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PREVALENCE AND RISK FACTORS OF CHRONIC RESPIRATORY DISEASES AMONG WOMEN IN

THIRUVATTAR

Dissertation Submitted to

THE TAMILNADU Dr. M.G.R MEDICAL UNIVERSITY

In partial fulfilment of the requirements for the award of the degree of

M.D COMMUNITY MEDICINE Branch XV

May2019

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I am privileged to express my extreme gratefulness to our Director, Dr.

Rema. V. Nair M.D, D.G.O, Sree Mookambika Institute of Medical Sciences and Chairman, Dr. C. K. Velayudhan Nair M.S, Sree Mookambika Institute of Medical Sciences for their constant encouragement and sustained support all through my career in this esteemed institution.

I would like to express my sincere thanks to our respected Principal Dr.

Padmakumar, M.S, M.Ch Vice Principal Dr. Mookambika. R.V, M.D, D.M and the Deputy Medical Superintendent Dr. Vinu Gopinath, M.S, M.Ch for their constant encouragement and sustained support all through my career in this esteemed institution.

I am grateful to Mr. J.S. Prasad, Administrative officer, for his help in the study.

I consider it a great privilege and honour to express my profound gratitude to my respected professor, mentor and guide Dr. M C Vasantha Mallika, MD,DPH Professor and Head of the Department of Community Medicine for her constant monitoring, support and valuable guidance at every stage of this study.

I sincerely express my deep sense of gratitude to my co guide Dr. Vishnu G Ashok, MD Assistant Professor, Department of Community Medicine for his guidance and encouragement throughout the study.

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A J and Dr. Priya R Panicker, Assisant Professors, Department of Community Medicine for their guidance and encouragement throughout the study.

I also thank Miss Jossy John, Lecturer in Statistics, Department of Community Medicine for her whole hearted support, help and encouragement during this study.

I am thankful to all my postgraduate colleagues and my friends for their help and valuable suggestions during the course of the study.

I am very grateful to my husband, my parents, my brother and my husband’s parents for their constant, support and encouragement.

Mrs. Ambika Kumari deserves special mention for her help and cooperation.

Above all, I thank Lord Almighty for his blessings, to undergo my postgraduate course.

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CONTENTS

SL.NO CONTENTS PAGE NUMBER

1 INTRODUCTION 1

2 OBJECTIVES 4

3 REVIEW OF LITERATURE 5

4 MATERIALS AND METHODS 40

5 RESULTS 46

6 DISCUSSION 78

7 SUMMARY AND

CONCLUSION

83

8 RECOMMENDATIONS 87

9 LIMITATIONS 88

10 REFERENCES -

11 ANNEXURES -

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Page 1

1 INTRODUCTION

Non communicable diseases (NCDs) form a major public health burden for developing countries including India in terms of disability, morbidity and mortality. In the year 2012, 68 % of the global deaths were due to NCDs.

Major NCDs are Cardio Vascular Disease (CVD), Cancer, Chronic Respiratory Diseases (CRDs) and Diabetes Mellitus (DM). These diseases account for 82%

of NCD deaths all around the world. Globally, CVD account for most of the NCD deaths (46.2%) followed by Cancer (21.7%), CRDs (10.7%) and DM (4%).1

CRDs are a group of chronic diseases affecting the airways and the other structures of the lungs. They form one of the leading causes of disability, morbidity and mortality worldwide. They include Asthma, Allergic Rhinitis (AR), Chronic Obstructive Pulmonary Disease (COPD) and other chronic respiratory conditions that affect the lives of millions worldwide.2

CRDs affect more than 1 billion people worldwide.3According to Global Burden of Disease Study 2015 CRDs account for 4 million premature deaths globally and more than 10% of all Disability Adjusted Life Years (DALYs).4CRDs have a major adverse impact on quality of life (QOL) and individual productivity. This also results in a substantial economic burden for both the individual and the community.5 The major risk factors of these diseases include tobacco smoking, indoor air pollution, outdoor pollution,

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Page 2 allergens and occupational risks. The impact of these diseases can be alleviated by taking mitigation steps against the risk. 6

As per the Global Disease Burden Report 2015, Asthma and COPD are the most common CRDs in the world. Asthma is the most prevalent CRD and COPD is almost half as prevalent as asthma.7, 3 According to WHO COPD affects 251 million people and is estimated to cause 3.15 million deaths per year worldwide.8 According to the Global Asthma Report 2018, Asthma affects around 339 million people in across the world.3Asthma affects190.2 million females and COPD affect 69.7 million females. Death from COPD (3.2 million) is eight times more common than deaths from Asthma (0.40 million).In 2015, COPD ranked 8th (2.6% of Global DALYs) and Asthma ranked 23rd (1.1% Global DALYs) among 315 causes of Global Burden Diseases.7 AR is one of the most common allergic diseases worldwide. It has a prevalence of 10% to 30% among the population worldwide9 and affects 500 million people approximately. It contributes to 55% of all allergies.10

In India, 65 million people suffer from respiratory diseases out of which COPD and asthma account for 42 million cases.11 CDRs account for 7% of deaths and 3% of DALYs.12 This number is likely to increase by 20% by 2030.11 COPD was considered to be the second leading cause of deaths and DALYs in India in the year 2016. The prevalence of COPD differs widely from state to state.1 The reported prevalence range from 2% to 22% in men and from 1.2% to 19% in women.13

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Page 3 In India, 15-20 million people are estimated to be asthmatic. The prevalence of asthma in adults is about 2% -12%. About 15 million DALYs lost annually are due to asthma, which represent 1% of the total global burden.14 In India 20% - 30% of the population suffers from at least any one of the allergic diseases. In the past few years the prevalence of allergic rhinitis tends to increase in India.9

In developing countries like India, women especially housewives who are invariably exposed to adverse domestic environmental factors are at a greater risk of developing chronic respiratory illness than their male counterparts. But awareness of women regarding domestic environmental risk factors and their adverse effect on health is poor.15 CRDs like other NCDs, also contribute to the financial burden on those who are affected, their families and communities.

The economic cost of respiratory diseases is considerable in terms of direct medical cost such as hospital admissions, cost of drugs and indirect cost in terms of opportunity cost of the time lost from work, premature death etc.6 Studies relating to the prevalence of chronic respiratory diseases are relatively few in South India and in particular Tamilnadu. International and national studies suggest that CRDs among women are under diagnosed and under surveyed by the physicians globally and nationally.16 The impact of CRDs with focus on women and the effect of environmental factors on them are the least studied. In south India, most of the time women, especially housewives, tend to confine themselves to domestic environment. Estimating the prevalence of CRDs and identifying their risk factors would help in formulating strategies to

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Page 4 reduce the burden of illness related to CRDs, which in turn, would help in considerably improving the financial status of the family and the community at large, in the long run. Modifying the risk factors would help to improve the health status and overall quality of life of women during their most productive life.

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2 OBJECTIVES

1. To find out, the prevalence of Chronic Respiratory Diseases among women in Thiruvattar block.

2. To study the risk factors associated with Chronic Respiratory Diseases among women in Thiruvattar block

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3 REVIEW OF LITERATURE

Lungs form the vital and vulnerable organ in the human body. Chronic respiratory diseases rank the second most common non communicable disease after cardiovascular disease. CRDs are included among the leading causes of disability in the world and in India.17

3.1 CHRONIC RESPIRATORY DISEASES (CRDs)

The term chronic respiratory diseases (CRDs) describe a range of diseases of the airways and the other structures of the lungs. They include Asthma and Respiratory allergies, chronic obstructive pulmonary disease (COPD) and other respiratory diseases.2 Revised International Classification of Diseases 10 (ICD 10) includes common CRDs. The codes for asthma, Chronic obstructive lung disease (including Chronic Obstructive Pulmonary Disease and for rhinitis is J44 – 46 (ICD 10), J40 – 44 (ICD 10) and J30-31, J45 (ICD 10) respectively.2 (Table 1)

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Table 1: showing the common CRDs with the International Classification of Diseases 10 (ICD 10).

2

SL No

DISEASE ICD 10

1. Asthma J44 – 46

2. Chronic obstructive lung disease (including COPD) J40 - 44

3. Rhinitis J30-31, J45

3.1.1 Problem Statement of CRDs

Hundreds of millions of people suffer from preventable CRDs which affect all ages throughout the world.2 More than 50% of them are from developing countries or constitute deprived population. The prevalence of CRDs is increasing universally, particularly among children and elderly people due to the faster pace of urbanization and industrialization.2 The burden of CRDs has major adverse impact on the QOL of the affected individuals. Five out of the 30 most common causes of death are respiratory diseases. Out of that COPD stands third followed by asthma in the twenty-eighth position.1 About four million people die prematurely from CRDs. Respiratory diseases are second only to cardiovascular diseases, including stroke, in terms of DALY and they account for more than 10% DALYs. In India CRDs were reported to be the third leading cause of deaths.18

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Page 8 Globally, about 2 billion people are exposed to the toxic smoke of biomass fuel used in poorly ventilated indoor stoves or fireplaces. One billion people inhale polluted outdoor air. One billion are exposed to tobacco smoke.

Respiratory impairment may cause disability or death in all the social classes of people. But overcrowding, poverty, environmental exposures and poor living conditions of the population may increase vulnerability to this large spectrum of disorders.17CRDs are under recognized, under diagnosed, under treated and insufficiently prevented. Most of the CRDs are preventable.19

In India the probability of dying from four major NCDs like CVD, cancer, CRDs and DM between the age of 30 and 70 years was more than or equal to 25 as per the WHO report in 2012.20 (Figure 1) According to the WHO, in India mortality due CRDs alone ranges from to 242 to 303 deaths per 100000 population.21 (Figure 2)

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Page 9 Figure 1: Showing the probability of dying from the four main Non Communicable Diseases (Cardiovascular diseases, Cancer, Chronic Respiratory Diseases and Diabetes) between the age 30 and 70 years, 2012.20

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Page 10 Figure 2: showing the Mortality due to Chronic Respiratory Diseases, 2008 (WHO)21

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3.1.1 Risk Factors of CRDs

Various Risk Factors of chronic respiratory diseases include: 16 1. Tobacco smoke

2. Environmental tobacco smoke

3. Indoor air pollution particularly biomass fuels 4. Outdoor air pollution

5. Allergens

6. Occupational exposure 7. Climatic variation.

3.1.2 Clinical Manifestations of CRDs

The main clinical signs and symptoms of CRDs include cough, abnormalities of breathing, dyspnoea, stridor, wheezing, hyperventilation, sneezing, abnormal sputum.2

3.1.3 Management of CRDs

Most of the CRDS are preventable. Treatments may differ depending on the condition even though some of the CRDs are incurable due to permanent damage done to the lungs. Most of the CRDs diseases are preventable by improving the quality of the air. Common sources of air pollution are tobacco, smoke, indoor and outdoor air pollution, and air containing microbes, toxic particles, fumes or allergens. Reducing tobacco consumption is the most important first step in reducing CRDs. Controlling pollution of air in the workplace can prevent occupational lung disease. Improving respiratory health

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Page 12 also include strengthening healthcare systems, training medical personnel, using established guidelines for health promotion and disease prevention, research and development and educating the population.17,22

3.1.4 Research studies related to CRDs

Behear et al (1998) had done a study to estimate blood carboxy haemoglobin levels following acute exposure to smoke of biomass fuel and found out that because of customary involvement of women in cooking they were more exposed to smoke from burning of biomass fuel than men.23

A study carried out by Tata Energy Research Institute in 2000in Tamilnadu found that 91% of the households use bio fuel for cooking out of which wood was used by 71.7%. Fuel wood was most common among 75% of the households followed by agricultural waste in 12% households and wood- chips in 4% of the households.24

J. Parikh et al. (2001) reported the link between the types of kitchen, fuels and pollution by monitoring the indoor air for rural houses in Tamil Nadu.

In this study, about 90% of the primary fuel used was biomass, out of which wood accounts for 56%, followed by crop residues for 16%, and dung-cakes for 21%. Burning of these bio fuels in poorly ventilated kitchens leads to the release of noxious gases and suspended particulate matter in very high concentrations. Women who cook with these bio fuels were exposed to these pollutants. The trends of pollution concentration among the following fuels are as follows: Dung>Crop residue>Wood>Charcoal>Kerosene>LPG>Electricity.

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Page 13 Only 16% of them cook in open air and less than 10% of the households used clean fuels (kerosene, LPG and biogas). The average cooking period in the sample was 2 hours.25

According to National Family Health Survey (2005 -2006) in India, about three-quarters of the Indian households use unprocessed fuel. It includes firewood, crop residues (straw, grass, and shrubs), coal, dung cakes and kerosene for domestic cooking. They also reported that 8% use kerosene, 22%

of households use firewood and 70% of households use cleaner fuels like LPG or electric stoves.26

Sundeep S Salvi et al (2009) mentioned that the biomass smoke exposure and environmental tobacco smoke are the main culprits behind the development of CRDs among women. Biomass include wood, crop residue and cow dung and it is mainly used for domestic cooking, heating, lighting.27

Salvi et al (2010) reported that in developing countries, girls start cooking at the age of 15. They spend an average of 4-6 hours daily for cooking.

During their lifetime, they are exposed to biomass smoke for 30-40 years which is equivalent to 60,000 hours of exposure and inhaling 25 million litres of polluted indoor air.28

A study done by Prasad et al (2012) in India regarding biomass fuel and respiratory diseases which found out that long term exposure to biomass fuel combustion smoke is associated with many respiratory diseases. It mostly includes acute respiratory infection (mostly in children under 5 years), chronic obstructive pulmonary disease, asthma, lung cancer, pulmonary tuberculosis,

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Page 14 pneumoconiosis and interstitial lung disease.29 According to World health Organisation (WHO) in 2012, solid fuels like firewood are used for domestic purpose by 65% of the Indian population.30

Jindal SK et al 2012 described about the Chronic Respiratory Diseases as the one of the most common causes of disease burden, both globally and in India. They have mentioned that Chronic Respiratory Diseases like Asthma and COPD together account for much of the disease burden. The reported prevalence of these diseases vary widely in different studies.12

Sukhsohale et al (2012) described about respiratory health among rural women and its association with biomass fuel use. He divided his study subjects into three categories according to use of biomass fuels. The three groups were:

Group A that use no biomass fuel, Group B that use biomass fuel partially along with other fuels and Group C that use biomass fuel exclusively. The prevalence of exclusive use of biomass fuel and partial use of biomass fuel were 33.2%and 29.6% respectively. The results in this study showed that in Group C who use biomass fuel exclusively had a significant reduction in the Peak Expiratory Flow rate with two times higher prevalence of abnormal Peak Expiratory Flow rate and more respiratory morbidities than the other two groups. When Group A and B was compared there was no difference in PEFR and respiratory symptoms.31

World Health Organization Fact Sheet in 2014 reported that CRDs like Asthma, COPD and AR represent a challenge to public health in the

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Page 15 industrialized and the developing countries because of their frequency and economic impact.14

The study done by Jeneth et al (2014) to compare the pulmonary function in women who were exposed to burning of biomass fuel and not exposed to biomass fuel and it was observed that almost three fourth of the women using biomass fuel had impaired lung function test. The relative risk of getting impairment in lung function was 4.5 times more among the biomass users as compared to the controls not exposed to burning of biomass fuel. 95%

CI for RR was 2.05 to 9.78 which was significant.32

Viswanathan et al (2017) had done a survey to find out the Prevalence of chronic respiratory diseases in Kerala. They found that the prevalence of CRDs in adults above 15 years was 10.9% (95% CI 10.35–11.45). Prevalence of self reported asthma was2.82% (95% CI 2.52–3.12) and that of chronic bronchitis was 6.19% (95% CI 5.76–6.62) while other CRDs which did not fit in to either constitute 1.89%. Prevalence of asthma among females was 3.14%

(95% CI 2.71–3.57). The prevalence of chronic bronchitis was 5.67% among females. 24.3% of those with CRD reported that they had smoked at least 100cigarettes/bidis in their life time. For females it was 0.43%. Among the study participants 20.09% of females were exposed to passive smoking in the house. 53.18% of females reported that they were usually exposed to the smoke from cooking inside the house using fire wood.33

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Page 16 3.2 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

COPD is defined as a ―disease characterized by chronic airflow limitation and a range of pathological changes in the lungs, some significant extra pulmonary effects important comorbidities which may contribute to severity of disease in individual patients‖. It is a slowly progressive disease which takes years to manifest the changes. COPD is considered to be a preventable disease and is treatable to a certain extent.18

3.2.1 Problem Statement of COPD

The prevalence, mortality and morbidity pattern of COPD varies largely across the world. It usually depends on the exposure of various risk factors.18 COPD affects about 174 million people worldwide out of which 65 million people suffer from moderate to severe COPD.34 According to WHO estimates globally, 3 million people die of COPD which corresponds to almost 5% of all deaths world wide.35According to the GDB report even though the number of deaths due to COPD declines over the past 2 decades from 3.1 million to 2.9 million still COPD is considered to be the third leading cause of mortality.

India and China contribute to 63% of deaths due to COPD.18

Globally different studies were done to estimate the prevalence of COPD and found that there was a wide difference in the prevalence. Von Hertenz et al (2000) carried out a nationwide study among adults aged 30 years or more in Finland and the prevalence of COPD was 14.1%. Respiratory symptom questionnaire, clinical examination and prebronchodilator spirometry (FEV1 / FVC <0.70) were used for the study. Fukuchi et al (2004) had done a

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Page 17 study in Japans among adults aged 40 years or more to estimate the prevalence of COPD and it was found to be 10.9%. Kim et al (2005) estimated the prevalence of COPD to be 7.8% among adults more than 18 years. Shahab et al (2006) carried out a national wide study in England among adults aged 35 years and more in which the prevalence of COPD was found to be 13.3%.18 The prevalence of COPD among women in different countries all around the world was found to be 6.3% in China (2003) ,13.5% in Philippines (2008), 16% in United Kingdom (2006), 16.2% in United States of America, 16.9% in South Africa (2005)18.

In India as per statistics of 2016, COPD was the second biggest cause of death.1 It was responsible for 10.2% of deaths in the age group of 25 to 69 years.18 The prevalence of COPD widely ranges between different states in different studies. One of the earliest studies to know the prevalence of COPD in India was carried out by Wig et al in 1964in rural Delhi and found to be 2.54 per cent in females.36 Viswanathan et al in 1966 reported the prevalence of COPD is 2.12 % in males and 1.33 % in females in Patna.37 A study done by Ray et al in 1995 at four villages belonging to the KV Kuppam block of North Arcot Ambedkar district in Tamil Nadu from south India found that the prevalence was 4.08 per cent in males and 2.55 per cent in females.13

A nationwide questionnaire-based study was done in 2012 by Jindal SK et al to estimate the prevalence of COPD in India and was found to be 3.49%.

The prevalence of COPD ranges from 1.1% in Mumbai to 10% in Thiruvananthapuram.12 The BOLD study conducted in 2014 to estimate

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Page 18 overall COPD prevalence found that the prevalence in Pune, Mumbai and Srinagar to be 6.25%, 6.8% and 16.05%, respectively38

COPD became the fourth leading cause of years of life lost (YLL) in Empowered Action Group (EAG) States including Bihar, Rajasthan, Uttar Pradesh, Jharkhand, Chhattisgarh, Madhya Pradesh, Odisha, and Uttarakhand.

In North-East States including Assam, Mizoram, Tripura, Sikkim, Arunachal Pradesh, Meghalaya, Nagaland, and Manipur COPD ranked seventh and among the remaining states of India COPD ranked fourth in terms of causes of YLL.8 (Figure 3)

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Page 19 Figure 3: showing the Geographic distribution of DALYs due to COPD

per 1,00,000 population in India 8

3.2.1 Pathophysiology of COPD

COPD is due to ongoing chronic inflammatory process characterised by morphological and cellular changes occurring in the lung parenchyma and airways.18 In this respiratory tissue inflammation occurs which will result in vasodilatation, congestion , mucosal edema and goblet cell hypertrophy. These events further trigger goblet cells to produce excess amount of mucous. In severe condition, the clusters of alveoli merge together leading to decrease in the number of alveoli resulting in increased space for air trapping.39 This will

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Page 20 lead to structural changes, small airway narrowing, and destruction of lung parenchyma. Small airways may contribute to airflow limitation and mucociliary dysfunction which may lead to increased airflow resistance, loss of elastic recoil and decreased expiratory flow rate.18 These are the characteristic feature of this disease. Chronic respiratory symptoms may manifest before the development of airflow limitation and may be associated with acute respiratory events.40

3.2.2 Risk Factor of COPD

The Risk factors for development COPD is mainly related to an interaction between both genetic and environmental factors. The risk factors for COPD are:40

1. Tobacco smoking 2. Indoor air pollutants 3. Outdoor air pollutants 4. Occupational Exposures 5. Genetic Factors

6. Socioeconomic status [40].

1. Tobacco smoking:

Tobacco smoking was an established causative risk factor associated with COPD. In India the prevalence of smoking among men is 28.5% and in women is 2.1%.41 It is estimated that by 2030, deaths due to any form of tobacco consumption will account for 10 million deaths per year.42 Tobacco smoking increases the risk of development of

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Page 21 COPD by 2- 3 folds when compared to non smokers. About 50% of the smokers develop COPD.18

2. Indoor air pollution:

It is of different types like Environmental Tobacco smoking (ETS) and Household air pollution.18

3. Environmental Tobacco smoking (ETS):

It is the most common and harmful forms of indoor air pollution.

It is composed of midstream smoke emitted from the mouldering tobacco between puffs and exhaled mainstream smoke from the smoker.

This smoke consist of over 4000 chemicals out of which 50 of them are known to cause cancer, ischemic heart disease and respiratory diseases (Asthma, COPD) in humans. There are many studies that has shown the association between ETS exposure or passive smoking or second hand smoke and development of COPD.43

4. Household air pollution:

It is estimated that 3 million people all around the world lives in homes that uses biomass fuel as the main source of fuel for cooking and heating purpose. The main biomass includes wood, crop residues, twigs and animal dungs. It emits high levels of indoor air pollution and most of the houses are poorly ventilated. Women, young girls and small children are more exposed to biomass smoke for a long time because they spend more time in the vicinity to the biomass smoke.28 The

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Page 22 biomass smoke exposure induces the same amount of risk of COPD as tobacco smoke.18

5. Outdoor air pollution:

Outdoor air pollution is one of the major causes of COPD. The gaseous and particulate matter components in the air pollutants have shown association with increasing cardiovascular mortality and respiratory morbidity. Exposure to high levels of respirable ambient air pollutants acts as an important risk factor for exacerbation of existing COPD.18, 44

6. Occupational Exposures:

Several Occupations are associated with increased risk for COPD. Exposure to toxic gases at workplace, dust and fumes from factories and grain dust in farms were strongly associated with the risk of development of COPD. [45]Occupations like farming have shown a strong association with COPD. Adults more than 40 years had shown an association between farming and COPD prevalence. The risk of COPD is attributable to farming was 7.7% and around 30% of them had at least mild COPD. Other Occupations like animal farming, building and construction work, mining, textile, rubber factory, cashew factory, polishing and stone cutting were at high risk for COPD.18

6. Genetic Factors:

COPD is predominantly an environmental lung disease that has an important genetic susceptibility. It can run in families and several

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Page 23 potential genes have been identified.46The best known risk factor linked to COPD is the deficiency of alpha 1- antitrypsin, inhibitor of serine proteases which arises in 1-3% of patients with COPD. In addition to alpha 1 antitrypsin deficiency, other genetic syndromes have a contributory role in development of COPD in non smoker.18

7. Socioeconomic Status:

COPD is associated with poor socioeconomic status and it is considered to be an independent risk factor. Other factors were history of repeated lower respiratory tract infections during childhood, history of pulmonary tuberculosis, maternal smoking, poor nutrition, housing conditions and intrauterine growth retardation are likely to contribute to the risk of COPD.18

3.2.3 Clinical features and Investigations of COPD`

3.2.3.1 Clinical features

COPD develops very slowly and most frequently diagnosed in people aged 40 years or over. COPD should be considered in any patient with dyspnoea, chronic cough or sputum production, and/or a history of exposure to risk factors sometimes they may present with wheeze.40 Most often chronic cough along with sputum production precede the development of airflow limitation, it may take many years to manifest. Only some individuals with cough and sputum production develop COPD in a long run. COPD is consisting of both chronic bronchitis and Emphysema. Chronic bronchitis was

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Page 24 defined as a cough productive of sputum for atleast 3 months, for two consecutive years.18

The patient may also present with wasting and weight loss along with the classical symptoms. Comorbidities along with COPD include Diabetes, Ischemic heart disease, Pulmonary vascular disease or Chronic cor pulmonale, Cardiac failure, Diabetes, Metabolic syndrome, Dysfunction of Thyroid, Pituitary and other endocrine organs and Depression.18

3.2.3.2 Investigations

In patients with clinical history of cough, increased sputum production and other symptoms and signs along with confirmatory tests should be done to confirm the diagnosis of COPD. Tests include Chest X ray, Pulmonary function test (PFT), Computed Tomography (CT) scan, Peak Expiratory Flow Rate (PEFR) and Arterial Blood Gas Analysis. Pulmonary function test is considered to the Gold standard test for COPD.8

3.2.4 Management of COPD

The management mainly focus on reducing the exposure to risk factors and Pharmacotherapy.

3.2.4.1 Risk factor and its prevention:

In COPD there is an important interaction between environmental factors and genetic predisposition for the development of disease. Reducing this interaction may help in effective control of the disease. It includes:

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Page 25 1. Cessation of Smoking

2. Avoiding Biomass Fuel Exposure

3. Protect against Indoor and Outdoor Air pollution at home and workplace 4. Identification of the individuals who are positive for genetic markers of

COPD.18

3.2.4.2 Pharmacotherapy and Non pharmacological treatments:

The drugs used in the treatment of COPD include:18

1. Bronchodilators: Anticholinergics, B2 agonist both oral and inhalational, Theophlline.

2. Corticosteroids

3. Phosphodiesterase Inhibitors 4. Oxygen supplementation 5. Antibiotics

6. Exercise

7. Better nutrition

8. Pulmonary rehabilitation

9. Non invasive and Invasive ventilation

Non invasive positive pressure Ventilation (NIPPV) has become the standard treatment for acute exacerbations of COPD in most of the secondary and tertiary hospitals in India. It is treated as per standard international norms.47

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3.2.5 Research studies related to COPD

A study by Behera et al (1991) on Respiratory symptoms in Indian women using domestic cooking fuels reported that an Indian housewife spends about six hours in the kitchen daily for cooking food and other purposes, mostly due to sociocultural reasons. She is exposed to the fuel at an early age of about 15 years. The location of the kitchen, the type of fuel used and the type of ventilation play a significant role on health. The symptomatic women had higher age (p<0.05 to 0.001) except for LPG users. Similarly, the symptomatic women had higher exposure index in all fuel groups (p<0.05 to 0.001) except the LPG users. Chronic bronchitis in chulla users was significantly higher than that of kerosene stove and mixed fuel users (p<0.05).48

Kirk R et al (2000) reported that in India and other developing countries had extensive practice of using unprocessed solid fuels mainly biomass and coal for cooking purpose in unventilated kitchens. This was the most important source of exposure to indoor air pollution. Cooking with solid fuels produces a high level of indoor house hold emissions which might result in elevated

‗‗neighbourhood‘‘ pollution particularly in densely populated communities.

Women were at high risk of exposure to this pollution because of their role as cook. Even though in India smoking rate among Women is very low they are prone to develop COPD. This was mainly due to chronic biomass smoke exposures.49

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Page 27 Brashier et al (2005) conducted a study in Pune using a questionnaire based COPD showed a prevalence rate of 6.5% (8.5% in males and 4.5% in females). Of those diagnosed with COPD, 69% were never smokers. Absence of a separate kitchen for cooking was an independent risk factor associated with COPD prevalence in males (OR=1.95, P=0.02) while use of kerosene fuel for cooking increased the odds of COPD in females by around 2.5 times (OR=2.48, P=0.01).50

Jindal et al (2005) reported that increasing use of biomass fuels in developing countries was mainly due to population growth and the rising price of alternative fuel such as kerosene and LPG. Exposure to biomass smoke increased the risk of respiratory disease such as COPD, asthma and respiratory allergies. The daily smoke exposure of household members poses a severe health risk which was preventable. Odds of developing COPD amongst non- smokers exposed to ETS and Fuel smoke were higher than for ETS exposure alone (OR 1.576).51

Gooptu B et al (2009) described that the risk factors for chronic respiratory disease were multifactorial. They included genetic and environmental factors. The interaction with these played an important role in development of these diseases. The genetic factors in COPD include antitrypsin deficiency occurs in 1-2% of individuals with COPD.52

Brashier et al (2012) reported in the study done in India, the overall prevalence of self- reported chronic bronchitis was 8.5%. In the age group

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Page 28 between 18 - 40 years the prevalence was 7% and in age group more than 40 years the prevalence was 10% in females. Ex-smoking (p = 0.004) and low- education status (p = 0.00) together form as significant risk factors for chronic bronchitis.53

Bhome et al (2012) described that in India major factors favouring COPD development were rural residence, lower socio-economic strata, smoking habit and advancing age.54 Vijayakumar et al descried that in India the usual victims of indoor air pollution were rural poor staying in ill ventilated houses and using dry wood as fuel. This was found to be leading to high prevalence of COPD among non-smoking females. This subset may help to throw significant light on the non-smokers COPD prevalence in India.55

BG Parasuramalu et al (2014) had done a survey on the prevalence of chronic obstructive pulmonary disease and its association with tobacco smoking and environmental tobacco smoke exposure among rural population in Bangalore, India. They found that the overall prevalence of COPD was 4.36%.

The prevalence among females was 3.41%. The prevalence was found to be increasing with an increase in age. The tobacco smoke and exposure to ETS was significantly associated with higher odds of COPD with adjusted odds ratio 2.97 and 2.67 respectively. Therefore there was a significant association between tobacco smoking and ETS exposure with COPD.56

Koul et al (2016) had done a study on prevalence of chronic airflow limitation in Kashmir. The prevalence of a forced expiratory volume in one

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Page 29 second/forced vital capacity (FEV1/FVC) ratio less than the lower limit of normal was 17.3% in males and 14.8% in females. Risk factors included higher age, cooking with wood and lower educational status.57

Varmaghani et al (2016) reported the prevalence of COPD was about 9.6% in Rwanda, Iran.The symptoms of Chronic bronchitis which was one of the two key components of COPD (along with emphysema) were found in 21.6% of general population in Belgrade.58

Hossain et al (2018) described that the Indian women who use biomass fuel (cow dung & wood) for cooking were at higher risk of development of COPD. Only few women preferred clean gas or cooking options. Tobacco pollutants in any contributed to adverse respiratory health. Biomass smoke inhalation was found to be a leading cause of COPD among non-tobacco users.8

3.3 ASTHMA

Asthma is most commonly affected CRDs all around the world. Asthma is defined as ―A heterogeneous disease, usually characterised by chronic inflammation. It is defined by history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity together with variable airflow limitation‖. It is a chronic inflammatory disease of the airway.59, 18

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Page 30

3.3.1 Problem Statement of Asthma

Asthma is most common CRDs which affects around 339 million people in all around the world. It causes a high global burden of disability and death.

Asthma leads to 1000 people dying each day. It is in the top 20 causes of years of life lived with disability. Globally, asthma is ranked 16th among the leading causes of years lived with disability and 23rd among the leading causes of burden of disease, as measured by DALYs.3, 18

The global estimate of asthma prevalence rates varies from 1.2% to 3.7% in Belgium to as high as 25.5% in Australia.60 Other countries had prevalence of asthma in the following rates Sweden (20.2%), UK (18.2%), Netherlands (15.3%), and Brazil (13.0%).61 In India several studies were carried out to determine the prevalence of Asthma mainly in Children. Only few studies were done among adults and estimated the prevalence of Asthma.

In a study done in multiple centers reported that 2.4% of the adults over 15 years had Asthma.41 In another study done in 2012 found that 2.05% of the adults were suffering from asthma.12 A cross-sectional study done in India in 2013 found that the prevalence of Asthma was 1.9% among women.62

3.3.2 Pathophysiology of Asthma

Asthma is characterized by airway hyper-responsiveness to a variety of stimuli. It is chronic inflammatory condition of the airway. It results from a complex interaction among inflammatory cells, mediators and airways.40 During this lining of the passages swell causing the airways to narrow and reducing the flow of air in and out of the lungs. It often starts in childhood but

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Page 31 can affect all age groups. Main feature of it is recurrent attacks of breathlessness and wheezing. It may vary in severity and frequency from person to person. In an individual it may occur from hour to hour and day to day.18

3.3.3 Risk factors for Asthma

Asthma is influenced by several risk factors that can be broadly classified into Host factors and Environmental factors. The development of asthma is mainly determined by host factors but the trigger is mostly caused by environmental exposures.18

Table 2: Important risk factors in Asthma

18

A. HOST FACTORS B. ENVIRONMENTAL FACTORS

1.

Age and sex

1.

Aeroallergens

2.

Socioeconomic status

2.

Infections

3.

Racial and Ethnic factors

3.

Occupational Exposures

4.

Genetic polymorphisms

4.

Outdoor and Indoor air pollutants

5.

Other Atopic conditions

5.

Diet

6.

Obesity

6.

Breastfeeding

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Page 32 3.3.3.1 Host factors

1. Age and sex:

In children less than 14 years of age asthma is twice common in boys when compared to girls of the same age group. In adults women are found to have a higher incidence than men in the same age group.18

2. Socioeconomic status:

It is found to be one of the risk factors in development as well as in triggering asthma.18

3. Race and Ethnic factors:

The prevalence of asthma is known to differ in prevalence among different racial and ethnic populations.18

4. Genetic polymorphism:

Asthma has a strong genetic predisposition. Presence of family history of Asthma and other allergies will predispose to Asthma. Multiple genetic polymorphisms are associated with clinical asthma.18

5. Other Atopic conditions:

Presence of allergic rhinitis and atopic dermatitis are frequently associated with asthma.18

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Page 33 6. Obesity:

Presence of obesity is also a recognized risk factor in asthma. In obesity non atopic mechanism are more relevant in causing asthma18.

3.3.3.2 Environmental Factors 1. Aeroallergens:

Contact with domestic pets, House dust mites, pollens of several plants (prosopis, ricinus, rubber tree, amaratus), fungal spores, cockroaches and number allergens are risk factors for development of Asthma.3

2. Infections:

Infections like Adenovirus, Para influenza, Influenza, Mycoplama and Chlamydia may trigger Asthma symptoms.3

3. Occupational Exposures:

Exposure to chemical vapours, irritant gases and other exhausts among persons engaged in different occupation may trigger asthma.18

4. Outdoor and Indoor air pollutants:

Exposure to Outdoor and Indoor air pollutants are the major reason for respiratory morbidity and asthma exacerbation. Exposure to Biomass fuel, passive smoking to tobacco smoke and maternal smoking are the important source of Indoor air pollutants which can lead to Asthma and trigger its episodes.3, 18

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Page 34 5. Diet:

Food items like egg, fish, and mushroom are some of the causes that can trigger asthma.18

6. Breastfeeding:

Breast milk fed infants have been shown to have lower incidence for Asthma.3,18

3.3.4 Clinical Features and Investigation of Asthma

3.3.4.1 Clinical Features

Asthma symptoms of asthma vary from person to person. The main

clinical features of Asthma were wheezing, breathlessness, chest tightness, cough and sputum production. Asthma may flare up in certain situations like exercise induced asthma in cold climate, occupational asthma due to chemicals, gases or dust at work place, allergy-induced asthma due to pollen, fungal spores, insects and animal dander.3,18

3.3.4.2 Investigations

To establish the diagnosis of Asthma the medical history along with physical examination and diagnostic tests should be positive. Investigations that can be done are X ray, Specific blood test, Pulmonary Function test (PFT) and Peak Expiratory Flow Rate (PEFR).3

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Page 35

3.3.5 Management of Asthma

The management of Asthma mainly depends on Essential components of Asthma care. It includes avoidance, monitoring, treatment and patient care.

Avoidance means elimination of Asthma trigs such as allergen exposure and home or workplace irritants. Monitoring means use of self assessment questionnaires, peak flow measures, and spirometry. Treatment include Anti inflammatory therapy and short acting bronchodilators. Patient education may be done by providing the necessary tools for self management. It includes an action plan for exacerbation of symptoms.18

3.3.6 Research studies related to Asthma

Brashier et al (2012) reported that in India the overall prevalence of self- reported asthma symptoms was 10%. In the age between 18 - 40 years the prevalence was 6.5% and in age more than 40 years the prevalence was 13.5.

Increasing age (p = 0.00), female gender (p = 0.001), unemployment (0.00) current smoking (p = 0.00) and ex-smoking (p = 0.004) emerged as significant risk factor for asthma.53

Mohammad Y et al (2013) conducted a survey among women in Syria and found that almost 80% of the women were non smokers. Asthma of frequency was 11.0%, and COPD of frequency was 4.8% among women.

Cough, wheezing, sputum and COPD were more common among cigarette- smoking women. In non smoking females exposed to passive smoking wheezing was more common and had lower lung function than non-exposed ones.16

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Page 36 In the Global Asthma Report 2014 NCDs are emerging as a major global public health problem. COPD and asthma was an important component of NCDs with regard to morbidity and usually its importance was being ignored and neglected. Asthma had got its origins during childhood. Childhood influences which might be aggravated by tobacco use in pregnancy, exposure to second hand smoke in childhood and taking up smoking in adolescent or adult years. Bronchial asthma was the most prevalent disease among the broad spectrum of allergic diseases. It was found to be dangerous and life- threatening. An important risk factor for asthma was AR. One efficient way to prevent bronchial asthma was to control and treat allergic rhinitis from the very beginning of its inception.3, 14

Varmaghani et al (2016) reported the prevalence of asthma in different countries: 7.6% in the United States, 10% in the United Kingdom, 4.8% in France, 4.8% in Germany, 4.7% in Italy, and 4.8% in Spain. 58

Ghoshal AG et al (2016) conducted a study to find out the prevalence CRDs and estimated the prevalence of Asthma as 42.4% ( 95% CI: 39.3% - 45.5%) was the most frequent primary diagnosis among enrolled patients.

Cough or coughing up phlegm was the main reason among 38% of the asthmatics.63

Yoo KH et al (2016) had done a study in Korea and found out the prevalence of Asthma to be 31.8% with a 95% CI of 29.0% - 34.8% and COPD to be 5.6% with a 95%CI of 4.3% -7.2%.64

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Page 37 3.4 ALLERGIC RHINITIS (AR)

Allergic rhinitis is defined as an allergen-induced inflammation of the membranes lining the nose. It is a heterogeneous disorder characterized by one or more of the following nasal symptoms: sneezing, itching, rhinorrhea, and/or nasal congestion. It is one of most common allergic diseases worldwide. It affects about 10-25% of population.9 AR frequently is accompanied by symptoms involving the eyes, ears, and throat, including postnasal drainage18

3.4.1 Problem Statement of AR

Over 400 million people were suffering from allergic rhinitis all around the world.18 The reported prevalence of rhinitis in epidemiologic studies, conducted in various countries, ranges from 3%to 19%.9 Epidemiological surveys conducted in Europe, North America and Asian countries such as Japan, Korea, and Singapore have demonstrated that there was a variation in the prevalence of AR in these regions and ranges from 11.8% to 46%.65, 66

The burden of AR constitutes about 55% of all allergies. In India 20- 30% of the population suffers from at least one allergic disease.67The estimated prevalence of AR in India was between 20 – 30%.68 Studies done over the past few years have shown that there was an increase in the prevalence of allergic rhinitis.8

Although AR reportedly occurs very frequently, data regarding the true underlying causes of rhinitis are difficult to interpret. Most population surveys rely on physician-diagnosed rhinitis for their data, possibly underestimating the

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Page 38 actual frequency with which rhinitis occurs. AR was an important health problem because of its prevalence and its impact on work productivity.8, 69

3.4.2 Pathophysiology of AR

The Pathophysiology of Allergic Rhinitis is Complex. There is a strong genetic component to these allergic responses. This will cause mucosal infiltration and acts on mast cells, plasma cells and eosinophils. The allergic response occurs in two phases. They are the ―early‖ and ―late‖ phase responses.

Within minutes of exposure to the allergen the early phase response occurs. It tends to produce itching, sneezing and rhinorrhea. Late phase response occurs within 4 to 8 hours after exposure to allergen. It is characterized by congestion, fatigue, malaise, irritability and possibly neurocognitive deficits.69

3.4.3 Risk Factors for AR

The prevalence of Allergic Rhinitis is high when the following risk factors are present. They are higher socioeconomic classes, individuals with a family history of allergy, in nonwhites, in individuals born during the pollen season, in some polluted areas, in firstborn children, in children with early introduction of foods or formula in the first years of life, heavy maternal cigarette smoke, exposure to indoor allergens such as pets animals and dust mites, higher serum IgE levels, the presence of positive allergen skin-prick tests and parental allergic disorders.70

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Page 39

3.4.4 Clinical Features and Investigations of AR

3.4.4.1 Clinical Features

The main symptoms in Allergic rhinitis are sneezing, itchy nose, itching of eyes, nasal blockage, thick mucus and anterior rhinorrhea. This will lead to post nasal drip and breathlessness. It is associated with number of comorbid conditions such as asthma, otitis media, atopic dermatitis, nasal polyps, conjunctivitis and sinusitis.71 The eye symptoms of AR include intense itching, watering, redness, swelling of the white of the eye, lid swelling and in severe cases periorbital edema which can be aggrevated by rubbing of the eye. Lower respiratory tract symptoms such as cough, shortness of breath and wheeze can also occur with AR.72

3.4.4.2 Investigations

The history and physical examination are the most effective tool for identification of AR. It includes the awareness of signs and symptoms. The standard method for detection of AR is by IgE antibody test to detect specific allergens. It can be detected with skin prick tests (SPTs) or with serum immunoassay. A positive history and demonstration of the symptoms along with the IgE antibody test for specific allergens confirms the diagnosis.69, 72

3.4.5 Management of AR

Prevention of AR is by avoidance of exposure to triggers such as allergen at home or workplace. Treatment of AR includes medications, as well as other therapeutic procedures. Medications are mainly antihistamines, nasal

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Page 40 decongestants, leukotriene antagonists and steroid nasal sprays and Immunotherapy. Immunotherapy is the effective treatment for AR. Nasal decongestants are used for short duration. They are not advised to use more than 3 days to relieve a stuffy nose and sinus pressure. Longer usage not encouraged. Corticosteroids reduce the inflammation and immune response. It can be used for long-term control.18

3.4.6 Research studies related to AR

A population-based cross-sectional study conducted by Zhang L et al (2009) conducted employing validated questionnaires among adults in 11 major cities on mainland China has reported that the age-and gender-adjusted self-reported prevalence of AR was highly variable ranging from 8.7% in Beijing in east China to 24.1% in Urumqi in west China.73

In a community based study done by Sinha et al (2015) to estimate the prevalence of AR in Delhi it was found that the prevalence of AR was 11%.

AR was diagnosed if the patient had two or more symptoms out of the following symptoms. They are rhinorrhea, itching of nose, nasal obstruction or sneezing which is lasting for at least one hour per day; for a duration of 4 days or more per week and also for period of 4 or more weeks in past 12 months.

Independent risk factors associated with AR were overcrowding, family history of allergic diseases, occupational exposure to dust/ smoke and tobacco smoking.10

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Page 41 Ming Zheng et al (2015) had done a study in china to estimate the prevalence of AR and found that the prevalence of self-reported AR was 19.1%. The subjects reported sneezing was the most commonly AR symptom in 57.7% followed by blocked nose in 54.1%. The elementary school of educational level increased the risk of having AR (adjusted OR=2.198, 95%

CI=1.072-2.236).74

Ghoshal AG et al (2016) conducted a study to estimate the prevalence of AR to be 29.9% with 95% CI: 27.1%- 32.8%. For patients with AR main complaint was watery and runny nose in 26% and sneezing in 18% of them.63

Yoo KH et al (2016) had done a study in Korea and found out the prevalence of Allergic rhinitis to be 55.7% with 95% CI of 52.5% - 58.8%, followed by Asthma (31.8%, 95%CI: 29.0%, 34.8%), Rhino sinusitis (6.9%, 95%CI: 5.4%, 8.7%), and COPD (5.6%, 95%CI: 4.3%, 7.2%).64

Passali D et al (2018) conducted an International Study on Allergic Rhinitis in Asia, Europe, the Americas, and Africa and the prevalence of AR was reported to be 15%–25%. Young adults, Children and adolescents were the age groups more affected by AR. The most common comorbidities were asthma, sinusitis, conjunctivitis, and nasal polyposis. The most common allergens were pollen and mites (67.31%), animal dander and pollutants (23.08%).75

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Page 42 3.5 WHO INITIATIVES FOR CRDs

The major initiatives for CRDs by WHO were World Health

Organization (WHO) Global Chronic Respiratory Disease (CRD)- oriented programmes, Global Initiative on Asthma (GINA), GOLD—Global Initiative for Chronic Obstructive Pulmonary Disease (COPD), Allergic Rhinitis and its Impact on Asthma (ARIA), and Practical Approach to Lung Health (PAL) have catalyzed creation of the Global Alliance Against CRD (GARD).76

3.5.1 World Health Organization (WHO) Global Chronic Respiratory Disease (CRD) programmes:

WHO took various initiatives to reduce the enormous heath burden and deaths due to CRDs. One of the earliest initiatives taken was World Health Organization (WHO) CRD programme in 1948. Other NCDs (CVD, cancer or diabetes) were comparatively well recognized while CRDs were under recognized and under estimated. This program has only a short life within WHO.76

3.5.2 Global Initiative on Asthma (GINA):

WHO and US based National Heart Lung and Blood Institute (NHLBI) in 1992 jointly formed Global Initiative on Asthma as ―Global Strategy for Asthma Management and Prevention‖. GINA was developed to document information on the nature and extent of asthma worldwide and to recommend appropriate approaches to its prevention and control. GINA was the first global CRDs programme whose outcome played a key role in

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Page 43 promoting asthma programme in all WHO regions. To spread GINA recommendations worldwide WHO celebrate World Asthma Day on 5th May every year.76

3.5.3 Global Initiative for Chronic Obstructive Lung Disease (GOLD):

WHO and NHLBI in 1998 launched the Consensus report

―Global strategy for the diagnosis, management, and prevention of COPD‖

in order to increase awareness about COPD. Then they launched ―Global Initiative for COPD‖ (GOLD) as the key player to promote this strategy.

Its objectives were to provide a non-biased review of the current evidence for the assessment, diagnosis and treatment of patients with COPD.

Secondly, to reduce the impact of symptoms and reducing the risk of adverse health events that may affect the patient in the future.77

3.5.4 Allergic Rhinitis and its Impact on Asthma (ARIA):

A new global initiative called ARIA (Allergic Rhinitis and its Impact on Asthma .was launched in1999 by WHO. Renowned experts became focal points for promotion and implementation of ARIA worldwide. ARIA main strategy was to prevention of bronchial asthma through the management of allergic rhinitis.76

3.5.5 Practical Approach to Lung Health (PAL):

PAL initiative was launched by WHO TB programme. PAL is a syndromic approach for the management of patients with respiratory symptoms attending a primary health care services. It is an integrated

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Page 44 health care service package. It mainly target on 20–30% of patients aged 5 years and above suffering from respiratory diseases such as TB, acute respiratory infection, asthma, and COPD.76,78

3.5.6 Global Alliance against Chronic Respiratory Diseases (GARD):

GARD was launched in 28 March 2006 in Beijing, China. It is a voluntary alliance of international and national organizations, institutions, agencies and committed towards the common goal to reduce the global burden of respiratory diseases. It is a part of the global work to prevent and control chronic diseases. Because most of the chronic respiratory diseases are under treated, under diagnosed and the access to essential medications is difficult in many countries. Its vision is a world where all people can breathe freely: free breath for all. Its member countries will develop activities according to the needs of their country. The WHO initiative GINA, GOLD, ARIA and PAL acts as a catalyst for the development of GARD.76, 79

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Page 45

4 MATERIALS & METHODS

4.1 STUDY DESIGN:

A Community Based Cross Sectional Study.

4.2 STUDY POPULATION:

The study population consist of women of the age group 18 years and above who are residing in Thiruvattar block for more than 6 months.

4.3 STUDY SETTING:

The study was conducted in Thiruvattar block area of Kanyakumari District. Thiruvattar is one among the nine blocks of Kanyakumari district of Tamilnadu, South India. Thiruvattar block comprises of 16 panchayats.

4.4 STUDY PERIOD:

The study was conducted during the period from February 2017 to July 2018 (1½years).

4.5 SAMPLE SIZE:

The prevalence of COPD was 19% among women in a study done by SK Jindal et al (2012)12. So assuming P as 19 and sample size was calculated using the formula: 12

Sample size (n) =Zα/22pq/d2 Zα/22

= 3.84, p= 19, q= (100-p) =81 d= 20% of p = 20% of 19= 14.44

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Page 46 n = (3.84 *19*81)/ 14.4

n=409.26

Assuming 5% non response rate n= 430 approximated to 450

n= 450.

4.6 INCLUSION CRITERIA:

Women in the age group 18 years and above who are residing permanently in Thiruvattar block for more than past 6 months duration and giving informed consent.

4.7 EXCLUSION CRITERIA:

 Woman who were having other CRDs such as lung cancer, occupational lung diseases, pulmonary hypertension, hypersensitivity pneumonitis, lung cancer and neoplasms of respiratory and intrathoracic organs, lung fibrosis, chronic pleural diseases, pneumoconiosis pulmonary

eosinophilia, pulmonary embolism, pulmonary hypertension and cor pulmonale, sarcoidosis , sleep apnoea syndrome and mentally

challenged are excluded from the study.

 Women satisfying all the inclusion criteria but not present in the house even after three visit for data collection were excluded from the study.

4.8 SAMPLING TECHNIQUE:

Multistage Random Sampling Technique was used.

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Page 47 4.9 SAMPLE SELECTION:

Stage 1:

Thiruvattar block consist of 16 panchayats namely Attoor,

Kulasekharam, Thripparapu Ponmanai, Kattathurai, Thiruvattar, Ayarode, Arivikkarai, Cherukode, Pechipparai, Surlacode, Kannaor, Kumarankudy, Yettacode, Pechipparai, Balamore, & Verkizkambi. 10 panchayats were selected randomly by lottery method from 16 panchayats.

Stage 2:

The selected panchayats are Arivikkarai, Surlacode, Cherukode Yettacode, Pechipparai, Attoor, Kulasekharam, Ponmanai, Thripparapu and Thiruvattar. One ward from each panchayat was selected randomly by lottery method.

Stage 3:

Houses in each ward were listed out and each house in a ward was assigned an individual number. This was taken as the sampling frame for the study. In each ward, forty five houses were selected by computer generated random number method to get 45 women. One woman from the selected house was enrolled for the study. If there were more than one woman in a house, one woman was selected by lottery method. If no woman was present in that house next house was selected from the rest of the houses by the random number technique. Thus 450 women satisfying the inclusion and exclusion criteria were selected for the study.

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Page 48 4.10 PROCEDURE IN DETAIL

The study was started after obtaining the clearance from Institutional Research Committee and Institutional Human Ethical Committee. The study was conducted among 430 Women who were residing in Thiruvattar block for more than 6 months duration. A pretested interview schedule was used by the principle investigator for interviewing the subjects who were satisfying the inclusion and exclusion criteria. The pretested interview schedule was developed by doing a pilot study among 30 women in Thiruvattar area. The final interview schedule was developed using the information gathered from the pilot study. The interview schedule was translated in local languages (Malayalam & Tamil) and was back translated to check the validity. A health worker fluent in both Malayalam and Tamil was accompanying the investigator during the interviews to avoid communication gaps. The purpose of the study was explained before getting an informed consent was obtained. Privacy was ensured before conducting the interview. Face to face interview was done. The interview schedule consisted of socio-demographic, socioeconomic status, environmental details & medical details.

4.11 PARAMETERS

 Sociodemographic characteristics details:

Age, Marital status, Education, Occupation, Income, Socioeconomic status, Type of family, Number of family members, Details of head of the family.

 Environmental characteristics details:

References

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