering a longer period for calculation of drug collection and by stressing the need for greater precision in diagnosis of cases who are put under treatment.

The study, conducted during 1968-1971, examined reasons for treatment default. More than 50% of the patients (742 out of 1,342) became defaulters in a Rural TB Clinic near Delhi. The defaulters were contacted in three different ways. The findings revealed that males predominated among the defaulters. About two thirds of the defaulters visited the clinics within 2 months but the rest had to be persuaded after a visit to their home. Among the causes of defaults, carelessness on the part of patients and, lack of proper education by the health visitors of the clinic, predominated. In the patients who did not come within 2 months of treatment, a visit by the health visitors was the most effective way to convert them. Communication to them by community representatives did not succeed. This shows that more members of staff (both the health visitors and doctors) are needed in rural clinics.

The study was conducted to determine if homevisiting made any difference in the regularity of drug-taking, in the domiciliary treatment area of the NDTC. All cases of pulmonary TB in this area were included in the study. Every patient’s home was visited once, within one week of starting treatment, to give routine advice, motivate and confirm that the patient was a bonafide resident of the area. Thereafter, the patients were randomly allocated to three groups based on certain criteria. The regularity in drug collection was defined as:

             Drugs collected any period
-------------------------------------------------------       X   100
Drugs which should have been collected

The interim analysis of the data shows that home visiting definitely helps to reduce default and increase the regularity of drug collection. Whether the policy of “Preventive” visiting pays better dividends than retrieving defaulters still remains to be seen.

ut of a total of 400 cases, only 272 cases could be followed up during the last 1 year in Kasturba TB clinic Lucknow. Of these, 112 patients defaulted 210 times during a period ranging from 4 months to 1 year. 82 cases were “lost”. The causes of default and their remedy have been discussed. The implementation of the urban TB control programme in the city of Lucknow is considered essential to minimise this problem.

To examine the problem of default in drug intake, a study of 320 patients with pulmonary TB and who were taking treatment at home from the domiciliary section of the TB Clinic in Indore, (Jan. 1969 - June 1970), was undertaken. Of 320 patients, 182 (56.2%) were defaulters. Sixty-six of these defaulters could not be studied for various reasons. Age and gender did not affect drug default while socio-economic factors such as caste, literacy status, social status and family system proved highly significant to default behaviour. Default was common in the joint family system, perhaps, due to lack of individual care when many members shared a common economy. Many defaults were due to family events, typically, births, deaths and marriages. Other important reasons for default were the patients’ feeling of having got well, toxicity of drug and carelessness, ignorance, financial difficulty and non-availability of drugs in TB Clinic. Suggestions to overcome the default problem include improving the general standard of living, eliminating poverty, illiteracy and backwardness, increasing patients’ awareness of the gravity of the disease and the need to take regular treatment, providing facilities for patients to continue domiciliary treatment under the supervision of the nearest medical center after initial check-up at the District TB Clinic, to avoid a long journey and expenses.

There are a number of potential causes of failure in the treatment of pulmonary TB, but some are unimportant in practice. Criteria of failure are suggested. Default from treatment is the commonest cause of treatment failure. Various remedies are discussed. Common errors are outlined. In many countries, a major educational effort is needed to ensure that all doctors treating TB are aware of potential causes of failure and how they can be avoided. The only drug regimen which should be used are those which have been proved by large scale, controlled trials to give virtually uniform success. Knowledge of these regimens needs to be regularly updated.

A study was conducted in a rural hospital in the Sind area of Pakistan, where the standard treatment was an 18-month course of isoniazid and thiacetazone, combined with PAS for the first three months. All patients were being treated for pulmonary TB although several also had orthopaedic, abdominal and neurological complications. The case notes of each of the 300 patients attending the TB Control Clinic at the hospital over a three-year period were studied. From this group, both attendance and default patterns were assessed. Sixty of these patients attending the clinic at the time of the study (Aug.-Sept. 1977) were individually assessed regarding compliance to the prescribed treatment. Compliant patients were compared with non-compliant ones. The results revealed a default rate of 66 percent and a compliance rate of 53 percent for PAS and 60 percent isoniazid measured by objective pharmacological tests. Suggestions were made for a change from the prescribed out-patient approach, to intermittent dose chemotherapy administered by health care workers in the community.

This study was undertaken to determine the number of patients who started anti-TB treatment at the TB Centre in Addis Ababa, but never completed a full regular course for one year. There were 460 or 6 percent of all the TB patients that were treated for the disease in this period. The reasons for treatment failure were analyzed. Although the commonest cause of default was clinical improvement before completion of therapy, many of the reasons related to the socio-economic situation and cultural background in Ethiopia. Despite defaulting, there was sputum conversion to negative in 85 percent of these cases, which is a good result for unsupervised TB chemotherapy, in a country such as Ethiopia.

A retrospective cohort of 996 TB patients, between Jan. 1986 and Feb. 1987, diagnosed and treated at a rural TB clinic in 24 Parganas District of West Bengal, was analysed with regard to case-holding, treatment completion and failure to achieve a successful result vis-a-vis sputum-positive patients. The overall treatment completion rate was 67% and sputum-conversion among the bacillary cases was 57%. The study revealed that the treatment completion rate in the project area cases, who got home visits and remotivation in the event of a default in drug collection, was no better than that of non-project patients who merely got postal reminders. Treatment compliance rate was significantly better among those below 30 years of age and females when compared with older and male patients. Other study results were comparable to those obtained in a DTC TB clinic in urban conditions.

The report provides an account of the research on patient adherence as it relates to the treatment and prevention of TB. It summarizes the literature on social and behavioural factors that relate to whether patients take anti-TB medicines and complete treatment and it suggests issues that require the attention of researchers who are interested in behavioural questions relative to TB. Several conclusions about measuring adherence can be drawn. Probably the best approach is to use multiple measures, including some combination of urine assays, pill counts and detailed patient interviews. Careful monitoring of patient behaviour early in the regimen will help predict whether adherence is likely to be a problem. Microelectronic devices in pill boxes or bottle caps have been used for measuring adherence among patients with TB, but their effectiveness has not been established. The use of these devices may be particularly troublesome for some groups such as the elderly, or precluded for those whose life styles might interfere with their use such as the homeless or migrant farm workers.

Carefully designed patient interviews should be tested to determine whether they can be used to predict adherence. Probably the best predictor of adherence is the patient`s previous history of adherence. However, adherence is not a personality trait but a task specific behaviour. For example, someone who misses many doses of anti-TB medication may successfully use prescribed eye drops or follow dietary recommendations. Providers need to monitor adherence to anti-TB medications early in the treatment in order to anticipate future problems and to ask patients about specific adherence tasks. Ongoing monitoring is essential for patients taking medicine for active TB. These patients typically feel well after a few weeks and either may believe that the drugs are no longer necessary or may forget to take medication because there are no longer physical cues of illness. Demographic factors, though easy to measure, do not predict adherence well. Tending to be surrogates for other causal factors, they are not amenable to interventions for behaviour change. Placing emphasis on demographic characteristics may lead to discriminatory practices. Patients with social support networks have been more adherent in some studies and patients who believe in the seriousness of their problems with TB are more likely to be adherent. Additional research on adherence predictors is needed, but it should reflect the complexity of the problem. This research requires a theory based approach which has been essentially missing from studies on adherence and TB. Research also needs to target predictors for specific groups of patients.

There is clear evidence on adherence, culturally influenced beliefs and attitudes about TB and its treatment. Therefore, culturally sensitive, targeted information is needed. A taxonomy of groups and their beliefs would assist in the development of educational materials. Educational interventions should emphasize adherence behaviours rather than general information about TB or treatment. Further research is needed to define the social and behavioural dimensions of effective treatment and control and, creative programming must take advantage of the latest research.

The most important cause of failure of anti-TB therapy is that the patient does not take the medication as prescribed. To assess this problem, a retrospective review was conducted using medical and nursing records, of adult patients treated at the TB clinic of the Montreal Chest Hospital in 1987-88. In all, 352 patients were identified of whom 59 percent were judged to have completed therapy. Completion of therapy was recorded in 92 percent of those with culture-positive disease, 76 percent of those with active but culture-negative disease and 54 percent among the 300 prescribed preventive therapy (p<0.001). Compliance with preventive therapy was highest among those who had been in contact with an active case, and lowest among those identified through a workforce screening survey (p<0.01). At the time of the first follow-up visit, patients identified to have suboptimal compliance were more likely to fail to complete therapy (p<0.001). Compliance was higher among those initially hospitalized, those assessed to have better understanding (p< 0.05), those prescribed 6-9 rather than 12 months of therapy (p <0.01), and those who returned for follow up within 4 weeks of initiation of therapy (p< 0.01). Compliance could be improved by enhancing patient understanding, closer follow-up and shorter therapy particularly, for those at lower risk of reactivation. Also, additional compliance enhancing interventions can be targeted to those patients with suboptimal compliance who can be accurately identified early in the course of therapy.

This article presents some studies to depict the dramatic increase in TB incidence in the United States due to its failure to co-ordinate the medicare care provision, disease surveillance and societal will to consistently provide TB therapy and monitor TB control. The author considers that the collective apathy has led to increase in multi-drug resistance. Using incidence rates to track TB (thus failing to track the completion of therapy) and, having no systematic national reporting of completion rates are regarded as evidence of institutionalised apathy. Maintaining a prevalence registry is administratively labor-intensive, therefore, it is suggested that local health departments must enter data into computers as reports arrive rather than perform batch entry, three months later. Generating monthly reports for field workers identifying non-compliant patients or non-reporting physicians, offering non-compliant patients, DOT, education and appropriate incentives are other steps to curb TB. Having automated laboratory surveillance of antibiotic susceptibilities of mycobacterial isolates is essential to produce timely reports to enable physicians to adjust their prescribing practices, to facilitate outcome research, to suggest useful regimens for study and allow for the creation of infrastructure necessary for organising countrywide clinical therapy trials.

The annual incidence of TB cases among Singapore residents fell steadily from 306 per 100,000 population in 1960 to 56/100,000 in 1987 but has since remained at between 50 and 55/100,000. One of the possible reasons for this non-decline may be persistence of transmission of TB in the community due to delayed diagnosis, treatment and ineffective case holding.

Compared to non-defaulting patients as controls, defaulters were mostly non-Chinese, and those live on their own or with friends. There was no significant association of defaulting with age, sex, marital or employment status, disease characteristics, or treatment-related factors. Seventy per cent defaulted during the continuation phase of treatment.

The study was a retrospective patient record based case control study conducted in the TB Control Unit (TBCU), Singapore. This being the main treatment centre, which treats about 50% of the cases was the venue of the study. The objectives were to: (i) identify any demographic, social, disease or treatment-related characteristics which may be predictive of patients defaulting from treatment; (ii) assess the effectiveness of home visits as a means of defaulter recall; and (iii) ascertain outcome in these patients. TB treatment defaulters were defined as the patients who missed their scheduled appointments and required a home visit to recall for treatment. Equal number of controls were randomly selected from non-defaulting patients who started treatment on the same dates as the defaulters. Majority of the patients were supplied drugs for self-administration at home and there were about 10% of the patients who were on DOTS during the study period.

Of the 44 treatment defaulters, 6 (13.6%) were contacted directly, 20 (45.5%) through a person at home during the visit and for 18 (40.9%) a recall letter was slipped through the door due to no contact with patient or any other person at home. Following home visits, 20 (45.5%) returned within 7 days. The treatment outcome was not very encouraging as only 19 (43.2%) completed treatment, 21 (47.7%) were not traceable, 1 was dead and 3 were hospitalized. However, of the 21 patients who were lost to follow-up, all except one had culture negative results. The study identifies the future prediction of default as those who were non-Chinese, living alone, male and had a previous history of treatment.

Impact of health education, specially, in regard to domiciliary chemotherapy, by exposing the patients to a tape-recorded message in a rural TB clinic, was evaluated. The measure appeared to have signficantly improved self- administration of the drugs as assessed by tape and post-tape regularity of chemotherapy of the patients. (From 28 pre-tapes in 1965 to 72 post-tapes in 1969). The measure also appeared to have improved knowledge in other aspects of TB as found by a comparative study of answers to questions between a group of tape-exposed tuberculous patients and another group of not exposed non-tuberculous persons on taped and untaped questions (on untaped questions, the difference was only 1.5 to 1, whereas on taped questions, this ratio was 18 to 1). It was therefore concluded, as a staff, time, and cost-saving measure, taped or gramophone recorded messages played at the clinic may prove of great educative value, specially for clinics serving predominantly illiterate patients.

The paper stresses the need for an interdisciplinary approach to the study of drug default among TB patients and presents several studies to discuss the role of motivation in reducing drug default, underscoring the importance of using an action-oriented definition of default. One study, conducted by the NTI, determined the number of defaults and the collection at which default occurred through a retrospective analysis of treatment cards. Analysis of the data collected from 2,419 patients showed that a large proportion of patients, whether they visited the (DTC - specialised institutions) or the Rural PHIs (GHIs), dropped out immediately after starting the treatment. Another study, on the influence of initial motivation, was conducted among adult patients newly diagnosed at the Bangalore LWTDTC. Three types of motivational contents for verbal communication were developed and a total of 407 patients were randomly distributed into three groups. The third study determined the influence of patient and family motivation on the drug collection of TB patients, using 250 newly diagnosed cases of TB at LWTDTC. It was concluded from the three studies that age, sex, education and occupation of the patients did not influence the drug collection pattern. Different schedules of motivation with variable quality of contents and, changed sequence of points did not appreciably affect the TB patients’ behaviour. Sputum-positive cases needed strong and more effective motivation compared to sputum-negative ones. Family motivation had a positive influence on the patients’ drug collection pattern.

The retrospective study aims at identifying a “risk group” among patients treated at the DTC & six PHIs in Kolar district of Karnataka state in order to focus on them for motivation and defaulter actions to improve case-holding. Since there were differences in the number of defaults made by the First Timers (who defaulted for the first time during the first month of treatment) and Others (who defaulted during the subsequent months), an in-depth analysis was undertaken to understand the behaviour dynamics of these two groups.

There were 231 First Timers and 141 Others. The analysis revealed that the First Timers had inferior results for all the parameters of case-holding. Mean Defaults Rate was 0.9 for First Timers & 0.7 for Others; Patients Lost to Treatment were 83% & 61%; Treatment Completion Rates were 25% & 59% and Bacteriological Conversion was 58.5% & 76.9% respectively. Inconsistencies observed in the rapidity of defaulter actions taken suggested a possible lapse in taking defaulter actions. Thus, First Timers could become predictors of default: They constitute the important target group for focussing intensive efforts to improve case holding, which is expected to improve to the extent of 30%.

This paper briefly highlights the factors responsible for treatment failure in clinical practice. The author has limited his discussion to the factors related to the physicians and drugs. The factors which influence the outcome of anti-TB treatment are classified as “intrinsic” - those related to the patient and “extraneous” - those which are not directly related to the disease or the mycobacteria, but influence the treatment outcome.

Prescription errors and drugs confusion are two important factors responsible for failure of treatment of TB. Both these factors are potentially preventable if greater inputs are made in programmes related to physician’s education and drug rationalization.