|Year : 2017 | Volume
| Issue : 3 | Page : 147-151
Sociodemographic profile and treatment outcome of tuberculosis patients registered under directly observed treatment short course in East Sikkim with reference to defaulters
Leona Sonam Lepcha, Amit Kumar Jain, Parvati Nandy
Department of General Medicine, Sikkim Manipal Institute of Medical Sciences, Gangtok, Sikkim, India
|Date of Web Publication||17-Aug-2017|
Amit Kumar Jain
Department of General Medicine, Central Referral Hospital, 5th Mile, Tadong, Gangtok - 737 102, Sikkim
Source of Support: None, Conflict of Interest: None
Background: India has the highest burden of tuberculosis (TB) despite it being one of the oldest diseases. Defaulting from antitubercular therapy is one of the challenges in the control of TB.
Objectives: To study the sociodemographic profile and outcome of TB patients registered under Directly Observed Treatment Short course (DOTS) in East Sikkim from 2009 to 2011, with reference to defaulters.
Methods: In this cross-sectional study, primary data were obtained by interviewing defaulters (only 32 out of total 46 defaulters). Secondary data for all defaulters were obtained from district TB registers. Data were entered into excel sheet and analyzed (Limitation of the study: All 46 defaulters could not be interviewed).
Results: The defaulters were more commonly from category II of DOTS with an equal male:female ratio with most common age group of defaulters being 20–39 years. The most common timing of default was the early intensive phase and the early continuation phase. The reasons for default were usually multiple in most with consumption of alcohol, relief of symptoms, and migration being the most common. Out of the 46 defaulters, 10 patients were retrieved back, 5 patients were started on non-DOTs therapy, 7 patients expired, 8 patients migrated out, 10 patients were lost to follow-up, and rest 6 patients could not be traced.
Conclusions: Causes of default are usually multiple, and most cases are preventable/rectifiable. Some flexibility with respect to drug administration and strengthening in DOTS program by reviewing it at regular intervals will go a long way in further.
Keywords: Default, Sikkim, tuberculosis
|How to cite this article:|
Lepcha LS, Jain AK, Nandy P. Sociodemographic profile and treatment outcome of tuberculosis patients registered under directly observed treatment short course in East Sikkim with reference to defaulters. J Med Soc 2017;31:147-51
|How to cite this URL:|
Lepcha LS, Jain AK, Nandy P. Sociodemographic profile and treatment outcome of tuberculosis patients registered under directly observed treatment short course in East Sikkim with reference to defaulters. J Med Soc [serial online] 2017 [cited 2019 Oct 20];31:147-51. Available from: http://www.jmedsoc.org/text.asp?2017/31/3/147/211100
| Introduction|| |
Tuberculosis (TB), due to infection with mycobacterium TB complex, is one of the major health problems and causes of morbidity and mortality in developing countries even after being one of the oldest diseases known to humanity. In India, TB still has a social stigma associated with it despite continuous efforts by the government leaving its aftermath physically, culturally, and intellectually on the affected patients and their families.
Asia and Africa have the highest burden of TB in the world with India and China together accounting for nearly 40% of the world's cases. India has highest number of new cases annually with about 40% of its population being infected with TB bacillus at anytime. The annual global incidence of TB according to the WHO was 9 million cases in 2011 and out of which 2.3 million cases were estimated to have occurred in India.
The Revised National Tuberculosis Control Program (RNTCP) was launched as a pilot project in 1993 and started as a national program in 1997 based on Directly Observed Treatment Short course (DOTS) strategy covering entire country by March 2006.
In Sikkim, RNTCP was launched simultaneously in the entire state on March 2002. Since its launch, there has been vivid progress in the diagnosis and treatment of TB. In Sikkim, from 2005 to 2009, the diagnosis rate was 55%, cure rate was 89.7%, and the total number of defaulters was 112 (1.8%).
Sikkim is the least populated state in India, being second smallest with respect to area, located in the Himalayas, divided into four districts. TB is a major public health problem in Sikkim, being the main cause of mortality due to communicable disease in the state. Around 1700 cases of TB are diagnosed and put on treatment every year in the state. Our study is based in the East Sikkim district of the state.
Present antitubercular therapy can nearly cure all patients. However, the long duration of the treatment in addition to the patients feeling better within two to three months into the treatment contributes to one of the reasons for non-compliance.
Default is one of the averse fallouts for patients on DOTS and serves as an essential challenge for the control program. Some studies, done on various causes and risk factors for default, have found gender, alcoholism, treatment after default, poor knowledge about the disease, irregular treatment, and socioeconomic status as some of the important factors associated with high default rates.
| Methods|| |
The study was conducted from 2009 to 2011 in East Sikkim, which included two TB units, namely, Gangtok TB Unit and Singtam TB Unit.
Case definition for the study was individuals who are residents of East Sikkim diagnosed with TB and registered for treatment under DOTS program of RNTCP and who defaulted from treatment. “Cases” were defined as patients registered in 2009–2011 as diagnosed with TB under DOTS with a recorded treatment outcome of default from the TB register. RNTCP defines default as a patient who has not taken anti-TB drugs for more than 2 months consecutively anytime after starting treatment (category III also was included in the study as under DOTS, last recruitment in category III was done in December 2010; from 2011 onward, no further new cases were recruited and only previously recruited cases completed their course).
Secondary data for the study group was taken from the TB register obtained from the district TB center Gangtok and Singtam TB Unit. To obtain primary data, the defaulters were interviewed by a pretested questionnaire.
The interview was carried out by visiting homes of the defaulters. The tracing of the defaulters was not an easy task as most of the defaulters could not be contacted on the first visit. Furthermore, the addresses given by them were incomplete or proper address was not given. It was only with the help of the local TB staff; 32 out of 46 defaulters and/or defaulters' family could be traced, and necessary information could be collected.
The data was collected and entered and analyzed using Excel worksheet.
The study was conducted after obtaining permission from the Institutional Ethical Committee.
| Results|| |
During the study period, there were a total of 2638 cases registered under DOTS in East Sikkim. Out of these, 1807 (68.5%) patients were of pulmonary TB and 831 (31.5%) patients of extrapulmonary TB. A total of 1635 (62%) patients were on category I, 634 (24%) patients on category II, and 369 (14%) patients on category III of DOTS.
The total number of defaulters during the study period was 46 (1.7%). Among these, 43 (93.5%) were pulmonary TB cases and the remaining 3 (6.5%) were extrapulmonary TB cases. Patients from category II (25/46 patients; 54.3%), i.e., relapse, failure, treatment after default, and others had defaulted the most [Table 1].
|Table 1: Distribution of tuberculosis defaulters according to type of patients of East Sikkim from 2009 to 2011|
Click here to view
Default was seen more in the Nepali ethnic group (36/46 patients; 78.26%), with most common age group being 20–39 years (24/46 patients; 52.17%) with equal representation of males and females.
Most of the people who defaulted were from lower income group, i.e., <5000 rupees/month (29/32 patients), with lower education level as in the ones who had attained elementary school and below (30/32 patients) and unemployed (14/32 patients).
Default time was observed more in the early intensive phase period, i.e., 0–1st month (23/46 patients; 50%) followed by early continuation phase, i.e., 3rd–4th month (16/46 patients; 34.78%). The reasons for default were usually multiple in most cases with common causes being consumption of alcohol, relief of symptoms, and migration [Table 2].
|Table 2: Distribution of tuberculosis defaulters of East Sikkim from 2009 to 2011 according to the reason for defaulting from treatment|
Click here to view
The outcome of TB patients registered under DOTS in East Sikkim from 2009 to 2011 is given in [Table 3]. Out of the 32 patients interviewed 10 patients could be persuaded to start treatment again under DOTS, 5 patients had started taking non-DOTS treatment from private practitioners and wanted to continue the same, 7 patients had expired, and rest 10 could not be persuaded to return to treatment repeated counseling sessions of the patient and their family members were possible.
|Table 3: Outcome of tuberculosis patients registered in East Sikkim from 2009 to 2011|
Click here to view
*Some data in the results are out of 46 patients and the rest out of 32 patients. This is because as only 32 out of 46 defaulters could be interviewed, but the data was also collected from the TB register. Thus, the data from the TB register are represented out of 46 and that from the interview out of 32.
| Discussion|| |
It was noticed in our study that the defaulters were most common in the retreatment group, i.e., relapse, failure, treatment after default, and others. Vijay et al. have stated in their study that patients returning after default and having poor knowledge of disease are additional risk factors for default. Hence, devoting attention to those at risk of default right from the initial start of treatment to completion would be helpful in preventing default.
There was an equal representation of males and females in our study. This is in contrast to studies by Vijay et al. at Bengaluru and Pillai et al. at Puducherry which showed an association of defaulting from treatment with male sex., Males being affected by TB has an adverse impact on the socioeconomic status of the family leading to burden on the other earning members increasing dependency. While Amoran et al. at Nigeria found that sex of the patient was not associated with default, which also shows that compliance with anti-TB drugs does not depend on sexual behaviors and roles in the society.
The default was noticed more in the Nepali population which also constitutes the maximum proportion of the population of the East Sikkim followed by the tribal Bhutia community where there were five defaulters. The Nepali community includes a wide range of people, and in this study, it was found that it was among the Nepali population that the default was maximum, and they also were the ones with the lower education level and with lower incomes. This can also be attributed to the fact that there are a large number of people, especially from the Nepali community who come to Sikkim for work. This factor was found to be of relevance in the study as there was a large group of people who migrated during treatment, and on inquiring, it was found that they were not actual residents of Sikkim. Thus, migration among the Nepali community in and around the adjoining states of Sikkim added to the burden of default as well as making it more difficult for tracing these patients.
Defaulters in our study were more in the age group of 20–39 years which is the most productive age group. In general, the study showed that treatment default occurred mainly in the age group most affected by the disease that is in the economic productive age that may be linked to several factors such as family responsibility and enforcement of working hours, which was also seen in the study done by da Silva Garrido et al. at Brazilian Amazon. This was in contrast to the study done by Kumar et al. at Lucknow were the 35–44 years age group was most noncompliant to DOTS.
Default time was observed more in the early intensive phase period (0–1 month) followed by early continuation phase. This observation was similar to most of the other studies where default is more common in the transition phase and during early phase of treatment. However, there is limited understanding of the timing of default in patients on the treatment of TB in the developing world. A wide range of default times has been reported from other studies and reflects the differences in period of study, context, patients, and specific programs. A substantial proportion of defaulters appear to leave treatment in the later stages of the current 6-month regimen, suggesting that new TB chemotherapeutic agents which can reduce the length of treatment have the potential to improve global TB treatment success rates.,,,,
In this study, it was found that most of the persons who defaulted were in the lower income group, similar to study by Mishra et al. at Nepal suggesting a lack of money is also an important risk factor for nonadherence to TB treatment.
In this study, it was found that the people who defaulted were more in the lower education level similar to other studies., Thus, higher educational levels and knowledge of TB are associated with better compliance to TB treatment and subsequently treatment success. Hence, health education and awareness about control of TB should be incorporated in TB treatment.
The reasons for default were usually multiple in most with common causes being consumption of alcohol, relief of symptoms, and migration. Various studies have shown that cause of default is usually multiple such as drug-related problems (nausea, vomiting, and giddiness), relief from symptoms, substance abuse, work-related problems, treatment from other private practitioners, commitments during treatment, and migration.,,,
Important commitments such as weddings/deaths, during treatment period, are an important cause of default. In Sikkim, death rituals are a lengthy process with the religious rites being carried on for 49 days and so if the family member is taking treatment, it becomes impossible for that person to go thrice weekly (intensive phase) to collect the drugs. Hence, during these compelling circumstances, flexibility could be exercised by providing one or two blister packs in intensive phase for self-administration with the knowledge of the medical personnel. Support and cooperation to the patient from care providers during this period will ensure that these patients will comply with treatment and in doing so complete their full course of treatment.
Substance abuse is also an important cause of default. The altered behavior under the influence of alcohol and other substances is believed to be the reason for such observations. When one is under the influence of alcohol, one is likely to forget to take the medicines, and higher chances of developing side effects that may subsequently lead to poor compliance.
Often, when patients commence treatment, they will be very sick and may be inactive. However, as the treatment progresses, their condition improves, and symptoms start to regress, the improvement in itself may become a barrier to continuation of treatment. The patient might not see the need to continue with treatment when they are feeling better or well.
All defaulters could not be interviewed, only 32 out of 46 defaulters and/or defaulter's family could be interviewed and there was no control group, and thus no statistical test of significance could be applied which is a limitations of our study.
| Conclusions|| |
Early diagnosis of disease and prompt initiation of treatment is essential for an effective TB control program, especially in areas where there is a movement of TB patients from one area to another. To reduce default, the DOTS program should be reviewed at regular intervals, and supervision and monitoring should be strengthened. There should also be strong commitment from the community health workers, volunteers, and nongovernmental organizations under the DOTS program. Proper records should be maintained for smooth monitoring of patients. Patients on treatment should be counseled for de-addiction against smoking and alcohol.
The patients need support and care to ensure that they adhere to treatment. Thus, they should be frequently motivated to continue their treatment and thereby reducing their tendency to interrupt treatment. Providing counseling, building good rapport, insistence on treatment regularity, repeated motivation, empathetic attitude, and timely provision of drugs are important in ensuring treatment regularity. Stress should also be laid on pretreatment counseling and education of TB before initiation of DOTS to ensure completion of treatment. This should include importance of completing the full course of treatment irrespective of sensation of feeling better, travel plans in between treatment, side effects, personal commitments, etc. Patients travelling away from the treatment center should be informed about the options available to ensure that they will not run short of drugs.
The DOTS program is rigid in terms of thrice-weekly drug administration under direct observation during intensive phase. To fulfill the requisites of DOTS, the patient often has to compromise with his personal, family, and social obligations which at times becomes difficult to sustain and leads to treatment interruption. Solution to this problem is often difficult; DOTS providers should be allowed to collect drugs for the very sick patients. Furthermore, patients can be allowed one or two blister packs in compelling circumstances.
We are grateful to Dr. Bidita Khandelwal, Professor and Head of Department, Department of Medicine, SMIMS, for her continuous guidance throughout the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Vijay S, Balasangameswara VH, Jagannatha PS, Saroja VN, Kumar P. Defaults among tuberculosis patients treated under DOTS in Bangalore city: A search for solution. Indian J Tuberc 2015;50:185-95.
Pillai D, Purty AJ, Stalin Prabakaran ZS, Soundappan G, Anandan V. Initial default among tuberculosis patients diagnosed in selected medical colleges of Puducherry: Issues and possible interventions. Int J Med Sci Public Health 2015;4:957-60.
Amoran OE, Osiyale OO, Lawal KM. Pattern of default among tuberculosis patients on directly observed therapy in rural primary health care centres in Ogun State, Nigeria. J Infect Dis Immun 2011;3:90-5.
da Silva Garrido M, Penna ML, Perez-Porcuna TM, de Souza AB, da Silva Marreiro L, Albuquerque BC, et al
. Factors associated with tuberculosis treatment default in an endemic area of the Brazilian Amazon: A case control-study. PLoS One 2012;7:e39134.
Kumar M, Singh JV, Srivastava AK, Verma SK. Factors affecting the noncompliance in directly observed short course chemotherapy in Lucknow district. Indian J Community Med 2002;27:114-7. [Full text]
Kaona FA, Tuba M, Siziya S, Sikaona L. An assessment of factors contributing to treatment adherence and knowledge of TB transmission among patients on TB treatment. BMC Public Health 2004;4:68.
Chatterjee P, Banerjee B, Dutt D, Pati RR, Mullick AK. A comparative evaluation of factors and reasons for defaulting in tuberculosis treatment in the states of West Bengal, Jharkhand and Arunachal Pradesh. Indian J Tuberc 2003;50:17-22.
Jaggarajamma K, Sudha G, Chandrasekaran V, Nirupa C, Thomas A, Santha T, et al
. Reasons for non-compliance among patients treated under Revised National Tuberculosis Control Programme (RNTCP), Tiruvallur district, South India. Indian J Tuberc 2007;54:130-5.
Daniel OJ, Oladapo OT, Alausa OK. Default from tuberculosis treatment programme in Sagamu, Nigeria. Niger J Med 2006;15:63-7.
Mishra P, Hansen EH, Sabroe S, Kafle KK. Socio-economic status and adherence to tuberculosis treatment: A case-control study in a district of Nepal. Int J Tuberc Lung Dis 2005;9:1134-9.
Balasubramanian R, Garg R, Santha T, Gopi PG, Subramani R, Chandrasekaran V, et al
. Gender disparities in tuberculosis: Report from a rural DOTS programme in south India. Int J Tuberc Lung Dis 2004;8:323-32.
O'Boyle SJ, Power JJ, Ibrahim MY, Watson JP. Factors affecting patient compliance with anti-tuberculosis chemotherapy using the directly observed treatment, short-course strategy (DOTS). Int J Tuberc Lung Dis 2002;6:307-12.
Pandit N, Choudhary SK. A study of treatment compliance in directly observed therapy for tuberculosis. Indian J Community Med 2006;31:241-3. [Full text]
[Table 1], [Table 2], [Table 3]