Adherence to tuberculosis treatment: lessons ... - Wiley Online Library

Tropical Medicine and International Health volume 8 no 7 pp 625–633 july 2003

Adherence to tuberculosis treatment: lessons from the urban setting of Delhi, India A. Jaiswal1, V. Singh1, J. A. Ogden2, J. D. H. Porter2, P. P. Sharma1, R. Sarin1, V. K. Arora1 and R. C. Jain1 1 Lala Ram Sarup (LRS) Institute of Tuberculosis and Allied Diseases, New Delhi, India 2 London School of Hygiene and Tropical Medicine, London, UK

Summary

The Revised National Tuberculosis Control Programme (RNTCP), which incorporated the WHO DOTS strategy* was introduced in India in the mid-1990s. An operational research project was conducted between 1996 and 1998 to assess the needs and perspectives of patients and providers in two chest clinics in Delhi, Moti Nagar and Nehru Nagar, during the introduction of the new strategy. This paper reports on the findings of the project, concentrating on information collected from 40 in-depth interviews with patient defaulters and from non-participant observations in clinics and directly observed treatment centres. In Moti Nagar chest clinic, 117 of 1786 (6.5%) patients and 195 of 1890 (10%) patients in Nehru Nagar left care before their treatment was complete. It was argued that the reasons for default stem from a poor correlation between patient and programme needs and priorities, and from particular characteristics of the disease and its treatment. Patient needs that were not met by the health system included convenient clinic timings, arrangements for the provision for treatment in the event of a family emergency and provision for complicated cases like alcoholics. The problems facing the provider were poor interpersonal communication with the health staff, lack of attention and support at the clinic, difficulty for patients to re-enter the system if they missed treatment and, in certain areas, long distances to the clinic. Problems related to diseases were inability of the staff to deal with drug side-effects, and patients’ conception of equating well-being with cure. Simple, practical measures could improve the provision of tuberculosis (TB) treatment: more flexible hours, allowances for poor patients to reach the clinics and training health care staff for respectful communication and monitoring drug side-effects. The findings indicate a need to rethink the label of ‘defaulter’ often given to the patients. The important areas for future operational research is also highlighted. keywords tuberculosis treatment, DOTS, operational research, defaulters, Delhi, patient management

Introduction India bears approximately 30% of the world’s burden of tuberculosis (TB), with an estimated incidence of new smear positive cases of 85 per 100,000 population (WHO 1998). There are nearly 1 million new smear positive cases of TB each year and about 2 million total new cases (Khatri & Frieden 2000). The National Tuberculosis Control Programme (NTP), implemented in 1962, was appropriate to the overall social and economic context of the country at that time (Andersen 1962; Banerji & Andersen 1963). Its design was based on high quality * DOTS is the brand name (not an acronym) given to the current international strategy for tuberculosis control endorsed by the World Health Organization and the International Union Against Tuberculosis and Lung Disease. For an overview of the strategy see http://www.who.int/gtb/dots/index/htm.

ª 2003 Blackwell Publishing Ltd

operational research, particularly from the National Tuberculosis Institute, Bangalore, and the Tuberculosis Research Centre, Chennai, research that still receives worldwide acclaim (Ogden et al. 1999b). Many of the principles which are now globally recommended in the DOTS strategy were researched and documented in India (Khatri & Frieden 2000). A national sample survey in the mid-1950s documented the high prevalence of TB in India and the NTP was launched in 1962. Over the years it has encountered many problems of implementation (WHO 1992, 1998; Ogden et al. 1999a; Crofton 2000). Following a review of the Indian TB programme in 1993, a Revised National TB Programme (RNTCP) based on the WHO DOTS strategy (Maher et al. 1997; WHO 1999) was launched. After having pre-tested in pilot phases, the RNTCP is being applied all over country (Khatri & Frieden 2000). The essence of the strategy is to provide committed and

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volume 8 no 7 pp 625–633 july 2003

A. Jaiswal et al. Adherence to TB treatment in Delhi

work was funded by the UK Department for International Development (DFID) as part of its assistance to the development and implementation of the RNTCP. This was a substantial piece of work that linked qualitative and quantitative methods, allowing for a process of triangulation (UK Department for International Development 1998). In a previous paper (Singh et al. 2002), the flow and logistics of the system for TB patients within the clinics and where it was disrupted was described. The results indicated that the poorest, most vulnerable patients were less likely to receive DOT and were collated from interviews with DOT patients, health visitors and from non-participant observation. This paper, in contrast, addresses the broad theme of default using data collected from in-depth interviews with 40 people who had defaulted1 from TB treatment, in order to determine the factors which led to this discontinuation. The report also includes information from other pieces of the work, including the non-participant observation of patients in the DOT centres.

standardized care for patients suffering from TB in a manner acceptable to them. Directly observed treatment (DOT), in which a health worker observes and assists as patients take their medicine, is the most controversial/ debatable component (Uplekar et al. 1999; Frieden 1999; Lienhardt et al. 1999). In RNTCP districts, the policy is for all patients registered for short course anti-TB treatment under the government health care system to receive their drugs under direct observation (DOT) for at least the first 2 months – the intensive phase – of treatment (Revised National Tuberculosis Control Programme, Government of India 1997a,b). Directly observed treatment presents a range of challenges for both patients and providers, and is a good test for the user-friendliness of a delivery system. As Balasubramanian et al. (2000) have suggested, the more compliant and responsive the system is, the more successful will be the outcome of completed treatment courses. The group of patients who highlight the difficulties, weaknesses and problems within the management system of DOT are those who fail to complete treatment – the so-called defaulters. These are people whose needs for TB treatment are not met, for one or a range of reasons, by the delivery system. Exploring these reasons highlights problems in programme implementation and indicates specific adjustments that had to be made. In this paper the reasons for default as explained by the patients themselves were explored. This information was supplemented with the data collected through non-participant observations in the DOT centres.

The research was conducted to assess the needs and perspectives of RNTCP patients and providers in Nehru Nagar and Moti Nagar chest clinics in New Delhi (Department for International Development 1998). The project employed a qualitative approach2 using a range of quantitative and qualitative methods. In this section the approach taken in each of the domains of interest is briefly outlined.

Background

Programme performance

The introduction of the RNTCP occurred in October 1993 through pilot districts that were established in a population of 2.35 million in five sites in different states (Delhi, Kerala, West Bengal, Maharashtra and Gujarat). In 1995, the programme was expanded to a population of 13.85 million and then to 20 million in 1996. Rapid scaling-up of the programme began in late 1998 when another 100 million population were included under the RNTCP (Khatri & Frieden 2000). From August 1996 to April 1998, the Lala Ram Swarup (LRS) Institute, New Delhi, The Foundation for Research in Community Health, Mumbai and the London School of Hygiene and Tropical Medicine conducted a series of operational research studies in two of the pilot areas in New Delhi, Moti Nagar and Nehru Nagar. Moti Nagar is situated in the west of Delhi and Nehru Nagar in the south. Both clinics started implementing the RNTCP in 1996. The study areas included urban, peri-urban and rural populations and populations representing all strata of society. The

Programme performance was explored through two avenues: clinic and laboratory records review and nonparticipant observation. In addition the two TB registers were reviewed for the period March 1997 to January 1998.

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Methods

Community/household Research was conducted in households and the broader community in order to localize findings from the TB patients themselves in the broader context of local 1 The guidelines or the Revised National Tuberculosis (TB) Control Programme (RNTCP) state that a person who has defaulted is ‘a patient who, at any time after registration, has not taken anti-tuberculosis drugs for 2 months or more consecutively’ (RNTCP guidelines 1997 – Government of India). If a patient does not keep an appointment, action is taken immediately (known as defaulter tracing). 2 For more information on the details of this methodology see Ogden & Porter (1999), Ogden (2000) and Singh et al. (2002).





health- and treatment-seeking preferences and options. Open-ended structured interviews were conducted in 1600 households, and 32 focus group discussions conducted among different groupings in various communities within the study site areas.

interviews were conducted for 21 TB health visitors (DOT providers). Permission for the study was received from the ethics committees at the LRS Institute and the London School of Hygiene and Tropical Medicine.

Patient/symptomatic behaviour

Results

The perspectives and experiences of patients and people with chest symptoms identified through the community survey were explored through semi-structured interviews, in-depth interviews and case studies. Semi-structured interviews were conducted for 341 TB patients. These individuals were randomly selected from patients attending DOTS centres and chest clinics. All centres were included in the randomization. Detailed histories were taken from 10 cases: five who had successfully completed treatment and five who had not. Detailed case interviews were conducted for 40 defaulters. Names and addresses of these patients were randomly selected from the respective district TB registers. They were visited at home and interviewed in-depth (20 from each district area). If a particular individual could not be contacted on two home visits, then the person whose name was next on the list was interviewed. Each interview lasted for 15–20 min. Patients were asked to talk about their reasons for stopping treatment. When appropriate, family members were asked to identify social factors that might have contributed to the person’s defaulting, and the perceived support systems. Detailed case interviews were conducted with 59 symptomatic patients, some of whom were refused or denied treatment under the RNTCP. This information has been reported in the previous paper which focuses on the flow of patients in the system and socio-economic factors (Singh et al. 2002).

Overall the interviews indicated that people default because the treatment programme does not fit in with their everyday lives, and because of the aspects and treatment of the disease. Thus factors precipitating default can be understood as patient-related, provider-related and disease-related. It is proposed that it is the interaction of these factors that sometimes leads to the departure of patients from care, but that relatively small changes in the programme operations alone could make it substantially easier for patients to adhere to treatment than was the case during the fieldwork.

Health services provision: the client–provider interface This domain was explored through non-participant observation, structured and in-depth interview with doctors and frontline providers. Non-participant observation was conducted at 22 of the 25 DOT centres. Four major areas were observed: the infrastructure of the centre, the work of the TB health visitor, the flow of the patients through the centre and the way the health provider dealt with the logistics of programme requirements (such as completion of registers, collection of sputum, patient care and the supervision of treatment). The attitudes, experiences and perceptions of health care providers at different levels were also explored to some detail. Questionnaires were administered to 225 private (qualified and nonqualified) and government doctors, and detailed case


1. Programme/supply-side 1 Between June 1996 and October 1997, the Moti Nagar chest clinic registered 1786 patients under the RNTCP from its 11 peripheral TB centres (DOT centres). A total of 117 (6.5%) patients were classified as having defaulted from treatment. The Nehru Nagar chest clinic had registered 1890 patients between January 1996 and September 1997. This clinic had 14 community outreach centres (DOT centres) providing short-course chemotherapy under direct observation. Totally 195 (10%) patients were classified as having defaulted from treatment (Table 1). The research indicates that a number of factors precipitating default and enabling adherence, emanated from the features of programme structure and functioning. While some of these factors dovetail with the experiences and behaviour of the frontline providers (discussed below), others are more clearly programme-specific. These include issues of location and drug supply. Location Although most patients are within 2–5 km of a DOT centre, the distance could still be challenging for the very sick and/or for the very poor3, and six of the 40 default patients stated that the DOT centre was difficult to reach. Four DOT centres catered for patients in a wide geographical area. In these areas, patients had to travel 4–10 km three times weekly for their observed treatment. 3

See Singh et al. (2002) p. 697.

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Table 1 Individuals who leave the DOTS system (from record review)

Total patient registration Period of registration Default Transfer out Left locality Total patients leaving system

Moti Nagar chest clinic

Nehru Nagar chest clinic

1786

1890

June 1996– October 1997 31 29 57 117 (6.5%)

January 1996– October 1997 78 42 75 195 (10.3%)

Drug supply Regular, sustained drug supply is an essential element in the RNTCP. With the information that TB drugs were becoming available and that each patient had his or her own box of drugs, patients began to believe that they could be cured, and some cited this as an incentive to adhere to their complete course of therapy, despite the difficulties that entailed. 2. Provider or supply-side 2 The supply side of the defaulter equation includes both the programme issues highlighted above, and issues relating more directly to the actions and behaviour of the front-line treatment providers. It is important to note that these aspects are inter-related, as the behaviour of the front-line providers is often an outcome of having to do within the structures – and strictures – of the programme design. Thus while it was found that issues such as poor communication and lack of attention and support, from the provider to the patient sometimes precipitated default, those features or behaviours are at least partly the result of the lack of the very same inputs (communication, attention and support), from the programme to the provider. The following data relate to patients’ perceptions and experiences with their TB providers. Communication The behaviour and attitude of the TB health visitor (TBHV) towards the patients has an important bearing on the ability of the patients to continue treatment. According to this data, six of the 40 defaulters stated that they had defaulted because of the poor communication skills of the health workers, who were described as being rude or unhelpful. RJ’s case report illustrated this point:

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RJ, a 38-year-old man registered under RNTCP, had been regularly taking his drugs under DOT for 2 weeks when he had to face the wrath of the TBHV. There was a perennial water shortage at the centre, but a jug of water was usually kept available by the TBHV. RJ requested water because the jug was empty. The TBHV, already under stress, threw away his treatment card. Thus after 2 weeks of DOT he left and went back to the private doctor from where he had chosen the government sector. He is now continuing with the private sector. Lack of attention and support received at the clinics/DOT centres A related problem was the lack of attention or support sometimes given by the TBHV when patients experienced side-effects. This was an important factor as the following case illustrates: DV, a newly diagnosed pulmonary TB case, was coming regularly for DOT for 3 months. His fever was not improving and he had developed an unpleasant metallic taste in his mouth. Approaching the TBHV for help, he asked if a non-vegetarian diet would improve this problem. He was laughed at by the TBHV along with a number of others in the clinic and some personal remarks were made. This agitated the patient and he finally left treatment. It is important to stress that not all patients had bad experiences. Cases in which the TBHV strove diligently to find ways of supporting patients to enable them to continue treatment were also found. These examples are important in themselves, but also in so far as they underscore more generally the importance of support and care for patients, the effectiveness of this approach, and its feasibility within programmes. The following case is one illustration: B, a category 2 patient who originally came from Rajasthan, asked the TBHV to give him medicines for a month or two at a time, so that he could go back to his native village. The TBHV politely but firmly declined. She asked him why he wanted to go back to his village without completing his treatment. The patient told her there was no one to look after him here in town, and he was becoming weak and unable to earn his livelihood. He was now forced at times to go without food. In order to enable him to stay in town and remain on treatment, the TBHV organized a loan for him from other patients, and this loan enabled him to start a small petty shop at his home. Thus, not only did she prevent a potential default, but





could vouch for his regularity. The patient could not arrange this, however, as he did not know any suitable person in the city and thus never re-entered the TB care services.

she also helped in the economic rehabilitation of the patient. Barriers to re-entry after default Non-participant observation at the DOT clinics revealed the existence of barriers to re-joining treatment after a period of interruption. Having defaulted, these patients became labelled as ‘unlikely to comply’ who could no longer be trusted to complete their treatment, and who were thus deemed likely to ‘spoil the results of a TB centre’4. This information was supported from the results of in-depth interviews where nine of the 40 default patients reported that they had been perceived as ‘difficult cases’. Upon returning to the DOT centre after stopping treatment, the patients were sometimes treated rudely by the staff as the following case illustrates: DL is a very old man who lives with his wife but no extended family. He was working until 1995 when he fell ill with TB. Eventually he was enrolled as a patient at one of the DOT centres and commenced treatment. Sometime into his course, however, his wife fell ill and had to be hospitalized in a private hospital. During the period of her illness DL was compelled to interrupt his TB therapy in order to look after her. Later, when he approached the DOT centre again, he was advised to go back to Moti Nagar chest clinic for another sputum examination. He borrowed Rs 50 from a neighbour to reach the clinic, but when he arrived and explained his situation (that he had previously been on treatment but had stopped), the staff there behaved rudely towards him. DL felt hurt and insulted. He returned home and refused to join back. In other cases returning patients were asked to produce a guarantor from the community who could vouch for their ability and willingness to complete their course of treatment5. Obtaining such a guarantor can be difficult if not impossible for those who are poor and/or relatively new to the city as the following case shows. PC and B (both male patients under RNTCP) were regular in their drug-taking until they had to leave for their village due to sickness in the family. On their return after 10–14 days, they were both refused re-enrolment. PC was asked to bring a guarantor who

3. Patient/demand-side Forty interviews were conducted with individuals who were classified by the programme as having defaulted from treatment. Thirty (75%) were receiving category I treatment (newly diagnosed pulmonary sputum smear positive, seriously ill smear negative, or seriously ill extrapulmonary), while the remaining 10 (25%) were receiving category II treatment (re-treatment, relapse, failure, treatment after default). Of these patients, 32 (80%) were men and eight (20%) were women. The mean age of the group was 36 years (range 18–56 years). All those interviewed had knowledge of TB and details of their treatment plan. All were initially motivated and agreed to adhere to the treatment plan. Default retrieval action was taken in all cases by the TB health worker. The average time of default was 6 weeks ± 3 weeks after starting chemotherapy. Patient priorities vs. programme structure The reasons patients leave treatment often relate to practical difficulties posed by the requirements of the programme. For example, 12 of 40 patients interviewed had left the area and returned to their home village for family emergencies (illness and death) and to fulfil family obligations (such as attendance at marriages). Many patients in the city, particularly from the lower income areas, are recent migrants with strong rural bonds. Often their entire family reside in the village while they venture out to cities in search of jobs to financially support the family. When crises arise, they are compelled to return home. Within the programme no provision could be made to enable patients to remain on treatment during these periods. Other practical problems highlighted in the interviews related to timing of the DOT centres. Many of the defaulters were compelled to leave treatment because they could not manage to get to work in time having gone to the centre and queued for DOT6. Thus they left treatment in order to retain their jobs. D had been very regular in his DOT schedule. He was getting better and wanted to rejoin duty in a bank as he had been on a long leave. But he found that he would be late for work if he went to the DOT clinic

4

See Ogden (2000) and the discussion in Singh et al. (2002). Also a discussion on the issues of targets within the domain of policies for infectious disease control in Porter et al. 1999. 5 This issue is discussed in detail in Singh et al. (2002) on p. 699.


6

See Singh et al. (2002) p. 697.

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which opened at 09:00. So, he asked his wife to collect drugs for him. This worked for a few doses but later the TBHV refused, as rules do not allow patients to take their treatment unobserved. As this patient could not remain out of work, and could not continue his treatment due to the clinic timings, he was compelled to default. The imperatives of employment, coupled with relative inflexibilities in the programme, also interfered with treatment for those who obtained a new job placement – either outside of Delhi or in a different part of Delhi, and for those having to leave town temporarily on business (10% of patients). Further problems arose for patients who were both poor and the sole wage earners in their families. The long duration of treatment, coupled with the requirement to go to the DOT centre to take their drugs three times per week, made it difficult to work and support their family. For these patients it made sense to leave treatment, as soon as they were able to work again. As one respondent, a fairly recent migrant to Delhi, noted: …. ‘We cannot remain out of a job for long. As soon as we feel better we would like to go to work. What do we do in this distant land (i.e. the city)? We have come here to earn and support our family. If I cannot earn, my whole family will suffer’. Alcoholism It is important to note, however, that practicalities were not the only blocks to treatment completion described by the patients and family members interviewed. For example, 11 of 40 interviewees described default due to alcoholism. Some of these individuals were simply uninterested in treatment, and were not amenable to suggestion or persuasion. These patients often get labelled as a difficult case by the health workers, and comments from family members sometimes concur with this label. As one family member noted … ‘When he cannot stop drinking, how can he be cured? He is not responsible for himself and we are not bothered about him any more’.

well-known within biomedicine, patients in our sample received little information about them and when the patient approached the health care delivery system for assistance, the TBHV had no symptomatic treatment available. Indeed the health visitors themselves were not given the information and logistical support they needed to help patients. It was found, for example, that when a TBHV asked her senior about the side-effects experienced by patients she was told: ‘No, there are no side-effects. Ask the patient to develop a strong will and continue with the treatment’. The poor understanding of these complaints and an inability of the TBHV to deal with them led to a lack of trust and confidence among the patients under care. The sheer number of tablets was also a problem for some patients. Among some people in India there is a belief that allopathic drugs are hot and produce a lot of heat in the body leading to side-effects. The amount of heat is related to the number of tablets ingested per day. As one patient lamented: ‘Nine tablets! Tell me, how can I have them at one go? They are also so big and I always feel nauseated when I eat them. So many times I vomited at the clinic itself.’ Clearly these issues became problematic because the clinic staff were neither trained nor equipped to support patients with them. The following case highlights this point: MS is a 35-year-old man who is a tailor of women’s garments, in a busy shop. Having started on shortcourse chemotherapy under DOT, he began to experience severe side effects (giddiness, severe lethargy, sleepiness for days, and loss of appetite) and could not bear to complete even the intensive phase of treatment. The side effects incapacitated him severely and he was unable to do any work. He approached his DOT centre at Moti Nagar for his problems but got little relief. He was unhappy with the attitude of the doctors at the clinic. Allegedly, at the clinic he was made to sit 6 metres distance from the provider. The doctor, he told us, heard only half of his complaint and then used ‘inconsiderate words’. Dissatisfied, he decided that he would not take his drugs any more.

4. Disease or process issues Two key disease or processes issues were highlighted in the work on default: the impact of side-effects and patients’ physical response to treatment. Twenty of 40 default patients interviewed reported side-effects of anti-TB drugs severe enough to precipitate default. Side-effects included: giddiness (n ¼ 14), vomiting (n ¼ 11), restlessness (n ¼ 7), excessive sleepiness and lethargy (n ¼ 8). Despite these problems, and despite the fact that these side-effects are

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Response to treatment Ten patients felt that their condition had worsened or not improved with treatment. The opinion of these patients was that ‘the drugs don’t suit me, so I had to stop taking them’. Conversely, few (two of 40) patients felt that their condition had improved. This led them to think they were cured, and therefore not in need of continued treatment.





Co-morbidity A small number of patients had severe breathlessness and could not reach the facilities. This is illustrated by BL’s experience. BL is an elderly smoker, suffering from severe breathlessness due to chronic obstructive respiratory disease. He happened to suffer from TB also. After he started the DOT regime, he found that the distance to the centre was too much for his physical condition and he could not afford to spend money on transport. He would get breathless and had to rest 3–4 times on his way to reach the centre. He soon started mistrusting the system, since instead of healing his ailment and curing his breathlessness it had added inconvenience. He subsequently left the RNTCP for treatment elsewhere. Discussion The data reported here show that default from TB treatment is the product of programme problems or failures as much as, if not more than, patient problems or failures. Viewing default as a patient problem alone is not only inaccurate, it is also unhelpful, as it does not empower programmes and programme implementors to identify and solve these problems. This leads us to question the label ‘defaulter’ when referring to patients who have left treatment. A dictionary definition of default offers the following: failure to perform a task or fulfil an obligation, loss by failure to appear, to fail to do what is required. If one assumes that TB programmes have an obligation to ensure all patients reporting to them for diagnosis and treatment are cured, then they have not only ‘failed to fulfil this obligation’ in the case of defaulters, but they have ‘failed to do what is required’ to enable the patients to stay in care. The obligations patients carry are multiple and often conflicting. They have obligations to their immediate families to provide food and shelter. They have obligations with their extended families to participate in important events and rituals. They have obligations to their employers to carry out the tasks expected of them. The failure of these patients ‘to appear’ for their thrice weekly DOT, and their explanations for this failure vividly illustrate the mismatch between the programme and daily life, and highlight very clearly areas requiring change. However, it is important to reiterate that the data were collected at a time of lesson learning, and studies such as the present one were useful in supporting policy makers and programmers in improving the strategies. The study was conducted only 2 years after the DOTS strategy was


launched by the WHO, and less than 1 year into the piloting of the RNTCP in India. As of 2002, important changes have occurred in both, which reflect that many of these important lessons have been learned (http:// www.tbindia.org; World Health Organization 2002). Despite these encouraging changes, however, it is clear that problems in the implementation of DOTS persist in some parts of the region. The implementation of the DOT element has proven particularly problematic (Balasubramanian et al. 2000). Indeed the relative importance of DOT for ensuring patient adherence has been questioned. In a randomized controlled trial in Pakistan, Walley et al. (2001) demonstrated that the health-worker DOT model (like that used in the RNTCP) was no more effective in ensuring the completion of treatment than either family member DOT or self-administration. While these findings are an important addition to the small evidence base on the effectiveness of DOT, perhaps the most useful contribution is around the feasibility of the patient’s choice in determining an appropriate treatment strategy. TB control will not be hampered by introducing some flexibility, giving patients some degree of choice in selecting the form of treatment management most suited to their daily lives. While we support these and other efforts to establish an evidence-base around DOT, this paper does not endeavour to challenge the use or appropriateness of this approach to treatment management. Instead, we seek to highlight surmountable obstacles and give guidance for its effective implementation. In so doing, we hope to continue to contribute to the revision and expansion of the expression, concept and effectiveness of the DOTS strategy as is being undertaken at the WHO (WHO 2002). There are a number of key elements in the revised DOTS strategy that the data from this study speak to (WHO 2002). The WHO state that the revised DOTS strategy is a ‘comprehensive support strategy – support to all providers, patients and people to tackle the problem of TB’. They note that the new effort gives equal attention to the technomanagerial and socio-political dimensions of TB control, giving ‘due attention to problem-solving and programmeoriented operations research’. The revised strategy further calls for the administration of short-course chemotherapy under ‘technically sound and socially supportive casemanagement conditions’, giving patients support and care that is ‘sensitive to their needs’. The data reported here can contribute to the Indian programme’s efforts, and thereby, improve the DOTS service they offer, and indicate how substantive operational research can enable programmes here and elsewhere to discover how to put the principles and guidelines set out in the revised DOTS strategy into practice.

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Simple practical changes can be made to the provision of DOTS to enable more patients to complete treatment. These measures include: more extensive/flexible hours of operation; reasonable allowances for patients who need to travel to meet family or employment obligations; training in patient care including management of side-effects; respectful and skilled communication; facilitate defaulter re-entry and measures to improve patient access to medical officers through strengthened integration of DOTS with primary health centre (PHC) (Singh et al. 2002). In addition, our data indicate two key areas for future operational research on TB in India. The first is around the question of support – a key feature of the revised DOTS framework. The data indicated that support to patients needs to be both practical and emotional. But what support means to patients, how and where they obtain it in their households and communities is less well understood. By learning more about patient support structures and networks, possibilities to develop on these lines to further strengthen the programme efforts can be explored. A second area demanding further enquiry is related to the first. This paper, like others in the literature, has focused largely on the problems. We spoke with, and have reported the stories of, patients who were unable to complete their course of treatment for a variety of reasons. Less work has been carried out for exploring the parameters and indicators of success. Key questions to be asked include what it that makes the difference for patients who are able to complete their therapy? ‘What is it about the personal, social and logistical aspects of people’s lives that enable them to be cured of TB?’ ‘To what extent can programmes manufacture these conditions for all patients?’ Tuberculosis is an ancient disease with which human communities have lived for many millennia. Freeing individuals, households and communities from TB is an enormous and ambitious undertaking. Achieving it will mean that all participants involved are responsible for doing their part. Taking steps to change the way we think about it is important. This may mean taking a new look at the way we use language that stigmatizes and places undue onus on one responsible set of patients over another (for example, misleadingly labelling patients as defaulters). A second important step is to undertake operational research, which enables us to turn our gaze inward at our own practices, highlighting the problems therein and showing us how to make the most effective and sustainable contribution towards effective and sustainable TB control. Acknowledgements We thank Dr Mukund Uplekar, Dr Sheela Rangan, Dr Morankar, and Sanjay Juvekar at the Foundation for 632

Research in Community Health, Mumbai, for their considerable work on this project. The work was funded by the UK Department for International Development (DFID). References Andersen S (1962) Some aspects of the economics of tuberculosis in India. Indian Journal Tuberculosis 9, 176. Balasubramanian VN, Oomme K & Samuel R (2000) DOT or not? Direct observation of anti-tuberculosis treatment and patient outcomes, Kerala state, India. International Journal of Tuberculosis Lung Disease 4, 409–413. Banerji D & Andersen S (1963) A sociological study of awareness of symptoms among persons with pulmonary tuberculosis. Bulletin World Health Organisation 29, 665. Crofton J (2000) Good news from India. International Journal of Tuberculosis Lung Disease 4, 189–190. Frieden TR (1999) Directly observed therapy and tuberculosis treatment completion. American Journal of Public Health 89, 604–605. Khatri GR & Frieden TR (2000) The status and prospects of tuberculosis control in India. International Journal of Tuberculosis Lung Disease 4, 193–200. Lienhardt C, Rowley J & Manneh K (1999) Directly observed treatment for tuberculosis. Lancet 353, 145–146. Maher D, Hausler HP, Raviglione MC et al. (1997) Tuberculosis care in community care organizations in sub-Saharan Africa: practice and potential. International Journal of Tuberculosis Lung Disease 1, 276–283. Ogden J (2000) Improving tuberculosis control – social science inputs. Transactions of the Royal Society of Tropical Medicine 94, 135–140. Ogden JA & Porter JDH (1999) Leprosy: applying qualitative techniques to research and intervention. Leprosy Review 70, 129–135. Ogden J, Rangan S & Lewin S (Eds) (1999a) TB control in India: a State of the Art Review. London School of Hygiene and Tropical Medicine, London. Ogden JA, Rangan S, Uplekar M et al. (1999b). Shifting the paradigm in tuberculosis Control: illustrations from India. International Journal of Tuberculosis Lung Disease 3, 855–861. Porter JDH, Ogden JA & Pronyk P (1999) Infectious disease policy: towards the production of health. Health Policy and Planning 14, 322–328. Revised National Tuberculosis Control Programme, Government of India (1997a) Technical Guidelines for Tuberculosis Control. Central TB Division, Directorate General Health Services, New Delhi. Revised National Tuberculosis Control Programme, Government of India (1997b) Operational Guidelines for Tuberculosis Control. Central TB Division, Directorate General Health Services, New Delhi. Singh V, Jaiswal A, Porter JDH et al. (2002) TB control, poverty and vulnerability in Delhi, India. Tropical Medicine and International Health 7, 693–700.





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Authors Dr A. Jaiswal, Dr V. Singh, Dr P. P. Sharma, Dr R. Sarin, Dr V. K. Arora and Dr R. C. Jain, Lala Ram Sarup Institute of Tuberculosis and Allied Diseases, LRS, Sri Aurobindho Marg, New Delhi, 110 030, India. Tel.: 6854922/6854929; Fax: 0091-11-6517834; E-mail: [email protected] Dr J. D. H. Porter (corresponding author) and Dr J. A. Ogden, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7 HT, UK. E-mail: [email protected]


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