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Indian Journal of Community Medicine

A Study of Treatment Compliance in Directly Observed Therapy for Tuberculosis

Author(s): N. Pandit, S.K. Choudhary

Vol. 31, No. 4 (2006-10 - 2006-12)

N. Pandit, S.K. Choudhary


Objective: To study the various aspects of compliance to directly observed therapy (DOT) for the treatment of tuberculosis. Design: Cross sectional study. Methods: The study has been carried out in two tuberculosis units in Anand district, state Gujarat, India. All the patients who registered for DOT treatment during last quarter (Oct-Nov-Dec) 2002 were included in the study. Results: Majority of study population (85%) was in age group of 15 – 55 years, which is the productive age. 34 patients, 12.4% of 274 patients had poor out come, during course of DOT therapy. Fifteen expired and 19 defaulted for therapy. The present study shows that 93% of study population was compliant to the DOT. The traditional risk factors for noncompliance like socio-demographic factors, timing, travel, cost of investigation and cost of therapy and long waiting period; were not major hurdles for treatment adherence. The toxicity of drugs was the major reason for defaulting for treatment. The study revealed that the compliance of DOT was significantly high among those who have good knowledge about various aspects of disease. Conclusion: In district Anand, India; the compliance to DOT treatment was good compared to other studies. But still major hurdle is the inadequate health education.

Key words: Tuberculosis, Compliance, Adherence, Directly Observed Therapy, Health Education, Incentive


Compliance to therapy is one of the important factors that affect the out come of therapy. Compliance can be defined as the extent to which a patient’s behavior coincides with medical advice. Non-compliance to self administered multi-drug tuberculosis treatment regimens is common and most important cause of failure of initial therapy and relapse.1 Non-compliance may also result in acquired drug resistance2, requiring more prolong and expensive therapy that is less likely to be successful than the treatment of drug susceptible tuberculosis.1 Studies on acquired resistance (drug resistance among previously treated cases) from Gujarat (1980-86) showed an increase resistance to isoniazid and rifampicin and MDR – TB rates of 30%.3-5 The adoption of DOT has been associated with reduced rate of treatment failure, relapse and drug resistance.2

Despite the impressive gains in compliance associated with the use of DOT, non-compliance with DOT also occurs when patients fail to make themselves available for the administration of drug therapy. To understand the various aspects of compliance in DOT, we conducted cross sectional study among tuberculosis patients on DOT, in Anand district of Gujarat, India.

Material and Methods

This is cross sectional study has been carried out in Anand district, state Gujarat, India. The district has been divided in four Tuberculosis Units (TU), named Petlad, Sarsa, Ras, and Khambhat. For the study two TU had been selected randomly.

From DTO (District Tuberculosis offi ce) the total registered patients on DOT during last quarter (Oct-Nov-Dec) 2002, were collected. It was decided to interview all patients of two TU. All tuberculosis patients who were registered during that quarter were only included. We excluded individuals who received therapy in the institution (Hospital).

During study, it was decided to interview all patients at their homes. After obtaining verbal consent from patients the pre tested questionnaire was administered by investigator. If patient could not be contacted in one visit subsequent visits were made. The modified Prasad classifi cation was used for socio-economic class of patients.14

To arrive at the criteria for non-compliance, the RNTCP definition of defaulter has been accepted here. During study poor out come of course of DOT was also reviewed. The poor outcome defi ned as one or more following events: 1) Defaulted in treatment and 2) deaths due to tuberculosis. The information thus collected was processed and analyzed using EPInfo 2000 Package.


Almost During last quarter of 2002, 292 patients were registered for DOT. A total of 274 (93.8%) patients could be contacted after repeated visits to their home. All 274 patients of tuberculosis were evaluated for compliance study.

Majority of study population (85%) was in age group of 15 - 55 years, which is the productive age. The mean age was 36.6 (SD 14.1). Almost 63% were male, who is usually earning member of family.

Table – I. Socio-demographic information of compliant and noncompliant patients

  Patients on
Education (χ2 = 6.32, p>0.05)
Illiterate 53 08 61 (23.5)
Primary 122 10 132(51.0)
Secondary 60 01 61 (23.5)
≥Graduate 05 00 5(2.0)
Occupation (χ2=11.63, p>0.05)
Govt. servant 06 01 07(2.7)
Farmer 04 00 04(1.5)
Business 15 00 15(5.8)
House wife 76 05 82(31.7)
Labour 113 11 124(47.9)
Retired 14 00 14(5.0)
Study 07 00 07(2.7)
Unemployed 05 02 07(2.7)

34 patients, 12.4% of 274 patients had poor out come, during course of DOT therapy. Fifteen expired and 19 defaulted for therapy. The disease specific death rate (case fatality rate) was 5.5%. The case fatality was highest among smear positive cases (6.4%). Majority of the deaths (9/15) 60% of patients were among productive age group (15 -55 years) and more so 73% (11/15) were males. Further details of dead patients were not collected hence they are excluded from total surveyed DOTs patients.

Socio-demographic information of study population revealed that 80% of patients on DOT had rural background. Almost 50% were educated up to primary and 23% were illiterate. Occupation distribution shows that nearly 50% of patients were labourers, few from either business or Government servants. Nearly 81% of patients were from socio-economic class IV and V, lower socio economic class or say poor. The present study shows that 93% of study population was compliant to the DOT. On asking the reasons for not taking treatment, it was observed that majority (12/19, 63.2%) of patients on DOT stopped treatment because of toxicity of drugs. The other reasons were feeling better during treatment (3/19, 15.8%) and lack of knowledge about various aspects of TB and its treatment (10.5%). The study revealed that the compliance of DOT was significantly high among those who have good knowledge about various aspects of disease. The three topics of health education were asked to all tuberculosis patients, about effectiveness of DOT2 = 19.22, p<0.001), knowledge about toxicity of drugs (χ2 = 15.77, p<0.001) and importance of completion of therapy (χ2 = 45.88, p<0.001). The study revealed that the patients who were observed by Government DOT workers defaulted twice than that of observed by volunteers odds ratio = 1.99).


In this study, the poor out come of DOT was studied which was 12%. The case fatality rate (5.5%) was higher than the National average which is 4% since implementation.7 The similar mortality was observed in the study of a south Indian district8.

The present study-shows that 93% of study population was compliant to the DOT. These results are good if compared to the other studies.9,10 The study done by Tekle et al, who found that 11.3% of all study population in Ethopia in 1997 - 99 were noncompliant.16 Study from China revealed that TB treatment was completed by 73.1% of patients within 9 months while 28.9% failed to complete their regime.11 The studies on the association of demographic characteristics of patients to compliance of anti-tuberculosis therapy have given inconsistent results.9,15 The present study revealed that the socio-demographic factors (age, sex, education, occupation and socio-economic status) were not associated signifi cantly with adherence (Table-I). Ashry Gad et al in their study also portrayed the same fact that the factors like age, sex, work and education had no association with adherence of treatment.9 But Johansson et al had found that patient’s economic situation is an important determinant of compliance and noncompliance.17

The main risk factors for non-compliance were studied and they were role of health education, toxicity of drugs, cost of investigation and therapy, timing of therapy, travel for therapy, long waiting period for treatment and role of DOT provider. Out of them the health education had major effect for non-compliance. The study revealed that the compliance of DOT was significantly high among those who have good knowledge about various aspects of disease. Similar observation has been documented by other authors in their study.9,12,13,16,18,19 The adequate knowledge about disease was found to be protective factor for defaulting to therapy in Ethiopia 200216. In addition to knowledge about disease, toxicity of medication is also thought to be associated with non-compliance. The present study also revealed same fact.

It was observed that majority of patients on DOT stopped treatment because of toxicity of drugs. The other reasons were feeling better during treatment and lack of knowledge about various aspects of TB and its treatment (10.5%). Tekle et al had revealed in their study, medication side effects were signifi cantly associated with defaulting.16 It was observed that those with adequate knowledge about disease defaulted less and this will also help in reducing the toxicity. The innovative strategies in health education are the need of the hour.

The second risk factor for noncompliance was the DOT providers. In DOT therapy, to reduce the travel cost and time the DOT providers are appointed as close to the patient’s home as possible. For the DOT providers, the fi rst preference is usually Government Health workers of that village, as per programme norms. If Government worker available in the village then medical offi cer can select any volunteers from that village.

Other traditional risk factors like timing, travel to collect drugs, cost of investigation and treatment, long waiting period and lack of drug supply were not major part of non-compliance.


I wish to express my gratitude to Charotar Arogya Mandal and Medical Research Society and the Dean P. S. Medical College, Karamsad, district Anand, Gujarat, who sponsored the project. I am thankful to Dr. S. K. Choudhary, Professor and Head and department colleagues for their invaluable help and continuous guidance through out the project. I am heartily thankful to Dr. Prajapati, DTO, Anand District for his co-operation. Last but not the least, My sincere thanks to all the patients on DOTs in district without whose support and cooperation it would have been impossible to arrive at this stage.


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Department of Community Medicine, P. S. Medical College,
Karamsad 388325, Gujarat, India
Email: [email protected],
[email protected]
Received: 25-11-04

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