A voluntary health worker project (Operation Elsies River) was started in a high incidence TB area in the Western Cape of South Africa, in order to assist the local TB control programme with case-holding. The objective is to evaluate the effectiveness of this group of volunteers in enhancing adherence of notified TB patients to TB treatment. A cohort study was conducted with 351 TB patients (203 children and 148 adults). The data from the child and the adult groups were analysed separately. The child group was more adherent to TB treatment than adults. The supervision option with staff dedicated to the treatment of TB, such as the clinic and the SANTA creche, achieved better adherence results for pre-school children. The supervision modalities for adults did not differ in their adherence performance even following adjustment for confounders.

The supervision option provided by the volunteers did not significantly improve the adherence of adult patients to anti-TB treatment.

In the United States, failure to comply with appropriate anti-TB chemotherapy is the most serious remaining barrier to the control of TB. Studies on patient compliance can be separated into a number of categories, yet, very little exists that is useful in overcoming the problem of non-compliance. A health belief model (Becker 1974) has been developed that contains the patient’s perception of susceptibility to and severity of his/her illness and, the costs and benefits of the recommended treatment. It was found that patients often report that they stop taking their medicine as soon as they feel better, a crucial phenomenon in the patient’s non-compliance. The author’s perception was that non-compliance represented self-destructive forces in the patient that were poorly understood by both the patient and the health care provider. Examples of such destruction were evident even within the health belief model. Data from reports on TB patients who completed their chemotherapy, received within 24 months by the Center for Disease Control, USA, revealed that approximately 23-31% of newly-diagnosed TB patients did not complete their chemotherapy within 24 months and, this result extrapolated for all patients in the US, led to an estimated 7,130 - 11,512 non-completers for the years 1970-1975.

Experience at Cook County Hospital in Chicago for 5 years is discussed in detail. The study, here, concluded that directly supervised chemotherapy was the only possible solution to poor compliance in inner city TB programmes. Organising the supervision of therapy was more crucial than the type of regimen chosen. It was suggested that the cost of such initial therapy would be less as multiple hospitalizations and treatment failures could be prevented.

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.

To solve compliance problems, they must first be detected by identifying patients who fail to keep appointments, identifying treatment failures, and identifying less overt forms of non-compliance by interviewing patients and performing pill counts and urine tests. To improve compliance, simple, specific instructions about the behaviour desired, must be given. If problems develop, the patients should be heard and obstacles to the desired compliant behaviour should be identified. The regimens to overcome these obstacles must be restructured and the support of family and friends elicited. Behavioural strategies such as verbal encouragement, tailoring, incentives, awards and contracts must be tried. Supervised therapy must be used whenever non-compliant behaviour persists. Institutionalization should be avoided whenever possible, but used if no other options remain. There are several methods of detecting non-compliant behaviour and a growing list of validated ways of improving compliance. Their judicious use can help prevent the additional cost, morbidity and mortality inevitably associated with poor compliance.

The paper discusses various aspects of compliance with anti-TB chemotherapy in developing countries. The problem of definition of compliance in a developing-country context, the classification and consequences of non-compliance and the entity (ies) responsible for compliance are elaborated. A description of the direct methods (several biological methods such as qualitative urine tests revealing the presence of isoniazid metabolites a day after drug is taken) and indirect methods of evaluating compliance such as monitoring patient attendance at the dates appointed for drug administration or receipt of drugs, is presented. Several steps are recommended to be taken to improve compliance in developing nations.

The problems of compliance among TB patients are similar in developed and developing nations and the solutions are a little different. The reasons for non-compliance, the kind of patients in whom non-compliance is high, the problems in detecting compliance, patients’ attitudes which affect compliance and suggestions to overcome these attitude problems are presented. Ways to reduce non-compliance include such means as providing SCC, directly administered therapy, providing all treatment medications only once daily, providing a fixed-dose combination of treatment drugs and, treating the patients on an out-patient basis.

Today, treatment of TB has developed into the concept of “case-holding” which involves the health agency, the patient, his/ her family and the community for the completion of treatment by the patient. The drug regimen plays a relatively minor role in case-holding when compared with other factors such as the active participation of the patient, family and close friends, the attitude and behaviour of the health staff who offer the treatment and, a constant supply of drugs and their availability to the patient. The services offering the treatment play a major role in reducing drug-default which is a primary problem in case-holding. The drug-default pattern in different situations is listed and the reasons for drug-default are discussed under three categories, technical, organizational and, administrative and socio-psychological.

A retrospective study of factors associated with poor patient compliance with anti-TB therapy was conducted in Taiping Perak, Malaysia. 219 patients were studied. Male patients and hospital referrals were significantly more likely to default. Patients with tuberculous lymphadenitis alone had a greater rate of default, but this just failed to reach significance (0.05 < P < 0.10). Six of 7 male hospital referrals with tuberculous lymphadenitis alone defaulted. Patients treated as out-patients from the start were more compliant. Housewives were also highly compliant. It was noticed that patients who defaulted tended to do so during early stages of treatment.

A case is made for devoting serious attention to the human element in reducing the world-wide incidence of TB. Poor patient compliance remains the principal cause of treatment failure in both developing and developed nations. Contributory factors to treatment failure include the lack of effective communication between national TB services and private practitioners, physicians’ attitudes, behaviour and lack of understanding of cultural differences in patients’ attitudes to TB, its diagnosis and therapy. Other local factors affecting compliance, the relationship between education and TB control and human factors that impact anti-TB programmes at the national and international levels are discussed.

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.

Historical evidence of non-compliance of TB patients is described to stress that non-compliance is a persistent and significant problem faced by health professionals. While there is no positive predictor of compliance, certain behavioural patterns have been identified as predicting compliance. A description of the groups exhibiting such behavioural patterns, identified from experience, are described. They include previous treatment failures, substance abusers, those with mental, emotional and physical impairments, persons comprising health workers and professionals who ought to be the most trustworthy, those who are blatantly honest (about not taking their medications even when intending to) or rebellious, persons who have failed on preventive treatment and where poor relationships have existed between the caregivers and the patients. Miscommunication because of the use of specialised technical vocabulary, cultural differences between patients and providers and institutional constraints on the forms of interaction that can take place, is a threat to any kind of personal interaction. A variety of strategies to deal with non-compliance including pill counts, urine testing for drugs or their metabolites, blood testing for the presence of anti-TB drugs and DOT are discussed. How to give DOT and problems faced in giving DOT are elaborated. Using various incentives and enablers to enhance compliance is recommended.

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.

A community-based TB treatment programme of fully supervised, intermittent (twice weekly) ambulatory (SIAT) treatment, in Zululand, S. Africa, is described. The area served was about 3,000 sq. kms. and 200,000 people who lived in scattered kraals. SIAT points were designated, starting with clinics and community health workers, and involving stores, tea rooms, schools and other non-health care sites as need arose. All patients, including children, were offered SIAT and the only indication for hospital admission was severe illness. Each patient was allocated a supervisor of his/ her choice and the emphasis was on the convenience of the patient, not the health service. All patients were transported to their supervisor who was given a 6-month supply of treatment for the patient. Verbal and written instructions were given to all supervisors, who were asked to watch the patient take the medication and then sign the TB card which they retained. The TB health worker visited each supervisor monthly, checked compliance, only visited patients if there was a problem with compliance, and attempted to trace defaulters. Most of the patients who absconded and were not traced had left the area in search of work. Over the study period, only one store refused to supervise a patient, and over 60 different stores were used. Non-health worker supervisors were unpaid.

The findings showed that 89% of surviving patients completed treatment under programme conditions. It was concluded that high completion of treatment rates were possible if services were well-structured, use an intermittent regime, utilise all possible community resources to ensure full supervision of treatment, and are regularly audited. Above all, the service must actively involve and be fully acceptable to the patient.

The study, a collaboration between the National Tuberculosis Institute, Hanoi, Vietnam and the Karolinska Institutet, Stockholm, Sweden, was carried out in a district of Quang Ninh Province in North Vietnam.

To describe TB services, attitudes of staff and attitudes of patients considered as defaulters to TB treatment.

Two focus group discussions were carried out with staff at the district hospital. Ten defaulter patients were interviewed in their homes.

This exploratory study has revealed some important aspects of staff and patients’ attitudes to TB and its treatment. TB is considered a ‘dirty’ disease, which mainly affects poor people. There is a tendency to avoid telling others about it. Obvious symptoms are explained as ‘being over-worked’. A patient with TB feels ‘less respected’ by others. The social stigmatization leads to delays in seeking medical care, often only after self-medication: anti-TB drugs can be brought without prescription in various pharmacies. The patient’s economic situation is also an important determinant of compliance and non-compliance. These factors need to be taken into consideration in TB control in Vietnam.

A prospective cohort study among new smear positive pulmonary TB cases initiated on SCC was undertaken in Kolar district of Karnataka. The objective was to study the treatment outcome and patient profile of treatment adherent (completed) and non-adherent (lost) patients. Data collection was done through interviews based on pre-tested structured schedules, soon after diagnosis and at the end of treatment. Of the 224 available patients in the cohort, 120 (53.6%) completed treatment, 68 (30.4%) were lost, 29 (12.9%) died and 7 (3.1%) migrated outside the district.

Persistence of cough at the end of treatment was significantly more among lost patients. The general profile of the patients, relating to socio-economic, demographic, literacy and employment details did not differ significantly between the 2 subgroups. However, the treatment related factors like distance from health centre, knowledge of treatment duration, advice on treatment given after diagnosis, payments made to staff and for tonics were significantly more among patients lost to treatment. Raising of money to meet the expenditure, particularly through selling of valuables too was proportionately more among lost patients. Defaulter retrieval action was not taken for more than 85% of all eligibles, both among completed and lost groups. The reasons for non-adherence to treatment as emerged from the study are mainly related to the treatment organization.

The study results emphasize the need to strengthen the treatment organization to achieve the desired treatment outcome. This would also be essential for a successful implementation of DOTS strategy.

In Pakistan, TB is a major health problem and is perceived as a stigmatised disease. Implementation of DOTS is limited to only few districts due to poor functioning of primary health care and inability to strengthen them before DOTS implementation. Bethania Hospital (BH) in Sialkot town of Punjab province in Pakistan is the acknowledged centre for treatment of TB patients since 1970. Still the major problem faced by BH has been poor compliance. Various alternatives to improve compliance were tried e.g., hospitalization for initial 6 weeks, introduction of SCC of 8 months, which had some improvement, but was not appreciable as SCC regimen had 12% initial defaulter and 34% of these put on treatment did not complete the treatment.

Keeping in view the social attitude and the health beliefs of the local people, it was decided to offer intensive counselling to improve treatment adherence. The objective of the study was to assess the overall impact of counselling on treatment defaulting and to identify sub-groups in which counselling was the most effective. The statistical design was a randomised controlled intervention trial. A total of 1019 adult TB patients were interviewed and taken into the study and the control group during full one year of 1995. Baseline data were obtained through semi-structured interviews by trained para-medicals of both genders and belonging to the same socio-economic background. Patients were followed until the end of treatment. The counselling was given at the start of treatment and at each subsequent visit for ambulatory patients, or weekly for hospitalized patients in the study group. The counselling, combined health education with strategies was aimed to strengthen the self-efficacy. Control group patients received the usual care. According to treatment policy, patients scheduled for SCC were advised to accept hospitalisation for the 2 months of intensive phase of treatment. Ambulatory patients mainly received a 12-month regimen. Of the 63% of patients who accepted hospitalisation, only 40% remained hospitalised for the full 2 months. The outcome measure was treatment default, cure, referral or death. Results showed that the default rate was 54% in the control and 47% in the intervention group; the default risk ratio was 8.7, implying a reduction in defaulting of 13%. Intensive counselling has a significant, although limited, impact on treatment adherence. The impact was stronger in women, ambulatory patients, re-treatment patients, women who worked at home, and patients who were not the main providers, those with poor knowledge of the disease or those with a short treatment delay. Counselling does not eliminate the need for closely supervised treatment but it is a useful additional strategy for improving treatment adherence. In the long run counselling has the potential to reduce the stigmatisation of TB patients. In countries like Pakistan, where the implementation of DOT is currently hampered by the absence of functional health infrastructure at the peripheral level, the combined strategy of counselling and family based DOT could offer a valid alternative to the immense and urgent problem of TB control.

Several studies have been carried out on the community based DOT in a variety of settings. However, although some have been very large, most of them have been relatively small. The Hlabisa TB Control Programme in rural south Africa has used community-based DOT extensively since mid 1991. A detailed analysis of the data belonging from 1991 to 1996 is done to find out reporting trends in adherence, timing of treatment interruption and risk factors for failing to complete therapy. The study was carried out in a population of 2.1 lakh zulu speaking people who are mostly farmers, labourers and pensioners with middle income and 69% literacy rate. HIV seroprevalence among adult TB patients increased from 36% in 1991 to 66% in 1997 and consequent to that annual case detection increased from 321 to 1250 by 1996. Of the 3610 surviving patients, 629 (17%) failed to complete treatment ranging from 11% in 1991-92 to 22% in 1996. Association of treatment interruption with age, sex, type of TB and HIV status was observed as follows: Age specific frequency distribution for treatment interruption was higher among those aged 25-34 years and significantly greater than among the patients aged 0-14 years and those aged 55 years and over. A similar age specific frequency distribution for treatment interruption was observed each year. Treatment interruption was higher in men than women. The interruption rate was similar among patients with smear positive pulmonary TB, smear negative and extra pulmonary disease. Treatment interruption was more frequent among patients known to be HIV infected (25%) than among those whose HIV status was unknown (17%) and those known to be HIV infected (12%). The pattern was observed each year and was unaffected by age or sex. The interruption of treatment among HIV infected and not tested for HIV patients was high when supervised by health worker. The interruption of treatment increased between 1991/92 – 1996 and was greatest among patients supervised at clinics. The single independent risk factor for treatment interruption was diagnosis between 1994-1996 compared with 1991-93 (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.6-2.4). The second factor was known HIV- positive status versus known HIV-negative status (OR 1.8, 95% CI 1.4-2.4); supervised by village clinic with community worker (OR 1.9) and male versus female (OR 1.3). In conclusion, adherence to therapy in a community with high caseload, migration remains a challenge even with the community based DOTS.

Laws found in almost every community make it clear that those involved in treatment of TB not only should but must concern themselves with patient compliance. Successful inducements and enforcements fall into three categories: 1) Changes in the health delivery system (example, elimination of long waiting hours, ease of access to treatment facilities), 2) Patient / Professional relationships - educational intervention and behaviour modification (example, incorporating the use of prescription drugs into some part of the patient’s daily routine, establishment of a long term, one-to-one relationship between the patient and professional), 3) Direct administration of medication. There is increased recognition and demonstration that oral medications, when administered in above normal dosages, also have a prolonged duration of action, leading to the formulation of treatment regimens that allow the treatment of patients on an out-patient basis. The estimation of cost of treatment, illustrated for Denver city, Colorado, USA, demonstrates that when compared to the minimum costs associated with standard regimens, the maximum costs of a directly administered ambulatory programme are still less. More importantly, the compliance problem is eliminated when medications are directly administered. The use of a medication monitor of the type suggested by Tom Moulding would permit the early detection of potential non-compliers. DOT is successful because patients quickly accept their part of the arrangement - freedom in exchange for co-operation.

The article lists the factors that influence compliance and presents, in detail, the action steps that may improve compliance with descriptions of studies to support several of the recommended actions. These action steps include: 1) Provide patient education at the time of diagnosis and periodically, throughout, treatment and follow-up, preferably in the patient’s native language, 2) Provide incentives as simple as coffee and conversation in the clinic or as complex as providing food and shelter for a homeless patient, 3) Provide appointment-keeping reminders through mail, phone calls or in pictorial form for illiterate/ low literacy patients, 4) Tailor the regimen, 5) Encourage self-monitoring, 6) Negotiate a health contract (this can be done only with those patients who have a strong, positive relationship with their providers and with those who would feel more motivated when they must depend on, or be accountable to, another person), 7) Provide supervised therapy (especially useful in the first 8 weeks of treatment), 8) Follow-up on broken appointments, 9) Provide training for health care personnel on current TB treatment regimens and on compliance-enhancing strategies. A possible solution to dealing with the major problem of patients who do not go to clinics such as the homeless is to create a cadre of urban “barefoot” doctors (former homeless, students etc.) to provide outreach services to the indigent as done by the Center for Disease Control, state and local health departments, Atlanta, Georgia, USA.

The findings of the Fifth TB Association of India’s SCC trial for the Jaipur Center were reanalysed. Sixty patients with pulmonary TB, who had not received any chemotherapy in the past, were divided into two groups. All the patients were put on isoniazid, rifampicin and pyrazinamide for 8 weeks followed by isoniazid and rifampicin for another 18 weeks. Group A patients were informed of the likely occurrence of anorexia and /or vomiting but Group B patients were not. Routine and default retrieval home visits were given to ensure maximal drug compliance.

Drug toxicity-related early defaults were significantly less common in Group A patients (1 of 30) as compared to group B (6 of 30).

Compliance with prescribed treatment remains a major problem in the control of TB, worldwide. A simple method of improving patient compliance with hospital-based treatment is described. Eighty-two patients paid a deposit at the start of their treatment which entitled them to cheaper drugs and was refundable on completion of the prescribed course. Sixty-two percent of patients completed the course compared with 23 percent of retrospective controls. A direct relationship was found between the amount of deposit paid and the rate of completion. Reasons why poor patients (who paid a lower deposit) may default include lack of understanding of the need for prolonged treatment due to inadequate education, poverty or low-income, preventing travel to the hospital and/ or paying for consultation and medication. Using a short regimen (2RHZ/4RH) for those who have never had previous TB treatment (and are therefore, unlikely to have resistance) and offering a cheaper regimen (2RHZ/10TH) to poorer patients, provided three sputum samples are negative for AFB at two months, would benefit even defaulters. It is recommended that similar schemes be assessed elsewhere.

A pilot study was initiated in 1990 to investigate the feasibility of patient-to-patient motivation by having a patient who had been regular for treatment to talk to a new patient. A controlled study was begun in 1991. Only those patients who were unsuitable for admission to the ongoing controlled clinical trial were admitted to the investigation. A stratified, random procedure was used to allocate patients to either routine motivation (motivation done by clinic staff only) and patient-to-patient motivation (motivation done by treated patients in addition to clinic staff, on admission and, at 1 and 4 months). Defaulter retrieval action was taken for both groups in accordance with the DTP manual. No home visits were made. Patients defaulting after retrieval actions for a month, were considered “lost.” All 297 admitted patients completed six months of treatment. 281 patients remained for analysis (4 died and 16 had change of treatment). Forty percent (143) of 281 patients had more than 90% of treatment in both groups and nearly 60% of lost patients were in the first phase of treatment in both groups. The study revealed that patient-to-patient motivation did not result in any greater improvement in patient compliance.

Four hundred and sixty eight newly diagnosed smear-positive pulmonary TB patients at the DTC, Goa Medical College, Goa, were studied on standard domiciliary therapy. 240 were suffering from alcoholism; 86.8 of non-alcoholics and 71.7 of alcoholic patients received full drug therapy. 9.7 of the controls and 25 of the alcoholic group defaulted. Overall default rate was 20.1 in this study. Alcoholic patients do respond to intensive and repeated motivation and become more compliant.

The mortality and morbidity from childhood TB may be influenced by the delay from the time of first symptoms until the start of and compliance with treatment. This study investigated these delay periods and the compliance with therapy in children with TB. During the study period in Cape Town, S. Africa, there were 49 children with probable and 123 with confirmed pulmonary TB (WHO criteria). The mean period from first symptoms until presentation was 4.3 weeks, from presentation until notification 5 weeks and from notification until therapy 0.9 weeks. Sixteen percent of children notified as having TB never received therapy. Significantly fewer children in the urban squatter communities received therapy than in urban settled (P = 0.02), rural agricultural (P = 0.0001) and rural settled (P = 0.09) communities. Twelve percent of the children did not complete their therapy. The delay in presentation (“patient delay”) was shorter than the delay in diagnosis (“doctor delay”). Failure to trace children and to complete therapy was particularly likely to occur in urban squatter communities. Easier access to health care facilities may shorten the “patient delay”, while greater awareness of TB and proper investigation of children may shorten the “doctor delay”.

Non-adherence to treatment by patients is a major impediment, worldwide, in controlling TB. Failure of approaches attempted so far, in effectively tackling the problem of non-adherence, has led to the inclusion of directly observed or supervised chemotherapy as an essential element of the WHO's revised strategy for global TB control. Supervise chemotherapy has also been made the most important component of India's NTP being revitalized with the help of a loan from the World Bank and technical assistance from WHO. The reason for advocating supervised chemotherapy in India is the failure to ever achieve desirable cure rates, under a well designed NTP in operation for ever 3 decades. The demonstration projects of several NGO's, claiming success in achieving high cure rates, rarely provide hard data as evidence and their results are often considered anecdotal and unsuitable for wider application. This paper presents alternative approaches adopted by two NGO‘s providing services to large populations in different settings, one a most backward area of rural Gujarat and the other in the slums of Bombay. Both organizations could ensure reasonably high levels of treatment completion and cure rates under field conditions. While the urban NGO used pre-registration screening and motivation as tools to ensure treatment completion and cure, the rural NGO successfully employed the services of the female anganwadi workers of the Integrated Child Development Services(ICDS) scheme. The reproducibility and wider applicability of some important elements of these approaches are discussed.

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 study was conducted to evaluate the effectiveness of unsupervised monthly-monitored treatment using an oral short-course regimen in hill and mountain districts of Nepal supported by an international NGO. In this prospective cohort study, outcomes for new cases of smear-positive TB starting treatment over a two year period in four districts in which a 6 month rifampicin containing regimen was introduced as first line treatment (subjects) were compared to outcomes for similarly defined cases in four districts where a 12 month regimen with daily streptomycin injections in the intensive phase continued to be used (controls).

Of 359 subjects started on the 6 month regimen, 85.2% completed an initial course of treatment compared to 62.8% of 304 controls started on the 12 month regimen (P < 0.001); 78.8% of subjects and 51.0% of controls were confirmed smear-negative at the end of treatment (P < 0.001). The case fatality rate during treatment was 5.0% among subjects and 11.2% among controls (P=0.003). Among those whose status was known at two years, 76.9% of subjects were smear negative without retreatment, compared to 60.9% of controls (P < 0.001).

In an NGO supported TB control programme in remote districts of Nepal, patient responsible short course therapy supported by rapid tracing of defaulters achieved acceptable outcomes. Where access and health care infrastructure are poor, district-level TB teams responsible for treatment planning, drug delivery and programme monitoring can be an appropriate service model.

Measures known to improve adherence such as short course chemoprophylaxis and directly observed therapy can be enhanced to a significant extent by the use of incentives. Adherence to TB therapy is influenced by several factors, including the health care system, complexity of therapeutic regimens and patient’s characteristics. Individual factors that negatively influence patient’s adherence are the most difficult to counter. Preventive TB therapy is doubly challenging because the benefit of treatment is not felt, while toxicity from the medication, when it occurs, is experienced immediately. Ingenious incentives therefore have to make it worth the patient’s while. During a study on preventive regimens, a request for an incentive, Sustacal, was observed to help completion of preventive regimens. Components of individual TB programs may help in patient adherence; it is important for health care staff to identify these aspects and, if they are successful, utilize these as an incentive to complete treatment.

Two adjacent Cape Town Local Authority health clinics in Cape Town, South Africa, were selected. Clinic A was designated the "intervention clinic" and Clinic B the ‘control clinic’. To asses whether the combined strategy of a patient-centred interview plus the issuing of a patient education booklet would have the effect of increasing the adherence of notified pulmonary TB patients to prescribed treatment.

A controlled intervention study was implemented using a cohort of the first 60 consecutive patients notified with pulmonary TB at both Clinic A and Clinic B; the patient cohort thus consisted of 120 patients. The risk of patient non-adherence to anti-TB treatment was significantly reduced at the intervention clinic compared to the control clinic.

The results of this study indicate the need for further operational research to assist health providers in developing standardised protocols of health education to enhance adherence to treatment in patients who require protracted treatment regimens.

The paper reviews current understanding of the behaviour and interactions of TB patients and private for-profit providers, as a precursor to devising interventions for field testing to win over the private practitioners and private voluntary organizations to the DOTS strategy. India is a vast and heterogeneous country. The location of the study sites are New Delhi, Agra, Jaipur, Lucknow, Morena, 24 Parganas, West Bengal, Wardha, Bombay, Pune, Tumkur, Madras, Bangalore, North-east which indicate that the available information is representative of the whole country. Even then specific local peculiarity cannot be excluded. The study period ranged from 1976 to 1996, most of them carried out in the 90s. In few instances, the evidence was supplemented by interviews with knowledgeable experts who had first hand information of the issues being discussed. The findings of the review report are as follows: The prevalence of TB is highest among male adults, belonging to low socio-economic strata and tribals. The general public was found to be reasonably aware of the symptoms of TB. Chest symptomatics are being found to be 5-10% of the general population. The process of health seeking behaviour of a TB patient is complex and may well last several years. Most persons in India requiring curative treatment without hospitalization choose private providers. People go to the nearest trusted health care providers who is usually a private for-profit providers. The poor and even in hilly areas choose them. Private practitioners are perceived more sympathetic, more conveniently located, more effective and more trusted for privacy than government run services as having condescending doctors, substandard drugs, inconvenient opening hours and long waiting times. However, once patients had switched from private to government run providers, they become far more appreciative of government-run services, drugs and staff. TB patient’s health seeking behaviour is dependent of their symptoms. About half of the TB patients seek help within a month, 50 to 80% from private for-profit providers. Diagnosis of TB is often delayed for weeks after first contact with a private provider. Almost 75% of smear positive patients found in the care of private doctors in mid-seventies were not being treated for TB. About half the patients continue treatment with the private providers who diagnosed the TB.

Most patients knew that they have TB even when the providers try to conceal this stigmatizing diagnosis. They knew that TB requires prolonged regular treatment. They start taking drugs, but loose interest after relief specially the low-income groups due to cost and inconvenience of taking drugs. With the passage of time, work and social commitments increasingly displace the chore of taking regular treatment. Even knowledge about consequence of irregular treatment did not prevent it. As their funds get depleted TB patients switch to government run services. The steady switching from private to government run services is not matched by switching from government-run to private providers. Except where DOTS is practiced, do not achieve consistent cure. With DOTS, 80% cure rate was demonstrated in pilot area while only 35% with standard regimen and 51.3% on SCC completed treatment in NTP. As implied by these events, long-duration patients accumulate in government-run services. Many TB patients believe that TB carries a social stigma. Ex-TB patients are less likely than average to find marriage partners in West Bengal. Unmarried girls with TB fear that they might never find a spouse, those married fears divorce. Women are typically less well placed than men to ensure their own cure.

Out of pocket costs for diagnosis and successful treatment in India are estimated at between 100 and 150 US Dollars per patient as per 1992-1995 rupees dollar rates. However, individual out of pocket expenditure on TB treatment dwarfs the substantial sums expended by the government on the NTCP. However, private expenditures on private TB treatment, which are estimated to exceed USD 150 million per year, are typically rewarded by palliation rather than cure of TB.

Over-diagnosis and over-prescription among private for-profit providers are predictable. X-ray was found the test of choice to rule out TB, with sputum examination done in only 10 to 20% of suspects. Treatment regimens prescribed were of 4 drugs intensive phase with six months duration and were probably adequate to achieve cure. Most of them prescribed anti-TB drugs and also gave expensive diet supplements and alcohol based tonics.

Private practitioners generally keep no patient records. Half of them admitted that they made no attempt to contact patients who defaulted from follow up visits. Only 5% stated that sputum negative smears were desired to call it a cured case. TB patients do not form an important part of the business; only 1% of patients seeking care at qualified allopathic provider while one-third had no patients. TB Specialists might consider TB as an importantpart of their business. Government services are normally free, but waiting time, wages lost and drug unavailability impose costs and inconveniences. Spot checks revealed that more than 50% of PHCs had one or more TB drugs not available. Only 15% of the patients knew that the treatment is free in government clinics. On the whole, government-run health care services in India have a poor image. The private for-profit health care sector plays a major health care / system in India. In 1989, there were about 2,42,650 qualified allopathic physicians as compared to 88,105 in the government services. The number of recognised hospitals in private sector grew from 2,764 in 1983 to 4488 in 1987. The profile of a typical rural private provider in Uttar Pradesh was a 38 year old male, with about 10-12 years of schooling, practicing a mixture of western and professional medicines. Only 7% were qualified, while 90% learn the skills from family members, or as compounders, pharmacist or as doctor’s assistants. Nearly all the rural practitioners sell medicines by margin added to the medications. About half of them were registered with some medical association.

Drug retailers in India consistently sell restricted drugs without requiring prescription. The legal and regulatory environment for health care in India is in a state of flux. On paper fairly well regulated but unregulated in practice. Consumer Protection Council (CPC) in India has taken an active role in pursuing cases of malpractice. However, CPC’s role has been questioned by the IMA and Supreme Court ruling.

Some important gaps in information persist. There is no reliable estimate of the number, density and distribution of specialist clinics where TB might form a more important part of the case load. Several options for interventions have been identified. Excluding TB drugs from private channels such as in Algeria and Chile. Mandatory referral of TB patients to government-run services such as in Oman. To run high quality and low costs to patients.

Involvement of private providers in the programme by modifying the prescribing behaviour by academic counseling. In any case complete regular treatment and standardized monitoring promise a greater improvement than changes in prescribing alone.

The feasibility of involving ‘Dai’s’ in supervised administration of an oral 6-month SCC regimen in DTP was studied in 2 districts. A concurrent comparison was made between the Dai Method and the present DTP procedure, called the PHI Method, in terms of treatment completion and cure rates at the end of treatment period. A total of 617 patients were observed; 332 in Dai method and 285 in PHI method. About 68% of patients in the Dai method and 33% in the PHI method took more than 75% of treatment in both intensive and continuation phases. The outcome in terms of smear negativity at the end of treatment period was 86.9% and 72.2% respectively. There were 17 (5.72%) deaths in the Dai method and 16 (8.5%) in the PHI method. Treatment completion and cure rates were significantly higher in the Dai method. It is concluded that Dais can be used for supervised drug administration in DTP for increasing the cure rates.

The feasibility of improving adherence to and outcome of treatment among smear positive pulmonary tuberculosis patients by involving traditional birth attendants (Dais) in administering anti-tuberculosis drugs was earlier studied and 86.9% were reported to be cured, 5.72% had died and 7.38% had remained sputum positive, at the end of 6 months. The present study reports the status of those patients at the end of 2 years. Of the 288 patients eligible for follow up, 283 could be contacted through home visits and interviewed for the presence of symptoms and further treatment taken; if dead, the cause of death was ascertained from relatives. Two sputum specimens were also collected from the contacted patients for microscopy, culture and drug sensitivity tests. At the end of 2 years, 79.6% had remained relapse free 7.42% had relapsed and 3.53% remained sputum positive (chronic cases) while 8.5% had died. Of the 251 patients interviewed, 131 still had chest symptoms, 2 years after treatment, but only 24 of them had bacteriologically positive disease. The remaining 7 sputum positive cases were either having non suggestive symptoms or no symptoms.

In view of the above findings, it is considered that DOTS delivered through Dais is feasible

Non-adherence to treatment is an obstacle to the control of TB. Among many reasons mentioned for non-adherence, providers’ attitude, behaviour and knowledge and skill in dealing with TB patients has been cited as an important factor. Few studies also indicate that communication between patient and provider during interaction also plays an important role in the therapeutic process. Hence, this present study on patient-provider interaction was designed to describe some of the factors affecting adherence to TB treatment at LWTDTC, at urban district of Bangalore and its catchment area. The main objectives of the study were to find out the rate of adherence, application of present national control programme, patient perception of DOTS, retrospective elucidation of patient provider interaction and its influence on adherence to treatment. Treatment cards of a total of 602 smear positive patients treated with SCC regimen during Jan to Sept 1997 were analysed. From among them, 11 completed patients and 13 non-adherent patients were selected by systematic random sampling for subsequent interviewing. Further, 10 patients out of 153 patients who were under treatment from April to May 1998 and 15 patients receiving DOTS from 4 Treatment Units were selected by purposive sampling for the interviews. In addition, 23 health care providers (physicians, nurses, health visitors, laboratory technicians and health workers) were interviewed.

Most of the patients interviewed have sought the help of private health services prior to their diagnosis with the belief that their illness is not severe and attributed to cold, fever and viral infections. A majority of the patients were diagnosed within four weeks at the place of treatment. Only some had delay of more than 4 weeks. They were either referred by the initial provider (majority) or by self-motivation. Of the 602 patients, 449 (74.5%) did not complete the treatment. The non-adherence was more significant in the age group of 21-40 years. Defaulting was higher among males than females. The defaulting was early, as 64.3% defaulted within three months. None of the non-adherent patients reported having received a letter or being personally contacted by the staff. The patients put on DOTS had a separate box of anti-TB drugs for him/her and were given drugs in the intensive phase three times a week under direct observation and once a week in the continuation phase and two doses for self-administration. The results were that 74.2% of the patients put on DOTS were cured at the end of treatment. The providers have strong belief that DOTS is the answer to the problem of low adherence.

The most common reasons given for non-adherence by patients, providers and key informants, were lack of family support, providers behaviour, drug side effect, disappearance of symptoms, alcohol and smoking. Adherent patients attributed family support, self-motivation and providers’ assurance as motivating factors for completion of the treatment.

Pulmonary TB is curable when presently available regimens are given to adherent patients under study conditions. Studies show that DOT i.e., a programme in which health care personnel witness patients taking all prescribed TB treatment to be more effective than traditional therapy in which prescribed medications are self-administered by the patients. It reduces the prevalence of chronic bacillary cases, relapse rates, incidence of primary, acquired and Multi Drug Resistant TB. Treatment completion and compliance rates are higher with DOT. This study compares the cost of TB treatment in DOT (it is not widely used; it is perceived to be too expensive) to the traditional therapy. The objective of the study was to directly measure the cost of TB treatment under actual programme conditions. The cost of staff salary, laboratory, outreach, medication and hospitalization were included in the measurement.

The study was a retrospective economic evaluation of all cases reported to the Tarrant County Texas Health Department, USA. The health department serves about 1 million people of greater Fort Worth metropolitan area. The patients who were culture positive, had no history of previous treatment and patients actually managed by traditional or observed therapy were eligible for intake; legally quarantined, lost to therapy, dying from other diseases, were not included for the cost analysis. Eligible patients presenting between Jan 1980 and Dec 1985 were included in the traditional group. Patient treatment costs were followed through 31st Dec 1987, while in the DOT group patients between Jan 1987 and 31st Dec 1992 were included and treatment costs were followed through 31st Dec 1994. Nearly all the patients in either group received their prescribed therapy. Cost estimates were characterized by a cost parameter and a unit rate with cost being determined from the products of the two. Cost parameters describe different elements of treatment i.e., number of X-rays, days hospitalized, physician care time, etc., and are independent of cost which provides a base for comparing the relative costs of each program. Unit rates reflect 1995 pricing for labour, services and materials and representative of costs in Tarrant County Texas. In-patient cost was determined as $600 per day for days hospitalized for TB, out-patient cost parameters included personnel service and travel time, travel mileage, number of laboratory tests, number of X-rays done and medication prescribed.

The Physicians treating TB have three out-patient management options, traditional therapy and universal or selective DOT. The selective DOT suffers from the same flaws as traditional therapy specially the inability to predict, identify and measure non-adherence.

The authors feel that out-patient management with universal DOT should be the standard public health treatment protocol, because it is both more effective and less expensive. A total of 659 patients were studied which included 257 traditional group and 402 in DOT group. The data shows that the treatment cost for traditional therapy is significantly higher ($27630 v/s $11260, P < 0.001). Out patient cost was significantly higher for patients treated with traditional therapy ($2920 v/s $2220) although personnel cost was greater for DOT group. Hospital costs were higher for patients treated with traditional group ($24710 v/s $9040, P < 0.001). The average cost of treatment failures was $94520 in the traditional group and $54350 in the observed group. Relapse or acquired resistance occurred in 10.9% of patients and accounted for 35.7% of the cost with traditional therapy as compared to 1.2% of patient and 6.0% of cost with observed therapy.

Drug default is the major hurdle in the management of TB and also the cause for relapse and treatment failure due to drug resistance. Non-compliant patient remains infectious for a longer period and is more likely to develop drug resistance. Non-compliance is usually associated with complex treatment regimens involving multiple drugs, prolonged duration of administration, confusing dosage schedule and unacceptable route of administration. Knowledge about disease and treatment can influence patient decision and is essential for treatment compliance. This study evaluates the role of better patient communication and motivation by the provider in improving the compliance to chemotherapy in pulmonary TB.

A randomized control trial was conducted with newly diagnosed pulmonary TB cases in the age group 15 to 70 years attending the chest clinic of Medical College and STC, Thiruvananthapuram, Kerala. The study population of 530 patients was randomly allotted to intervention (267) and control groups (263). The intervention group was provided with daily chemotherapy, innovative communication and motivation strategy, whereas the control group received daily chemotherapy with usual motivation by Social Worker/Treatment Organizer. Information provided to the patient was understandable, unbiased, and indicated both risks & benefits. Baseline characteristics like mean age, disease severity, and pre diagnostic cost were similar in both the groups. Most of the default occurred in the initial months of chemotherapy; 76% in the control and 50% in the intervention groups occurring during the second and third months of chemotherapy. Treatment completion rate was significantly lower in the control group (63%) compared to intervention group (85%). Mortality rate was 7% and 2% for control and intervention groups respectively (p = 0.0004).

In the multivariate analysis of the study population, age, co-morbidity, income and severity of disease did not emerge as significant predictors of compliance. Significantly higher treatment completion rate among the intervention group compared to the control group indicates that to get better results, curing should be combined with caring mode in the management of TB. The study highlights the need for improved communication with patients to help them successfully complete treatment without default.