A cross-sectional study of lung function and domestic exposure in a patient population at Okhaldhunga Community Hospital in Nepal

Transcription

1 A cross-sectional study of lung function and domestic exposure in a patient population at Okhaldhunga Community Hospital in Nepal Prosjektoppgave ved Medisinsk Fakultet Fagfelt Samfunnsmedisin Hanne Harbo og Kristina Melling Grøthe Veiledere Norge Johny Steinar Kongerud Nepal Erik Bøhler 1

2 Abstract COPD is an important and increasing health problem worldwide. The association between COPD and exposure to indoor air pollution is recent years reported in medical literature and is accepted as the most important risk factor for COPD in less developed countries. This study aimed at investigating this association in Okhaldhunga District in rural Nepal, where the main part of the population uses wood as their main source of fuel. By introducing spirometry as a new diagnostic tool, the study was able to quantify the already known high prevalence of COPD among a patient population at Okhaldhunga Community Hospital. Data was collected in January Patients above the age of 40 years coming to the outpatient department, constituted the participant population. 114 participants were included in the study. Participants performed a spirometry for assessment of their lung function. To investigate their degree of exposure to pulmonary irritants, a standardized questionnaire was used. Of the participants, 49% showed an obstructive spirometry and 85% used wood as their only source of fuel, while 98% used wood combined with other fuels. Age of onset of COPD was considerably lower than in Norway. The findings highlight airflow limitation as an extensive health issue and indoor air pollution as an important risk factor for disease in Okhaldhunga district. The study was not able to verify the association between exposure to indoor air pollution and airflow limitations as established in literature, however data suggested that spirometry could be a useful diagnostic tool especially when symptoms were difficult to interpret. 2

3 Abbreviations and definitions UiO COPD OCH IAP OPD CMA SPSS GOLD NYHA Smoker FEV1 FVC Obstructive Non-obstructive Hospital records Respiratory conditions Low efficiency fuel High efficiency fuel University of Oslo Chronic Obstructive Pulmonary Disease Okhaldhunga Community Hospital Indoor air pollution Outpatient department Community Medical Assistant Software package used for statistical analysis ( Statistical package for the Social Science ) Global Initiative for Chronic Obstructive Lung Disease; diagnosis of COPD are based on their guidelines New York Heart Association A person having smoked more than one cigarette every day for at least a year Forced Expiratory Volume in the 1st second: Volume expired in the first second of spirometry Forced vital capacity: total volume expired during spirometry A person performing a spirometry which shows a FEV1/FVC ratio of < 0,7 A person performing a spirometry which shows a FEV1/FVC ratio of > 0,7 Records are kept from July-July according to the Nepali calendar system. Number referred to are therefore in this order Most common conditions referred to: pneumonia, chronic cough, a variety of an asthmatic/obstructive condition previously diagnosed ( dom meaning COPD or asthma) and tuberculosis Typically wood, charcoal and animal dung Typically gas, kerosene and electricity 3

4 Preface When thinking of a subject for this project, the authors (HH and KMG) had an urge to see a different health care system and meet a new culture. The possibility to collect data at a hospital located in a remote area of Nepal seemed very appealing. We knew students from UiO who had traveled to Okhaldhunga Community Hospital (OCH) earlier. Through them we came in contact with Dr. Erik Bøhler, who works as attending doctor at OCH. He presented the issue of Chronic Obstructive Pulmonary Disease (COPD) as an extensive problem for the hospital. Through further correspondence with Dr. Bøhler, we were invited to come to Okhaldhunga. We were asked to investigate the impact of exposure to different risk factors for COPD, with domestic exposure being the most interesting variable. The ability to use a new diagnostic tool, in this case spirometry, was also interesting, and three different spirometers were donated to OCH after the data collection was completed. The hospital issued an ethical approval enabling us to perform a study in their outpatient department. Through our visit, which lasted 5 weeks, we gained an insight to an every day life very different from our own. The cultural differences were immense. Though it was challenging to live in such a different place for an extended period of time, it was enriching, and we were touched by so many lives. The staff at the hospital gave us a warm welcome, included us in many procedures and invited us to join in social activities. We are left with an impression of the Nepali people as a people of great hospitality and kindness. Through interaction with the Nepali people; patients, staff and participants of the study, we gained a dimension of greater understanding when it comes to interpreting the results. The hospital is placed in a rural area with facilities poorer than many can imagine. The patients access to the hospital is limited, as many will have to walk for several hours, maybe even days, to reach it. Healthcare offered at the hospital may compete with care offered by different kinds of alternative methods. For instance, the belief in relief from illness by seeking a Shaman is very abundant, especially among older patients. This creates a boundary when it comes to gaining the patients trust and it explains why they are so eager to convey their need for medical attention when having reached the hospital. 4

5 Acknowledgments We would like to extend a great thank you to the many persons who have made this project possible. Our main supervisor Johny Steinar Kongerud, Professor II, head of department of Respiratory Medicine at Rikshospitalet, Oslo University Hospital; thank you for great supervision, patience, teachings on methodology and your share of interest in this project with us. Our local supervisor Dr. Erik Bøhler, attending doctor at OCH; thank you for inviting us to come to Okhaldhunga, letting us be a part of the hospital, making sure our experience in Okhaldhunga was diverse, and wishing we got to experience more than just the hospital life. Our interpreter Usha; without you there would be no way of conducting the study. Thanks to Kristin, Fred, Cyndi, Phul Kumari, the nursing staff and doctors, for great hospitality, patience, teachings and so much more. Thanks to Dominic Hoff, Senior advisor at UiO s Biostatistical division, for aid and guidance using SPSS. NIGAARD Pharma AS donated two handheld spirometers to OCH. 5

6 Table of contents ABSTRACT... 2 ABBREVIATIONS AND DEFINITIONS... 3 PREFACE... 4 ACKNOWLEDGMENTS... 5 GENERAL BACKGROUND... 7 HEALTH CARE IN NEPAL... 7 Okhaldhunga Community Hospital... 7 INTRODUCTION... 9 REASONS FOR THE STUDY RESEARCH QUESTION, HYPOTHESES AND AIMS METHOD PILOT STUDY PARTICIPANT POPULATION TRANSLATION QUESTIONNAIRE SPIROMETRY ANALYSIS OF RESULTS QUALITATIVE INTERVIEWS WITH COPD-PATIENTS ETHICAL ASPECTS RESULTS CHARACTERISTICS OF POPULATION MEASUREMENTS OF LUNG FUNCTION QUALITATIVE RESULTS DISCUSSION DISCUSSION OF METHOD Selection bias...19 Information bias...19 Technical bias...20 Qualitative data...20 DISCUSSION OF RESULTS Airflow limitations...20 Smoking, gender differences and age...21 Fuel...22 IMPLICATIONS OF THE FINDINGS CONCLUSIONS APPENDIX APPENDIX I: HOSPITAL STATISTICS APPENDIX II: QUESTIONNAIRE APPENDIX III: ETHICAL APPROVAL FROM OCH REFERENCES

7 General background Health care in Nepal The data collection for this study took place at Okhaldhunga Community Hospital (OCH) located in a remote area of Nepal. Nepal is a country with a total population of (1). The life expectancy at birth is averaged at 68 years (2), but life expectancy varies greatly between different regions of the country. Non-communicable diseases are estimated to account for 60% of total deaths, of which chronic respiratory diseases account for 13% (3). While the medical coverage in Norway is estimated to 42,8 physicians per inhabitants, in Nepal it is estimated to only 2 per The Norwegian government s health expenditure per capita per year is estimated to 7919 USD, compared to only 14 USD in Nepal (4). Okhaldhunga Community Hospital OCH is located in Okhaldhunga district in eastern Nepal. Without this hospital, more than inhabitants of the district would lack most health services. The hospital also treats patients from neighboring districts. Statistics * from July 2013 to July 2014 show that a total of patients received treatment at the hospital. Among these 4037 patients were admitted to the hospital. This made an estimate of 450 patients per week, of which 75 were in-patients, while the remaining were treated in the outpatient department (OPD). The staff consists of approximately 70 people. 4-5 are physicians, many of them staying for only 3-6 months as a part of their Figure 1: Okhaldhunga Community Hospital and surrounding buildings as of January education to become a specialist in general practice of medicine and surgery. It is challenging to recruit doctors for longer periods of time because of the remote location. As for the remaining staff, 5 are fully educated as nurses with at least 3 years education. The remaining nurses have completed an 18-month course becoming an Auxiliary Nurse Midwife. The hospital also has 5 Community Medical Assistants (CMAs). CMAs have a 15-month education, which prepares them to diagnose and treat the most common health issues. They work mainly in the OPD and perform many tasks normally considered performed by physicians. Totally 80-90% of the patients at Okhaldhunga Community Hospital are treated by CMAs. The hospital is run and supported by the international mission organization United Mission to Nepal and receives financial support from several other organizations and funds. Yet, * Appendix I 7

8 most of the expenditures are covered by the patients own payments. As the hospital is not a state governed hospital, financing from the governments of Nepal make up only about 1% of the total expenditures. The poorest patients who cannot afford to pay for treatment can receive funding from the Medical assistance fund run by the hospital s social office. Additionally, all children below 12 kg receive free treatment and all obstetric aid is free of charge. The infrastructure in Okhaldhunga and neighboring districts is poor, though improving. It is possible to transfer patients with severe conditions to a healthcare center with greater expertise, but often the patients are either too poor or too ill to handle the journey. As a result, acute conditions are treated at the hospital, even if it challenges the resources available. If transferal is an option, most of these go to hospitals in the capital Katmandu, which is an eight to ten-hour drive from Okhaldhunga (5). 8

9 Introduction COPD is a disease affecting an increasing proportion of the world s population and it is estimated that more than 65 million people suffer from moderate to severe COPD. It is predicted that COPD will be the 3 rd leading cause of death by 2020 (6). The main risk factor for developing COPD in the developed world is tobacco smoking. This is also an important risk factor in the developing world, however they face an additional challenge. Almost 3 billion people worldwide use solid biomass fuels as the main energy source for cooking, heating and other household needs. Solid biomass fuels are typically wood, charcoal, dried animal dung and agricultural residues. These are considered low combustion efficient energy sources, which will result in a bad indoor air climate (7). The extent of ventilation in the associated households is often limited, increasing indoor air pollution (IAP). The direct cost of using solid biomass fuels is lower than the cost of alternative higher efficiency fuels such as kerosene, liquefied petroleum gas and biogas fuels. However, studies show that the indirect cost, because of increased health expenditures among those who use solid biomass fuels, is higher than the cost investing in alternative fuels methods (8). In these particular communities, IAP constitutes a greater risk for developing COPD than smoking (6). The Worlds Health Organization (WHO) has identified IAP resulting from the use of solid biomass fuels as the eight most important cause of disease globally. It contributes to 1,6 million deaths associated with respiratory disease worldwide (9). Domestic use of biomass fuel accounts for the high prevalence of COPD among non-smoking women in rural areas in the world (6). A meta-analysis by Hu et. al shows an stronger association between COPD and exposure to smoke from biomass fuels than between COPD and passive smoking (10). The association is similar to that seen with COPD and smoking. Due to the fact that 3 billion people currently are exposed to biomass smoke daily, while only 1.1 billion are smokers, it seems likely that exposure to biomass smoke is the biggest risk for COPD globally (11). 9

10 Reasons for the study COPD is a condition affecting a significant proportion of the patient population of OCH. The diagnostic tools of OCH do not include spirometry measurements. Patients with airflow limitations are diagnosed based on clinical symptoms including abnormal shortness of breath, chronic cough and productive sputum (6). Many patients with mild forms might go undiagnosed. In this study spirometry was introduced as a measurement of airflow limitations. The aim was to identify not only patients with symptoms, but also patients with subclinical airflow limitations, and to quantify the amount of affected individuals to some extent. From July 2013 to July 2014 a total of 159 patients were admitted to the hospital and received treatment for the diagnosis of COPD. This was the second most common diagnosis given to the inpatients, only preceded by pneumonia (295 patients). COPD accounted for 4 out of 49 total inpatient mortalities. In the OPD a total of 909 patients were registered with the disease during this period. Having COPD has a serious impact on the patient s life, and it may implicate severe consequences for the affected family. Using wood as the main source of energy fuel is very prevalent in this area and most people live in small houses with poor ventilation. Conducting a student project thesis on this topic was therefore interesting and beneficial for the hospital and the community. Figure 2: Room used for cooking. 10

11 Research question, hypotheses and aims The foundation for this study relied on the knowledge that a large proportion of the population of Okhaldhunga was heavily exposed to IAP and on the knowledge that the hospital viewed COPD as an extensive health issue. The chosen topic was to investigate how the lung function of people could be associated with exposure to different pulmonary irritants, IAP being the most interesting variable. The following research question was defined: Is there a significant difference in exposure to pulmonary irritants among those who have an obstructive spirometry compared to those who show a normal spirometry? The following hypotheses were defined: Due to the fact that women carry out most domestic work in the form of cooking, and as such are more exposed than men, a gender difference in the prevalence of patients showing an obstructive spirometry is expected. A higher prevalence of airflow limitations among people who use solid biofuels as their main source of energy is expected. As obstructive pulmonary disease is a slowly progressing disease, the prevalence is expected to increase with increasing age. Perhaps the age of onset is lower in Nepal than in Norway as people in Nepal are more heavily exposed from early age. The following aims were defined: Study the association between lung function and irritant exposure (IAP, smoking and other factors). Explore the associations between domestic work and airflow limitations in females and possible gender differences regarding occurrence of COPD. Assess the association between age and development of COPD. Evaluate the implementation of spirometry in a rural population of Nepal. 11

12 Method The study was designed as a cross-sectional study among patients registered day by day at the OPD of OCH. The patients coming to the OPD had no appointment or referral. They received a queue number and priority upon arrival and waited for their consultation. Data collection took place Within this period, 15 days were used for data collection, as the OPD was closed Wednesdays and Sundays. Pilot study Inclusion criteria, aspects of the method used for carrying out spirometry, and some questions in the questionnaire were modified after carrying out a pilot study with 5 participants. The pilot study was performed the The participants from the pilot study were not included in the results. Participant population The main inclusion criterion was persons above the age of 40 coming to the OPD for any medical reason. A hospital worker registered all the patients coming to the OPD, and from this list, potential participants were selected. They were then requested for participation in the study, which would be carried out at a convenient time for the participant, either while waiting for their consultations, lab tests, or after. Participants were informed that participation was voluntary and that the investigations would not be a part of their treatment, nor conduct any extra expenses. Figure 3: Waiting area for patients outside the OPD. Originally the cut-off for age was set at 50. After the pilot study, the age limit was lowered to 40, in case many participants would have to be excluded due to unsatisfying performance of spirometry. 14 patients were excluded due to this concern. It was experienced that older participants generally showed poorer results concerning spirometry. Therefore, it was assumed that by including participants from the age of 40, more comparable groups would be obtained (normal spirometry vs. airflow limitations). Each day during the period of data collection, patients above the age of 40 were registered at the OPD, giving approximately 500 possible participants. On average 8-10 patients per day were included in the study. The remaining patients did not participate due to different reasons. Patients unable to understand instructions or carry out spirometry were excluded (E.g. patients with obviously severe physical condition, drunk patients and mentally challenged patients). As at least 20 minutes per participant was required. Many suitable participants had to be excluded due time being a limiting factor for them. Some patients were not convinced that participation would not cause them extra expenses and 12

13 therefore declined participation. Some had seen others performing the spirometry and considered themselves unable to perform it, and declined participation. The remaining of patients excluded had originally agreed participation, but were lost track of as they were checked up, going to lab tests, etc. Translation An interpreter was used for translation between English and Nepali. The same interpreter was used for all participants. In cooperation with the interpreter, the request of participation and explanation of how to perform the spirometry was standardized and therefore not translated simultaneously. Questionnaire * To record symptoms and exposure in the last year, the participants were asked questions modified and selected from a questionnaire issued in the study Astma i Telemark. Before performing the study, the questionnaire was sent to Dr. Bøhler who gave suggestions on how to adjust the questions to local conditions. Some questions were modified after the pilot study. As most of participants were illiterate, the questionnaire was carried out as an interview, with the interpreter simultaneously translating each question from English to Nepali, and the conductor filling out the questionnaire form. Spirometry To measure lung function, spirometry was carried out. The same instrument, MicroDirect MicroPlus MS03, was used on all participants. Height, weight, age and gender were recorded for each participant. The conductor demonstrated how to perform the spirometry while the interpreter explained the task. The participants needed at least 1 trial run before giving a satisfying result. As many participants found the test exhausting, it was decided to aim for 2 sets of satisfying results instead of 3 (as is standard according to GOLD-criteria). Due to lack of time and resources the reversibility test was excluded. Analysis of results Results were analyzed based on GOLDcriteria (12), with some modifications. Participants were accordingly split into two groups, those showing a normal lung function and those showing airflow limitation. The cut-off for airflow limitation was set at FEV1/FVC < 0,7. Figure 4:Male participant performing spirometry guided by the interpreter To process the results, the analytics software IBM SPSS Statistics 22 was used. Exclusively simple analyses, such as descriptive frequencies, were carried out. More advanced analyses, * Appendix II 13

14 such as multiple regression, were not carried out, due to several reasons. The results showed varying degree of uncertainty, the population size was limited and the results lacked scattering in means of exposure. The best set of FEV1/FVC-ratio of the participants was chosen based on the best FVC-value. To classify participants degree of exposure to IAP, the lifetime total hours of exposure was calculated (age x hours of exposure per day x 365). This is a simplification, assuming that the participants have had the same amount of exposure to IAP throughout their lives. Qualitative interviews with COPD-patients In order to get a deeper understanding of what impact COPD had on the people affected, interviews with in-patients diagnosed with COPD and their next of kin were carried out. Totally, 5 such interviews were carried out, giving 12 interviewees *. Some of this information was useful when interpreting the results and were respectively used in the discussion. The in-patients and their next of kin were asked about the debut and progression of the disease, their experience of COPD and what impact this had on their families and everyday lives. Further questions concerned what they felt were the main challenges of suffering from COPD and their thoughts about causes and risk factors for COPD. The patients were also asked about their main worries accompanying the disease and reflections concerning treatment and hospital admission. Ethical aspects Spirometry is present in any general practice and hospital in Norway. In this study, spirometry was introduced as a new diagnostic tool in this local setting. It could therefore be regarded as a quality control of the diagnostic procedures of COPD at OCH. The study was considered to be valuable for the hospital and beneficial for the patient population. It aimed at increasing awareness and knowledge about airflow limitation and its risk factors among the people of Okhaldhunga. An ethical approval from the Internal Management Committee of OCH was received before the commencement of the study **. The study is approved by REK sør-øst ***. Participation in the study was voluntary. The participants gave an oral consent in advance after being informed of the investigation. Their identity remained anonymous at all times during the study and in the database. * Five in-patients and one to two next of kin per in-patient ** Appendix III *** Ref. 2016/933 14

15 Results Characteristics of population A total of 128 (70 females) patients were registered in the study (fig. 5). The mean age (SD) was 54 (11) years. 500 patients > 40 years coming to the OPD 128 participants included 114 able to perform spirometry 14 unable to perform spirometry 60 female 54 male Figure 5: Participants included in the analysis of data. Table 1: Number of patients in 10-year age groups. Age range Male Female Total (35%) 24 (40%) 43 (38%) (26%) 20 (33%) 34 (30%) (17%) 11 (18%) 20 (18%) (22%) 5 (8%) 17 (15%) Total 54 (100%) 60 (100%) 114 (100%) The number of participant within each gender decreased with increasing age. This was especially evident for the females, where 73% were below the age of 60 (61% of males). The reasons given for contact with the OPD were classified as either respiratory condition, other condition or unknown as some patients were not able to communicate their reason. Table 2: Reason for contact with the OPD. Male Female Total Respiratory condition 13 (24%) 8 (13%) 21 (18%) Other Condition 37 (69%) 47 (78%) 84 (73%) Unknown 4 (7%) 5 (8%) 9 (8%) Total 54 (100%) 60 (100%) 114 (100%) A higher proportion of women, as opposed to men, reported that they had never smoked. 52% of the participants reported that they had smoked more than one cigarette per day for at least a year. This defined more than half of the participants as smokers. Table 3: Smoking status among patients showing distribution between genders. Smoking status Male Female Total No 15 (28%) 31 (52%) 46 (40%) Yes 32 (59%) 27 (45%) 59 (52%) Occasionally 7 (13%) 2 (3%) 9 (8%) Total 54 (100%) 60 (100%) 114 (100%) 15

16 Among those defined as smokers, only 25% participants were still smoking, 75% claimed they had stopped smoking (data not shown). Table 4: Types of fuel used. Frequency Cumulative Percent Wood 97 (85%) 85% Wood + other low efficiency 2 (2%) 87% fuel Wood + high efficiency fuel 13 (11%) 98% Gas 2 (2%) 100% Total 114 (100%) 85% reported wood as their only source of fuel, while an additional 13% reported using wood in combination with another type of fuel. The added fuel was often a high-energy source. 2 participants reported using gas only as fuel in their household. The system used for combustion of fuel was important in determining the impact the fuel might have on health. Table 5: Systems for combustion. Frequency Cumulative Percent Open fire 64 (56%) 56% Smokeless stove 31 (27%) 83% Other systems 2 (2%) 85% Any combination of the systems 17 (15%) 100% Total 114 (100%) Open fire was the most frequently used system. 56% used this as their only system. However, the use of a smokeless stove accounted for 27%, not counting the ones who use this in combination with either open fire or other systems. When asked if they had a window in the cooking area, 86% confirmed. Almost all who had a window answered that this was not covered with glass, but with wood, suggesting the possibility that some ventilation could occur in the room (data not shown). Measurements of lung function The following results were connected to the different hypothesis presented in aims Table 6: Participants classification after spirometry. Male Female Total Normal ratio 27 (50%) 31 (52%) 58 (51%) Obstructive ratio 27 (50%) 29 (48%) 56 (49%) Total 54 (100%) 60 (100%) 114 (100%) FEV1/FVC ratio < 0,7 = obstructive Of the participants, 49% were classified as being obstructive. The remaining 51% were classified as non-obstructive. There was no evident gender difference. 16

17 Table 7: Airflow limitations as a function of age > 70 Total Normal Ratio 28 (65%) 14 (41%) 10 (50%) 6 (35%) 58 (51%) Obstructive Ratio 15 (35%) 20 (59%) 10 (50%) 11 (65%) 56 (49%) Total 43 (100%) 34 (100%) 20 (100%) 17 (100%) 114 (100%) A trend that airflow limitations increase with increasing age was found, as suggested in aims. The age group did not follow this trend. The percentage of obstructive participants in the lowest age group was calculated to 35%. Based on the information that almost every participant was exposed to IAP thorough burning wood, it was important to investigate if different degrees of exposure showed an association with different degrees of lung function. Table 8: Appearance of airflow limitations as a function of degree of exposure. Degree of exposure Normal ratio Obstructive ratio Total Mild exposure 8 (14%) 5 (9%) 13 (11%) Moderate exposure 42 (72%) 41 (73%) 83 (73%) Heavy exposure 8 (14%) 10 (18%) 18 (16%) Total 58 (100%) 56 (100%) 114 (100%) Degree of exposure was calculated based on how many hours each participant reported that they were exposed to burning fuel every day. This number was multiplied by age. The assumption that they had been exposed to fuel the same amount of hours per day throughout their lives was made. To define moderate exposure, the mean number of hours was identified to be hours. Moderate exposure was defined as mean exposure ± 1 standard deviation. This showed that increasing exposure was associated with participants showing airflow limitations. When the results were analyzed in subgroups based on age (patients < 60 years and patients > 60 years), a similar trend is not apparent (data not shown). When comparing smoking status and the presence of obstructive spirometry, there was no evident trend showing a higher proportion of obstructive pattern among smokers than nonsmokers, as one would expect from literature (data not shown). 83% of women reported that they were the main person in charge of cooking in their household, as compared to only 15% of males. When analyzed in relation to the presence of an obstructive spirometry, there was no trend showing that the main persons in charge were more often obstructive. Even though men were less involved in the actual cooking of foods, there is no evident trend concerning gender when it comes to reporting how many hours the participants are inside the house per day while the fuel is burning (data not shown). Table 9: Appearance of airflow limitations in relation to reporting of symptoms. Reporting any No Yes Total COPD-symptom Normal ratio 11 (73%) 47 (48%) 58 (51%) Obstructive ratio 4 (27%) 52 (52%) 56 (49%) Total 15 (100%) 99 (100%) 114 (100%) 17

18 A total of 87% of participants report one or more symptoms (data not shown). Among the participants reporting symptoms, the same prevalence of airflow limitations as in the general participant population was found. A small fraction of the participants (13%) reported no symptoms. Of these 4 participants (27%) were defined as obstructive. Qualitative results When interviewing patients admitted with the diagnosis of COPD and their next of kin noteworthy information was obtained. COPD was regarded as a lifestyle disease by both patients and their next of kin, but none of the interviewees had any understanding about an association between IAP and COPD. Factors the patients and their next of kin attributed as the cause COPD were alcohol and smoking along with heavy physical labor. Younger generations (e.g. grandchildren of the patients) generally had greater understanding of how smoking affect lung function, but none seemed to think about IAP in their house as the worst risk factor for COPD in their community. 2 of the female patients believed that returning to hard physical labor shortly after giving birth could have lead to them developing COPD. Several interviewees claimed that there was nothing in their household contributing to their disease. Studies show that switching from a traditional open fire place to a smokeless stove where fumes are directed outside the house in a chimney-like construction improve respiratory health and reduce IAP (13, 14). When asked, most of the in-patients reported they did not have such a construction. However, comments from the participants in the OPD suggested that the common designs for the construction in the area were not functioning ideally. 18

19 Discussion The present study has limitations regarding the results being reproducible and applicable to other settings. These aspects, as well as the study s strengths, are discussed. The study was conducted using the best resources available and with consideration to cultural and language barriers. Discussion of method Selection bias Subjects recruited by random from the people living in villages in Okhaldhunga district would have been a more proper study population. Their lives should show even variety considering age, income, previously diagnosed diseases, and level of education. The participant population in this study was chosen among people coming to the OPD seeking medical attention. One could argue that this did not give representative results of the population, but it was still carried out, as this was the only achievable solution to gather participants. It probably represents a systematic bias in the direction of an overrepresentation of obstructive participants. Because there were other aspects interesting to investigate as mentioned in aims, this method was still considered valuable. The participant population was set to be a selection of patients above the age of 40 coming to the OPD. It proved to be easier to recruit patients among younger age groups than older. Older patients were generally more skeptical to the study. It was challenging to get them to understand that the study did not require any payment and that it conducted no treatment or intervention, which represents a selection bias. One of the main aims of the study was to identify and quantify the number of participants with airflow limitations. Potential participants suffering from the most severe respiratory conditions would be directly admitted as in-patients when arriving at the OPD, thus excluding them from the study. Information bias Several challenges were associated with the use of an interpreter, the most prominent being the limitations of the interpreter s English. An example would be when the participants were asked about symptoms of pulmonary obstruction. The distinction between the physiological out-of-breath feeling due to hard physical labor, was probably confused with the pathological feeling of dyspnea. This can be viewed as a point lost in translation, or one can make the point that this is a subjective feeling. Regardless, this probably lead to an over-reporting of symptoms. Asking about degree of symptoms compared to other people of same age could have been a way to minimize this misclassification. When achieving answers for the questionnaire, several issues that may affect the results were encountered. There was a bias in the way the participants answered the questions. Health care is a limited resource in Okhaldhunga, and most people traveled far to reach the hospital. They may have wanted to appear ill in front of health workers in order to be taken seriously. One may assume that many participants instinctively reported a higher degree of symptoms than what actually was present. 19

20 The participants had, presumably, a tendency to give answers they thought the conductors wanted to hear. For example, when their exposure to cigarette smoke was investigated; strikingly many had recently stopped smoking. Due to both recall bias and, lack of education, some patients may have had difficulties understanding and answering questions including numbers, e.g. for how many years they have been smoking. This made the analysis of the impact of smoking difficult. The participants were accordingly classified as non-smokers or smokers, with no further subdivision according to pack years. The questionnaire also addressed the participants exposure to pulmonary irritants other than IAP. The intention when asking this was to identify the participants being highly exposed to irritants such as animal dust, through their working life. It was gradually understood that very few people in Okhaldhunga district has the same occupation over time. Their working life was more hand-to-mouth based, resulting in exposure to different irritants over shorter periods of time. The questionnaire could not identify to which extent this exposure might be of interest. Using an interpreter was inevitable but proved to also bring positive aspects to the study. More information was obtained as participants answered the questions from the questionnaire in an interview-like session, rather than filling it out themselves. It became evident that most people use wood not only for cooking, but also to a larger for heating in the cold season. This was not accounted for in the original questionnaire, but a change was made after the pilot study. Technical bias The greatest challenge was to achieve the participants understanding of how to perform a proper spirometry. The instrument used was simple and gave no graph of airflow. Therefore there was no easy way to identify and exclude those performing a technically not satisfactory spirometry. Yet, most of the participants were able to perform the test two times, in addition to the trial run. For the majority of the participants, the sets of test showed little variation in the results. It was not achievable to conduct reversibility testing giving no objective way to distinguish COPD from other reasons to airflow limitations, such as asthma. The cutoff of FEV1/FVC ratio < 0,7 is used to classify participants as having COPD. This could be a misclassification giving a higher yield of participants having COPD. Qualitative data It was useful to include some qualitative aspects in the data. This part of the study was not carried out according to ideal guidelines of qualitative studies. The number of interviewees can be criticized of being small. Accordingly, one cannot generalize from the results. However, the results were found interesting as they increased the understanding of the problem of IAP and COPD in Okhaldhunga. Many people lacked knowledge of IAP being an important risk factor in their society. This points to how important information about this association is. Discussion of results Airflow limitations While 49% were defined as obstructive, only 18% of the participants gave a respiratory condition as their reason for contact with the hospital. When asked specifically about symptoms for COPD, 87% reported one or more symptoms that have bothered them the last 20

21 year. This could indicate either that the participants did not consider their symptoms severe enough to call medical attention, or that they did not consider their symptoms as actual symptoms of disease. However, among the 87% reporting symptoms, half of the participants (52%) were identified as obstructive and half (48%) as non-obstructive. The total number reporting no symptoms at all was overall low, but among this group, four patients were defined as obstructive. This indicates that reporting of symptoms associated with COPD is not a good predictor of being obstructive according to GOLD-standards. These results strengthen the value of introducing spirometry as a diagnostic tool. The reporting of symptoms might have been misclassified, as stated above. If this answer concerning out of breath had been excluded from the analysis as a symptom, more participants would fall into the category of no symptoms, giving perhaps a different estimation of obstructive with symptoms and non-obstructive without symptoms. GOLDstandards and NYHA classifications define being out of breath as criteria for one of the categories, therefore it was chosen not to exclude this answer from the analysis. Regarding the hypothesis that the age of onset might be lower in Nepal that in Norway, this was confirmed. 35% of the participants in the age group were found to be obstructive, while the prevalence of COPD in Norway in the similar age group (35-49) was 5% (15). An attempt to classify the obstructive patients according to GOLD-stages was made. Approximately half of the obstructive participants were classified as GOLD-stage 2. As the sample of participant was relatively small, it was chosen to disregard this classification. Did the high number of obstructive participants represent the truth among the participant population? In a cross-sectional study of prevalence of COPD among adults in rural and urban areas of Bangladesh, the prevalence of COPD was estimated to be 13,5%, though higher among rural inhabitants than urban inhabitants (17% vs. 9,9%) (16). A study from Nigeria reported that women using biomass fuel had 4 times the risk of presenting with chronic bronchitis than women using high-efficiency energy fuel (17). The overall prevalence of airflow limitations was lower in both studies than what was found in the present study. This could suggest that methodological weaknesses could be identified as reason for the high prevalence. It should be mentioned that the results mentioned from Bangladesh and Nigeria were obtained from randomly selected adults in a general population. The difficulty of obtaining satisfactory spirometry results may have led to a misclassification of COPD patients. Difficulties blowing hard/long enough would have given too low FEV1/FVC ratio; hence more participants would be defined as obstructive. Smoking, gender differences and age When analyzed by gender, there was no apparent trend that women showed more airflow limitations than men, as assumed in aims. Yet, more women reported that they had never smoked in their life; therefore, excluding them from the direct effect cigarette smoke may have on their lungs. 83% of the women and only 15% of the men reported that they were the main persons in charge of cooking in their households. This suggested that women were more exposed to IAP than men while cooking. To make a rough suggestion, the lack of direct contact with fumes from fuel in cooking, might outweigh the exposure men gained through smoking. There was no obvious gender difference in relation to number of hours inside the household while fuel was burning. This confirmed, as obtained from the qualitative interviews, that the 21

22 fuel was used also for heating maybe to a greater extent than cooking. This extended the number of heavily exposed persons from the one in charge of cooking to the whole household. But as with smoking, the recollection of stating number of hours may have been misreported. Age is factored into the formula constructed to calculate total exposure to IAP. From this formula the participants were divided into subgroups of exposure defined as mild, moderate and heavy. The results show that increasing exposure (participants defined as heavily exposed) is associated with an increased proportion of participants defined as being obstructive. But if the results are analyzed in subgroups above and below 60 years of age, a similar trend cannot be verified. This could imply that age is a variable with greater influence than exposure over time for developing an obstructive pattern. Fuel When planning the study, it was assumed that more participants would use gas as their source of energy. Then one could divide participants into two groups; a high-energy fuel group and a low-energy fuel group, and accordingly compare their spirometry measurements. However, in Okhaldhunga district, most inhabitants are still very poor, and make a living from farming. And many with increasing income still hold on to their fire based combustion site as this provides heat to a bigger extent that a gas apparatus, warming them in the cold and long winter in this mountain area. Therefore, almost all participants used wood as their source of energy. Due to low variation in exposure to IAP, it was not possible to compare two such groups. Other than what was presented above, no further analysis between exposure and degree of airflow limitations were therefore carried out. The fact that almost every participant was exposed to dangerous smoke from their fireplace for many hours every day was to some extent modified by the fact Figure 5: Smokeless stove used to improve IAP. that 27% reported they used a smokeless stove when burning the fuel. This would direct most of the fumes out of the house through the chimney from the floor where the wood is burning, without it swirling into the room, if functioning properly. Another modifying point is that 86% had windows in their cooking area almost all not covered with glass, giving them ventilation to some degree. Implications of the findings This study aimed at showing an association between high exposure to IAP and airflow limitations. It was not possible to verify this hypothesis. Other researchers (7, 9-11, 17) have verified this association in other parts of the world, and there is reason to believe the same is true in Okhaldhunga. 22

23 Several elements of this study made it challenging to draw conclusions. Among these, the most important were the participants difficulties of performing spirometry properly and recall bias when answering the questionnaire. The limited number of participants, the lack of scattering of exposure in the population, and the choice not to perform reversibility testing are factors that make concluding difficult. According to aims, the study should evaluate implementation of spirometry as a diagnostic tool. Results showed that clinical symptoms alone were not a good predictor of being obstructive. The use of spirometry is most advantageous in the earliest stages of COPD, where symptoms are mild and difficult to distinguish from other airway conditions. Diagnosing COPD in these stages is important to prevent development to more severe stages. However, it is discussable if it is possible and beneficial in a place like Okhaldhunga to use spirometry for diagnosing COPD. One would risk labeling persons not feeling ill as having a disease. Follow-up will most likely be challenging as the patient do not regard him-/herself as ill. Resources available for an adequate treatment and follow-up are limited. Spirometry will be useful in situations where respiratory symptoms are difficult to interpret as COPD or other respiratory conditions. It could also be used to assess if airflow limitations persist after acute conditions are treated, indicating that COPD is the underlying respiratory condition. Whether it is useful or not to use spirometry on wider indications are difficult to draw conclusions on based on this study. If it is beneficial in Okhaldhunga, or in similar places, to use spirometry to identify airflow limitations in asymptomatic patients is an interesting research question generated from this study. In relation to this, COPD patients (asymptomatic and symptomatic) compliance of follow-up and treatment needs to be investigated. Other interesting research questions generated were investigation of the real effect of the smokeless stoves. To which degree may this construction reduce IAP, and can this be an important way of reducing COPD as an extensive health problem worldwide? Further on, a more profound qualitative study investigating patients' understanding of COPD and its risk factors in areas like Okhaldhunga is called for. The intention when conducting this study was that the findings could in some way beneficial to the staff of OCH. The findings showed high prevalence of airflow limitation and extensive use of wood as energy source in Okhaldhunga, which hopefully may increase the staff s awareness of COPD and IAP as an important risk factor for this. Through increasing their understanding of the problem and its severity, it is also possible to increase the population s awareness of airflow limitations as an important health problem; and their knowledge of how to prevent this. These findings also indicate that in order to improve the health of the Nepali people, the government needs to increase their attention towards IAP. Information to the people about the consequences of using biomass fuel for heating and cooking is needed. But most importantly establishing affordable ways of reducing IAP in their home is called for. 23

24 Conclusions Four main findings stood out from the rest. The first being the high number of participants found to have airflow limitations (49%), compared to Norway (14%). The second being that reporting of symptoms associated to COPD was not a good predictor of being obstructive. The third being the high percentage of obstructive participants in the youngest age group (35% in group years). The fourth main finding was the high number of participants using wood as their main source of energy fuel (87% only wood, 98% wood in combination with another type of fuel). No evident gender difference was found in regards to have airflow limitations. Figure 6: Posters in the village, encouraging a change to smokeless stoves, showing that the community has started to assess the problem of IAP. The aim of showing an association between domestic exposure to IAP and participants defined as having airflow limitations was not successfully achieved. However, the findings that so many people were defined as obstructive, combined with the acquired knowledge that most people in this area lack the understanding of IAP s negative impact on health, call attention to this being an issue deserving increased focus. Through introducing spirometry as a new diagnostic tool, the study was able to quantify the problem of COPD in Okhaldhunga among patients coming to the OPD. In addition, using spirometry will be useful when clinical symptoms are difficult to interpret. The results of this study may be important for Okhaldhunga Community Hospital, contributing to their work to improve the conditions of COPD patients as well as preventing this disease through information. 24

25 Appendix Appendix I: Hospital statistics Table: Hospital record of number of admitted patients and patients treated in the OPD with the diagnosis of COPD. Year Admitted patients (with COPD) Patients in OPD (with COPD) (100) (994) (132) (995) (163) (995) (159) (909) (186) (879) 25

26 Appendix II: Questionnaire (Page 1:2) Patient no. Gender Male Female Age Height Weight Body temperature... C Symptoms in the last 12 months 1) Have you experienced coughing? Yes No If yes, how often? Daily Weekly Monthly Only when having a cold 2) Do you often have mucus in your lungs that is difficult to dislodge? Yes No If yes, what color does the mucus have? Red Black Yellow Green White Brown 3) Have you experienced shortness of breath while undertaking physical activities? Yes No If yes, what is the minimum activity you carry out before you feel short of breath? I am always short of breath Walking on a flat surface Walking up a hill Running How long have you experienced this problem? < 1month 1-3 months 3-6 months > 6 months 4) Have you experienced wheezing or rasping in your chest? Yes No 5) Has a health worker ever diagnosed you with respiratory disease? Yes No If yes, what kind? Asthma COPD Pneumonia Other 6) Do you currently take any medication to help with your breathing? (spray, inhalation powder, tablets) Yes No 26