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Indian Journal of Community Medicine

Factors Affecting the Non-Compliance in Directly Observed Short Course Chemotherapy in Lucknow District

Author(s): Mahesh Kumar, J.V. Singh, A.K. Srivastava, S.K. Verma*

Vol. 27, No. 3 (2002-07 - 2002-09)

Deptts. of Community Medicine & *T.B. & Chest Diseases, K.G. Medical College, Lucknow


Research question: What are the various factors affecting the non-compliance in directly observed short course chemotherapy.

Objective: To assess the compliance of patients attending DOTS clinic.

Study design: Observational cohort study.

Setting: Five DOTS clinics in Lucknow District, U.P. Participants: Tuberculosis patients attending DOTS clinic.

Sample size: 386.

Study variables: Age, sex, education, occupation, religion, socio-economic status, over crowding, smoking history etc.

Statistical analysis: Proportions, Chi square test.

Results: In the present study compliance rate was 89.4%, however, 10.6% patients did not comply to the treatment. Non-compliance was equally prevalent amongst male and female patients wherein it was found to be 10.4% and 11% respectively. The study revealed that non-compliance was maximum in age group 35-44 years (25.4%) patients. Non-compliance was also more prevalent in illiterates (13.9%), upper class (16%) and among smokers (11.5%), alcoholics (23.9%) and drug users (47.4%).

Keywords: DOTS, Compliance, Non-compliance


India has more cases of tuberculosis than any other country in the world. Around 2.2 million people are detected to be having tuberculosis every year (approximately 25% of the global cases) and over 0.5 million die of this disease every year (17% of global TB deaths) i.e. more than 10,000 every day. Total population suffering from active disease in India is 14 million of which 3-3.5 million (20-25% of total) are positive for sputum.

Despite the existence of National Tuberculosis Control Programme since 1962, tuberculosis remains the leading infectious cause of death in India. Inspite of the programme having been in operation for three decades, no significant epidemiological impact on disease prevalence has been observed.

With this background, in 1992, the Govt. of India together with the World Health Organization and Swedish International Development Agency (SIDA) reviewed the national programme and concluded that the programme suffered from managerial weakness, inadequate funding, over reliance on X-ray, non-standard treatment regimens and low rate of treatment completion etc. A Revised National Tuberculosis Control Programme (RNTCP) was designed.

The goal of RNTCP is to detect at least 70% of new smear positive cases of tuberculosis and to cure at least 85% of such cases1,2.

Material and Methods:

The present study was carried out on patients attending DOTS clinics in Lucknow District from Sept. 2000 to Aug. 2001. According to "Epi Info" version 6 programme on computer3, the total sample size required was found to be 384 at 95% confidence interval and 80% power with 10% prevalence rate. However, total 386 patients were included in this study.

The stratified random sampling was used to select the DOTS clinics in Lucknow District. The stratification was done on the basis of geographical set up of the clinics such as Urban and Rural settings.

Thus, 5 DOTS clinics - Kasturba Chest Hospital, K.G. Medical College, Lucknow, Shyama Prasad Mukharjee (Civil) Hospital, Lucknow, Balrampur Hospital, Thakurganj T.B. Chest Hospital, Primary Health Centre Sarojini Nagar, Lucknow were selected and the patients attending these centres were enrolled for the study.

A pretested schedule was administered to the subjects.


Table I: Distribution of patients according to their compliance to treatment.

Compliance No. (%)
Yes 345 (89.4)
No 41 (10.6)
Total 386 (100.0)

Missing >2 consecutive weeks of DOTS was taken as non-compliance. 10.6% patients did not comply to the treatment.

Table II: Association of non-compliance with age of patients.

Age (years) Total No. Non-compliance
15-24 86 3 (3.5)
25-34 165 9 (5.4)
35-44 63 16 (25.4)
45+ 72 13 (18.1)
Total 386 41 (10.6)
x2 = 18.00, df = 3, p=0.001.

It was observed that the non-compliance was maximum (25.4%) in age group of 35-44 years and was minimum (3.5%) in age group 15-24 years. However, non-compliance was 18.1% in patients aged 45 years and above. The association of non-compliance with age is statistically highly significant (p=0.001). 

Table III: Association of non-compliance with sex of patients.

Sex Total No. Non-compliance
Male 222 23 (10.4)
Female 164 18 (11.0)
Total 386 41 (10.6)

x2 = 0.04, df = 1, p>0.05.

Non-compliance was slightly higher among female patients (11.0%) than male patients (10.4%). The association between non-compliance and sex of the patient was not statistically significant (p>0.05).

Table IV: Association of non-compliance with educational status of patients.

Education Total No. Non-compliance
Illiterate 180 25 (13.9)
Primary 123 8 (6.5)
JHS 42 5 (11.9)
HS 21 1 (4.8)
Intermediate & + 20 2 (10.0)
Total 386 41 (10.6)

x2 = 1.45, df = 4, p=0.22.

Non-compliance was maximum (13.9%) among illiterates, and among literates, non-compliance was 7.8%. Among educated people non-compliance to the treatment was less. The association was not statistically significant (p=0.22).

Table V: Association of non-compliance with religion of patients.

Religion Total No. Non-compliance
Hindu 264 24 (9.1)
Muslim 118 17 (14.4)
Others 4 0 (0)
Total 386 41 (10.6)

x2 (between Hindu and Muslim) = 2.41, df = 1, p=0.12.

Majority of the patients studied (264) were Hindus and non-compliance in Hindus was found in 24(9.1%) patients. Amongst 118 Muslims studied, the non-compliance was found to be 17(14.4%). The association of non-compliance with religion is statistically not significant.

Table VI: Association of non-compliance with socio-economic status of patients.

Total No. Non-compliance
Upper class 25 4 (16.0)
Middle class 254 29 (11.4)
Lower class 107 8 (7.4)
Total 386 41 (10.6)

x2 = 0.71, df = 2, p=0.40.

Patients of upper class had higher (16.0%) non-compliance as compared to patients of lower class (7.4%). However, the difference was not statistically significant.

Table VII: Association of non-compliance with smoking.

Total No. Non-compliance
Yes 321 37 (11.5)
No 65 4 (6.1)
Total 386 41 (10.6)

x2 = 1.64, df = 1, p=0.19.

Non-compliance was found more among smokers (11.5%) in comparison to the non-smokers (6.1%). However the association was not statistically significant.

Table VIII: Association of non-compliance with alcohol addiction.

Alcohol addiction
Total No. Non-compliance
Yes 96 23 (23.9)
No 290 18 (6.2)
Total 386 41 (10.6)

x2 = 23.94, df = 1, p=0.001.

More non-compliance to the treatment was observed among alcoholics (23.9%) than non-alcoholics. The association between alcohol addiction and non-compliance was found to be statistically highly significant (p=0.001).

Table IX: Association of non-compliance with drug addiction.

Drug addiction
Total No. Non-compliance
Yes 17 9 (47.4)
No 367 32 (8.7)
Total 386 41 (10.6)

x2 = 28.42, df = 1, p=0.001.

In comparison to patients not addicted to any kind of drugs, non-compliance was found (Table IX) to be more prevalent among drug abusers (47.4%). It was found to be statistically highly significant (p=0.001).


In the present study, 10.6% patients did not comply to the treatment. Overall compliance rate was 89.4%. Alcaide Megias et al4 (1999) found compliance rate of 91.8%. Similarly, Smirnoff et al5 (1998) reported 85% overall compliance with DOTS treatment. Sunil Bhat et al6 (1998) reported adherence to treatment to the extent of 80%.

It is evident from the study that patients falling in 35-44 years age group are more non-compliant (25.4%) to the treatment followed by the patients aged above 45 years (18.1%) and the patients in age group 15-24 years were least (3.5%) non-compliant. Since 25.4% of these patients (35-44 years) were found to be non-complaint and the reason for this may be that in majority of these cases, patient was only economically active person in the family and hence could not spare time to visit DOTS clinic on a regular basis. Menzis D et al7 (1996) found that older subjects were less compliant.

The present study shows that non-compliance to treatment was equally prevalent among male (10.4%) and female (11.0%) patients. Moore8 (2001) observed non-compliance to be more prevalent among female patients, due to non-availability of any person to accompany them while visiting the DOTS clinics and they are stigmatized if found to have tuberculosis. Polo Friz et al9 (1997) also observed higher non-compliance among females.

The present study indicates that non-compliance was more among illiterate patients. Only 7.7% of the literate patients were non-compliant to the treatment. Probably the illiterate patients did not understand the ill consequences of irregular treatment.

The present study found that non-compliance to DOTS was more among patients of upper class in comparison to patients of lower class. It may be because the patients of upper class are economically well so they shift to private practitioners. Secondly, they may prefer private practitioners for privacy. Menzis et al (1996) found that residents of affluent neighbourhood were less likely to report for treatment.

Non-compliance was also found to be more among alcoholics and drug abusers, 23.9% and 47.4% respectively. Burman et al10 (1997) also attributed non-compliance to alcoholism and homelessness. Pulide Ortoga et al11 (1997) observed in their study that non-compliance was 20% in drug users. Seetha et al12 (1998) observed adverse reactions due to drugs in 10.3% patients.


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