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MA Khan, JD Walley, SN Witter, SK Shah, S Javeed, Tuberculosis patient adherence to direct observation: results of a social study in Pakistan, Health Policy and Planning, Volume 20, Issue 6, November 2005, Pages 354–365, https://doi.org/10.1093/heapol/czi047
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Abstract
A randomized controlled trial was carried out in Pakistan in 1999 to establish the effectiveness of the direct observation component of DOTS programmes. It found no significant differences in cure rates for patients directly observed by health facility workers, community health workers or by family members, as compared with the control group who had self-administered treatment. This paper reports on the social studies which were carried out during and after this trial, to explain these results. They consisted of a survey of all patients (64% response rate); in-depth interviews with a smaller sample of different types of patients; and focus group discussions with patients and providers. One finding was that of the 32 in-depth interview patients, 13 (mainly from the health facility observation group) failed to comply with their allocated DOT approach during the trial, citing the inconvenience of the method of observation. Another finding was that while patients found the overall TB care approach efficient and economical in general, they faced numerous barriers to regular attendance for the direct observation of drug-taking (most especially, time, travel costs, ill health and need to pursue their occupation). This may be one of the reasons why there was no overall benefit from direct observation in the trial. Provider attitudes were also poor: health facility workers expressed cynical and uncaring views; community health workers were more positive, but still arranged direct observation to suit their, rather than patients’, schedules. The article concludes that direct observation, if used, should be flexible and convenient, whether at a health facility close to the patient's home or in the community. The emphasis should shift in practice from tablet watching towards treatment support, together with education and other adherence measures.
Introduction
Tuberculosis (TB) remains one of the most common causes of adult deaths in developing countries. Numbers of cases are continuing to grow, due to population growth, HIV and, in some circumstances, inadequate treatment. There is therefore considerable interest in improving the performance of health services in treating TB, and in particular in increasing patient adherence. Non-adherence rates are often high, and can lead to relapse and the development of drug-resistant strains, which are harder and more expensive to treat.
The search for improved treatment and improved patient adherence led to the development of the DOTS (directly observed therapy, short course) strategy, with its five key elements of strengthening diagnosis, treatment, outcome monitoring, drug supplies and direct observation of treatment. The implementation of DOTS programmes has led to improved cure rates (see the systematic review by Volmink and Garner 2002). However, there has been some debate about how much additional benefit is derived from the element of direct observation.
Observational studies in India found that early DOTS successes were based, at least partly, on patient selection by health workers; patients who would be able to comply with the DOT regime were identified, with ‘unsuitable’ patients being denied the short-course treatment (Porter and Grange 1999; Singh et al. 2002). A study in South Africa (Zwarenstein et al. 2000) found some benefit from DOT using lay health workers, but the result was not statistically significant. A study in Swaziland (Wright et al. 2004) also found no significant difference in cure rates between direct observation by community health workers (CHWs) and by family members. A Thai study (Kamolratanakul et al. 1999) found DOT to be effective, but they had adapted the original DOT model, including a choice of DOT (nearly all chose DOT by family members), supported by a once-weekly home visit from health workers.
A review of DOT and treatment adherence (Volmink et al. 2000) emphasized the importance of a wide array of interventions to promote adherence, such as reminder letters, financial incentives and increased supervision by staff. The study observed that factors such as the quality of interaction between patients and supervisors may be more relevant than the DOT itself, and recommended that the World Health Organization (WHO) make explicit both the mixture of inputs which are required to improve adherence and the additional resources which successful implementation of DOT usually requires. These issues were later incorporated in the WHO framework and guidelines (WHO 2002, 2003), which recognized that DOT should be applied to fit patients’ needs and that the issue of adherence to treatment is complex and multidimensional, with DOT being just one of a wide range of measures recommended to promote treatment adherence.
A clinical trial was conducted in Pakistan from 1996 to 1999 (see Walley et al. 2001) to determine which form of DOT was most effective. It concluded that the strengthened TB care (following the WHO/StopTB strategy known as DOTS) in the then operational conditions in Pakistan increased cure rates from 26% to 60% in the trial group as a whole. However, there was no statistically significant difference between the health worker DOT, family member DOT or self-administered (control) arms. There were similar results from the trial's three sites. Within the health worker arm, according to the international practice, if patients had reasonable access (less than 2 km/low travel cost), they were requested to attend their chosen health facility, while others were observed by a CHW of their choice, commonly a Lady Health Worker (LHW). Sub-group analysis showed that those within the health worker arm allocated to health facility direct observation had worse outcomes than those overall. The lack of a benefit from DOT, and poor results from health facility DOT in particular, raised some important questions for the implementation of the DOT strategy in this and other countries.
Alongside the clinical trial, an economic study was carried out to investigate the costs faced by the health service and the patients under the different arms. Cost-effectiveness analysis, using these data, suggested that health worker observation was the least cost-effective strategy; that the control group (self-administered) was most cost-effective; and that the group observed by CHWs achieved the highest cure rates at a cost only slightly higher than the self-administered group (Khan et al. 2002). This study suggested that the high costs of attending health centres might be deterring patients, and in particular, economically active patients who have most to lose from the time taken in attending.
In order to investigate the factors affecting patient adherence and non-adherence with different strategies, social studies were carried out before and after the clinical trial. The first one, focusing on identifying socio-cultural factors to be considered in the design of the study, has been published (Khan et al. 2000). This paper presents the results of social studies carried out during and after the trial, to shed light on the results of the clinical trial.
Methods
The randomized controlled clinical trial
The randomized controlled trial was carried out with a total of 497 patients in three study arms across three trial sites in Pakistan. All received a strengthened TB care service (i.e. the other components of DOTS), but those in one arm had their treatment supervised by health workers, those in a second were supervised by family members, and the third arm were self-administered. Within the arm supervised by health workers, patients were divided into two sub-groups: those living within 2 km of the nearest health centre were supervised by health workers based in those centres, while more distant patients visited their local CHW (commonly a LHW). The health worker DOT followed the WHO guidelines, adapted to the Pakistan context. In contrast, family member DOT is not recommended by WHO but was included as a possible alternative when access to health workers is poor. The self-administered group was the current practice in Pakistan and was included as a control.
The treatment takes 8 months. The ‘intensive phase’, during which observation of treatment is carried out, covers the first 2 months. Three visits to a diagnostic centre are required during the first 2 months, for initial diagnosis, sputum smears and follow-up. During the remaining 6 months, a further two visits should be made for sputum examination and clinical assessment. During this second phase, all treatment groups visit their local health facility every 2 weeks to collect their drugs.
The difference between the arms lies in the number of daily visits required for direct observation of treatment during the first 2 months. Patients allocated to the health facility group made an additional 40 visits during this period to their local health facility to be watched taking their drugs, while the CHW group visited their village health worker an additional 53 times, and family member patients had 53 meetings with the family member chosen to supervise their drug taking.
The outcome was measured in terms of cure rates for the different arms, using the WHO/International Union Against Tuberculosis and Lung Disease definition of cure – sputum smear-negative at 7 or 8 months, and on at least one previous occasion.
Social studies
Post-trial social survey
A survey was conducted towards the completion of trial implementation, just before conducting the second qualitative study, which is described below. The main purpose was to understand the patients’ perceptions and experiences of TB care, including direct observation. The main areas explored in the study were: perceived health status; constraints to accessing the health services (including community-based health workers); TB-associated stigma; experience of direct observation; social support received from the family; and reasons for stopping the treatment early.
All the registered trial patients were visited by teams of trained interviewers (each team had two interviewers and a supervisor). The data collection process was monitored by the Regional Co-ordinators. Three hundred and sixteen trial patients (i.e. 64% of the total number) were interviewed using a structured questionnaire. Incomplete or changed address, patient death, patient unavailability or refusals were the main reasons for not being able to interview all the trial patients. The study helped the research team to identify areas for further exploration in the in-depth interviews and focus group discussions (FGDs).
Post-trial interviews and FGDs
A second qualitative study was conducted towards the completion of trial activities in Pakistan. The purpose was to understand the attitudes, social pressures and enabling factors that influenced the patients’ adherence to the treatment protocols (in particular, direct observation), and to provide suggestions for improving the acceptability and effectiveness of DOT approaches in Pakistan.
The qualitative study consisted of 39 semi-structured interviews with various classes of male and female trial patients in Rawalpindi district (see Table 1 for details). A group of four trained field interviewers (two male and two female) visited the selected trial patients, at their residence, to conduct in-depth interviews in a period of about 15 days. The interview checklist was developed, field-tested and refined by the research team before being used in the study. Patients were selected randomly from the lists prepared separately for each class of patient to be interviewed. The trial field staff facilitated the interviewers’ access to the trial patients.
Direct observation option . | Successful . | . | . | . | Defaulter . | . | Total . | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
. | Female . | . | Male . | . | Female . | Male . | . | ||||
. | Rural . | Urban . | Rural . | Urban . | . | . | . | ||||
Health facility | 2 | 1 | 2 | 2 | 1 | 1 | 9 | ||||
Community health worker | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Family member | 2 | 2 | 2 | 3 | – | 1 | 10 | ||||
Self-administered | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Total | 8 | 7 | 8 | 9 | 3 | 4 | 39 |
Direct observation option . | Successful . | . | . | . | Defaulter . | . | Total . | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
. | Female . | . | Male . | . | Female . | Male . | . | ||||
. | Rural . | Urban . | Rural . | Urban . | . | . | . | ||||
Health facility | 2 | 1 | 2 | 2 | 1 | 1 | 9 | ||||
Community health worker | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Family member | 2 | 2 | 2 | 3 | – | 1 | 10 | ||||
Self-administered | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Total | 8 | 7 | 8 | 9 | 3 | 4 | 39 |
Direct observation option . | Successful . | . | . | . | Defaulter . | . | Total . | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
. | Female . | . | Male . | . | Female . | Male . | . | ||||
. | Rural . | Urban . | Rural . | Urban . | . | . | . | ||||
Health facility | 2 | 1 | 2 | 2 | 1 | 1 | 9 | ||||
Community health worker | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Family member | 2 | 2 | 2 | 3 | – | 1 | 10 | ||||
Self-administered | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Total | 8 | 7 | 8 | 9 | 3 | 4 | 39 |
Direct observation option . | Successful . | . | . | . | Defaulter . | . | Total . | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
. | Female . | . | Male . | . | Female . | Male . | . | ||||
. | Rural . | Urban . | Rural . | Urban . | . | . | . | ||||
Health facility | 2 | 1 | 2 | 2 | 1 | 1 | 9 | ||||
Community health worker | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Family member | 2 | 2 | 2 | 3 | – | 1 | 10 | ||||
Self-administered | 2 | 2 | 2 | 2 | 1 | 1 | 10 | ||||
Total | 8 | 7 | 8 | 9 | 3 | 4 | 39 |
The patient interviews in Rawalpindi were supplemented by eight FGDs with various classes of trial patients in Gujranwala and Sahiwal districts (see Table 2), and three FGDs with family member supervisors, health facility staff and CHWs in Rawalpindi district. Two trained social scientists, facilitated by the trial field staff, conducted the FGDs. The checklists for the discussions with patients and care providers were developed, field-tested and refined by the research team. A FGD was arranged with defaulters, but never carried out, due to the failure of the defaulters to attend.
Direct observation option . | Focus group of trial patients . | . | |
---|---|---|---|
. | Female . | Male . | |
Health facility staff | 1 | 1 | |
Community health worker | 1 | 1 | |
Family member | 1 | 1 | |
Self-administered | 1 | 1 | |
Total | 4 | 4 |
Direct observation option . | Focus group of trial patients . | . | |
---|---|---|---|
. | Female . | Male . | |
Health facility staff | 1 | 1 | |
Community health worker | 1 | 1 | |
Family member | 1 | 1 | |
Self-administered | 1 | 1 | |
Total | 4 | 4 |
Direct observation option . | Focus group of trial patients . | . | |
---|---|---|---|
. | Female . | Male . | |
Health facility staff | 1 | 1 | |
Community health worker | 1 | 1 | |
Family member | 1 | 1 | |
Self-administered | 1 | 1 | |
Total | 4 | 4 |
Direct observation option . | Focus group of trial patients . | . | |
---|---|---|---|
. | Female . | Male . | |
Health facility staff | 1 | 1 | |
Community health worker | 1 | 1 | |
Family member | 1 | 1 | |
Self-administered | 1 | 1 | |
Total | 4 | 4 |
Results
Survey
The survey covered patient perceptions of:
constraints to visiting health centres;
constraints to visiting CHWs;
motivation for direct observation;
type of family support received during treatment;
reasons for non-completion of course; and
ways of motivating patients to keep appointments at the treatment centre.
Patients were asked to list the main constraints to visiting the nearest health centre. Results are presented in the Table 3, disaggregated by locality, gender and arm of treatment.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 115) . | (n = 115) . | (n = 230) . | (n = 117) . | (n = 113) . | (n = 230) . | (n = 33) . | (n = 57) . | (n = 72) . | (n = 68) . | (n = 230) . |
Cost of travel/visit | 23 | 23 | 23 | 20 | 26 | 23 | 9 | 32 | 24 | 21 | 23 |
Job/occupational reasons | 19 | 20 | 19.5 | 24 | 15 | 20 | 24 | 14 | 21 | 21 | 20 |
Time for round trip | 15 | 23 | 19 | 15 | 23 | 19 | 15 | 16 | 22 | 19 | 19 |
Social events: marriage/birth/death | 6 | 3 | 4 | 0 | 9 | 4 | 3 | 7 | 1 | 6 | 4 |
Unavailability of person to accompany | 10 | 3.5 | 7 | 6 | 8 | 7 | 6 | 10.5 | 3 | 9 | 7 |
Health related reasons | 19 | 14 | 16.5 | 23 | 10 | 16.5 | 18 | 19 | 14 | 16 | 16.5 |
Excessive waiting time at treatment centre | 3 | 11 | 7 | 9 | 6 | 7 | 12 | 2 | 11 | 4 | 7 |
Unfriendly attitude of staff | 4 | 3.5 | 4 | 4 | 3.5 | 4 | 9 | 0 | 4 | 4 | 4 |
Lack of social support by significant people | 1 | 0 | 0.5 | 1 | 0 | 0.5 | 3 | 0 | 0 | 0 | 0.5 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 115) . | (n = 115) . | (n = 230) . | (n = 117) . | (n = 113) . | (n = 230) . | (n = 33) . | (n = 57) . | (n = 72) . | (n = 68) . | (n = 230) . |
Cost of travel/visit | 23 | 23 | 23 | 20 | 26 | 23 | 9 | 32 | 24 | 21 | 23 |
Job/occupational reasons | 19 | 20 | 19.5 | 24 | 15 | 20 | 24 | 14 | 21 | 21 | 20 |
Time for round trip | 15 | 23 | 19 | 15 | 23 | 19 | 15 | 16 | 22 | 19 | 19 |
Social events: marriage/birth/death | 6 | 3 | 4 | 0 | 9 | 4 | 3 | 7 | 1 | 6 | 4 |
Unavailability of person to accompany | 10 | 3.5 | 7 | 6 | 8 | 7 | 6 | 10.5 | 3 | 9 | 7 |
Health related reasons | 19 | 14 | 16.5 | 23 | 10 | 16.5 | 18 | 19 | 14 | 16 | 16.5 |
Excessive waiting time at treatment centre | 3 | 11 | 7 | 9 | 6 | 7 | 12 | 2 | 11 | 4 | 7 |
Unfriendly attitude of staff | 4 | 3.5 | 4 | 4 | 3.5 | 4 | 9 | 0 | 4 | 4 | 4 |
Lack of social support by significant people | 1 | 0 | 0.5 | 1 | 0 | 0.5 | 3 | 0 | 0 | 0 | 0.5 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 115) . | (n = 115) . | (n = 230) . | (n = 117) . | (n = 113) . | (n = 230) . | (n = 33) . | (n = 57) . | (n = 72) . | (n = 68) . | (n = 230) . |
Cost of travel/visit | 23 | 23 | 23 | 20 | 26 | 23 | 9 | 32 | 24 | 21 | 23 |
Job/occupational reasons | 19 | 20 | 19.5 | 24 | 15 | 20 | 24 | 14 | 21 | 21 | 20 |
Time for round trip | 15 | 23 | 19 | 15 | 23 | 19 | 15 | 16 | 22 | 19 | 19 |
Social events: marriage/birth/death | 6 | 3 | 4 | 0 | 9 | 4 | 3 | 7 | 1 | 6 | 4 |
Unavailability of person to accompany | 10 | 3.5 | 7 | 6 | 8 | 7 | 6 | 10.5 | 3 | 9 | 7 |
Health related reasons | 19 | 14 | 16.5 | 23 | 10 | 16.5 | 18 | 19 | 14 | 16 | 16.5 |
Excessive waiting time at treatment centre | 3 | 11 | 7 | 9 | 6 | 7 | 12 | 2 | 11 | 4 | 7 |
Unfriendly attitude of staff | 4 | 3.5 | 4 | 4 | 3.5 | 4 | 9 | 0 | 4 | 4 | 4 |
Lack of social support by significant people | 1 | 0 | 0.5 | 1 | 0 | 0.5 | 3 | 0 | 0 | 0 | 0.5 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 115) . | (n = 115) . | (n = 230) . | (n = 117) . | (n = 113) . | (n = 230) . | (n = 33) . | (n = 57) . | (n = 72) . | (n = 68) . | (n = 230) . |
Cost of travel/visit | 23 | 23 | 23 | 20 | 26 | 23 | 9 | 32 | 24 | 21 | 23 |
Job/occupational reasons | 19 | 20 | 19.5 | 24 | 15 | 20 | 24 | 14 | 21 | 21 | 20 |
Time for round trip | 15 | 23 | 19 | 15 | 23 | 19 | 15 | 16 | 22 | 19 | 19 |
Social events: marriage/birth/death | 6 | 3 | 4 | 0 | 9 | 4 | 3 | 7 | 1 | 6 | 4 |
Unavailability of person to accompany | 10 | 3.5 | 7 | 6 | 8 | 7 | 6 | 10.5 | 3 | 9 | 7 |
Health related reasons | 19 | 14 | 16.5 | 23 | 10 | 16.5 | 18 | 19 | 14 | 16 | 16.5 |
Excessive waiting time at treatment centre | 3 | 11 | 7 | 9 | 6 | 7 | 12 | 2 | 11 | 4 | 7 |
Unfriendly attitude of staff | 4 | 3.5 | 4 | 4 | 3.5 | 4 | 9 | 0 | 4 | 4 | 4 |
Lack of social support by significant people | 1 | 0 | 0.5 | 1 | 0 | 0.5 | 3 | 0 | 0 | 0 | 0.5 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
In urban areas, cost and time are the largest constraints to accessing health centres, compared with occupational reasons and health for rural areas. For men, cost, time and occupational reasons rank foremost, which is not dissimilar to women, although health, rather than time, comes third in their ranking. Unavailability of a person to accompany them and social events are more significant issues for woman than for men.
Looking at the different treatment arms, some of the results are unexpected, but may be explained by the fact that, within the health worker arm, people were allocated to health facility supervision on the basis of reasonable access, that is, living within 2 km of the facility (hence the low ranking of cost of travel for this group).
Table 4 gives responses on constraints to visiting the CHW/LHW. Time comes out as the major factor, in general, scoring higher amongst males, in rural areas, and for the self-administered group. Health problems are the next most cited constraint, with an especially high profile for patients in the health facility arm. For women, confidentiality gets a relatively high score. Few in any categories have concerns about CHW attitudes. An unexpectedly high proportion (31%) of the CHW arm patients report that they have no CHW nearby, perhaps a reflection of their experience in having to walk to the CHW's house.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 60) . | (n = 48) . | (n = 108) . | (n = 63) . | (n = 45) . | (n = 108) . | (n = 15) . | (n = 45) . | (n = 20) . | (n = 28) . | (n = 108) . |
Socially unacceptable to patient | 3 | 8 | 5.5 | 6 | 4 | 5 | 0 | 4 | 10 | 7 | 6 |
Socially unacceptable to family | 13 | 2 | 8 | 6 | 11 | 8 | 7 | 4 | 20 | 7 | 8 |
Confidentiality concern | 22 | 8 | 16 | 14 | 18 | 16 | 7 | 9 | 30 | 21 | 16 |
Lack of suitable time to visit | 25 | 35 | 30 | 36 | 20 | 30 | 27 | 25 | 20 | 46 | 30 |
Health problems | 20 | 29 | 24 | 24 | 24 | 24 | 47 | 22 | 20 | 18 | 24 |
Unfriendly attitude of CHW | 0 | 4 | 2 | 2 | 2 | 2 | 0 | 4 | 0 | 0 | 2 |
No CHW nearby | 17 | 12.5 | 15 | 11 | 20 | 15 | 13 | 31 | 0 | 0 | 15 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 60) . | (n = 48) . | (n = 108) . | (n = 63) . | (n = 45) . | (n = 108) . | (n = 15) . | (n = 45) . | (n = 20) . | (n = 28) . | (n = 108) . |
Socially unacceptable to patient | 3 | 8 | 5.5 | 6 | 4 | 5 | 0 | 4 | 10 | 7 | 6 |
Socially unacceptable to family | 13 | 2 | 8 | 6 | 11 | 8 | 7 | 4 | 20 | 7 | 8 |
Confidentiality concern | 22 | 8 | 16 | 14 | 18 | 16 | 7 | 9 | 30 | 21 | 16 |
Lack of suitable time to visit | 25 | 35 | 30 | 36 | 20 | 30 | 27 | 25 | 20 | 46 | 30 |
Health problems | 20 | 29 | 24 | 24 | 24 | 24 | 47 | 22 | 20 | 18 | 24 |
Unfriendly attitude of CHW | 0 | 4 | 2 | 2 | 2 | 2 | 0 | 4 | 0 | 0 | 2 |
No CHW nearby | 17 | 12.5 | 15 | 11 | 20 | 15 | 13 | 31 | 0 | 0 | 15 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker; LHW = Lady Health Worker.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 60) . | (n = 48) . | (n = 108) . | (n = 63) . | (n = 45) . | (n = 108) . | (n = 15) . | (n = 45) . | (n = 20) . | (n = 28) . | (n = 108) . |
Socially unacceptable to patient | 3 | 8 | 5.5 | 6 | 4 | 5 | 0 | 4 | 10 | 7 | 6 |
Socially unacceptable to family | 13 | 2 | 8 | 6 | 11 | 8 | 7 | 4 | 20 | 7 | 8 |
Confidentiality concern | 22 | 8 | 16 | 14 | 18 | 16 | 7 | 9 | 30 | 21 | 16 |
Lack of suitable time to visit | 25 | 35 | 30 | 36 | 20 | 30 | 27 | 25 | 20 | 46 | 30 |
Health problems | 20 | 29 | 24 | 24 | 24 | 24 | 47 | 22 | 20 | 18 | 24 |
Unfriendly attitude of CHW | 0 | 4 | 2 | 2 | 2 | 2 | 0 | 4 | 0 | 0 | 2 |
No CHW nearby | 17 | 12.5 | 15 | 11 | 20 | 15 | 13 | 31 | 0 | 0 | 15 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 60) . | (n = 48) . | (n = 108) . | (n = 63) . | (n = 45) . | (n = 108) . | (n = 15) . | (n = 45) . | (n = 20) . | (n = 28) . | (n = 108) . |
Socially unacceptable to patient | 3 | 8 | 5.5 | 6 | 4 | 5 | 0 | 4 | 10 | 7 | 6 |
Socially unacceptable to family | 13 | 2 | 8 | 6 | 11 | 8 | 7 | 4 | 20 | 7 | 8 |
Confidentiality concern | 22 | 8 | 16 | 14 | 18 | 16 | 7 | 9 | 30 | 21 | 16 |
Lack of suitable time to visit | 25 | 35 | 30 | 36 | 20 | 30 | 27 | 25 | 20 | 46 | 30 |
Health problems | 20 | 29 | 24 | 24 | 24 | 24 | 47 | 22 | 20 | 18 | 24 |
Unfriendly attitude of CHW | 0 | 4 | 2 | 2 | 2 | 2 | 0 | 4 | 0 | 0 | 2 |
No CHW nearby | 17 | 12.5 | 15 | 11 | 20 | 15 | 13 | 31 | 0 | 0 | 15 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker; LHW = Lady Health Worker.
Table 5 summarizes the reasons given by patients for agreeing to supervision. The desire for ‘short, free and quality services’ is ranked highest for all categories, apart from women, urban dwellers and patients in the family member arm, who put conviction in the approach first.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 101) . | (n = 121) . | (n = 222) . | (n = 116) . | (n = 106) . | (n = 222) . | (n = 45) . | (n = 67) . | (n = 110) . | (n = 0) . | (n = 222) . |
I am convinced by the idea | 40 | 35 | 37 | 33 | 42 | 37 | 20 | 30 | 54 | n.a. | 37 |
I had no problem in agreeing to the suggestion | 15 | 15 | 15 | 16 | 14 | 15 | 13 | 12 | 17 | n.a. | 15 |
To get short, free and quality services | 38 | 42 | 40 | 47 | 33 | 40 | 58 | 51 | 26 | n.a. | 40 |
The alternate sources were not available/unaffordable | 8 | 7 | 8 | 5 | 10 | 8 | 9 | 8 | 7 | n.a. | 7 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 101) . | (n = 121) . | (n = 222) . | (n = 116) . | (n = 106) . | (n = 222) . | (n = 45) . | (n = 67) . | (n = 110) . | (n = 0) . | (n = 222) . |
I am convinced by the idea | 40 | 35 | 37 | 33 | 42 | 37 | 20 | 30 | 54 | n.a. | 37 |
I had no problem in agreeing to the suggestion | 15 | 15 | 15 | 16 | 14 | 15 | 13 | 12 | 17 | n.a. | 15 |
To get short, free and quality services | 38 | 42 | 40 | 47 | 33 | 40 | 58 | 51 | 26 | n.a. | 40 |
The alternate sources were not available/unaffordable | 8 | 7 | 8 | 5 | 10 | 8 | 9 | 8 | 7 | n.a. | 7 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 101) . | (n = 121) . | (n = 222) . | (n = 116) . | (n = 106) . | (n = 222) . | (n = 45) . | (n = 67) . | (n = 110) . | (n = 0) . | (n = 222) . |
I am convinced by the idea | 40 | 35 | 37 | 33 | 42 | 37 | 20 | 30 | 54 | n.a. | 37 |
I had no problem in agreeing to the suggestion | 15 | 15 | 15 | 16 | 14 | 15 | 13 | 12 | 17 | n.a. | 15 |
To get short, free and quality services | 38 | 42 | 40 | 47 | 33 | 40 | 58 | 51 | 26 | n.a. | 40 |
The alternate sources were not available/unaffordable | 8 | 7 | 8 | 5 | 10 | 8 | 9 | 8 | 7 | n.a. | 7 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 101) . | (n = 121) . | (n = 222) . | (n = 116) . | (n = 106) . | (n = 222) . | (n = 45) . | (n = 67) . | (n = 110) . | (n = 0) . | (n = 222) . |
I am convinced by the idea | 40 | 35 | 37 | 33 | 42 | 37 | 20 | 30 | 54 | n.a. | 37 |
I had no problem in agreeing to the suggestion | 15 | 15 | 15 | 16 | 14 | 15 | 13 | 12 | 17 | n.a. | 15 |
To get short, free and quality services | 38 | 42 | 40 | 47 | 33 | 40 | 58 | 51 | 26 | n.a. | 40 |
The alternate sources were not available/unaffordable | 8 | 7 | 8 | 5 | 10 | 8 | 9 | 8 | 7 | n.a. | 7 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
Next the survey investigated the type of family support that members reported receiving. The results for this are presented in Table 6. Accompanying the patient to the treatment centre is the most common form of support (especially so for women), followed by encouragement, ensuring they take their drugs, and financial support. Almost no-one recorded the drug intake of the patient. Women were more likely to share workload with one another, whereas men reported a high degree of encouragement. Rural-urban differences were small, although urban patients were more likely to receive support in the form of ensuring drugs were taken. Patients in the health facility arm reported higher rates of financial support (perhaps to help with transport costs), while those in the family member arm reported higher rates of relatives ensuring they take their drugs, which is what you would hope to see, given that they were specifically mandated to do so. (The family support across all the trial arms, as a part of the culture, makes it difficult to study the effect of family support in the patients randomized to the family member arm.)
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 166) . | (n = 150) . | (n = 316) . | (n = 185) . | (n = 131) . | (n = 316) . | (n = 41) . | (n = 63) . | (n = 106) . | (n = 106) . | (n = 316) . |
Financial support | 16 | 24 | 20 | 22 | 17 | 20 | 34 | 25 | 14 | 16 | 20 |
Accompanying patient to treatment centre | 34 | 13 | 24 | 25 | 23 | 24 | 19 | 29 | 18 | 30 | 24 |
Encouragement/advocacy | 9 | 37 | 22 | 23 | 21 | 22 | 37 | 22 | 23 | 17 | 22 |
Sharing workload | 16 | 6 | 11 | 11 | 12 | 11.5 | 7 | 11 | 8 | 17 | 11 |
Ensuring daily intake of drugs | 24 | 19 | 22 | 18 | 27 | 22 | 2 | 13 | 37 | 20 | 22 |
Recording drug intake | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 166) . | (n = 150) . | (n = 316) . | (n = 185) . | (n = 131) . | (n = 316) . | (n = 41) . | (n = 63) . | (n = 106) . | (n = 106) . | (n = 316) . |
Financial support | 16 | 24 | 20 | 22 | 17 | 20 | 34 | 25 | 14 | 16 | 20 |
Accompanying patient to treatment centre | 34 | 13 | 24 | 25 | 23 | 24 | 19 | 29 | 18 | 30 | 24 |
Encouragement/advocacy | 9 | 37 | 22 | 23 | 21 | 22 | 37 | 22 | 23 | 17 | 22 |
Sharing workload | 16 | 6 | 11 | 11 | 12 | 11.5 | 7 | 11 | 8 | 17 | 11 |
Ensuring daily intake of drugs | 24 | 19 | 22 | 18 | 27 | 22 | 2 | 13 | 37 | 20 | 22 |
Recording drug intake | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 166) . | (n = 150) . | (n = 316) . | (n = 185) . | (n = 131) . | (n = 316) . | (n = 41) . | (n = 63) . | (n = 106) . | (n = 106) . | (n = 316) . |
Financial support | 16 | 24 | 20 | 22 | 17 | 20 | 34 | 25 | 14 | 16 | 20 |
Accompanying patient to treatment centre | 34 | 13 | 24 | 25 | 23 | 24 | 19 | 29 | 18 | 30 | 24 |
Encouragement/advocacy | 9 | 37 | 22 | 23 | 21 | 22 | 37 | 22 | 23 | 17 | 22 |
Sharing workload | 16 | 6 | 11 | 11 | 12 | 11.5 | 7 | 11 | 8 | 17 | 11 |
Ensuring daily intake of drugs | 24 | 19 | 22 | 18 | 27 | 22 | 2 | 13 | 37 | 20 | 22 |
Recording drug intake | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 166) . | (n = 150) . | (n = 316) . | (n = 185) . | (n = 131) . | (n = 316) . | (n = 41) . | (n = 63) . | (n = 106) . | (n = 106) . | (n = 316) . |
Financial support | 16 | 24 | 20 | 22 | 17 | 20 | 34 | 25 | 14 | 16 | 20 |
Accompanying patient to treatment centre | 34 | 13 | 24 | 25 | 23 | 24 | 19 | 29 | 18 | 30 | 24 |
Encouragement/advocacy | 9 | 37 | 22 | 23 | 21 | 22 | 37 | 22 | 23 | 17 | 22 |
Sharing workload | 16 | 6 | 11 | 11 | 12 | 11.5 | 7 | 11 | 8 | 17 | 11 |
Ensuring daily intake of drugs | 24 | 19 | 22 | 18 | 27 | 22 | 2 | 13 | 37 | 20 | 22 |
Recording drug intake | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
Table 7 presents reasons for defaulting (hence the smaller sample size of 59). One striking result is that absence of drugs was not a factor for anyone (the DOTS programme was clearly well managed in that respect). The most common reason given was lack of belief in the efficacy of the drugs, followed by the belief that the drugs were harmful. Men in particular were likely to feel that they were already cured, while more common amongst women was the belief that they had not had TB in the first place. Some 9% overall had started taking alternative treatments. Factors that are commonly cited as constraints, such as time, cost, social factors and ill health, are not given high prominence here. Whether this is partly because defaulters are being defensive, or are rationalizing their decision, is not clear.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 21) . | (n = 38) . | (n = 59) . | (n = 33) . | (n = 26) . | (n = 59) . | (n = 11) . | (n = 10) . | (n = 15) . | (n = 23) . | (n = 59) . |
Already cured | 10 | 16 | 14 | 15 | 12 | 14 | 9 | 0 | 7 | 26 | 14 |
Were not suffering from TB | 14 | 3 | 7 | 6 | 8 | 7 | 9 | 10 | 7 | 4 | 7 |
Drugs were not effective | 19 | 29 | 25 | 12 | 42 | 25 | 9 | 40 | 27 | 26 | 25 |
Drugs were harming health | 33 | 13 | 20 | 24 | 15 | 20 | 9 | 30 | 20 | 22 | 20 |
Did not have enough money for travel | 5 | 8 | 7 | 12 | 0 | 7 | 0 | 10 | 7 | 9 | 7 |
Did not have time to visit health facility | 5 | 8 | 7 | 12 | 0 | 7 | 9 | 10 | 13 | 0 | 7 |
Not fit enough to visit the health facility | 0 | 8 | 5 | 6 | 4 | 5 | 16 | 0 | 7 | 0 | 5 |
Were unable to manage the social constraints | 0 | 8 | 5 | 6 | 4 | 5 | 9 | 0 | 7 | 4 | 5 |
Drugs were not available at due time | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative attitude of health staff | 0 | 3 | 2 | 3 | 0 | 2 | 9 | 0 | 0 | 0 | 2 |
Alternative medication started | 14 | 5 | 9 | 3 | 15 | 9 | 18 | 0 | 7 | 9 | 9 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 21) . | (n = 38) . | (n = 59) . | (n = 33) . | (n = 26) . | (n = 59) . | (n = 11) . | (n = 10) . | (n = 15) . | (n = 23) . | (n = 59) . |
Already cured | 10 | 16 | 14 | 15 | 12 | 14 | 9 | 0 | 7 | 26 | 14 |
Were not suffering from TB | 14 | 3 | 7 | 6 | 8 | 7 | 9 | 10 | 7 | 4 | 7 |
Drugs were not effective | 19 | 29 | 25 | 12 | 42 | 25 | 9 | 40 | 27 | 26 | 25 |
Drugs were harming health | 33 | 13 | 20 | 24 | 15 | 20 | 9 | 30 | 20 | 22 | 20 |
Did not have enough money for travel | 5 | 8 | 7 | 12 | 0 | 7 | 0 | 10 | 7 | 9 | 7 |
Did not have time to visit health facility | 5 | 8 | 7 | 12 | 0 | 7 | 9 | 10 | 13 | 0 | 7 |
Not fit enough to visit the health facility | 0 | 8 | 5 | 6 | 4 | 5 | 16 | 0 | 7 | 0 | 5 |
Were unable to manage the social constraints | 0 | 8 | 5 | 6 | 4 | 5 | 9 | 0 | 7 | 4 | 5 |
Drugs were not available at due time | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative attitude of health staff | 0 | 3 | 2 | 3 | 0 | 2 | 9 | 0 | 0 | 0 | 2 |
Alternative medication started | 14 | 5 | 9 | 3 | 15 | 9 | 18 | 0 | 7 | 9 | 9 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 21) . | (n = 38) . | (n = 59) . | (n = 33) . | (n = 26) . | (n = 59) . | (n = 11) . | (n = 10) . | (n = 15) . | (n = 23) . | (n = 59) . |
Already cured | 10 | 16 | 14 | 15 | 12 | 14 | 9 | 0 | 7 | 26 | 14 |
Were not suffering from TB | 14 | 3 | 7 | 6 | 8 | 7 | 9 | 10 | 7 | 4 | 7 |
Drugs were not effective | 19 | 29 | 25 | 12 | 42 | 25 | 9 | 40 | 27 | 26 | 25 |
Drugs were harming health | 33 | 13 | 20 | 24 | 15 | 20 | 9 | 30 | 20 | 22 | 20 |
Did not have enough money for travel | 5 | 8 | 7 | 12 | 0 | 7 | 0 | 10 | 7 | 9 | 7 |
Did not have time to visit health facility | 5 | 8 | 7 | 12 | 0 | 7 | 9 | 10 | 13 | 0 | 7 |
Not fit enough to visit the health facility | 0 | 8 | 5 | 6 | 4 | 5 | 16 | 0 | 7 | 0 | 5 |
Were unable to manage the social constraints | 0 | 8 | 5 | 6 | 4 | 5 | 9 | 0 | 7 | 4 | 5 |
Drugs were not available at due time | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative attitude of health staff | 0 | 3 | 2 | 3 | 0 | 2 | 9 | 0 | 0 | 0 | 2 |
Alternative medication started | 14 | 5 | 9 | 3 | 15 | 9 | 18 | 0 | 7 | 9 | 9 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 21) . | (n = 38) . | (n = 59) . | (n = 33) . | (n = 26) . | (n = 59) . | (n = 11) . | (n = 10) . | (n = 15) . | (n = 23) . | (n = 59) . |
Already cured | 10 | 16 | 14 | 15 | 12 | 14 | 9 | 0 | 7 | 26 | 14 |
Were not suffering from TB | 14 | 3 | 7 | 6 | 8 | 7 | 9 | 10 | 7 | 4 | 7 |
Drugs were not effective | 19 | 29 | 25 | 12 | 42 | 25 | 9 | 40 | 27 | 26 | 25 |
Drugs were harming health | 33 | 13 | 20 | 24 | 15 | 20 | 9 | 30 | 20 | 22 | 20 |
Did not have enough money for travel | 5 | 8 | 7 | 12 | 0 | 7 | 0 | 10 | 7 | 9 | 7 |
Did not have time to visit health facility | 5 | 8 | 7 | 12 | 0 | 7 | 9 | 10 | 13 | 0 | 7 |
Not fit enough to visit the health facility | 0 | 8 | 5 | 6 | 4 | 5 | 16 | 0 | 7 | 0 | 5 |
Were unable to manage the social constraints | 0 | 8 | 5 | 6 | 4 | 5 | 9 | 0 | 7 | 4 | 5 |
Drugs were not available at due time | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative attitude of health staff | 0 | 3 | 2 | 3 | 0 | 2 | 9 | 0 | 0 | 0 | 2 |
Alternative medication started | 14 | 5 | 9 | 3 | 15 | 9 | 18 | 0 | 7 | 9 | 9 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker.
The responses on ways of reminding patients who are defaulting (Table 8) vary very little between categories of patients. By far the most popular method is a written letter from health staff (perhaps because this is less of an intrusion, compared with a visit). By far the least popular is a message sent with a fellow villager (either this is thought to be ineffectual, or it presents too much of a threat to confidentiality).
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 174) . | (n = 164) . | (n = 338) . | (n = 191) . | (n = 147) . | (n = 338) . | (n = 44) . | (n = 73) . | (n = 110) . | (n = 111) . | (n = 338) . |
Health staff visit their house to encourage them | 16 | 22 | 19 | 19 | 18 | 19 | 16 | 14 | 27 | 15 | 19 |
Health staff write them a letter | 63 | 52 | 58 | 55 | 61 | 58 | 61 | 48 | 56 | 64 | 58 |
Message is sent through LHW/CHW | 16 | 21 | 18 | 19 | 18 | 18 | 23 | 30 | 12 | 15 | 18 |
Message is sent through fellow villager | 5 | 5 | 5 | 6 | 3 | 5 | 0 | 8 | 5 | 5 | 5 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 174) . | (n = 164) . | (n = 338) . | (n = 191) . | (n = 147) . | (n = 338) . | (n = 44) . | (n = 73) . | (n = 110) . | (n = 111) . | (n = 338) . |
Health staff visit their house to encourage them | 16 | 22 | 19 | 19 | 18 | 19 | 16 | 14 | 27 | 15 | 19 |
Health staff write them a letter | 63 | 52 | 58 | 55 | 61 | 58 | 61 | 48 | 56 | 64 | 58 |
Message is sent through LHW/CHW | 16 | 21 | 18 | 19 | 18 | 18 | 23 | 30 | 12 | 15 | 18 |
Message is sent through fellow villager | 5 | 5 | 5 | 6 | 3 | 5 | 0 | 8 | 5 | 5 | 5 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker; LHW = Lady Health Worker.
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 174) . | (n = 164) . | (n = 338) . | (n = 191) . | (n = 147) . | (n = 338) . | (n = 44) . | (n = 73) . | (n = 110) . | (n = 111) . | (n = 338) . |
Health staff visit their house to encourage them | 16 | 22 | 19 | 19 | 18 | 19 | 16 | 14 | 27 | 15 | 19 |
Health staff write them a letter | 63 | 52 | 58 | 55 | 61 | 58 | 61 | 48 | 56 | 64 | 58 |
Message is sent through LHW/CHW | 16 | 21 | 18 | 19 | 18 | 18 | 23 | 30 | 12 | 15 | 18 |
Message is sent through fellow villager | 5 | 5 | 5 | 6 | 3 | 5 | 0 | 8 | 5 | 5 | 5 |
Description . | Female . | Male . | Total . | Rural . | Urban . | Total . | Health facility arm . | CHW arm . | Family member arm . | Control . | Total . |
---|---|---|---|---|---|---|---|---|---|---|---|
. | (n = 174) . | (n = 164) . | (n = 338) . | (n = 191) . | (n = 147) . | (n = 338) . | (n = 44) . | (n = 73) . | (n = 110) . | (n = 111) . | (n = 338) . |
Health staff visit their house to encourage them | 16 | 22 | 19 | 19 | 18 | 19 | 16 | 14 | 27 | 15 | 19 |
Health staff write them a letter | 63 | 52 | 58 | 55 | 61 | 58 | 61 | 48 | 56 | 64 | 58 |
Message is sent through LHW/CHW | 16 | 21 | 18 | 19 | 18 | 18 | 23 | 30 | 12 | 15 | 18 |
Message is sent through fellow villager | 5 | 5 | 5 | 6 | 3 | 5 | 0 | 8 | 5 | 5 | 5 |
*Figures rounded up or down to nearest half or whole.
CHW = community health worker; LHW = Lady Health Worker.
In-depth interviews and focus group discussions
Socioeconomic profile of the patients interviewed
All of the patients interviewed belonged to the middle and lower income groups, with little variation between urban and rural families. The majority were living in joint families (more than one married couple living in the same house and sharing a kitchen). Most of the men were labourers, vendors or farmers, though a substantial minority had had to leave their work due to illness. Of the women, the large majority were housewives, if married, or contributing to household chores, if not. The age range of the respondents was 17–50 years and the majority were married, often with several children.
Disease history and family attitudes
There was a common pattern of early symptoms (cough, fever and weakness), but also of misdiagnosis by local doctors, both allopathic and traditional (‘Hakims’), leading to considerable delays before the patients were properly diagnosed. During this time, considerable expenditures could be incurred, in seeking various forms of treatment.
When our daughter got infected with TB, we took her to private doctors for treatment, which was so expensive that we were forced to sell the things we had kept for her dowry. The sad part is that in spite of spending so much, she was still not cured. Afterwards, a relative referred us to the TB Centre.
(in-depth interview, family member supervised arm – female, Rawalpindi district)
Patients reported many misconceptions about the cause of the illness, particularly before they started the treatment. Constipation, ghee (clarified butter), stress, occupational hazards, cold weather and poor diet were all cited as causal factors, though after treatment, a more accurate understanding was reported.
Attitudes towards TB were mixed. Most said that family members were supportive, but many had hidden their illness from family and neighbours for fear of a hostile response, and some had been badly treated on account of their illness.
My husband and in-laws told me to leave the house, after I had been diagnosed as a TB patient. I now live with my poor parents. When I used to go to collect medicines from the health facility, neighbours also used to gossip and say nasty things about my character.
(in-depth interview, control arm – female, Rawalpindi district)
Patients had been advised on ways of avoiding infecting their families, but many had ignored them, feeling fatalistic about disease transmission.
Many participants complained of aches and pains, and thought that they were either not fully cured, or were developing the disease again. Two were buying medicines and continuing their treatment on their own, without the involvement of doctors.
Treatment process
There was a universal feeling amongst these patients that the community-based treatment process had been economical and effective. None reported being charged for treatment or drugs. More than half were unaware of being directly observed during the treatment.
One of the main problems mentioned by all, irrespective of study arm, was transport for getting to the TB centre and to their designated drug collection point. Transport was hard to access and expensive, especially in the rural areas. Those in the health facility arm were particularly inconvenienced, as they had to travel daily. People in the CHW arm were slightly better off, but many complained of the difficulty of walking to the worker's house, given their poor health. There were complaints that the CHW was often out at the designated time, or gave appointments at inconvenient times.
As a result of this inconvenience and expense, a number were unable to comply with their allocated type of DOT, some with the agreement of their care provider, though many of these were not reported to the health staff.
I tried it for a week, but she used to be out many times. So with her agreement, I used to go on a weekly basis, collect my medicines and take them myself. She would fill up the card.
(focus group, CHW arm – male, Rawalpindi district)
Out of 32 cases, 13 (40%) of the respondents reported not continuing to follow the form of DOT they were allocated to (Table 9). More than half of the health facility DOT group were unable to continue being directly observed at the health facility and other arrangements were made formally or informally. This is an important but not unexpected finding of this study. The difficulty for patients of following the DOT protocol may in large part explain why cure rates did not differ significantly between the different arms in the trial.
Categories . | No. of cases . | Proportion changing . |
---|---|---|
Health facility | 4 out of 7 | 57% |
Community health worker | 2 out of 8 | 25% |
Self-administered | 3 out of 8 | 37% |
Family member | 4 out of 9 | 44% |
Total cases | 13 out of 32 | 41% |
Categories . | No. of cases . | Proportion changing . |
---|---|---|
Health facility | 4 out of 7 | 57% |
Community health worker | 2 out of 8 | 25% |
Self-administered | 3 out of 8 | 37% |
Family member | 4 out of 9 | 44% |
Total cases | 13 out of 32 | 41% |
Categories . | No. of cases . | Proportion changing . |
---|---|---|
Health facility | 4 out of 7 | 57% |
Community health worker | 2 out of 8 | 25% |
Self-administered | 3 out of 8 | 37% |
Family member | 4 out of 9 | 44% |
Total cases | 13 out of 32 | 41% |
Categories . | No. of cases . | Proportion changing . |
---|---|---|
Health facility | 4 out of 7 | 57% |
Community health worker | 2 out of 8 | 25% |
Self-administered | 3 out of 8 | 37% |
Family member | 4 out of 9 | 44% |
Total cases | 13 out of 32 | 41% |
Faced with the need to make daily visits to the health centre, which is costly and takes time, many in the health facility arm chose to collect their drugs weekly instead, and either self-administer or be observed by a family member. Some mentioned that they were unable to get to work on time if they attended the health facility during its opening hours.
In the CHW arm, the theory was that the CHW would visit the patient's house, but in practice, in most cases it was left for the patient to visit the CHW, even if they were very ill.
On the instructions of the doctor, the CHW was designated to give me medicines, but she did not want to visit our house, because we were of a lower caste than her. My health was so bad that I was not in a position to visit her, therefore, after taking permission from the doctor, my mother started to give me the medicines. The CHW just came once to fill the card.
(in-depth interview, CHW arm – female, Rawalpindi district)
I left the treatment process, because the CHW who had been designated to me would send me back if her husband was not present. This was very annoying for me as many times I had to return without meeting her.
(in-depth interview, CHW defaulter – male, Rawalpindi district)
I was in a very serious condition, but the CHW refused to come to my residence. So my husband use to take me to the CHW's house everyday.
(in-depth interview, CHW arm – female, Rawalpindi district)
In the case of the family member observed group, the main factors behind non-adherence seem to have been patient unease, and irregularity on the part of the supposed supervisor.
It just does not make sense as to why a grown up person should be given medicines by someone else. I felt very awkward, and tried to take my own medicines.
(focus group, family member supervised arm – male, Gujranwala district)
My cousin had been asked to supervise my treatment. But as he works as a truck driver, he had to leave for work during the treatment process. During those periods, I took my own medicines. There were times when he would be gone for 2 or more weeks.
(in-depth interview, family member supervised arm – male, Rawalpindi district)
Three out of 8 of the self-administered (control group) patients also reported receiving family member observation. This seems to have been related to family pressures, to make sure the patient got better (not always for altruistic reasons though).
My mother-in-law insisted on giving me the medicines herself. She was quite nasty to me during my illness and used to say that I had brought this infection from my parents’ house. She wanted me to get cured quickly, because the house work was being affected and also due to scare of spreading the disease in the family.
(in-depth interview, control arm – female, Rawalpindi district)
My husband used to give me the medicines himself. Children and housework were being neglected and he was very concerned about that.
(in-depth interview, control arm – female, Rawalpindi district)
Continued symptoms were reported in a quarter of the 32 in-depth interviews. In half of these cases, patients admitted not taking the drugs properly (in one case, a full month had been missed in the continuation phase). Others felt that they were not responding to the drugs. Guidelines on diet had also not been followed by many, for economic reasons and because it was hard for a patient to eat better quality food than the rest of their family.
Firstly, I could not afford the type of food recommended by the doctor. And even if once in a while there was something available, I could not bear to eat it in front of my children, who ate ordinary food, like chappaties and lentils.
(focus group, family member arm – male, Gujranwala, district)
Women were thought to be more motivated to continue the treatment. In the case of older, married women, this was connected to their sense of responsibility for the household and the children. Some also cited pressure from their in-laws. In the case of younger women, their marriageability was negatively affected by TB and other diseases.
Women have to take care of the house and children. Therefore, they want to get cured quickly and are more responsible in taking their medicines.
(focus group, health facility arm – female, Sahiwal district)
We did not tell anyone that she was sick. Everyday, the family car was used to transport her to the facility for collection of medicines. We did not want people talking about her illness, as she is a young girl, who has her entire life ahead of her.
(mother of patient during in-depth interview, health facility arm – female, Gujranwala district)
Joint families were thought to be better able to look after and support sick members, compared with nuclear ones where there was no-one to substitute for the missing labour.
According to the interviews, adherence was better for the self-administered patients. They were more regular in taking their medicines and expressed more satisfaction with the treatment process.
Perspective of the providers
Focus group discussions were held with health facility staff members, with CHWs and with family supervisors.
The health facility staff (five medical assistants and one lady health visitor) expressed a number of negative attitudes, which contrasted with the patients’ general view that the DOTS treatment process was ‘economical and effective’. They showed a cynicism and lack of commitment to the DOTS programme and, indeed, their whole profession. Some complained about lack of involvement in training prior to implementation of the trial (some had been transferred to the facility during the trial implementation process). They felt that financial incentives would have helped them to take more interest in the process.
We were given a responsibility for which we received no additional benefit. If you expect some output, some input is to be expected, like money.
(focus group, care providers, Rawalpindi district)
Some of them openly said that they were not really concerned about the outcomes for patients.
If the patient came we gave him/her the medicine, otherwise, we were not concerned if he was absent for even 2 weeks or had not taken the medicine on a regular basis. If the NGO staff personnel reminded us, we once in a while asked the patient the reason for being irregular, or we just let the matter rest. In many cases, we told the patients to fill up their own cards.
(focus group, care providers, Rawalpindi district)
The staff felt that supervised treatment was a concept beyond the understanding of the general patient who came to these centres. People were poor and illiterate, and could not adhere to the proper protocols of the programme.
People in our society think that proper treatment is only through injections and syrups. They do not like taking tablets.
(focus group, care providers, Rawalpindi district)
A FGD was also held with seven CHWs in Rawalpindi. They gave the impression that they had followed the procedures correctly and had formed good relationships with the patients. However, some of the information they gave was at odds with the patients’ perspectives. For example, in all seven cases, patients had visited the house of the CHW to collect drugs. The CHWs stated that this was the desire of the patients.
My patient came to me because I live quite far away from her home, so she decided to come to me instead.
(focus group, CHWs, Rawalpindi district)
He was a young boy and he said that he would come himself as there was some distance between his residence and mine.
(focus group, CHWs, Rawalpindi district)
By contrast, patients stated that they found this very inconvenient, especially in the intensive phase. They also portrayed relationships with CHWs as no more than functional in most cases.
Ten family supervisors were interviewed. They shared a similar perspective to the patients in general. They expressed general satisfaction with the programme, and care and concern towards the patient. All claimed to be regular in supervising medicine taking, but said that, if they were not present for some reason, they instructed the patient to take the medicine themselves, or asked some other family member to supervise.
Discussion
The randomized controlled clinical trial (Walley et al. 2001) found two unexpected results which this social study can help to explain: first, the lack of significant difference in the cure rates between the different direct observation arms; and, secondly, a significantly higher cure rate for women (71%, compared with 50% for men). These will be discussed in turn.
The in-depth interviews, if they reflect a broader pattern, suggest that one factor behind the insignificant difference in cure rates may be that many patients did not strictly follow the appropriate protocols for direct observation. Thirteen of our sample of 32 patients (41% overall and 57% in the case of the health facility patients) failed to follow the style of direct observation to which they had been allocated. It appears that health workers either agreed with or accepted these decisions, but did not always inform the trial organizers. [Within the trial, 18% of patients randomized to the health worker DOT (either health centre or CHW) were officially recorded as unable to persevere and were given self-administered treatment (Walley et al. 2001). For family member DOT, the figure was 2%.] The inconvenience of the mode of direct observation seems to have been the main factor motivating patients to drop out of direct observation.
This issue was anticipated, and as is accepted practice, the trial results were analyzed according to the arm allocated (intention to treat analysis). This is unaffected by whether the patient change was or was not known. The trial was conducted under operational conditions, so evaluating the effectiveness, not efficacy, of the direct observation intervention. The trial reflected the reality that patients may switch if they find the form of direct observation difficult to continue. This social study adds to the conclusions of the economic study (Khan et al. 2002) that the time, distance and cost of accessing health facilities is a major constraint and is likely to negate any benefits of direct observation by health facility health workers.
Another important finding is the negative attitudes of health workers (though our sample was small and may not have been representative). Their cynicism and lack of concern for patient outcomes is something that any direct observation regime would have to take into account and overcome. Clearly it undermines their effectiveness as supervisors and patient motivators. The problem is less acute in the case of the CHWs, but even here, they are inclined to put their own comfort ahead of that of patients. Patients resent having to visit their house, even when severely ill, and arriving at agreed times to find the CHW out.
This study found that self-reported adherence and satisfaction with the process was highest in the self-administered group. The findings are compatible with the economic study (Khan et al. 2002), which found self-administered treatment (control) to be the most cost-effective, then the family and CHW DOT, with the health facility DOT group last.
It gives cause for concern that a quarter of the interviewees report continued symptoms, and that of these, half admitted to not taking their drugs regularly. This and the responses of defaulters (25% of whom dropped out because they thought the treatment was not effective) reinforce the need for continuous support, education and encouragement.
Time, travel costs and ill health emerge as the main constraints to attending health centres for direct observation. For men, time and work constraints are especially acute. They may have to forego income or even risk losing their jobs to go for daily treatment. Women, by contrast, being largely occupied in the home, are more able to substitute for one another and avoid high time costs of attendance. They are also reported as being more motivated by their family responsibilities and the social stigma attached to illness, particularly in young women. This is consistent with the findings of the preliminary social survey (Khan et al. 2000).
These findings are consistent with those of other studies of community-based TB programmes. In Swaziland, for example, a recent study found that patients preferred community-based treatment, but that treatment supporters (chosen by patients) had to take a more active role than merely observing treatment. The need for ongoing support of treatment supporters and community education was emphasized (Escott and Walley, forthcoming). The paper concluded that there should be choice and flexibility for patients and that a supportive rather than policing role was appropriate for the ‘direct observer’. This kind of client-centred approach is likely to be more effective, but to pose greater organizational challenges, compared with top-down, large-scale programming.
Some of the issues raised here may be specific to the Pakistani context. For example, some of the social pressures on women may not be found in other contexts. However, the common issues of cost and inconvenience, of health worker attitudes and patient perceptions of the disease, are likely to be found in most contexts. We feel that these results raise issues likely to be found in most DOT programmes and possibly in other contexts where direct observation is practiced (for example, if it is adopted for anti-retrovirals).
Conclusion
The findings of this social study reinforce the conclusions of the clinical trial and economic study – that direct observation, especially at health facilities, is inconvenient and costly for patients, and especially for economically active patients, and that improved ways of motivating patients and improving adherence should be sought.
Community treatment supporters may be appreciated for the wider support they give to the patient. However, great care should be taken in dialogue with the patient to select a treatment supporter who is accessible, acceptable, reliable and concerned to support the completion of treatment. The Thai randomized controlled trial, which is the only such trial to demonstrate significantly improved cure rates amongst those receiving DOT, permitted clients to choose the mode of DOT (almost entirely a family member) and offered home visits with outreach workers (Kamolratanakul et al. 1999). Other measures should also be considered which reduce inconvenience and costs to patients, such as evening opening hours or even assistance with some of the costs.
Delivery of the DOTS package also requires a high degree of health care staff commitment at all levels. In many developing countries with relatively dissatisfied public sector health workers, such commitment cannot be taken for granted. The care delivery roles and responsibilities of various staff cadres need be addressed realistically, taking into account the national context.
This work shows that emphasizing direct observation alone is not sufficient for treating TB: patients face a host of socioeconomic constraints. Implementation of a flexible therapy that is community-based and includes DOT as one component of a comprehensive package aimed at addressing the unmet health and social needs of this population remains a challenge. This conclusion is consistent with the results of other related studies that have been carried out to date (see, for example, Floyd et al. 1997; Wilkinson and Davies 1997), and also with trends towards more emphasis on patient-friendly care and flexibility in DOT approaches at WHO Geneva (WHO 2003). It also raises some interesting issues in relation to providing anti-retrovirals for HIV/AIDS patients – here too, direct observation is under discussion and would face similar and even greater challenges, given that treatment is open-ended.
Biographies
Amir Khan, Ph.D., MPH, DHA, MBBS, is chairman of the Association for Social Development (ASD) in Islamabad, Pakistan, and Principal Research Fellow on the DFID-funded Tuberculosis Research Programme, managed jointly by the London School of Hygiene and Tropical Medicine and the Nuffield Centre for International Health and Development, Leeds. He has been technically assisting the national programmes in various research development and planning related activities, and has written a number of articles on tuberculosis control and DOTS in Pakistan.
John Walley, MBBS, DRCOG, DTM&H, MComH, is a public health specialist and senior lecturer at the Nuffield Centre for Health and Development, University of Leeds. He is Director of the Leeds TB research and development programme. He has been the principal investigator on the TB trial and social studies and ongoing support to the national TB programme in Pakistan. The programme has similar work ongoing in Nepal, Swaziland and elsewhere. Previously he worked as regional advisor in Ethiopia and provincial medical officer of health in Zimbabwe, implementing TB, MCH and other PHC programmes. He has recently been involved in the development of the WHO Integrated Management of Adolescent and Adult Illness protocol.
Sophie Witter, MA, Econ., is a Research Fellow with the IMMPACT project, based at the University of Aberdeen. She is currently engaged on a Ph.D. relating to user fees and exemptions in developing countries. Recent work includes a health financing study in Burundi; a review of 45 years of work by Save the Children (UK) in Uganda; studies related to care of orphans and vulnerable children in Uganda; and an evaluation of a drug revolving fund in Khartoum.
Karam Shah is the manager of the National TB Control Programme in Pakistan. He has wide experience in developing, implementing and evaluating TB care interventions. He chairs the DOTS Expansion Working Group of the Stop TB Partnership. He has co-authored many articles on various aspects of tuberculosis control and DOTS.
Sarah Javeed is an anthropologist with experience of designing and conducting qualitative research projects, with emphasis on health care delivery.
We would like to acknowledge DFID funding for the trial and related studies. We also acknowledge the active support of (now retired) National Tuberculosis Programme Manager, Dr Hussain Khan; the staff of the National Tuberculosis Centre, Rawalpindi; the District Anti-TB Association of Gujranwala; the Red Crescent TB Centre, Sahiwal; and the district health offices in Islamabad, Rawalpindi, Gujranwala and Sahiwal.
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Author notes
1Association for Social Development, Islamabad, Pakistan, 2Nuffield Centre for Health and Development, University of Leeds, UK, 3IMMPACT, University of Aberdeen, UK, 4National TB Control Programme, Pakistan and 5Freelance consultant, Pakistan