European Journal of Cardiovascular Medicine

The NTEP's objective is to make India TB-free, with no TB-related deaths, disease, or poverty. Its goal is to achieve a rapid reduction in TB burden, morbidity, and death while working toward TB elimination in India by 2025^[1].

The initiative aims

1. to reduce tuberculosis incidence by 80%, from 211 per lakh to 43 per lakh.
2. 90% reduction in tuberculosis mortality (from 32 to 3 per lakh).

3.0% of patients had catastrophic expenditures owing to tuberculosis.

Tuberculosis (TB) is the leading infectious cause of death globally. ^[2] India, a country with a high TB burden, accounts for almost 2.7 million (27%) of the predicted 10 million global cases in 2017. Similarly, the country accounts for one-third of estimated TB mortality (excluding TB-human immunodeficiency virus [HIV]) globally. It is also one of the countries with the highest number of multidrug-resistant TB and TB-HIV cases.^[3]

By 2006, India's National TB Elimination Program (NTEP) had covered all of the country's districts for tuberculosis management.^[4] The country has designed and implemented a National Strategic Plan (NSP) for TB elimination 2017-2025, by the END TB strategy and Sustainable Development Goal (SDG) 3.3.^[5] The NTEP has been consistently addressing challenges linked to tuberculosis control in the country through programmatic modifications based on findings from operational research. Using sputum smear microscopy and intermittent directly observed treatment short course (DOTS), the program consistently detected 70% of pulmonary tuberculosis patients and achieved 85% treatment effectiveness.^[4]

Because of the significant relapse rate and development of medication resistance with intermittent regimens, the Joint Monitoring Mission has recommended switching to a daily fixed-dose combination (FDC) regimen from October 2017. ^[6] Newer interventions, such as 99 DOTS (an innovative and low-cost intervention for ensuring medication adherence), NikshayPoshanYojana (financial assistance for patient nutritional support), universal drug sensitivity testing (DST), and improved adverse event surveillance and reporting, have been implemented to meet the NSP goals by 2025.^[4]

Because the new regimen was just recently implemented, insufficient research has been conducted to determine the compliance rate to the new regimen, current factors of treatment failure, or the presence of novel determinants. As a result, it is necessary to analyze patient compliance with the new regimen and identify the factors that contribute to treatment failure.

OBJECTIVES:

1. To determine the compliance rate in patients with microbiologically confirmed Tuberculosis registered under NTEP daily regimen.
2. To identify the determinants of ‘treatment after loss to follow up’ under NTEP daily regimen.

Study Design: Hospital-based, cross-sectional study.

Study area: The study was conducted in the Department of General Medicine.

Study period: 1 year.

Study population:TB patients attending OP and IP at the Department of General Medicine and Pulmonology.

Sample size: The study consisted of a total of 50 subjects.

Sampling Technique:  Simple Random technique.

InclusionCriteria:

• Patients above 18 years of age
• Patients with microbiologically confirmed Tuberculosis, either new or previously treated under NTEP Daily Regimen

Exclusion criteria:

• Patients below the age of 18 years
• Radiologically and clinically confirmed cases of tuberculosis
• Patients not willing to participate

Study tools and Data collection procedure:

A validated questionnaire was developed. Consent was obtained from the Chief Health Officer and the District Tuberculosis Officer. The MO-TC conducts the weekly meeting in each TU. The investigator attended such meetings in all the TUs and briefed the STS and health visitors about the study, seeking their cooperationin tracking the defaulters. The ‘treatment after loss to follow up’ thus traced were visited at their residences through the address obtained from the designated microscopic centres, were interviewed at their residences and telephone using the standardized questionnaire.

Statistical analysis:

Data was analyzed using SPSS V16 software. Descriptive statistics was used to provide an overview of the socio-demographic profile of the study population. A chi-square test was employed for discrete data. P<0.005 was considered a statistically significant value.

677 patients were registered under the NTEP during the study period and 61 (9.01%) patients were treated after loss to follow-up. 616 (90.98%) patients adhered to the treatment and followed up regularly. 50 patients among them were considered for the study.

TABLE NO 1: SEX DISTRIBUTION

60% i.e., 30 of them were males, and 20 i.e., 40% were females.

TABLE NO 2: AGE DISTRIBUTION

In our study, we categorized the patients below 25 years, 25 to 50 years and above 50 years. 10 % of patients were less than 25 years old, 58% belonged to the 25 to 50 years group and 32% were above 50.

TABLE NO 3: FACTORS AFFECTING TREATMENT AFTER LOSS TO FOLLOW-UP

In our study, 36% of the patients were lost to follow-up due to Therapy-related factors, 22% due to Patient condition-related factors, 18% due to Socio-economic factors, 16% due to Disease-related factors, healthcareteam-related factors and 6% due to other factors like COVID- 19.

TABLE NO 4: THERAPY-RELATED FACTORS

18 (36%) out of 50 patients belonged to this category. 7 of them stopped the treatment due to the side effects of the drugs. 6 of them stopped due to the long duration of treatment. 5 of them were lost to follow-up due to the frequent administration of drugs.

Regarding the patient condition-related factors affecting the treatment after loss to follow-up, 11 (22%) out of 50 patients belonged to this category. 8 of them stopped the treatment due to a lack of knowledge about the disease and its consequences. 2 of them stopped due to substance abuse like alcoholism during the treatment. Depression due to the long duration of treatment was the reason for treatment after the loss offollow-up in one of the patients.

TABLE NO 5: SOCIOECONOMIC FACTORS

9 (18%) out of 50 patients belonged to this category. 3 of them stopped the treatment due to their low-income status. 3 others stopped due stigma attached to the disease. Busy work schedule, relocation to another residence, and transportation costs to the health care centre were the other reasons for treatment after loss offollow-up in one of the patients.

TABLE NO 6: DISEASE-RELATED FACTORS

8 (16%) out of 50 patients belonged to this category. 3 of them stopped the treatment due to the existence of other co-morbidities like diabetes mellitus and hypertension. 3 others felt that their symptoms subsided and hence stopped the treatment. 2 others felt better after initiation of treatment which was the reason for treatment after loss to follow up.

One patient reported that the healthcare team did not explain the risks and benefits of taking medications regularly.

The present study was carried out in 50 patients. The total number of patients with microbiologically confirmed tuberculosis cases under the designated microscopic centre was 677. Among them 90.98% i.e., 616 patients were compliant with the treatment and were following up regularly. The total number of ‘treatment after loss to follow up’ among the registered patients was 61. The number of ‘treatment after loss to follow up’ who could be traced and interviewed was 50. The default rate is around 9.01%

In this study, 20 females, and 30 males were enrolled. We categorized them based on the age as less than 25 years, 26 to 50 years and above 50 years. 10% were less than 25 years of age and 58% were between the ages of 26 to 50 years. Above 50 years, 32% were enrolled. It was observed that the proportion of defaulting was not the same in all the age groups. The proportion was higher in this age group as compared with the others, this probably could be explained by the fact that 26 to 50 years is considered a productive age group and their employment status could be the reason for treatment after loss of follow-up. This study follows the study by Santa et al.⁷ and Dodar^[7] where male patients were at increased risk of treatment after loss offollow-up. In a study done by Holtz et al.⁸, done at Pretoria, South Africa, most patients were male (59% of cases, 61% of controls). The higher rate of default in men compared to women can be attributed to their role of being the earning member of the family. Men tend to leave their homes quite early for work to provide for their families and therefore may find it difficult to come regularly to the health care facility, especially during the intensive phase of the treatment.

36% of the patients discontinued the medication due to “Therapy-related factors, " one of the major drivers for discontinuation, followed by 22% due to “Patient conditions-related factors”. 18% due to “Socio-economic factors” and due to “Disease-related factors” 16% discontinued medication. 2% discontinued due to COVID-19-related issues and 6% due to other miscellaneous factors.

Therapy-related factors: 18 out of 50 ‘treatment after loss to follow up’ (36%). Side effects of the drugs, Long duration of treatment, Frequent administration of tablets, Tablet size, use of alternate medicine, and Treatment complexity of the regimen were assessed. 7 patients discontinued due to side effects of the drug like followed by 6 patients because of ‘Long duration of the treatment’ and 5 patients for ‘Frequent administration of drugs’

A qualitative follow-up study in Tashkent by Hasker et.al.⁹ in 2005 found that there is a widespread belief that TB is not a curable disease. Patients who lack proper information on the cause of TB and the reason for the long duration of treatment, tend to perceive it to be an incurable disease. This calls for intensifying counselling and educational strategies for improved understanding of the disease. Adverse reactions are common occurrences during the early part of therapy and may form an important cause of default. Advance information about the adverse reactions, early withdrawal of the drugs on a transient basis and timely referral to a higher centre for proper management of these adverse reactions will keep a check on defaults due to this reason. It will also keep the confidence of the patient in the programme intact.

For Patient condition-related factors, Physical impairment, Cognitive impairment, Lack of Knowledge, Lack of self-motivation, Depression due to long-term treatment, Substance abuse, and awarenessof treatment was free of cost or not were assessed. The patients who lacked knowledge about the disease and its consequences accounted for 8 cases. They perceived the disease as incurable.

Probably the not literate patients did not understand the consequences of irregular treatment properly. Effective patient-provider interaction is a means of providing treatment-related information and clearing doubts regarding disease and treatment. This plays a decisive role in enhancing treatment compliance. Male patients & those with alcoholism were at increased risk of default. 2 such patients were identified in our study. Elicitation of history of alcoholism before treatment initiation will help in identifying potential ‘treatment after loss to follow up’ needing special attention during treatment. Improving compliance among alcoholic patients through support from family, health staff and social organizations is a challenge to be addressed. One of the patients stopped treatment due to depression as the patient perceived the disease to be of long duration and incurable.

Migration is a common occurrence in the urban environment, where people move from rural to urban areas to seek employment. Failure to thrive in cities after an illness may compel them to return to their native habitat. This problem could be tackled successfully through an efficient referral/transfer system as recommended in NTEP. Provision of this facility should be made known to patients repeatedly during treatment. TB-infected individuals perceive themselves to be at risk for several stigma-related social and economic consequences. Because the most common result of TB stigma is isolation from other members of the community, TB infection can substantially impact economic opportunities.

In disease-related factors, 3 patients each discontinued due to the existence of comorbid conditions like diabetes mellitus and hypertension and 3 others ‘felt that the symptoms subsided’ whereas another two discontinued as they felt better after the initiation of the treatment. Key risk factors and comorbidities such as HIV infection, diabetes, malnutrition, tobacco, and substance use disorders drive the global TB epidemic and are associated with poorer TB treatment outcomes. People with TB also have a higher risk of mental health disorders. Conversely, TB and its treatment can complicate the management of some of these conditions. Chronic and infectious diseases often co-exist due to mutual risk factors as well as direct interactions between the diseases. One of the major challenges is the double burden of diabetes and pulmonary tuberculosis.

Effect of COVID-19 on TUBERCULOSIS: The COVID-19 pandemic has had a significant impact on the delivery of various tuberculosis prevention, surveillance, and treatment programs. It was observed that there was a marked reduction in the number of presumptive and confirmed TB cases detections during this pandemic. COVID-19 prevention and lockdown strategies have restricted diagnosis and access to test and treatment centres. A dramatic drop was observed since the lockdown according to the Central TB Nikshay portal of the Government of India. As the population in some regions are latently infected, it is anticipated that SARS-CoV-2 infection might initiate the development of active TB in the coming months. Lockdown and public health guidelines have resulted in tough challenges in the traditional management of tuberculosis and have required reconfiguration of methods to support patients including wider use of remote consultations.

Thus, based on the foregoing facts, it is possible to conclude that, while 90.98% adhered to the new treatment regimen, 9.01% did not. This 'treatment after loss to follow up' is a significant impediment to the NTEP program's success. It was discovered that therapy-related factors (36%), followed by patient condition-related factors (27%), socioeconomic factors (22%), disease-related factors (16%), health-care-related factors (2%) and other factors such as the COVID-19 pandemic (6%) had an impact on defaulting behaviour despite switching to a daily regimen with fixed-dose combination as opposed to an intermittent regimen.

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