A Review of the State of Chronic Obstructive Pulmonary Disease in Portugal

Transcription

1 A Review of the State of Chronic Obstructive Pulmonary Disease in Portugal Bruno Guerreiro Semedo 2010 Supervisor: Lars Lindholm

2 The best way to fight a disease is to have the best knowledge about it. (Bruno Semedo, 2010) - ii -

3 Abstract Introduction: COPD in one of the major non communicable diseases in the world and has a tendency to increase in the next years. Portugal has been following the same tendency. This study tries to give an idea about the status of the disease in Portugal in terms of health indicators and what has been done so far in relation to the risk factors and in relation to the awareness of the disease. Methods: The methods of this study consisted in a literature review of the most recent reports and articles about the health indicators of the COPD in Portugal like prevalence, incidence, mortality, hospitalizations, burden, direct costs, major risk factors and awareness of the general population about the disease. Results: COPD is a disease that is being underestimated in Portugal. The estimated prevalence values were believed to be underestimated and the same happened with the mortality rates. The mortality rates had also a big difference among the different regions of the country and among different sexes. The hospitalization numbers due to COPD have been increasing almost every year and again with some relative differences among the different regions. The burden of COPD corresponded to DALY's lost. The direct costs of COPD were more than 25o million Euros and the way that the values were obtained was not completely clear. The tobacco smoking represented 78% of all prevalent cases. The other main risk factors needed to be studied in more detail. The awareness of the disease among the population was not the desirable one and there were some inconsistencies with the treatments. Conclusion: The disease is indeed being underestimated. There is a great need to perform more studies to increase the knowledge of the disease in the country and to prepare the health system for probable demographic and / or climate changes. Key Words: COPD, Portugal. - iii -

4 List of Abbreviations CDCP COPD DALY DPOC EUPHIX FEV(1) FVC GOLD INE INS Centers for Disease Control and Prevention USA Chronic Obstructive Pulmonary Disease Disability Adjusted Life Year Doença Pulmonar Obstrutiva Crónica (COPD in Portuguese) European Union Public Health Information System Forced Expiration Volume in one second (the first second) Forced Vital Capacity Global Initiative for Chronic Obstructive Lung Disease Instituto Nacional de Estatística (Statistics Portugal) Instituto Nacional de Saúde (National Health Institute) INSA Inquérito Nacional de Saúde (National Health Inquiry ) MS ONDR PNHS SAMMEC WB WHO Ministério da Saúde (Ministry of Health) Observatório Nacional de Doenças Respiratórias (National Respiratory Diseases Observatory) Portuguese National Healthcare System Smoking-Attributable Mortality, Morbidity, and Economic Costs World Bank World Health Organization - iv -

5 Content Abstract iii List of Abbreviations iv Content v Illustration List vii Table List vii 1 Introduction 1 2 Background What is COPD? What causes COPD and the risk factors Inhalational Exposures Genetic Background Infection Sex Socio Economic Status Diagnose of COPD Symptoms Medical History Physical Examination Measurement of Airflow Limitation Spirometry The severity stages classification for COPD Treatments Reduction of Risk Factors Managing COPD After the Diagnose COPD in the World 7 3 Justification of the study 8 4 Objectives of the study 8 5 Methods Prevalence and incidence of the disease Mortality from COPD Hospitalizations related to COPD The Burden of the Disease The Direct Costs of COPD in Portugal The Disease Risk Factors Risk of smoking Occupational exposures Indoor and Outdoor Pollution Managing COPD After the Diagnose 12 6 Results 13 - v -

6 6.1 The Prevalence and Incidence of COPD in Portugal Calculation of the Total Number of COPD Prevalent Cases in the Country Mortality Related to COPD Hospitalizations Related to COPD The Burden of COPD in Portugal The Direct Costs of COPD in Portugal Total Direct Cost Estimation Risk Factors Tobacco Smoke Calculation of the number of COPD prevalent cases due to tobacco smoke Calculation of the number of COPD prevalent reducible cases Occupational exposures Indoor and Outdoor Pollution Managing COPD After the Diagnose 21 7 Discussion 22 8 Recommendations 29 9 Conclusions 30 Acknowledgements 31 References 32 Annexes Annex 1 PAF and PRF calculations Annex 2 COPD direct costs estimation for 2006 in Sweden using the Eurostat values for the inflation rates since 2002 Appendices Appendix 1 Extra information about the Daly measure i i ii iii iii - vi -

7 Illustration List Illustration 1 - The comparison between an healthy lung and a lung with COPD. 1 Illustration 2 - Examples of spirometry tests. 4 Illustration 3 - The COPD treatment according with the severity stage and according with the GOLD criteria. Illustration 4 - Hospitalisations related to COPD in the Portuguese hospitals since Table List Table 1 - The COPD severity stages. 5 Table 2 - Prevalence and Incidence of COPD in Portugal according with sex and age. 13 Table 3 - Estimation of the total number of COPD prevalent cases in Portugal for Table 4 - Mortality in Portugal related to chronic airways diseases. 15 Table 5 - Mortality in Portugal related to chronic airways diseases in 2003 by group age. Table 6 - Mortality in Portugal related to chronic airways diseases in 2003 by sex. 15 Table 7 - Mortality in Portugal related to chronic airways diseases in 2003 from the Portuguese national healthcare system administrative regions. Table 8 Number of hospitalizations and deaths related to COPD in 2006 and 2007 and the respective variance in %. Table 9 Hospitalizations in the Portuguese hospitals related to COPD according with the Portuguese national health care system administrative regions. Data relative to 2006 and Table 10 - Resultant DALY's from COPD in Portugal. Values from Table 11- The direct costs of COPD in Portugal. 18 Table 12 - Total direct costs estimation related to COPD in Portugal for Table 13 The prevalence of tobacco smoking in the Portuguese population. 19 Table 14 - Results of the total COPD prevalent cases calculation for Portugal, relative to Table 15 - Results of the total COPD prevalent cases reducible if everyone stopped smoking in Portugal, relative to vii -

8 1 Introduction The aim of this study is to review the state of Chronic Obstructive Pulmonary Disease (COPD) in Portugal from a public health perspective. It is the author's idea that this disease is being underestimated. The prevalence of the disease has a tendency to increase in the future even without taking in consideration the population ageing. The probable prevalence increase would tend to drag the mortality rates, the number of hospitalization cases, the total burden and the financial costs. To study these and some other factors is the major intention of this study, always with positive critics according with the author's limited knowledge about the disease. 2 Background 2.1 What is COPD? As it was already referred above, COPD stands for Chronic Obstructive Pulmonary Disease. It is a progressive chronic lung condition and it is preventable and treatable. There are always two components present, the extra pulmonary that affects specifically the severity of every single patient, and the intrapulmonary component that is qualified by airflow limitation that is never fully correctable. The air flow limitation is usually progressive and it is associated to an abnormal inflammatory response to particles and aggressive gases, specially the ones that come from the tobacco smoke (GOLD 2009). The limitation comes from the obstruction of the bronchi and it is due to a bronco constriction and due to a change on the secretion quantity and quality. The two factors together will result in more inflammation until the total obstruction. When the lung condition is tested and COPD is diagnosed, from the clinical point of view, there are usually two diseases present named chronic bronchitis and emphysema. Chronic Bronchitis is when the airways become narrowed, because the muscles get tighten and the mucus builds up inside. All these processes will result in a limitation of the airflow in both ways (getting air in and out of the lungs). In the extremity of the peripheral airways there are some tiny air sacks called alveoli. Since the air gets permanent trapped inside the alveoli, the continuous pressure will destroy them leading to Emphysema, a disease that is not totally reversible. Illustration 1 shows the difference between a healthy lung and a lung with COPD. Illustration 1 - The comparison between an healthy lung and a lung with COPD. (U. S. Department of Health & Human Services 2010)

9 2.2 What causes COPD and the risk factors Cigarette smoking has been proven to be the major risk factor for the development of the disease (GOLD 2009). The application of smoking cessation programs to the communities has been the most successful preventive measure of COPD as well as one of the major intervention procedures for the already COPD patients. Even if cigarette smoking is the major risk factor, it is not the only one. There are other risk factors that contribute, in a minor scale, to the disease. A genetic factor called alpha-1 anti trypsin deficiency is a hereditary factor present mostly in Northern Europe (Stoller & Aboussouan 2005). It has been proven to have an influence on the disease, but it has not been proven until which degree. Other factors are also associated to the disease, but once again, they are not proven until which degree. A small description will be presented next Inhalational Exposures There are various types of Inhalational exposures like the tobacco smoke, occupational dusts and chemicals and indoor and outdoor pollution. The tobacco smoke was already described and referenced in section 2.2 has being the leading risk factor for COPD. There is at least one Portuguese study that proved the same (Borges et al. 2009). Being a passive smoker is also a risk factor for the development of COPD. The number of inhaled noxious particles is higher when compared to someone that doesn't inhale any cigarette smoke (Eisner et al. 2005). The occupational dusts and chemicals can be from many sources, but the most important are the different kinds of organic and inorganic dusts, fumes and chemical agents. There is at least one study that corroborates 10-20% of the COPD cases with occupational exposures (Balmes et al. 2003). It has been proven that the indoor pollution plays an important role in the development of respiratory diseases, including COPD. There are some studies that associate the cooking and heating of poor ventilated houses with biomass to the development of the respiratory conditions referred (Sezer et al. 2006). All this process is happening mostly in developing countries and the future repercussions are still uncertain. There is a general knowledge that the outdoor pollution is harmful for everyone and specially for patients with hart or lung diseases, but further studies have to be performed in order to reach a clear conclusion to how much is the burden of those hart or lung diseases associated with outdoor pollution Genetic Background Even if the tobacco smokers are the population in highest risk of having COPD (as it was stated above), there are some smokers that never develop COPD, taking in consideration that also the genetic background is important (Smith & Harrison 1997). Another aspect already stated above is the alpha-1 anti trypsin deficiency that is a predisposing factor for COPD

10 2.2.3 Infection The increased respiratory symptoms in adulthood and the reduced lung function have been associated with severe respiratory infections like pneumonia during the first 2 years of age (Shaheen et al. 1994) or with the low birth weight during the first year of life (Barker et al. 1991). The individual results are clear, but usually pneumonia in the first two years of life is associated with low birth weight, so, the relationship between COPD and these two combined factors are unclear. An airflow obstruction in adults is also associated with a tuberculosis history in the early life (Menezes et al. 2007) Sex The reviewed studies reported a higher prevalence of COPD among men when compared to women (ONDR 2008). When the major risk factor is present (tobacco smoke), men have a higher relative risk to develop COPD when compared to women (Borges et al. 2009) Socio Economic Status There is some evidence that people from a lower socio economic status are more prone to develop COPD when compared to people from a higher economical status (Prescott et al. 1999). The factors that promote that association are not clear. 2.3 Diagnose of COPD There are several aspects to take in consideration for the diagnose of COPD. The most important are the symptoms, the medical history, the physical examination and the measurement of the airflow limitation and all of them will be described next in more detail Symptoms The major symptoms to refer are the presence of dyspnoea (the most important symptom), chronic cough and / or the existence of permanent (and excess) of sputum production Medical History The medical history is another important factor to take in consideration. Previous exposure to the disease risk factors and / or previous hospitalizations related to respiratory problems Physical Examination Even if the physical examination can help with the identification of the disease, the signals only appear in an advanced state of the disease (Kesten & Chapman An example of a signal can be the barrel chest (Loveridge et al. 1986) Measurement of Airflow Limitation Spirometry Spirometry is an airflow measuring test and for the assessment of COPD is divided in two phases. The first phase is the measurement of the forced vital capacity (FVC), this is the measurement of the total air exhalation from the initial point of maximum inspiration. The second phase is the measurement of the air exhaled on the first phase, but only during the first second of exhalation. It is called forced expiration volume in one second (FEV1). Illustration 2 shows the normal pattern and a possible abnormal pattern obtained from a spirometry test. The only value presented in the illustrations is zero and it represents the starting point

11 Illustration 2 - Examples of spirometry tests. The left graph represents the normal pattern, the right graph represents an abnormal pattern. Above the zero (X) corresponds to expiration and under the zero (X) corresponds to inspiration (Adapted from McCarthy & Dweik 2009). After reaching these two values, the ratio between them should be calculated (FEV1/FVC). There some pre-defined values to be used as a reference. These reference values were obtained taking in consideration age, sex, height and race (Pellegrino et al. 2005). For the COPD patients, a bronco dilator should be taken before the test and the FEV1/FVC ratio should be < 70. Even if this result is generally accepted some attention must be paid to some factors to avoid over-diagnose (GOLD 2009). Some other factors should be always taken in consideration for the diagnose of COPD. Factors like complementary diagnostic examinations, bronco dilator reversibility testing, arterial blood gas measurement, alpha1 anti trypsin deficiency screening, the clear differentiation between COPD and other diseases (e.g. asthma). 2.4 The severity stages classification for COPD This disease is divided in four severity stages and the threshold values between the stages is widely accepted (Gold 2009). Table 1 shows the standard values for the four stages. An important note is that for the assessment of the severity stage, after the spirometry the results should be compared according with the age, sex, height and race. Note that there is also a pre stage that according with the same GOLD criteria is named stage 0 and it is referred to a reduction in the air flow (according with the average standards) and with a FEV < 70% but without obstruction. The stage 0 will not be included in the table 1 since it is classified as before COPD

12 Table 1 - The COPD severity stages. Classification of COPD severity stages from a spirometry test with previous bronco dilator usage Stage I Mild FEV1/FVC < 0,70 FEV1 80% predicted Stage II Moderate FEV1/FVC < 0,70 50% FEV1 < 80% predicted Stage III Severe FEV1/FVC < 0,70 30% FEV1 < 50% predicted Stage IV Very Severe FEV1/FVC < 0,70 FEV1 < 30% predicted or FEV1 < 50% predicted plus chronic respiratory failure (GOLD 2009, Treatments There are several classes of treatments (GOLD 2009), from the reduction of the exposure to the risk factors to pharmacology and rehabilitation. There will be presented a brief description of the most important treatments presently available Reduction of Risk Factors This point is the base for the COPD treatment that all patients from all stages (and everyone else) should follow. It acts both as a treatment and as a preventive measure. Smoking prevention and cessation (with or without the usage of pharmacotherapy) should be the main priority. An air without smoke will influence negatively the progression of the disease. The reduction or even the complete abolishment of various hazard substances present during the work or hobbies should be achieved. For this is required a good supervision of the working environments. Protection of the individuals against these kinds of pollution should be achieved. It is both a personal and a public responsibility. Pertinent examples are the reduction (or complete abolishment) of biomass burning indoors or creating a national air pollution standard. Then, try to reach the standard in practice and after that go even forward and reduce the values lower then the standards. Factors to take in consideration for outdoor (and indoor sometimes) pollution are the tropospheric ozone and the particulate mater < 10 ɥ m that can help to increase the disease symptoms and / or accelerate the occurrence of exacerbations (ONDR 2006). Other factors like the socio-economic status are more difficult to tackle since every case is very particular. The health personnel should be aware of the patient situation and try to help with all the available means (e.g. contact social assistance)

13 2.5.2 Managing COPD After the Diagnose This approach involves the main medical treatment that can come from different kinds of healthcare providers. The most widely used approaches are education and awareness of the patient, the usage of pharmacologic treatments and also the usage of non pharmacologic treatments. Theses approaches will be described briefly next. The education and the awareness of the patients does not treat the disease by itself, but it increases their knowledge in how to react to unexpected situations caused by the disease, the patient's will have the knowledge of his particular status and an his performance will probably increase when in therapy. The pharmacologic treatments are very important and from time to time there are new and supposedly better drugs appearing in the market. Some treatments have long term effects and some have specific effects for a short period of time. The medication is used according with the stage of the disease and the most important examples are the bronco dilators (with short or long activity), vaccination (like against Influenza) and inhaled glucocorticosteroids. There are several non pharmacologic approaches. The most important is pulmonary rehabilitation, it should involve several types of health professionals and it is very important for the symptoms reduction and to improve the quality of life. It also promotes physical and emotional interaction from part of the patient for the everyday activities. Usually the the pulmonary rehabilitation is only a requirement on stage 2, but some tips and /or advices or training can be given from the diagnose of the disease. There are also other approaches like oxygen therapy. This kind of therapy is usually introduced to the patients on stage 4 and it involves more than 15 hours of oxygen administration per day. The aim is to increase the oxygen pressure in the blood. Ventilation support is another approach and it is used in respiratory failure (so it is not a routine treatment), but is can be sometimes used in combination with the long term oxygen therapy. To finalise with the non pharmacologic approaches it will be referred the surgical treatments. There are several kinds of surgeries for COPD patients. The most well documented are bullectomy, lung transplantation and lung volume reduction surgery. Even if possible, the surgical procedures have a relative high risk due to postoperative cardiac complications, this way, they should be only used as a last resort and always very well pondered. There are some guidelines for the COPD treatment according with the severity stage. This guidelines are widely accepted and presented on the GOLD reports. A schematic figure will be presented next

14 I llustration 3 - The COPD treatment according with the severity stage and according with the GOLD criteria (GOLD 2006, COPD in the World It seemed important to explain in this section and before the major work about COPD in Portugal the status of COPD in the world and some predictions for the future. According with the data from the World Health Organization (WHO) in 2008, the disease was widely spread out throughout the world with very different prevalence rates across the globe. The estimated number of people with COPD in the world was 210 million, 80 million were in the moderate or severe stages and more than 3 million of people died having COPD as the main cause of death. The Global Burden of Disease (WHO 2008) referred that COPD was the fourth cause of death in the developed countries with, the third cause of death in the middle income countries and the sixth cause of death in the low income countries with 5,1%, 7,4% and 3,6% of all deaths respectively. When the data was combined as a whole it put COPD responsible as the fifth leading cause of death worldwide with respectively 5% of the total deaths (2,7 million of people) and 2% of all DALY's lost (28 millions of healthy life years lost). Even if the disease is preventable and treatable, it is responsible for heavy economic and social costs to the countries. It also threats the quality of life and it is for the most part underestimated and undiagnosed (Araújo A. Teles, n.d.). It was also referred that there will be 30% more deaths related to COPD in the next 10 years increasing the rank from the fifth place to the third if there is not an urgent action to reduce the exposition to the risk factors with special emphasis to the tobacco smoke

15 3 Justification of the study The justification for this study of COPD in Portugal is that in the author s opinion the effects of this disease are being underestimated and since this is a disease for the future it has to be properly studied. Only with good knowledge it is possible to fight the disease and apply better health policies that could include a reduction of the risk factors. 4 Objectives of the study The first aim of this study is to review the past and current state of COPD in Portugal in terms of health indicators like prevalence, incidence, mortality, burden, costs and the state of the major risk factors for the disease. The second aim of the study is to calculate, according with the most recent data, the total number of COPD prevalent cases in the country, the direct costs according to a health care system perspective and the approximate number of prevalent and reducible cases due to the tobacco smoking. Both parts will be presented together to follow the reasoning. 5 Methods This work will consist in data collection from different sources related to COPD in Portugal. The areas to be approached will be prevalence and incidence of the disease, the burden of the disease,the hospitalization trends, the mortality associated to COPD, the financial costs of the disease and the relationship between the risk factors and the disease in the Portuguese specific setting. This part will be divided into sections according with the specific health indicator. The literature review will consist in a comprehensive systematic search of databases like MEDLINE, PubMed and The Web of Science. After this search, the web will be reviewed using Google to search for relevant information about COPD in Portugal from associations web pages, official reports and systematic reviews. The keywords to be used will be COPD Portugal and DPOC Portugal. The literature review will give knowledge about the state of the disease, the calculations will try to update and to harmonize some health indicator values of the disease for the Portuguese setting. The obtained values can reinforce (or not) the information collected for the review. Both sections should be presented together to complement each other, the same method will be used for the discussion part Prevalence and incidence of the disease This data will be mostly collected from the ONDR reports and the prevalence will be presented in percentages and the incidence in cases per The number of official estimated COPD patients for the country will also be looked for from the available national reports

16 It will also be calculated the total number of COPD prevalent cases according with the values accepted for the prevalence and with the last official information about the demographic status of the country. It seems important for the author to have an updated estimation of the number of COPD prevalent cases in the country. The formulas to be used are described next: TNMPC = PM * TNM and TNWPC = PW * TNW, it means that TNPC = TNMPC + TNWPC where TNMPC refers to the Total Number of Men Prevalent Cases, PM to the Prevalence in Men, TNM to the Total Number of Men in the whole population, TNWPC to the Total Number of Women Prevalent Cases, PW to the Prevalence in Women, TNW to the Total Number of Women it the whole Population and TNPC to the Total Number of Prevalent Cases in the country. 5.2 Mortality from COPD For this part, data will be reviewed from official reports and from WHO. Since mortality is one of the most easier health indicator to obtain, it seems important to refer it in this work because maybe it will probably be detailed and even probably divided by regions Hospitalizations related to COPD For this part, data will be collected from the ONDR and from official reports and it will emphasise on the hospitalization trends related to COPD in Portugal. Hospitalizations are costly (directly and indirectly) and it is an important health indicator to obtain more knowledge about the state of the disease in a country or area. 5.4 The Burden of the Disease The burden of disease for Portugal will be reviewed. The data will be collected from the WHO reports and also from national reports. It is then important to explain the used measure for the burden of disease, the Disability Adjusted Life Years (DALY). The explanation will be done according with the WHO and with Lindstrand et al DALY is an health indicator that not only takes in consideration the premature mortality but also disability caused by injury or disease at it measures the burden at a population level. It was created by Murray and Lopez in 1994 and it was created to measure the global burden of disease. The first organizations to use DALY were the World Bank (WB) and the World Health Organization (WHO) to compare the burden of diseases across the different regions of the world and to give a value (life years lost) for the different interventions possible. It is used to measure the health impact of all injuries and diseases allowing the comparison since it uses standardised values. The method covers in theory all causes of death using 107 diagnoses and almost all disability possibilities (95%). For the calculation of the years lost it is used the standard value of 80 years for males and 82,5 years for females (values from Japan with the highest life expectancy in the world). To every disease is attributed a weight value. The weight value varies from 0 to 1 where zero corresponds to an absence of burden and 1 corresponds to death (e.g. 0,8 for Schizophrenia) and it is measured in length in years and in severity. For this particular case, Schizophrenia has a high burden, and it will mean that a person with a quality of life 1 will remain with a quality of life of 0,2 with Schizophrenia. The weights for every disease and disability were obtained from a panel of experts. The Daly measure also takes in consideration the age of - 9 -

17 occurrence of the disability or disease, called Age Weights. If someone becomes sick with the age of 24 years, will have a higher burden per year lost when compared with the same situation happening at the age of 60 years. After all these referred procedures, the years lost in the future are discounted with a rate of 3% since it is considered that a lost year in the present is more valuable that a lost year in the future. Even with all the innovations brought by this health indicator, it is not immune to critics. The four main critiques are the different weight for sexes, different weight for ages, the discount of future years and the severity of the weighting for the disabilities (Lindstrand et al 2006). Despite the weaknesses of DALY, it is still interesting since it was the first measure to give a raw value of the whole burden of disease in the world. It is also useful to make projections for the future. More details about the DALY measure will be available in Appendix The Direct Costs of COPD in Portugal This part will include a review of the direct costs related to COPD in Portugal. The data will be collected from the major national reports and articles. After the data collection it will be calculated approximate values of the total direct costs of the disease and then the average direct cost per patient per year. The formulas to be used will be presented next. DDC = hospitalization costs + ambulatory costs DDC / TNP = ADCPY where DDC refers to the Direct Disease Costs, TNP refers to the total COPD patients estimation (section 5.1) and ADCPY refers to the average direct costs per patient per year 5.6 The Disease Risk Factors This will be an important part, since it will be referred the risk factors of the disease for the particular setting of Portugal with special emphasis on tobacco smoking Risk of smoking The first thing to be done in this part will be a literature review about the latest tobacco smoke trends in Portugal. After this part it will be attempted to calculate the total number of COPD prevalent cases and also to calculate the number of avoided cases if everyone stopped smoking. This will be done, using the latest tobacco smoking data available in the country for smokers and ex smokers (INSA ), the relative risks for smokers and ex smokers to get the disease (data from CDCP, Project SAMMEC and available in the article from Borges et al 2009), and using two epidemiological formulas presented in the same article (Borges et al. 2009). The data will then be adapted according to the latest obtained number of COPD prevalent cases (section 5.1). The formulas used for the calculations will be described next: PAF = Ps * (RRs 1) + Pexs (RRexs 1) / Ps * (RRs 1) + Pexs (RRexs 1)

18 where PAF refers to the Population Attributable Fraction, Ps refers to the Prevalence of Smokers, RRs refers to the Relative Risk for the Smokers to have the disease, Pexs refers to the Prevalence of Ex smokers and RRexs refers to the Relative Risk of getting the disease being an Ex smoker. The result from PAF will represent the proportion of the burden of the disease that will not exist if there had never been smokers among the Portuguese population (there will be specific values for men and women). The other formula will be: PRF = Ps * (RRs RRexs) / Ps * (RRs 1) + Pexs * (RRexs -1) + 1 where PRF refers to the Population Reducible Fraction and all the other values have the same names as stated for the formula above. This formula will answer to the question what would happen to the burden of the disease if all the Portuguese smokers stopped smoking? (there will also be available in this part specific values for men and women). From the values of the first formula, will be then possible to calculate the total number of COPD prevalent cases estimated in Portugal due to smoking. The calculation procedures will be the presented next: PAFmen * TNMPC = TNMPCTS PAFwomen * TNWPC = TNWPCTS TNMPCTS + TNWPCTS = TNPCTS where TNMPCTS refers to the Total Number of COPD Man Prevalent Cases due to Tobacco Smoke, TNWPTS refers to the Total Number of COPD Women Prevalent Cases due to Tobacco Smoke and TNPCTS refers to the Total Number of COPD Prevalent Cases due to Tobacco Smoke. From the value of the second formula, it will be possible to calculate the amount of prevalent cases that would be avoided is all the population stopped smoking. The calculation procedures will be presented next: PRFmen * TNMPC = TNMPCRTS PRFwomen * TNWPC = TNWPCRTS TNMPCRTS + TNWPCRTS = TNPCRTS where TNMPCRTS refers to the Total Number of COPD Man Prevalent Cases Reducible if all Men stopped with Tobacco Smoking, TNWPCRTS refers to the Total Number of COPD Women Prevalent Cases Reducible if all Women stopped with Tobacco Smoking and TNPCRTS refers to the Total Number of COPD Prevalent Cases if everyone stopped with Tobacco Smoking

19 5.6.2 Occupational exposures The information will be gathered from the official reports. It seems important to verify the state of the occupational exposures in Portugal that could lead to professional pulmonary diseases like COPD and the number of cases and costs also due to occupational exposures in Portugal Indoor and Outdoor Pollution It seems important to verify the state of the indoor and outdoor pollutants in Portugal since they influence the state of the respiratory diseases and in this particular case, COPD. The information will be gathered from official reports. 5.7 Managing COPD After the Diagnose This is the last part of the study, and here it will be reviewed the general awareness of the disease among the Portuguese population. There will also be a review about important aspects of the medical treatments that are being followed in the Portuguese setting. This is important to get a general idea if the COPD patients are being treated with the best options available

20 6 Results 6.1 The Prevalence and Incidence of COPD in Portugal According to the last available data, the prevalence of COPD in the Portuguese population was 5,34% from the age of 35 to the age of 70 years and the prevalence according with sex was 6,3% in men and 4,5% in women respectively (ONDR 2008). The sample size for the study was 1384 people that supposedly represented the whole Portuguese population. There was also another made study (Borges et al. 2009) that estimated the prevalence rates of COPD in 2005 for the Portuguese population. This study used the health statistical data was from INSA and the database from the Pneumobil project 2001 (Ferreira et al. 2009) that had a sample population of individuals. The prevalence rates were estimated and divided in groups by sex and age. The revised data is presented in table 2. Table 2 - Prevalence and Incidence of COPD in Portugal according with sex and age. Men Women Ages Prevalence (%) Incidence /1000 Prevalence (%) Incidence/ ,01 0,06 1,77 3, ,02 1,07 2,72 0, ,19 0,88 2,45 0, ,55 2,95 2,52 0, ,78 14,13 6,24 5, ,18 8,31 10,25 4,84 > 80 25,17 4,12 14,02 3,00 Total 5,27 3,14 4,03 1,66 (Borges et al. 2009) From the table data, the most important numbers to retain are the prevalence of 5,27% in men and 4,03% in women. The prevalence and the incidence of the disease starts to be higher after the age of 60 and it generally continues to increase with age. Other important data to retrieve from the study is the prevalence of men and women in the older age, specially after 80 years with 25,172% of men and 14,015% of women respectively. The incidence rate of the disease was estimated to be 3,14 cases /1000 in men and 1,66 cases /1000 in women. There was also the reference of some previous made studies. Two called the author's special attention. The first reported a study made on April 2007 (ONDR 2008). The sample size was 1899 citizens (42,8% males and 57,2% females with an average age of 47,2 years) and the results was a COPD prevalence of 7,3% with 9,4% of the population having a FEV < 70%

21 The second study is from 2002 (ONDR 2005) and it was the only study found with some values related to the severity stages of the disease in the Portuguese COPD patients. The study was performed by Boehringer Ingelheim / Pfizer in 2002 and the results were a COPD prevalence between the ages of 35 to 70 years of 5,34% (6,3% for men and 4,5% for women), 10,5% had a FEV <70 but without obstruction (stage 0 according with the GOLD criteria), 47% were in stage 1, 40,5% on stage 2, 11% on stage 3 and 1,5% on stage 4. The sample size and / or the reference was not available on the report, but by the numbers, it looks like this study had some relation with the one referred in the beginning of this section present in the ONDR report of There was also found an estimation of the total number of COPD patients in Portugal. This estimation corresponded to the number of people with diagnosed COPD. The value was and it was relative to 2006 (ONDR 2007) Calculation of the Total Number of COPD Prevalent Cases in the Country For this calculation, the last official values available were the ones from INE Statistics Portugal for 2008 (INE 2008). The data chosen for the prevalence was the one from the second study from section (Borges et al. 2009). The values from the second study were more detailed and they included the whole population, even if the data collection raised some questions. The results obtained are presented in table 3. Table 3 - Estimation of the total number of COPD prevalent cases in Portugal for (Author's estimation) Estimation of the total number of COPD prevalent cases in Portugal Population for 2008 Men Women Total Prevalence of COPD Men Women Total 5,27 4,03 4,63 COPD Prevalent Cases Men Women Total The estimation was conducted by multiplying the total population with the prevalence of the disease. The estimated number of COPD prevalent cases for 2008 was it total, (55,08%) men and (44,92%) women. 6.2 Mortality Related to COPD The first estimation about COPD mortality in Portugal came from WHO in 1990 with an estimated 3750 deaths per year, corresponding to approximately 50 cases /1000 in men and to 20 cases /1000 in women (ONDR 2008). These values would represent a relative risk of 2,5 higher for men to die with COPD when compared to women. The next estimation from the same source had slightly different numbers with 2600 people dying with COPD during the year of 2002 (WHO Disease and Injury Country Estimates 2008). However, since

22 there were some values from official data, relating 2434 deaths in 2003 to chronic airways diseases (ONDR 2008). Is was also stated on the same report that in 2003, the chronic airways diseases were the 3 rd cause of death from all respiratory diseases. The COPD mortality trends in Portugal have been decreasing since 1998 (with only the exception of 1999) in a total of -7,7%. More details are presented in table 4. Table 4 - Mortality in Portugal related to chronic airways diseases. Mortality in Portugal related to Chronic Airways Diseases Year Variation Number of Deaths ,7% (ONDR 2006, The mortality trend reached a peak in 1999, but it has been going down since then. According with the same report used for the table, (ONDR 2006) the possible justification for that, was a probable increase of the the health care system quality. The mortality according with the different age groups was also available for 2003 and it is presented in table 5. Table 5 - Mortality in Portugal related to chronic airways diseases in 2003 by group age. Mortality according with the age group for 2003 Age < 30 years years years > 65 years TOTAL Number of Deaths Percentage 0,2% 1,4% 7,3% 91,1% 100% (ONDR 2006, The mortality resultant from the chronic airways diseases tended to increase from a very low value of 0,2% relative to the age group < 30 years to a very high value of 91,1% for the age group of > 65 years. The values of mortality from chronic airways diseases according with sex for 2003 were available and they will be presented in table 6. Table 6 - Mortality in Portugal related to chronic airways diseases in 2003 by sex. Mortality according with sex for 2003 Men Women Total Number of Cases Percentage 66,8% 33,2% 100% (ONDR 2006, The mortality values for men were much higher when compared to the ones for women corresponding to 66,8% and 33,2% respectively. It was also noted the mortality rates related to COPD from each of the administrative health regions of the country and the values are presented in table

23 Table 7 - Mortality in Portugal related to chronic airways diseases in 2003 from the Portuguese national healthcare system administrative regions. Deaths from COPD according with the PNHS regions (2003) Region of the Country Deaths from COPD / inhabitants North 35,4 Centre 31,9 Lisbon and Tagus valley 29,9 Alentejo 37,0 Algarve 31,4 Azores 55,8 Madeira 27,5 (ONDR 2006, The mortality rates varied from 31,4 cases / in the region of Algarve to 55,8 cases / in the Azores autonomous region. 6.3 Hospitalizations Related to COPD The last available data was taken from the ONDR report from 2008 and it referred the number of hospitalizations related to COPD from the years 2006 and It also referred the number of deaths related to the hospitalizations and the variation between both years. The numbers are presented in table 8. Table 8 Number of hospitalizations and deaths related to COPD in 2006 and 2007 and the respective variance in %. Year Number of hospitalizations Deaths Percentage of deaths ,20% ,20% Variation 12,90% -2,60% (ONDR 2008, The data from the table referred an increase of 12,% on hospitalizations. The number of deaths related to COPD hospitalizations decreased, but to avoid biases, it should be not taken in consideration the differences between only two years. This factor was also stated in the same source of the data (ONDR 2008) and since it was also the author's opinion, another report was used with trends since The respective illustration related to the report is presented next

24 Illustration 4 - Hospitalisations related to COPD in the Portuguese hospitals since 1994 (Teles de Araújo n.d., From the illustration 4, it was noted an increasing tendency in hospitalizations related to COPD. Even if the increase it was not noted every year, it more then doubled from 1994 with just above 4000 hospitalizations until 2007 with more than It was also evaluated the hospitalization numbers according with the Portuguese national health care system administrative regions. The respective values will be presented in table 9. Table 9 Hospitalizations in the Portuguese hospitals related to COPD according with the Portuguese national health care system administrative regions. Data relative to 2006 and Hospitalisations from COPD according with some PNHCS regions (2006 & 2007) Number of Hospitalisations Hospitalisations / Regions Years North ,6 98,0 Centre ,4 83,3 Lisbon and Tagus valley ,4 108,0 Alentejo ,0 44,2 Algarve ,2 39,6 (ONDR 2008, The total number of hospitalizations increased but it was not a fact in all regions. The northern and central areas of the country had the highest number of cases and most important, the highest number of cases per inhabitants. The southernmost areas on the other hand had the lowest values. An important note is that there was no available data from the autonomous islands of Azores and Madeira

25 6.4 The Burden of COPD in Portugal According with the WHO data, the estimated burden of COPD for Portugal would be DALY's lost for 2002 (WHO Disease and Injury Country Estimates 2008), however, and due to a Portuguese study (Gouveia et al. 2006), the values were estimated this time from real data. The data used for the calculation was the same used in 6.2.1, for the the prevalence and mortality values it was used the data from the national health statistics for (INSA ), the specific prevalence data for the demographic groups classified by sex and age came from the Pneumobil study (Ferreira et al., 2009), for the duration of the disease according with the age and sex it was used the WHO values for western Europe zone A (Barendregt 2001). The model used for the calculations was the DisModel II (Barendregt 2001). The calculated values are described in table 10. Table 10 - DALY's from COPD in Portugal. Values from Resultant DALY's from COPD in Portugal (2006) Men Women Total (ONDR 2007, The values from the table referred a total number of DALY's lost due to COPD, DALY's for men, DALY's for women. This means that from the total number of DALY's lost, 61,1% corresponded to men and 38,9% to women, representing a much higher burden for men. Most of the DALY's lost were related to tobacco smoking (61,3%) and the smoking issue will be taken in consideration further on in section 6.6.1, but it seemed important to refer them now since the reviewed study was the same. 6.5 The Direct Costs of COPD in Portugal As it was stated in section 5.5, the financial costs of COPD refer only to the total direct costs from a healthcare system perspective. The reason was that these were the only costs found in all the reports. They were divided in two groups; the hospitalization costs and the ambulatory costs and they were relative to 2006 (ONDR 2007). The hospitalization costs included all the costs due to COPD inpatients and the ambulatory costs included all the treatments and outpatient appointments, and they were referred to be calculated by a group of experts. The values will be presented in table 11. Table 11 - The direct costs of COPD in Portugal. Hospitalisation costs COPD costs in Portugal for 2006 Ambulatory costs (ONDR 2007, The data in the table referred the hospitalization costs of (8095 was the total number of hospitalizations) in The ambulatory costs were and the values were also from

26 6.5.1 Total Direct Cost Estimation The values were calculated and the values are presented in the next table: Table 12 - Total direct costs estimation related to COPD in Portugal for Total direct costs for COPD in Portugal for 2006 Total direct costs for COPD in Portugal Total direct costs for COPD per patient 546 (Author's estimation) The total direct costs for COPD in Portugal were with a relative cost per patient of Risk Factors Tobacco Smoke As it was stated in section , the tobacco smoking is the major responsible of COPD. The latest data about the smoking trends in Portugal was from 2005 and the previous data before 2005 was from 1998 (Borges et al. 2009). The values from both years define never smokers, ex smokers and current smokers by sex. The data will be presented in table 13. Table 13 The prevalence of tobacco smoking in the Portuguese population. Prevalence of smoking in the Portuguese population Never Smokers Ex Smokers Current Smokers Men 43,7% 42,5% 23,5% 26,5% 32,8% 31,0% Women 86,1% 83,9% 4,4% 5,8% 9,5% 10,3% Total 66,1% 64,1% 13,4% 15,7% 20,5% 20,2% (Borges et al. 2009) From this data it is important to refer the decrease of current men smokers and the increase of ex men smokers. On the other hand, there was an increase in current women smokers and in ex women smokers. The last values for current men and women smokers are not exactly the same when compared to other sources like the Eurostat (Eurostat 2010) (not presented here). The Eurostat data presents similar smoking prevalences for men and lower for women when compared to the official values. Other factor noted was the lower prevalence of Portuguese women smokers when compared for example to the Swedish or the Spanish women. The prevalence of smoking for young people in Portugal (15-24), according with the same source was around 20% Calculation of the number of COPD prevalent cases due to tobacco smoke. For this section, there will be used the values obtained for PAF. The PAF calculations will be present in detail in annex 1. The PAF values were multiplied by the TNMPC and TNWPC and then both results were added to make the total number of prevalent cases attributed to tobacco smoke (in other words the number of existent COPD prevalent cases only due to the tobacco smoke risk factor). The calculations results will be presented in table