TREATMENT OUTCOMES OF PATIENTS UNDER RNTCP

DOTS IN KOLLAM DISTRICT, KERALA

Dr Shibu Vijayan

Dissertation submitted in partial fulfillment of the requirements for the

award of the degree of Master of Public Health

Achutha Menon Center for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences & Technology

Trivandrum

October 2007

l .

Declaration

I hereby certify that the work embodied in this dissertation titled 'Treatment

Outcomes of Patients under RNTCP DOTS in Kollam District, Kerala' is the result

of original research and has not been submitted in any form for another

degree/diploma at any university or other institution of higher education.

v ?;

{\

<

Trivandrum Dr Shibb Vijayan

October 2007

~

Acknowledgements

The most important part of this study could only be covered by the co-operation of respondents and the health staff especially the staff in RNTCP. Their hospitality, and the many hours spent together with them, made this work an outstanding experience which has deeply impressed me. I would like to thank all the respondents of the study.

I am extremely obliged to my guide Dr Manju Nair, Scientist C, AMCHSS, and it was a piece of good luck to have her as my mentor.

I am also indebted to Dr.Biju Soman, Assistant Professor, AMCHSS, Dr. Srinivasan, Kerala State WHO-RNTCP consultant, and Dr. Hemachandran, WHO consultant, PPM­DOTS, Kerala for their cooperation in conceptualization of the research and preparation of study tools and sharing data.

I extend my heartfelt thanks to Dr. Jayasanker former District TB Officer, Kollam, Dr Neetha District TB Officer Kollam and Dr Sabeena second MO Kollam for their fabulous support offered to me for conducting the study. I am also thanking the RNTCP staff in Kollam district who helped me without any incentive to materialize this thesis.

I would like to thank all Medical Officers, TB control for arranging the staff for helping me in my data collection.

I would like to thank Dr. K. Mohandas, Director, Dr K R Thankappan, Professor and head, AMCHSS, and all my teachers including Dr. K Sundari Ravindran, Honorary Professor, Dr. V Raman Kutty, Professor, Dr. Mala Ramanathan, Additional Professor, Dr. P Sankara Sarma, Additional Professor and Dr. Richard A Cash, Visiting Professor, Harvard School of Public Health for their constructive criticisms and suggestions during the progress of the research and up until completion. I am also grateful to Mr. Sundar Jayasingh, Assistant Registrar, for his support in helping me through all the administrative procedures. Last, but not least, I do remember my family back in Kollam who have shared in my zest and supported me silently.

Certificate

Certified that the dissertation titled 'Treatment Outcomes of Patients under

RNTCP DOTS in Kollam District, Kerala' is a bonafide record of original research

work undertaken by Dr Shibu Vijayan, in partial fulfillment of the requirements for

the award of the Master of Public Health degree under my guidance and

supervision.

Guide~-Dr Manju Nair R Scientist C Achutha Menon Center for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum. October 2007

iii

Chapter List of abbreviations Abstract Introduction-! 1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4

1.2.5 1.2.6 1.2.7 1.2.8 1.3 1.4 1.5 Methodology-2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 Results-3 3.1 3.1.1 3.1.2 3.1.3 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9

Table of Contents

Page 1 2

Background 3 Literature review 4 Evolution of Tuberculosis control strategy.,. Global scenario 4 DOTS strategy 4 Evolution of Tuberculosis control strategy in India 6 Revised National Tuberculosis Control Programme (RNTCP) 7 DOTS Regimen 7 Impact of DOTS strategy in India 8 Factors affecting the treatment outcomes of Tuberculosis 9 Relapse 17 Rationale for the study 18 Objectives 19 Research Questions 19

Study type Study setting Sample size Sample selection procedures Definition of study variables Data collection Data collection methods Data entry and Analysis Ethical considerations

Characteristics of the cohort Age and Sex wise distribution of the cohort Initial smear status Outcome at the end of DOTS treatment Survey findings Characteristics of the sample Educational status Employment status Marital status House hold characteristics Type ofhouse Place of residence Socioeconomic status Smoking status

20 20 20 20 20 21 22 22 22

25 25 25 26 27 27 28 28 28 28 29 29 29 29

3.2.10 Smokeless tobacco use 30 3.2.11 Alcohol use 31 3.2.12 History of exposure to tuberculosis 31 3.2.13 Knowledge and perception about Tuberculosis and

Its treatment 31 3.2.14 History of previous Anti tuberculosis drugs 32 3.2.15 Facility first sought by patient for diagnosis 32 3.2.16 DOTS and its components 32 3.2.17 Profile of DOT centre 33 3.2.18 Intake of drugs 33 3.2.19 Treatment components 34 3.2.20 Duration of treatment 34 3.2.21 Adverse effects of drugs 34 3.2.22 Confidentiality and stigma 35 3.2.23 Co morbidities 35 3.2.24 Treatment outcome 18 months after completion

of treatment 36 3.2.25 Relapse 37 3.2.26 Death 37 3.2.27 Defaulters 37 3.2.28 Failure 37 3.2.29 Patients with unsupervised drug intake 37 3.2.30 Chest symptomatics 37 3.3 Factors affecting the outcome 38 3.3.1 Age group and outcome after the treatment (7 months) 38 3.3.2 Sex differential among treatment outcome 38 3.3.3 Pre treatment smear status and outcome. 39 3.3.4 Use of alcohol and treatment outcome 39 3.3.5 DOTS centre and type of drug intake 40 3.3.6 Diabetes and treatment outcomes 40 3.3.7 Type of DOTS centre and outcome 40 3.3.8 Outcome after 18 months after completion of

Treatment 41 3.3.8.1 Treatment outcomes 18 months after completion ofDOTS

And sex 41 3.3.8.2 Age and treatment outcomes after 18 months after

completion of treatment 42 3.4 Findings of verbal autopsy 42

Discussion-4 4.1 4.2 4.3 4.4 4.5 References

Annexure

Outcomes DOTS factors influencing outcomes Deaths Limitation of the study Conclusion and programme implications

44 48 50 52 52

54

•

AIDS

ATT

DM

DOTS

DTC

GOI

HIV

NACO

NTP

PTB

RNTCP

TB

WHO

MDRTB

SES

LIST OF ABBREVIATIONS

Acquired ImmunoDeficiency Syndrome

Anti Tuberculosis Treatment

Diabetes mellitus

Directly Observed Treatment Short course

District Tuberculosis Center

Government Of India

Human Immunodeficiency Virus

National AIDS control Organization

National Tuberculosis Program

Pulmonary Tuberculosis

Revised National Tuberculosis Control Program

Tuberculosis

World Health Organization

Multi Drug Resistant Tuberculosis

Socio Economic Status

•

Abstract Background: DOTS as a strategy was introduced to the Tuberculosis control programme in the District of Kollam, Kerala in 2000. The impact of the programme on treatment outcomes and the estimation of relapse within the DOTS has not been assessed ever since. The objective of the study is to identify the treatment outcomes of a cohort of new smear positive pulmonary tuberculosis patients registered under RNTCP- DOTS in the first quarter of 2005 after completion of treatment and after 18 months, and to analyze the factors associated with the various treatment outcomes

Methods: Cross sectional study of cohort of new sputum smear positive patient registered under RNTCP-DOTS during the first quarter of 2005 in the district of Kollam. The outcomes were assessed at the end of the DOTS treatment at the end of seven months after start of treatment and the patients interviewed at the end of eighteen months after completion of DOTS. Among 241 patient registered for DOTS, at the end of seven months 20 patients had died and at the time of study, excluding the patients who had died in the interim period and those lost to follow up a total of 193 patients were interviewed of which148 (76.7%) males. Pre tested structured questionnaire was used for data collection. Results: Mean age ofthe cohort was 51.04 (±16.18), males 53.09 (±15.27) and females is 43.58 (±17.35).At the end of seven months 85.9% cure rate death rate was 8.3%. Deaths were more among age group 2: 65, while youngest age group 100% cure. The initial smear status of the cohort was 3+ (57%), 2+ (23%) and 1+ and scanty (20%). Among the sample surveyed, ever smoker male were 124(83.8%) and current smokers 65 (43.9).Alcohol use among males ever used 113 (76.4%), current use 62 (41.9%) and consumption more than twice a week was 32 (21.8%). 180 ( 94.2%) took medicine as supervised or DOTS. The prevalence of diabetics was 30%. In bivariate analysis younger age group, not consuming alcohol more than twice a week was associated with favorable outcome (x2, P <.05). Significant association established with supervised drug intake and type of DOT centre in favorable of door delivery. No associations were found with initial smear status, co morbidities and smoking status with outcome. After 18 months 192 (90.9 %) disease free, 18 (8.5%) dead, and one patient unknown status. One patient relapsed and cured with DOTS retreatment within the period. Relapse rate 1 relapse/334 person years. Death rate is 16.5%.

Conclusion: The main finding of this study was the high cure rate and low relapse and default rates among the cohort of patients who had undergone DOTS. This may be due to the effective program implementation including retrieval of defaulter and timely follow up of those on treatment Use of alcohol was found to be significantly associated with treatment outcomes and there is a need to strengthen the alcohol cessation activities in RNTCP. The negative finding was a death rate of 8.3 percent which is more than double the program indicators which may be due to late arrival of patients for treatment seeking with in the advanced stages of the disease or late detection which requires further exploration. •

1.1 Background

Chapter I Introduction

Out of an estimated 8.8 million new TB cases occurring annually worldwide about 95

percent occur in developing countries, 7.4 million in Asia and sub-Saharan Africa I .A total

of 1.6 million people died of TB, including 195 000 patients infected with HIV2.India

accounts for one fifth of global incidence of TB and tops the list of 22 high TB burden

countries and, affects around 1.8 million Indians newly every year and killing 370,000

annually 3 .In India, more than 40 percent of population is infected with TB bacilli, it . is

estimated. two of every five Indians are infected with the TB bacillus, of them, 1 0 percent

will develop TB disease during their lifetime.3 Every smear-positive person, if left untreated,

has the potential to infect 10-15 persons per year, thereby increasing the pool of infected

persons4 •• Every day, about 5,000 people develop the disease and around 1000 die. Every

year, almost 1.8 million new cases occur in the country, of which almost half are infectious.

Patients with infectious pulmonary TB disease can infect 10-15 persons in a year. 5 Poorly

treated patients can develop drug-resistant and potentially incurable forms of TB. In India,

TB kills more adults in the most productive age group (15-54 years) than any other infectious

disease;

The Revised National Tuberculosis Control Program (RNTCP) has been implemented in the

country for close to a decade now, and more than 6.7 million patients have been put on

Directly Observed Treatment- Short Course (DOTS). It has geographically expanded to

achieve nation-wide coverage in March 2006, while maintaining a success rate higher than

3

the global target of 85 percent, and New Smear Positive case detection rate close to the

global benchmark of 70 percent. Under the TB Control program, priority is given to the

smear positive cases. The spread of HIV during the last two decades and the emergence of

MDR-TB pose additional challenges to effective TB control.

1.2 Literature review

1.2.1. Evolution of Tuberculosis control strategy- Global scenario

Scientific studies carried out on the treatment of TB in India6 had shown the necessity and

feasibility of giving drugs under supervision as also efficacy and safety of domiciliary

treatmene.Directly observed treatment, in which a DOT provider observes and assists as

patients take their medicine, is the most important component ofDOTS8,9' 10' 11 ' 12•

Global efforts to control TB were revamped in 1991, when a World Health Assembly

(WHA) resolution recognized TB as a major global public health problem and "a global

target of cure of 85 percent of sputum-positive patients under treatment and detection of 70

percent of cases by the year 2000"13• These targets were based on epidemiological modeling,

which suggests that achievement of an 85 percent cure rate and 70 percent case detection will

reduce the prevalence of infectious (sputum smear-positive) TB cases, the number of infected

contacts, and the incidence of infectious cases14 In 1994, the internationally recommended

control strategy, later named DOTS, was launched 15• The DOTS framework has

subsequently been expanded, further clarified, and implemented in 182 countries16•

1.2.2. DOTS strategy

Epidemiological evidences suggest that decrease in cases results from an interruption in the

spread of infection because of better rates of completion of treatment and expanded use of

DOTS17. Another positive aspect of DOTS was its cost effectiveness, even though the initial

4

costs are same for the DOTS as well as self administered treatment, but by preventing

failures and drug resistance that cost can be saved. 18 ' 19

Mortality due to TB has been declining and incidence diminishing or stabilizing in all world

regions except sub-Saharan Africa and, to some extent, Eastern Europe. The global treatment

success rate among new smear-positive TB cases had reached 83 percent by 2003 and in

2004 the case detection rate, which has accelerated globally since 2001 was 53 percene0• In

the United States, Baltimore demonstrated a marked reduction in case rates with use of

DOTS despite a higft rate of HIV infection21 • In New York city, by 1991, half of the TB

patients were HIV infected and one in five had multidrug resistant tuberculosis, but DOTS

resulted in a rapid decrease in both tuberculosis and in multidrug resistance22' 20• Experiences

in Malawi, Mozambique and Tanzania, documenting cure rates of 86-90 percent 23.Universal

DOT implementation in Cuba was associated with a substantial decline in tuberculosis24•

Prevalence of smear-positive tuberculosis in Beijing decreased form 127 per 100,000 in 1979

to 16 per 100,000 population in 1990, a decrease of 17 percent annually25• In the South-East

Asia Region, Bangladesh had had excellent success in DOTS implementation, with coverage

of more than two-thirds of the country and cure rates above 80 percent.26

The re emergence of tuberculosis (TB) as a public health problem in industrialized countries

was attributed to the combined effects of the human immunodeficiency virus (HIV) epidemic

and social factors such as rising poverty and homelessness in large cities, increased

demographic pressure, immigration and poorly organized TB control programmes. 27 ' 28 ' 29 ' 30

In short DOTS implementation has helped countries to improve national TB control

programmes (NTPs) and make major progress in TB control.

DOTS is a systematic strategy which has five components. These are as follows:

5

• Political and administrative commitment

• Good quality diagnosis, primarily by sputum smear microscopy

• Uninterrupted supply of good qua~ity drugs

• Directly observed treatment (DOT)

• Systematic monitoring and accountability

1.2.3 Evolution of tuberculosis control strategy in India

TB is the number one killer of adults among all infectious diseases, in India 1• 3· The TB

• control strategies started in India, with the establishment of the first open-air sanatorium

during the year 1906 at Tilonia near Ajmer. The Tuberculosis Association of India was

started in February 1939. Bac~llus Calmette Guerin (BCG) vaccination was the only avenue

for protection and prevention of tuberculosis and was introduced in India by 1948.. As a

preventiye measure, it was extensively used in most of the European countries in 1920s. The

National Sample Survey (1955 to 1958) was an eye opener, which revealed that the problem

of TB was uniformly distributed, both in the urban and rural population of the country31 .At

that time, the standard treatment for TB in India, and throughout the world, called for

isolation of TB patients in sanatoria. Thereafter, in 1962 a National TB Control Program was

started under which District TB centers were established. The idea was to set up a clinic

where patients could come and collect their drugs. It failed due to managerial problems and

lack of drug availability.

The burden ofHIV infection in India is estimated to be 5.22 million, which equates to

approximately 0.9 percent of the adult population of the country. Tuberculosis is one of the

earliest opportunistic diseases to develop amongst persons infected with HIV. Based on

6

mathematical modeling, WHO has estimated a prevalence of 5.2 percent of HIV in adult TB

patients in India32•

In 1992, GOI-WHO carried out an in depth review ofTB program in India as a part

of global review and observed glaring deficiencies like, inadequacy in budget allocation,

over-dependence on X-ray, poor treatment compliance, inadequate health infrastructure in

the urban areas and impending threat ofHIV worsening the scenario ofTB.

1.2.4. Revised National Tuberculosis Control Program (RNTCP) •

Based on the review, RNTCP took its roots in India in 1993 with WHO recommended

DOTS, by pilot testing the strategy in a population of about 18 million. From 1998-2001,

the population coverage and expansion was scaled up to cover a population of about 350

million33• Large-scale expansion of DOTS services in India began in 1997. In the past 8

years, RNTCP has been expanding rapidly covering 50 percent of the population in 2002,

and full nation wide coverage was achieved by March.

The goal of RNTCP is to decrease mortality and morbidity due to TB and cut transmission of

infection until TB ceases to be a major public health problem.

The objectives of RNTCP are to achieve and maintain a cure rate of at least 85 percent

among newly detected infectious (new sputum smear positive) cases, and to achieve and

maintain detection of at least 70 percent of such cases in the population.

1.2.5. DOTS regimen

Treatment under direct observation is given thrice weekly. For new smear-positive patients,

intensive phase treatment is given for two months (three months if the sputum smear is

positive at two months) with isoniazid, rifampicin, pyrazinamide and ethambutol. The policy

states that during the intensive phase every dose taken is to be directly observed by a health

7

worker or a community volunteer who is not a family member. In the continuation phase, the

first dose of treatment every week is to be directly observed, with the remaining two follow-

up doses self-administered by the patient30.

Sputum is examined after two and four months of treatment, at the end of treatment, and if

symptoms develop after stopping treatment. The treatment regimens used are those

recommended by the World Health Organization. Patients are considered cured if the results

of two sputum smears for acid-fast bacilli (AFB) are negative, one of which is done at the .. end of treatment. Treatment is considered to have failed if a patient has a positive smear 5

months or more after starting treatment. Relapse is considered to have occurred when a

patient who had previously been cured and was sputum smear-negative has a positive

smear34• A patient, who at any time after registration does not take anti-tuberculosis drugs

consecutively for 2 months or more, is said to have defaulted.

Other than the outcomes of treatment outcomes described two more outcomes are described,

Treatment completed- Sputum smear-positive patient who has completed treatment, with

negative· smears at the end of the . intensive phase but none at the end of treatment and Died-

Patient who died during the course of treatment regardless of cause.

1.2.6. Impact of DOTS strategy in India

The new smear positive (NSP) pulmonary TB case detection rate was 72 percent in 2004, 66

percent in 2005 and 66 percent in 2006, which is close to the global target of 70 percent.

Treatment success rate has been maintained consistently over the 85 percent global target.

Deaths due to TB have been reduced from over 500,000 annually at the beginning of the

program to currently fewer than 370,0002 • The quality of diagnosis was improved, with the

ratio of smear-positive to smear-negative patients being maintained at 1: 1. Treatment success

8

was achieved in 81 percent of new smear-positive patients, 82 pecent of new smear-negative

patients, 89 percent of patients with extra-pulmonary tuberculosis, and 70 percent of re­

treatment patients35•

Considering both smear-positive and smear-negative cases in India, DOTS reduces the case

fatality rate by about 80 percene6• Following DOTS implementation, prevalence of culture­

positive tuberculosis decreased rapidly following a gradual decline for the previous 30 years

with out DOTS37•

The National case detectio~ rate is 66 percent in 2006 and the cure is 83 percent5• The case

detection in Kerala is 43 percent an<;l cure is 82 percent5·

1.2.7. Factors affecting the treatment outcomes ofTB

Socioeconomic and demographic factors

In the developing countries, the communicable diseases like TB hit the poor much harder

than they hit the rich, though the people of all income ·groups are affected. An episode of

illness may reduce a poor household to penury, especially when they have to sell their

productive assets in order to cover health care expenses and poverty is thrust on to the next

generation38•

Low education level39' 40 ,being poor, overcrowding41 , not having a separate kitchen,38 low­

income households, percentage of elderly population in the house hold42 are significant

predictors for tuberculosis disease. Non-working females in urban area, farmers which are

male43 more prone to get disease. A study on adherence from Nepal found that

unemployment, low status occupation, low annual income, and cost of travel to the TB

treatment facility were associated with non adherence oftreatment44•

9

A study from Canada reports an increase of 0.1 ppr (person per room) in a community was

associated with increase in risk of TB cases occurring. This study shows a significant

association between housing density, isolation, income levels, and TB. Overcrowded housing

has the potential to increase exposure of susceptible individuals to infectious TB cases, and

isolation from health services may.increase the likelihoodofTB45 •

Homelessness has been associated with the emergence of MDR-TB. Homeless populations

are less likely to have access to medical care, and the close contact, overcrowding, and lack

of sufficient ventilation that mlfy exist in homeless shelters would foster the spread of

tuberculosis infection and the emergence of drug-resistant strains46•

· A study from India examining the relation between biomass cooking fuels (wood or dung)

and active tuberculosis found persons living in households that primarily use biomass for

cooking fuel have substantially higher prevalence of active tuberculosis than persons living

in households that use cleaner fuels. The analysis also indicates that, among persons age 20

years and over, 51 percent of the prevalence of active tuberculosis is attributable to cooking

smoke47.A study from Chandigarh reports, age, level of education, crowding, type of

housing, water supply and number of consumer articles in the household was found to be

independently and significantly associated with a higher risk of TB48• In short, there is

substantial evidence found that the TB is more among poorer socio-economic class.

Age as a factor in disease and treatment outcome.

Older people that live in nursing homes are at a special high risk for developing pulmonary

TB, as are those on naval vessels, and those in prisons, jails, mental hospitals, chronic disease

hospitals, juvenile detention facilities, and shelters for the homeless49.The reported average

age at death due to TB was 45 years for males and 39 years for females50 - 51 .A meta analytic

10

review, showed that male predominance among TB patients was similar in both younger and

older tuberculous populations. It also revealed a greater evolution time in older patients as

compared to younger patients. The prevalence of concomitant conditions, such as

cardiovascular disorders, COPD, diabetes, gastrectomy history, and malignancies was higher

in older patients to, while alcoholism was more frequently seen in younger patients.

Symptoms also showed variation among older age group52•

A retrospective study in an urban TB clinic in Delhi reports the case fatality rate was

significantly higher in the age gtoup 65 years and above as compared to patients between 50-

65 years . The failure rate was signific~ntly higher in the age group 65 years and above than

among patients in the 50-65 years age-group53 •

Patients in the older age groups had more advanced disease at the time of diagnosis and a

higher proportion had comorbid illnesses. They also had significantly higher mortality

compared with the younger age groups54.0lder people with TB were more likely to be male,

to smok~, to have had TB previously, to have coexisting medical diseases, to be

socioeconomically disadvantaged, and to weigh less than younger people with TB. More

severe form of Tuberculosis' and extensive lung involvement in old age55• Substantial

differences were found between older and younger TB patients and many of these were

associated with unfavorable outcome

Sex differentials in disease patterns and outcomes of treatment

The rate of tuberculosis was consistently higher in men than in women, irrespective of age

group. More women completed treatment, and fewer women missed treatment appointments.

A higher proportion of men had relapse pulmonary disease that was more extensive, a history

11

of previous default from treatment and co morbid illnesses56 ' 57• Male sex is more prone for

default46• One study from Vietnam reports similar prevalence ofTB in men and women58 •

Gender differences in health seeking behavior and utilization of services

Many of these differences by sex have been related to gender. This includes the lesser to

health care seeking and health care qecision making among women and therefore under

reporting to the health system, women having poor access than men to tuberculosis

diagnostic services and to effective treatment59• More specific to care seeking for

tuberculosis, are poor knowled~e of the disease and poor interpretation of its signs and

symptoms by women themselves as well as by health workers, the social stigma associated

with being diagnosed as TB patient affecting women more than men, and financial and time

costs of the prolonged course of tuberculosis treatment55 • Study from Kerala also reports

that women were less likely th~m men to receive DOTS60•

Effect of Smoking and Alcoholism on treatment outcomes

One of the major determinants of population health is its health-related behavior61 .Tobacco

smoking and TB are two of the world's greatest public health problems, although TB is

largely confined to developing countries. There is definitive evidence that it is biologically

plausible that smoking could increase risks for TB infection and TB disease. Suggested

mechanisms include decreased immune response, CD4 lymphopenia, defects in macrophage

immune responses, and mechanical disruption of cilia function in the airways62 • A meta­

analysis produced evidence th,.at smoking is a risk factor for TB infection and TB disease or

to be precise results suggest that tobacco smoking interacts with M tuberculosis complex to

the exte.nt of promoting infection and disease63 • Another meta- analytic review found

substantial evidence that tobacco smoking is positively associated with TB, regardless of the

12

specific TB outcomes. Compared with people who do not smoke, smokers have an increased

risk of having a positive tuberculin skin test, of having active TB, and of dying from TB. The

associations of passive smoking and indoor air pollution, increased the risk of TB disease, are

less strongly supported by the available evidence64•

In a cross sectional population survey in Cape Town found association between smoking and

TB infection65• A study from Thiruvallur, Tamilnadu establishes a positive association

between tobacco smoking and pulmonary (bacillary) tuberculosis. The association also

shows a strong dose-response relationship66• Severe form of TB among smokers, both

clinically and radiologically. Mortallity from TB, high levels of default and failures among

smokers established67 ' 41 • A Thomas et al reports, smoking and alcoholism were associated

with a higher likelihood of relapse68 • Biological evidence shows that chronic alcohol

consumption worsens pulmonary infection with M. tuberculosis in a murine model69.Several

studies identified alcoholism as risk factor for default. Low treatment success, high default

rate and non compliance were reported among alcoholics.

Default and treatment outcomes

According to Annik Rouillon former Executive Director of the International Union against

Tuberculosis and Lung Diseases (IUATLD), 'default is the natural reaction of normal,

sensible people, a person who continues to swallow drugs or have injections with complete

regularity in the absence of encourage~ent and help from others is the abnormal one'70.As

one cannot predict which patients are likely to be regular for treatment it becomes mandatory

to give each and every patient, drugs under direct observation. Adherence to treatment in

most diseases requiring long-term treatment is inversely proportional to the length of

13

treatmene1• When a patient with pulmonary TB feels better there is no compelling reason to

continue to take medicines14•

The leading cause of drug resistance was noncompliance or incomplete medical treatment72 •

Factors associated with treatment default and fatality were studied among tuberculosis

patients registered during 1999-2000 in Spain where the default rate was as high as 14

percent and factors like sex, age, homelessness, incarceration, DOT or hospitalization were

not associated with defaule3• A retrospective descriptive study in Nicaragua, from 1988-1996

showed that the default rate decreased from 16 percent in 1988-1991 to 1 0 percent in 1992-

1996 after implementing DO'fS74• Poor knowledge about TB can lead to high chances of

defaule5

A study jn Tamilnadu looking into the risk factors for default in the intensive phase identified

age more than 45, alcoholism, smoking, and those who reported DOTS as being

inconvenient. 84 percent attributed their default to drug related problems, 32 percent to work

related problems and 23 percent each to alcoholism and being symptom free followed by

domestic problems and taking treatment from outside48 •

The national default rate is 8.5 percent ad Kerala is 6.1 percent5•

Co-morbidities affecting Tuberculosis and their treatment outcomes

Chronic disease, mainly diabetes38• 40 history of previous TB, TB exposure (mostly from

family members) associated with relapse.49

Patients with tuberculosis infection are prone to reactivation; one of the conditions that may

predispose to reactivation is diabetes mellitus. The relative risk of developing

bacteriologically confirmed pulmonary tuberculosis is up to five times higher in diabetics76•

14

Significant association of MDR- TB and Diabetes is found also follow up of these patients

with PTB-DM revealed more deaths compared with non diabetic TB 77 •

Previous History of A TT and the duration of treatment also increase the risk of drug

resistance 78 .A study by Costello et al found that 41 percent of 4,017 patients with previous

treatment for TB developed drug-resistant TB, and that the percentage of those excreting

drug-resistant strains increased with increasing duration of the previous treatmene9•

A study from Saudi Arabia reports the mean time taken to achieve sputum AFB smear

conversion was 5.4 weeks in the PTB-DM group compared to 4.6 weeks in the PTB group,

besides diabetes, other factors such as increasing age, multiple cavitary disease, bilateral

disease and numerous AFB on sputum smear examination were significant factors associated

with increased time to sputum conversion80• Study from Congo diabetes appeared to have an

induction and aggravating effect on tuberculosis. Tuberculosis was found to be more frequent

in diabetics, had more pronounced radiological signs, treatment failures and deaths were also

more frequent81 •

The incidence of tuberculosis infection with diabetes in 4,349 diabetics admitted in the

Bombay Hospital was 5.77 percent, the majority of cases were between 40-60 years, males

predominated, and the duration of diabetes in majority were between one year to five years.

out of ~,349 cases of diabetes. It was seen that the incidence of tuberculosis was not related to the

duration of diabetes82.Another study in Mumbai, tuberculosis was found to be the most common

complicating illness (5.9%) in a large cohort of over 8000 patients with diabetes mellitus83•

A study from the Regional Institute of Medical Sciences, Imphal, the prevalence of

pulmonary tuberculosis in diabetics was found to be 27 percent by radiological diagnosis and

6 percent by sputum positivity. A rising prevalence of tuberculosis in diabetes has been seen

15

with age. Mortality rates in these patients are reported to be several times higher than in non-

diabetic . pulmonary tuberculosis patieflts84• Co- morbidities are associated with increased

default rate85•

Provider/ system side factors

DOTS is central to the success of tuberculosis control programmes, it is not easy to

implement. DOTS needs to be given at a location, which is convenient to the patient, and, by

a treatment provider who is accountable to the health system. Several types of providers have

successfully carried out treatment observation in various countries. They include health

workers in China, community volunteers in Africa, religious leaders in Philippines and

members of non-governmental organizations in Bangladesh86' 87' 88' 89' 90•

In Africa, volunteers and community health workers successfully delivered community-based

DOT and were able to maintain higher treatment completion rates than the health worker in a

clinic83.Delay to treatment initiation and diagnosis forced patients to drug shops or

pharmacies and private clinics more commonly than government health units as initial

contacts91 • C Nirupa et al in Tamilnadu reports high treatment success rates can be achieved

by identifying DOT providers, who. are accessible and acceptable to patients and

Governmental DOT providers are skilled in tackling patients' drug related complaints,

whereas Anganwadi workers and .community volunteers have minimal training in health

related issues92• Chandrashekharan et ai reports incoveninece of DOTS as a reason for initial

default41 • A study from Pathanamthitta in Kerala found, although all patients were recorded

as having received DOT, more than a quarter of patients did not actually receive it. The

patients who were not directly observed were much more likely to have treatment failure or

relapse, as compared to those who had received DOr1 .Involvement of non allopathic

16

r J

I practitioners into RNTCP-DOTS has shown an increase in case detection and improved

patient access without affecting treatment outcomes93• In nine out of 12 Public private mix

(PPM)projects in India showed the treatment outcomes are exceeding the 85percent cure

targets, in which private sector was the DOT provider, 2 projects showed results in par with

the public sector only one project was badly performing, also this PPM increased the case

detection94•

Experience from Kannur, Kerala reveals that there was a substantial increase in case

detection after establishing public-private. partnership, but among those diagnosed in private

sector 11 percent were referred for non DOT treatment in private sector in contrast to 1. 7

percent in Government sector95•

To conclude well- known risk factors for TB infection or disease include overcrowding, poor

nutrition, alcoholism, socioeconomic status, diabetes mellitus, and human immunodeficiency

virus infection96•

1.2.8. Relapse

According to RNTCP Relapse is a ·TB patient who was declared cured or treatment

completed by a physician, but who reports back to the health service and is now found to be

sputum smear-positive. Relapse rate varies from 1.6-19 percent as reported by various

studies, this variation is partly due to the inconsistency of the definition of relapse. Relapse

can be due to re-infection or recurrence. DNA fingerprinting have demonstrated that

exogenous reinfection with M. tuberculosis occurs in immunocompromised persons97• A

study from South Africa refutes longstanding views that exogenous reinfection with M.

tuberculosis is uncommon among immunocompetent persons. In this study, DNA

fingerprinting was performed on isolate pairs for 16 patients with suspected TB relapse.

17

Twelve of the 16 patients had disco~dant fingerprints between the first and second TB

episodes, suggesting exogenous reinfection rather than relapse98 •

A study from Hong Kong reports, history of opiate use, coexisting extrapulmonary

tuberculosis, higher radiographic extent and cavitation on initial chest radiograph, body

weight below 50 kg, thrice-weekly treatment throughout, and persistence of positive culture

after 2 to 3 months of treatment were associated with increased risks ofrelapse99•

Co morbidities, alcoholism, immunosuppression, smoking, poor social conditions which are

the risk factors for TB, it is true for relapse also.

1.3. Rationale for the study

Cure of Tuberculosis is thus a complex construct ofthe patient factors, sociocultural factors

and the provider or health system side factors. DOTS as a strategy envisages to bridge many

of the issues regarding drug availability and supervised administration. A patient who had

DOTS, with a favorable or unfavorable outcome, again remaining exposed to the risk factors

will leave him in the uncertainty of getting the disease again. Studying those who are

currently on DOTS will impose a bias, because they are in an artificial environment created

by the disease status.

RNTCP has been implemented in Kerala since the year 2000. Apart from the routine

program. evaluation, which evaluate within the program conditions, no study has attempted to

look into the various factors affecting treatment outcomes. Moreover the true relapse rate of

DOTS will be obtained by following up a cohort. This study is to explore and describe the

factors associated with the various outcomes of a cohort of patients registered in the Kollam

district during the first quarter of2005.

18

r J I

1.4. Objectives

1. To identify the treatment outcomes of a cohort of smear positive pulmonary tuberculosis

patients registered under RNTCP- DOTS in the first quarter of2005.

2. To analyze the factors associated with the various treatment outcomes.

1.5. Research Questions

1. What are the various treatment outcomes at the end of treatment (7 months) and 18 months

after treatment?

2. What are the individual, community and provider level factors that influence. treatment

outcomes?

3. What is the prevalence of relapse?

4. What are the characteristics of the relapse?

•.

19

2.1. Study type

Chapter 2

Methodology

Cross sectional study of a cohort of new smear positive pulmonary tuberculosis patients

registered under RNTCP- DOTS in the first quarter of2005 in Kollam District, Kerala.

2.2. Study setting

The study was based in Kollam District of Kerala, India. It is bound on the south by

Thiruvaoanthapuram district, on the north by Pathanamthitta and Alappuzha, on the east by

Tamil Nadu and on the west by the Arabian Sea. The total population of the district is 25.84

Lakhs

2.3. Sample size

All newly detected sputum smear positive patients registered under RNTCP -DOTS during

1st January 2005 to 31st March 2005 was included in the study.

2.4. Sample selection procedures

All patients registered under RNTCP -DOTS during 1st January 2005 to 31st March 2005

were included in the study and their characteristics and outcomes assessed at the end of their

DOTS treatment (at the end of seven months) and followed up at the time ofthe study (after

eighteen months after completion of treatment)

2.5 Definition of study variables

a. Patients are considered cured if the results of two sputum smears for acid-fast bacilli

(AFB) are negative, one ofwhich is done at the end of treatment.

b. Treatment is considered to have failed if a patient has a positive smear 5 months or more

after starting treatment.

20

•

c. Definition of relapse: - Any patient from the cohort who turns sputum smear positive at

the period of study and those who are or were on treatment for sputum smear positive

pulmonary tuberculosis after the initial DOTS treatment.

d. Default A patient who at any time after registration does not take anti-tuberculosis drugs

consecutively for 2 months or more, is said to have defaulted.

Other than the outcomes of treatment outcomes described two more outcomes are described,

e. Status unknown- Sputum smear-positive patient who has completed treatment, with

negative smears at the end of the intensive phase but none at the end of treatment ( Defined

as just 'treatment completed' as per RNTCP)

f. Died-Patient who died during the course of treatment regardless of cause.

2.6. Data collection

The name and address of the patients was collected from the TB register from the

corresponding TB units in the district: After obtaining consent of the Medical Officer TB

Control, in charge of the TB unit, addresses ofthe individual patients was collected and with

the help of TB health Visitors, other field staff or DOT provider's patients were traced. TB

register and treatment cards were reviewed for details of the initial sputum smear status

smear conversion and outcome at the end of treatment (7 months).

The interviewer (the researcher himself) collected the data from each respondent after

obtaining the informed consent of each individual respondent After obtaining informed

consent from the patients, those who have cough for more than three weeks at the time of

interview were subjected to sputurri s~ear examination from the nearest microscopic centre.

Verbal autopsy was done in the case of every patient who had died in the interim, by the

researcher himself.

21

2.7. Data collection methods

Secondary data from the TB register and treatment cards and interview using a pre tested

structured questionnaire.

2.8. Data entry and Analysis

Along with data collection, the data was entered in Microsoft Excel spread sheet and

analysed using in SPSS Version 11.5.

2.9. Ethical considerations

The consent was obtained from Medical Officer TB Control and other authorities concerned

for the conduct of the study. A list of patients was prepared and those who were willing to

participate in the survey were contacted by a field worker and appointment was fixed

according to the patient's convenience. The place and time of interview were fixed as per

patient convenience. Informed verbal consent was sought before interview of each

respondent and also for sputum smear examination. Sputum smear examination results were

communicated to the patient tfirough the concerned field worker.

22

Chapter 3

Results

The study cohort consisted of 241 newly detected sputum smear positive patients registered

underRNTCP DOTS in Kollam district, Kerala during 1st January 2005 31st March 2005.

The patient's treatment outcomes at the end of the DOTS treatment (end of seven months)

were assessed from the Tuberculosis Treatment Register and the treatment cards.

At the end of completion of treatment at 7 months after initiation of treatment 20 patients had

died. The study population was thus reduced to 221, and at the time of follow up and

interview of these patients after 18 months from their end of treatment, 18 patients had died,

10 patients were lost to follow up and the number of study subjects interviewed were 193.

All the 1·93 patients participated in the survey resulting in a response rate of 100 percent. Out

of 193, there were 148 males and 45 females.

The results are discussed in two sections; the first section comprises of the outcomes for the

whole cohort and its characteristics which is mainly based on analysis of data from the TB

register and the treatment cards at the TB centre; and the second section regarding the

characteristics of the study subjects interviewed and the treatment outcomes after 18 months

after completion of their treatment.

23

I Transition of cohort over time. I Study Group 241

6 to 7 months of DOTS treatment

+ + + + ~ ~·

Cured Status Died Default Failure Transferred 207 unknown-1 20 7 5 out -1

.

18 months after completi >n. of treatment

Cohort size 221

Died Lost follow-up 18 (not traced)-1 0

Sample interviewed 193

l One patient relapsed l and cured Disease Status free unknown 192 1

24

3.1. Characteristics of the cohort

3.1.1. Age and Sex wise distribution of the cohort

The total size of the cohort was 241, out of which 78.4 percent were males and 21.6 percent

were females.

Table 3:1. Age and Sex distribution of the cohort. Age group Male#(%) Female#(%) Total#(%)

15-24 4 (26.7) 11(73.3) 15(6.2) 25-34 21 (70) 9 (30) 30(12.4)

35-44 27(77.2) 8 (22.8) 35(14.5)

45-54 43(86) 7(14) 50(20.7)

55-64 46(85~~) 8 (14.8) 54(22.4)

>65 48(84.2) 9 ( 15.8) 57(23.7)

Total 189 ( 78.4) 52( 21.6) 241 (100)

The mean age of the population was 51.04 (±16.18) minimum being 19 and maximum 86.

The mean age of males was 53.09 (±15.27)minimum being 22 and maximum 86 while the

mean age of females is 43.58 (±17.35) and ranging from 19 to 76.

Females accounted for 73.3 percent in the age group 15-24 females and the maximum

proportion of patients belongea to the older age group of 65 tears and above.

3.1.2. Initial Smear--status .

The initfal smear status among 57 percent of the patients were 3+, 23 percent belonged to the

category of 2+ while 20 percent of the cohort were either in the 1 + and scanty category.

Fifty seven percent of the males and 60 percent of the females belonged to the 3+ category

25

3.1.3. Outcome at the end of DOTS treatment (at the end of7 months)

The definitions used for the treatment outcomes classification were adopted from RNTCP.

Patients who had completed the course of treatment but their sputum results at the end of

treatment was not done is classified as just 'treatment completed' in RNTCP. In the study

this group was redefined as status unknown.

At the end of the DOTS treatment (seven months after initiation of treatment) out of the 241

patients 207 patients were cured, one patient was classified as status unknown, seven had

defaulted, five had treatment failure, one transferred out of district· and 20 died during the

treatment period.

Table 3.2. Treatment outcome of the DOTS cohort at the end of 7 months. Outcomes Male(#-%) Female(#-%) Total(#-%)

Cured 159 (84.1) 48(92.3) 207(85.9)

Status Unknown 1 (.~) 0 1 (.4)

Died 18 (9.5) 2 (3.8) 20 (8.3)

Failure 4 (2.1) 1(1.9) 5 (2.1)

Defaulted 7 (3.7) 0 7(2.9)

Transferred out 0 1 (1.9) 1 (.4)

Total 189 (100) 52 (100) 241(100)

In the sample the cure rate was 85.9 percent, with 84.1 percent among males and 92.3 percent

among females. Death rate was 8.3 percent with more deaths among males; 18 out of the 20

who died were males. Cure rates among males were also low in comparison to females. It

was also interesting to note that there were no defaulters among females The cure rate was

26

almost 100 percent among the younger age groups, while deaths were maximum among the

age group 65 and above. (Table 3.3)

Table 3.3. Treatment outcome of the DOTS cohort at the end of 7 months by age Age Cured Treatment Died Failure Default Transferred Total group completed out

15-24 15 (100) 0 0 0 0 0

25-34 27 (90) 0 2 (6.7) 0 1 (3.3) 0

35-44 32 (91.4) 0 0 0 2 (5.7) 1{2.9)

45-54 42(84) 0 3 (6) 2 (4) 3 (6) 0

55-64 48 (88.9) 1 (1.9) 3 (5.6) 2 (3.7) 0 0

65&> 43 (75.4) 0 12 (21.1) 1 (1.8) I (1.8) 0

Total 207 20 5 7 1

3.2. Survey findings (Among the cohort, eighteen months after completion of

treatment)

3.2.1 Characteristics of the sample

15

30

35

50

54

57

241

Total patients remaining of the initial cohort was 221, out of which 18 had died in the period

between the completion of treatment and the time of interview. among the surviving 203

patients and excluding the ten patients who were lost to follow up, the number of patients

available for interview was 193.The total sample population surveyed was thus 193 of which

148 (76.7 percent) were males and 45 (22.3 percent) were females.

27

3.2.2. Educational status

Table 3. 4. Educational status of the sample population Education level Male#(%) Female#(%) Total#(%)

No education 7 (70) 3 (30) 10 (5.2)

Lower primary 44 (91.7) 4 (8.3) 48 (24.9)

Upper primary 48 (82.8) 10 (17.2) 58 (30)

Secondary 31(62) 19 (38) 50 (25.9)

Degree and above 18 (66.7) 9 (33.3) 27 ( 14)

Total 148 (76.7) 45 (23.3) 193 (100)

3.2.3. Employment status

Of the sample surveyed 149 (77.2 percent) were currently employed. 77 percent of the

maless and 77.8 percent (35) ofthe females were currently employed.

Majority of the males were manual .labourers followed by agriculture and small scale

business. Majority of the females were homemakers

3.2.4. Marital Status

Twenty four patients in the sample (12.4 percent) were never married 159 (82.4 percent) of

the study population were currently married and 10 (5.2 percent) were either widow/

widower. Males constituted 40 percent of the widowers males and females 60 percent.

3.2.5. House hold characteristics

Mean number of members i"n the house hold is 4.64 (± 1.3) ranging from zero to 10.

Regarding the type of family, nuclear family accounts for 58.5 percent followed by

38.3perc·erit. joint family.

Ninety seven percent of the subjects were staying with the family, only three percent

responded as staying alone or away from the family. Seventy eight percent of the subjects

28

were res~ding in their own house. Mean number of rooms in the house hold was 2.8 (± 1.16).

Mean number of persons per room is 1.9 (± 0.79). Ninety seven percent of the houses had a

separate room for cooking and the 36 percent of the houses were using exclusively biomass

(fire wood) as fuel for cooking, 31 percent using mixed fuels which include biomass also,

rest using other type of fuels. Use of biomass fuels is an indicator of indoor air pollution.

3.2.6. Type of the house

Forty four percent of the houses were semipucca followed by 32.6percent pucca and 23.3

percent Kuccha houses. .

3.2.7. Place of residence

Eighty one percent of the study population were resided in the rural area where as 19 percent

in the urban area.

3.2.8. Socioeconomic status (SES)

SES was assessed subjectively by the researcher and accordingly, 59.6 percent (115) of the

patients were in the low SES category and 30.1 percent (58) in the middle SES. Only 10.4

percent of the study population belonged to the high SES category.

3.2.9. Smoking status

Table 3 .5. Prevalence of smoking among the study population Smoking status · #( %)

Ever smoker 124 (83.8)

Current smoker 65 (43.9)

No females in the study population reported either ever or current tobacco smoking. Mean

duration of smoking was 17.9 years (± 17 .3) years ranging from 1- 60 years.

29

Table 3.6. Change in smoking after diagnosis of TB Smoking decreased following TB diagnosis 63 (42.6%)

Quit smoking following TB diagnosis 37(25%)

Sixty three (97 percent) of current smokers responded that they reduced smoking after being

diagnosed ofTB. Out of ever smokers 30 percent (37) quit smoking following diagnosis of

TB. Current smoker is those had experienced tobacco smoke in the last 30 days.

3.2.10. Smokeless tobacco use

Smokeless tobacco use among the study sample was eight percent (15) ever used and seven

percent were (13) current users .Out of current users 53.3 percent (8) had reduced use

following TB. Out of the 15 ever users 13.3 percent (2) quit following TB disease. While one

patient use snuff the rest of the smokeless tobacco users were chewers.

Among males ever use of smokeless tobacco was reported by seven percent (1 0) and current

use by 5.4 percent (8).0ut of current users 50 percent (4) decreased use following TB

diagnosis and 20 percent (2) of ever users quit smokeless tobacco following TB disease.

Though smoking (ever and current use) was nil among the females, smokeless tobacco use

was reported by 11.1 percent ( 5) of females. The prevalence of current use of smokeless

tobacco among women was 11.1 percent (5). Eighty percent (4) of them reported decrease in

use following TB while none of the .women had quit use after being diagnosed with TB

30

3.2.11. Alcohol use

Table 3.7 Prevalence of alcohol use among the study population Alcohol Use # ( %)

Ever user

Current user

Use more than 2 times/week

114(59.1)

63 (32.6)

32 (16.6)

Sixteen percent of subjects used alcohol while they were taking DOTS, but only two percent

missed anti TBdrugs due to alcohol use. Only one female responded as ever and current user

of alcohol, but she never took it more than twice a week. Current use was defined as

consumption of alcohol with in the last 30 days.

3.2.12. History of exposure to Tuberculosis

Twelve percent of the subjects give history of contact with Tuberculosis patients in the house

hold, neighborhood or work place. Most of the contacts were family members within the

same house hold only.

3.2.13. Knowledge and perception about Tuberculosis disease and its treatment

This was assessed by a questionnaire (Hoa et al) comprising of 12 questions and accordingly

scored. .With respect to the scores obtained the responses were categorized as good,

satisfactory and bad. Fifteen patients did not respond to these questions

Table 3.8.Knowledge and perceptions about TB disease and treatment Knowledge level Male#(%) Female#(%) Total#(%)

Bad Satisfactory Good Total

26 (19.3) 35(25.9) 74(54.8) 135 (100)

* Fifteen patients not responded to these questions.

10 (23.3) 5 (11.6) 28 (65.1) 43 (100)

36 (20.2) 40 (22.5) 102 (57.3) 178* (100)

31

3.2.14. History of previous anti tuberculosis drugs

Eight pe~cent (16) of the study subjects.gave history of previous anti tuberculosis treatment.

3.2.15. Facility first sought by the patient for diagnosis

Eighty one percent sought a government facility first for diagnosis where as 19 percent

sought private facilities. Eighty percent of males sought government services as first facility

for diagnosis of TB while in females it was eighty four percent. Twenty percent and 16

percent in males and females respectively sought the private sector facilities first for .

diagnosis ofTB.

3.2.16. DOTS and its compmients

All patients were put under category -1 (thrice weekly Directly Observed intermittent

Antituberculous Treatment {ATT). Not a single patient was on non DOTS or daily ATT.

Ninety percent of patients reported that they had a detailed briefing. about the treatment

before starting the treatment, three percent said that they were not briefed, and four percent

could not recollect any such details.

The components of the counseling were treatment duration, drug dosing, drug side effects,

need for regular drug intake, follow up for smear examination. Twelve percent of the subjects

were not able to recollect the .components of the counseling. Fifty two percent reported that

they were told about all the components and the rest gave mixed responses.

Regarding specifics during counseling like smoking cessation, al~ohol cessation and

nutritional advices, 65 percent responded that they were told about tobacco cessation, alcohol

cessation and were given nutritional advice, 10 percent had problems with recall and the rest

gave mixed responses.

32

r J

I The persons involved in counseling were government doctors and health workers as reported

by 42 percent, followed by health worker alone by 33 percent. Thus in almost 75 percent

counseling efforts the health worker is involved and 10.4 percent patients were not able to

recollect the event. .

With respect to the behaviour of the DOTS provider, ninety nine percent of the patients were

satisfied with the behavior of the DOT provider; none responded any conflict with the DOT

provider.

3.2.17. Profile of the DOT centre

Table 3.9. Type of DOT centre DOT centre Male Female Total#(%)

Anganwadi 59 (39.9) 18 (40) 77 (39.9)

Door delivery 13 (8.8) 7 (15.6) 20 (10.4) PHC/SC 38 (25.7) 9(20) 47 (24.4) Government Hospital 28 (18.9) 3 (6.7) 31 (16.1) Others 10 (6.8) 8 (17.8) 18(9.3)

Total 148 (100) 45 (100) 193 (100)

Anganwadi was the most common f.?OT centre in the study population. Door delivery

includes neighborhood and community DOT provider who delivers the drugs to the.patient's

house; this facility was availed mostly by very old patients and ill patients. Others include

private facilities, like private hospitals, clinics and some other systems of medicine

practitioners.

3.2.18. Intake of drugs

Table 3.10. Type of drug intake. Type of Drug intake Male(#-%)

Supervised 139 (94.6)

Unsupervised 8 (5.4)

Total 147.(100)

Female(#-%)

41 (93.2)

3 (6;8)

44 (100)

Total(#-%)

180 (94.2)

11 (5.8)

191* (100)

33

*The response from two study subjects were inconsistent and therefore not considered for

analysis. Proportion of unsupervised intake was maximum in DOT centers in Government

hospitals (12.9 percent) followed by Private Facilities (11.1 percent). All the patients in the

door delivery category took drugs supervised.

Fifteen percent of patients in the high SES category had unsupervised treatment, whereas it

was seven percent and 3.6 percent respectively in middle and low SES.

3.2.19. Treatment components

Ninety seven percent perceived that their health improved after taking ATT and only 2.6

percent perceived any deterioration.

3.2.20. Duration of treatment

Eighty one percent of the patients took treatment for 6 months followed by 13.5 percent who

took for 7 months. Twenty eight patients reported that they failed to take drugs in time and

64.3 percent of them were retrieved in time and brought back to treatment within one week.

Others were also retrieved back into DOTS but it took more than one week.

Twenty percent of the subjects had got monetary incentive from the government for

completing the treatment.

3.2.21. Adverse effects of the drugs

Slightly· more than one in three (34.7%) of the study subjects reported that they had some

adverse reactions due to drugs. Out of them 30.4 percent were males and 48.9 percent

females. Most common adverse reaction reported was tiredness or weakness, followed by

gastric discomfort and vomiting. Adverse reactions were experienced more in the initial

phase of treatment. Nobody reported even a single episode of serious or fatal adverse

reaction reported.

34

3.2.22. Confidentiality and stigma

Eighty five percent disclosed the disease status to the family, rest kept it confidential. Eight

four percent rated the respopse from the family members as good, 2.6 percent rated it as

satisfactory, rest gave mixed responses. There was one patient who recollected stigmatising

issues li]5:e keeping separate vessels for the diseased and keeping away kids from him.

Only 30 percent disclosed the disease status to the neighbors or friend. Majority stated fear of

stigma as reason for not disclosing it, followed by the feeling that there was no need to

disclose their disease status and fear of losing job. Four women reported that being female

disclosure of disease status would affect the prospects of the future marriage alliances. No

stigmatizing experience from the neighborhood was reported.

3.2.23. Co- Morbidities

The presence of co morbidities was assessed as reported by the patients. Thirty four percent

experienced co morbidities. Among co morbidities 87.8 percent were diabetic and10.6

percent reported hypertension. Prevalence of diabetes was 30 percent .One third (31.1

percent) of the males and slightly more than one fourth (26.7 percent) of the females reported

Diabetes Mellitus (DM). Mean age ofDM patients was 56 (Male 57.3 and Female 55.6).Ten

percent of diabetics also suffered from hypertension. Hypertension was present in 3.6 percent

of the study subjects (3.4 percent males and 4.4 percent females).

35

3.2.24. Treatment outcomes 18 months after completion of treatment

Table 3.11. Treatment Outcome 18 months after completion of treatment. Outcomes Male Female Total

Disease free Died

Unknown status. Total

(#-%) (#-%) (#-%) 147(90.7) 45 (91.8) 192(90.9) 14 (8.6) 4 (8.1) 18 (8.5)

1 (.6) 0 1 (.5) 162 (100) 49 (100) 211(100)

Out of the 221 patients who remained of the cohort after seven months of DOTS, 192 were

disease free, one patient who was che~t symptomatic but was not willing for sputum smear

microscopy was classified as status unknown, 10 patients could not be traced and 18 had

died. All the 193 patients who were surviving at the time of the study were interviewed.

Nineteen of them were chest symptomatic at the time of interview. All but one chest

symptomatic were tested for sputum smear microscopy. One patient refused consent for

sputum microscopy. Those who tested negative were classified as disease free.

Table 3.12. Treatment outcomes after 18 months by age Age group Disease Died Unknown Total

free status 15-24 15 (100) 0 0 15

25-34 25 (96.2) 1 (3.8) 0 26

35-44. 30 (93.6) 2 (6.2)" 0 32

45-54 41(93.2) 2 (4.5) 1 (2.1) 44

55-64 49 (98) 1 (2) 0 50

65&> 32 (72.7) 12 (27.3) 0 44

Total 192 (90.9) 18 (8.5) 1 (.5) 211

Here also the picture is almost similar to the outcome at the end of treatment, with 100

percent being disease free in the younger age group and maximum death in the age group 65

and above.

36

3.2.25. Relapse

One patient had relapsed within the period of follow up and cured 2 weeks prior to the study

visit. Th~ relapse rate calculated for the· study sample was one relapse/ 334 person years.

3.2.26. Death

Death rate among the cohort after 18 months of treatment completion.- 38/231= 16.5%

Mean age of death is 63 (±15.5). Mean age of death at the end of 7 months is 62.3(±15.22)

and the end of 18 months is 63.8 (±16.2).

3.2.27. Defaulters

Out of the seven defaulters, after 18 months five were traced of which three had died, one

patient was disease free, and one status unknown.

3.2.28. Failure

Out of the five patients with treatment failure after the initial treatment, three died and two

were disease free after eighteen months.

3.2.29. Patients with unsupervised drug intake

Among patients who took unsupervised DOTS, all were cured after treatment and were

disease free after 18 months.

3.2.30. Chest symptomatic

Defined as those who are having cough more than 3 weeks at the time of visit. Nineteen (9.8

percent) patients were chest symptomatic of which 18 patients were subjected to sample

sputum -examination, all were negative for AFB. One person not wiling to do sputum

examination, classified as unknown.

37

3.3. Factors affecting the outcome

For analysis the outcome variable is modified into favorable outcome (cure) and the rest

unfavorable outcome.

3.3.1. Age group and outcome after the treatment (7 months)

Table 3.13. Association of treatment outcomes with age FavoraOle Unfavorable Total Chi-square outcome outcome # value for

#(%) # (%) trend P value

Age 15-24 15(100) 0(0) 15 .011 group 25-34 27(90) 3(10) 30 (significant)

35-44 32(91.4) 3(8.6) 35 45-54 42(84) 8(16) 50 55-64 48(88.9) 6(11.1) 54 65 and above 43(75.4) 14(24.6) 57

Total 207(85.9) 34(14.1) 241

Significant association existeg between cure and age, increased cure among younger age

group.

3.3.2 SeJ: differentials among treatment outcomes

Table 3.14 Association of treatment outcomes with sex Favorable Unfavorable Total Fishers exact outcome outcome # test

# (%) # (%) P value Sex Male 159( 84 .. 1) 30(15.9) 189 0.097

Female 48(92.3) 4 (7.7) 52 (Not

Total 207(85.9) 34(14.1) 241 significant)

There was no significant difference in the outcomes of DOTS treatment between males and

females according to this study finding.

38

3.3.3. Pre treatment smear status and outcome .

Table 3.15. Pretreatment smear status and treatment outcomes Favorable Unfavorable Total Chi square test outcome outcome #(%) for trend

#(%) #(%) P value Pretreatment smear 3+ 122(88.4) 16(11.6) 138(100) 0.132 status 2+ 48(87.3) 7(12.7) 55(100) (Not

1+ 24(72.7) 9(27.3) 33(100) significant)

Scanty 13(86.7) 2(13.3) 15(100)

Total 207(85.9) 34(14.1) 241(100)

It is interesting to note that ~here is no association between pretreatment or initial smear

status and cure. Irrespective of the bacterial load, the treatment outcomes of DOTS seems to

be good ..

3.3.4. Use of alcohol and treatment outcomes

Table 3.16.Association of consumption of alcohol and treatment outcomes

Alcohol more than twice a week Not taking alcohol more than twice a week. Total

Favorable Unfavorable Total Fishers Exact outcome outcome test

# (%) # (%) P value 30(93.8) 2(6.3) 32(100) .000

(significant) 157(97.5) 4(2.5) 161(100)

187(96.9) 6(3.1) 193(100)

Significant association exits between cure and alcohol consumption of. more than twice a

week. .Patients who consume akohol more than twice a week is prone for unfavorable

outcomes when compared to those who were not consuming alcohol more than a week.

39

3.3.5. DOTS centre and type of drug intake

Table 3.17.DOTS centre wise distribution of drug intake Supervised Unsupervised Total Chi square for

trend P value

DOT centre Anganwadi 73(97.3) 2(2.7) 75(100) .032 Door delivery 20(100) 0(0) 20{100) (significant) PHC/Sub 44(93.6) 3(6.4) 47(100) centre Government 27(87.1) 4(12.9) 31(100) hospital Others 16(88.9) 2(11.1) 18(100)

Total 180(94.2) 11(5.8) 191(100)

· Significant association was found between supervised intake of drug and type of DOTS

centre in favorable of door delivery. Those who sorted door delivery as mode of drug intake

are more likely to consume drugs under supervision compared to other DOTS centers. I

3.3.6. Diabetes and treatment out~omes .

As seen in the Table 3.18 there is no significant difference in the cure rates between diabetics

and non diabetics.

Table.3.18 Association of treatment outcomes with Diabetes as co morbidity

Diabetic Non diabetic Total

Favorable Unfavorable Total Fishers exact test outcome outcome P value

# (%) #(%) 56(96.6) 2(3.4)

131 (97 .8) 3(2.2) 187(97.4) 5(2.6)

58(100) 134(100) 192(100)

.302 (Not significant)

Regarding other co-morbidities like hypertension and heart disease, the numbers are so small

to do a statistical analysis.

3.3.7. Type of DOTS centre and outcome

Since Anganwadi was the most common DOTS centre, analysis was done by considering

those who took DOTS in Anganwadi as one group and others as another group.

40

Table 3.19 Association of treatment outcomes and the type of DOT centre Favorable Unfav Total Fishers exact test outcome orable

outco P value me

Anganwadi Yes 76 (98.7) 1(1.3) 77(100) .000 No 111(95.7) 5(4.3) 116(100) ( significant)

Total 187(96.9) 6(3.1) 193(100)

When the patients were classified as those who sought Anganwadi as their DOTS centre and

the rest as others there was a significant association of more favorable outcomes for those

who took treatment from Anganwadis 'Yhen compared to the rest.

There was however no statistically significant association between treatment outcome and

the individual type of DOTS centre (P= .080). The. patients who had taken door delivery of

DOTS showed cent percent cure though the difference with the other DOTS providers was

not significant.

3.3.8. Outcome after 18 months after completion of treatment

For analysis the outcome variable is modified into favorable outcome as disease free and the

rest unfavorable outcome

3.3.8.1. Treatment outcomes 18 ~onths after completion of DOTS and Sex

Table 3."20. Association of treatment outcome Favorable Unfavorable Total Chi square outcome outcome # (%) P value

# (%) #(%) Sex Male 147(86) 24(14) 171(100) 0.492(not

Female 45(90) 5(10) 50(100) significant)

Total 192(86.9) 29(13.1) 221(100)

The increased occurrence of disease free status among females compared to males is not

significant, or otherwise the disease free status at the time of follow up was not dependent on

the sex of the patient.

41

3.3.8.2. Age and treatment outcomes after 18 months after completion of treatment

Table 3.21. Association of treatment outcomes after 18 months and age Favorable Unfavorable · Total Chi square test for

Age group

Total

15-24 25-34 35-44 45-54 55-64 65 and above

outcome outcome #(%) trend #~ #~ P~oo

15(100) 0(0) 15(100) .036(significant) 25(89.3) 3(10.7) 28(100) 30(85.7) 5(14.3) 35(100) 41(87.2) 6(12.8) 47(100) 49(96.1) 2(3.9) 51(100) 32(71.1) 13(28.9) 45(100)

192(86.9) 29(13.1) 221(100)

Here also the same picture prevails as in the outcome after treatment at the end of 7 months,

with the younger age group maintaining maximum of disease free status compared to others.

Further analysis was not possible because the data exits only for those who were alive at the

time of interview, in that case we cannot compare any risk factor with outcome, only possible

analysis was with age and sex.

3.4. Findings of verbal autopsy

Verbal autopsy of38 patients died was performed and coded

Table 3.22 Findings of verbal autopsy. Cause of death # (%) High certaintyofTB 15 ( 39.4) Medium certainty ofTB 5 (13.2) Other causes 18 (47.4) Total ·38 (100)

At the e~d of seven months, among the 20 patients who died, the cause of death could be

coded as may be due to TB high certainty 50 percent (10) of patients and in 20 percent (4))

it was with medium certainty, other causes account for 30 percent. Twelwe deaths occurred

in the intensive phase (within the first 2 months)and rest in the continuation phase of

treatment.

42

Eighteen months after the treatment completion, among the 18 who died, the cause of death

with high certainty for TB was 27.8 percent (5) and medium certainty for TB was 5.5 percent

(1), rest may be death due to other causes 66.8 percent (12).

43

Chapter 4

Discussion

The main objectives ofthe study were to assess the treatment outcomes of DOTS and to fmd

the factors associated with it in a district in Kerala. The outcomes were assessed at the end of

the course of treatment at 7 months and 18 months after the completion of treatment. The

discussion on the treatment outcomes, the factors that might have contributed to the

outcome'S including the DOTS factors and how it compares with the available studies and

reports and the programme implications are presented in this chapter.

4.1. Outcomes

Cure rate:

While exploring the outcomes of DOTS, the most important finding of this study was the

maintenance of high cure rate and low relapse rate among the patients registered for

treatment. According to the study findings the cure rate at the end of treatment was 85.9

percent. This figure is the RNTCP ·target which is 85 percent and also in tune with the cure

rates reported by various studies from across the country ranging from 74 to 98

percentJoo,JoJ,J02,J03 .

Default rate:

The observed default rate in the present study was 2.9 percent and the failure rate was 2.1

percent. Both these figures fall well with in the accepted program upper limits of 5 percent

and 4 percent respectively. However the default rate of 2.9 percent as observed in this study

is very low compared to the national and Kerala averages, also seems low compared. with

44

other studies Indian and international which range from 4 to 25 percene5•101•103•104•105• Failure

rates also are low with compm:ed to the reports and studies which range from 1 to 4101•103•105•

Relapse rate:

The relapse rate among the cohort at the end of treatment was 0.4 percent. The relapse rate

otherwise reported range from zero percent to 3.8 percent 60•100•104•105•

Death rate:

A significant finding in the study cohort was that the death rate of the study cohort after the

DOTS treatment (after 7 months) was 8.3 percent which is more than twice the program

expectation of four percent. Many follow up cohort studies report eight percent to 35

percent55•106•107•108• The variations in the figures also depend on the duration of follow up. The

death rate at the end of 18 months was 16.5 percent which is higher in comparison to the

figures reported by other studies.

Factors affecting treatment outcomes

One of the factors affecting the treatment outcome was age with more favorable outcome in

younger age groups. Other evidence also suggests that older age group is prone for

tuberculosis and unfavorable treatment outcomes. The reasons for this according to studies

available suggest that it could be due to the waning immunity and presence of co

morbidities50••

Significant association was found between the supervised intake of drpgs and type of DOT

centre in favor of door delivery and Anganwadi. Similar fmding exist in a study done in

Delhi reports success rates among patients treated by different DOT providers as Anganwadi

workers (80%), governmental outreach workers (81 %), community volunteers (76%) and

PHI staff(76%)109•

45

Regarding the sex differentials, global experience indicates that rate of tuberculosis was

consistently higher in men than in women, irrespective of age group. This held true even in

the present study with majority of the cohort being male. However in the current study in the

age group 15-24, females accounted for 73.3 percent of cases. The finding is similar to

another Indian study which also found that in younger age groups females· constituted 61.3

percent and males 38.7 perceht respectively104• It needs to be further explored wh~ther the

detection of women in the higher age groups are lower due to the stigma associated with TB,

marital status and other social factors preventing their access to health care seeking and

treatment.

Cure rates. among males are low compared to females and there were no defaulters among

females. Low default may be a proxy indicator of treatment adherence that will account for

the higher cure rates in the females.

The default rate and bad treatment outcomes was higher among alcohol users and smokers62•

In our study even though the. default rates were not high, default occurred in males only.

Studies have indicated that male sex itself is more prone for default42•

Sixteen {8.3 percent) of patients gave a history of ATT prior to taking DOTS. This indicates

that these patients were misclassified as new smear positive cases. The reason for the

misclassification cited by the RNTCP staff was the lack of proper awareness about the

definition of the previous treatment.

Alcohol intake more than twice a week was found to be significantly associated with the

unfavorable treatment outcomes, even though the number of patients having unfavorable

outcome is less. The only limitation is that the alcohol use patterns of patients who died in .

the interim or those who were lost to follow up are not known.

46

The high prevalence {30 percent of diabetics is emphasizing the need for, early detection and

treatment of diabetics and need for proper screening of all diabetic chest symptomatic.

Patients with diabetes mellitus are also at a higher risk of tuberculosis. This has been

highlighted by several retro.spective and prospective studies. In a study in Mumbai,

tuberculosis was found to be the most common complicating illness (5.9 percent) in a large

cohort o.f over 8000 patients with diabetes mellitus. In a recent study from the Regional

Institute of Medical Sciences, Imp hal, the prevalence of pulmonary tuberculosis in diabetics

was found to be 27 percent by radiological diagnosis and 6 percent by sputum positivity. A

rising prevalence of tuberculosis in diabetes has been seen with age. Mortality rates in these

patients are reported to be several times higher than in non-diabetic pulmonary tuberculosis

patients. The limitation of the current study is the prevalence of Diabetes Mellitus among

patients who had died is not known. The TB registers do not mention the co morbidities and

their control though it is a proven fact that many of them affect treatment outcomes ofTB.

Studies conducted after the introduction of the glucose tolerance test in 1950s, have shown

high prevalence of impaired glucose tolerance test in patients with tuberculosis with rates

ranging from 2 to 41 percent. The use of different criteria for diagnosis of diabetes mellitus

makes comparisons between the results of the studies almost impossible.

Regarding stigma towards TB patients, it was not an issue for treatment in the present study.

only one patient had reported stigma from others due to the lack of awareness regarding TB.

However the fact that many of them did not disclose their disease status either to family or

friends reflect the nature of stigma that is still associated with the disease.

There was no association between pretreatment smear status and cure, which implies what

ever be the smear grading the DOTS regime could cure it. This finding is extremely valid in

47

the face of apprehension among at least some physicians who argue against DOTS as a

strategy.

4.2. DOTS factors influencing outcomes

The reason for the good outcomes as reflected by the study findings may be many.

The. good cure rates would not have been possible without many of the programme factors

working well. A cure rate of 85 percent would happen when the programme factors work

hand in hand with the treatment and patient factors These factors start with timely diagnosis,

identification of an appropriate DOT provider that is acceptable to the patient and

accountable to the health system, effectiveness of monitoring, spotting of default and relapse

and retrieval of them back to DOTS. The study findings may be indicative of a good

programme in the District which is reflected by the high supervised intake of medicine and

the favorable outcomes.

The finding that the only patient who had relapse was traced and cured by retreatment

through DOTS and cured indicates the good follow up and also faith of patient in the health

system. Even though RNTCP is a horizontal program, the vertical components that it has

like staff with exclusive responsibility of tuberculosis control including senior treatment

supervisors, middle level supervisory staff like Medical officer TB control and a District

level District TB Officer might be a crucial factor. Meticulous managem~nt, data

management including data consolidati9n, analysis and timely feedback of the WHO medical

consultants also may be factors facilitating the monitoring and midcourse corrections within

programme implementation.

These vertical components of the program also ensures, patients house visit and intermittent

monitoring and motivation for timely follow up of the patients by the RNTCP staff. The

48

relation the staff maintains with the patients is commendable, as they are identified as "TB

sirs" or "Sense of family between staff, patients". Broadly what we discussed above can be

referred as good program conditions. These good conditions which is ensuring the contact

with the patient, and allows good follow up makes the DOTS meaningful rather than a

supervised swallowing of drug. More over Kerala the prevalence of HIV is low, which in a

big way skew the outcomes towards unfavorable. So it needs to emphasize all these

achievements are in a HIV low setting.

Moving to the some subtle factors of DOTS, the pretreatment counseling of the patient is a

key component to ensure that the patient should understand the need for taking drugs and

also refrain from the bad behavior. This is not a one time process, and will happen at

different levels also, starting ·from the Doctor who prescribes the treatment to the DOTS

provider. This effect seems to be reflected in the reduction in the number of smokers in the

cohort. The effective counseling reduced smoking among TB patients as evidenced by almost

30% patients quit smoking following the TB. Smoking identified as a risk factor for

relapse68. However the aim of the programme should be on reinforcement of tobacco

cessation messages throughout the course of treatment and afterwards. Capacity building of

staff including medical officers regarding the need and the techniques of tobacco cessation

may be an additional area of emphasis that the programme needs to take

Kerala tops the country in terms of per capita consumption of alcohol. In this context

it is interesting to note that alcohol intake for more than two times a week was significantly

associatttd with unfavourable treatment outcomes. In addition to tobacco cessation, stress

needs to be made on alcohol cessation among patients on DOTS and this may require

additional capacity building of the programme implementers.

49

4.3. Deaths

This high death rate of 8.3 percent in the study population in contrast to the RNTCP

programme limit of 4 percent may . be due to the fact that patients present themselves for

treatment in already advanced stages of the disease emphasizing the need to consider ways

and means to encourage early treatment seeking. more prompt referral and diagnosis so that

patients .can be treated earlier in the course of their TB illness. Since it may also be due to

late treatment seeking. urgent steps needs to be taken to further widely disseminate the

information regarding TB and its symptoms and the effective treatment options among all

sections of the public.

Most of the deaths in the seven months after start of DOTS seems to have happened within

two months of initiation of treatment (intensive phase). It needs to be further explored

whether the death rates are similarly high among other cohorts and whether it has any

relation to the bacterial load. immune status. symptom profile. presence of co morbidities.

compliance. adherence or other related factors. It is not possible to completely rule out the

chance that the patients who had died might have defaulted treatment and were not

supervised effectively.

Other possibility is the high prevalence of HIV infection among TB patients. that was not

possible in 2005 since the HIV TB programme coordination was not existent at that period in

the study area. The age groups in which deaths have occurred in this,study is slightly higher

than that one would expect with HN.

The possibility of late detection still remains high since detection rates of the study district

are far behind (around 40 in the 1st· quarter 2005) the program target of 70 percent. All other

50

-------------··--·------··--~---- ·-----

parameters, like default rate, failure rate, treatment completed rates are well within the

program targets.

This picture illustrates that once the patient is diagnosed, the good program conditions ensure

excellent follow up of the patients, leading to favorable treatment outcome. This might also

meant that though the programme is succeeding in provision of effective treatment it may not

be detecting and reaching out to many cases in the community. The objective of case

detection is to detect at least. 70 percent of the estimated load and the case detection rate

should increase over a period of time. It is anticipated that with the spread of the concept of

eff~ctiveness of RNTCP in the community, more individuals would seek treatment. It is

estimated that there would be 7 5 new smear positive patients per lakh population per year

(estimated ARI: 1.5%) in India

The low detection may be due to change in prevalence of the TB disease. The average age at

contracting illness also has showed an upward trend indicating the epidemiological impact.

This is evident in the change in the mean age of New Smear Positive TB cases in Kerala

from 46 to 48 ( male -48 - 50 and females 38 - 40), which is the same for the study district

also.

Even though the study district has a go.od public private mix in RNTCP it is not reflected in

the total case detection which is falling over the years. The increasing case detection form the

private sector and the decreasing trend in detection in the public sector may be due to the

successful linkage of the programme with the private sector. There has been a steady increase

in the number of TB cases enrolled for DOTS from the private private sector indirectly

indicating the success of the PPM (private public mix) component of the RNTCP. The

51

private sector was earlier co~pletely treating their patients with non DOTS or daily drugs

regimen.

The pa~em of death in the cohort is also interesting. Out of the 20 deaths that occurred

within the treatment period 12 (60 percent) deaths occurred in the intensive phase of the

treatment, which indicates patient might have been in advanced stage of disease. So it

emphasizes the need for institutional or specialized monitoring by a physician for those who

are in advanced disease condition and those in the older age groups. In case of elderly

whether we need to review the diagnostic criteria, like reducing the duration of chest

symptoms to cough more than 2 weeks rather than 3 weeks for sputum examination, presence

of co morbidities and their control and an assessment of their general condition may be

necessary to avoid progression of disease and prevention of deaths.

4.4. Limitation of the study

The study being done in the patients those who are registered under RNTCP, so the findings

will not reflect the true relapse rates of TB. The morbidity data collected was all self reported

by the patient, problems of recall were there. The program setting is different in different

districts of the state, so the findings may be difficult to project to the entire Kerala.

4.5. Conclusion and programme implications

The RNTCP programme and·the DOTS strategy seems to have favorable outcomes for the

patients post treatment (after 7 months) and long term (18 months after completion of

treatment) .The cure rates were high and relapse rates low irrespective of the initial smear

status or bacterial load. The nature of the DOTS provider or other factors like trained staff

accountability and follow up may be the reasons contributing to this.

52

Low detection rate however is a concern emphasizing the need for training of the doctors and

other staff so as to ensure prompt referral of the chest symptomatics .Further explorations

also may be necessary to identify whether the falling detection rates are due to the impact of

the programme itself, the epidemiological transition or some programmatic failures that may

be prevailing.

The programme even now seems to give little importance to co morbidities like Diabetes

Mellitus and coexisting risk behaviours like smoking and alcohol consumption. RNTCP

might achieve higher cure rates and lower relapse, failure and deaths if these are taken into

consideration and controlled. The effect of co morbidities with treatment outcomes of DOTS

also requires more research and attention. Tobacco and Alcohol cessation measures should

work hand in hand with RNTCP. The RNTCP having good follow up and contact with the

patients, give opportunity non pharmacological tobacco cessation measures. To reach this

goal the RNTCP field staffs could be trained in this direction.

The high prevalence of mortaiity in the higher age group also needs to be compared with the

age specific death rates of the district. The death rates among TB patients undergoing DOTS

may have to be monitored and compared with the age standardized mortality. Whether it is

due to late detection or due to other factors needs to be studied.

53

References:

l.Report on the Tuberculosis Epidemic. WHO/TB/97.224. World Health Organization,

Geneva, 1997

2.WHO REPORT 2007,Global Tuberculosis Control WHO 2007.

3. Chadha VK: Global Trends ofTB- An epidemiological review; NTI Bulletin, 1997,33,1

1-18.

4. Sepkowitz, Kent A. "How Contagious is Tuberculosis?" Clinical Infectious Diseases, pp

954 -62, 1996

5. TB INDIA 2007 RNTCP status repott 2007.

6.Fox, W. The problem of self administration of drugs with particular reference to pulmonary

tuberculosis. J Br Tuberc Assoc 39: 269, 1958.

7.Tuberculosis Chemotherapy Centre. A concurrent comparison of home and sanatorium

treatment of pulmonary tuberculosis in south India. Bull World Health Organ, 21: 51, 1959.

8. Uplekar M, Walley J, Newell J. Directly observed treatment of tuberculosis. Lancet 1999;

353: 145.

9. Lienhardt C, Rowley J, Manneh K. Directly observed treatment of tuberculosis. Lancet

1999; 353: 145.

10. Frieden T R. Directly observed treatment of tuberculosis. Lancet 1999; 353: 145.

11. Harries A D, Salaniponi F M, K wanjana J H. Directly observed treatment of tuberculosis.

Lancet 1999; 353: 145.

12. Zwarenstein M. Directly observed treatment oftuberculosis. Lancet 1999; 353: 145.

54

13. Resolution WHA44.8. Tuberculosis control programme. In: Handbook of resolutions

and decisions ofthe World Health Assembly and the Executive Board. Volume III, 3rd ed.

(1985-1992). Geneva, World Health Organization, 1993.

14. Styblo K, Bumgarner JR. Tuberculosis can be controlled with existing technologies:

evidence. Tuberculosis Surveillance Research Unit Progress Report, 2:60-72 1991.

15. WHO Tuberculosis Programme: framework for effective tuberculosis control. Geneva,

World Health Organization, 1994.

16. An expanded DOTS framework for effective tuberculosis control. Geneva, World Health

Organization, 2002.

17. Frieden T R, Fujiwara, et al ; Tuberculosis in New York City . Turning the tide. N Engl J

Med 333: 229, 1995.

18. Burman W J, Dalton C B, et al . A cost effectiveness analysis of directly observed

therapy vs self- administered therapy for treatment of tuberculosis. Chest 112: 63, 1997.

19. Floyd K, Wilkinson D and Gilks C. Comparison of cost effectiveness of directly

observed treatment (DOT) and conventionally delivered treatment for tuberculosis:

Experience from .rural south Africa. BMJ 315: 1407, 1997.

20. Global tuberculosis control: surveillance, planning, financing. WHO report 2005.

Geneva, World Health Organization, 2005.

21. Chaulk C P, Moore-Rice K, Rizzo Rand Chaisson R E. Eleven years of community­

based directly observed therapy for tuberculosis. JAMA 274: 945, 1995.

22. Frieden T R, Sterling T, Pablos-Mendez A, Kilburn J 0, Cauthen G M and Dooley S W.

The emergence of drug resistant tuberculosis in New York City. NEJM: 521, 1993

55

23. MuJlaay C J L, Dejonghe E, Chum H J, Nyangulu D S, Salomao A and Styblo K. Cost

effectiveness of chemotherapy for pulmonary tuberculosis in three sub-Saharan African

countries. Lancet 338: 1305, 1991.

24. Gonzalez E, Arma L and Alonso A. Tuberculosis in the republic of Cuba: Its possible

elimination. Tuberc Lung Dis 75: 188, 1994.

25. China Tuberculosis Control Collaboration. Results of directly observed short course

chemotherapy in 112, 842 Chinese patients with smear positive tuberculosis. Lancet 347:

358, 1996.

26. Kumaresan J A, Md Ahsan Ali A K and Parkkali L M. Tuberculosis control in

Bangladesh: Success of the DOTS strategy. Int J Tuberc Lung Dis 2: 992, 1998.

27. Snider DE, Roper W L. The new tuberculosis. New Engl J Med 1992; 326: 703-705.

28. Cantwell M F, Snider D E Jr, Cauthen G M, Onorato I M. Epidemiology of tuberculosis

in the United States, 1985 through 1992. JAMA 1994; 272: 535-539

29. Raviglione M C, Snider D E, Kochi A. Global epidemiology of tuberculosis. Morbidity

and mortality of a world-wide epidemic. JAMA 1995; 273: 220-226

30. World Health Organization. Framework for effective tuberculosis control. WHO

Tuberculosis Programme. WHO/TB/94.179. Geneva, Switzerland: WHO, 1994

31. Indian Council of Medical Research. Tuberculosis in India; A National Sample Survey

1955-58, ICMR Technical report series, New Delhi. ICMR 1959; 1-12.

32. B G Williams, R Granich, L S Chauhan, N S Dharmshaktu, and C Dye. The impact of

HIV _AIDS on the control of tuberculosis in India. PNAS 102 (27)9619-9624, 2005 ..

33 Central TB Division, Directorate General of Health Services, Ministry of Health &

Family Welfare, New Delhi. TB India 2001; 9-12.

56

34. World Health Organization. Treatment of tuberculosis. Guidelines for national

programmes. 2nd ed. WHO/T~/97.220. Geneva: WHO, 1997.

35. G R Khatri, T R Frieden. The status and prospects of tuberculosis control in India Int

Journal 'fB Lund Dis 2000. (3):193-20.0.

36. Thomas R Frieden. Can tuberculosis be controlled? International Journal of

Epidemiology 2002;31 :894-899

37. Subramani R, Santha T et al Active community surveillance of the impact of different

tuberculosis control measures, Tiruvallur, South India, 1968-2001. International Journal of

Epidemiology, September 22, 2006.

38. Rajeswari, R., Balasubramaian,et al .Socio-economic impact of tuberculosis on patients

and family in India. Int J Tuberc Lung Dis 3: 869, 1999.

39. N Shetty, M Shemko, et alAn epidemiological evaluation of risk factors for tuberculosis

in South India: a matched case control study; Int J Tuberc Lung Dis 10(1):80-86 2006.

40. V Chandrasekaran, P G Gopi, et al ; Default during intensive phase of treatment under

DOTS programme: Indian J Tuberc 2005; 52:197-202

41. N Bhatti, M R Law et al; Increasing incidence of tuberculosis in England and Wales: a

study ofthe likely causes . BMJ 1995;310:967-969.

42. MChan-Yeung, A G 0 Yeh, et al; Socio-demographic and geographic indicators and

distribution of tuberculosis in~Hong Kong: a spatial analysis ;Int J Tuberc Lung Dis 2005

9(12): 1320-1326.

43. Metin Akuni, Hasan Katnari; et al ."Clinical and social characteristics of the patients with

tuberculosis in Eastern Anatolia: TUberkUloz ve Toraks Dergisi 2006; 54(4): 349-354

57

44. P Mishra, E H Hansen, et al; Socio-economic status and adherence to tuberculosis

treatment: a case-control study in a district of Nepal Int J Tuberc Lung Dis 2005 9(1 0): 1134-

1139.

45. Michael Clark, Peter Ribena, et al ; The association of housing density, isolation and

tuberculosis in Canadian First Nations communities: international Journal of Epidemiology

2002;31 :940-945.

46. Concato J, Rom WN. Endemic tuberculosis among homeless men in New York City.

Arch Intern Med 1994; 154:2069-2073.

47. Vinod K Mishra, Robert D Retherford, et al ; Biomass Cooking Fuels and Prevalence of

Tuberculosis in India: International Journal oflnfectious Diseases I Volume 3, Number 3,

1999.

48. Dheeraj Gupta, Kshaunish Das,et al ; Role of socio-economic factors in tuberculosis

prevalence : India J Tuberculosis 2004, 51:27-31.

49. Stead WW, Logfren JP, Warren E, et al. Tuberculosis as an endemic and nosocomial

infection among the elderly in nursing homes. N Engl J Med 1985; 312:1483-1487

50. Murray C J L. Epidemiology and demography of TB. In: Adult Mortality in Latin

America. Eds. I.M. Timaeus, J. Chackiel and L. Ruzieka. L. Clarendon, Oxford, p.l99, 1996.

51. Global Tuberculosis Control. World Health Organization, Geneva, 2000.

52. Carlos Pe'rez-Guzma' n; Mario H Vargas et al ;Does Aging Modify Pulmonary

Tuberculosis? Chest 999; 116;961-967

53. S N Gaurl, V K Dhingra et al; Tuberculosis in the Elderly and their Treatment outcome

under DOTS: Indian J Tuberculosis 2004; 51:83-87.

58

54. M Chan-Yeung, K Noertjojo, et al Tuberculosis in the elderly in Hong Kong: Int J

Tuberc Lung Dis 2002 6(9):771-779

55. ChiC Leung, MB Wing, W Yew, et al; Tuberculosis in Older People: A Retrospective

and Comparative Study from Hong Kong: Journal of American Geriatric Society 2002 50

(7), 1219-1226.

56. M Chan-Yeung, K Noertjojo, et al ; Sex differences in tuberculosis in Hong Kong: Int J

Tuberc Lung Dis 2002, 6(1):11-18.

57. End line Evaluation Study: Central Tb Division: February 2006.

58. A Thorson, N P Hoa et al; Do women with tuberculosis have a lower likelihood of

getting diagnosed? Prevalence and case detection of sputum smear positive pulmonary TB, a

population-based study from Vietnam : Journal of clinical epedemiology, April 2004, Pages

398-402

59. M J Boeree, AD Harries, et al; Gender differences in relation to sputum submission and

smear-positive pulmonary tuberculosis in Malawi: Int J Tuberc Lung Dis 2000 4(9):882-884

60. V N Balasubramanian, K Oommen, et al ; DOT or not? Direct observation of anti­

tuberculosis treatment and patient outcomes, Kerala State, India :Int J Tuberc Lung Dis 2000.

4(5):409-413

61. World Health Organization. Reducing risks, promoting healthy life. World Health Report

2002. Geneva: World Health Organization; 2002.

62. Arcavi L, Benowitz NL. Cigaratte smoking and infection. Arch Intern Med. 2004;

164:2206-2216.

59

63. Michael N Bates, Asheena Khalkadina et al ; Risk of Tuberculosis From exposure to

Tobacco Smoke. Arch Intern Med. 200?;167:335-342.

64. Lin HH, Ezzati M, Murray M (2007) Tobacco smoke, indoor air pollution and

tuberculosis: A systematic review and meta-analysis. PLoS Med 4(1): e20. doi:10.1371/

journal.pmed.0040020

65. S den Boon, S W P van Lill et al; Association between smoking and tuberculosis

infection: a population survey in a high tuberculosis incidence area ( in two urban

communities in cape town): Thorax 2005;60:555-557

66. C Kolappan, P G Gopi; Tobacco smoking and pulmonary tuberculosis Thorax

2002;57 :964-966.

67. T Sahtha, R Garg, et al; Risk factors associated with default, failure and death among

tuberculosis patients treated in a DOTS programme in Tiruvallur District, South India, 2000:

Int J Tuberc Lung Dis 2002 6(9):780-788.

68. A Thomas, P G Gopi, et al ; Predictors of relapse among pulmonary tuberculosis patients

treated in a DOTS programme in South India: Int J Tuberc Lung Dis 2005; 9(5):556-561

69. Carol M Mason, Elizabeth Dobard, et al ; Alcohol Exacerbates Murine Pulmonary

Tuberculosis: Infection and I~munity, May 2004, p. 2556-2563.

70. Rouillon A. Defaulters and motivation. Bulletin of the International Union of

Tubercu~osis 47: 68, 1972.

71. Chaulk, C.P. and Kazandjian, V.A. Directly observed therapy for treatment completion of

pulmonary tuberculosis. JAMA 279: 943, 1998.

72. Frieden T, Sterling T, et al. The emergence of drug-resistant tuberculosis in New York

City. N Engl J Med 1993; 328:521-526

60

73. Cayla JA, Caminero JA, Rey R, Lara N, Valles X, Galdos- Tanguis H. Current status of

treatment completion and fatality among tuberculosis patients in Spain. Int J Tuberc Lung

Dis 2004; 8(4): 458-464.

74. Heldal E, Amadottir T, Cruz JR, Tardencilla A, Chacon L. Low failure rate in

standardised retreatment of tuberculosis in Nicaragua: Patient category, drug resistance and

survival of 'chronic' patients. Int J Tuberc Lung Dis 2001; 5(2): 129-136.

75. Sophia Vijay, VH Balasangameswara, et al ;Defaults among patients treated under DOTS

in Bangalore city: A search for solution: Ind. J Tub., 2003, 50, 185.

76. Kim SH, Hong YP, Lew WJ, et al. Incidence of pulmonary tuberculosis among diabetics.

Tuberc Lung Dis 1995; 76: 529-523

77. Mona Bashar ; Phil Alcabes; et al. Increased Incidence of Multi drug- Resistant

Tuberculosis in Diabetic Patients on the Bellevue Chest Service, 1987 to 1997. Chest 2001;

120:1514-1519

78. Afranio L, Kritski, et al :Retreatment Tuberculosis Cases. Factors Associated With Drug

Resistance and Adverse Outcomes: CHEST 1997;111;1162-1167.

79. Costello HD, Caras GJ, et al; Drug resistance among previously treated tuberculosis

patients: a brief report. Am Rev Respir Dis 1980; 121:313-16.

80. R Singla, N Khan, et al ; Influence of diabetes on manifestations and treatment outcome

of pulmonary TB patients Int J Tuberc Lung Dis 10(1)2006 :74-79

81. Mboussa J, Monabeka H, Kombo M, Yokolo D, Yoka-Mbio A, Yala F. Course of

tuberculosis in diabetics. Rev Pneumol Clin. 2003, 359, 39

82. J C Patel, De Souza, Cheryl S S Jigjini Indian Journal Of Tuberculosis Vol. XXIV: No.

4 October 1977.

61

f' .

83. Patel JC. Complications in 8793 cases of diabetes mellitus 14 years study in Bombay

Hospital, Bombay, India. lnd J Med Sci. 1989, 43, 177

84. Ezung T, Devi NT, Singh NT, Singh TB. Pulmonary tuberculosis and diabetes mellitus-a

study. J. oflndian Medical Association. 2002, 100, 376

85. MChan-Yeung K Noertjojo et al; Prevalence and predictors of default

from tuberculosis treatment in Hong Kong: Hong Kong Med J Vol9 No 4 August 2003. 263-

8.

86. Zhang LX, Kan GQ. Tub~rculosis control programme in Beijing. Tuberc LungDis 1992;

73: 162-166.

87. Wilkinson D, Davies GR. Coping with Africa's increasing Tuberculosis burden: Are

community supervisors an essential component of the DOT strategy?. Trop Med Int Health

1997; 2 (7): 700-704.

88. Barker RD, Millard FJ, Nthangeni ME. Unpaid community volunteers-effective providers

of directly observed therapy (DOT) in rural South Africa. S Afr Med J 2002; 92( 4): 291-294

89. ManaloF, Tan F, Sbarbaro JA, Iseman MD. Community based short-course treatment of

pulmonary tuberculosis in a developing nation. Initial report of an eight-month

largely intermittent regimen in a popu~ation with a high prevalence of drug resistance. Am

Rev Respir Dis 1990; 142: 1301-1305.

90. Islam MA, Wakai S, Ishikawa N, Chowdhury AM, Vaughan JP. Cost-effectiveness of

community health workers in tuberculosis control in Bangladesh. Bull World Health

Organ 2002; 80(6): 445-450.

62

f

91. Mpungu S Kiwuwa, Karamagi Charles et al; Patient and health service delay in

pulmonary tuberculosis patients attending a referral hospital: a cross-sectional study: BMC

Public Health 2005; 5.122.

92. C Nirupa, G Sudha, et al ; Evaluation of Directly Observed Treatment Providers in the

RNTCP Indian J Tuberc 2005; 52:73-77

93 A A Singh, R C Arora, et al .Involvement of non Allopathic Private Practitioners Under

POTS in an urban area ofNorth India. Indian J Tuberc 2005; 52:184-187]

94. Puneet K Dewan, S S Lal et al Improving tuberculosis control through public-private

collaboration in India: literature review; BMJ, doi:10.1136/bmj.38738.473252.7C (published

8 February 2006)

95. M K A Kumar, P K Dewan, et al. Improved tuberculosis case detection through public­

private partnership and laboratory-based surveillance, Kannur District, Kerala, India, 2001-

2002; Int J Tuberc Lung Dis 2005 9(8):870-876

96. Leinhardt ·C. From exposure to disease; the role of environment factors in susceptibility

to and development oftuberculosis. EpidemiolRev.2001; 23: 288-301.

97. Small P, Shafer R, Hopewell P. Exogenous reinfection with mutidrug- resistant

Mycobacterium tuberculosis in patients with advanced HIV infection. N Engl J Med 1993;

328: 1137-1144.

98. Van Rie A, Warren R, Richardson A, et al. Exogenous reinfection as a cause of recurrent

tuberculosis after curative treatment. N Engl J Med 1999; 341: 1173-1179.

99. KwakC Chang, ChiC Leung, et al. A Nested Case-Control Study on Treatment-related

Risk Factors for Early Relapse of Tuberculosis. Am J Respir Crit Care Med Vol 170. pp

1124-1130, 2004

63

100. Robert M Jasmer, Christopher B Seaman, Leah C Gonzalez, L Masae Kawamura,

Dennis H Osmond, and Charles L Daley. Tuberculosis Treatment Outcomes Directly

Observed Therapy Compared with Self-Administered Therapy: Am J Respir Crit Care Med

Vol170. pp 561-566,2004

101. Santha T, Garg R, Frieden TR, Chandrasekaran V, Subramani R, Gopi PG, et al, Risk

factors associated with default, failure, and death among tuberculosis patients treated in a

DOTS program in Thiruvallur District, South India,2000.Int J Tuberc Lung Dis. 2002 Sep;.

6(9): 780-8.

102. Taqir Mohammad, Sharma S K, Rohrberg, Duncan-smith, Gupta Deepak:

DOTS at a tertiary care center in northern India: successes, challenges & the next steps in

tuberculosis control:Indian Journal of Medical Research, May 2006.

103. TB India 2005.

104. S L Chadha and R P Bhagf Treatment Outcome in Tuberculosis patients placed under

DOTS- A Cohort; Ind J. Tub . .2000, 47, 155.

105. Ya~in Dholakia, Usha Danani and. Chhaya Desai Relapse following DOTS- A follow

up study. Indian Journal of Tuberculosis. 2000 Oct; 47(4): 233-6

106. Kherosheva T, Thorpe LE, Kiryanova E, Rybka L, Gerasichev V, Shulgina M, et al;

Encouraging outcomes in the first year of a TB control demonstration programme.

Oreloblast, Russia. Int J Tuberc Lung Dis 2003; 7(11 ): 1045-1051.

64

f I ~

107. Mohamed Guled Farah, Aage Tverdal, Tore W Steen, Einar Heldal, Arne B Brantsaeter

and Gunnar Bjune: Treatment outcome of new culture positive pulmonary

tuberculosis in Norway ;BMC Public Health 2005, 5:14

108. Kang'ombe C, Harries AD, Banda H, Nyangulu DS, Whitty CJ, Salaniponi FM, et al;

High mortality rates in tuberculosis patients in Zomba Hospital, Malawi, during 32

months of follow-up. Trans R Soc Trop Med Hyg. 2000 May-Jun;94(3):305-9.

109. C Nirupa, G Sudha, et al; Evaluation of Directly Observed Treatment Providers in the

RNTCP ;Indian J Tuberc 2005; 52:73-77

65

f 1

Annexure Treatment outcomes of pulmonary tuberculosis patients under RNTCP- DOTS in Kollam District, Kerala.

Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute of Medical Science and Technology

Thiruvananthapuram

Schedule no:

Date: Time:

Personal Information

1 Name: 2 Age in Completed Years 3 Sex: 1. Male2. Female 4 Educational Status: 1-No education

2-Lower primary 3- Upper Primary 4-High school 5- Secondary 6- Graduation 7- Post graduation 8- Professional 9- Others

5 Occupation : 6 Currently employed 1. Yes 2. No 7 Marital Status 1-Never married

2-Currently married 3-Widow/Widower 4-Divorced 5-Separated

8 Monthly Household Income 9 Total No. of the members in the

family: 10 Type of family 1. Joint 2.Extended 3. Nuclear 11 Place of stay 1. With the family 2. Staying alone

3. Others 12 What is the highest educational

achievement of the Household member?

13 What is the color of the ration card in 1. Pink 2. Blue 3. Do not have a your household? ration card

A

l l

14 How will you assess your Socio 1. Low 2. Middle 3. High economic Class

15 Own house 1. Yes2. No 16 Researchers impression of the 1. Low 2. Middle 3. High

family's SES Housing Conditions

17 Location of House 1. Urban 2. Rural 18 Type of house 1. Kutcha 2. Semi Pucca 3. Pucca 19 Number of rooms in the house

( excluding Kitchen) 20 Separate room for cooking 1. Yes 2. No 21 Main fuel for cooking 1. Fire wood 2. Kerosene 3. Gas 4.

Electricity 5. Others Details of Habits ..

22 Have you ever taken any alcoholic 1. Yes 2. No If drinks {Toddy, Beer, foreign liquor,

~ Arrack) 23 Do you currently consume any 1. Yes 2. No

alcoholic drink ? 24 IfNo, When did you discontinue? 1- After starting the treatment;

2- Before starting the treatment; 3- Others;

25 Do you consume alcohol more than 2 1. Yes 2. No times a week?

26 Have you ever taken any alcoholic 1. Yes2. No drinks during treatment period?

27 Have you missed taking drugs on any 1. Yes 2. No day due to alcohol consumption?

28 Tobacco use . ( if not applicable Go 29) __. I Ever Stopped Reduced use Current smoker/ Duration of use used after first After the user (used

episode of first episode within last 30 TB ofTB days)

Smoking

Chewing

Snuff

History of Exposure to TB 29 Do you know any one suffering from 1. Yes 2. No

TB? 30 What is your relation to this person? 1. Immediate family member

B

' I l residing in the same Dousehold 2. Relative 3. Friend 4. Neighbor 5. Others( specify)

31 What is the stage of treatment of this 1. Completed person? 2. Still on Treatment

3. Cured 4. NotCured 5. No Treatment

32. KNOWLEDGE AND PERCEPTION ON TB AND ITS TREATMENT

No Question Response Matching Scoring scientifically

correct answer 1 What is the cause ofTB? Germ Yes 1

Other No 0 Don't Know No 0

2 Is TB transmissible? Yes Yes 1 No No 0

Don't Know No 0 3 How does it spread? Droplet spread Yes 1

Other No 0 Don't Know No 0

4 Is it curable? Yes Yes 1 No No 0

Don't Know No 0 5 How long it will take to treat 6/8 months Yes 1

TB? >/<6/8 months No 0 Don't know No 0

6 How many times sputum 3times Yes 1 follow-up is carried out?

>I< No 0 3 times Don't know No 0

7 Will inadequate /incomplete Yes Yes 1

treatment increase the risk of No No 0

its spread to others? Don't know No 0

8 Will inadequate /incomplete Yes Yes 1

treatment leads to No No 0 Don't know No 0

c

reoccurrence?

9 Will inadequate /incomplete Yes Yes 1 treatment lead to Death? No No 0

Don't know No 0 10 Will inadequate /incomplete Yes Yes 1

treatment lead to No No 0 development of resistant Don't know No 0 disease?

11 Do you think that taking Yes No 0 meat, milk and eggs are No Yes 1 important in getting cured of Don't know No 0 TB?

12 Do you know that the Yes Yes 1 diagnosis and treatment for No No 0 TB in Govt. Hospitals is No No 0 entirely free?

SCORE STATUS RANGE

0-3 POOR

4-7 MODERATE

8-12 GOOD

32 Knowledge on TB and its I. Poor treatment: 2-Medium

3-Good Past Treatment Hist«!_ry

33 Have you been treated for 1. Yes 2. No tuberculosis previously?

34 If yes, how many time? 35 When was it? 36 Where did you seek 1 - Government facility

treatment from? 2 - Private clinician 3 Others specify.

37 What was the type of I-DOTS treatment received? 2-continious treatment

3-Intermittent 38 Do you had a detailed 1. Yes

briefing before starting the 2. No treatment?

39a If yes, what all things were 1. Treatment duration discussed? 2. Drug dosing

3. Drug side effects 4. need for regular drug intake

D

5. Follow up for smear examination.

39b If yes, who did it? 1. Government doctor 2.Health worker 3. DOT Provider 4.Private doctor 5. Others (specify 1. Yes 2. No

39c Did they advice you Stop smoking 1. Yes 2. anything listed? No

Stop alcohol 1. Yes 2. No Nutritional advice 1. Yes 2. No No advice was given 1. Yes 2. No

40 If he/she used DOTS l.Good treatment, how was the behavior of the DOTS 2.Bad provider?

41. Did you have any conflict 1. Yes 2. No with the DOTS provider?

42 If yes explain? 43 From where did you l.Anganwadi

collect the drugs? 2. Home delivery 3 .PHC/sub center 4 .Govt Hospital 5.Pvt Hospital 6. Others

44 How many times a week 1 Thrice a week were you going to collect 2 Once a week the drugs? 3 Once in 4 weeks

4 Others (specify)

Intensive Period:

Continuation Period: 45 Was there any 1. Yes 2. No

improvement in your health condition after starting treatment?

46 What was the duration of the treatment?

47 Did you complete the 1. Yes 2. No treatment?

48 If no, why didn't you l.Lack of motivation

E

l i ~·

complete treatment? 2 .Lack of awareness 3 .Distance from the provider

I l

4 .Lack of drug availability 5.Lack of money to purchase drugs 6.Side effects from the drugs ?.Timings were not convenient 8. I hate long duration treatment 9. DOT provider's attitude was hostile.

49 Did you get any visit or 1. Yes 2. No any type of alert message from the health workers/health services when you missed the drugs?

50 Were you offered any 1. Yes 2. No incentive for completing treatment?

51 Did you have any side 1. Yes 2. No effects while on treatment?

52 What were the side 1- Drowsiness; effects? 2- Red/orange

urine/tears; 3- Gastrointestinal

upset; 4- vomiting 5- Burning in

hands and feet; 6- Joint pains; 7- Impaired vision; 8- Ringing in the

ears; 9- Dizziness; 10- Loss of hearing; 11- Loss ofbalance; 12- Jaundice;

53 Did you know that there 1. Yes 2. No would be side effects of treatment?

54 Did all your family 1. Yes 2. No members know that you had Tuberculosis?

55 Did you inform your 1. Yes 2. No If no 58

F

family members that you had TB at that time?

56 If yes, how did the family react to you?

57 Were there any changes in 1. Yes 2. No the family's attitude to you?

58 If you did not inform you family, why didn't you inform?

59 Did your neighbours know 2. Yes 2. No ____. that you had TB at that If no time? 60

60 Why didn't you tell? 61 Have you experienced any 1. Yes 2. No

discrimination from anybody being a TB patient?

62 If Yes, explain 63 COMORBIDITIES AND TREATMENT If no

64 Do you have Yes/No Ifyes, time How long

any of the since diagnosis have you

following in been taking ____.

disease/ years/months. treatment for

diseases the condition

Diabetes

HighBP

Heart disease

Lung disease

Others

RE-TREATMENT HISTORY 64 When was the treatment

begun? 65 What were the symptoms 1. Chronic cough

that prompted you to seek 2. Fever treatment? 3. Weakness

4. Weight loss 5. Blood in sputum

G

-------··------·-··~---~---

l 1 I

66 When did the symptoms started?( days , weeks, or months after the initial DOTS)

67 Who referred you for l.Private doctor treatment? 2.Government doctor

3 .Health worker 4.Family member 5.Friend 6.0thers (specify)

68 Where did you undergone 3. Government facility treatment? 4. Private facility

5. Others. 69 What was the type of l.Thrice weekly regime with

treatment? injections 2. Thrice weekly regime without injections 3. Daily drugs. 4. Others if specify.

70 Are you suffering from l.Yes cough more than 3 weeks? 2.No

Information from the treatment card/TB registers

Name: Age: TBNo.

Address:

Treatment Category:

TB Unit: Initial Sputum Status: Date of Starting the Treatment: Sputum conversion status:

1. At the end of 2 months. 2. At the end of 3 months 3. At the end of 4 months 4. At the end of 5months 5. At the end of treatment

Treatment Unit:

Current Phase of treatment:

H

INFORMED CONSENT

I am Dr Shibu Vijayan , a post graduate student in Public Health studying in Sree Chitra Tirunal Institute for Medical Sciences and Technology in Trivandrum, Kerala. Thank you for permitting me to contact you. I would like to ask you some information about yourself, your previous Tuberculosis treatment, and your current health status as a part of my study. This interview might take a maximum of forty five minutes. If you are currently suffering from cough more than three weeks, your sputum will be examined. I am collecting information from around two hundred and fifty persons like you. You have freedom to take the decision whether or not to continue with the interview at any point oftime. Your identity and the information given by you will be analysed by myself alone for research purposes only. If you do not want to answer any question or series of questions, you can refuse to say at any point in time. If you have any queries or doubt please feel free to clarify those. I will try my level best to answer to any of your queries right now or in future as well. My contact number is 9446261303 .If you want to know any further information regarding this study you can contact Head of tb.e Department, Achutha Menon Centre for Health Science Studies (AMCHSS), SCTIMST, Trivandrum at phone number0471-2443152. After getting the oral agreement from the participant the signature of a witness will be taken.

Place Signature of the witness

Date -------

Signature of the researcher Signature ,ofthe patient

I

Map ofKollam